gemcitabine (Rx)

Brand and Other Names:Gemzar, Infugem
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Dosing & Uses

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Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 200mg/single-use vial (Gemzar, generics)
  • 1g/single-use vial (Gemzar, generics)

solution for injection (generics)

  • 200mg/2mL (100mg/mL)
  • 200mg/5.26mL (38mg/mL)
  • 1g/10mL (100mg/mL)
  • 1g/26.3mL (38mg/mL)
  • 1.5g/15mL (100mg/mL)
  • 2g/20mL (100mg/mL)
  • 2g/52.6mL (38mg/mL)

injection, single-dose premixed infusion bag (Infugem)

  • 10mg/mL (contains gemcitabine in 0.9% NaCl) concentration in following sizes:
    • 1200mg/120mL
    • 1300mg/130mL
    • 1400mg/140mL
    • 1500mg/150mL
    • 1600mg/160mL
    • 1700mg/170mL
    • 1800mg/180mL
    • 1900mg/190mL
    • 2000mg/200mL
    • 2200mg/220mL
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Pancreatic Cancer

Indicated as a single-agent for pancreatic cancer

1000 mg/m² IV infusion over 30 min once weekly x 7 weeks; rest 1 week, THEN 

1000 mg/m² IV once weekly for 3 weeks of each 28-day cycle

Various regimens exist including monotherapy and in combination with other chemotherapy agents (eg, erlotinib, paclitaxel protein bound, capecitabine)

Also see Administration

Non-small Cell Lung Cancer

Indicated in combination with cisplatin for non-small cell lung cancer

1000 mg/m² IV infusion over 30 minutes on days 1, 8, and 15 of each 28-day cycle, OR 

1250 mg/m² IV infusion over 30 minutes on days 1 and 8 of each 21-day cycle

Administer cisplatin 100 mg/m² IV after gemcitabine on day 1

Also see Administration

Breast Cancer

Indicated in combination with paclitaxel for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated

1250 mg/m² IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle 

With paclitaxel 175 mg/m² on Day 1 as a 3 hr infusion before gemcitabine

Also see Administration

Ovarian Cancer

Indicated in combination with carboplatin for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy

1000 mg/m² IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle 

With carboplatin AUC 4 on Day 1 after gemcitabine

Also see Administration

Dosage Modifications

Myelosuppression (ovarian cancer)

  • Day 1
    • Absolute neurophil count (ANC) ≥1,500 x 10^6/L AND platelet count ≥100,000 x 10^6/L: No dosage adjustment necessary
    • ANC <1,500 x 10^6/L OR platelets <100,000 x 10^6/L: Delay treatment
  • Day 8
    • ANC≥1,500 x 10^6/L AND platelets ≥100,000 x 10^6/L: No dosage adjustment necessary
    • ANC 1,000 to 1499 x 10^6/L OR platelets 75,000 to 99,999 x 10^6/L: 50% of the full dose
    • ANC <1,000 x 10^6/L OR platelets <75,000 x 10^6/L: Hold treatment
  • Initial or subsequent occurrences
    • ANC <500 x 10^6/L for more than 5 days OR
    • ANC <100 x 10^6/L for more than 3 days OR
    • Febrile neutropenia OR
    • Platelets <25,000 x 10^6/L OR
    • Cycle delay of more than 1 week due to toxicity
    • If any of the above toxicities occur after the initial dose reduction, permanently reduce dose to 800 mg/m² on Days 1 and 8

Myelosuppression (breast cancer)

  • Day 1
    • ANC ≥1,500 x 10^6/L AND platelet count ≥100,000 x 10^6/L: No dosage adjustment necessary
    • ANC <1,500 x 10^6/L OR platelets <100,000 x 10^6/L: Hold treatment
  • Day 8
    • ANC≥1,200 x 10^6/L AND platelets ≥75,000 x 10^6/L: No dosage adjustment necessary
    • ANC 1,000 to 1199 x 10^6/L OR platelets 50,000 to 75,000 x 10^6/L: 75% of the full dose
    • ANC 700 to 999 x 10^6/L AND platelets ≥50,000 x 10^6/L: 50% of the full dose
    • ANC <700 x 10^6/L OR platelets <50,000 x 10^6/L: Hold treatment

Myelosuppression (non-small cell lung cancer or pancreatic cancer)

  • ANC ≥1,000 x 10^6/L AND platelets ≥100,000 x 10^6/L: No dosage adjustment necessary
  • ANC 500 to 999 x 10^6/L OR platelets 50,000 to 99,999 x 10^6/L: 75% of the full dose
  • ANC <500 x 10^6/L OR platelets ≥50,000 x 10^6/L: Hold treatment

Non-hematologic adverse reactions

  • Permanently discontinue for any of the following:
    • Unexplained dyspnea or other evidence of severe pulmonary toxicity
    • Hemolytic uremic syndrome
    • Severe hepatic toxicity
    • Capillary leak syndrome
    • Posterior reversible encephalopathy syndrome
  • Other severe (Grade 3 or 4) non-hematological toxicity: Withhold or reduce dose by 50% until resolved
  • No dose modifications are recommended for alopecia, nausea, or vomiting

Dosing Considerations

Premix bag only: Select the premixed bag that allow for a variance of up to 5% of the BSA-calculated dose (see Administration)

Bladder Cancer (Off-label)

May be considered for muscle-invasive bladder cancer in combination with cisplatin

Cholangiocarcinoma (Orphan)

Orphan designation for treatment of cholangiocarcinoma

Sponsor

  • InnoPharmax, Inc; 9F, No. 22, Lane 478, Rueiguang Road; Taipei

Safety and efficacy not established

In clinical studies, patients with various cancers who received gemcitabine as a single agent had a higher rate of Grade 3-4 thrombocytopenia in older patients as compared to younger patients

In a randomized trial in women with ovarian cancer, there was significantly higher Grade 3/4 neutropenia in women 65 years of age or older

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Interactions

Interaction Checker

and gemcitabine

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Adverse Effects

            >10%

            N/V (69%)

            Anemia (65%)

            Elev LFTs (68%)

            Neutropenia (63%)

            Leukopenia (62%)

            Pain (48%)

            Proteinuria (45%)

            Fever (41%)

            Hematuria (35%)

            Rash (30%)

            Thrombocytopenia (24%)

            Dyspnea (23%)

            Constipation (23%)

            Diarrhea (19%)

            Flu-like syndrome (19%)

            Hemorrhage (17%)

            BUN increased (16%)

            Infection (16%)

            Alopecia (15%)

            Edema (13%)

            Elev bilirubin (13%)

            1-10%

            Paresthesia (2-10%)

            Creatinine increased (2-8%)

            Inj site reactions (4%)

            Bronchospasm (2%)

            Postmarketing Reports

            Cardiovascular: CHF, MI, arrhythmias, supraventricular arrhythmias

            Vascular disorders: Peripheral vasculitis, gangrene, capillary leak syndrome

            Skin: Cellulitis, pseudocellulitis, severe skin reactions, including desquamation and bullous skin eruptions

            Hepatic: Hepatic failure, hepatic veno-occlusive disease

            Pulmonary: Interstitial pneumonitis, pulmonary fibrosis, pulmonary edema, ARDS

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            Warnings

            Contraindications

            Hypersensitivity

            Cautions

            Myelosuppression reported

            In combination with carboplatin or paclitaxel: patients should have ANC >1.5 x 10^6/mL and platelet count >10^8/mL prior to each cycle

            Capillary leak syndrome reported with severe consequences; discontinue if symptoms occur

            Pulmonary toxicity, including interstitial pneumonitis, pulmonary fibrosis, pulmonary edema, and ARDS reported; onset of pulmonary symptoms may occur up to 2 weeks after last dose; discontinue treatment in patients who develop unexplained dyspnea, with or without bronchospasm, or have any evidence of pulmonary toxicity

            Hemolytic uremic syndrome reported, including fatalities; permanently discontinue therapy in patients with HUS or severe renal impairment; renal failure may not be reversible even with discontinuation of therapy

            Drug-induced liver injury reported, including liver failure and death; assess hepatic function prior to initiation of therapy and periodically during treatment; discontinue drug in patients that develop severe liver injury

            Not indicated for use with radiation therapy; know to exacerbate radiation toxicity, including life-threatening mucositis, especially esophagitis and pneumonitis; excessive toxicity not observed when treatment is administered more than 7 days before or after radiation; radiation recall has been reported in patients who received drug after prior radiation

            Infusions longer than 60 minutes or more frequently than qWk increase the incidence of clinically significant hypotension, severe flu-like symptoms, myelosuppression, and asthenia; gemcitabine half-life is influenced by the length of the infusion

            Posterior reversible encephalopathy syndrome (PRES) reported; PRES can present with headache, seizure, lethargy, hypertension, confusion, blindness, and other visual and neurologic disturbances; discontinue if PRES develops

            Advise females of reproductive potential to use effective contraception during treatment and for 6 months after final dose; advise male patients with female partners of reproductive potential to use effective contraception during and for 3 months following final dose

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            Pregnancy & Lactation

            Pregnancy

            Based on animal data and its mechanism of action, therapy can cause fetal harm when administered to a pregnant woman; therapy is expected to result in adverse reproductive effects; drug was teratogenic, embryotoxic, and fetotoxic in mice and rabbits; advise pregnant women of potential risk to a fetus

            Contraception

            • Advise females of reproductive potential to use effective contraception during treatment and for 6 months after final dose
            • Advise male patients with female partners of reproductive potential to use effective contraception during and for 3 months following final dose

            Fertility

            • Based on animal studies, Gemcitabine Injection may impair fertility in males of reproductive potential

            Lactation

            There are no data on presence of drug in human milk, or effects of gemcitabine on breastfed infant or milk production; because of potential for serious adverse reactions in nursing infants from therapy, advise a lactating woman not to breastfeed during treatment and for one week after the final dose

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Pyrimidine analog; inhibits DNA synthesis by inhibiting the ribonucleotide reductase, cell cycle-specific for the S-phase of the cycle (also blocks cellular progression at G1/S-phase)

            Metabolized by nucleoside kinases to diphosphate (dFdCDP) and triphosphate (dFdCTP) nucleosides

            Gemcitabine diphosphate inhibits ribonucleotide reductase, resulting in reductions in deoxynucleotide concentrations, including dCTP

            Gemcitabine triphosphate competes with dCTP for incorporation into DNA; reduction in the intracellular concentration of dCTP by the action of the diphosphate enhances the incorporation of gemcitabine triphosphate into DNA (self-potentiation)

            After the gemcitabine nucleotide is incorporated into DNA, only one additional nucleotide is added to the growing DNA strands, which eventually results in the initiation of apoptotic cell death

            Distribution

            Vd was increased with infusion length

            Vd: 50 L/m² (following infusions lasting <70 minutes); 370 L/m² (long infusions)

            Metabolism

            Active metabolite, gemcitabine triphosphate, can be extracted from peripheral blood mononuclear cells

            Elimination

            Excretion: Urine (92-98%)

            Half-life: 1.7-19.4 hr

            Clearance

            • Male: 92.2 L/hr/m² (29 years); 75.7 L/hr/m² (45 years); 55.1 L/hr/m² (65 years); 40.7 L/hr/m² (79 years)
            • Female: 69.4L/hr/m² (29 years); 57 L/hr/m² (45 years); 41.5 L/hr/m² (65 years); 30.7 L/hr/m² (79 years)
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            Administration

            IV Incompatibilities

            Y-site: acyclovir, amphotericin B, cefoperazone, cefotaxime, furosemide, ganciclovir, imipenem/cilastatin, irinotecan, methotrexate, methylprednisolone sodium succinate, mitomycin, piperacillin, piperacillin/tazobactam, prochlorperazine

            IV Compatibilities

            Y-site (partial list): ampicillin, carboplatin, cefazolin, chlorproazine, cimetidine, clindamycin, cytarabine, diphenhydramine, dopamine, etoposide, heparin, linezolid, metoclopramide, morphine, paclitaxel, KCl, NaHCO3, topotecan, vancomycin, zidovudine

            IV Preparation

            Follow guidelines for handling and disposal of chemotherapeutic agents

            Lyophilized powder

            • Reconstitute 200 mg vial with 5 mL 0.9% NaCl or 1000 mg vial with 25 mL 0.9% NaCl
            • Resulting solution is 38 mg/mL
            • The appropriate dose may be further diluted with 0.9% NaCl to concentrations as low as 0.1 mg/mL

            Solution for injection (from either 38 mg/mL or 100 mg/mL vials)

            • Inspect solution and discard vial if particulate matter or discoloration is observed
            • Dilute with 0.9% NaCl to concentrations as low as 0.1 mg/mL
            • Do not shake; mix diluted solution by gentle inversion

            Premixed Bag

            • Infusion bag selection
              • Premixed bags are ready for infusion and do not require any further preparation prior to use
              • Do not dilute prior to use
              • Do not remove or add medication
              • Select premixed bag(s) for infusion based on the patient’s BSA range as outlined below in the prescribing information
              • Administered dose may vary from the BSA-calculated dose by no more than 5%

            IV Administration

            For IV infusion only

            Solution for injection (ie, 38 mg/mL, 100 mg/mL) must be diluted before IV administration

            Infuse IV over 30 min

            Avoid rapid infusions

            IV Administration (Premixed Bag)

            Infuse over 30 minutes

            If two premixed infusion bags are required, infuse the total volume of both bags over 30 minutes.

            Remove overwrap; check for leaks by squeezing the inner bag firmly

            If leaks are found, discard the bag

            Injection is a clear, colorless solution

            Visually inspect for any particulate matter or discoloration prior to use

            Discard if particulate matter or discoloration is found

            Follow applicable special handling and disposal procedures; exercise caution and wear gloves when handling drug; immediately wash the skin thoroughly or rinse the mucosa with copious amounts of water if drug contacts the skin or mucus membranes

            Death has occurred in animal studies due to dermal absorption

            Storage

            Lyophilized powder

            • Unopened vials: Store at room temperature 20-25°C (68-77°F)
            • Reconstituted solution: Store at room temperature for up to 24 hr; do NOT refrigerate (crystallization can occur)

            Solution for injection

            • 38 mg/mL
              • Unopened vials: Refrigerate at 2-8°C (36-46°F)
              • Do not freeze
            • 100 mg/mL
              • Crystallization can occur if refrigerated
              • Unopened vials: Store at 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F)
              • After initial withdrawal with a needle, the remaining portion in the vial may be stored at room temperature and should be used or discarded within 28 days
            • Diluted solution (from either 38 mg/mL or 100 mg/mL vials)
              • Store at controlled room temperature for up to 24 hr; do NOT refrigerate

            Premixed bag

            • Unopened infusion bags: Stable until the expiration date indicated on the package when stored at 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F); do not freeze as crystallization can occur
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            Formulary

            FormularyPatient Discounts

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            • Compare formulary status to other drugs in the same class.
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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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