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Bleonix

Bleonix15 unit/vial

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Medicine overview

Indications of Bleonix 15 unit/vial

tonguetonsilnasopharynxoropharynxsinuspalatelipbuccal mucosagingivaeepiglottisskinlarynx)peniscervixnon-Hodgkin’s lymphoma.Testicular Carcinoma: Embryonal cellchoriocarcinomaand teratocarcinoma. Bleomycin sulfate has also been shown to be useful in the management of Malignant Pleural Effusion

Theropeutic Class

Cytotoxic Chemotherapy

Pharmacology

Although the exact mechanism of action of Bleonix 15 unit/vial is unknown, available evidence indicates that the main mode of action is the inhibition of DNA synthesis with some evidence of lesser inhibition of RNA and protein synthesis.

Absorption

Bleomycin is known to cause single, and to a lesser extent, double-stranded breaks in DNA.

Distribution

In in vitro and in vivo experiments, bleomycin has been shown to cause cell cycle arrest in G2 and in mitosis.

Metabolism

When administered into the pleural cavity in the treatment of malignant pleural effusion, Bleonix 15 unit/vial acts as a sclerosing agent.

Dosage & Administration of Bleonix 15 unit/vial

Notes:Because of the possibility of an anaphylactoid reaction, lymphoma patients should be treated with 2 units or less for the first 2 doses. If no acute reaction occurs, then the regular dosage schedule may be followed. Squamous cell carcinoma, non-Hodgkin’s lymphoma, testicular carcinoma: 0.25 to 0.50 units/kg (10 to 20 units/m2) given intravenously, intramuscularly, or subcutaneously weekly or twice weekly
Hodgkin’s disease
Dosage:0.25 to 0.50 units/kg (10 to 20 units/m2) given intravenously, intramuscularly, or subcutaneously weekly or twice weekly
Notes:After a 50% response, a maintenance dose of 1 unit daily or 5 units weekly intravenously or intramuscularly should be given. Pulmonary toxicity of Bleomycin sulfat appears to be dose-related with a striking increase when the total dose is over 400 units. Total doses over 400 units should be given with great caution
Note
Dosage:When Bleomycin sulfat is used in combination with other antineoplastic agents, pulmonary toxicities may occur at lower doses
Notes:Improvement of Hodgkin’s disease and testicular tumors is prompt and noted within 2 weeks. If no improvement is seen by this time, improvement is unlikely. Squamous cell cancers respond more slowly, sometimes requiring as long as 3 weeks before any improvement is noted
Malignant Pleural Effusion
Dosage:60 units administered as a single dose bolus intrapleural injection

Dosage of Bleonix 15 unit/vial

Notes:Because of the possibility of an anaphylactoid reaction, lymphoma patients should be treated with 2 units or less for the first 2 doses. If no acute reaction occurs, then the regular dosage schedule may be followed. Squamous cell carcinoma, non-Hodgkin’s lymphoma, testicular carcinoma: 0.25 to 0.50 units/kg (10 to 20 units/m2) given intravenously, intramuscularly, or subcutaneously weekly or twice weekly
Hodgkin’s disease
Dosage:0.25 to 0.50 units/kg (10 to 20 units/m2) given intravenously, intramuscularly, or subcutaneously weekly or twice weekly
Notes:After a 50% response, a maintenance dose of 1 unit daily or 5 units weekly intravenously or intramuscularly should be given. Pulmonary toxicity of Bleomycin sulfat appears to be dose-related with a striking increase when the total dose is over 400 units. Total doses over 400 units should be given with great caution
Note
Dosage:When Bleomycin sulfat is used in combination with other antineoplastic agents, pulmonary toxicities may occur at lower doses
Notes:Improvement of Hodgkin’s disease and testicular tumors is prompt and noted within 2 weeks. If no improvement is seen by this time, improvement is unlikely. Squamous cell cancers respond more slowly, sometimes requiring as long as 3 weeks before any improvement is noted
Malignant Pleural Effusion
Dosage:60 units administered as a single dose bolus intrapleural injection

Interaction of Bleonix 15 unit/vial

Increased incidence and severity of lung toxicity with previous or concurrent radiotherapy to the chest. Combination with vinca alkaloids may result to a syndrome corresponding to morbus Raynaud, ischaemia 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 with clozapine.

Contraindications

Acute pulmonary infection or greatly reduced lung function. Concomitant brentuximab, cisplatin or oxygen. Lactation.

Side Effects of Bleonix 15 unit/vial

Common side effects of Bleonix 15 unit/vial include injection site reactions (pain, redness, warmth, itching, or swelling), fever, chills, vomiting, loss of appetite, weight loss, darkening or discoloration of the skin, changes in fingernails or toenails, itching, or pain near your tumor.

Pregnancy & Lactation

Pregnancy Category D. It is not known whether the drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, it is recommended that nursing be discontinued by women receiving Bleonix 15 unit/vial therapy.

Precautions & Warnings

Caution should be taken in patient with severe heart disease, Renal impairment, Elderly & Pregnancy.

Overdose Effects of Bleonix 15 unit/vial

Symptoms: Hypotension, fever, rapid pulse and general symptoms of shock. Management: Symptomatic. In case of resp complications, treat with a corticosteroid and a broad-spectrum antibiotic.

Storage Conditions

Store between 2-8°C. Protect from light and should not be used after the expiration date is reached.

Use In Special Populations

Pediatric Use: Safety and effectiveness of Bleomycin in pediatric patients have not been established.Geriatric Use: In clinical trials, pulmonary toxicity was more common in patients older than 70 years than in younger patients

Reconstitution

IM/SC: Add 1-5 mL or 2-10 mL of sterile water for inj, NaCl 0.9% inj, or bacteriostatic water for inj to the vial labelled as containing 15 IU or 30 IU of bleomycin, respectively, to provide a soln containing 3-15 IU/mL. IV: Add 5 mL or 10 mL of NaCl 0.9% into the vial labelled as containing 15 IU or 30 IU of bleomycin, respectively, to provide a soln containing ≤3 IU/mL. Admin slowly over a 10-min period. Intrapleural: Dissolve 60 IU of bleomycin in 50-100 mL NaCl 0.9% inj.

Drug Classes

Cytotoxic Chemotherapy

Mode Of Action

Although the exact mechanism of action of Bleonix 15 unit/vial is unknown, available evidence indicates that the main mode of action is the inhibition of DNA synthesis with some evidence of lesser inhibition of RNA and protein synthesis.Bleomycin is known to cause single, and to a lesser extent, double-stranded breaks in DNA. In in vitro and in vivo experiments, bleomycin has been shown to cause cell cycle arrest in G2 and in mitosis. When administered into the pleural cavity in the treatment of malignant pleural effusion, Bleonix 15 unit/vial acts as a sclerosing agent.

Pregnancy

Pregnancy Category D. It is not known whether the drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, it is recommended that nursing be discontinued by women receiving Bleonix 15 unit/vial therapy.

Pediatric Uses

Pediatric Use: Safety and effectiveness of Bleomycin in pediatric patients have not been established.Geriatric Use: In clinical trials, pulmonary toxicity was more common in patients older than 70 years than in younger patients

Frequently Asked Questions

What is Bleonix 15 unit/vial used for?

Bleomycin sulfate should be considered a palliative treatment. It has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents:Squamous Cell Carcinoma: Head and neck ... Read moreBleomycin sulfate should be considered a palliative treatment. It has been shown to be useful in the management of…

What is the dosage of Bleonix 15 unit/vial?

Because of the possibility of an anaphylactoid reaction, lymphoma patients should be treated with 2 units or less for the first 2 doses. If no acute reaction occurs, then the regular dosage schedule may be followed.Squamous cell carcinoma, non-Hodgkin’s lymphoma, testicular carcinoma: 0.25 to 0.50 units/kg (10 to 20 units/m2) given intravenously, intramuscularly, or subcutaneously weekly or twice …

What are the side effects of Bleonix 15 unit/vial?

Common side effects of Bleomycin Sulfate include injection site reactions (pain, redness, warmth, itching, or swelling), fever, chills, vomiting, loss of appetite, weight loss, darkening or discoloration of the skin, changes in fingernails or toenails, itching, or pain near your tumor.

Who should not take Bleonix 15 unit/vial?

Acute pulmonary infection or greatly reduced lung function. Concomitant brentuximab, cisplatin or oxygen. Lactation.

What precautions should be taken with Bleonix 15 unit/vial?

Caution should be taken in patient with severe heart disease, Renal impairment, Elderly & Pregnancy.

Is Bleonix 15 unit/vial safe during pregnancy and breastfeeding?

Pregnancy Category D. It is not known whether the drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, it is recommended that nursing be discontinued by women receiving Bleomycin Sulfate therapy.

Disclaimer

The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.

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