Bleocin Special Precautions

After dissolution, use as promptly as possible.
Careful Administration (The following patients should be carefully observed and Bleocin should be administered with care by reducing the dose, prolonging the dose interval, etc.): Patients with a history or complication of lung disorder: [Serious pulmonary manifestation such as interstitial pneumonia and pulmonary fibrosis may occur.]
Patients aged 60 years or older: [Serious pulmonary manifestation such as interstitial pneumonia and pulmonary fibrosis may occur.]
Patients with renal disorder: [Adverse reactions may occur strongly.]
Patients with heart disorder: [Adverse reactions may occur strongly.]
Patients who have received radiation therapy to the chest: [Serious pulmonary manifestation such as interstitial pneumonia and pulmonary fibrosis may occur.]
Patients with liver disorder: [Adverse reactions may occur strongly.]
Patients with chickenpox: [Fatal general system disorders may occur.]
Important Precautions: (1) Interstitial pneumonia or pulmonary fibrosis: The condition of the patient should be sufficiently monitored [Refer to text as follows], and careful attention should be paid to the onset of crepitations (rales), because crepitations (rales), because crepitations may offer an early sign of interstitial pneumonia or pulmonary fibrosis. If any abnormality is noted, administration of Bleocin should be immediately discontinued. In accordance with treatment and procedures for idiopathic pulmonary fibrosis, adrenal cortical hormones should be administered and appropriate antibiotics should be administered to prevent secondary infection.
The frequency of interstitial pneumonia or pulmonary fibrosis is high even with a total dose of ≤150 mg (potency) in patients with underlying pulmonary diseases and aged 60 years or older, thus great care is required.
Patients receiving Bleocin should be maintained under sufficient observation of clinical symptoms including fever, cough, exertional dyspnea, etc. and should also be followed up to detect any abnormality on chest radiogram and the crepitation (rale). Also, alveolar-arterial oxygen tension difference (A-aDO₂), arterial oxygen tension (PaO₂), carbon monoxide diffusing capacity (DL_CO), etc. should be examined, where such examinations are available. These observations and examinations should be performed on a regular basis during treatment and until approximately 2 months after the completion of administration.
Examination for A-aDO₂, PaO₂, etc. should be performed once a week if possible, and if there is an increase in A-aDO₂ or decrease in PaO₂ during 2 consecutive weeks, administration of Bleocin should be discontinued. More specifically, if A-aDO₂ and PaO₂ worsen by ≥ 10 Torr compared with the values prior to Bleocin treatment, the condition of the patient should be carefully monitored along with other clinical symptoms. When an adverse reaction is suspected, Bleocin should be immediately discontinued and medications such as steroids should be commenced. Also, the measures should be taken in a small manner if DL_CO decreases by ≥15% compared with that prior to Bleocin treatment.
If Bleocin has to be administered in a patient in whom decreased pulmonary function parameters are noted before treatment, the clinical course of the patient should be carefully monitored, and Bleocin should be immediately discontinued if any decrease in the parameters is noted.
(2) With long-term administration, adverse reactions may appear strongly and become prolonged, thus administration must be performed with care.
(3) When Bleocin is administered in patients receiving peplomycin or other bleomycin products, toxicity is thought to be additive, thus administration must be performed with care.
(4) Careful attention should be paid to the onset or exacerbation of infection and any bleeding tendency.
(5) If Bleocin has to be administered in pediatric patients or patients of reproductive age, effects on the gonads should be taken into account.
Precautions concerning Use: Intravenous administration: Since intravascular administration may cause vascular pain, due care should be paid to concentration and administration speed. Give intravenously as slowly as possible.
Intramuscular administration: To avoid affecting tissue, nerves, etc., the following points must be considered. 1) Intramuscular administration may cause induration at the injection site. Particularly, repeated injection at the same site should be avoided. Special care is required when Bleocin is administered in neonates, low birth weight babies, infants or children.
2) Pay due attention to avoid injecting at innervated sites.
3) If a patient complains of severe pain or back flow of blood into syringe is identified when a needle is inserted, the needle should be immediately pulled out and inserted into a different site.
Other Precautions: Myocardial infarction, cerebral infarction, etc. due to the concomitant use of Bleocin and other anti-cancer agents have been reported in overseas countries.
Bleocin has been reported to cause fibrosarcoma and renal carcinoma in laboratory animals (rats) administered subcutaneously.
Use during Pregnancy, Delivery or Lactation: The administration of Bleocin is not recommended for pregnant women or women who may possibly be pregnant. [Bleocin has been reported to have teratogenic effects in laboratory animals (mice and rats).]
Administration of Bleocin should be avoided in nursing mothers. If administration of Bleocin is unavoidable, instruct the patient to discontinue breast feeding.
[The safety of Bleocin in nursing mothers has not been established.]
Use in Children: particular care is required concerning the appearance of adverse reactions when administering this drug to children.
[The safety of this drug in children has not been established.]
Use in the Elderly: Since patients aged 60 years or older are more likely to experience interstitial pneumonia or pulmonary fibrosis, Bleocin should be administered with care.
[The incidence of serious pulmonary manifestation such as interstitial pneumonia and pulmonary fibrosis was 5.9% for patients aged <50 years, 8.1% for patients in their 50s, 10.9% for patients in their 60s, and 15.5% for patients ≥70 years, showing an increase with age.]