Bleocin Injection
Bleomycin
15mg/vial
Nippon Kayaku Co Ltd,.Japan
| Pack size | 1 amps pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 1121.75 AED |
Indications
Bleocin Injection is used for:
Squamous Cell Carcinoma, Hodgkin Disease, Non-Hodgkin Lymphoma, Testicular Carcinoma, Pleural Sclerosing
Adult Dose
Squamous Cell Carcinoma, Testicular Carcinoma
0.25-0.5 unit/kg (10 to 20 unit/m²) IV/IM/SC weekly or twice weekly.
Hodgkin's Disease, Non-Hodgkin's Lymphoma
Administer test dose of 1-2 units of bleomycin before first 1-2 doses; monitor vital signs q15min; wait 1 hour minimum before administering remainder of dose; if no acute reaction observe, may administer regular dosage schedule
0.25 to 0.5 unit/kg (10 to 20 unit/m²) IV/IM/SC weekly or twice weekly.; reduce to the maintenance dose of 1 unit once daily or 5 unit Weekly IV/IM after 50% response
Child Dose
Not recommended
Renal Dose
Renal Impairment
CrCl >50 mL/min: Dose adjustment not necessary
CrCl 40-50 mL/min: 70% of normal dose
CrCl 30-40 mL/min: 60% of normal dose
CrCl 20-30 mL/min: 55% normal dose
CrCl 10-20 mL/min: 45% normal dose
CrCl 5-10 mL/min: 40% normal dose
Administration
IV/IM Preparation
IV: reconstitute 15 U vial in 5 mL & 30 U vial in 10 mL NS to yield 3 U/mL solution
IM/SC: reconstitute 15 U vial in 1-5 mL & 30 U vial in 2-10 mL NS/SWI/BWI
Do not use dextrose-containing diluents
Although may be stable for longer periods, preferably use within 24 hr of reconstitution
In lymphoma patients, give first 2 doses at 1-2 units to test for anaphylactoid reaction
Limit lifetime dose to <400 units because of risk of pulmonary fibrosis
Low ADRs w/intrapleural administration
Contra Indications
Hypersensitivity. Severe pulmonary disease; pregnancy and lactation.
Precautions
Severe idiosyncratic reactions including hypotension, confusion, fever, chills, and wheezing occurring usually after the first or second dose have been reported.
Monitoring is very important after administering these doses.
Pneumonitis that progresses to pulmonary fibrosis is the most severe toxicity reported. Risk increases in elderly persons and with doses >400 units.
The drug should be administered under the supervision of an experienced cancer chemotherapy physician.
Patients receiving therapy must be observed carefully and frequently during and after therapy; it should be used with extreme caution in patients with significant impairment of renal function or compromised pulmonary function
Pulmonary toxicities occur in 10% of treated patients; in approximately 1%, the nonspecific pneumonitis induced by bleomycin progresses to pulmonary fibrosis and death; although this is age and dose-related, the toxicity is unpredictable; frequent roentgenograms recommended
A severe idiosyncratic reaction (similar to anaphylaxis) consisting of hypotension, mental confusion, fever, chills, and wheezing reported in approximately 1% of lymphoma patients receiving therapy; since these reactions usually occur after first or second dose, careful monitoring is essential after these doses
Renal or hepatic toxicity, beginning as deterioration in renal or liver function tests, reported; these toxicities may occur at any time after initiation of therapy
Patients with creatinine clearance values of < 50 mL/min should be treated with caution and their renal function should carefully monitored during the administration; lower doses of bleomycin may be required in these patients than those with normal renal function
Monitoring Parameters
Chest X-ray weekly or twice weekly.
Pregnancy-Lactation
Pregnancy
Therapy can cause fetal harm when administered to a pregnant woman; there have been no studies on pregnant women
If injection is used during pregnancy, or if patient becomes pregnant while receiving this drug, the patient should be apprised of potential hazard to fetus
Women of childbearing potential should be advised to avoid becoming pregnant during therapy
Animal data
Has been shown to be teratogenic in rats; administration of intraperitoneal doses of 1.5 mg/kg/day to rats (about 1.6 times the recommended human dose on a unit/m2 basis) on days 6 to 15 of gestation caused skeletal malformations, shortened innominate artery and hydroureter
This drug is abortifacient but not teratogenic in rabbits at intravenous doses of 1.2 mg/kg/day (about 2.4 times the recommended human dose on a unit/m2 basis) given on gestation days 6 to 18
Lactation
Not known whether the drug is excreted in human milk; because many drugs are excreted in human milk and because of potential for serious adverse reactions in nursing infants, recommended that nursing be discontinued by women receiving bleomycin therapy
Interactions
Increased incidence and severity of lung toxicity w/ previous or concurrent radiotherapy to the chest. Combination w/ vinca alkaloids may result to a syndrome corresponding to morbus Raynaud, ischemia which can lead to necrosis of peripheral parts of the body (fingers, toes, nose tip). May reduce the absorption of phenytoin. Increased risk of agranulocytosis w/ clozapine.
Potentially Fatal: Increased pulmonary toxicity w/ oxygen, cisplatin or brentuximab.
Contraindicated (1)
brentuximab vedotin
Serious (5)
adenovirus types 4 and 7 live, oral
etrasimod
influenza virus vaccine quadrivalent, adjuvanted
influenza virus vaccine trivalent, adjuvanted
palifermin
Adverse Effects
Side effects of Bleomycin :
>10%
Mucocutaneous toxicity including rash, erythema, hyperpigmentation, urticaria (>50%),Febrile reactions, acute (25-50%),Mucositis (30%),Stomatitis (30%),Interstitial pneumonitis (10%),Pulmonary fibrosis (10%),Anorexia,Weight loss,Rales,Tachypnea
1-10%
Alopecia (1-10%),Fatal pulmonary fibrosis (1%),Confusion,Shivering,Anphylactoid rxns,Onycholysis,Pruritus,Skin thickening,Skleroderma
<1%
Nausea,Malaise,Myocardial infarction,Hypotension,Cerebral vascular accident,Raynaud's phenomenon,Fatal pulmonary fibrosis,Hepatotoxicity,Renal toxicity,Necrolysis,Hyperpigmentation
Potentially Fatal: Pulmonary toxicity, interstitial pneumonitis, fibrosis, cardiorespiratory collapse in patients with lymphoma.
Mechanism of Action
Bleomycin causes breakage of single- and double- stranded DNA by binding to DNA and inhibiting DNA synthesis. To a lesser extent, it also inhibits RNA and protein synthesis. It causes very little bone marrow suppression.
Note
Bleocin 15mg/vial Injection manufactured by Nippon Kayaku Co Ltd,.Japan. Its generic name is Bleomycin. Bleocin is availble in Bangladesh.
Farmaco BD drug index information on Bleocin Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.