Gemcitabine (Page 2 of 8)

2.3 Non-Small Cell Lung Cancer

Recommended Dose and Schedule

28-day schedule

The recommended dosage of gemcitabine for injection is 1000 mg/m2 intravenously over 30 minutes on Days 1, 8, and 15 of each 28-day cycle in combination with cisplatin 100 mg/m2 administered intravenously on Day 1 after gemcitabine for injection administration.

21-day schedule

The recommended dosage of gemcitabine for injection is 1250 mg/m2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle in combination with cisplatin 100 mg/m2 administered intravenously on Day 1 after gemcitabine for injection administration.

Refer to cisplatin prescribing information for additional information.

Dosage Modifications

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

2.4 Pancreatic Cancer

Recommended Dose and Schedule

The recommended dosage of gemcitabine for injection is 1000 mg/m2 intravenously over 30 minutes. The recommended treatment schedule is as follows:

  • 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 each 28-day cycle.

Dosage Modifications

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

Table 4: Recommended Dosage Modifications for Gemcitabine For Injection for Myelosuppression in Pancreatic Cancer and Non-Small Cell Lung Cancer
Absolute Neutrophil Count(x 10 6 /L) Platelet Count(x 10 6 /L) Dosage Modification
Greater than or equal to 1000 And Greater than or equal to 100,000 None
500 to 999 Or 50,000 to 99,999 75% of full dose
Less than 500 Or Less than 50,000 Hold

2.5 Dosage Modifications for Non-Hematologic Adverse Reactions

Permanently discontinue gemcitabine for injection for any of the following:

  • Unexplained dyspnea or evidence of severe pulmonary toxicity [see Warnings and Precautions (5.3)]
  • Hemolytic-uremic syndrome (HUS) or severe renal impairment [see Warnings and Precautions (5.4)]
  • Severe hepatic toxicity [see Warnings and Precautions (5.5)]
  • Capillary leak syndrome (CLS) [see Warnings and Precautions (5.8)]
  • Posterior reversible encephalopathy syndrome (PRES) [see Warnings and Precautions (5.9)]

Withhold gemcitabine for injection or reduce dose by 50% for other Grade 3 or 4 non-hematological adverse reactions until resolved. No dose modifications are recommended for alopecia, nausea, or vomiting.

2.6 Preparation

  • Gemcitabine for injection vials contain no antimicrobial preservatives and are intended for single use only.
  • Gemcitabine for injection is a cytotoxic drug. Follow applicable special handling and disposal procedures.1
  • Exercise caution and wear gloves when preparing gemcitabine for injection solutions. Immediately wash the skin thoroughly or rinse the mucosa with copious amounts of water if gemcitabine for injection contacts the skin or mucus membranes. Death has occurred in animal studies due to dermal absorption.
  • Reconstitute the 200 mg vial with 5 mL and the 1 g vial with 25 mL of 0.9% Sodium Chloride Injection, USP to yield a gemcitabine for injection concentration of 38 mg/mL. Reconstituted gemcitabine for injection is a clear, colorless to light straw-colored solution.
  • Visually inspect reconstituted product for particulate matter and discoloration. Discard if particulate matter or discoloration is observed.
  • Withdraw the calculated dose from the vial and discard any unused portion.
  • Prior to administration, dilute the reconstituted solution with 0.9% Sodium Chloride Injection, USP to a minimum final concentration of at least 0.1 mg/mL.
  • Store gemcitabine solutions (reconstituted and diluted) at controlled room temperature of 20°C to 25°C (68°F to 77°F). Do not refrigerate as crystallization can occur. Discard gemcitabine solutions if not used within 24 hours after reconstitution.
  • No incompatibilities have been observed with infusion bottles or polyvinyl chloride bags and administration sets.

3 DOSAGE FORMS AND STRENGTHS

For injection:

Gemcitabine For Injection USP, 200 mg is a white to off-white, lyophilized powder available in sterile a single-dose vial containing 200 mg gemcitabine.

Gemcitabine For Injection USP, 1 g is a white to off-white, lyophilized powder available in sterile a single-dose vial containing 1 g gemcitabine.

4 CONTRAINDICATIONS

Gemcitabine for injection is contraindicated in patients with a known hypersensitivity to gemcitabine. Reactions include anaphylaxis [see Adverse Reactions (6.1)].

5 WARNINGS AND PRECAUTIONS

5.1 Schedule-Dependent Toxicity

In clinical trials evaluating the maximum tolerated dose of gemcitabine for injection, prolongation of the infusion time beyond 60 minutes or more frequent than weekly dosing resulted in an increased incidence of clinically significant hypotension, severe flu-like symptoms, myelosuppression, and asthenia. The half-life of gemcitabine for injection is influenced by the length of the infusion [see Clinical Pharmacology (12.3)]. Refer to the recommended gemcitabine for injection dosage [see Dosage and Administration (2.1, 2.2, 2.3, 2.4)].

5.2 Myelosuppression

Myelosuppression manifested by neutropenia, thrombocytopenia, and anemia occurs with gemcitabine for injection as a single agent and the risks are increased when gemcitabine for injection is combined with other cytotoxic drugs. In clinical trials, Grade 3-4 neutropenia, anemia, and thrombocytopenia occurred in 25%, 8%, and 5%, respectively of the 979 patients who received single agent gemcitabine for injection. The frequencies of Grade 3-4 neutropenia, anemia, and thrombocytopenia varied from 48% to 71%, 8% to 28%, and 5% to 55%, respectively, in patients receiving gemcitabine for injection in combination with another drug [see Adverse Reactions (6.1)].

Prior to each dose of gemcitabine for injection, obtain a complete blood count (CBC) with a differential and a platelet count. Modify the dosage as recommended [see Dosage and Administration (2.1, 2.2, 2.3, 2.4)].

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