Medicine Overview of Bleonix 15mg/vial Injection
Bleonix is a medicine used for treatment of cancer in various parts of the body such as cervical, Cancer of the mouth, nasopharynx and paranasal sinuses, larynx, esophagus, and skin. It works by interfering with the growth of cancer cells, which are eventually destroyed.
Bleonix may be used alone or with other medicines as part of combination therapy.It is given under the supervision of a healthcare professional and should not be self-administered. Your doctor will decide what dose is necessary and how often you need to take it. This will depend on what you are being treated for and may change from time to time. You should take it exactly as your doctor has advised. Taking it in the wrong way or taking too much can cause very serious side effects. It may take several weeks or months for you to see or feel the benefits but do not stop taking it unless your doctor tells you to. You should avoid drinking alcohol as it may increase your risk of liver damage.
The most common side effects of this medicine include fever, loss of appetite, loss of hair, weight loss, nausea, inflammation of the lungs (interstitial pneumonia), shortness of breath or cough. If they do not go away or get worse, tell your doctor. There may be ways of preventing or reducing these effects. It is very strong medicine and some people may develop serious side effects while taking it. This medicine may lower your ability to fight infections and lead to problems with your blood, liver or kidneys. Your doctor will advise you regular blood tests to check for these.
Before taking it, tell your doctor if you have stomach, liver, or kidney problems or are taking any medicines to treat infections. Many other medicines can affect, or be affected by, this medicine so let your doctor know all medications you are using. This medicine is not recommended during pregnancy or while breastfeeding. It may harm your baby. You and your partner should avoid becoming pregnant or fathering a child for several months after your treatment with it has stopped. Your doctor may perform several tests such as blood tests, X-rays and physical examinations both before and during treatment with this medicine.
- Cervical cancer
- Cancer of mouth, nasopharynx and paranasal sinuses, larynx, oesophagus
- Skin cancer
- Fever
- Hair loss
- Interstitial pneumonia
- Loss of appetite
- Low blood platelets
- Nail discoloration
- Nausea
- Pulmonary fibrosis
- Rigors
- Scratch dermatitis
- Skin pigmentation
- Stomatitis (Inflammation of the mouth)
- Vomiting
- Weight loss
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Inform your doctor before taking bleomycin if you have severe heart disease, kidney problems, lung problems requiring use of oxygen, impaired liver function, and chicken pox or if you are about to undergo a surgery.
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Inform your doctor before taking bleomycin if you are taking other anticancer/cytotoxic drugs such as vinca alkaloids or cisplatin, drugs such as clozapine or if you have received radiation in the chest area.
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Seek immediate medical advice if you develop dry cough, breathlessness, rapid breathing or any other lung problems.
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Do not drive or operate heavy machinery after taking this drug as it may make you feel weak or tired.
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Tell your doctor if you are or planning to become pregnant or are breastfeeding.
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
Squamous Cell Carcinoma, Testicular Carcinoma
0.25-0.5 unit/kg (10 to 20 unit/m²) IV/IM/SC q1-2Weeks
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 q1-2Weeks; reduce to maintenance dose of 1 unit qDay or 5 unit qWeek IV/IM after 50% response
Hepatic Impairment: Dose adjustment not necessary
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
Pulmonary infection, preexisting pulmonary function impairment, renal impairment. Patients who received radiotherapy, particularly to the thorax. Regular chest x-rays should be done. Elderly. Discontinue treatment if chest x-rays show infiltrates or breathlessness occurs.
Lactation: It is not known whether the drug is excreted in milk. Because of the potential for serious adverse reactions in nursing infants, it is recommended that nursing be discontinued by women receiving bleomycin therapy.
>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.
Pregnancy Category: D
Lactation: It is not known whether the drug is excreted in milk. Because of the potential for serious adverse reactions in nursing infants, it is recommended that nursing be discontinued by women receiving bleomycin therapy.
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, 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 w/ clozapine.
Potentially Fatal: Increased pulmonary toxicity w/ oxygen, cisplatin or brentuximab.
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