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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; preservative-free; contains mannitol.

Company:
Lilly, Eli and Company

Therapeutic Use:

Indications for GEMZAR:

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.

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.

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. Use effective contraception during and for 6 months (females) or 3 months (males w. female partners) after last dose. Nursing mothers: not recommended (during and for ≥1 week after last dose).

Pharmacological Class:

Antimetabolite.

Interactions:

Severe radiation toxicity with concomitant radiation therapy: not recommended.

Adverse Reactions:

Myelosuppression, nausea, vomiting, elevated transaminases, increased alkaline phosphatase, proteinuria, fever, hematuria, rash, dyspnea, edema; pulmonary toxicity, HUS, renal failure, hepatotoxicity, CLS, PRES.

How Supplied:

Single-use vials—1

Indications for GEMZAR:

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

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.

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. Use effective contraception during and for 6 months (females) or 3 months (males w. female partners) after last dose. Nursing mothers: not recommended (during and for ≥1 week after last dose).

Pharmacological Class:

Antimetabolite.

Interactions:

Severe radiation toxicity with concomitant radiation therapy: not recommended.

Adverse Reactions:

Myelosuppression, nausea, vomiting, elevated transaminases, increased alkaline phosphatase, proteinuria, fever, hematuria, rash, dyspnea, edema; pulmonary toxicity, HUS, renal failure, hepatotoxicity, CLS, PRES.

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 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.

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. Use effective contraception during and for 6 months (females) or 3 months (males w. female partners) after last dose. Nursing mothers: not recommended (during and for ≥1 week after last dose).

Pharmacological Class:

Antimetabolite.

Interactions:

Severe radiation toxicity with concomitant radiation therapy: not recommended.

Adverse Reactions:

Myelosuppression, nausea, vomiting, elevated transaminases, increased alkaline phosphatase, proteinuria, fever, hematuria, rash, dyspnea, edema; pulmonary toxicity, HUS, renal failure, hepatotoxicity, CLS, PRES.

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 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.

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. Use effective contraception during and for 6 months (females) or 3 months (males w. female partners) after last dose. Nursing mothers: not recommended (during and for ≥1 week after last dose).

Pharmacological Class:

Antimetabolite.

Interactions:

Severe radiation toxicity with concomitant radiation therapy: not recommended.

Adverse Reactions:

Myelosuppression, nausea, vomiting, elevated transaminases, increased alkaline phosphatase, proteinuria, fever, hematuria, rash, dyspnea, edema; pulmonary toxicity, HUS, renal failure, hepatotoxicity, CLS, PRES.

How Supplied:

Single-use vials—1

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