Sanbelat Special Precautions

Bleomycin should only be used under strict supervision of a physician who has specialized in the use of oncolytics, preferably in institution experienced in this kind of therapy.
In patients treated with Bleomycin, lung function examination as well as thorax X-rays should be performed on a regular basis, for the entire duration of the treatment up to 8 weeks after completion of the treatment. In the event of simultaneous radiotherapy of the thorax, the lungs should be X-rayed more often. Examination of pulmonary function, in particular measuring carbon monoxide diffusion and vital capacity, often allow early diagnosis of pulmonary toxicity.
If unaccountable coughing, dyspnoea, basal crepitations or a diffuse reticular image on the thorax X-ray is observed, each of these phenomena in itself is a motive to discontinue the administration of Bleomycin, until bleomycin toxicity as a possible cause has been ruled out. Administration of antibiotics and, if necessary, corticosteroid is advised. In the event of lung damage as a result of Bleomycin, no further Bleomycin should be administered.
Although the pulmonary toxicity of Bleomycin clearly increases in a cumulative dose of 400 U (225 U/m²), this can also occur in considerably lower doses, particularly in older patients (see Dosage and Administration), patients with a hepatic or renal insufficiency, pre-existent lung disease, previous radiation of the lungs and in patients on oxygen.
Bleomycin sensitivity increases in the elderly.
As 2/3 the administered quantity of Bleomycin is excreted unchanged in the urine, the excretion rate is greatly influenced by the renal function. Plasma concentrations are sharply increased if usual doses are given to patients with renal function disorders. Due to the potential teratogenicity and mutagenicity of Bleomycin with respect to male and female reproductive cells, adequate contraception measures should be taken care of until three months after the end of therapy for male as well as female patients.
Extravasation: Extravasation usually does not require specific precaution. In case of doubt (concentrated solution or sclerotic tissue), perfusion with saline should be administered.
The usual caution in the preparation and administration of cytostatics is called for (see Safe handling under Cautions for Usage).
Effects on ability to drive and use machines: No influence on the ability to drive by bleomycin is to be expected on the basis of the pharmacological activity.
Bleomycin may impair the ability to drive or operate machines due to nausea and vomiting.
Use in Pregnancy and lactation: Insufficient information is available about the use of this drug in human pregnancy assess any harmfulness. Bleomycin will pass the placenta. Animal tests have shown this medication to the harmful.
On the basis of the pharmacological activity, harmfulness is possible if used in pregnancy.
The use of Bleomycin in pregnancy should be avoided, particularly during the first trimester.
During the treatment with Bleomycin no breast-feeding should take place.