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GEMZAR
Breast cancer
Gynecologic cancers
Pancreatic, thyroid, and other endocrine cancers
Respiratory and thoracic cancers
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Drug Name:

GEMZAR Rx

Generic Name and Formulations:
Gemcitabine HCl 200mg, 1g; per vial; lyophilized pwd for IV infusion after reconstitution; contains mannitol.

Company:
Lilly, Eli and Company

Therapeutic Use:

Indications for GEMZAR:

First-line treatment of metastatic breast cancer (in combination with paclitaxel) after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were contraindicated.

Adult:

Infuse over 30 mins (increased toxicity if infusion goes beyond 60 mins). 1250mg/m2 on Days 1 and 8 of each 21-day cycle. Adjust dose based on toxicity (full labeling).

Children:

Not established.

Warnings/Precautions:

Not for use in combination with radiation therapy. Discontinue if unexplained dyspnea, pulmonary toxicity, severe liver injury, capillary leak syndrome, or posterior reversible encephalopathy syndrome (confirm with MRI) occurs. Permanently discontinue if hemolytic uremic syndrome or severe renal impairment. Concurrent liver metastases. History of hepatitis, alcoholism, liver cirrhosis. Assess renal and hepatic function prior to therapy, then periodically thereafter. Monitor for myelosuppression; obtain CBCs, platelets prior to each dose. Elderly. Pregnancy (Cat.D); avoid. Nursing mothers: not recommended.

Interactions:

See Warnings/Precautions. Concomitant radiation therapy: may cause severe radiation toxicity.

Pharmacological Class:

Antimetabolite.

Adverse Reactions:

Myelosuppression, nausea, vomiting, elevated transaminases, increased alkaline phosphatase, proteinuria, fever, hematuria, rash, dyspnea, edema, flu-like symptoms, infection, alopecia, neurotoxicity, others; rare: renal or liver failure, hemolytic uremic syndrome, capillary leak syndrome, posterior reversible encephalopathy syndrome.

How Supplied:

Single-use vials—1

Indications for GEMZAR:

Advanced ovarian cancer (in combination with carboplatin) that has relapsed at least 6 months after completion of platinum-based therapy.

Adult:

Infuse over 30 mins (increased toxicity if infusion goes beyond 60 mins). 1000mg/m2 on Days 1 and 8 of each 21-day cycle. Adjust dose based on toxicity (see full labeling).

Children:

Not established.

Warnings/Precautions:

Not for use in combination with radiation therapy. Discontinue if unexplained dyspnea, pulmonary toxicity, severe liver injury, capillary leak syndrome, or posterior reversible encephalopathy syndrome (confirm with MRI) occurs. Permanently discontinue if hemolytic uremic syndrome or severe renal impairment. Concurrent liver metastases. History of hepatitis, alcoholism, liver cirrhosis. Assess renal and hepatic function prior to therapy, then periodically thereafter. Monitor for myelosuppression; obtain CBCs, platelets prior to each dose. Elderly. Pregnancy (Cat.D); avoid. Nursing mothers: not recommended.

Interactions:

See Warnings/Precautions. Concomitant radiation therapy: may cause severe radiation toxicity.

Pharmacological Class:

Antimetabolite.

Adverse Reactions:

Myelosuppression, nausea, vomiting, elevated transaminases, increased alkaline phosphatase, proteinuria, fever, hematuria, rash, dyspnea, edema, flu-like symptoms, infection, alopecia, neurotoxicity, others; rare: renal or liver failure, hemolytic uremic syndrome, capillary leak syndrome, posterior reversible encephalopathy syndrome.

How Supplied:

Single-use vials—1

Indications for GEMZAR:

First-line treatment of locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) pancreatic cancer.

Adult:

Infuse over 30 mins (increased toxicity if infusion goes beyond 60 mins). 1000mg/m2 once weekly for up to 7 weeks, followed by a week of rest; subsequent cycles: infuse once weekly for 3 consecutive weeks out of every 4 weeks. Adjust dose based on toxicity (see full labeling).

Children:

Not established.

Warnings/Precautions:

Not for use in combination with radiation therapy. Discontinue if unexplained dyspnea, pulmonary toxicity, severe liver injury, capillary leak syndrome, or posterior reversible encephalopathy syndrome (confirm with MRI) occurs. Permanently discontinue if hemolytic uremic syndrome or severe renal impairment. Concurrent liver metastases. History of hepatitis, alcoholism, liver cirrhosis. Assess renal and hepatic function prior to therapy, then periodically thereafter. Monitor for myelosuppression; obtain CBCs, platelets prior to each dose. Elderly. Pregnancy (Cat.D); avoid. Nursing mothers: not recommended.

Interactions:

See Warnings/Precautions. Concomitant radiation therapy: may cause severe radiation toxicity.

Pharmacological Class:

Antimetabolite.

Adverse Reactions:

Myelosuppression, nausea, vomiting, elevated transaminases, increased alkaline phosphatase, proteinuria, fever, hematuria, rash, dyspnea, edema, flu-like symptoms, infection, alopecia, neurotoxicity, others; rare: renal or liver failure, hemolytic uremic syndrome, capillary leak syndrome, posterior reversible encephalopathy syndrome.

How Supplied:

Single-use vials—1

Indications for GEMZAR:

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).

Adult:

Infuse over 30 mins (increased toxicity if infusion goes beyond 60 mins). 4-week schedule: 1000mg/m2 on Days 1, 8, and 15 of each 28-day cycle; or 3-week schedule: 1250mg/m2 on Days 1 and 8 of each 21-day cycle. Adjust dose based on toxicity (see full labeling).

Children:

Not established.

Warnings/Precautions:

Not for use in combination with radiation therapy. Discontinue if unexplained dyspnea, pulmonary toxicity, severe liver injury, capillary leak syndrome, or posterior reversible encephalopathy syndrome (confirm with MRI) occurs. Permanently discontinue if hemolytic uremic syndrome or severe renal impairment. Concurrent liver metastases. History of hepatitis, alcoholism, liver cirrhosis. Assess renal and hepatic function prior to therapy, then periodically thereafter. Monitor for myelosuppression; obtain CBCs, platelets prior to each dose. Elderly. Pregnancy (Cat.D); avoid. Nursing mothers: not recommended.

Interactions:

See Warnings/Precautions. Concomitant radiation therapy: may cause severe radiation toxicity.

Pharmacological Class:

Antimetabolite.

Adverse Reactions:

Myelosuppression, nausea, vomiting, elevated transaminases, increased alkaline phosphatase, proteinuria, fever, hematuria, rash, dyspnea, edema, flu-like symptoms, infection, alopecia, neurotoxicity, others; rare: renal or liver failure, hemolytic uremic syndrome, capillary leak syndrome, posterior reversible encephalopathy syndrome.

How Supplied:

Single-use vials—1

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