HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use CAMPTOSAR safely and effectively. See full prescribing information for CAMPTOSAR.
CAMPTOSAR ® (Irinotecan) Injection, intravenous infusion
Initial U.S. Approval: 1996
WARNING: DIARRHEA and MYELOSUPPRESSION
See full prescribing information for complete boxed warning.
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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.
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Severe myelosuppression may occur.
INDICATIONS AND USAGE
CAMPTOSAR is a topoisomerase inhibitor indicated for:
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First-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum. (1)
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Patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. (1)
DOSAGE AND ADMINISTRATION
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Colorectal cancer combination regimen 1: CAMPTOSAR 125 mg/m2 intravenous infusion over 90 minutes on days 1, 8,15, 22 with LV 20 mg/m2 intravenous bolus infusion on days 1, 8, 15, 22 followed by 5-FU intravenous bolus infusion on days 1, 8, 15, 22 every 6 weeks. (2.1)
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Colorectal cancer combination regimen 2: CAMPTOSAR 180 mg/m2 intravenous infusion over 90 minutes on days 1, 15, 29 with LV 200 mg/m2 intravenous infusion over 2 hours on days 1, 2, 15, 16, 29, 30 followed by 5-FU 400 mg/m2 intravenous bolus infusion on days 1, 2, 15, 16, 29, 30 and 5-FU 600 mg/m2 intravenous infusion over 22 hours on days 1, 2, 15, 16, 29, 30. (2.1)
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Colorectal cancer single agent regimen 1: CAMPTOSAR 125 mg/m2 intravenous infusion over 90 minutes on days 1, 8, 15, 22 then 2-week rest. (2.2)
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Colorectal cancer single agent regimen 2: CAMPTOSAR 350 mg/m2 intravenous infusion over 90 minutes on day 1 every 3 weeks. (2.2)
DOSAGE FORMS AND STRENGTHS
CAMPTOSAR Injection is available in three single-dose sizes: (3)
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2 mL-fill vial containing 40 mg irinotecan hydrochloride injection
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5 mL-fill vial containing 100 mg irinotecan hydrochloride injection
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15 mL-fill vial containing 300 mg irinotecan hydrochloride injection
CONTRAINDICATIONS
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Hypersensitivity to CAMPTOSAR or its excipients (4)
WARNINGS AND PRECAUTIONS
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Diarrhea and Cholinergic Reactions: Early diarrhea (occurring during or shortly after infusion of CAMPTOSAR) is usually transient and may be accompanied by cholinergic symptoms. Consider prophylactic or therapeutic administration of 0.25 mg to 1 mg of intravenous or subcutaneous atropine (unless clinically contraindicated). Late diarrhea (generally occurring more than 24 hours after administration of CAMPTOSAR) can occur. Monitor and replace fluid and electrolytes. Treat with loperamide. Use antibiotic support for ileus and fever. Interrupt CAMPTOSAR and reduce subsequent doses if severe diarrhea occurs. (5.1)
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Myelosuppression: Manage promptly with antibiotic support. Interrupt CAMPTOSAR and reduce subsequent doses if necessary. (5.2)
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Patients with Reduced UGT1A1 Activity: Individuals who are homozygous for the UGT1A1*28 allele are at increased risk for neutropenia following initiation of CAMPTOSAR treatment. (5.3)
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Hypersensitivity: Hypersensitivity reactions including severe anaphylactic or anaphylactoid reactions have been observed. Discontinue CAMPTOSAR if this occurs. (5.4)
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Renal Impairment/Renal Failure: Rare cases of renal impairment and acute renal failure have been identified, usually in patients who became volume depleted from severe vomiting and/or diarrhea. (5.5)
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Pulmonary Toxicity: Interstitial Pulmonary Disease (IPD)-like events, including fatalities, have occurred. Interrupt for new or progressive dysnpnea, cough, and fever pending eva luation. If IPD diagnosed, discontinue and institute appropriate treatment as needed. (5.6)
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Toxicity of the 5 Day Regimen: CAMPTOSAR should not be used in combination with a regimen of 5-FU/LV administered for 4–5 consecutive days every 4 weeks outside of a clinical study. (5.7)
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Embryofetal Toxicity: CAMPTOSAR can cause fetal harm when administered to a pregnant woman. (5.9)
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Patients with Hepatic Impairment: In clinical trials, CAMPTOSAR has not been administered to patients with serum bilirubin > 2.0 mg/dL, or transaminases > 3 times ULN if no liver metastases, or transaminases > 5 times ULN if liver metastases. With the weekly dosage schedule, patients with total bilirubin levels 1.0–2.0 mg/dL had greater likelihood of grade 3–4 neutropenia. (5.10)
ADVERSE REACTIONS
Common adverse reactions (≥30%) observed in combination therapy clinical studies are: nausea, vomiting, abdominal pain, diarrhea, constipation, anorexia, mucositis, neutropenia, leukopenia (including lymphocytopenia), anemia, thrombocytopenia, asthenia, pain, fever, infection, abnormal bilirubin, alopecia. (6.1)
Common adverse reactions (≥30%) observed in single agent therapy clinical studies are: nausea, vomiting, abdominal pain, diarrhea, constipation, anorexia, neutropenia, leukopenia (including lymphocytopenia), anemia, asthenia, fever, body weight decreasing, alopecia. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at 1-800-438-1985 or www.pfizer.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
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Strong CYP3A4 Inducers: Do not administer strong CYP3A4 inducers with CAMPTOSAR. (7.2)
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Strong CYP3A4 Inhibitors: Do not administer strong CYP3A4 inhibitors with CAMPTOSAR. (7.3)
USE IN SPECIFIC POPULATIONS
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Nursing Mothers: Discontinue nursing when receiving therapy with CAMPTOSAR. (8.3)
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Geriatric Use: Closely monitor patients greater than 65 years of age because of a greater risk of early and late diarrhea in this population. (8.5)
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Patients with Renal Impairment: Use caution and do not use in patients on dialysis. (8.6)
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Patients with Hepatic Impairment: Use caution. (2.1, 5.10, 8.7, 12.3)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 12/2014
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
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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.
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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.
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.
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