Camptosar

Camptosar Manufacturers

• Pharmacia And Upjohn Company
  

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  Camptosar | Pharmacia And Upjohn Company

  

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  2.1 Colorectal Cancer Combination Regimens 1 and 2

  Administer CAMPTOSAR as a 90-minute intravenous infusion followed by LV and 5-FU. The currently recommended regimens are shown in Table 1.

  A reduction in the starting dose by one dose level of CAMPTOSAR may be considered for patients with any of the following conditions: prior pelvic/abdominal radiotherapy, performance status of 2, or increased bilirubin levels. Dosing for patients with bilirubin >2 mg/dL cannot be recommended because there is insufficient information to recommend a dose in these patients.

  Table 1. Combination-Agent Dosage Regimens and Dose Modifications* * Dose reductions beyond Dose Level –2 by decrements of ≈ 20% may be warranted for patients continuing to experience toxicity. Provided intolerable toxicity does not develop, treatment with additional cycles may be continued indefinitely as long as patients continue to experience clinical benefit. † Infusion follows bolus administration. Regimen 1
  6-wk cycle with bolus 5-FU/LV
  (next cycle begins on day 43) CAMPTOSAR
  LV
  5-FU 125 mg/m2 intravenous infusion over 90 minutes, days 1,8,15,22
  20 mg/m2 intravenous injection bolus, days 1,8,15,22
  500 mg/m2 intravenous injection bolus, days 1,8,15,22 Starting Dose & Modified Dose Levels (mg/m2) Starting Dose Dose Level -1 Dose Level -2 CAMPTOSAR 125 100 75 LV 20 20 20 5-FU 500 400 300 Regimen 2
  6-wk cycle with infusional 5-FU/LV
  (next cycle begins on day 43) CAMPTOSAR 180 mg/m2 intravenous infusion over 90 minutes, days 1,15,29 LV 200 mg/m2 intravenous infusion over 2 hours, days 1,2,15,16,29,30 5-FU    Bolus 400 mg/m2 intravenous injection bolus, days 1,2,15,16,29,30 5-FU    Infusion† 600 mg/m2 intravenous infusion over 22 hours, days 1,2,15,16,29,30 Starting Dose & Modified Dose Levels (mg/m2) Starting Dose Dose Level -1 Dose Level -2 CAMPTOSAR 180 150 120 LV 200 200 200 5-FU    Bolus 400 320 240 5-FU    Infusion† 600 480 360

  Dosing for patients with bilirubin >2 mg/dL cannot be recommended because there is insufficient information to recommend a dose in these patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

  Dose Modifications

  Based on recommended dose levels described in Table 1, Combination Regimens of CAMPTOSAR and Dose Modifications, subsequent doses should be adjusted as suggested in Table 2, Recommended Dose Modifications for Combination Regimens. All dose modifications should be based on the worst preceding toxicity.

  Table 2. Recommended Dose Modifications for CAMPTOSAR/5-Fluorouracil (5-FU)/Leucovorin (LV) Combination Schedules Patients should return to pre-treatment bowel function without requiring antidiarrhea medications for at least 24 hours before the next chemotherapy administration. A new cycle of therapy should not begin until the granulocyte count has recovered to ≥1500/mm3, and the platelet count has recovered to ≥100,000/mm3, and treatment-related diarrhea is fully resolved. Treatment should be delayed 1 to 2 weeks to allow for recovery from treatment-related toxicities. If the patient has not recovered after a 2-week delay, consideration should be given to discontinuing therapy. Toxicity
  NCI CTC Grade* (Value) During a Cycle of Therapy At the Start of Subsequent Cycles of Therapy† * National Cancer Institute Common Toxicity Criteria (version 1.0) † Relative to the starting dose used in the previous cycle ‡ Pretreatment § Excludes alopecia, anorexia, asthenia No toxicity Maintain dose level Maintain dose level Neutropenia 1 (1500 to 1999/mm3) Maintain dose level Maintain dose level 2 (1000 to 1499/mm3) ↓ 1 dose level Maintain dose level 3 (500 to 999/mm3) Omit dose until resolved to ≤ grade 2, then ↓ 1 dose level ↓ 1 dose level 4 (<500/mm3) Omit dose until resolved to ≤ grade 2, then ↓ 2 dose levels ↓ 2 dose levels Neutropenic fever Omit dose until resolved, then ↓ 2 dose levels Other hematologic toxicities Dose modifications for leukopenia or thrombocytopenia during a cycle of therapy and at the start of subsequent cycles of therapy are also based on NCI toxicity criteria and are the same as recommended for neutropenia above. Diarrhea 1 (2–3 stools/day > pretx‡) Delay dose until resolved to baseline, then give same dose Maintain dose level 2 (4–6 stools/day > pretx) Omit dose until resolved to baseline, then ↓ 1 dose level Maintain dose level 3 (7–9 stools/day > pretx) Omit dose until resolved to baseline, then ↓ 1 dose level ↓ 1 dose level 4 (≥10 stools/day > pretx) Omit dose until resolved to baseline, then ↓ 2 dose levels ↓ 2 dose levels Other nonhematologic toxicities§ 1 Maintain dose level Maintain dose level 2 Omit dose until resolved to ≤ grade 1, then ↓ 1 dose level Maintain dose level 3 Omit dose until resolved to ≤ grade 2, then ↓ 1 dose level ↓ 1 dose level 4 Omit dose until resolved to ≤ grade 2, then ↓ 2 dose levels ↓ 2 dose levels For mucositis/stomatitis decrease only 5-FU, not CAMPTOSAR For mucositis/stomatitis decrease only 5-FU, not CAMPTOSAR. 2.2 Colorectal Single Agent Regimens 1 and 2

  Administer CAMPTOSAR as a 90-minute intravenous infusion. The currently recommended regimens are shown in Table 3.

  A reduction in the starting dose by one dose level of CAMPTOSAR may be considered for patients with any of the following conditions: prior pelvic/abdominal radiotherapy, performance status of 2, or increased bilirubin levels. Dosing for patients with bilirubin >2 mg/dL cannot be recommended because there is insufficient information to recommend a dose in these patients.

  Table 3. Single-Agent Regimens of CAMPTOSAR and Dose Modifications * Subsequent doses may be adjusted as high as 150 mg/m 2 or to as low as 50 mg/m 2 in 25 to 50 mg/m 2 decrements depending upon individual patient tolerance. † Provided intolerable toxicity does not develop, treatment with additional cycles may be continued indefinitely as long as patients continue to experience clinical benefit. ‡ Subsequent doses may be adjusted as low as 200 mg/m 2 in 50 mg/m 2 decrements depending upon individual patient tolerance. Regimen 1 (weekly)* 125 mg/m2 intravenous infusion over 90 minutes, days 1,8,15,22 then 2-week rest   Starting Dose and Modified Dose Levels† (mg/m2) Starting Dose Dose Level -1 Dose Level -2 125 100 75 Regimen 2 (every 3 weeks)‡ 350 mg/m2 intravenous infusion over 90 minutes, once every 3 weeks†   Starting Dose and Modified Dose Levels (mg/m2) Starting Dose Dose Level -1 Dose Level -2 350 300 250

  Dose Modifications

  Based on recommended dose-levels described in Table 3, Single-Agent Regimens of CAMPTOSAR and Dose Modifications, subsequent doses should be adjusted as suggested in Table 4, Recommended Dose Modifications for Single-Agent Schedules. All dose modifications should be based on the worst preceding toxicity.

  Table 4: Recommended Dose Modifications For Single-Agent Schedules* A new cycle of therapy should not begin until the granulocyte count has recovered to ≥1500/mm3, and the platelet count has recovered to ≥100,000/mm3, and treatment-related diarrhea is fully resolved. Treatment should be delayed 1 to 2 weeks to allow for recovery from treatment-related toxicities. If the patient has not recovered after a 2-week delay, consideration should be given to discontinuing CAMPTOSAR. Worst Toxicity
  NCI Grade† (Value) During a Cycle of Therapy At the Start of the Next Cycles of Therapy (After Adequate Recovery), Compared with the Starting Dose in the Previous Cycle* Weekly Weekly Once Every 3 Weeks * All dose modifications should be based on the worst preceding toxicity † National Cancer Institute Common Toxicity Criteria (version 1.0) ‡ Pretreatment § Excludes alopecia, anorexia, asthenia No toxicity Maintain dose level ↑ 25 mg/m2 up to a maximum dose of 150 mg/m2 Maintain dose level Neutropenia 1 (1500 to 1999/mm3) Maintain dose level Maintain dose level Maintain dose level 2 (1000 to 1499/mm3) ↓ 25 mg/m2 Maintain dose level Maintain dose level 3 (500 to 999/mm3) Omit dose until resolved to ≤ grade 2, then ↓ 25 mg/m2 ↓ 25 mg/m2 ↓ 50 mg/m2 4 (<500/mm3) Omit dose until resolved to ≤ grade 2, then ↓ 50 mg/m2 ↓ 50 mg/m2 ↓ 50 mg/m2 Neutropenic fever Omit dose until resolved, then ↓ 50 mg/m2 when resolved ↓ 50 mg/m2 ↓ 50 mg/m2 Other hematologic toxicities Dose modifications for leukopenia, thrombocytopenia, and anemia during a cycle of therapy and at the start of subsequent cycles of therapy are also based on NCI toxicity criteria and are the same as recommended for neutropenia above. Diarrhea 1 (2–3 stools/day > pretx‡) Maintain dose level Maintain dose level Maintain dose level 2 (4–6 stools/day > pretx) ↓ 25 mg/m2 Maintain dose level Maintain dose level 3 (7–9 stools/day > pretx) Omit dose until resolved to ≤ grade 2, then ↓ 25 mg/m2 ↓ 25 mg/m2 ↓ 50 mg/m2 4 (≥10 stools/day > pretx) Omit dose until resolved to ≤ grade 2 then ↓ 50 mg/m2 ↓ 50 mg/m2 ↓ 50 mg/m2 Other nonhematologic§ toxicities 1 Maintain dose level Maintain dose level Maintain dose level 2 ↓ 25 mg/m2 ↓ 25 mg/m2 ↓ 50 mg/m2 3 Omit dose until resolved to ≤ grade 2, then ↓ 25 mg/m2 ↓ 25 mg/m2 ↓ 50 mg/m2 4 Omit dose until resolved to ≤ grade 2, then ↓ 50 mg/m2 ↓ 50 mg/m2 ↓ 50 mg/m2 2.3 Dosage in Patients with Reduced UGT1A1 Activity

  When administered in combination with other agents, or as a single-agent, a reduction in the starting dose by at least one level of CAMPTOSAR should be considered for patients known to be homozygous for the UGT1A1*28 allele [see Dosage and Administration (2.1 and 2.2) and Warnings and Precautions (5.3)]. However, the precise dose reduction in this patient population is not known, and subsequent dose modifications should be considered based on individual patient tolerance to treatment (see Tables 1–4).

  2.4 Premedication

  It is recommended that patients receive premedication with antiemetic agents. In clinical studies of the weekly dosage schedule, the majority of patients received 10 mg of dexamethasone given in conjunction with another type of antiemetic agent, such as a 5-HT3 blocker (e.g., ondansetron or granisetron). Antiemetic agents should be given on the day of treatment, starting at least 30 minutes before administration of CAMPTOSAR. Physicians should also consider providing patients with an antiemetic regimen (e.g., prochlorperazine) for subsequent use as needed. A similar antiemetic regimen should be used with Camptosar in combination therapy.

  Prophylactic or therapeutic administration of atropine should be considered in patients experiencing cholinergic symptoms.

  2.5 Preparation of Infusion Solution

  Inspect vial contents for particulate matter and discoloration and repeat inspection when drug product is withdrawn from vial into syringe.

  CAMPTOSAR Injection 20 mg/mL is intended for single use only and any unused portion should be discarded.

  CAMPTOSAR Injection must be diluted prior to infusion. CAMPTOSAR should be diluted in 5% Dextrose Injection, USP, (preferred) or 0.9% Sodium Chloride Injection, USP, to a final concentration range of 0.12 mg/mL to 2.8 mg/mL. Other drugs should not be added to the infusion solution.

  The solution is physically and chemically stable for up to 24 hours at room temperature and in ambient fluorescent lighting. Solutions diluted in 5% Dextrose Injection, USP, and stored at refrigerated temperatures (approximately 2° to 8°C, 36° to 46°F), and protected from light are physically and chemically stable for 48 hours. Refrigeration of admixtures using 0.9% Sodium Chloride Injection, USP, is not recommended due to a low and sporadic incidence of visible particulates. Freezing CAMPTOSAR and admixtures of CAMPTOSAR may result in precipitation of the drug and should be avoided.

  The CAMPTOSAR Injection solution should be used immediately after reconstitution as it contains no antibacterial preservative. Because of possible microbial contamination during dilution, it is advisable to use the admixture prepared with 5% Dextrose Injection, USP, within 24 hours if refrigerated (2° to 8°C, 36° to 46°F). In the case of admixtures prepared with 5% Dextrose Injection, USP, or Sodium Chloride Injection, USP, the solutions should be used within 4 hours if kept at room temperature. If reconstitution and dilution are performed under strict aseptic conditions (e.g., on Laminar Air Flow bench), CAMPTOSAR Injection solution should be used (infusion completed) within 12 hours at room temperature or 24 hours if refrigerated (2° to 8°C, 36° to 46°F).

  2.6 Safe Handling

  Care should be exercised in the handling and preparation of infusion solutions prepared from CAMPTOSAR Injection. The use of gloves is recommended. If a solution of CAMPTOSAR contacts the skin, wash the skin immediately and thoroughly with soap and water. If CAMPTOSAR contacts the mucous membranes, flush thoroughly with water. Several published guidelines for handling and disposal of anticancer agents are available.

  2.7 Extravasation

  Care should be taken to avoid extravasation, and the infusion site should be monitored for signs of inflammation. Should extravasation occur, flushing the site with sterile water and applications of ice are recommended.

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• Pharmacia And Upjohn Company
  

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  Camptosar | Pharmacia And Upjohn Company

  

  ---

  2.1 Colorectal Cancer Combination Regimens 1 and 2

  Administer CAMPTOSAR as a 90-minute intravenous infusion followed by LV and 5-FU. The currently recommended regimens are shown in Table 1.

  A reduction in the starting dose by one dose level of CAMPTOSAR may be considered for patients with any of the following conditions: prior pelvic/abdominal radiotherapy, performance status of 2, or increased bilirubin levels. Dosing for patients with bilirubin >2 mg/dL cannot be recommended because there is insufficient information to recommend a dose in these patients.

  Table 1. Combination-Agent Dosage Regimens and Dose Modifications* * Dose reductions beyond Dose Level –2 by decrements of ≈ 20% may be warranted for patients continuing to experience toxicity. Provided intolerable toxicity does not develop, treatment with additional cycles may be continued indefinitely as long as patients continue to experience clinical benefit. † Infusion follows bolus administration. Regimen 1
  6-wk cycle with bolus 5-FU/LV (next cycle begins on day 43) CAMPTOSAR
  LV
  5-FU 125 mg/m2 intravenous infusion over 90 minutes, days 1,8,15,22
  20 mg/m2 intravenous injection bolus, days 1,8,15,22
  500 mg/m2 intravenous injection bolus, days 1,8,15,22 Starting Dose & Modified Dose Levels (mg/m2) Starting Dose Dose Level -1 Dose Level -2 CAMPTOSAR 125 100 75 LV 20 20 20 5-FU 500 400 300 Regimen 2
  6-wk cycle with infusional 5-FU/LV (next cycle begins on day 43) CAMPTOSAR 180 mg/m2 intravenous infusion over 90 minutes, days 1,15,29 LV 200 mg/m2 intravenous infusion over 2 hours, days 1,2,15,16,29,30 5-FU Bolus 400 mg/m2 intravenous injection bolus, days 1,2,15,16,29,30 5-FU Infusion† 600 mg/m2 intravenous infusion over 22 hours, days 1,2,15,16,29,30 Starting Dose & Modified Dose Levels (mg/m2) Starting Dose Dose Level -1 Dose Level -2 CAMPTOSAR 180 150 120 LV 200 200 200 5-FU Bolus 400 320 240 5-FU Infusion† 600 480 360

  Dosing for patients with bilirubin >2 mg/dL cannot be recommended because there is insufficient information to recommend a dose in these patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

  Dose Modifications

  Based on recommended dose levels described in Table 1, Combination Regimens of CAMPTOSAR and Dose Modifications, subsequent doses should be adjusted as suggested in Table 2, Recommended Dose Modifications for Combination Regimens. All dose modifications should be based on the worst preceding toxicity.

  Table 2. Recommended Dose Modifications for CAMPTOSAR/5-Fluorouracil (5-FU)/Leucovorin (LV) Combination Schedules * National Cancer Institute Common Toxicity Criteria (version 1.0) † Relative to the starting dose used in the previous cycle ‡ Pretreatment § Excludes alopecia, anorexia, asthenia Patients should return to pre-treatment bowel function without requiring antidiarrhea medications for at least 24 hours before the next chemotherapy administration. A new cycle of therapy should not begin until the granulocyte count has recovered to ≥1500/mm3, and the platelet count has recovered to ≥100,000/mm3, and treatment-related diarrhea is fully resolved. Treatment should be delayed 1 to 2 weeks to allow for recovery from treatment-related toxicities. If the patient has not recovered after a 2-week delay, consideration should be given to discontinuing therapy. Toxicity
  NCI CTC Grade* (Value) During a Cycle of Therapy At the Start of Subsequent Cycles of Therapy† No toxicity Maintain dose level Maintain dose level Neutropenia 1 (1500 to 1999/mm3) Maintain dose level Maintain dose level 2 (1000 to 1499/mm3) ↓ 1 dose level Maintain dose level 3 (500 to 999/mm3) Omit dose until resolved to ≤ grade 2, then ↓ 1 dose level ↓ 1 dose level 4 (<500/mm3) Omit dose until resolved to ≤ grade 2, then ↓ 2 dose levels ↓ 2 dose levels Neutropenic fever Omit dose until resolved, then ↓ 2 dose levels Other hematologic toxicities Dose modifications for leukopenia or thrombocytopenia during a cycle of therapy and at the start of subsequent cycles of therapy are also based on NCI toxicity criteria and are the same as recommended for neutropenia above. Diarrhea 1 (2–3 stools/day > pretx‡) Delay dose until resolved to baseline, then give same dose Maintain dose level 2 (4–6 stools/day > pretx) Omit dose until resolved to baseline, then ↓ 1 dose level Maintain dose level 3 (7–9 stools/day > pretx) Omit dose until resolved to baseline, then ↓ 1 dose level ↓ 1 dose level 4 (≥10 stools/day > pretx) Omit dose until resolved to baseline, then ↓ 2 dose levels ↓ 2 dose levels Other nonhematologic toxicities§ 1 Maintain dose level Maintain dose level 2 Omit dose until resolved to ≤ grade 1, then ↓ 1 dose level Maintain dose level 3 Omit dose until resolved to ≤ grade 2, then ↓ 1 dose level ↓ 1 dose level 4 Omit dose until resolved to ≤ grade 2, then ↓ 2 dose levels ↓ 2 dose levels For mucositis/stomatitis decrease only 5-FU, not CAMPTOSAR For mucositis/stomatitis decrease only 5-FU, not CAMPTOSAR. 2.2 Colorectal Single Agent Regimens 1 and 2

  Administer CAMPTOSAR as a 90-minute intravenous infusion. The currently recommended regimens are shown in Table 3.

  A reduction in the starting dose by one dose level of CAMPTOSAR may be considered for patients with any of the following conditions: prior pelvic/abdominal radiotherapy, performance status of 2, or increased bilirubin levels. Dosing for patients with bilirubin >2 mg/dL cannot be recommended because there is insufficient information to recommend a dose in these patients.

  Table 3. Single-Agent Regimens of CAMPTOSAR and Dose Modifications * Subsequent doses may be adjusted as high as 150 mg/m 2 or to as low as 50 mg/m 2 in 25 to 50 mg/m 2 decrements depending upon individual patient tolerance. † Provided intolerable toxicity does not develop, treatment with additional cycles may be continued indefinitely as long as patients continue to experience clinical benefit. ‡ Subsequent doses may be adjusted as low as 200 mg/m 2 in 50 mg/m 2 decrements depending upon individual patient tolerance. Regimen 1 (weekly)* 125 mg/m2 intravenous infusion over 90 minutes, days 1,8,15,22 then 2-week rest   Starting Dose and Modified Dose Levels† (mg/m2) Starting Dose Dose Level -1 Dose Level -2 125 100 75 Regimen 2 (every 3 weeks)‡ 350 mg/m2 intravenous infusion over 90 minutes, once every 3 weeks†   Starting Dose and Modified Dose Levels (mg/m2) Starting Dose Dose Level -1 Dose Level -2 350 300 250

  Dose Modifications

  Based on recommended dose-levels described in Table 3, Single-Agent Regimens of CAMPTOSAR and Dose Modifications, subsequent doses should be adjusted as suggested in Table 4, Recommended Dose Modifications for Single-Agent Schedules. All dose modifications should be based on the worst preceding toxicity.

  Table 4: Recommended Dose Modifications For Single-Agent Schedules* * All dose modifications should be based on the worst preceding toxicity † National Cancer Institute Common Toxicity Criteria (version 1.0) ‡ Pretreatment § Excludes alopecia, anorexia, asthenia A new cycle of therapy should not begin until the granulocyte count has recovered to ≥1500/mm3, and the platelet count has recovered to ≥100,000/mm3, and treatment-related diarrhea is fully resolved. Treatment should be delayed 1 to 2 weeks to allow for recovery from treatment-related toxicities. If the patient has not recovered after a 2-week delay, consideration should be given to discontinuing CAMPTOSAR. Worst Toxicity
  NCI Grade† (Value) During a Cycle of Therapy At the Start of the Next Cycles of Therapy (After Adequate Recovery), Compared with the Starting Dose in the Previous Cycle* Weekly Weekly Once Every 3 Weeks No toxicity Maintain dose level ↑ 25 mg/m2 up to a maximum dose of 150 mg/m2 Maintain dose level Neutropenia 1 (1500 to 1999/mm3) Maintain dose level Maintain dose level Maintain dose level 2 (1000 to 1499/mm3) ↓ 25 mg/m2 Maintain dose level Maintain dose level 3 (500 to 999/mm3) Omit dose until resolved to ≤ grade 2, then ↓ 25 mg/m2 ↓ 25 mg/m2 ↓ 50 mg/m2 4 (<500/mm3) Omit dose until resolved to ≤ grade 2, then ↓ 50 mg/m2 ↓ 50 mg/m2 ↓ 50 mg/m2 Neutropenic fever Omit dose until resolved, then ↓ 50 mg/m2 when resolved ↓ 50 mg/m2 ↓ 50 mg/m2 Other hematologic toxicities Dose modifications for leukopenia, thrombocytopenia, and anemia during a cycle of therapy and at the start of subsequent cycles of therapy are also based on NCI toxicity criteria and are the same as recommended for neutropenia above. Diarrhea 1 (2–3 stools/day > pretx‡) Maintain dose level Maintain dose level Maintain dose level 2 (4–6 stools/day > pretx) ↓ 25 mg/m2 Maintain dose level Maintain dose level 3 (7–9 stools/day > pretx) Omit dose until resolved to ≤ grade 2, then ↓ 25 mg/m2 ↓ 25 mg/m2 ↓ 50 mg/m2 4 (≥10 stools/day > pretx) Omit dose until resolved to ≤ grade 2 then ↓ 50 mg/m2 ↓ 50 mg/m2 ↓ 50 mg/m2 Other nonhematologic§ toxicities 1 Maintain dose level Maintain dose level Maintain dose level 2 ↓ 25 mg/m2 ↓ 25 mg/m2 ↓ 50 mg/m2 3 Omit dose until resolved to ≤ grade 2, then ↓ 25 mg/m2 ↓ 25 mg/m2 ↓ 50 mg/m2 4 Omit dose until resolved to ≤ grade 2, then ↓ 50 mg/m2 ↓ 50 mg/m2 ↓ 50 mg/m2 2.3 Dosage in Patients with Reduced UGT1A1 Activity

  When administered in combination with other agents, or as a single-agent, a reduction in the starting dose by at least one level of CAMPTOSAR should be considered for patients known to be homozygous for the UGT1A1*28 allele [see Dosage and Administration (2.1 and 2.2) and Warnings and Precautions (5.3)]. However, the precise dose reduction in this patient population is not known, and subsequent dose modifications should be considered based on individual patient tolerance to treatment (see Tables 1 – 4).

  2.4 Premedication

  It is recommended that patients receive premedication with antiemetic agents. In clinical studies of the weekly dosage schedule, the majority of patients received 10 mg of dexamethasone given in conjunction with another type of antiemetic agent, such as a 5-HT3 blocker (e.g., ondansetron or granisetron). Antiemetic agents should be given on the day of treatment, starting at least 30 minutes before administration of CAMPTOSAR. Physicians should also consider providing patients with an antiemetic regimen (e.g., prochlorperazine) for subsequent use as needed. A similar antiemetic regimen should be used with CAMPTOSAR in combination therapy.

  Prophylactic or therapeutic administration of atropine should be considered in patients experiencing cholinergic symptoms.

  2.5 Preparation of Infusion Solution

  Inspect vial contents for particulate matter and discoloration and repeat inspection when drug product is withdrawn from vial into syringe.

  CAMPTOSAR Injection 20 mg/mL is intended for single use only and any unused portion should be discarded.

  CAMPTOSAR Injection must be diluted prior to infusion. CAMPTOSAR should be diluted in 5% Dextrose Injection, USP, (preferred) or 0.9% Sodium Chloride Injection, USP, to a final concentration range of 0.12 mg/mL to 2.8 mg/mL. Other drugs should not be added to the infusion solution.

  The solution is physically and chemically stable for up to 24 hours at room temperature and in ambient fluorescent lighting. Solutions diluted in 5% Dextrose Injection, USP, and stored at refrigerated temperatures (approximately 2° to 8°C, 36° to 46°F), and protected from light are physically and chemically stable for 48 hours. Refrigeration of admixtures using 0.9% Sodium Chloride Injection, USP, is not recommended due to a low and sporadic incidence of visible particulates. Freezing CAMPTOSAR and admixtures of CAMPTOSAR may result in precipitation of the drug and should be avoided.

  The CAMPTOSAR Injection solution should be used immediately after reconstitution as it contains no antibacterial preservative. Because of possible microbial contamination during dilution, it is advisable to use the admixture prepared with 5% Dextrose Injection, USP, within 24 hours if refrigerated (2° to 8°C, 36° to 46°F). In the case of admixtures prepared with 5% Dextrose Injection, USP, or Sodium Chloride Injection, USP, the solutions should be used within 4 hours if kept at room temperature. If reconstitution and dilution are performed under strict aseptic conditions (e.g., on Laminar Air Flow bench), CAMPTOSAR Injection solution should be used (infusion completed) within 12 hours at room temperature or 24 hours if refrigerated (2° to 8°C, 36° to 46°F).

  2.6 Safe Handling

  Care should be exercised in the handling and preparation of infusion solutions prepared from CAMPTOSAR Injection. The use of gloves is recommended. If a solution of CAMPTOSAR contacts the skin, wash the skin immediately and thoroughly with soap and water. If CAMPTOSAR contacts the mucous membranes, flush thoroughly with water. Several published guidelines for handling and disposal of anticancer agents are available.

  2.7 Extravasation

  Care should be taken to avoid extravasation, and the infusion site should be monitored for signs of inflammation. Should extravasation occur, flushing the site with sterile water and applications of ice are recommended.

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