It is not known whether this drug in human milk. Because many drugs are determined in human milk, should stop breast-feeding or stop taking the drug, taking into account the importance of the treatment to the mother.
In connection fluoxymesterone halotestin with the suppression of bone marrow function, it should be analyzed weekly blood cells for at least six weeks after taking the prescribed dose.
Along with the study of pulmonary function in patients before starting treatment, repeated studies during treatment should be carried out. For high-risk group includes patients with the proper performance of forced vital capacity and lung diffusion capacity below 70%.
Since Shiina may impair liver function, you must periodically carry out appropriate analyzes. You should also periodically check kidney function.
After 3-6 hours after administration Shiina may experience nausea and vomiting that typically last up to 24 hours. The frequency and duration of these side effects can be reduced through the use of antiemetic drugs before taking Shiina, as well as through the appointment Shiina patients fasting.
Toxicity with respect to the hematopoietic system
The main fluoxymesterone halotestin and the most severe toxicity associated with late Shiina suppression of bone marrow function, which usually occurs within 4-6 weeks after drug administration and is dose-dependent.Thrombocytopenia develops an average of 4 weeks and may persist for 1-2 weeks. Approximately 6 weeks after receiving Shiina develop leukopenia, persistent for 1-2 weeks. Approximately 65% of patients with WBC counts may be less than 5000 / mm 3 and 36% of patients less than 3000 / mm 3 . Typically, thrombocytopenia is more severe than leukopenia. However, both types of toxicity may limit the dose.
Shiina may cause cumulative myelosuppression, and after receiving repeated doses may experience more pronounced bone marrow suppression or myelosuppression duration can be greater. It was reported on acute leukemia and bone marrow dysplasias as a result of treatment nitrosourea drugs.
There may also be anemia, but it develops less often and is less severe, than thrombocytopenia and leukopenia.
The toxic effects on the lungs
In rare cases it reported appearance of infiltrates in the lungs and / or lung fibrosis Shiina during use. The appearance of toxic effects observed after 6 months (or over longer periods) after the start of treatment with cumulative doses of the drug more than 1100 mg / m 2 . It reported one case of pulmonary toxicity at a cumulative dose of only 600 mg.
Other toxic effects
In rare cases, it noted the appearance of stomatitis, alopecia and anemia. A number of patients treated with Shiina, observed neurological reactions such as confusion, lethargy, ataxia, and speech articulation disorder. However, the relationship of these effects to the drug intake in these patients has not been established.
In patients receiving high cumulative doses of the drug in a long-term treatment Shiina and other drugs nitrosoureas, marked renal dysfunction, is a reduction of kidney size, progressive azotemia and renal failure. Occasionally also reported kidney damage in patients receiving lower total doses.
Toxic effects on the liver
It was reported a reversible toxic effect on the liver, manifested in the fluoxymesterone halotestin increase in transaminases, alkaline phosphatase and bilirubin, a small percentage of patients treated with Shiina.
Dosing and Administration
Shiina recommended dose in adults and children is 130 mg / m 2 after a single ingestion every 6 weeks.
In patients with reduced bone marrow function the dose can be reduced , while maintaining a six-week interval between doses.
Repeated courses Shiina should not be used when the number of platelets less and the number of white blood cells less than 4000 / mm 3 , because the hematologic toxicity is late and is cumulative. The content of blood cells should be checked weekly.
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