Trepar Special Precautions

Dactinomycin should be used with caution in the following: Patients with hepatic impairment; renal impairment; bone marrow suppression; complicated infections.
Dactinomycin should not be administered subcutaneously or intramuscularly.
When this drug is administered intravenously, care should be taken to avoid extravasation.
Dactinomycin should be administered only under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents.
This drug is highly toxic and both powder and solution must be handled and administered with care. Inhalation of dust or vapors and contact with skin or mucous membranes, especially those of the eyes, must be avoided. Should accidental eye contact occur, copious irrigation with water should be instituted immediately, followed by prompt ophthalmologist consultation. Should accidental skin contact occur, the affected part must be irrigated immediately with copious amounts of water for at least 15 minutes.
As with all antineoplastic agents, Dactinomycin is a toxic drug; therefore, frequent observations of the patient for adverse reactions are necessary. These reactions may involve any tissue of the body. The possibility of an anaphylactoid reaction should be borne in mind.
Particular caution is necessary when administering Dactinomycin within two months of irradiation for the treatment of right-sided Wilms' tumor, since hepatomegaly and elevated SGOT levels have been noted.
Nausea and vomiting due to Dactinomycin make it necessary to give this drug intermittently. It is extremely important to observe the patient daily for toxic side effects when multiple chemotherapy is employed, since a full course of therapy occasionally, is not tolerated.
If stomatitis, diarrhea or severe hemopoietic depression appear during therapy, Dactinomycin should be discontinued until the patient has recovered.
Recent reports indicate an increased incidence of second primary tumors following treatment with radiation and antineoplastic agents, such as Dactinomycin. Multi-modal therapy creates the need for careful, long-term observation of cancer survivors.
Many abnormalities of renal, hepatic, and bone marrow function have been reported in patients with neoplastic disease receiving Dactinomycin. It is advisable to check renal, hepatic and bone marrow functions frequently.
It has been reported that Dactinomycin may interfere with bioassay procedures for the determination of antibacterial drug levels.
Bleeding may be indicative of the presence of an infection.
Carcinogenicity, Mutagenicity or Impairment of Fertility: It has been proven that Dactinomycin is a positive carcinogen in animals. Local sarcomas were produced in mice and rats after repeated subcutaneous or intraperitoneal injection. Studies have demonstrated that mesenchymal tumor has developed when Dactinomycin is administered to a rabbit intraperitoneally. Dactinomycin has been shown to be mutagenic in a number of test systems in vitro and in vivo including human fibroblasts, leucocytes and HELA cells. DNA damage and cytogenetic effects have been observed in mice and rats. Studies in animals (rat, intraperitoneal administration) have reported the occurrence of spermatogenic depression.
Use in Pregnancy & Lactation: Pregnancy Category C.
Dactinomycin has been shown to cause malformations and embryotoxicity in rats, rabbits and hamsters when given in doses of 50-100 μg/kg intravenously (3-7 times the maximum recommended human dose).
There are no adequate and well-controlled studies in pregnant women. Dactinomycin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether Dactinomycin is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Dactinomycin, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Use in Children: The greater frequency of toxic effects of Dactinomycin in infants suggests that this drug should be given to infants only over the age of 12 months.
Use in children or patients of childbearing potential should be considered because of the possible effect on the gonads.