Carmustine Side Effects

Some side effects of carmustine 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 carmustine: implant device, intravenous powder for injection

Get emergency medical help if you have any of these signs of an allergic reaction while taking carmustine: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• new or worsening cough, fever, trouble breathing;

• shortness of breath with mild exertion;

• chest discomfort, dry cough or hack;

• feeling weak or tired, loss of appetite, rapid weight loss;

• fever, chills, body aches, flu symptoms, sores in your mouth and throat;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

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

• urinating less than usual or not at all;

• drowsiness, confusion, mood changes, increased thirst, swelling, weight gain, feeling short of breath;

• severe burning, irritation, or skin changes where the injection was given; or

• redness of your eyes or skin and severe warmth or tingling under your skin (within 2 to 4 hours after your carmustine injection).

Common side effects may include:

• nausea, vomiting;

• headache; or

• mild pain, swelling, redness, or darkened skin color where the injection was given.

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 carmustine: implant device, intravenous powder for injection

Respiratory

Most of the patients with respiratory toxicity received prolonged therapy with total doses greater than 1400 mg/m2, although respiratory problems have been reported in patients receiving as little as 600 mg/m2.

Delayed onset pulmonary fibrosis occurring up to 17 years after treatment has been reported in one long-term study (n=17) on patients who received carmustine in childhood and early adolescence combined with cranial radiotherapy (for intracranial tumors). Chest X-rays revealed pulmonary hypoplasia with upper zone contraction. Thoracic CT scans showed an unusual pattern of upper zone fibrosis. Some late reduction of pulmonary function was reported in all long-term survivors. In this long-term study, 8 of 17 died of delayed pulmonary lung fibrosis, including all those initially treated (5 of 17) at less than 5 years old.

Respiratory side effects including pulmonary infiltrates and/or fibrosis have been reported to occur from 9 days to 43 months after treatment with carmustine and related nitrosoureas. Cases of fatal respiratory toxicity have been reported.

Hematologic

Carmustine may produce cumulative myelosuppression. Thrombocytopenia has generally been reported to occur approximately four weeks after administration. Leukopenia has generally been reported to occur approximately five to six weeks after administration. Both have been reported to persist for one to two weeks.

Use of carmustine in combination with cimetidine has resulted in greater myelotoxicity (e.g., leucopenia, neutropenia).

Hematologic side effects including myelosuppression have been reported frequently. Thrombocytopenia, leukopenia, and less frequently, anemia have also been reported. Acute leukemia and bone marrow dysplasias have been reported following long-term nitrosourea therapy.

Gastrointestinal

Nausea and vomiting generally appear within two hours of dosing and last for four to six hours. Prior administration of antiemetics has been effective in diminishing and sometimes preventing these side effects.

Gastrointestinal side effects including nausea and vomiting have been reported frequently.

Hepatic

Hepatic side effects including increased transaminase, alkaline phosphatase, and bilirubin levels have been reported infrequently.

The increased levels are generally reversible.

Renal

Renal side effects including progressive azotemia, decrease in kidney size, and renal failure have been reported in patients after prolonged therapy and usually after large cumulative doses.

Cardiovascular

Cardiovascular side effects including hypotension and tachycardia have been reported. Three cases of myocardial ischemia during and immediately after high-dose carmustine infusion have been reported.

Local

Local side effects including burning and hyperpigmentation have been reported.

Other

Other side effects have included intensive flushing of the skin and suffusion of the conjunctiva following rapid intravenous infusion of carmustine.

This effect usually has been reported to occur within two hours and last for approximately four hours.

Ocular

Ocular side effects including neuroretinitis have been reported.

General

General side effects including chest pain and headache have been reported.

Oncologic

Oncologic side effects have included spontaneous reports of cyst formation after gliadel wafer implantation. Carcinogenicity has been reported in animal studies.

Cyst formation occurred at varying time intervals postimplantation. Cyst formation has also been reported in patients following resection of malignant glioma who have not had gliadel implanted.

Carmustine has been reported in animal studies to produce a marked increase in tumor incidence at doses approximating clinical doses.

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