Gemcitabine

— THERAPEUTIC CATEGORIES —
  • Breast cancer
  • Gynecologic cancers
  • Pancreatic, thyroid, and other endocrine cancers
  • Respiratory and thoracic cancers

Gemcitabine Generic Name & Formulations

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

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

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

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

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

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

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

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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