Package:
VIALS: 4 x 10 mg. Dosage:
See prescribing information for full details. Prescribing Restrictions:
Indications:
I.V. administration for the palliative treatment of Hodgkin's disease (stages III and IV), and mycosis fungoides. Contra-Indications:
Known infectious diseases and previous anaphylactic reactions to Mustargen. Special Precautions:
Extravasation of the drug into S.C. tissues results in painful inflammation. The area usually becomes indurated and sloughing may occur. Prompt infiltration of the area with sterile isotonic sodium thiosulfate (1/6 molar) and application of ice compress for 6-12 hours may minimize the local reaction. Before initiation of treatment, an accurate histologic diagnosis of the disease, a knowledge of its natural course, and an adequate clinical history are important. The hematologic status of the patient must first be determined. Careful clinical judgement must be exercised in selecting patients. If the indication for its use is not clear, the drug should not be used. Treatment should only be used if foci of acute and chronic suppurative inflammation are absent. 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. Rubber gloves should be worn when handling the product. Precaution must be observed with the use of Mustargen and X-ray therapy or other chemotherapy in alternating courses. Neither Mustargen following X-ray therapy nor X-ray therapy subsequent to the drug should be given until bone marrow function has recovered. In particular, irradiation of such areas as sternum, ribs and vertebrae shortly after a course of nitrogen mustard may lead to hematologic complications. Use of this drug may predispose the patient to bacterial, viral or fungal infection. Hyperuricemia may develop during therapy. Adequate methods for control should be instituted and careful attention directed toward adequate fluid intake before treatment. Therapy with alkylating agents may be associated wtih an increased incidence of a second malignant tumor, especially when such therapy is combined with other antineoplastic agents or radiation therapy. Pregnancy and lactation: Can cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant. 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. Side Effects:
Therapy should preferably be given at night in case sedation for side effects is required. Premedication with antiemetics, in addition to sedatives, may help control severe nausea and vomiting. Anorexia, weakness and diarrhea may also occur. Local toxicity: Thrombosis and thrombophlebitis may result from direct contact of the drug with the intima of the injected vein. Systemic toxicity: Hypersensitivity reactions, including anaphylaxis. Nausea, vomiting and depression of formed elements in the circulating blood are dose-limiting and usually occur with the use of full doses. Jaundice, alopecia, vertigo, tinnitus and diminished hearing may occur. Lymphocytopenia, significant granulocytopenia, thrombocytopenia. May lead to bleeding from the gums and G.I. tract, petechiae, and small S.C. hemorrhages. Treatment may be followed by delayed catamenia, oligomenorrhea, or temporary or permanent amenorrhea. Impaired spermatogenesis, azoospermia and total germinal aplasia have been reported in male patients. See prescribing information for full details. Drug Interactions:
N/A
