Irinotecan hydrochloride (Camptosar)

Irinotecan hydrochloride (Camptosar)
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gloria Picoy [2]

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Black Box Warning

WARNING: DIARRHEA AND MYELOSUPPRESSION See full prescribing information for complete Boxed Warning. * 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 irinotecan hydrochloride and reduce subsequent doses if severe diarrhea occurs. Severe myelosuppression may occur.

Overview

Irinotecan hydrochloride (Camptosar) is an antineoplastic agent that is FDA approved for the treatment of metastatic carcinoma of the colon or rectum. There is a Black Box Warning for this drug as shown here. Common adverse reactions include nausea, vomiting, abdominal pain, diarrhea, constipation, anorexia, mucositis, neutropenia, leukopenia (including lymphocytopenia), anemia, thrombocytopenia, asthenia, pain, fever, infection, abnormal bilirubin and alopecia.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indication

• 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.
• For patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.

Dosage

• Colorectal cancer combination regimen 1

• Irinotecan hydrochloride 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.

• Colorectal cancer combination regimen 2

• Irinotecan hydrochloride 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.

• Colorectal cancer single agent regimen 1

• Irinotecan hydrochloride 125 mg/m2 intravenous infusion over 90 minutes on days 1, 8, 15, 22 then 2-week rest.

• Colorectal cancer single agent regimen 2

• Irinotecan hydrochloride 350 mg/m2 intravenous infusion over 90 minutes on day 1 every 3 weeks.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Irinotecan hydrochloride in adult patients.

Non–Guideline-Supported Use

• Acute lymphoid leukemia
• Acute myeloid leukemia
• Carcinoma of cervix
• Carcinoma of esophagus

• Induction chemotherapy: irinotecan (65 milligrams/square meter (mg/m(2)) and cisplatin (30 mg/m(2)), 2 weeks on and 1 week off, for two 3-week cycles
• Then, 6 weeks of radiotherapy in 180 centigray (cGy) daily fractions to a total dose of 5040 cGy.
• During treatment with radiation, cisplatin was given at a dose of 30 mg/m(2) followed by escalating doses of irinotecan (40, 50, 65, and 80 mg/m(2), once weekly on days 1, 8, 22, and 29 of radiation therapy.

• Colorectal cancer
• First-line treatment of extensive stage small cell lung cancer in combination with carboplatin

• First-line treatment of extensive stage small cell lung cancer in combination with cisplatin

• Irinotecan 60 milligrams/square meter (mg/m(2)) on days 1, 8, and 15 plus cisplatin 60 mg/m(2) on day 1, administered every 4 weeks; or etoposide 100 mg/m(2) on days 1, 2, and 3 plus cisplatin 80 mg/m(2) on day 1, administered every 3 weeks.

• Gastric cancer
• Recurrent or progressive disease of malignant glioma of brain
• Refractory metastatic breast cancer
• Non-Hodgkin's lymphoma
• Non-small cell lung cancer
• Platinum-refractory or platinum-resistant ovarian cancer

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Irinotecan hydrochloride (Camptosar) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Irinotecan hydrochloride in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Irinotecan hydrochloride in pediatric patients.

Contraindications

There is limited information regarding Irinotecan hydrochloride (Camptosar) Contraindications in the drug label.

Warnings

WARNING: DIARRHEA AND MYELOSUPPRESSION See full prescribing information for complete Boxed Warning. * 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 irinotecan hydrochloride and reduce subsequent doses if severe diarrhea occurs. Severe myelosuppression may occur.

There is limited information regarding Irinotecan hydrochloride (Camptosar) Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Irinotecan hydrochloride (Camptosar) Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Irinotecan hydrochloride (Camptosar) Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Irinotecan hydrochloride (Camptosar) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Irinotecan hydrochloride (Camptosar) in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Irinotecan hydrochloride (Camptosar) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Irinotecan hydrochloride (Camptosar) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Irinotecan hydrochloride (Camptosar) in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Irinotecan hydrochloride (Camptosar) in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Irinotecan hydrochloride (Camptosar) in geriatric settings.

Gender

There is no FDA guidance on the use of Irinotecan hydrochloride (Camptosar) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Irinotecan hydrochloride (Camptosar) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Irinotecan hydrochloride (Camptosar) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Irinotecan hydrochloride (Camptosar) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Irinotecan hydrochloride (Camptosar) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Irinotecan hydrochloride (Camptosar) in patients who are immunocompromised.

Administration and Monitoring

Administration

Intravenous

Monitoring

There is limited information regarding Irinotecan hydrochloride (Camptosar) Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Irinotecan hydrochloride (Camptosar) and IV administrations.

Overdosage

There is limited information regarding Irinotecan hydrochloride (Camptosar) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Irinotecan hydrochloride (Camptosar) Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Irinotecan hydrochloride (Camptosar) Mechanism of Action in the drug label.

Structure

There is limited information regarding Irinotecan hydrochloride (Camptosar) Structure in the drug label.

Pharmacodynamics

There is limited information regarding Irinotecan hydrochloride (Camptosar) Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Irinotecan hydrochloride (Camptosar) Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Irinotecan hydrochloride (Camptosar) Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Irinotecan hydrochloride (Camptosar) Clinical Studies in the drug label.

How Supplied

There is limited information regarding Irinotecan hydrochloride (Camptosar) How Supplied in the drug label.

Storage

There is limited information regarding Irinotecan hydrochloride (Camptosar) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Irinotecan hydrochloride (Camptosar) Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Irinotecan hydrochloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Irinotecan hydrochloride (Camptosar) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Irinotecan hydrochloride (Camptosar) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.