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Gemcitabine: Drug information

Gemcitabine: Drug information
2024© UpToDate, Inc. and its affiliates and/or licensors. All Rights Reserved.
For additional information see "Gemcitabine: Patient drug information" and "Gemcitabine: Pediatric drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Infugem [DSC]
Pharmacologic Category
  • Antineoplastic Agent, Antimetabolite;
  • Antineoplastic Agent, Antimetabolite (Pyrimidine Analog)
Dosing: Adult

Dosage guidance:

Safety: Prolongation of the infusion duration >60 minutes and administration more frequently than once weekly have been shown to increase toxicity.

Dosage form information: If using premixed infusion bags, select the premixed bag(s) that allows for a variance of ≤5% of the BSA-based calculated dose; do not use premixed infusions bags for patients requiring a bag size of <1,200 mg/dose (select a different formulation).

Clinical considerations: Refer to the protocol or institutional guidance for additional details of off-label dosing.

Biliary tract cancer, adjuvant therapy

Biliary tract cancer, adjuvant therapy (off-label use): IV: 1,000 mg/m2 on days 1 and 8 of a 21-day cycle (in combination with capecitabine) for 4 cycles, followed by capecitabine in combination with concurrent radiotherapy (Ref).

Biliary tract cancer, advanced

Biliary tract cancer, advanced (off-label use): IV: 1,000 mg/m2 over 30 minutes days 1 and 8 of a 21-day cycle (in combination with cisplatin) until disease progression or unacceptable toxicity or a maximum of 8 cycles (Ref) or 1,000 mg/m2 over 30 minutes days 1 and 8 of a 21-day cycle (in combination with capecitabine) until disease progression or unacceptable toxicity (Ref) or 1,000 mg/m2 infused at 10 mg/m2/minute every 2 weeks (in combination with oxaliplatin) until disease progression or unacceptable toxicity (Ref) or 1,000 mg/m2 on days 1 and 8 of a 21-day cycle (in combination with durvalumab and cisplatin) for up to 8 cycles, followed by durvalumab as a single agent until disease progression or unacceptable toxicity (Ref) or 1,000 mg/m2 on days 1 and 8 of a 21-day cycle (in combination with cisplatin [maximum 8 cycles] and pembrolizumab [maximum 35 cycles]) until disease progression or unacceptable toxicity (Ref).

Bladder cancer, muscle invasive, neoadjuvant therapy

Bladder cancer, muscle invasive, neoadjuvant therapy (off-label use): IV: 1,000 mg/m2 on days 1 and 8 of a 21-day treatment cycle (in combination with cisplatin) for 4 cycles (Ref) or 1,250 mg/m2 on days 1 and 8 of a 21-day treatment cycle (in combination with cisplatin) for 4 cycles (Ref).

Bladder cancer, non–muscle invasive, transitional cell, refractory

Bladder cancer, non–muscle invasive, transitional cell, refractory (off-label use): Intravesicular instillation : 2,000 mg (in 100 mL NS; retain for 1 hour) twice weekly for 3 weeks; repeat cycle every 4 weeks for at least 2 cycles (Ref).

Breast cancer, metastatic

Breast cancer, metastatic: IV: 1,250 mg/m2 over 30 minutes days 1 and 8; repeat cycle every 21 days (in combination with paclitaxel) until disease progression or unacceptable toxicity (Ref) or

Off-label dosing/combinations: IV: 800 mg/m2 over 30 minutes days 1, 8, and 15 of a 28-day treatment cycle (as a single agent) until disease progression or unacceptable toxicity; dose could be increased if the first cycle was tolerated (Ref) or 1,000 mg/m2 on days 1 and 8 every 3 weeks (in combination with carboplatin and pembrolizumab for triple-negative breast cancer) (Ref).

Cervical cancer, recurrent or persistent

Cervical cancer, recurrent or persistent (off-label use): IV: 1,000 mg/m2 days 1 and 8; repeat cycle every 21 days (in combination with cisplatin) (Ref) or 1,250 mg/m2 over 30 minutes days 1 and 8; repeat cycle every 21 days (in combination with cisplatin) (Ref) or 800 mg/m2 over 30 minutes days 1, 8, and 15; repeat cycle every 28 days (as a single-agent) (Ref) or 800 mg/m2 days 1 and 8; repeat cycle every 28 days (in combination with cisplatin) (Ref).

Head and neck cancer: nasopharyngeal, locally advanced, advanced, or metastatic

Head and neck cancer: nasopharyngeal, locally advanced, advanced, or metastatic (off-label use):

Locally advanced disease: Gemcitabine/cisplatin induction chemotherapy: IV: 1,000 mg/m2 on days 1 and 8 of a 21-day cycle (in combination with cisplatin) for 3 cycles followed by chemoradiation (Ref). A minimum of 2 cycles is recommended (Ref).

Adjuvant therapy for N2-3 disease: IV: 1,000 mg/m2 on days 1 and 8 every 3 weeks (in combination with cisplatin) for 3 cycles following concurrent chemoradiotherapy (Ref).

Metastatic or recurrent, locally advanced (first-line treatment): IV: 1,000 mg/m2 on days 1 and 8 of a 21-day cycle (in combination with cisplatin and toripalimab) until disease progression or unacceptable toxicity for up to a maximum of 6 combination cycles (whichever occurred first); followed by single-agent toripalimab until disease progression or unacceptable toxicity (Ref).

Advanced or metastatic disease: IV: 1,000 mg/m2 over 30 minutes days 1, 8, and 15 every 28 days (Ref) or 1,000 mg/m2 over 30 minutes days 1 and 8 every 21 days (in combination with vinorelbine) (Ref).

Hodgkin lymphoma, relapsed

Hodgkin lymphoma, relapsed (off-label use): IV: 1,000 mg/m2 (800 mg/m2 if post-transplant) over 30 minutes days 1 and 8; repeat cycle every 21 days (in combination with vinorelbine and doxorubicin liposomal) (Ref) or 800 mg/m2 days 1 and 4; repeat cycle every 21 days (in combination with ifosfamide, mesna, vinorelbine, and prednisolone) (Ref).

Malignant pleural mesothelioma

Malignant pleural mesothelioma (off-label use): IV: 1,250 mg/m2 over 30 minutes days 1, 8, and 15 every 28 days (as a single agent) for up to 10 cycles or until disease progression or unacceptable toxicity (Ref) or 1,000 mg/m2 over 30 minutes days 1, 8 and 15 every 28 days (in combination with cisplatin) for up to 6 cycles (Ref) or 1,250 mg/m2 over 30 minutes days 1 and 8 every 21 days (in combination with cisplatin) for up to 6 cycles (Ref).

Non-Hodgkin lymphoma, refractory

Non-Hodgkin lymphoma, refractory (off-label use): IV: 1,000 mg/m2 over 30 minutes days 1 and 8; repeat cycle every 21 days (in combination with cisplatin and dexamethasone) (Ref) or 1,000 mg/m2 every 15 to 21 days (in combination with oxaliplatin and rituximab) (Ref).

Non–small cell lung cancer, inoperable, locally advanced, or metastatic

Non–small cell lung cancer, inoperable, locally advanced, or metastatic: IV: 1,000 mg/m2 over 30 minutes on days 1, 8, and 15; repeat cycle every 28 days (in combination with cisplatin) for a maximum of 6 cycles (Ref) or 1,250 mg/m2 over 30 minutes on days 1 and 8; repeat cycle every 21 days (in combination with cisplatin) for a maximum of 6 cycles (Ref) or

Non-small cell lung cancer off-label dosing/combinations:

In combination with durvalumab, tremelimumab, and a platinum (squamous histology): IV: 1,000 or 1,250 mg/m2 on days 1 and 8 every 21 days (in combination with either cisplatin or carboplatin, and durvalumab and tremelimumab) for 4 cycles, followed by tremelimumab (for 1 additional dose) and durvalumab; continue durvalumab until disease progression or unacceptable toxicity (Ref).

In combination with carboplatin: IV: 1,000 mg/m2 over 30 minutes on days 1 and 8; repeat cycle every 21 days (in combination with carboplatin) for up to 4 cycles (Ref) or 1,000 mg/m2 over 30 minutes on days 1, 8, and 15; repeat cycle every 28 days (in combination with carboplatin) for up to 4 cycles (Ref).

In combination with docetaxel: IV: 1,000 mg/m2 over 30 minutes on days 1 and 8; repeat cycle every 21 days (in combination with docetaxel) for 8 cycles (Ref).

In combination with vinorelbine: IV: 1,000 mg/m2 on days 1, 8, and 15; repeat cycle every 28 days (in combination with vinorelbine) for 6 cycles (Ref).

In combination with nivolumab and cisplatin (neoadjuvant therapy): IV: 1,000 or 1,250 mg/m2 on days 1 and 8 every 3 weeks (in combination with nivolumab and cisplatin) for up to 3 cycles (Ref).

Ovarian cancer, advanced

Ovarian cancer, advanced: IV: 1,000 mg/m2 over 30 minutes days 1 and 8; repeat cycle every 21 days (in combination with carboplatin) (Ref) or

Off-label dosing (as a single agent): IV: 1,000 mg/m2 over 30 to 60 minutes days 1 and 8; repeat cycle every 21 days (Ref).

Pancreatic cancer, locally advanced or metastatic

Pancreatic cancer, locally advanced or metastatic: IV: Initial: 1,000 mg/m2 over 30 minutes once weekly for 7 weeks followed by 1 week rest; then administer on days 1, 8, and 15 every 28 days (Ref) or

Off-label dosing/combinations: IV: 1,000 mg/m2 days 1, 8, and 15 every 28 days (in combination with paclitaxel [protein bound]) (Ref) or 1,000 mg/m2 over 30 minutes days 1, 8, and 15 every 28 days (in combination with capecitabine) (Ref) or 1,000 mg/m2 over 30 minutes weekly for up to 7 weeks followed by 1 week rest; then weekly for 3 weeks out of every 4 weeks (in combination with erlotinib) (Ref) or 1,000 mg/m2 over 30 minutes days 1 and 15 every 28 days (in combination with cisplatin) (Ref) or 1,000 mg/m2 infused at 10 mg/m2/minute every 14 days (in combination with oxaliplatin) (Ref).

Pancreatic cancer, potentially curable, adjuvant therapy

Pancreatic cancer, potentially curable, adjuvant therapy (off-label use; alternative therapy): Note: American Society of Clinical Oncology guidelines for potentially curable pancreatic cancer recommend 6 months of adjuvant therapy if recovery is complete; while first-line therapy with another regimen is preferred, the gemcitabine/capecitabine regimen or single-agent gemcitabine therapy are options if toxicity/tolerance are concerns with the preferred regimen (Ref).

Combination regimen: IV: 1,000 mg/m2 on days 1, 8, and 15 every 28 days (in combination with capecitabine) for 6 cycles beginning within 12 weeks of resection (Ref).

Single-agent therapy: IV: 1,000 mg/m2 on days 1, 8, and 15 every 28 days for 6 cycles (Ref).

Renal carcinoma, non-clear cell, metastatic

Renal carcinoma, non-clear cell, metastatic (off-label use): IV: 1,250 mg/m2 over 30 minutes on days 1 and 8 every 21 days (in combination with either cisplatin or carboplatin) or until disease progression or unacceptable toxicity for up to a maximum of 9 cycles (Ref).

Sarcomas

Sarcomas (off-label uses):

Ewing sarcoma, refractory: IV: 675 mg/m2 over 90 minutes days 1 and 8; repeat cycle every 21 days (in combination with docetaxel) (Ref).

Osteosarcoma, refractory: IV: 675 mg/m2 over 90 minutes days 1 and 8; repeat cycle every 21 days (in combination with docetaxel) (Ref) or 1,000 mg/m2 weekly for 7 weeks followed by 1 week rest; then weekly for 3 weeks out of every 4 weeks (Ref).

Soft tissue sarcoma, advanced: IV: 800 mg/m2 over 90 minutes days 1 and 8; repeat cycle every 21 days (in combination with vinorelbine) (Ref) or 675 mg/m2 over 90 minutes days 1 and 8; repeat cycle every 21 days (in combination with docetaxel) (Ref) or 900 mg/m2 over 90 minutes days 1 and 8; repeat cycle every 21 days (in combination with docetaxel) (Ref).

Small cell lung cancer, relapsed/refractory

Small cell lung cancer, relapsed/refractory (off-label use): IV: 1,000 to 1,250 mg/m2 over 30 minutes days 1, 8, and 15 every 28 days (as a single agent) (Ref).

Testicular cancer, refractory germ cell

Testicular cancer, refractory germ cell (off-label use): IV: 1,000 to 1,250 mg/m2 over 30 minutes days 1 and 8 every 21 days (in combination with oxaliplatin) (Ref) or 1,000 mg/m2 over 30 minutes days 1, 8, and 15 every 28 days for up to 6 cycles (in combination with paclitaxel) (Ref) or 800 mg/m2 over 30 minutes days 1 and 8 every 21 days (in combination with oxaliplatin and paclitaxel) (Ref).

Thymic malignancies, refractory

Thymic malignancies, refractory (off-label use): IV: 1,000 mg/m2 on days 1 and 8 every 21 days (in combination with capecitabine) until disease progression (Ref).

Unknown primary carcinoma

Unknown primary carcinoma (off-label use): IV: 1,250 mg/m2 days 1 and 8 every 21 days (in combination with cisplatin) (Ref) or 1,000 mg/m2 over 30 minutes days 1 and 8 every 21 days for up to 6 cycles (in combination with docetaxel) (Ref) or 1,000 mg/m2 on days 1 and 8 every 21 days (in combination with irinotecan) for 4 to 6 cycles (Ref).

Urothelial carcinoma, locally advanced, unresectable, or metastatic

Urothelial carcinoma, locally advanced, unresectable, or metastatic (off-label use): IV: 1,000 mg/m2 over 30 to 60 minutes days 1, 8, and 15; repeat cycle every 28 days (in combination with cisplatin) for up to 6 cycles (Ref) or 1,000 mg/m2 over 30 minutes days 1 and 8; repeat cycle every 21 days (in combination with carboplatin) until disease progression or unacceptable toxicity (Ref) or 1,000 mg/m2 over 30 minutes on days 1 and 8 every 21 days (in combination with paclitaxel and cisplatin [PCG regimen]) for up to 6 cycles or until disease progression or unacceptable toxicity (Ref) or 1,000 mg/m2 over 30 minutes on days 1 and 8 every 21 days (in combination with nivolumab and cisplatin) for up to 6 cycles, followed by nivolumab (as a single agent) until disease progression, unacceptable toxicity, or for up to 2 years (Ref).

Uterine sarcoma

Uterine sarcoma (off-label use): IV: 900 mg/m2 over 90 minutes days 1 and 8 every 21 days (in combination with docetaxel) (Ref) or 1,000 mg/m2 over 30 minutes days 1, 8, and 15 every 28 days (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.

Dosage adjustment prior to treatment initiation:

Altered kidney function:

CrCl ≥30 mL/minute: IV: No dosage adjustment necessary (Ref).

CrCl <30 mL/minute: IV: No dosage adjustment necessary. However, risk of hematologic toxicity may be increased in these patients, which may require gemcitabine dose modification (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. Younger 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 necessary (Ref).

Hemodialysis, intermittent (thrice weekly): Gemcitabine is metabolized intracellularly and then converted to dFdU; dFdU is dialyzable (~50% removal by single session (Ref)).

IV: No dosage adjustment necessary (Ref). Consider performing hemodialysis 6 to 12 hours after completing the gemcitabine infusion to limit the potential toxic effects of dFdU accumulation (Ref). Risk of hematologic toxicity may be increased in patients with severe kidney impairment, which may require gemcitabine dose modification (Ref).

Peritoneal dialysis: Extent of dialyzability unknown:

IV: No dosage adjustment necessary (Ref). Risk of hematologic toxicity may be increased in patients with severe kidney impairment, which may require gemcitabine dose modification (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) and minimal residual kidney function unless otherwise noted. Close monitoring of response and adverse reactions (eg, myelosuppression) due to drug accumulation is important.

IV: No dosage adjustment necessary (Ref).

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

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

IV: No dosage adjustment necessary (expert opinion). Consider performing PIRRT 6 to 12 hours after completing the gemcitabine infusion to limit the potential toxic effects of dFdU accumulation (Ref).

Dosage adjustment for renal toxicity during treatment:Discontinue if severe renal toxicity or hemolytic uremic syndrome occur during gemcitabine treatment.

Dosing: Hepatic Impairment: Adult

Dosage adjustment for hepatic impairment prior to treatment initiation:

There are no dosage adjustments provided in the manufacturer's labeling. The following adjustments have been reported:

Transaminases elevated (with normal bilirubin or total bilirubin <1.6 mg/dL): No dosage adjustment necessary (Ref).

Serum bilirubin >1.6 mg/dL: Use initial dose of 800 mg/m2; may escalate if tolerated (Ref).

Total bilirubin ≥1.6 mg/dL: May begin with 80% of the usual gemcitabine dose and increase the dose if tolerated or may consider initiating with full dose and careful active monitoring (Ref).

Dosage adjustment for hepatotoxicity during treatment: Discontinue if severe hepatotoxicity occurs during gemcitabine treatment.

Dosing: Obesity: Adult

American Society of Clinical Oncology guidelines for appropriate chemotherapy dosing in adults with cancer with a BMI ≥30 kg/m2: Utilize patient's actual body weight for calculation of BSA- or weight-based dosing; manage regimen-related toxicities in the same manner as for patients with a BMI <30 kg/m2; if a dose reduction is utilized due to toxicity, may consider resumption of full, weight-based dosing (or previously tolerated dose level) with subsequent cycles only if dose escalations are allowed in the prescribing information, if contributing underlying factors (eg, hepatic or kidney impairment) are sufficiently resolved, AND if performance status has markedly improved or is considered adequate (Ref).

Dosing: Adjustment for Toxicity: Adult

Note: If administering in combination, concomitant chemotherapy agents may also require treatment interruption, dosage reduction, and/or discontinuation.

Nonhematologic toxicity (all indications):

Withhold or decrease gemcitabine dose by 50% for severe (grade 3 or 4) nonhematologic toxicity until resolved (excludes nausea, vomiting, or alopecia [no dose modifications are recommended for these toxicities]).

Permanently discontinue gemcitabine for any of the following: Unexplained dyspnea (with or without bronchospasm), or evidence of severe pulmonary toxicity, severe hepatotoxicity or severe liver injury, hemolytic uremic syndrome or severe renal impairment, capillary leak syndrome, posterior reversible encephalopathy syndrome.

Hematologic toxicity:

Breast cancer:

Day 1:

ANC ≥1,500/mm3 and platelet count ≥100,000/mm3: Administer 100% of full gemcitabine dose.

ANC <1,500/mm3 or platelet count <100,000/mm3: Hold gemcitabine dose.

Day 8:

ANC ≥1,200/mm3 and platelet count >75,000/mm3: Administer 100% of full gemcitabine dose.

ANC 1,000 to 1,199/mm3 or platelet count 50,000 to 75,000/mm3: Administer 75% of full gemcitabine dose.

ANC 700 to 999/mm3 and platelet count ≥50,000/mm3: Administer 50% of full gemcitabine dose.

ANC <700/mm3 or platelet count <50,000/mm3: Hold gemcitabine dose.

Non–small cell lung cancer (cisplatin dosage may also require adjustment):

ANC ≥1,000/mm3 and platelet count ≥100,000/mm3: Administer 100% of full gemcitabine dose.

ANC 500 to 999/mm3 or platelet count 50,000 to 99,999/mm3: Administer 75% of full gemcitabine dose.

ANC <500/mm3 or platelet count <50,000/mm3: Hold gemcitabine dose.

Ovarian cancer:

Day 1:

ANC ≥1,500/mm3 and platelet count ≥100,000/mm3: Administer 100% of full gemcitabine dose.

ANC <1,500/mm3 or platelet count <100,000/mm3: Delay treatment cycle.

Day 8:

ANC ≥1,500/mm3 and platelet count ≥100,000/mm3: Administer 100% of full gemcitabine dose.

ANC 1,000 to 1,499/mm3 or platelet count 75,000 to 99,999/mm3: Administer 50% of full gemcitabine dose.

ANC <1,000/mm3 or platelet count <75,000/mm3: Hold gemcitabine dose.

Hematologic toxicity in previous cycle (dosing adjustment for subsequent cycles):

Initial occurrence: ANC <500/mm3 for >5 days, ANC <100/mm3 for >3 days, neutropenic fever, platelet count <25,000/mm3, or cycle delay >1 week due to toxicity: Permanently reduce gemcitabine dose to 800 mg/m2 on days 1 and 8.

Subsequent occurrence (after initial dose reduction): ANC <500/mm3 for >5 days, ANC <100/mm3 for >3 days, neutropenic fever, platelet count <25,000/mm3, or cycle delay >1 week due to toxicity: Permanently reduce gemcitabine dose to 800 mg/m2 and administer on day 1 only.

Pancreatic cancer (locally advanced or metastatic):

ANC ≥1,000/mm3 and platelet count ≥100,000/mm3: Administer 100% of full gemcitabine dose.

ANC 500 to 999/mm3 or platelet count 50,000 to 99,999/mm3: Administer 75% of full gemcitabine dose.

ANC <500/mm3 or platelet count <50,000/mm3: Hold gemcitabine dose.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Gemcitabine: Pediatric drug information")

Note: Details concerning dosing in combination regimens should also be consulted. Prolongation of the infusion time >60 minutes and administration more frequently than once weekly have been shown to increase toxicity. Gemcitabine is associated with a low emetic potential risk; antiemetics are recommended to prevent nausea and vomiting (Ref).

Germ cell tumor, refractory

Germ cell tumor, refractory: Limited data available: Adolescents ≥16 years: IV: 1,200 mg/m2/dose over 30 minutes on days 1, 8, and 15; repeat cycle every 28 days for up to 6 cycles (Ref).

Hodgkin lymphoma, relapsed or refractory

Hodgkin lymphoma, relapsed or refractory: Limited data available; dosing regimens variable:

Gemcitabine in combination with brentuximab: Children and Adolescents: IV: 1,000 mg/m2/dose over 100 minutes on days 1 and 8 (in combination with brentuximab); repeat cycle every 21 days; in the trial, the inclusion criteria had no minimum age and the youngest patient was 5 years of age (Ref).

Gemcitabine in combination with vinorelbine:

Children ≥10 years and Adolescents: IV: 1,000 mg/m2/dose over 100 minutes on days 1 and 8 (in combination with vinorelbine); repeat cycle every 21 days (Ref).

Adolescents ≥17 years: IV: 1,000 mg/m2/dose over 60 minutes on days 1, 8, and 15 (in combination with vinorelbine); repeat cycle every 28 days (Ref). Alternatively, 800 mg/m2/dose on days 1 and 4 (in combination with ifosfamide and vinorelbine); repeat cycle every 21 days (Ref).

Sarcomas, refractory or relapsed

Sarcomas, refractory or relapsed (including Ewing sarcoma, osteosarcoma): Limited data available: Children ≥3 years and Adolescents: IV: 675 or 1,000 mg/m2/dose over 90 minutes on days 1 and 8 (in combination with docetaxel); repeat cycle every 21 days (Ref). Alternatively, 1,000 mg/m2/dose over 30 minutes on days 1 and 8 (in combination with oxaliplatin and irinotecan); repeat cycle every 28 days (Ref).

Solid tumors, relapsed/refractory

Solid tumors, relapsed/refractory: Limited data available: Children ≥1 year and Adolescents: IV: 1,000 mg/m2/dose over 30 minutes on days 1 and 8 (in combination with oxaliplatin and irinotecan); repeat cycle every 28 days (Ref). Alternatively, 1,000 mg/m2/dose over 100 minutes on day 1 (in combination with oxaliplatin); repeat cycle every 14 days (Ref).

Note: Dosage reductions for toxicity (Ref): 800 mg/m2/dose over 80 minutes if grade 3/4 nonhematological toxicity, grade 4 neutropenia with documented infection or lasting >7 days, grade 3/4 thrombocytopenia lasting >7 days or requiring platelets during >7 days, or delay of next cycle ≥14 days; if necessary, dose could be reduced a second time to 600 mg/m2/dose.

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. Refer to specific protocol for management in pediatric patients if available.

Adult:

Nonhematologic toxicity (all indications):

Hold or decrease gemcitabine dose by 50% for the following: Severe (grade 3 or 4) nonhematologic toxicity until resolved (excludes nausea, vomiting, or alopecia [no dose modifications recommended]).

Permanently discontinue gemcitabine for any of the following: Unexplained dyspnea (or other evidence of severe pulmonary toxicity), severe hepatotoxicity, hemolytic uremic syndrome (HUS), capillary leak syndrome (CLS), posterior reversible encephalopathy syndrome (PRES).

Hematologic toxicity:

Breast cancer:

Day 1:

Absolute neutrophil count (ANC) ≥1,500/mm3 and platelet count ≥100,000/mm3: Administer 100% of full dose.

ANC <1,500/mm3 or platelet count <100,000/mm3: Hold dose.

Day 8:

ANC ≥1,200/mm3 and platelet count >75,000/mm3: Administer 100% of full dose.

ANC 1,000 to 1,199/mm3 or platelet count 50,000 to 75,000/mm3: Administer 75% of full dose.

ANC 700 to 999/mm3 and platelet count ≥50,000/mm3: Administer 50% of full dose.

ANC <700/mm3 or platelet count <50,000/mm3: Hold dose.

Non-small cell lung cancer (cisplatin dosage may also require adjustment):

ANC ≥1,000/mm3 and platelet count ≥100,000/mm3: Administer 100% of full dose.

ANC 500 to 999/mm3 or platelet count 50,000 to 99,999/mm3: Administer 75% of full dose.

ANC <500/mm3 or platelet count <50,000/mm3: Hold dose.

Ovarian cancer:

Day 1:

ANC ≥1,500/mm3 and platelet count ≥100,000/mm3: Administer 100% of full dose.

ANC <1,500/mm3 or platelet count <100,000/mm3: Delay treatment cycle.

Day 8:

ANC ≥1,500/mm3 and platelet count ≥100,000/mm3: Administer 100% of full dose.

ANC 1,000 to 1,499/mm3 or platelet count 75,000 to 99,999/mm3: Administer 50% of full dose.

ANC <1,000/mm3 or platelet count <75,000/mm3: Hold dose.

Hematologic toxicity in previous cycle (dosing adjustment for subsequent cycles):

Initial occurrence: ANC <500/mm3 for >5 days, ANC <100/mm3 for >3 days, febrile neutropenia, platelet count <25,000/mm3, or cycle delay >1 week due to toxicity: Permanently reduce gemcitabine to 800 mg/m2 on days 1 and 8.

Subsequent occurrence: ANC <500/mm3 for >5 days, ANC <100/mm3 for >3 days, neutropenic fever, platelet count <25,000/mm3, or cycle delay >1 week due to toxicity: Permanently reduce gemcitabine to 800 mg/m2 and administer on day 1 only.

Pancreatic cancer:

ANC ≥1,000/mm3 and platelet count ≥100,000/mm3: Administer 100% of full dose.

ANC 500 to 999/mm3 or platelet count 50,000 to 99,999/mm3: Administer 75% of full dose.

ANC <500/mm3 or platelet count <50,000/mm3: Hold dose.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; based on experience in adult patients, discontinue if severe kidney impairment or hemolytic uremic syndrome (HUS) occurs during gemcitabine treatment.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling; use with caution. Based on experience in adult patients, discontinue if severe hepatotoxicity occurs during treatment with gemcitabine.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency of adverse reactions reported for single-agent use of gemcitabine only.

>10%:

Cardiovascular: Peripheral edema (20%), edema (≤13%)

Central nervous system: Drowsiness (11%)

Dermatologic: Skin rash (30%), alopecia (15%)

Gastrointestinal: Nausea and vomiting (69%), diarrhea (19%), stomatitis (11%; grade 3: <1%)

Genitourinary: Proteinuria (45%), hematuria (35%)

Hematologic & oncologic: Anemia (68%; grade 3: 7%; grade 4: 1%), neutropenia (63%; grade 3: 19%; grade 4: 6%), thrombocytopenia (24%; grade 3: 4%; grade 4: 1%), hemorrhage (17%; grade 3: <1%; grade 4: <1%)

Hepatic: Increased serum alanine aminotransferase (68%), increased serum aspartate aminotransferase (67%), increased serum alkaline phosphatase (55%), hyperbilirubinemia (13%)

Infection: Infection (16%)

Renal: Increased blood urea nitrogen (16%)

Respiratory: Dyspnea (23%), flu-like symptoms (19%)

Miscellaneous: Fever (41%)

1% to 10%:

Central nervous system: Paresthesia (10%)

Local: Injection site reaction (4%)

Renal: Increased serum creatinine (8%)

Respiratory: Bronchospasm (<2%)

Frequency not defined:

Hypersensitivity: Nonimmune anaphylaxis

<1%, postmarketing, and/or case reports (reported with single-agent use or with combination therapy): Acute myocardial infarction, acute respiratory distress syndrome, bullous skin disease, capillary leak syndrome, cardiac arrhythmia, cardiac failure, cellulitis (including pseudocellulitis), cerebrovascular accident (Kuenen 2002), desquamation, eosinophilic pneumonitis, gangrene of skin and/or subcutaneous tissues, hemolytic-uremic syndrome, hepatic failure, hepatic sinusoidal obstruction syndrome, hepatotoxicity, interstitial pneumonitis, petechia (Nishijima 2013; Zupancic 2007), pruritus (Curtis 2016), pulmonary edema, pulmonary fibrosis, radiation recall phenomenon, renal failure syndrome, respiratory failure, reversible posterior leukoencephalopathy syndrome, sepsis, severe dermatological reaction, supraventricular cardiac arrhythmia, thrombotic microangiopathy, thrombotic thrombocytopenic purpura (Nishijima 2013; Zupancic 2007), vasculitis (peripheral)

Contraindications

Known hypersensitivity to gemcitabine or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Bone marrow suppression: May cause bone marrow suppression (neutropenia, thrombocytopenia, and anemia), including grade 3 or 4 hematologic toxicity. Myelosuppression is generally the dose-limiting toxicity and is increased when used in combination with other chemotherapy.

• Capillary leak syndrome: Capillary leak syndrome with serious consequences has been reported, both with single-agent gemcitabine and with combination chemotherapy.

• Hemolytic uremic syndrome: Hemolytic uremic syndrome (HUS) has been reported; may lead to renal failure and dialysis (including fatalities). Most fatal cases of renal failure were due to HUS. Thrombotic microangiopathy other than HUS has also been reported. Assess for HUS in patients who develop anemia with microangiopathic hemolysis, elevation of bilirubin or lactate dehydrogenase, reticulocytosis, severe thrombocytopenia, and/or renal failure (increased serum creatinine or BUN). Renal failure may not be reversible despite gemcitabine discontinuation.

• Hepatotoxicity: Serious hepatotoxicity (including liver failure and death) has been reported with gemcitabine (when used alone or with other potentially hepatotoxic medications). The use of gemcitabine in patients with hepatic impairment (history of cirrhosis, hepatitis, or alcoholism) or in patients with hepatic metastases may lead to exacerbation of hepatic impairment.

• Hypersensitivity: Anaphylaxis and allergic reactions (including bronchospasm and anaphylactoid reactions) have been observed.

• Posterior reversible encephalopathy syndrome: Posterior reversible encephalopathy syndrome (PRES) has been reported, both with single-agent therapy and with combination chemotherapy. PRES may manifest with blindness, confusion, headache, hypertension, lethargy, seizure, and other visual and neurologic disturbances.

• Pulmonary toxicity: Pulmonary toxicity, including adult respiratory distress syndrome, interstitial pneumonitis, pulmonary edema, and pulmonary fibrosis, has been observed; may lead to respiratory failure (some fatal) despite gemcitabine discontinuation. The onset of pulmonary toxicity symptoms may be delayed up to 2 weeks beyond the last gemcitabine dose.

Special populations:

• Older adult: In some studies, higher rates of grades 3 and 4 neutropenia and thrombocytopenia have been observed in patients ≥65 years of age (compared to patients <65 years of age).

• Radiation therapy recipients: Gemcitabine is not recommended for use in combination with radiation therapy; radiation toxicity, including tissue injury, severe mucositis, esophagitis, or pneumonitis, has been reported with concurrent and nonconcurrent administration. Gemcitabine has radiosensitizing activity when gemcitabine and radiation therapy are given together or ≤7 days apart. Radiation recall may occur when gemcitabine and radiation therapy are given >7 days apart.

Dosage form specific issues:

• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated with hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Zar 2007). See manufacturer's labeling.

Other warnings/precautions:

• Infusion duration/frequency: Prolongation of the infusion duration >60 minutes or more frequent than weekly dosing have been shown to alter the half-life and increase toxicity (hypotension, flu-like symptoms, myelosuppression, weakness). A fixed-dose rate (FDR) infusion rate of 10 mg/m2/minute has been studied in adults in order to optimize the pharmacokinetics (off-label); prolonged infusion times increase the intracellular accumulation of the active metabolite, gemcitabine triphosphate (Ko 2006; Tempero 2003). Patients who receive gemcitabine FDR experience more grade 3/4 hematologic toxicity (Ko 2006; Poplin 2009).

• Multiple concentrations: Gemcitabine is available in multiple formulations and concentrations; verify product and concentration prior to admixture to assure appropriate dose preparation.

Warnings: Additional Pediatric Considerations

Some dosage forms may contain propylene glycol; in neonates, large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).

Dosage Forms: US

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

Solution, Intravenous:

Generic: 200 mg/5.26 mL (5.26 mL); 200 mg/2 mL (2 mL); 1 g/10 mL (10 mL); 1 g/26.3 mL (26.3 mL); 1.5 g/15 mL (15 mL); 2 g/20 mL (20 mL); 2 g/52.6 mL (52.6 mL)

Solution, Intravenous [preservative free]:

Generic: 200 mg/5.26 mL (5.26 mL); 1 g/26.3 mL (26.3 mL); 2 g/52.6 mL (52.6 mL)

Solution, Intravenous, as hydrochloride [preservative free]:

Infugem: gemcitabine hydrochloride 1,200 mg/120 mL in NaCl 0.9% (120 mL [DSC]); gemcitabine hydrochloride 2,200 mg/220 mL in NaCl 0.9% (220 mL [DSC]); gemcitabine hydrochloride 2,000 mg/200 mL in NaCl 0.9% (200 mL [DSC]); gemcitabine hydrochloride 1,300 mg/130 mL in NaCl 0.9% (130 mL [DSC]); gemcitabine hydrochloride 1,400 mg/140 mL in NaCl 0.9% (140 mL [DSC]); gemcitabine hydrochloride 1,500 mg/150 mL in NaCl 0.9% (150 mL [DSC]); gemcitabine hydrochloride 1,600 mg/160 mL in NaCl 0.9% (160 mL [DSC]); gemcitabine hydrochloride 1,700 mg/170 mL in NaCl 0.9% (170 mL [DSC]); gemcitabine hydrochloride 1,800 mg/180 mL in NaCl 0.9% (180 mL [DSC]) [latex free]

Infugem: gemcitabine hydrochloride 1,900 mg/190 mL in NaCl 0.9% (190 mL [DSC])

Solution Reconstituted, Intravenous:

Generic: 200 mg (1 ea); 1 g (1 ea); 2 g (1 ea)

Solution Reconstituted, Intravenous [preservative free]:

Generic: 200 mg (1 ea); 1 g (1 ea)

Generic Equivalent Available: US

Yes

Pricing: US

Solution (Gemcitabine HCl Intravenous)

1 g/10 mL (per mL): $7.92

1 g/26.3 mL (per mL): $1.00 - $2.07

1.5 g/15 mL (per mL): $6.60

2 g/20 mL (per mL): $7.04

2 g/52.6 mL (per mL): $1.02 - $2.07

200 mg/2 mL (per mL): $26.40

200 mg/5.26 mL (per mL): $1.14 - $2.13

Solution (reconstituted) (Gemcitabine HCl Intravenous)

1 g (per each): $50.26 - $800.23

2 g (per each): $136.18 - $154.44

200 mg (per each): $9.29 - $14.46

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.

Solution, Intravenous:

Generic: 38 mg/mL (5.3 mL, 26.3 mL, 52.6 mL); 40 mg/mL (5 mL, 25 mL, 50 mL)

Solution Reconstituted, Intravenous:

Generic: 1 g (1 ea); 2 g (1 ea)

Administration: Adult

IV: For labeled indications, infuse over 30 minutes; if utilizing premixed infusion bags and 2 premixed bags are required, infuse the total volume of both bags over 30 minutes (follow manufacturer’s instructions to spike premixed bag and add administration set).

For off-label uses, infusion times may vary (refer to specific references). Note: Prolongation of the infusion time >60 minutes has been shown to increase toxicity. Gemcitabine has been administered at a fixed-dose rate (FDR) infusion rate of 10 mg/m2/minute to optimize the pharmacokinetics (off-label); prolonged infusion times increase the intracellular accumulation of the active metabolite, gemcitabine triphosphate (Ref). Patients who receive gemcitabine FDR experience more grade 3/4 hematologic toxicity (Ref).

Bladder cancer (transitional cell; off-label use): For intravesicular (bladder) instillation (off-label route), gemcitabine was diluted in 50 to 100 mL normal saline; patients were instructed to retain in the bladder for 1 hour (Ref).

Administration: Pediatric

IV: Per manufacturer: Infuse over 30 minutes; if utilizing premixed infusion bags and 2 premixed bags are required, infuse the total volume of both bags over 30 minutes; however, for other protocols and uses, infusion times may vary (refer to specific protocols). Note: Prolongation of the infusion time >60 minutes has been shown to prolong gemcitabine's half-life and increase toxicity in adults; gemcitabine has been administered in adults utilizing a fixed-dose rate (FDR) of 10 mg/m2/minute to optimize the pharmacokinetics; prolonged infusion times increase the intracellular accumulation of the active metabolite, gemcitabine triphosphate (Ref); patients who receive gemcitabine FDR experience more grade 3/4 hematologic toxicity (Ref).

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).

Use: Labeled Indications

Breast cancer, metastatic: First-line treatment of metastatic breast cancer (in combination with paclitaxel) after failure of adjuvant chemotherapy that contained an anthracycline (unless anthracyclines are contraindicated).

Non-small cell lung cancer, inoperable, locally advanced, or metastatic: First-line treatment (in combination with cisplatin) of inoperable, locally advanced (stage IIIA or IIIB) or metastatic (stage IV) non-small cell lung cancer (NSCLC).

Ovarian cancer, advanced: Treatment of advanced ovarian cancer (in combination with carboplatin) that has relapsed at least 6 months following completion of platinum-based chemotherapy.

Pancreatic cancer, locally advanced or metastatic: First-line treatment of locally advanced (nonresectable stage II or III) or metastatic (stage IV) pancreatic adenocarcinoma. Gemcitabine is indicated for patients previously treated with fluorouracil.

Guideline recommendations:

Metastatic pancreatic cancer: American Society of Clinical Oncology (ASCO) guidelines for metastatic pancreatic cancer (ASCO [Sohal 2020]) recommend gemcitabine (in combination with paclitaxel [protein bound]) as first-line therapy in patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, a relatively favorable comorbidity profile, a preference for relatively aggressive therapy, and a suitable support system. First-line therapy with single-agent gemcitabine is recommended in patients with ECOG performance status of 2 or a comorbidity profile prohibiting more aggressive therapy when there is a preference for cancer-directed therapy; paclitaxel (protein bound), capecitabine, or erlotinib (added to gemcitabine) may also be offered (with proactive dose/schedule adjustments to minimize toxicities) in this situation. Gemcitabine (in combination with paclitaxel [protein bound]) may be utilized as second-line therapy in patients who received first-line FOLFIRINOX therapy, have an ECOG performance status of 0 or 1, have a relatively favorable comorbidity profile, a preference for aggressive therapy, and a suitable support system. Second-line therapy with gemcitabine (alone or with paclitaxel [protein bound]) may also be considered as an option (with proactive dose/schedule adjustments) in patients with ECOG performance status of 2 or a comorbidity profile prohibiting more aggressive regimens when there is a preference to pursue cancer-directed therapy.

Locally advanced, unresectable pancreatic cancer: According to the ASCO guidelines for locally advanced, unresectable pancreatic cancer (ASCO [Balaban 2016]), induction with 6 months of initial systemic therapy (with a combination regimen) is generally recommended, although there is not enough evidence to encourage one regimen over another, and gemcitabine-based therapies recommended in the metastatic setting have not been evaluated in randomized controlled studies for locally advanced unresectable pancreatic cancer. If disease progression occurs, treatment according to guidelines for metastatic pancreatic cancer should be offered.

Use: Off-Label: Adult

Biliary tract cancer, adjuvant therapy; Biliary tract cancer, advanced; Bladder cancer, muscle invasive, neoadjuvant therapy; Bladder cancer, non–muscle invasive, transitional cell, refractory; Cervical cancer, recurrent or persistent; Ewing sarcoma, refractory; Head and neck cancer: nasopharyngeal, locally advanced, advanced, or metastatic; Hodgkin lymphoma, relapsed; Malignant pleural mesothelioma; Non-Hodgkin lymphoma, relapsed or refractory; Osteosarcoma, refractory; Pancreatic cancer, potentially curable, adjuvant therapy; Renal carcinoma, non-clear cell, metastatic; Small cell lung cancer, refractory or relapsed; Soft tissue sarcoma, advanced; Testicular cancer, refractory germ cell; Thymic malignancies, refractory; Unknown-primary carcinoma; Urothelial carcinoma, locally advanced, unresectable, or metastatic; Uterine sarcoma

Medication Safety Issues
Sound-alike/look-alike issues:

Gemcitabine may be confused with gemtuzumab ozogamicin

Gemzar may be confused with Zinecard

High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (chemotherapeutic agent, parenteral and oral) 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:

Multiple concentrations: Gemcitabine is available in multiple formulations and concentrations; verify product and concentration prior to admixture to assure appropriate dose preparation.

Metabolism/Transport Effects

None known.

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.

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

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

Bleomycin: Gemcitabine may enhance the adverse/toxic effect of Bleomycin. The risk of pulmonary toxicity may be increased. Risk C: Monitor therapy

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

Cedazuridine: May increase the serum concentration of Cytidine Deaminase Substrates. Risk X: Avoid combination

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: Agents that Undergo Intracellular Phosphorylation may diminish the therapeutic effect of Cladribine. Risk X: Avoid combination

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

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

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

Fluorouracil (Systemic): Gemcitabine may increase the serum concentration of Fluorouracil (Systemic). Risk C: Monitor therapy

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

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

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

PACLitaxel (Protein Bound): May enhance the adverse/toxic effect of Gemcitabine. Specifically, the risk for thrombotic microangiopathy may be increased with this combination. 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

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

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

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

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

Warfarin: Gemcitabine may enhance the anticoagulant effect of Warfarin. Risk C: Monitor therapy

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

Reproductive Considerations

Verify pregnancy status (with pregnancy test) prior to treatment initiation in patients who could become pregnant. Patients who could become pregnant should use effective contraception during treatment and for 6 months after the final gemcitabine dose. Patients with partners who could become pregnant should use effective contraception during treatment and for 3 months after the final gemcitabine dose.

Pregnancy Considerations

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

Information related to the use of gemcitabine in pregnancy is limited (Lubner 2011; Wiesweg 2014).

A pregnancy registry is available for all cancers diagnosed during pregnancy at Cooper Health (877-635-4499).

Breastfeeding Considerations

It is not known if gemcitabine is present in breast milk.

Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended during treatment and for at least 1 week after the last gemcitabine dose.

Monitoring Parameters

CBC with differential and platelet count (prior to each dose); LFTs (baseline and periodically), renal function (serum creatinine and BUN; prior to initiation of therapy and periodically, thereafter); monitor electrolytes, including potassium, magnesium, and calcium (when in combination therapy with cisplatin). Evaluate pregnancy status prior to treatment initiation (in patients who could become pregnant). Monitor pulmonary function. Monitor for signs/symptoms of capillary leak syndrome, hemolytic uremic syndrome (HUS; assess for HUS if anemia with microangiopathic hemolysis, elevation of bilirubin or lactate dehydrogenase, reticulocytosis, severe thrombocytopenia, and/or renal failure [increased serum creatinine or BUN] develops), hepatotoxicity, hypersensitivity, posterior reversible encephalopathy syndrome (confirm diagnosis with MRI), and pulmonary toxicity.

The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.

Mechanism of Action

Gemcitabine is a pyrimidine antimetabolite that inhibits DNA synthesis by inhibition of DNA polymerase and ribonucleotide reductase, cell cycle-specific for the S-phase of the cycle (also blocks cellular progression at G1/S-phase). Gemcitabine is phosphorylated intracellularly by deoxycytidine kinase to gemcitabine monophosphate, which is further phosphorylated to active metabolites gemcitabine diphosphate and gemcitabine triphosphate. Gemcitabine diphosphate inhibits DNA synthesis by inhibiting ribonucleotide reductase; gemcitabine triphosphate incorporates into DNA and inhibits DNA polymerase.

Pharmacokinetics (Adult Data Unless Noted)

Distribution: Widely distributed into tissues; present in ascitic fluid; Vd: Infusions <70 minutes: 50 L/m2; Long infusion times (70 to 285 minutes): 370 L/m2

Protein binding: Negligible

Metabolism: Metabolized intracellularly by nucleoside kinases to the active diphosphate (dFdCDP) and triphosphate (dFdCTP) nucleoside metabolites; the metabolites are then converted to inactive uracil metabolite (dFdU).

Half-life elimination:

Gemcitabine: Infusion time ≤70 minutes: 42 to 94 minutes; infusion time 3 to 4 hours: 4 to 10.5 hours (affected by age and gender)

Metabolite (gemcitabine triphosphate), terminal phase: 1.7 to 19.4 hours

Time to peak, plasma: 30 minutes after completion of infusion

Excretion: Urine (92% to 98%; primarily as inactive uracil metabolite [dFdU]); feces (<1%)

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Older adult: The lower clearance in geriatric patients results in higher concentrations of gemcitabine for any given dose.

Sex: Gemcitabine clearance is lower and the half-life is longer in females (compared with males).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AR) Argentina: Gembio;
  • (AT) Austria: Gemalata | Gemcitabin | Gemcitabin Accord | Gemcitabin ebewe | Gemcitabin hospira | Gemcitabin Stada | Gemsol;
  • (AU) Australia: Dbl gemcitabine | Gemcitabine | Gemcitabine as | Gemcitabine ebewe;
  • (BE) Belgium: Gemcitabine Mylan | Gemcitabine Teva | Gemsol;
  • (BF) Burkina Faso: Gemtero;
  • (BG) Bulgaria: Gembin | Gemcitabine accord | Gemcitabine actavis | Gemcitabine hospira | Gemsol;
  • (BR) Brazil: Cloridrato de gencitabina;
  • (CH) Switzerland: Gemcitabin Accord | Gemcitabin fresenius | Gemcitabin sandoz | Gemcitabin teva;
  • (CI) Côte d'Ivoire: Gembin;
  • (CL) Chile: Gemcitabina | Genuten;
  • (CN) China: Yu jie | Ze fei;
  • (CO) Colombia: Gebitan | Gemcitabina | Virulizin;
  • (CZ) Czech Republic: Gemcitabin Accord | Gemcitabin ebewe | Gemcitabin teva | Gemcitabine hospira | Gemcitabine kabi | Gemstad | Gemzar;
  • (DE) Germany: Ebegemci | Gemci Cell | Gemcitabin Accord | Gemcitabin actavis | Gemcitabin Hexal | Gemcitabin hikma | Gemcitabin hospira | Gemcitabin NC | Gemcitabin Onkovis | Gemcitabin teva | Gemsol NC | Ribozar;
  • (DO) Dominican Republic: Gensitax;
  • (EC) Ecuador: Talbin;
  • (EE) Estonia: Gemcitabine accord | Gemcitabine ebewe | Gemcitabine kabi;
  • (EG) Egypt: Eupizar | Gemazar | Gemcitabine | Gemzar;
  • (ES) Spain: Gemcitabina Accord | Gemcitabina actavis | Gemcitabina fresenius | Gemcitabina Hospira | Gemcitabina prasfarma | Gemcitabina Stada;
  • (FI) Finland: Gemcitabin hospira | Gemcitabin sun | Gemcitabine accord;
  • (FR) France: Gemcitabine actavis | Gemcitabine arrow | Gemcitabine Intas | Gemcitabine sandoz | Gemcitabine sun | Gemcitabine Teva | Gemzar;
  • (GB) United Kingdom: Gemcitabine;
  • (GR) Greece: Gemcitabine accord | Gemnil | Medigem;
  • (HK) Hong Kong: Gemcitabin ebewe;
  • (HR) Croatia: Gemcitabin hospira | Gemcitabin sandoz | Gemzar;
  • (HU) Hungary: Gemcitabin teva | Gemcitabine accord | Gemcitabine ebewe | Gitrabin;
  • (ID) Indonesia: Gemcitabine ebewe | Kabigeta;
  • (IE) Ireland: Gemcitabine;
  • (IL) Israel: Gemzar;
  • (IN) India: Stricyte;
  • (IT) Italy: Gembin | Gemcitabina | Gemcitabina Accord | Gemcitabina aurobindo | Gemcitabina Hospira | Gemcitabina sun | Gemsol | Solgekma;
  • (JP) Japan: Gemcitabine sandoz;
  • (KE) Kenya: Gemcirex | Gemita | Gemzar;
  • (KR) Korea, Republic of: Crabcitabin | Gemcitabine | Gemtan | Geroam | Pfizer gemcitabine | Syg gemcitabine hcl | Zeroam;
  • (LB) Lebanon: Gemci Cell | Gemzar;
  • (LT) Lithuania: Gembin | Gemcitabine hospira | Gemcitabine kabi | Gemcitabine Stada | Gemsol;
  • (LV) Latvia: Gembin | Gemcitabine hospira | Gemcitabine kabi | Gemsol;
  • (MX) Mexico: Celge | Kavya | Lenfitabin | Topeteno;
  • (MY) Malaysia: Gemita rtu;
  • (NG) Nigeria: Gembin | Gemcitabine sandoz;
  • (NL) Netherlands: Gemcitabine | Gemcitabine Hikma | Gemcitabine sun;
  • (NO) Norway: Gemcitabin | Gemcitabin Accord | Gemcitabin actavis | Gemcitabin sandoz | Gemkabi;
  • (NZ) New Zealand: Gemcitabine;
  • (PH) Philippines: Gemzar | Zefei;
  • (PK) Pakistan: Biogem | Gemcitabel | Zefei;
  • (PL) Poland: Gembin | Gemcitabine actavis | Gemcitabine hospira | Gemcitabine Teva | Gemliquid | Gemsol;
  • (PR) Puerto Rico: Gemcitabine | Gemcitabine HCL | Infugem;
  • (PT) Portugal: Gemcitabina | Gemcitabina Accord | Gemcitabina actavis | Gemcitabina aurovitas | Gemcitabina Hospira | Gemcitabina Kabi;
  • (PY) Paraguay: Clorhidrato de gemcitabina blau | Gemcitabina cipla | Gemcitabina gebina | Gemcitabina imedic | Gemcitabina intas | Gemcitabina kemex | Gemcitabina libra | Gemcitabina tuteur;
  • (QA) Qatar: Citabol;
  • (RO) Romania: Gemcitabina Accord | Gemcitabina ebewe | Gemcitabina teva;
  • (RU) Russian Federation: Cytogem | Gemcitabin | Gemcitabine | Gemcitabine ebewe | Gemzar;
  • (SA) Saudi Arabia: Gemcitabine;
  • (SE) Sweden: Gemcitabin hospira | Gemcitabin sandoz | Gemcitabin sun | Gemcitabine accord | Gemkabi | Gemzar | Gitrabin;
  • (SG) Singapore: Gemcitabine;
  • (SI) Slovenia: Gemcitabin ebewe | Gemzar;
  • (SK) Slovakia: Gemcitabin Mylan | Gemcitabine kabi | Gemliquid | Gemstad;
  • (TH) Thailand: Gemcitabine sandoz;
  • (TN) Tunisia: Cytogem | Gemsol;
  • (TR) Turkey: Gemful | Gemtu | Gesita;
  • (TW) Taiwan: Dbl gemcitabine | Gemcitabine | Gemmis;
  • (UA) Ukraine: Gemcimeda | Gemcitabine accord;
  • (UG) Uganda: Gemtero;
  • (UY) Uruguay: Gemzar;
  • (ZA) South Africa: Cytigem | Gemcitabine sandoz | Gemita | Spalgem;
  • (ZM) Zambia: Gemcitabine ebewe | Gemtero;
  • (ZW) Zimbabwe: Gemlife | Gemtero
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