Gemcitabine

GEMCITABINE- gemcitabine hydrochloride injection, powder, lyophilized, for solution
Bedford Laboratories

structurefigure1figure2figure3figure4200CARTON200VIAL1VIAL1CARTON

1 INDICATIONS AND USAGE

1.1 Ovarian Cancer

Gemcitabine for injection 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.

1.2 Breast Cancer

Gemcitabine for injection 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.

1.3 Non-Small Cell Lung Cancer

Gemcitabine for injection 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.

1.4 Pancreatic Cancer

Gemcitabine for injection 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. Gemcitabine for injection is indicated for patients previously treated with 5-FU.

2 DOSAGE AND ADMINISTRATION

Gemcitabine for injection is for intravenous use only. Gemcitabine for injection may be administered on an outpatient basis.

2.1 Ovarian Cancer

Recommended Dose and Schedule

The recommended dose of gemcitabine for injection 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 gemcitabine for injection administration on Day 1 of each 21-day cycle. Refer to carboplatin prescribing information for additional information.

Dose Modifications

Recommended gemcitabine for injection dose modifications for myelosuppression are described Table 1 and Table 2 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for recommendations for non-hematologic adverse reactions.

Table 1: Dosage Reduction Guidelines for Gemcitabine For Injection 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 to 1499 or 75,000 to 99,999 50
<1000 or <75,000 Hold

Table 2: Gemcitabine For Injection 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 25,000×106 /L Cycle delay of more than one week due to toxicity Permanently reduce gemcitabine for injection 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 gemcitabine for injection dose to 800 mg/m2 on Day 1 only

2.2 Breast Cancer

Recommended Dose and Schedule

The recommended dose of gemcitabine for injection 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 gemcitabine for injection administration.

Dose Modifications Recommended dose modifications for gemcitabine for injection for myelosuppression are described in Table 3 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for recommendations for non-hematologic adverse reactions.

Table 3: Recommended Dose Reductions for Gemcitabine For Injection for Myelosuppression on Day of Treatment in Breast Cancer

Treatment Day Absolute granulocyte count (x 106 /L) Platelet count(x 106 /L) % of full dose
Day 1 ≥1500 and ≥ 100,000 100%
less than1500 or less than 100,000 Hold
Day 8 ≥ 1200 and > 75,000 100%
1000 to 1199 or 50,000 to 75,000 75%
700 to 999 and ≥ 50,000 50%
< 700 or < 50,000 Hold

2.3 Non-Small Cell Lung Cancer

Recommended Dose and Schedule

Every 4-week schedule The recommended dose of gemcitabine for injection 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 gemcitabine for injection.

Every 3-week schedule

The recommended dose of gemcitabine for injection 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 gemcitabine for injection.

Dose Modifications

Recommended dose modifications for gemcitabine for injection myelosuppression are described in Table 4 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for gemcitabine for injection recommendations for non-hematologic adverse reactions.

2.4 Pancreatic Cancer

Recommended Dose and Schedule

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

• Weeks 1 to 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 gemcitabine for injection for myelosuppression are described in Table 4 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for recommendations for non-hematologic adverse reactions.

Patients receiving gemcitabine for injection 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 Gemcitabine For Injection 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 to 999 Or 50,000 to 99,999 75
<500 Or <50,000 Hold

2.5 Dose Modifications for Non-Hematologic Adverse Reactions

Permanently discontinue gemcitabine for injection for any of the following

  • Unexplained dyspnea or other evidence of severe pulmonary toxicity
  • Severe hepatic toxicity
  • Hemolytic-Uremic Syndrome
  • Capillary Leak Syndrome
  • Posterior reversible encephalopathy syndrome

Withhold gemcitabine for injection 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.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.