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Sanbelat

Sanbelat Adverse Reactions

bleomycin

Manufacturer:

Sanbe

Marketer:

Sanbe
Full Prescribing Info
Adverse Reactions
As applies to most cytostatics, Bleomycin can have both an acute and a delayed toxic effect.
Acute symptoms may be: Anorexia, fatigue. Pain at the injection site or in the tumour region may occur, as well as arterial hypotension and venous occlusion in case of intravenous administration.
Lungs: The most severe side effect (in 2-10% patients) which may occur during or after the discontinuation of Bleomycin treatment is interstitial pneumonia. If not immediately identified and treated, this may lead to irreversible lung fibrosis. The risk of pulmonary toxicity increases with cumulative dose. Pulmonary toxicity may occur even in very low cumulative dosages in older patients, patients who underwent radiation therapy of the thorax or those who received oxygen.
Vascular changes occurs in the lung, which partly affect the elasticity of the vascular wall.
If unaccountable coughing, dyspnoea, basal crepitations or a diffuse reticular image on the thorax X-ray develops, each of these phenomena in itself is a reason to discontinue the administration of Bleomycin, until bleomycin toxicity as a cause has been ruled out. There is no specific therapy for Bleomycin-related lung toxicity. In some cases a favourable effect was described after treatment with corticosteroids.
Fever: Fever may occur 2 to 6 hours after the first injection (see also Hypersensitivity reactions as follows). If the fever persists, administration of antipyretics may be necessary. The incidence of the development of a fever decreases after subsequent injections.
Skin and mucous membrane: Skin and mucous membrane changes are the most common symptoms (up to 50 % of the patients). Skin problems usually occur in the area of the hands and feet. Thickening, hyperkeratosis, redness, swelling of the fingertips, discolouration of the nails, swelling of the skin in places subject to pressure such as elbows, loss of hair and stomatitis may occur. These side effects are rarely severe and will usually disappear after completion of the therapy. Also paraesthesia and hyperaesthesia of the fingers is possible, but reversible. Ulceration of the mucous membranes can exacerbate if Bleomycin is combined with radiation therapy or other drugs that are toxic to the mucous membranes.
Stomach/intestines: Gastrointestinal side effects such as nausea, vomiting, loss of appetite, weight loss and inflammation of the mucous membrane may occur, particularly in high dosages. Antiemetics may be useful.
Hypersensitivity reactions: Severe idiosyncratic reactions were observed in approximately 1% of the patients, predominantly lymphoma patients. These severe, partially delayed, anaphylactic reactions cause fever attacks and may be fatal. This reaction may occur immediately, or after a delayed period of several hours after the first or second dose.
Circulation: Hypotensive episodes have been described in patients with Hodgkin's disease who were treated with high initial dose. Damage to blood vessels (eg. cardiac infarction, coronary heart disease, circulatory disorders in the brain, inflammation of the cranial arteries, so-called haemolytic uraemic syndrome) rarely occurs.
Bone marrow: Bleomycin causes only a minor bone marrow suppresion. Slight thrombopenia may occur, which is quickly reversed when therapy is completed. This is a result of increased use of platelets and is not attributable to reduction of new thrombocyte formation.
Other adverse reactions: Pain in the muscles, limbs and at the site of injection.
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