Gliadel Side Effects

Generic Name: carmustine

Please note - some side effects for Gliadel may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Gliadel - for the Consumer

Gliadel Implant Wafer

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Gliadel Implant Wafer:

Anxiety; constipation; diarrhea; drowsiness; hair loss; headache; nausea; vomiting; weakness.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; dizziness; fainting; fever; memory trouble or loss of memory; mental or mood changes; muscle weakness; pain; seizures; severe stomach pain; stiff neck; swelling or infection of the surgical site; tremor; trouble sleeping; trouble speaking; unusual bruising or bleeding; unusual numbness or tingling; vision changes.

Side Effects by Body System

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.

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 post-implantation. 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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