Camptosar Side Effects

Generic name: irinotecan

Note: This document contains side effect information about irinotecan. Some of the dosage forms listed on this page may not apply to the brand name Camptosar.

Some side effects of Camptosar may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to irinotecan: intravenous solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking irinotecan (the active ingredient contained in Camptosar) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor whenever you have diarrhea during your treatment with irinotecan.

Also call your doctor at once if you have:

• severe stomach pain, fever, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, trouble breathing;

• wheezing, feeling short of breath;

• chest pain, dry cough;

• pale skin, feeling light-headed, rapid heart rate, trouble concentrating;

• runny nose, watery eyes, increased sweating, stomach cramps, and flushing (warmth, redness, or tingly feeling);

• black, bloody, or tarry stools;

• nausea or vomiting that keeps you from drinking enough fluids;

• burning, pain, or swelling around the IV needle;

• sudden numbness or weakness, problems with vision, speech, or balance;

• swelling, rapid weight gain; or

• feeling very thirsty or hot, being unable to urinate, heavy sweating, feeling light-headed, or hot and dry skin.

Less serious side effects of irinotecan may include:

• dizziness;

• temporary hair loss.

• loss of appetite, constipation;

• mild skin rash; or

• redness or peeling of the skin on your hands and feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to irinotecan: intravenous solution

Gastrointestinal

"Early" diarrhea usually occurs during or shortly after dosage administration. It may appear as a component of early cholinergic syndrome and may be preceded by complaints of diaphoresis and abdominal cramping. Symptoms may usually be quickly ameliorated by atropine.

Late diarrhea can be prolonged, may lead to dehydration and electrolyte imbalance and can be life threatening. Late diarrhea should be treated promptly with aggressive high dose loperamide therapy. The patient may be treated with 4 mg at the first loose stool or increase in frequency of bowel movements and every 2 hours until the patient is diarrhea-free for 12 hours. Patients with severe diarrhea should be carefully monitored and given fluid and electrolyte replacement if they become dehydrated. Administration of irinotecan (the active ingredient contained in Camptosar) should be interrupted if severe diarrhea occurs and the dose may need to be reduced.

Ulcerative and ischemic colitis can be complicated by ulceration, bleeding, ileus, obstruction, and infection, including typhlitis. Patients experiencing ileus should receive prompt antibiotic support.

Gastrointestinal side effects including "early" diarrhea occurring within 24 hours of the administration of irinotecan (50.7%) and "late" diarrhea occurring over 24 hours after dosage administration (87.8%) have been reported. Nausea (86.2%), vomiting (66.8%), anorexia (54.9%), constipation (29.9%), flatulence (12.2%), stomatitis (11.8%) and dyspepsia (10.5%) have also been reported. Cases of ulcerative and ischemic colitis have been reported infrequently. Intestinal perforation, symptomatic pancreatitis, and asymptomatic elevated pancreatic enzymes have also been reported rarely. Cases of megacolon have been reported in post-marketing experience.

Hematologic

Hematologic side effects including leukopenia (63.2%), anemia (60.5%) and neutropenia (53.9%) have been reported.

Reduction in neutrophils has been the predominant clinically relevant hematologic effect. The median time to nadir for hematologic values ranges from 14 days for platelets to 21 days for hemoglobin, neutrophils and leukocytes. The median time to nadir for platelets has been reported to have decreased as the starting dose increased.

General

General side effects including asthenia (75.7%), abdominal cramping/pain (56.9%), fever (45.4%), pain (23.7%), headache (16.8%), back pain (14.5%), chills (13.8%), minor infections (14.5%), edema (10.2%) and abdominal enlargement (10.2%) have been reported. Hiccups have been reported in post-marketing experience.

Minor infections consisted primarily of upper respiratory infections.

Metabolic

Metabolic side effects including loss of body weight (30.3%), dehydration (14.8%), increased alkaline phosphatase (13.2%), and increased SGOT (10.5%) have been reported. Rare cases of hyponatremia (mostly related with diarrhea and vomiting) have also been reported.

Dermatologic

Dermatologic side effects including alopecia (60.5%), sweating (16.4%), rash (12.8%), and paresthesias have been reported. A case of skin toxicity has also been reported.

Respiratory

Respiratory side effects including dyspnea (22%), increased coughing (17.4%) and rhinitis (15.5%) have been reported. Interstitial pulmonary disease presenting as pulmonary infiltrates has been uncommon during irinotecan (the active ingredient contained in Camptosar) therapy. A case of interstitial pneumonia has also been reported.

Interstitial pulmonary disease can be fatal. Risk factors include pre-existing lung disease, use of pneumotoxic drugs, radiation therapy, and colony stimulating factors. Patients with risk factors should be closely monitored for respiratory symptoms before and during irinotecan therapy.

Nervous system

Neurologic side effects including insomnia (19.4%) and dizziness (14.8%) have been reported.

Cardiovascular

Cardiovascular side effects including vasodilation (11.2%) have been reported. Myocardial ischemic events have been observed following irinotecan (the active ingredient contained in Camptosar) therapy in post-marketing experience.

Hepatic

Hepatic side effects including elevation of hepatic transaminases (8%) have been reported. Transient increase of amylase and occasionally transient increase of lipase have been reported in post-marketing experience.

Other

Other side effects including a case of dysarthria have been reported.

Hypersensitivity

Hypersensitivity side effects including severe anaphylactic or anaphylactoid reactions have been reported.

Renal

Renal side effects have been reported. Infrequent cases of renal insufficiency including acute renal failure, hypotension, or circulatory failure have been observed in patients who experienced episodes of dehydration associated with sepsis, diarrhea, and/or vomiting.

Musculoskeletal

Musculoskeletal side effects including muscular contractions and cramps have been reported.

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