Bleocin Adverse Reactions

The frequently observed adverse reactions to Bleocin in total 1,613 patients (374 patients at the time of approval and 1,239 patients from post-marketing surveillance) were serious pulmonary manifestation such as interstitial pneumonia and pulmonary fibrosis (10.2%), dermal sclerosis and pigmentation (40.6%), fever and chills (39.8%), alopecia (29.5%), anorexia and weight decreased (28.7%), general malaise (16.0%), nausea and vomiting (14.6%), stomatitis (13.3%), nail changes (11.2%), etc.
Clinically significant adverse reactions: Interstitial pneumonia, pulmonary fibrosis (10%): Since serious interstitial pneumonia and pulmonary fibrosis may occur, sufficient observation is necessary, and if any abnormality is noted by examination for A-aDO₂, PaO₂, and DL_CO or on chest radiography [see Important Precautions under Precautions], or if pulmonary manifestations including cough, exertional dyspnea or crepitation (rale) develops, administration of Bleocin should be immediately discontinued and administration of adrenal cortical hormones and treatment with appropriate antibiotics, etc. should be implemented.
Shock (<0.1%): Since treatment with Bleocin may cause shock, sufficient observation is necessary. In case of any abnormality, administration of Bleocin should be discontinued and appropriate measures should be taken. (Shock often develops in patients with malignant lymphoma at the first or second administration. Therefore, treatment with Bleocin should be started at the initial and second doses of ≤5 mg (potency). The dose is then increased to the normal dose after confirming that no acute reactions have been caused.)
Hemorrhage (2%): Careful attention should be paid, because a focus of the cancer may rapidly necrotize, resulting in bleeding.
Other adverse reactions: (See Table 4.)

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