Gemcitabine Generic Name & Formulations
Legal Class
Rx
General Description
Gemcitabine HCl 200mg, 1g, 2g; per vial; lyophilized pwd for IV infusion after reconstitution; preservative-free; contains mannitol.
Pharmacological Class
Antimetabolite.
How Supplied
Contact supplier
Manufacturer
Gemcitabine Indications
Indications
In combination with paclitaxel for the first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were contraindicated.
Gemcitabine Dosage and Administration
Adult
Infuse over 30mins. 1250mg/m2 on Days 1 and 8 of each 21-day cycle (in combination with paclitaxel 175mg/m2 administered on Day 1 before gemcitabine). Dose modifications: see full labeling.
Children
Not established.
Gemcitabine Contraindications
Not Applicable
Gemcitabine Boxed Warnings
Not Applicable
Gemcitabine Warnings/Precautions
Warnings/Precautions
Increased risk of hypotension, severe flu-like symptoms, myelosuppression, and asthenia with prolonged infusion beyond 60mins or more frequent than weekly dosing. Permanently discontinue if unexplained dyspnea, severe pulmonary toxicity, hemolytic uremic syndrome (HUS) or severe renal impairment, severe hepatotoxicity, capillary leak syndrome (CLS), or posterior reversible encephalopathy syndrome (PRES; confirm with MRI) occurs. Concurrent liver metastases. History of hepatitis, alcoholism, liver cirrhosis. Monitor for myelosuppression; obtain CBCs, platelets prior to each dose. Assess renal and hepatic function prior to initiation, then periodically thereafter. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Advise use of effective contraception during and for 6 months (females) or 3 months (males w. female partners) after final dose. Nursing mothers: not recommended (during and for ≥1 week after final dose).
Gemcitabine Pharmacokinetics
See Literature
Gemcitabine Interactions
Interactions
Severe radiation toxicity with concomitant radiation therapy: not recommended.
Gemcitabine Adverse Reactions
Adverse Reactions
Myelosuppression, nausea, vomiting, elevated transaminases, increased alkaline phosphatase, proteinuria, fever, hematuria, rash, dyspnea, edema; pulmonary toxicity, HUS, thrombotic microangiopathy, renal failure, hepatotoxicity, CLS, PRES.
Gemcitabine Clinical Trials
See Literature
Gemcitabine Note
Notes
Formerly known under the brand name Gemzar.
Gemcitabine Patient Counseling
See Literature
Gemcitabine Generic Name & Formulations
Legal Class
Rx
General Description
Gemcitabine HCl 200mg, 1g, 2g; per vial; lyophilized pwd for IV infusion after reconstitution; preservative-free; contains mannitol.
Pharmacological Class
Antimetabolite.
How Supplied
Contact supplier
Manufacturer
Gemcitabine Indications
Indications
Advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy, in combination with carboplatin.
Gemcitabine Dosage and Administration
Adult
Infuse over 30mins. 1000mg/m2 on Days 1 and 8 of each 21-day cycle (in combination with carboplatin AUC 4 administered on Day 1 after gemcitabine). Dose modifications: see full labeling.
Children
Not established.
Gemcitabine Contraindications
Not Applicable
Gemcitabine Boxed Warnings
Not Applicable
Gemcitabine Warnings/Precautions
Warnings/Precautions
Increased risk of hypotension, severe flu-like symptoms, myelosuppression, and asthenia with prolonged infusion beyond 60mins or more frequent than weekly dosing. Permanently discontinue if unexplained dyspnea, severe pulmonary toxicity, hemolytic uremic syndrome (HUS) or severe renal impairment, severe hepatotoxicity, capillary leak syndrome (CLS), or posterior reversible encephalopathy syndrome (PRES; confirm with MRI) occurs. Concurrent liver metastases. History of hepatitis, alcoholism, liver cirrhosis. Monitor for myelosuppression; obtain CBCs, platelets prior to each dose. Assess renal and hepatic function prior to initiation, then periodically thereafter. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Advise use of effective contraception during and for 6 months (females) or 3 months (males w. female partners) after final dose. Nursing mothers: not recommended (during and for ≥1 week after final dose).
Gemcitabine Pharmacokinetics
See Literature
Gemcitabine Interactions
Interactions
Severe radiation toxicity with concomitant radiation therapy: not recommended.
Gemcitabine Adverse Reactions
Adverse Reactions
Myelosuppression, nausea, vomiting, elevated transaminases, increased alkaline phosphatase, proteinuria, fever, hematuria, rash, dyspnea, edema; pulmonary toxicity, HUS, thrombotic microangiopathy, renal failure, hepatotoxicity, CLS, PRES.
Gemcitabine Clinical Trials
See Literature
Gemcitabine Note
Notes
Formerly known under the brand name Gemzar.
Gemcitabine Patient Counseling
See Literature
Gemcitabine Generic Name & Formulations
Legal Class
Rx
General Description
Gemcitabine HCl 200mg, 1g, 2g; per vial; lyophilized pwd for IV infusion after reconstitution; preservative-free; contains mannitol.
Pharmacological Class
Antimetabolite.
How Supplied
Contact supplier
Manufacturer
Gemcitabine Indications
Indications
First-line treatment of locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) pancreatic cancer, for patients previously treated with fluorouracil.
Gemcitabine Dosage and Administration
Adult
Infuse over 30mins. 1000mg/m2 once weekly for the first 7 weeks, followed by 1 week of rest; subsequent cycles: infuse once weekly on Days 1, 8, and 15 of each 28-day cycle. Dose modifications: see full labeling.
Children
Not established.
Gemcitabine Contraindications
Not Applicable
Gemcitabine Boxed Warnings
Not Applicable
Gemcitabine Warnings/Precautions
Warnings/Precautions
Increased risk of hypotension, severe flu-like symptoms, myelosuppression, and asthenia with prolonged infusion beyond 60mins or more frequent than weekly dosing. Permanently discontinue if unexplained dyspnea, severe pulmonary toxicity, hemolytic uremic syndrome (HUS) or severe renal impairment, severe hepatotoxicity, capillary leak syndrome (CLS), or posterior reversible encephalopathy syndrome (PRES; confirm with MRI) occurs. Concurrent liver metastases. History of hepatitis, alcoholism, liver cirrhosis. Monitor for myelosuppression; obtain CBCs, platelets prior to each dose. Assess renal and hepatic function prior to initiation, then periodically thereafter. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Advise use of effective contraception during and for 6 months (females) or 3 months (males w. female partners) after final dose. Nursing mothers: not recommended (during and for ≥1 week after final dose).
Gemcitabine Pharmacokinetics
See Literature
Gemcitabine Interactions
Interactions
Severe radiation toxicity with concomitant radiation therapy: not recommended.
Gemcitabine Adverse Reactions
Adverse Reactions
Myelosuppression, nausea, vomiting, elevated transaminases, increased alkaline phosphatase, proteinuria, fever, hematuria, rash, dyspnea, edema; pulmonary toxicity, HUS, thrombotic microangiopathy, renal failure, hepatotoxicity, CLS, PRES.
Gemcitabine Clinical Trials
See Literature
Gemcitabine Note
Notes
Formerly known under the brand name Gemzar.
Gemcitabine Patient Counseling
See Literature
Gemcitabine Generic Name & Formulations
Legal Class
Rx
General Description
Gemcitabine HCl 200mg, 1g, 2g; per vial; lyophilized pwd for IV infusion after reconstitution; preservative-free; contains mannitol.
Pharmacological Class
Antimetabolite.
How Supplied
Contact supplier
Manufacturer
Gemcitabine Indications
Indications
First-line treatment of inoperable, locally advanced (Stage IIIA or IIIB), or metastatic (Stage IV) non-small cell lung cancer (NSCLC), in combination with cisplatin.
Gemcitabine Dosage and Administration
Adult
Infuse over 30mins. 28-day schedule: 1000mg/m2 on Days 1, 8, and 15 of each 28-day cycle. 21-day schedule: 1250mg/m2 on Days 1 and 8 of each 21-day cycle. Both: give in combination with cisplatin 100mg/m2 administered on Day 1 after gemcitabine. Dose modifications: see full labeling.
Children
Not established.
Gemcitabine Contraindications
Not Applicable
Gemcitabine Boxed Warnings
Not Applicable
Gemcitabine Warnings/Precautions
Warnings/Precautions
Increased risk of hypotension, severe flu-like symptoms, myelosuppression, and asthenia with prolonged infusion beyond 60mins or more frequent than weekly dosing. Permanently discontinue if unexplained dyspnea, severe pulmonary toxicity, hemolytic uremic syndrome (HUS) or severe renal impairment, severe hepatotoxicity, capillary leak syndrome (CLS), or posterior reversible encephalopathy syndrome (PRES; confirm with MRI) occurs. Concurrent liver metastases. History of hepatitis, alcoholism, liver cirrhosis. Monitor for myelosuppression; obtain CBCs, platelets prior to each dose. Assess renal and hepatic function prior to initiation, then periodically thereafter. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Advise use of effective contraception during and for 6 months (females) or 3 months (males w. female partners) after final dose. Nursing mothers: not recommended (during and for ≥1 week after final dose).
Gemcitabine Pharmacokinetics
See Literature
Gemcitabine Interactions
Interactions
Severe radiation toxicity with concomitant radiation therapy: not recommended.
Gemcitabine Adverse Reactions
Adverse Reactions
Myelosuppression, nausea, vomiting, elevated transaminases, increased alkaline phosphatase, proteinuria, fever, hematuria, rash, dyspnea, edema; pulmonary toxicity, HUS, thrombotic microangiopathy, renal failure, hepatotoxicity, CLS, PRES.
Gemcitabine Clinical Trials
See Literature
Gemcitabine Note
Notes
Formerly known under the brand name Gemzar.
Gemcitabine Patient Counseling
See Literature
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