gemcitabine (Rx)

Brand and Other Names:Gemzar
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 200mg/vial
  • 1g/vial

solution for injection

  • 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)
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Pancreatic Cancer

Indicated as first-line treatment for locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas

1000 mg/m² IV infusion over 30 minutes once/week x7 weeks; rest 1 week, THEN 

1000 mg/m² IV on Days 1, 8, and 15 of each 28-day cycle

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

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

Breast Cancer

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

Ovarian Cancer

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

Dosing Considerations

Monitor: CBC before each dose; renal/hepatic function; (with cisplatin): serum creatinine, electrolytes

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

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Interactions

Interaction Checker

and gemcitabine

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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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, 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

            Hemolytic uremic syndrome reported, including fatalities

            Drug-induced liver injury reported, including liver failure and death

            Not indicated for use with radiation therapy; know to exacerbate radiation toxicity, including life-threatening mucositis, especially esophagitis and pneumonitis

            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

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            Pregnancy & Lactation

            Pregnancy Category: D

            Lactation: not known if excreted in breast milk; do not nurse

            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; kills cells in S-phase (undergoing DNA synthesis)

            Pharmacokinetics

            Vd: 50 L/sq.meter (short infusions); 370 L/m² (long infusions)

            Metabolites: diphosphate (dFdCDP), triphosphate (dFdCTP)

            Half-Life: 42-94 min (short infusions); 245-638 min (long infusions)

            Clearance: 40-92 L/hr/sq.meter

            Excretion: urine

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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

            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

            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
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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            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.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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