Cosmegen Side Effects, and Drug Interactions - Dactinomycin

Cosmegen Side Effects, and Drug Interactions - Dactinomycin

SIDE EFFECTS

Toxic effects (excepting nausea and vomiting) usually do not become apparent until two to four days after a course of therapy is stopped, and may not peak until one to two weeks have elapsed. Deaths have been reported. However, adverse reactions are usually reversible on discontinuance of therapy. They include the following: Miscellaneous: malaise, fatigue, lethargy, fever, myalgia, proctitis, hypocalcemia, growth retardation, infection.

Oral: cheilitis, dysphagia, esophagitis, ulcerative stomatitis, pharyngitis.

Lung: pneumonitis.

Gastrointestinal: anorexia, nausea, vomiting, abdominal pain, diarrhea, gastrointestinal ulceration, liver toxicity including ascites, hepatomegaly, hepatic veno-occlusive disease, hepatitis, and liver function test abnormalities. Nausea and vomiting, which occur early during the first few hours after administration, may be alleviated by the administration of anti-emetics.

Hematologic: anemia, even to the point of aplastic anemia, agranulocytosis, leukopenia, thrombocytopenia, pancyto-penia, reticulocytopenia. Platelet and white cell counts should be performed frequently to detect severe hematopoietic depression. If either count markedly decreases, the drug should be withheld to allow marrow recovery. This often takes up to three weeks.

Dermatologic: alopecia, skin eruptions, acne, flare-up of erythema or increased pigmentation of previously irradiated skin.

Soft tissues: Dactinomycin is extremely corrosive. If extravasation occurs during intravenous use, severe damage to soft tissues will occur. In at least one instance, this has led to contracture of the arms. Epidermolysis, erythema, and edema, at times severe, have been reported with regional limb perfusion.

LaboratoryTests

Many abnormalities of renal, hepatic, and bone marrow function have been reported in patients with neoplastic diseases receiving COSMEGEN. Renal, hepatic, and bone marrow functions should be assessed frequently.

DRUG INTERACTIONS

Dactinomycin may interfere with bioassay procedures for the determination of antibacterial drug levels.