Irinotecan (conventional): Pediatric drug information

For additional information see "Irinotecan (conventional): Drug information" and "Irinotecan (conventional): Patient drug information"

For abbreviations, symbols, and age group definitions show table

ALERT: US Boxed Warning

Diarrhea:

Early and late forms of diarrhea can occur. Early diarrhea may be accompanied by cholinergic symptoms which may be prevented or ameliorated by atropine. Late diarrhea can be life-threatening and should be treated promptly with loperamide. Monitor patients with diarrhea and give fluid and electrolytes as needed. Institute antibiotic therapy if patients develop ileus, fever, or severe neutropenia. Interrupt irinotecan and reduce subsequent doses if severe diarrhea occurs.

Bone marrow suppression:

Severe myelosuppression may occur.

Brand Names: US

Camptosar

Brand Names: Canada

Camptosar [DSC]

Therapeutic Category

Antineoplastic Agent, Camptothecin;
Antineoplastic Agent, Topoisomerase I Inhibitor

Dosing: Pediatric

Note: A reduction in the starting dose by at least one dose level should be considered for prior pelvic/abdominal radiotherapy, performance status of ≥2, or known homozygosity for UGT1A1*28 allele. Consider prophylaxis with oral third generation cephalosporins (Ref), and/or atropine IV or SubQ for treatment in patients with cholinergic symptoms (eg, increased salivation, diaphoresis, abdominal cramping) or diarrhea. Irinotecan is associated with a moderate emetic potential; antiemetics are recommended to prevent nausea and vomiting (Ref). Details concerning dosage in combination regimens should also be consulted. Irinotecan (conventional) and irinotecan (liposomal) are NOT interchangeable. Dosing differs between formulations; verify intended product and dose prior to preparation and administration.

Neuroblastoma, refractory or palliative

Neuroblastoma, refractory or palliative: Limited data available: Children ≥2 years and Adolescents: IV: 50 mg/m² over 1 hour once daily on days 1 to 5 (5 doses), in combination with temozolomide; repeat cycle every 21 days (Ref)

Solid tumor or CNS tumor; refractory or relapsed

Solid tumor or CNS tumor; refractory or relapsed (low-dose, protracted schedule): Limited data available: Children ≥2 years and Adolescents: IV: 15 mg/m² over 1 hour once daily on days 1 to 5 (5 doses) and days 8 to 12 (5 doses) of a 28-day treatment cycle; in the trial, a maximum dose of 30 mg/dose was reported; may repeat cycle if tolerated in combination with temozolomide and vincristine (Ref)

Solid tumor or CNS tumor; refractory or relapsed: Limited data available: Children and Adolescents:

Daily regimen:

IV: Children ≥2 years and Adolescents: 50 mg/m² over 1 hour once daily on days 1 to 5 (5 doses) as a single agent; repeat cycle every 21 days (Ref); some protocols include combination with temozolomide (Ref)

Oral: Children and Adolescents: 90 mg/m²once daily on days 1 to 5 (5 doses) repeat every 3 weeks; in combination with vincristine and temozolomide (Ref)

Weekly regimen (Ref):

Heavily pretreated patients (eg, ≥2 prior chemotherapy regimens): IV: 125 mg/m²/dose once weekly for 4 weeks over 90 minutes, repeat cycle every 6 weeks

Less-heavily pretreated patients (≤2 prior chemotherapy regimens): IV: 160 mg/m²/dose once weekly for 4 weeks over 90 minutes, repeat cycle every 6 weeks

Rhabdomyosarcoma, refractory or metastatic

Rhabdomyosarcoma, refractory or metastatic: Limited data available: Children and Adolescents: IV: 50 mg/m² once daily for 5 days (maximum dose: 100 mg/dose) on protocol specific weeks (Ref)

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing adjustment for toxicity: The presented dosing adjustments are based on experience in adult patients; specific recommendations for pediatric patients are limited. Refer to specific protocol for management in pediatric patients if available. See tables for adult dosage recommendations.

It is recommended that new courses begin only after the granulocyte count recovers to ≥1,500/mm³, the platelet counts recover to ≥100,000/mm³, and treatment-related diarrhea has fully resolved. Depending on the patient's ability to tolerate therapy, adult doses should be adjusted in increments of 25 to 50 mg/m². Treatment should be delayed 1 to 2 weeks to allow for recovery from treatment-related toxicities. If the patient has not recovered after a 2-week delay, consider discontinuing irinotecan. See tables for adult dosage recommendations.

**Colorectal Cancer: Single-Agent Schedule: Recommended Adult Dosage Modifications^A**
Toxicity NCI Grade^B (Value)	During a Cycle of Therapy	At Start of Subsequent Cycles of Therapy (After Adequate Recovery), Compared to Starting Dose in Previous Cycle^A
Toxicity NCI Grade^B (Value)	Weekly	Weekly	Once Every 3 Weeks
^AAll dose modifications should be based on the worst preceding toxicity.
^BNational Cancer Institute Common Toxicity Criteria (version 1.0).
^CExcludes alopecia, anorexia, asthenia.
No toxicity	Maintain dose level	↑ 25 mg/m² up to a maximum dose of 150 mg/m²	Maintain dose level
Neutropenia
1 (1,500 to 1,999/mm³)	Maintain dose level	Maintain dose level	Maintain dose level
2 (1,000 to 1,499/mm³)	↓ 25 mg/m²	Maintain dose level	Maintain dose level
3 (500 to 999/mm³)	Omit dose until resolved to ≤ grade 2, then ↓ 25 mg/m²	↓ 25 mg/m²	↓ 50 mg/m²
4 (<500/mm³)	Omit dose until resolved to ≤ grade 2, then ↓ 50 mg/m²	↓ 50 mg/m²	↓ 50 mg/m²
Neutropenic Fever (grade 4 neutropenia and ≥ grade 2 fever)	Omit dose until resolved, then ↓ 50 mg/m²	↓ 50 mg/m²	↓ 50 mg/m²
Other Hematologic Toxicities	Dose modifications for leukopenia, thrombocytopenia, and anemia during a course of therapy and at the start of subsequent courses of therapy are also based on NCI toxicity criteria and are the same as recommended for neutropenia above.
Diarrhea
1 (2-3 stools/day >pretreatment)	Maintain dose level	Maintain dose level	Maintain dose level
2 (4-6 stools/day >pretreatment)	↓ 25 mg/m²	Maintain dose level	Maintain dose level
3 (7-9 stools/day > pretreatment)	Omit dose until resolved to ≤ grade 2, then ↓ 25 mg/m²	↓ 25 mg/m²	↓ 50 mg/m²
4 (≥10 stools/day > pretreatment)	Omit dose until resolved to ≤ grade 2, then ↓ 50 mg/m²	↓ 50 mg/m²	↓ 50 mg/m²
Other Nonhematologic Toxicities^C
Grade 1	Maintain dose level	Maintain dose level	Maintain dose level
Grade 2	↓ 25 mg/m²	↓ 25 mg/m²	↓ 50 mg/m²
Grade 3	Omit dose until resolved to ≤ grade 2, then ↓ 25 mg/m²	↓ 25 mg/m²	↓ 50 mg/m²
Grade 4	Omit dose until resolved to ≤ grade 2, then ↓ 50 mg/m²	↓ 50 mg/m²	↓ 50 mg/m²

Dosing: Kidney Impairment: Pediatric

There are no pediatric specific dosage adjustments; refer to individual protocols; use with caution. Dialysis: Based on experience in adult patients, avoiding use or dosing adjustment suggested.

Dosing: Hepatic Impairment: Pediatric

There are no pediatric specific dosage adjustments; refer to individual protocols. Based on experience in adult patients, dosing adjustment suggested.

Dosing: Adult

(For additional information see "Irinotecan (conventional): Drug information")

Note: A reduction in the starting dose by at least 1 dose level should be considered for prior pelvic/abdominal radiotherapy or performance status of 2 (subsequent dosing/adjustments should be based on individual tolerance). Irinotecan (conventional) and irinotecan (liposomal) are NOT interchangeable. Dosing differs between formulations; verify intended product and dose prior to preparation and administration.

Reduced UGT1A1 activity:Consider a dose reduction in the starting irinotecan dose by at least 1 dose level for patients known to be homozygous for the UGT1A1*28 or *6 alleles (*28/*28, *6/*6) or compound heterozygous for the UGT1A1*28 and *6 alleles (*6/*28); base subsequent dosing modifications on individual tolerance.

Premedications: Consider premedication of atropine 0.25 to 1 mg IV or SubQ in patients with cholinergic symptoms (eg, increased salivation, rhinitis, miosis, diaphoresis, abdominal cramping) or early-onset diarrhea. Irinotecan is associated with a moderate emetic potential; antiemetics are recommended to prevent nausea and vomiting (Ref).

Colorectal cancer, metastatic, combination therapy

Colorectal cancer, metastatic, combination therapy:

In combination with fluorouracil and leucovorin:

Regimen 1: IV: 125 mg/m² over 90 minutes on days 1, 8, 15, and 22 of a 6-week cycle (in combination with bolus leucovorin and fluorouracil; leucovorin administered immediately following irinotecan; fluorouracil immediately following leucovorin); continue until disease progression or unacceptable toxicity.

Adjusted dose level −1: 100 mg/m².

Adjusted dose level −2: 75 mg/m².

Further adjust if needed in decrements of ~20%.

Regimen 2 (FOLFIRI regimen): IV: 180 mg/m² over 90 minutes on days 1, 15, and 29 of a 6-week cycle (in combination with infusional leucovorin and bolus/infusion fluorouracil; leucovorin administered immediately following irinotecan; fluorouracil immediately following leucovorin); continue until disease progression or unacceptable toxicity.

Adjusted dose level −1: 150 mg/m².

Adjusted dose level −2: 120 mg/m².

Further adjust if needed in decrements of ~20%.

Note: FOLFIRI regimens may also be administered in combination with bevacizumab (Ref), cetuximab (Ref), panitumumab (Ref), ramucirumab (Ref), or ziv-aflibercept (Ref); refer to protocols for further information.

FOL FOXIRI regimen (off-label dosing): IV: 165 mg/m² over 1 hour once every 2 weeks (in combination with oxaliplatin, leucovorin, and fluorouracil); continue until disease progression or unacceptable toxicity (Ref) or 165 mg/m² over 1 hour once every 2 weeks (in combination with oxaliplatin, leucovorin, fluorouracil, and bevacizumab) for up to 12 cycles (Ref) or 150 mg/m² over 1 hour once every 14 days (in combination with oxaliplatin, leucovorin, fluorouracil, and panitumumab) until disease progression or resection for up to a maximum of 12 preoperative cycles; after resection, patients received the same regimen as adjuvant therapy for a total of 12 perioperative cycles (Ref).

In combination with cetuximab (off- label combination): IV: 180 mg/m² over 30 minutes once every 2 weeks (in combination with cetuximab) until disease progression or unacceptable toxicity (Ref).

Colorectal cancer, metastatic, single-agent therapy

Colorectal cancer, metastatic, single-agent therapy:

Weekly regimen: IV: 125 mg/m² over 90 minutes on days 1, 8, 15, and 22 of a 6-week treatment cycle (may adjust upward to 150 mg/m² if tolerated); continue until disease progression or unacceptable toxicity.

Adjusted dose level −1: 100 mg/m².

Adjusted dose level −2: 75 mg/m².

Further adjust to 50 mg/m² (in decrements of 25 to 50 mg/m²) if needed.

Once-every-3-week regimen: IV: 350 mg/m² over 90 minutes, once every 3 weeks; continue until disease progression or unacceptable toxicity.

Adjusted dose level −1: 300 mg/m².

Adjusted dose level −2: 250 mg/m².

Further adjust to 200 mg/m² (in decrements of 25 to 50 mg/m²) if needed

Cervical cancer, recurrent or metastatic

Cervical cancer, recurrent or metastatic (off-label use): IV: 125 mg/m² over 90 minutes once weekly for 4 consecutive weeks followed by a 2-week rest during each 6-week treatment cycle; continue until disease progression or unacceptable toxicity (Ref).

CNS tumor, recurrent glioblastoma

CNS tumor, recurrent glioblastoma (off-label use): IV: 125 mg/m² over 90 minutes once every 2 weeks (in combination with bevacizumab); continue for up to 2 years or until disease progression or unacceptable toxicity. NOTE: In the studies, the irinotecan dose was increased in patients taking concurrent antiseizure enzyme-inducing medications; refer to protocols for further information (Ref).

Esophageal cancer, metastatic or locally advanced

Esophageal cancer, metastatic or locally advanced (off-label use): IV: 65 mg/m² over 90 minutes days 1, 8, 15, and 22 of a 6-week treatment cycle (in combination with cisplatin); continue until disease progression or unacceptable toxicity (Ref) or 180 mg/m² over 90 minutes every 2 weeks (in combination with leucovorin and fluorouracil); continue until disease progression or unacceptable toxicity (Ref) or 250 mg/m² every 3 weeks (in combination with capecitabine) for up to a maximum of 24 weeks or until disease progression or unacceptable toxicity (Ref).

Ewing sarcoma, recurrent or progressive

Ewing sarcoma, recurrent or progressive (off-label use): IV: 20 mg/m² days 1 to 5 and days 8 to 12 every 3 weeks (in combination with temozolomide); continue for up to 12 cycles (patients received a median of 7.5 cycles) (Ref).

Gastric cancer, metastatic or locally advanced

Gastric cancer, metastatic or locally advanced (off-label use): IV: 150 mg/m² (as a single agent) on days 1 and 15 of a 4-week treatment cycle; continue until disease progression or unacceptable toxicity (Ref) or 65 mg/m² over 90 minutes days 1, 8, 15, and 22 of a 6-week treatment cycle (in combination with cisplatin); continue until disease progression or unacceptable toxicity (Ref) or 70 mg/m² over 90 minutes on days 1 and 15 of a 4-week treatment cycle (in combination with cisplatin) for up to 6 cycles (or until disease progression or unacceptable toxicity are detected) (Ref) or 180 mg/m² over 90 minutes every 2 weeks (in combination with leucovorin and fluorouracil); continue for at least 4 cycles or until disease progression or unacceptable toxicity (Ref) or 250 mg/m² every 3 weeks (in combination with capecitabine); continue until disease progression or unacceptable toxicity (Ref).

Non–small cell lung cancer, advanced

Non–small cell lung cancer, advanced (off-label use): IV: 60 mg/m² days 1, 8, and 15 every 4 weeks (in combination with cisplatin); continue for 3 or more cycles until disease progression or unacceptable toxicity (Ref).

Ovarian cancer, recurrent

Ovarian cancer, recurrent (off-label use):

Platinum- and taxane-resistant: IV: 100 mg/m² days 1, 8, and 15 every 4 weeks (as a single-agent) for up to 6 cycles (Ref).

Platinum- refractory/resistant: IV: Initial: 50 mg/m² on days 1 and 8 every 3 weeks (in combination with gemcitabine) until disease progression or unacceptable toxicity; chemotherapy doses were modified based on the presence or absence of toxicity; refer to protocol for further information (Ref).

Pancreatic cancer, advanced or metastatic

Pancreatic cancer, advanced or metastatic (off-label use): FOLFIRINOX regimen: IV: 180 mg/m² over 90 minutes every 2 weeks (in combination with oxaliplatin, leucovorin, and fluorouracil) until disease progression or unacceptable toxicity (12 cycles were recommended in patients who responded) (Ref).

Pancreatic cancer, potentially curable, adjuvant therapy

Pancreatic cancer, potentially curable, adjuvant therapy (off-label use): Note: American Society of Clinical Oncology (ASCO) guidelines recommend 6 months of adjuvant therapy if recovery is complete; if preoperative chemotherapy therapy was received, a total of 6 months of adjuvant therapy (including the preoperative regimen) is recommended (Ref).

mFOLFIRINOX regimen: IV: 150 mg/m² every 2 weeks (in combination with fluorouracil, leucovorin, and oxaliplatin; modified FOLFIRINOX regimen) for 24 weeks (Ref). According to ASCO guidelines, mFOLFIRINOX is the preferred first-line adjuvant regimen for potentially curable disease (Ref).

Rhabdomyosarcoma, metastatic or relapsed/progressive

Rhabdomyosarcoma, metastatic or relapsed/progressive (off-label use):

Adults <50 years of age: IV: 50 mg/m² (maximum: 100 mg/dose) once daily for 5 days during protocol-specific weeks (in combination with ifosfamide, etoposide, vincristine, doxorubicin, cyclophosphamide, dactinomycin, and radiation; high-risk disease); protocol-specific weeks assigned were weeks 1, 4, 20, 23, 47, and 50 (refer to protocol for details) (Ref). In adult patients <21 years of age, may consider the regimen below.

Adults <21 years of age: IV: 50 mg/m² once daily for 5 days at weeks 1 and 4 (in combination with vincristine); if complete or partial response occurs, continue 50 mg/m² once daily for 5 days at weeks 13, 25, 34, 46, and 49 (Ref). Refer to protocol for details.

Small bowel adenocarcinoma, advanced unresectable or metastatic

Small bowel adenocarcinoma, advanced unresectable or metastatic (off-label use): Note: Ampullary adenocarcinomas were excluded from this study (Ref).

FOLFIRI regimen (following progression on a platinum-based regimen): IV: 180 mg/m² over 90 minutes once every 2 weeks (in combination with leucovorin and fluorouracil); continue until disease progression or unacceptable toxicity (Ref).

Small cell lung cancer, extensive stage

Small cell lung cancer, extensive stage (off-label use): IV: 60 mg/m² days 1, 8, and 15 every 4 weeks (in combination with cisplatin) for 4 cycles (Ref) or 65 mg/m² days 1 and 8 every 3 weeks (in combination with cisplatin) for a minimum of 4 cycles (Ref) or 175 mg/m² day 1 every 3 weeks for 4 cycles (in combination with carboplatin) (Ref) or 50 mg/m² days 1, 8 and 15 every 4 weeks (in combination with carboplatin); in the study, patients received a median of 4 cycles (Ref). According to ASCO guidelines, platinum-based therapy (cisplatin or carboplatin) in combination with either etoposide or irinotecan for 4 to 6 cycles is recommended over other regimens for extensive stage disease (Ref).

Small cell lung cancer, limited stage

Small cell lung cancer, limited stage (off-label use): Consolidation therapy (administer after induction cisplatin, etoposide, and radiation therapy): IV: 60 mg/m² days 1, 8, and 15 every 3 to 4 weeks (in combination with cisplatin) for 3 cycles (Ref).

Unknown primary adenocarcinoma

Unknown primary adenocarcinoma (off-label use): IV: 100 mg/m² on days 1 and 8 every 3 weeks (in combination with gemcitabine) for 4 to 6 cycles (Ref) or 60 mg/m² on days 1, 8, and 15 every 4 weeks (in combination with carboplatin) for up to 6 cycles (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Altered kidney function:

Note: Irinotecan clearance is complex with extensive interpatient variability (Ref); kidney function is one consideration (Ref) in the context of additional factors influencing drug disposition and toxicity (eg, liver function, UGT1A1 genotype, liver function, concurrent medications) (Ref). Monitor patients with kidney impairment closely for development of toxicity.

IV:

CrCl ≥60 mL/minute: No dosage adjustment necessary (Ref).

CrCl 30 to <60 mL/minute: Consider initiating with 75% to 100% of the usual indication-specific dose; if starting with a reduced dose, increase if tolerated (Ref). Although the clearance of irinotecan in these patients appears unaltered, unbound fraction may be increased (Ref). Additionally, a retrospective study in which patients received 350 mg/m² irinotecan every 3 weeks found a 2.5-times higher risk of grade 3 or 4 neutropenia in patients with CrCl 35 to 66 mL/minute compared to patients with CrCl >98 mL/minute (Ref).

CrCl <30 mL/minute: Consider initiating with 50% to 66% of the usual indication-specific dose; increase if tolerated; use with caution. The unbound AUC of SN-38 (active metabolite) is increased 4.4-fold potentially due to reduced nonrenal metabolism, and adverse effects are more likely (Ref).

Augmented renal clearance (measured urinary CrCl ≥130 mL/minute/1.73 m²):

Note: Augmented renal clearance (ARC) is a condition that occurs in certain critically ill patients without organ dysfunction and with normal serum creatinine concentrations. Young patients (<55 years of age) admitted post trauma or major surgery are at highest risk for ARC, as well as those with sepsis, burns, or hematologic malignancies. An 8- to 24-hour measured urinary CrCl is necessary to identify these patients (Ref).

IV: No dosage adjustment likely to be necessary (Ref).

Hemodialysis, intermittent (thrice weekly): Irinotecan may be partially dialyzable, SN38 (active metabolite) is not (Ref).

IV: The manufacturer does not recommend use and some studies suggest higher risk of toxicity in patients with end-stage kidney disease (ESKD) (Ref). Initial: If benefits outweigh the risks may initiate with 50% to 66% of the usual recommended dose (Ref) or given the variability in patient response, when the usual indication-specific dose is 100 to 150 mg/m² once weekly, it may be safest to reduce the dose to 50 mg/m² once weekly (Ref).

Doses may be increased with caution if tolerated; severe toxicity at 80 mg/m² weekly (grade 4 neutropenia and death in a patient with UGT1A polymorphism) and 100 mg/m² weekly (grade 4 diarrhea) has been reported (Ref). Administer after hemodialysis or on nondialysis days (Ref).

Peritoneal dialysis:

IV: The manufacturer does not recommend use and some studies suggest higher risk of toxicity in patients with ESKD (Ref). Initial: If benefits outweigh the risks may initiate with 50% to 66% of the usual recommended dose or when the usual indication-specific dose is 100 to 150 mg/m² once weekly, it may be safest to reduce the dose to 50 mg/m² once weekly (Ref).

CRRT:

Note: Drug clearance is dependent on the effluent flow rate, filter type, and method of renal replacement. Recommendations are based on high-flux dialyzers and effluent flow rates of 20 to 25 mL/kg/hour (or ~1,500 to 3,000 mL/hour) unless otherwise noted. Appropriate dosing requires consideration of adequate drug concentrations. Close monitoring of response and adverse reactions (eg, diarrhea, myelosuppression) due to drug accumulation is important.

IV: Dose as for CrCl <30 mL/minute; use with caution (Ref).

PIRRT (eg, sustained, low-efficiency diafiltration):

Note: Drug clearance is dependent on the effluent flow rate, filter type, and method of renal replacement. Appropriate dosing requires consideration of adequate drug concentrations. Close monitoring of response and adverse reactions (eg, diarrhea, myelosuppression) due to drug accumulation is important.

IV: Dose as for CrCl <30 mL/minute; use with caution. When scheduled dose falls on PIRRT days, dose after PIRRT or on non-PIRRT days (Ref).

Dosing: Hepatic Impairment: Adult

Manufacturer's labeling:

Liver metastases with normal hepatic function: No dosage adjustment necessary.

Bilirubin >ULN to ≤2 mg/dL: Consider reducing initial dose by 1 dose level.

Bilirubin >2 mg/dL: Use is not recommended.

Alternate recommendations: The following adjustments have also been recommended:

Bilirubin 1.5 to 3 mg/dL: Administer 75% of dose (Ref).

Bilirubin 1.51 to 3 times ULN: Reduce dose from 350 mg/m² every 3 weeks to 200 mg/m² every 3 weeks (Ref).

Weekly irinotecan dosing:

Bilirubin 1.5 to 3 times ULN and ALT/AST ≤5 times ULN or bilirubin ≤1.5 times ULN and ALT/AST >5 to 20 times ULN: Administer 60 mg/m² (Ref).

Bilirubin >3 to 5 times ULN and ALT/AST ≤5 times ULN: Administer 50 mg/m² (Ref).

Bilirubin 1.5 to 3 times ULN and ALT/AST >5 to 20 times ULN: Administer 40 mg/m² (Ref).

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Dermatologic: Alopecia (46%), skin rash (14%)

Gastrointestinal: Abdominal pain (68%), anorexia (44%), constipation (32%), diarrhea (84%, grades 3/4: 22%; late: 83%, grades 3/4: 31%; early: 43%, grades 3/4: 7%), nausea (70% to 82%; grades 3/4: 11% to 16%), stomatitis (30%; grades 3/4: 2%), vomiting (62% to 63%; grades 3/4: 12% to 14%)

Hematologic & oncologic: Anemia (97%; grades 3/4: 5% to 7%), leukopenia (96%; grades 3/4: ≤22%), neutropenia (30% to 96%; grades 3/4: ≤31%), thrombocytopenia (96%; grades 3/4: 1% to 4%)

Hepatic: Increased serum bilirubin (84%)

Infection: Infection (14%; including bacterial infection, fungal infection, viral infection)

Nervous system: Asthenia (69%), cholinergic syndrome (47%), dizziness (21%), pain (23%)

Respiratory: Cough (20%), dyspnea (22%)

Miscellaneous: Fever (44%)

1% to 10%:

Cardiovascular: Hypotension (6%), thromboembolic complications (5%; including acute myocardial infarction, angina pectoris, arterial thrombosis, cerebral infarction, cerebrovascular accident, deep vein thrombophlebitis, ischemic heart disease, lower extremity embolism, peripheral vascular disease, pulmonary embolism, thrombophlebitis, thrombosis), vasodilation (9%)

Hematologic & oncologic: Febrile neutropenia (grades 3/4: 2% to 6%), hemorrhage (grades 3/4: 1% to 5%), neutropenic infection (grades 3/4: 1% to 2%)

Nervous system: Confusion (3%), drowsiness (9%)

Respiratory: Pneumonia (4%)

Frequency not defined:

Cardiovascular: Cardiac arrhythmia (grades 3/4), ischemia (grades 3/4), syncope (grades 3/4)

Endocrine & metabolic: Weight loss

Hematologic & oncologic: Lymphocytopenia

Hepatic: Ascites (grades 3/4), hepatomegaly (grades 3/4), jaundice (grades 3/4)

Hypersensitivity: Hypersensitivity reaction (including anaphylaxis, nonimmune anaphylaxis)

Nervous system: Vertigo (grades 3/4)

Renal: Acute kidney injury, kidney impairment

Respiratory: Pulmonary toxicity

Postmarketing:

Endocrine & metabolic: Hyponatremia

Gastrointestinal: Increased pancreatic enzymes, intestinal perforation, non-Hirschsprung megacolon, pancreatitis

Hepatic: Increased serum alanine aminotransferase, increased serum aspartate aminotransferase

Nervous system: Dysarthria

Contraindications

Known hypersensitivity to irinotecan or any component of the formulation.

Canadian labeling: Additional contraindications (not in the US labeling): Coadministration with azole antifungals (ketoconazole, fluconazole, itraconazole); patients with hereditary fructose intolerance.

Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Warnings/Precautions

Concerns related to adverse effects:

• Bone marrow suppression: Irinotecan may cause severe myelosuppression. Deaths due to sepsis following severe neutropenia have been reported. Complications due to neutropenia should be promptly managed with antibiotics. Patients who have previously received pelvic/abdominal radiation therapy have an increased risk of severe bone marrow suppression; the incidence of grade 3 or 4 neutropenia was higher in patients receiving weekly irinotecan who have previously received pelvic/abdominal radiation therapy. Concurrent radiation therapy is not recommended with irinotecan (based on limited data).

• Diarrhea: Severe diarrhea may be dose-limiting and potentially fatal; early-onset and late-onset diarrhea may occur. Early diarrhea occurs during or within 24 hours of receiving irinotecan and is characterized by cholinergic symptoms; may be prevented or treated with atropine. Late diarrhea may be life-threatening and should be promptly treated with loperamide. Antibiotics may be necessary if patient develops ileus, fever, or severe neutropenia. Early diarrhea is generally transient and rarely severe; cholinergic symptoms may include increased salivation, rhinitis, miosis, diaphoresis, flushing, abdominal cramping, and lacrimation; bradycardia may also occur. Cholinergic symptoms may occur more frequently with higher irinotecan doses. Late diarrhea occurs more than 24 hours after treatment, which may lead to dehydration, electrolyte imbalance, or sepsis. Late diarrhea may be complicated by colitis, ulceration, bleeding, ileus, obstruction, or infection; cases of megacolon and intestinal perforation have been reported. The median time to onset for late diarrhea is 5 days with every-3-week irinotecan dosing and 11 days with weekly dosing. Advise patients to have loperamide readily available for the treatment of late diarrhea.

• Extravasation: Irinotecan is an irritant. Avoid extravasation; if extravasation occurs, the manufacturer recommends flushing the external site with sterile water and applying ice.

• Hypersensitivity: Severe hypersensitivity reactions (including anaphylaxis) have occurred.

• Pulmonary toxicity: Fatal cases of interstitial pulmonary disease–like events have been reported with single-agent and combination therapy. Risk factors for pulmonary toxicity include preexisting lung disease, use of pulmonary toxic medications, radiation therapy, and colony-stimulating factors.

• Renal toxicity: Renal impairment and acute renal failure have been reported, possibly due to dehydration secondary to diarrhea.

Disease-related concerns:

• Bowel obstruction: Patients with bowel obstruction should not be treated with irinotecan until resolution of obstruction.

• Hepatic impairment: Exposure to the active metabolite (SN-38) is increased in hepatic impairment; toxicities may be increased. Patients with even modest elevations in total serum bilirubin levels (1 to 2 mg/dL) have a significantly greater likelihood of experiencing first-course grade 3 or 4 neutropenia than those with bilirubin levels that were <1 mg/dL. Patients with abnormal glucuronidation of bilirubin, such as those with Gilbert syndrome, may also be at greater risk of myelosuppression when receiving therapy with irinotecan.

Concurrent drug therapy issues:

• Drug-drug interactions: CYP3A4 enzyme inducers may decrease exposure to irinotecan and SN-38 (active metabolite); enzyme inhibitors may increase exposure. For use in patients with CNS tumors (off-label use), selection of antiseizure medications that are not enzyme inducers is preferred.

Special populations:

• Older adult: Patients >65 years of age are at greater risk for early and late diarrhea. A dose reduction is recommended for patients ≥70 years of age receiving the every-3-week regimen.

• Pelvic/abdominal radiation recipients: Previously received pelvic/abdominal radiation may increase risk of severe myelosuppression.

• Performance status: Higher rates of hospitalization, neutropenic fever, thromboembolism, first-cycle discontinuation, and early mortality were observed in patients with a performance status of 2 than in patients with a performance status of 0 or 1.

• Reduced UGT1A1 activity: Patients homozygous for either the UGT1A1*28 or *6 alleles (*28/*28, *6/*6) or who are compound or double heterozygous for the UGT1A1*28 and *6 alleles (*6/*28) are at increased risk of severe or life-threatening neutropenia with irinotecan due to poor metabolism of UGT1A1; UGT1A1-poor metabolizers have increased systemic exposure to SN-38 (active metabolite). Patients who are heterozygous for either the UGT1A1*28 or *6 alleles (*1/*28, *1/*6) are intermediate metabolizers and may also be at increased risk of severe or life-threatening neutropenia.

Dosage form specific issues:

• Conventional vs liposomal formulation dosing: Irinotecan (conventional) and irinotecan (liposomal) are NOT interchangeable. Dosing differs between formulations; verify intended product and dose prior to preparation and administration.

• Sorbitol: Product contains sorbitol; do not use in patients with hereditary fructose intolerance.

Other warnings/precautions:

• Appropriate use: Except as part of a clinical trial, use in combination with the fluorouracil and leucovorin administered for 4 or 5 consecutive days every 4 weeks (“Mayo Clinic” regimen) is not recommended due to increased toxicity.

Warnings: Additional Pediatric Considerations

In pediatric patients, provide antibiotic support if patient develops persistent diarrhea (grade 3 or 4), ileus, fever, sepsis, or severe neutropenia; cefixime (8 mg/kg/day, maximum dose: 400 mg) has been used in children as prophylaxis for diarrhea beginning 5 days prior to irinotecan therapy and continued throughout course (Wagner 2008); cefpodoxime (10 mg/kg/day divided twice daily, maximum dose: 200 mg) has also been used (McNall-Knapp 2010; Wagner 2010).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous, as hydrochloride:

Generic: 40 mg/2 mL (2 mL); 100 mg/5 mL (5 mL); 300 mg/15 mL (15 mL)

Solution, Intravenous, as hydrochloride [preservative free]:

Camptosar: 40 mg/2 mL (2 mL); 100 mg/5 mL (5 mL); 300 mg/15 mL (15 mL)

Generic: 40 mg/2 mL (2 mL); 100 mg/5 mL (5 mL); 300 mg/15 mL (15 mL); 500 mg/25 mL (25 mL)

Generic Equivalent Available: US

Yes

Pricing: US

Solution (Camptosar Intravenous)

40 mg/2 mL (per mL): $16.59

100 mg/5 mL (per mL): $9.90

300 mg/15 mL (per mL): $9.10

Solution (Irinotecan HCl Intravenous)

40 mg/2 mL (per mL): $5.40 - $138.08

100 mg/5 mL (per mL): $4.32 - $138.07

300 mg/15 mL (per mL): $8.00 - $8.96

500 mg/25 mL (per mL): $7.73

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Intravenous:

Camptosar: 20 mg/mL ([DSC])

Generic: 20 mg/mL (2 mL, 5 mL, 25 mL)

Solution, Intravenous, as hydrochloride:

Generic: 100 mg/5 mL (5 mL); 500 mg/25 mL (25 mL)

Administration: Pediatric

Irinotecan is associated with a moderate emetic potential; antiemetics are recommended to prevent nausea and vomiting (Ref).

Parenteral: IV infusion: Infuse usually over 90 minutes; some pediatric protocols infuse the dose over 1 hour (Ref); consult specific protocol. Higher incidence of cholinergic symptoms (increased salivation, rhinitis, miosis, diaphoresis, abdominal cramping) have been reported with more rapid infusion rates; consider prophylaxis with oral cephalosporin antibiotics or rescue atropine for acute-onset diarrhea.

Administration: Adult

IV: Administer by IV infusion, usually over 90 minutes.

Premedications: Irinotecan is associated with a moderate emetic potential (Ref); premedication with dexamethasone and a 5-HT₃ blocker is recommended 30 minutes prior to administration; prochlorperazine may be considered for subsequent use (if needed). Consider atropine 0.25 to 1 mg IV or SubQ as premedication for or treatment of cholinergic symptoms (eg, increased salivation, rhinitis, miosis, diaphoresis, abdominal cramping) or early onset diarrhea.

Diarrhea management: Advise patients to have loperamide readily available for management of late diarrhea. The recommended regimen to manage late diarrhea is loperamide 4 mg orally at onset of late diarrhea, followed by 2 mg every 2 hours (or 4 mg every 4 hours at night) until 12 hours have passed without a bowel movement. If diarrhea recurs, then repeat loperamide administration. Loperamide should not be used for more than 48 consecutive hours.

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2016 [group 1]).

Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2016; USP-NF 2020).

Storage/Stability

Note: Storage/stability information may vary based on manufacturer; refer to specific prescribing information for details.

Store intact vials at 15°C to 30°C (59°F to 86°F). Protect from light; retain vials in original carton until use.

Various products: Solutions diluted in NS may precipitate if refrigerated. Solutions diluted in D5W are stable for 24 hours at room temperature or 48 hours under refrigeration at 2°C to 8°C (36°F to 46°F), although the manufacturer recommends use within 24 hours if refrigerated, or within 4 to 12 hours (manufacturer dependent; refer to specific prescribing information) at room temperature (including infusion time) only if prepared under strict aseptic conditions (eg, laminar flow hood). Do not freeze.

Camptosar: Prepare the infusion solution immediately prior to use. If immediate use is not possible, may store the solution diluted for infusion for up to 24 hours at 2°C to 8°C (36°F to 46°F) or discard. Do not use if visible particulates are present in the infusion solution.

Extemporaneously prepared oral solutions (pediatric): Undiluted commercially available injectable solution prepared in oral syringes is stable for 21 days under refrigeration (Wagner 2010).

Use

Treatment of metastatic carcinoma of the colon or rectum (FDA approved in adults); has also been used in the treatment of refractory solid tumor, neuroblastoma, or CNS tumor and refractory or metastatic rhabdomyosarcoma

Medication Safety Issues

Sound-alike/look-alike issues:

Conventional formulation (Camptosar) may be confused with the liposomal formulation (Onivyde)

Irinotecan (conventional) may be confused with irinotecan (liposomal), sacituzumab govitecan, topotecan

High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (chemotherapeutic agent, parenteral and oral; conventional forms with liposomal counterparts) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care, Community/Ambulatory Care, and Long-Term Care Settings).

Administration issues:

Irinotecan (conventional) and irinotecan (liposomal) are NOT interchangeable. Dosing differs between formulations; verify intended product and dose prior to preparation and administration.

Metabolism/Transport Effects

Substrate of BCRP/ABCG2, CYP3A4 (major), OATP1B1/1B3 (SLCO1B1/1B3), P-glycoprotein/ABCB1 (minor), UGT1A1; Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program

5-Aminosalicylic Acid Derivatives: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy

Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Antithymocyte Globulin (Equine): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of cytotoxic chemotherapy is reduced. Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy

Antithyroid Agents: Myelosuppressive Agents may enhance the neutropenic effect of Antithyroid Agents. Risk C: Monitor therapy

Atazanavir: May increase serum concentrations of the active metabolite(s) of Irinotecan Products. Specifically, serum concentrations of SN-38 may be increased. Risk X: Avoid combination

Baricitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination

BCG Products: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination

Belumosudil: May increase the serum concentration of UGT1A1 Substrates. Management: Avoid coadministration of belumosudil with substrates of UGT1A1 for which minimal concentration increases can cause serious adverse effects. If coadministration is required, dose reductions of the UGT1A1 substrate may be required. Risk D: Consider therapy modification

Brincidofovir: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy

Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Capecitabine: Irinotecan Products may enhance the nephrotoxic effect of Capecitabine. Risk C: Monitor therapy

Chikungunya Vaccine (Live): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination

Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy

Chloramphenicol (Systemic): Myelosuppressive Agents may enhance the myelosuppressive effect of Chloramphenicol (Systemic). Risk X: Avoid combination

Cladribine: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor therapy

Coccidioides immitis Skin Test: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing cytotoxic chemotherapy several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification

COVID-19 Vaccine (Adenovirus Vector): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters). Risk D: Consider therapy modification

COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy

COVID-19 Vaccine (mRNA): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider therapy modification

COVID-19 Vaccine (Subunit): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy

COVID-19 Vaccine (Virus-like Particles): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy

CYP3A4 Inducers (Moderate): May decrease serum concentrations of the active metabolite(s) of Irinotecan Products. Specifically, concentrations of SN-38 may be reduced. Risk C: Monitor therapy

CYP3A4 Inducers (Strong): May decrease serum concentrations of the active metabolite(s) of Irinotecan Products. Specifically, serum concentrations of SN-38 may be reduced. CYP3A4 Inducers (Strong) may decrease the serum concentration of Irinotecan Products. Management: Avoid administration of strong CYP3A4 inducers during irinotecan treatment, and substitute non-CYP3A4 inducing agents at least 2 weeks prior to irinotecan initiation, whenever possible. If combined, monitor for reduced irinotecan efficacy. Risk D: Consider therapy modification

CYP3A4 Inhibitors (Moderate): May increase serum concentrations of the active metabolite(s) of Irinotecan Products. Specifically, the serum concentration of SN-38 may be increased. CYP3A4 Inhibitors (Moderate) may increase the serum concentration of Irinotecan Products. Risk C: Monitor therapy

CYP3A4 Inhibitors (Strong): May increase serum concentrations of the active metabolite(s) of Irinotecan Products. Specifically, serum concentrations of SN-38 may be increased. Management: Avoid administration of strong CYP3A4 inhibitors during and within 1 week prior to irinotecan administration, unless no therapeutic alternatives to these agents exist. If combined, monitor closely for increased irinotecan toxicities. Risk D: Consider therapy modification

Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider therapy modification

Dengue Tetravalent Vaccine (Live): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination

Denosumab: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and cytotoxic chemotherapy. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider therapy modification

Deucravacitinib: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Etrasimod: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination

Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Consider avoiding this combination if possible. If required, monitor patients closely for increased adverse effects of the CYP3A4 substrate. Risk D: Consider therapy modification

Inebilizumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy

Influenza Virus Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating chemotherapy if possible. If vaccination occurs less than 2 weeks prior to or during chemotherapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification

Itraconazole: May increase serum concentrations of the active metabolite(s) of Irinotecan Products. Specifically, serum concentrations of SN-38 may be increased. Risk X: Avoid combination

Ketoconazole (Systemic): May increase serum concentrations of the active metabolite(s) of Irinotecan Products. Specifically, serum concentrations of SN-38 may be increased. Risk X: Avoid combination

Leflunomide: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents, such as cytotoxic chemotherapy. Risk D: Consider therapy modification

Lenograstim: Antineoplastic Agents may diminish the therapeutic effect of Lenograstim. Management: Avoid the use of lenograstim 24 hours before until 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Risk D: Consider therapy modification

Linezolid: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy

Lipegfilgrastim: Antineoplastic Agents may diminish the therapeutic effect of Lipegfilgrastim. Management: Avoid concomitant use of lipegfilgrastim and myelosuppressive cytotoxic chemotherapy. Lipegfilgrastim should be administered at least 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Risk D: Consider therapy modification

Mitapivat: May decrease the serum concentration of UGT1A1 Substrates. Risk C: Monitor therapy

Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination

Nadofaragene Firadenovec: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination

Natalizumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination

Ocrelizumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy

Ofatumumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy

Olaparib: Myelosuppressive Agents may enhance the myelosuppressive effect of Olaparib. Risk C: Monitor therapy

Palifermin: May enhance the adverse/toxic effect of Antineoplastic Agents. Specifically, the duration and severity of oral mucositis may be increased. Management: Do not administer palifermin within 24 hours before, during infusion of, or within 24 hours after administration of myelotoxic chemotherapy. Risk D: Consider therapy modification

Pidotimod: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy

Pimecrolimus: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Pneumococcal Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy

Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination

Polymethylmethacrylate: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the potential for allergic or hypersensitivity reactions to Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification

Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy

Rabies Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification

Ritlecitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination

Ropeginterferon Alfa-2b: Myelosuppressive Agents may enhance the myelosuppressive effect of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider therapy modification

Ruxolitinib (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination

Sacituzumab Govitecan: Irinotecan Products may enhance the adverse/toxic effect of Sacituzumab Govitecan. Risk X: Avoid combination

Sipuleucel-T: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants, such as cytotoxic chemotherapy, prior to initiating sipuleucel-T therapy. Risk D: Consider therapy modification

Sphingosine 1-Phosphate (S1P) Receptor Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk C: Monitor therapy

St John's Wort: May decrease serum concentrations of the active metabolite(s) of Irinotecan Products. Specifically, concentrations of SN-38 may be reduced. St John's Wort may decrease the serum concentration of Irinotecan Products. Management: Avoid administration of St John's wort during irinotecan treatment, and consider substituting non-CYP3A4 inducing agents at least 2 weeks prior to irinotecan initiation, whenever possible. If combined, monitor for reduced irinotecan efficacy. Risk D: Consider therapy modification

Tacrolimus (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination

Talimogene Laherparepvec: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination

Telotristat Ethyl: May decrease serum concentrations of the active metabolite(s) of Irinotecan Products. Risk C: Monitor therapy

Tertomotide: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination

Tobacco (Smoked): May decrease serum concentrations of the active metabolite(s) of Irinotecan Products. Risk C: Monitor therapy

Tofacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Tofacitinib. Risk X: Avoid combination

Typhoid Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination

Ublituximab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy

UGT1A1 Inhibitors: May increase serum concentrations of the active metabolite(s) of Irinotecan Products. Specifically, concentrations of SN-38 may be increased. UGT1A1 Inhibitors may increase the serum concentration of Irinotecan Products. Risk X: Avoid combination

Upadacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination

Vaccines (Live): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Vaccines (Live) may diminish the therapeutic effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to starting chemotherapy when possible. Patients vaccinated less than 14 days before or during chemotherapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification

Yellow Fever Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination

Dietary Considerations

Contains sorbitol; do not use in patients with hereditary fructose intolerance.

Reproductive Considerations

Verify pregnancy status prior to use in patients who could become pregnant. Patients who could become pregnant should use highly effective contraception during therapy and for 6 months after the last irinotecan dose. Patients with partners who could become pregnant should use condoms during therapy and for 3 months after the last dose of irinotecan.

Menstrual cycle changes and impairment of female fertility may occur with irinotecan therapy.

Pregnancy Considerations

Based on the mechanism of action and data from animal reproduction studies, in utero exposure to irinotecan may cause fetal harm.

Outcome data following maternal use of irinotecan (conventional) during pregnancy are limited (Abellar 2009; Cirillo 2012; Kozai 2022; Taylor 2009).

The European Society for Medical Oncology has published guidelines for diagnosis, treatment, and follow-up of cancer during pregnancy. The guidelines recommend referral to a facility with expertise in cancer during pregnancy and encourage a multidisciplinary team (obstetrician, neonatologist, oncology team) approach. In general, if chemotherapy is indicated, it should be avoided in the first trimester and there should be a 3-week time period between the last chemotherapy dose and anticipated delivery, and chemotherapy should not be administered beyond week 33 of gestation (ESMO [Peccatori 2013]).

A long-term observational research study is collecting information about the diagnosis and treatment of cancer during pregnancy. For additional information about the pregnancy and cancer registry or to become a participant, contact Cooper Health (1-877-635-4499).

Monitoring Parameters

Signs of diarrhea and dehydration, serum electrolytes, serum BUN and creatinine; infusion site for signs of inflammation; CBC with differential and platelet count, hemoglobin, liver function tests, and serum bilirubin

A test is available for genotyping of UGT1A1; however, guidelines for use are not established and not recommended; in patients who have experienced toxicity, a dose reduction is recommended

Mechanism of Action

Irinotecan and its active metabolite (SN-38) bind reversibly to topoisomerase I-DNA complex preventing religation of the cleaved DNA strand. This results in the accumulation of cleavable complexes and double-strand DNA breaks. As mammalian cells cannot efficiently repair these breaks, cell death consistent with S-phase cell cycle specificity occurs, leading to termination of cellular replication.

Pharmacokinetics (Adult Data Unless Noted)

Distribution:

Children and Adolescents: ~37 L/m² (range: 15.2 to 77 L/m²) (Ma 2000); distributes to pleural fluid, sweat, and saliva

Adults: 33 to 150 L/m²

Protein binding, plasma: Predominantly albumin; Irinotecan: 30% to 68%, SN-38 (active metabolite): ~95%

Metabolism: Primarily hepatic to SN-38 (active metabolite) by carboxylesterase enzymes; may also undergo CYP3A4-mediated oxidative metabolism to several inactive metabolites (one of which may be hydrolyzed to release SN-38). SN-38 undergoes conjugation by UDP-glucuronosyl transferase 1A1 (UGT1A1) to form a glucuronide metabolite. SN-38 AUC is increased in patients who are homozygous for either the UGT1A1*28 or *6 alleles, or who are compound heterozygous for these alleles.

Bioavailability: Median: 9%; increased in presence of gefitinib (median: 42%) (Furman 2009)

Half-life elimination:

Children and Adolescents (Ma 2000): Irinotecan: 2.66 hours (range: 1.82 to 4.47 hours); SN-38 (active metabolite): 1.58 hours (range: 0.29 to 8.28 hours)

Adults: Irinotecan: 6 to 12 hours; SN-38: ~10 to 20 hours

Time to peak:

Irinotecan: Oral: Children and Adolescents: 3 hours (Wagner 2010a)

SN-38: Following 90-minute infusion: ~1 hour

Excretion: Urine: Irinotecan (11% to 20%), metabolites (SN-38 <1%, SN-38 glucuronide, 3%)

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Hepatic function impairment: Clearance of irinotecan is decreased and exposure to the active metabolite (SN-38) is increased proportional to the degree of hepatic impairment.

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(AE) United Arab Emirates: Campto | Irinotecan;
(AR) Argentina: Camptosar | Irinogen | Irinotecan | Irinotecan gp pharm | Irinotecan ima | Itoxaril | Kebirtecan | Satigene | Tiagrel | Trinotecan | Winol;
(AT) Austria: Campto | Irinoliquid | Irinotecan accord | Irinotecan actavis | Irinotecan arcana | Irinotecan ebewe | Irinotecan fresenius | Irinotecan hikma | Irinotecan hospira | Irinotecan kabi | Irinotecan stada;
(AU) Australia: Camptosar | Irinoccord | Irinotecan | Irinotecan accord | Irinotecan actavis | Irinotecan ga | Irinotecan kabi | Irinotecan myx | Meditab irinotecan | Omegapharm Irinotecan | Tecan;
(BD) Bangladesh: Irinox;
(BE) Belgium: Campto | Irinosin | Irinotecan accord | Irinotecan actavis | Irinotecan EG | Irinotecan hospira | Irinotecan kabi | Irinotecan Mylan | Irinotecan Sandoz | Irinotecan vianex;
(BG) Bulgaria: Irinotecan accord | Irinotecan bulgerm | Irinotecan hospira | Irinotecan Hydrochloride Cipla | Irinotecan novamed;
(BR) Brazil: Camptosar | Camptrix | Cloridrato de irinotecano | Cloritecan | Dosatecan | Evoterin | Irimac | Irnocam | Proto Itecan | Tecnotecan | Tevairinot | Zotecan;
(CH) Switzerland: Campto | Irinotecan accord | Irinotecan actavis | Irinotecan ebewe | Irinotecan fresenius | Irinotecan Labatec | Irinotecan Orion | Irinotecan Sandoz | Irinotecan Teva;
(CL) Chile: Irinotecan | Itoxaril | Linatecan;
(CN) China: Ai li | Campto;
(CO) Colombia: Blastovin | Camptosar | Irinkan | Irinocyt | Irinoseven | Irinotecan | Irinotel | Itoxaril | Labdosa fixano | Linatecan | Oncotan | Rotecan;
(CZ) Czech Republic: Campto | Irinocol | Irinotecan accord | Irinotecan actavis | Irinotecan ebewe | Irinotecan fresenius | Irinotecan kabi | Irinotecan medac | Irinotecan Mylan | Irinotecan stada | Irinotecan Teva;
(DE) Germany: Axinotecan | Bw irican | Campto | Irino | Irinomedac | Irinotecan accord | Irinotecan actavis | Irinotecan amneal | Irinotecan aurobindo | Irinotecan awd | Irinotecan Cell Pharm | Irinotecan ever pharma | Irinotecan haemato | Irinotecan Hameln | Irinotecan hcl aqvida | Irinotecan hcl liv pharma | Irinotecan Hcl Omnicare | Irinotecan hcl ratiopharm | Irinotecan heumann | Irinotecan Hexal | Irinotecan hospira | Irinotecan kabi | Irinotecan Medicopharm | Irinotecan Oncotrade | Irinotecan Onkovis | Irinotecan Ratiopharm | Irinotecan tillomed | Irinotecan vipharm | Irinotecan Zyo | Irinotesin | Riboirino;
(DO) Dominican Republic: Camptosar | Hidrotecan | Irinotecan libra | Irinotel;
(EC) Ecuador: Camptosar | Clorhidrato de irinotecan | Irinogen | Irinotecan | Irinotecan clorhidrato | Irinotecan clorhidrato trihidrato | Irinotecan Sandoz | Itoxaril | Kebirtecan | Linatecan;
(EE) Estonia: Campto | Irinotecan accord | Irinotecan fresenius | Irinotecan hospira | Irinotecan kabi | Irinotecan Mayne;
(EG) Egypt: Campto | Irinotecan | Irinotel;
(ES) Spain: Campto | Irinotecan accord | Irinotecan actavis | Irinotecan Gp-Pharm | Irinotecan Juste | Irinotecan Mylan | Irinotecan rovi | Irinotecan Sandoz | Irinotecan stada | Irinotecan Teva;
(ET) Ethiopia: Irinotecan;
(FI) Finland: Campto | Irinotecan accord | Irinotecan actavis | Irinotecan Bmm Pharma | Irinotecan ebewe | Irinotecan fresenius kabi | Irinotecan Mayne | Irinotecan medac | Irinotecan Mylan | Irinotecan Teva;
(FR) France: Campto | Irinotecan accord | Irinotecan actavis | Irinotecan Ebewe pharma France | Irinotecan hikma | Irinotecan hospira | Irinotecan kabi | Irinotecan medac | Irinotecan Mylan | Irinotecan Teva Sante;
(GB) United Kingdom: Campto | Irinotecan | Irinotecan accord | Irinotecan medac;
(GR) Greece: Biotecan | Campto | Irican | Irinocan/demo | Irinotecan accord | Irinotecan medac | Irinotecan Teva | Irinotecan/Generics | Irinotecan/medicus | Mizantrone | Santacil;
(HK) Hong Kong: Campto | Irinotecan | Irinotecan Teva | Irinotesin;
(HR) Croatia: Campto | Irinotecan kabi | Irinotesin;
(HU) Hungary: Campto | Irinotecan accord | Irinotecan actavis | Irinotecan ebewe | Irinotecan hikma | Irinotecan hms pharma | Irinotecan Medico Uno | Irinotecan Mylan | Irinotecan Polpharma | Irinotecan Ratiopharm | Irinotecan Teva | Tekazol;
(ID) Indonesia: Actatecan | Campto | Irinotecan | Iritero | Irnocam | Kabitec | Romisan;
(IE) Ireland: Campto | Irinotecan;
(IN) India: Campto | Imtus | Irinomil | Irinopar | Irinot | Irinotel | Irinotraz | Iritero | Irnocam | Irnocel | Irnozen | Lilrincan | ReliTecan | Rinotec | Stritosar;
(IT) Italy: Campto | Irinotecan | Irinotecan accord | Irinotecan kabi | Irinotecan M.G. | Irinotecan Sandoz | Irinotecan Tev;
(JO) Jordan: Campto | Irinotecan;
(JP) Japan: Campto | Irinotecan | Irinotecan HCL | Irinotecan hydrochloride sandoz | Irinotecan hydrochloride taiho | Topotecin;
(KE) Kenya: Campto | Irinogen | Irinotel;
(KR) Korea, Republic of: Boryung irinotecan hcl | Calmtop | Campto | Camtecan | Camtotecan | Crabcan | Dongsung irinotecan hydrochloride | Ildong irinotecan | Inocan | Inotecan | Irinotecan HCL | Irinotecan HCL Boryung | Irinotel | Iritecan | Iritecin | Pfizer irinotecan;
(LB) Lebanon: Campto | Irinotecan | Irinotecan gp pharm;
(LT) Lithuania: Campto | Irinotecan | Irinotecan accord | Irinotecan actavis | Irinotecan alvogen | Irinotecan hospira | Irinotecan kabi | Irinotecan Mayne | Irinotecan seacross | Irinotecan Teva;
(LV) Latvia: Campto | Irinotecan accord | Irinotecan ebewe | Irinotecan kabi | Irinotecan Mayne;
(MX) Mexico: Asinib | Badix | Camptocrin | Camptosar | Colizactive | Daritex a | Etoniri | Feradech | Iraplax | Irinkan | Irinotecan | Junostal | Zurisar;
(MY) Malaysia: Campto | Irinotecan | Seacross irinotecan hydrochloride | Tekamen;
(NG) Nigeria: Campto | Irnocel;
(NL) Netherlands: Campto | Irinotecan | Irinotecan actavis | Irinotecan hcl 3 water mylan | Irinotecan hcl 3 water pch | Irinotecan hcl cf | Irinotecan hcl trihydraat fresenius kabi | Irinotecan hcl trihydraat hospira | Irinotecan hcl trihydraat ratiopharm | Irinotecan hcl trihydraat sandoz | Irinotecan hydrochloride trihydraat accord;
(NO) Norway: Campto | Irinokabi | Irinotecan accord | Irinotecan actavis | Irinotecan Bmm Pharma | Irinotecan fresenius kabi | Irinotecan hospira | Irinotecan Mayne;
(NZ) New Zealand: Camptosar | Irinotecan | Irinotecan accord | Irinotecan Rex;
(PE) Peru: Irinotecan;
(PH) Philippines: Biomedis irinotecan | Campto | Irican | Irino | Irinotesin | Iritero | Pfizer irinotecan | Topoblock;
(PK) Pakistan: Campto | Irinocan | Irinotecan medac;
(PL) Poland: Campto | Irinotecan accord | Irinotecan ebewe | Irinotecan fresenius | Irinotecan kabi | Irinotecan medac | Irinotecan Polpharma | Irinotesin;
(PR) Puerto Rico: Camptosar | Irinotecan HCL;
(PT) Portugal: Campto | Faultenocan | Irinotecano | Irinotecano accord | Irinotecano Basi | Irinotecano hikma;
(PY) Paraguay: Efixano | Irinogen | Irinotecan fada | Irinotecan fusa | Irinotecan lasca | Irinotecan libra | Irinotecan nl pharma | Irinotecan tuteur | Itoxaril | Kebirtecan | Linatecan | Trinotecan | Trinotecan filaxis;
(QA) Qatar: Campto;
(RO) Romania: Campto | Irinotecan accord | Irinotecan alvogen | Irinotecan ebewe | Irinotecan kabi | Irinotecan medac | Irinotecan stada | Irinotesin;
(RU) Russian Federation: Camptera | Campto | Campto cs | Irinotecan | Irinotecan filaxis | Irinotecan j | Irinotecan medac | Irinotecan Pliva-lachema | Irinotecan Teva | Irinotel | Iriten | Iritero | Irnocam;
(SA) Saudi Arabia: Campto | Irinotecan | Irinotel;
(SE) Sweden: Campto | Irinotecan accord | Irinotecan actavis | Irinotecan ebewe | Irinotecan fresenius kabi | Irinotecan hospira | Irinotecan Teva | Irinotecan vianex;
(SG) Singapore: Campto | Irinotecan dbl;
(SI) Slovenia: Campto | Irinotekan Actavis | Irinotekan ebewe | Irinotekanijev klorid mylan;
(SK) Slovakia: Campto | Irinotecan accord | Irinotecan ebewe | Irinotecan HCL Actavis | Irinotecan hikma | Irinotecan kabi | Irinotecan medac | Irinotecan stada | Irinotecan Teva;
(TH) Thailand: Campto | DBL Irinotecan | Irinotel | Irinotesin;
(TN) Tunisia: Campto | Irinotecan kabi | Irinotecan Mylan | Irinotesin;
(TR) Turkey: Campto | Irinocam | Tekamen;
(TW) Taiwan: Campto conc | Herocan conc | Irenax | Irino | Irinotecan | Irinotel;
(UA) Ukraine: Camptera | Campto | Camptomeda | Irinosindan | Irinotecan | Irinotecan accord | Irinoval | Irinovista | Iritero | Irnocam;
(UY) Uruguay: Efixano | Irinotecan | Irinotecan clorhidrato trihidrato Servycal | Itoxaril | Trinotecan;
(VE) Venezuela, Bolivarian Republic of: Elinatecan | Irinotecan;
(ZA) South Africa: Accord Irinotecan | Campto | Cipla Irinotecan | Irinotas | Irinotecan safeline | Iritero | Sandoz irinotecan;
(ZM) Zambia: Irinotel;
(ZW) Zimbabwe: Imtus | Irinotel

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Topic 13238 Version 475.0

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Irinotecan (conventional): Pediatric drug information