Camptosar

CAMPTOSAR- irinotecan hydrochloride injection, solution
Pharmacia and Upjohn Company

WARNING: DIARRHEA and MYELOSUPPRESSION

  • Early and late forms of diarrhea can occur. Early diarrhea may be accompanied by cholinergic symptoms which may be prevented or ameliorated by atropine. Late diarrhea can be life threatening and should be treated promptly with loperamide. Monitor patients with diarrhea and give fluid and electrolytes as needed. Institute antibiotic therapy if patients develop ileus, fever, or severe neutropenia. Interrupt CAMPTOSAR and reduce subsequent doses if severe diarrhea occurs.
  • Severe myelosuppression may occur.

1 INDICATIONS AND USAGE

  • CAMPTOSAR Injection is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum.
  • CAMPTOSAR is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.

2 DOSAGE AND ADMINISTRATION

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) CAMPTOSARLV5-FU 125 mg/m2 intravenous infusion over 90 minutes, days 1,8,15,2220 mg/m2 intravenous injection bolus, days 1,8,15,22500 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.

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