Trade Names:Blenoxane- Sterile powder for Injection 30 unit vial (30 units = 30 mg)
Trade Names:Bleomycin Sulfate- Sterile powder for Injection 15 unit vial (15 units = 15 mg)
Bleomycin sulfate is a mixture of cytotoxic glycopeptide antibiotics. It inhibits DNA synthesis. When administered intrapleurally, bleomycin acts as a sclerosing agent.
High concentrations are found in the skin and lungs; low concentrations are found in bone marrow.
The t ½ is about 115 min; 60% to 70% is excreted in urine as active bleomycin.
In those with Ccr less than 35 mL/min, the t ½ increases.
Lymphomas (Hodgkin and non-Hodgkin); testicular carcinoma (eg, embryonal cell, choriocarcinoma, teratocarcinoma); sclerosis of malignant pleural effusions (eg, treatment, prevention); treatment of squamous cell carcinomas (eg, head, neck).
Mycosis fungoides, osteosarcoma, AIDS-related Kaposi sarcoma.
IV / IM / Subcutaneous Because of the possibility of anaphylactoid reaction, treat lymphoma patents with 2 units or less for the first 2 doses. If no acute reaction occurs, follow the regular dosage schedule.Hodgkin DiseaseAdults
IV / IM / Subcutaneous 10 to 20 units/m 2 1 or 2 times/wk. After a 50% regression of tumor size, a maintenance dose of 1 unit/day or 5 units/wk can be given IV or IM. Response is usually seen within 2 wk. To minimize the risk of pulmonary toxicity, the max cumulative dose should not exceed 400 units. When bleomycin is used in combination with other antineoplastic agents, pulmonary toxicities may occur at lower doses.Pleural EffusionsAdults
Thoracostomy tube 60 units diluted with 50 to 100 mL sodium chloride 0.9% is instilled into chest via a thoracotomy tube following drainage of excess pleural fluid and confirmation of complete lung expansion. The amount of drainage from the chest tube should be as minimal as possible prior to installation of bleomycin. The thoracotomy tube is then clamped. The patient is moved from the supine to the left and right lateral positions several times during the next 4 h. The clamp is then removed and suction re-established. It is generally accepted that chest tube drainage should be below 100 mL in a 24-h period prior to sclerosis. However, bleomycin instillation may be appropriate when drainage is between 100 and 300 mL under clinical conditions that necessitate sclerosis therapy.Squamous Cell Carcinoma, non-Hodgkin Lymphoma, Testicular CarcinomaAdults
IV / IM / Subcutaneous 10 to 20 units/m 2 1 or 2 times/wk. Response is usually seen within 3 wk. Squamous cell cancers respond more slowly, sometimes requiring 3 wk for improvement and testicular tumors is noticed within 2 weeks.
Store powder for injection in refrigerator (36° to 46°F). Bleomycin is stable for 24 h at room temperature when reconstituted with sodium chloride 0.9% injection. Discard any unused solution. Do not save any unused solution for future use.
Bleomycin may decrease serum concentrations of digoxin and phenytoin.
None well documented.
Hypotension; cerebral arteritis, cerebrovascular accidents, MI, thrombotic microangiopathy, Raynaud phenomenon (with combination chemotherapy).
Alopecia, erythema, hyperkeratosis, hyperpigmentation, nail changes, pruritus, rash, skin tenderness, stomatitis, striae, vesiculation (approximately 50%); scleroderma-like skin changes (postmarketing).
Pain; pain at tumor site; phlebitis.
Weight loss (common).
Pneumonitis, pulmonary fibrosis, dyspnea, rales.
Idiosyncratic reaction including chills, fever, hypotension, mental confusion, and wheezing (about 1% of lymphoma patients); chills; fever; acute chest pain.
Pneumonitis; life-threatening pulmonary fibrosis. Pulmonary toxicities occur in 10% of treated patients. In about 1%, the drug-induced nonspecific pneumonitis progresses to pulmonary fibrosis and death. Risk factors include the following: increased age, radiation to the lungs, oxygen therapy during or after bleomycin, recent cisplatin therapy, declining renal function. Toxicity may occur at cumulative doses more than 400 mg when risk factors are present, and it has occurred in young patients.
The earliest symptom associated with bleomycin pulmonary toxicity is dyspnea. The earliest sign is rales.Idiosyncratic reaction
A severe idiosyncratic reaction consisting of hypotension, mental confusion, fever, chills, and wheezing has occurred in about 1% of lymphoma patients. These reactions may be immediate or delayed for several hours and usually occur after the first or second dose; careful monitoring is essential. Treatment is symptomatic including volume expansion, pressor agents, and antihistamines.
Document total cumulative dose. Because of the risk of pulmonary toxicity, ensure that dosing beyond 400 units is only attempted after careful evaluation of the patient and clinical situation.
Ensure chest x-rays are obtained and evaluated every 1 to 2 wk during therapy to monitor for onset of pulmonary toxicity. If changes are noted ensure that therapy is discontinued until it is determined if changes are drug related.
Ensure diffusion capacity for carbon monoxide (DLco) is determined before starting therapy and then monthly during treatment. Ensure that therapy is discontinued if DLco falls below 30% to 35% of pretreatment value.
Category D .
Undetermined. It is recommended that breast-feeding be discontinued by women receiving therapy.
Safety and efficacy not established.
Pulmonary toxicity was more common in patients older than 70 years of age.
Because of the risk of anaphylactoid-like reactions (ie, hypotension, mental confusion, fever, chills, and wheezing) in lymphoma patient, ensure that lymphoma patient receives no more than 2 units of bleomycin for the first 2 doses. Frequently monitor patient during and after therapy. Be prepared to treat reactions symptomatically. Regular dosing schedule can be followed if no acute reactions occur after either dose.
Patients with a Ccr of less than 35 mL/min should receive a reduced dose of bleomycin. Guidelines for dosage reduction are empiric. Renal toxicity has occurred infrequently. This toxicity may occur at any time.
Hepatic toxicity has occurred infrequently. This toxicity may occur at any time.
Death has been rarely reported in association with bleomycin pleurodesis in very seriously ill patients.
Local irritation or phlebitis may occur. Refer to your institution specific protocol.
Skin toxicity, a relatively late manifestation, appears to be related to the cumulative dose. It usually develops in the second and third week of treatment after administration of 150 to 200 units of the drug.
If patient is to undergo surgical intervention, ensure that surgical team (including anesthesiologist) is aware of treatment with bleomycin and that FI O 2 should be maintained, if possible, at concentrations no greater than 25%. Fluid replacement should consist of colloids rather than crystalloids to reduce the risk of lung damage.
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