Recommended Topic Related To:

Gemzar

"Dec. 3, 2012 -- One of the oldest, cheapest, and most widely used diabetes drugs may be a promising new cancer treatment.

In new research from the Mayo Clinic, ovarian cancer patients who took the drug metformin survived longer than p"...

Gemzar

Gemzar

INDICATIONS

Ovarian Cancer

Gemzar in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.

Breast Cancer

Gemzar in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.

Non-Small Cell Lung Cancer

Gemzar is indicated in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB), or metastatic (Stage IV) non-small cell lung cancer.

Pancreatic Cancer

Gemzar is indicated as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. Gemzar is indicated for patients previously treated with 5-FU.

DOSAGE AND ADMINISTRATION

Ovarian Cancer

Recommended Dose and Schedule

The recommended dose of Gemzar is 1000 mg/m² as an intravenous infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, in combination with carboplatin AUC 4 intravenously after Gemzar administration on Day 1 of each 21-day cycle. Refer to carboplatin prescribing information for additional information.

Dose Modifications

Recommended Gemzar dose modifications for myelosuppression are described Table 1 and Table 2 [see WARNINGS AND PRECAUTIONS]. Refer to Dosage and Administration for recommendations for non-hematologic adverse reactions.

Table 1: Dosage Reduction Guidelines for Gemzar for Myelosuppression on Day of Treatment in Ovarian Cancer

Treatment Day Absolute granulocyte count (x 106/L)   Platelet count (x 106/L) % of full dose
Day 1 ≥ 1500 and ≥ 100,000 100%
< 1500 or < 100,000 Delay Treatment Cycle
Day 8 ≥ 1500 and ≥ 100,000 100
1000-1499 or 75,000-99,999 50
< 1000 or < 75,000 Hold

Table 2: Gemzar Dose Modification for Myelosuppression in Previous Cycle In Ovarian Cancer

Occurrence Myelosuppression During Treatment Cycle Dose Modification
Initial Occurrence Absolute granulocyte count less than 500 x 106/L for more than 5 days
Absolute granulocyte count less than 100 x 106/L for more than 3 days
Febrile neutropenia
Platelets less than 25,000x106/L Cycle delay of more than one week due to toxicity
Permanently reduce Gemzar to 800 mg/m² on Days 1 and 8
Subsequent Occurrence If any of the above toxicities occur after the initial dose reduction Permanently reduce Gemzar dose to 800 mg/m² on Day 1 only

Breast Cancer

Recommended Dose and Schedule

The recommended dose of Gemzar is 1250 mg/m² intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle that includes paclitaxel. Paclitaxel should be administered at 175 mg/m² on Day 1 as a 3 hour intravenous infusion before Gemzar administration.

Dose Modifications

Recommended dose modifications for Gemzar for myelosuppression are described in Table 3 [see WARNINGS AND PRECAUTIONS]. Refer to Dosage and Administration (2.5) for recommendations for non-hematologic adverse reactions.

Table 3: Recommended Dose Reductions for Gemzar for Myelosuppression on Day of Treatment in Breast Cancer

Treatment Day Absolute granulocyte count   Platelet count % of full dose
Day 1 ≥ 1500
less than 1500
and
or
≥ 100,000
less than 100,000
100%
Hold
Day 8 ≥ 1200
1000-1199
and
or
> 75,000 50,000-75,000 100%
75%
700-999
< 700
and
or
≥ 50,000
< 50,000
50%
Hold

Non-Small Cell Lung Cancer

Recommended Dose and Schedule

Every 4-week schedule

The recommended dose of Gemzar is 1000 mg/m² intravenously over 30 minutes on Days 1, 8, and 15 in combination with cisplatin therapy. Administer cisplatin intravenously at 100 mg/m² on Day 1 after the infusion of Gemzar.

Every 3-week schedule

The recommended dose of Gemzar is 1250 mg/m² intravenously over 30 minutes on Days 1 and 8 in combination with cisplatin therapy. Administer cisplatin intravenously at 100 mg/m² on Day 1 after the infusion of Gemzar.

Dose Modifications

Recommended dose modifications for Gemzar myelosuppression are described in Table 4 [see WARNINGS AND PRECAUTIONS]. Refer to Dosage and Administration (2.5) for Gemzar recommendations for non-hematologic adverse reactions.

Pancreatic Cancer

Recommended Dose and Schedule

The recommended dose of Gemzar is 1000 mg/m² over 30 minutes intravenously. The recommended treatment schedule

  • Weeks 1-8: weekly dosing for the first 7 weeks followed by one week rest.
  • After week 8: weekly dosing on Days 1, 8, and 15 of 28-day cycles.
Dose Modifications

Recommended dose modifications for Gemzar for myelosuppression are described in Table 4 [see WARNINGS AND PRECAUTIONS]. Refer to Dosage and Administration (2.5) for recommendations for non-hematologic adverse reactions.

Patients receiving Gemzar should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet count. If marrow suppression is detected, therapy should be modified or suspended according to the guidelines in Table 4.

Table 4: Recommended Dose Reductions for Gemzar for Myelosuppression in Pancreatic Cancer and Non-Small Cell Lung Cancer

Absolute granulocyte count (x 106/L)   Platelet count (x 106/L) % of full dose
≥ 1000 And ≥ 100,000 100
500-999 Or 50,000-99,999 75
< 500 Or < 50,000 Hold

Dose Modifications for Non-Hematologic Adverse Reactions

Permanently discontinue Gemzar for any of the following

Withhold Gemzar or reduce dose by 50% for other severe (Grade 3 or 4) non-hematological toxicity until resolved. No dose modifications are recommended for alopecia, nausea, or vomiting.

Preparation and Administration Precautions

Exercise caution and wear gloves when preparing Gemzar solutions. Immediately wash the skin thoroughly or rinse the mucosa with copious amounts of water if Gemzar contacts the skin or mucus membranes. Death has occurred in animal studies due to dermal absorption. For further guidance on handling Gemzar go to “OSHA Hazardous Drugs” (refer to antineoplastic weblinks including OSHA Technical Manual) at OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

Preparation for Intravenous Infusion Administration

Reconstitute the vials with 0.9% Sodium Chloride Injection without preservatives.

Add 5 mL to the 200-mg vial or 25 mL to the 1-g vial. These dilutions each yield a Gemzar concentration of 38 mg/mL. Complete withdrawal of the vial contents will provide 200 mg or 1 g of Gemzar. Prior to administration the appropriate amount of drug must be diluted with 0.9% Sodium Chloride Injection. Final concentrations may be as low as 0.1 mg/mL.

Reconstituted Gemzar is a clear, colorless to light straw-colored solution. Inspect visually prior to administration and discard for particulate matter or discoloration. Gemzar solutions are stable for 24 hours at controlled room temperature of 20° to 25°C (68° to 77°F). Do not refrigerate as crystallization can occur.

No incompatibilities have been observed with infusion bottles or polyvinyl chloride bags and administration sets.

HOW SUPPLIED

Dosage Forms And Strengths

Gemzar (gemcitabine for injection USP) is a white to off-white lyophilized powder available in sterile single-use vials containing 200 mg or 1 g gemcitabine.

Gemzar (gemcitabine for injection, USP), is available in sterile single-use vials individually packaged in a carton containing: 200 mg white to off-white, lyophilized powder in a 10-mL size sterile single-use vial – NDC 0002-7501-01 (No. 7501) 1 g white to off-white, lyophilized powder in a 50-mL size sterile single-use vial – NDC 0002-7502-01 (No. 7502)

Storage and Handling

Unopened vials of Gemzar are stable until the expiration date indicated on the package when stored at controlled room temperature 20° to 25°C (68° to 77°F) and that allows for excursions between 15° and 30°C (59° and 86°F) [See USP Controlled Room Temperature] [see DOSAGE AND ADMINISTRATION].

Marketed by: Lilly USA, LLC Indianapolis, IN 46285, USA. Revised: 05/2013

Last reviewed on RxList: 6/13/2013
This monograph has been modified to include the generic and brand name in many instances.

A A A

Gemzar - User Reviews

Gemzar User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Gemzar sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Cancer

Get the latest treatment options.

Related Supplements
advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations