Hameln Rds Gmbh

Hameln Rds Gmbh Drugs

• Gemcitabine Hydrochlori...
  

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  Gemcitabine Hydrochloride

  

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

  2.1 Ovarian Cancer

  Gemcitabine for Injection USP should be administered intravenously at a dose of 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle. Carboplatin AUC 4 should be administered intravenously on Day 1 after Gemcitabine for Injection USP administration. Patients should be monitored prior to each dose with a complete blood count, including differential counts. Patients should have an absolute granulocyte count ≥1500 × 106/L and a platelet count ≥100,000 × 106/L prior to each cycle.

  Dose Modifications

  Gemcitabine for InjectionUSP dosage adjustment for hematological toxicity within a cycle of treatment is based on the granulocyte and platelet counts taken on Day 8 of therapy. If marrow suppression is detected, Gemcitabine for Injection USP dosage should be modified according to guidelines in Table 1.

  Table 1: Day 8 Dosage Reduction Guidelines for Gemcitabine for Injection USP in Combination with Carboplatin Absolute granulocyte count(× 106/L) Platelet count(× 106/L) % of full dose ≥1500 And ≥100,000 100 1000–1499 And/or 75,000–99,999 50 <1000 And/or <75,000 Hold

  In general, for severe (Grade 3 or 4) non-hematological toxicity, except nausea/vomiting, therapy with Gemcitabine for Injection USP should be held or decreased by 50% depending on the judgment of the treating physician. For carboplatin dosage adjustment, see manufacturer's prescribing information.

  Dose adjustment for Gemcitabine for Injection USP in combination with carboplatin for subsequent cycles is based upon observed toxicity. The dose of Gemcitabine for Injection USP in subsequent cycles should be reduced to 800 mg/m2 on Days 1 and 8 in case of any of the following hematologic toxicities:

  Absolute granulocyte count <500 × 106/L for more than 5 days Absolute granulocyte count <100 × 106/L for more than 3 days Febrile neutropenia Platelets <25,000 × 106/L Cycle delay of more than one week due to toxicity

  If any of the above toxicities recur after the initial dose reduction, for the subsequent cycle, Gemcitabine for Injection USP should be given on Day 1 only at 800 mg/m2.

  2.2 Breast Cancer

  Gemcitabine for Injection USP should be administered intravenously at a dose of 1250 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle. Paclitaxel should be administered at 175 mg/m2 on Day 1 as a 3-hour intravenous infusion before Gemcitabine for Injection USP administration. Patients should be monitored prior to each dose with a complete blood count, including differential counts. Patients should have an absolute granulocyte count ≥1500 × 106/L and a platelet count ≥100,000 × 106/L prior to each cycle.

  Dose Modifications

  Gemcitabine for Injection USP dosage adjustment for hematological toxicity is based on the granulocyte and platelet counts taken on Day 8 of therapy. If marrow suppression is detected, Gemcitabine for Injection USP dosage should be modified according to the guidelines in Table 2.

  Table 2: Day 8 Dosage Reduction Guidelines for Gemcitabine for Injection USP in Combination with Paclitaxel Absolute granulocyte count(× 106/L) Platelet count(× 106/L) % of full dose ≥1200 And >75,000 100 1000–1199 Or 50,000–75,000 75 700–999 And ≥50,000 50 <700 Or <50,000 Hold

  In general, for severe (Grade 3 or 4) non-hematological toxicity, except alopecia and nausea/vomiting, therapy with Gemcitabine for Injection USP should be held or decreased by 50% depending on the judgment of the treating physician. For paclitaxel dosage adjustment, see manufacturer's prescribing information.

  2.3 Non-Small Cell Lung Cancer

  Two schedules have been investigated and the optimum schedule has not been determined [see Clinical Studies (14.3)]. With the 4-week schedule, Gemcitabine for Injection USP should be administered intravenously at 1000 mg/m2 over 30 minutes on Days 1, 8, and 15 of each 28-day cycle. Cisplatin should be administered intravenously at 100 mg/m2 on Day 1 after the infusion of Gemcitabine for Injection USP. With the 3-week schedule, Gemcitabine for Injection USP should be administered intravenously at 1250 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle. Cisplatin at a dose of 100 mg/m2 should be administered intravenously after the infusion of Gemcitabine for Injection USP on Day 1. See prescribing information for cisplatin administration and hydration guidelines.

  Dose Modifications

  Dosage adjustments for hematologic toxicity may be required for Gemcitabine for Injection USP and for cisplatin. Gemcitabine for Injection USP dosage adjustment for hematological toxicity is based on the granulocyte and platelet counts taken on the day of therapy. Patients receiving Gemcitabine for Injection USP should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet counts. If marrow suppression is detected, therapy should be modified or suspended according to the guidelines in Table 3. For cisplatin dosage adjustment, see manufacturer's prescribing information.

  In general, for severe (Grade 3 or 4) non-hematological toxicity, except alopecia and nausea/vomiting, therapy with Gemcitabine for Injection USP plus cisplatin should be held or decreased by 50% depending on the judgment of the treating physician. During combination therapy with cisplatin, serum creatinine, serum potassium, serum calcium, and serum magnesium should be carefully monitored (Grade 3/4 serum creatinine toxicity for gemcitabine plus cisplatin was 5% versus 2% for cisplatin alone).

  2.4 Pancreatic Cancer

  Gemcitabine for Injection USP should be administered by intravenous infusion at a dose of 1000 mg/m2 over 30 minutes once weekly for up to 7 weeks (or until toxicity necessitates reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles should consist of infusions once weekly for 3 consecutive weeks out of every 4 weeks.

  Dose Modifications

  Dosage adjustment is based upon the degree of hematologic toxicity experienced by the patient [see Warnings and Precautions (5.2)]. Clearance in women and the elderly is reduced and women were somewhat less able to progress to subsequent cycles [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)].

  Patients receiving Gemcitabine for Injection USP 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 3.

  Table 3: Dosage Reduction Guidelines Absolute granulocyte count(× 106/L) Platelet count(× 106/L) % of full dose ≥1000 And ≥100,000 100 500–999 Or 50,000–99,999 75 <500 Or <50,000 Hold

  Laboratory evaluation of renal and hepatic function, including transaminases and serum creatinine, should be performed prior to initiation of therapy and periodically thereafter. Gemcitabine for Injection USP should be administered with caution in patients with evidence of significant renal or hepatic impairment as there is insufficient information from clinical studies to allow clear dose recommendation for these patient populations.

  Patients treated with Gemcitabine for Injection USP who complete an entire cycle of therapy may have the dose for subsequent cycles increased by 25%, provided that the absolute granulocyte count (AGC) and platelet nadirs exceed 1500 × 106/L and 100,000 × 106/L, respectively, and if non-hematologic toxicity has not been greater than WHO Grade 1. If patients tolerate the subsequent course of Gemcitabine for Injection USP at the increased dose, the dose for the next cycle can be further increased by 20%, provided again that the AGC and platelet nadirs exceed 1500 × 106/L and 100,000 × 106/L, respectively, and that non-hematologic toxicity has not been greater than WHO Grade 1.

  2.5 Preparation and Administration Precautions

  Caution should be exercised in handling and preparing Gemcitabine for Injection USP solutions. The use of gloves is recommended. If Gemcitabine for Injection USP solution contacts the skin or mucosa, immediately wash the skin thoroughly with soap and water or rinse the mucosa with copious amounts of water. Although acute dermal irritation has not been observed in animal studies, 2 of 3 rabbits exhibited drug-related systemic toxicities (death, hypoactivity, nasal discharge, shallow breathing) due to dermal absorption.

  Procedures for proper handling and disposal of anti-cancer drugs should be considered. Several guidelines on this subject have been published [see References (15)].

  2.6 Preparation for Intravenous Infusion Administration

  The recommended diluent for reconstitution of Gemcitabine for Injection USP is 0.9% Sodium Chloride Injection without preservatives. Due to solubility considerations, the maximum concentration for Gemcitabine for Injection USP upon reconstitution is 40 mg/mL. Reconstitution at concentrations greater than 40 mg/mL may result in incomplete dissolution, and should be avoided.

  To reconstitute, add 5 mL of 0.9% Sodium Chloride Injection to the 200-mg vial or 25 mL of 0.9% Sodium Chloride Injection to the 1-g vial. Shake to dissolve. These dilutions each yield a gemcitabine concentration of 38 mg/mL which includes accounting for the displacement volume of the lyophilized powder (0.26 mL for the 200-mg vial or 1.3 mL for the 1-g vial). The total volume upon reconstitution will be 5.26 mL or 26.3 mL, respectively. Complete withdrawal of the vial contents will provide 200 mg or 1 g of gemcitabine, respectively. 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 Gemcitabine for Injection USP is a clear, colorless to light straw-colored solution. After reconstitution with 0.9% Sodium Chloride Injection, the pH of the resulting solution lies in the range of 2.7 to 3.3. The solution should be inspected visually for particulate matter and discoloration prior to administration, whenever solution or container permit. If particulate matter or discoloration is found, do not administer.

  When prepared as directed, Gemcitabine for Injection USP solutions are stable for 24 hours at controlled room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Discard unused portion. Solutions of reconstituted Gemcitabine for Injection USP should not be refrigerated, as crystallization may occur.

  The compatibility of Gemcitabine for Injection USP with other drugs has not been studied. No incompatibilities have been observed with infusion bottles or polyvinyl chloride bags and administration sets.

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