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Gemcitabine: Pediatric drug information

Gemcitabine: Pediatric drug information
(For additional information see "Gemcitabine: Drug information" and see "Gemcitabine: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Gemzar [DSC];
  • Infugem
Brand Names: Canada
  • ACT Gemcitabine [DSC];
  • Gemcitabine SUN [DSC]
Therapeutic Category
  • Antineoplastic Agent, Antimetabolite (Pyrimidine Antagonist)
Dosing: Pediatric

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 (POGO [Dupuis 2011]; POGO [Dupuis 2013]).

Hodgkin lymphoma, refractory or relapsed: 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 (Cole 2018).

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 (Cole 2009).

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 (Suyanı 2011). Alternatively, 800 mg/m2/dose on days 1 and 4 (in combination with ifosfamide and vinorelbine); repeat cycle every 21 days (Santoro 2007).

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 (Mora 2009; Navid 2008). 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 (Hartmann 2011).

Solid tumors, refractory or relapsed: 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 (Hartmann 2011). Alternatively, 1,000 mg/m2/dose over 100 minutes on day 1 (in combination with oxaliplatin); repeat cycle every 14 days (Geoerger 2011).

Note: Dosage reductions for toxicity (Geoerger 2011): 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.

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 (Einhorn 1999).

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.

Dosing: Adult

(For additional information see "Gemcitabine: Drug information")

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

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 (Ben-Josef 2015).

Biliary tract cancer, advanced

Biliary tract cancer, advanced (off-label use): IV: 1,000 mg/m2 over 30 minutes days 1 and 8; repeat cycle every 21 days (in combination with cisplatin) (Valle 2010) or 1,000 mg/m2 over 30 minutes days 1 and 8; repeat cycle every 21 days (in combination with capecitabine) (Knox 2005) or 1,000 mg/m2 infused at 10 mg/m2/minute every 2 weeks (in combination with oxaliplatin) (Andre 2004) or 1,000 mg/m2 on days 1 and 8; repeat cycle every 3 weeks (in combination with durvalumab and cisplatin) for up to 8 cycles, followed by durvalumab as a single agent until disease progression or unacceptable toxicity (Oh 2022).

Bladder cancer

Bladder cancer (off-label use):

Advanced or metastatic: IV: 1,000 mg/m2 over 30 to 60 minutes days 1, 8, and 15; repeat cycle every 28 days (in combination with cisplatin) (von der Maase 2000) 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 (De Santis 2012).

Transitional cell carcinoma (refractory): 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 (Dalbagni 2006).

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 (Albain 2008) or

Off-label dosing (as a single-agent): IV: 800 mg/m2 over 30 minutes days 1, 8, and 15 of a 28-day treatment cycle (Carmichael 1995).

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) (Monk 2009) or 1,250 mg/m2 over 30 minutes days 1 and 8; repeat cycle every 21 days (in combination with cisplatin) (Burnett 2000) or 800 mg/m2 over 30 minutes days 1, 8, and 15; repeat cycle every 28 days (as a single-agent) (Schilder 2005) or 800 mg/m2 days 1 and 8; repeat cycle every 28 days (in combination with cisplatin) (Brewer 2006).

Head and neck cancer: nasopharyngeal, advanced or metastatic

Head and neck cancer: nasopharyngeal, advanced or metastatic (off-label use): IV: 1,000 mg/m2 over 30 minutes days 1, 8, and 15 every 28 days (Zhang 2008) or 1,000 mg/m2 over 30 minutes days 1 and 8 every 21 days (in combination with vinorelbine) (Chen 2012).

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) (Bartlett 2007) or 800 mg/m2 days 1 and 4; repeat cycle every 21 days (in combination with ifosfamide, mesna, vinorelbine, and prednisolone) (Santoro 2007).

Malignant pleural mesothelioma

Malignant pleural mesothelioma (off-label use): IV: 1.25 g/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 (van Meerbeeck 1999) or 1 g/m2 over 30 minutes days 1, 8 and 15 every 28 days (in combination with cisplatin) for up to 6 cycles (Nowak 2002) or 1.25 g/m2 over 30 minutes days 1 and 8 every 21 days (in combination with cisplatin) for up to 6 cycles (van Haarst 2002).

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) (Crump 2004) or 1,000 mg/m2 every 15 to 21 days (in combination with oxaliplatin and rituximab) (Lopez 2008).

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 days 1, 8, and 15; repeat cycle every 28 days (in combination with cisplatin) or 1,250 mg/m2 over 30 minutes days 1 and 8; repeat cycle every 21 days (in combination with cisplatin) or

Off-label dosing/combinations: IV: 1,000 mg/m2 over 30 minutes days 1 and 8; repeat cycle every 21 days (in combination with carboplatin) for up to 4 cycles (Grønberg 2009) or 1,000 mg/m2 over 30 minutes days 1, 8, and 15; repeat cycle every 28 days (in combination with carboplatin) for up to 4 cycles (Danson 2003) or 1,000 mg/m2 over 30 minutes days 1 and 8; repeat cycle every 21 days (in combination with docetaxel) for 8 cycles (Pujol 2005) or 1,000 mg/m2 days 1, 8, and 15; repeat cycle every 28 days (in combination with vinorelbine) for 6 cycles (Greco 2007).

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) (Pfisterer 2005) 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 (Mutch 2007).

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 (Burris 1997) or

Off-label dosing/combinations: IV: 1,000 mg/m2 days 1, 8, and 15 every 28 days (in combination with paclitaxel [protein bound]) (Von Hoff 2013) or 1,000 mg/m2 over 30 minutes days 1, 8, and 15 every 28 days (in combination with capecitabine) (Cunningham 2009) 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) (Moore 2007) or 1,000 mg/m2 over 30 minutes days 1 and 15 every 28 days (in combination with cisplatin) (Heinemann 2006) or 1,000 mg/m2 infused at 10 mg/m2/minute every 14 days (in combination with oxaliplatin) (Louvet 2005).

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 (ASCO [Khorana 2019]).

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 (Neoptolemos 2017).

Single-agent therapy: IV: 1,000 mg/m2 on days 1, 8, and 15 every 28 days for 6 cycles (Oettle 2007; Oettle 2013).

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 (Oudard 2007).

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) (Navid 2008).

Osteosarcoma, refractory: IV: 675 mg/m2 over 90 minutes days 1 and 8; repeat cycle every 21 days (in combination with docetaxel) (Navid 2008) or 1,000 mg/m2 weekly for 7 weeks followed by 1 week rest; then weekly for 3 weeks out of every 4 weeks (Merimsky 2000).

Soft tissue sarcoma, advanced: IV: 800 mg/m2 over 90 minutes days 1 and 8; repeat cycle every 21 days (in combination with vinorelbine) (Dileo 2007) or 675 mg/m2 over 90 minutes days 1 and 8; repeat cycle every 21 days (in combination with docetaxel) (Leu 2004) or 900 mg/m2 over 90 minutes days 1 and 8; repeat cycle every 21 days (in combination with docetaxel) (Maki 2007).

Small cell lung cancer, refractory or relapsed

Small cell lung cancer, refractory or relapsed (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) (Masters 2003).

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) (DeGiorgi 2006; Kollmannsberger 2004; Pectasides 2004) 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) (Hinton 2002) or 800 mg/m2 over 30 minutes days 1 and 8 every 21 days (in combination with oxaliplatin and paclitaxel) (Bokemeyer 2008).

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 (Palmieri 2010; Palmieri 2014).

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) (Culine 2003; Gross-Goupil 2012) or 1,000 mg/m2 over 30 minutes days 1 and 8 every 21 days for up to 6 cycles (in combination with docetaxel) (Pouessel 2004) or 1,000 mg/m2 on days 1 and 8 every 21 days (in combination with irinotecan) for 4 to 6 cycles (Hainsworth 2010).

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) (Hensley 2008) or 1,000 mg/m2 over 30 minutes days 1, 8, and 15 every 28 days (Look 2004).

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

Dosage adjustment for altered kidney function prior to treatment initiation:

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

Mild to severe renal impairment: No dosage adjustment necessary (Janus 2010; Li 2007).

ESRD (on hemodialysis): Hemodialysis should begin 6 to 12 hours after gemcitabine infusion (Janus 2010; Li 2007).

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): No dosage adjustment necessary (Venook 2000).

Serum bilirubin >1.6 mg/dL: Use initial dose of 800 mg/m2; may escalate if tolerated (Ecklund 2005; Floyd 2006; Venook 2000).

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

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

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

Solution Reconstituted, Intravenous:

Gemzar: 200 mg (1 ea [DSC]); 1 g (1 ea [DSC])

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); 2 g (1 ea [DSC])

Generic Equivalent Available: US

Yes

Dosage Forms: Canada

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

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: 200 mg ([DSC]); 1 g (1 ea); 2 g (1 ea)

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 (Ko 2006; Tempero 2003); patients who receive gemcitabine FDR experience more grade 3/4 hematologic toxicity (Ko 2006; Poplin 2009).

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 (Ko 2006; Tempero 2003). Patients who receive gemcitabine FDR experience more grade 3/4 hematologic toxicity (Ko 2006; Poplin 2009).

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 (Addeo 2010; Dalbaghi 2006)

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

Lyophilized powder: Store intact vials at room temperature of 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Reconstituted vials are stable for 24 hours at room temperature (discard if not used within 24 hours of reconstitution). Do not refrigerate (may form crystals).

Concentrated solution for injection (vials): Varies by manufacturer; refer to product labeling.

Premixed infusion solutions: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Do not freeze (may result in crystallization).

Solutions prepared/diluted for infusion in NS are stable for 24 hours at room temperature. Do not refrigerate (may result in crystallization).

Use

Treatment of locally advanced, inoperable (stage IIIA or IIIB), or metastatic (stage IV) non-small cell lung cancer (NSCLC), metastatic breast cancer, and advanced relapsed ovarian cancer as part of combination therapy (FDA approved in adults); treatment of locally advanced or metastatic pancreatic cancer as a single agent (FDA approved in adults); has also been used in the treatment of refractory solid tumors (including brain tumors), refractory or relapsed sarcomas (including Ewing sarcoma, osteosarcoma), refractory or relapsed Hodgkin lymphoma, and refractory germ cell tumors.

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

Gemcitabine may be confused with gemtuzumab ozogamicin

Gemzar may be confused with Zinecard

High alert medication:

This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes which have a heightened risk of causing significant patient harm when used in error.

Administration issues:

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

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:

• Elderly: 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).

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 Lexicomp 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

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

BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). 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

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

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

Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. 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 vaccine at least 28 days after the primary vaccine dose. Patients should also receive 2 booster doses of mRNA vaccine - one 2 months after the 2nd (additional) dose and another 4 months after the first booster dose. 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, and a booster dose 3 months after the 3rd dose in the primary series, to patients taking immunosuppressive medications. Patients 12 years of age and older should also receive a 2nd booster 4 months after the first booster. 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

Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Risk X: Avoid combination

Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. 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

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

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 post-exposure rabies vaccination is required during immunosuppressant therapy, administer a 5th dose of vaccine and check for rabies antibodies. Risk D: Consider therapy modification

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

Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of 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 Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination

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

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

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

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

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, gemcitabine may cause fetal harm if administered during pregnancy.

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).

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

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); feces (<1%)

Pharmacokinetics: Additional Considerations

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

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

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 - $2.07

Solution (Infugem Intravenous)

1200MG/120ML 0.9% (per mL): $4.56

1300MG/130ML 0.9% (per mL): $4.56

1400MG/140ML 0.9% (per mL): $4.56

1500MG/150ML 0.9% (per mL): $4.56

1600MG/160ML 0.9% (per mL): $4.56

1700MG/170ML 0.9% (per mL): $4.56

1800MG/180ML 0.9% (per mL): $4.56

1900MG/190ML 0.9% (per mL): $4.56

2000 mg/200 mL 0.9% (per mL): $4.56

2200MG/220ML 0.9% (per mL): $4.56

Solution (reconstituted) (Gemcitabine HCl Intravenous)

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

2 g (per each): $128.00 - $154.44

200 mg (per each): $9.29 - $48.00

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.

Brand Names: International
  • Abingem (ZW);
  • Accogem (MX);
  • Bigemax (VN);
  • Celgem (IN);
  • Citabol (ID);
  • Citafine (ZW);
  • Cytogem (ID, IN, UA);
  • DBL (TW);
  • Dercin (HU);
  • Dhacibine (MY);
  • Gemaccord (AU);
  • Gembid (AR);
  • Gembine (KR);
  • Gembio (PH);
  • Gemcetin (BD);
  • Gemcibine (KR);
  • Gemcikal (ID, PH);
  • Gemcirena (CZ);
  • Gemcit (BR, KR, LK, PE, PH, PT, TH);
  • Gemedac (ID);
  • Gemezar (JO);
  • Gemflor (TW);
  • Gemhope (PH);
  • Gemita (LK, PH, SG, TH, TW);
  • Gemkab (FI);
  • Gemkabi (NO);
  • Gemmis (TW);
  • Gemnil (IL);
  • Gemofas (AR);
  • Gemoxen (BD);
  • Gemplan (AU);
  • Gemra (GR);
  • Gemsol (AT);
  • Gemtan (KR);
  • Gemtavis (ID);
  • Gemtaz (ZA);
  • Gemtero (PH, SG, TH, ZW);
  • Gemtin (TH);
  • Gemtra (KR);
  • Gemtro (AR);
  • Gemzar (AE, AT, AU, BB, BF, BG, BJ, BO, BR, CH, CI, CL, CN, CO, CY, DE, DO, EE, EG, ET, GH, GM, GN, HK, ID, IL, IS, IT, JP, KE, KR, LB, LK, LR, LT, LU, MA, ML, MR, MT, MU, MW, MX, MY, NE, NG, PA, PE, PH, PK, PL, PR, PT, PY, RO, RU, SA, SC, SD, SE, SG, SI, SK, SL, SN, TH, TN, TR, TW, TZ, UG, UY, VE, VN, ZA, ZM);
  • Genuten (CL);
  • Getanosan (ID);
  • Getmist (DK);
  • Gezt (LB, PY);
  • Gitrabin (HK, HR, HU, RO, SE, SG);
  • Jemta (IT);
  • Oncogem (LB);
  • Oncogen (VE);
  • Oncoril (LK);
  • Pamigen (CR, DO, EC, GT, HN, MX, NI, PA, SV);
  • Ribozar (DE);
  • Triamzar (MX);
  • Zefei (PH)


For country abbreviations used in Lexicomp (show table)
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