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Blenoxane

Last reviewed on RxList: 6/22/2010
Blenoxane Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 1/10/2016

Blenoxane (bleomycin sulfate) for Injection is a cancer medication used to treat squamous cell carcinoma, a skin cancer. Blenoxane is also used to treat Hodgkin's disease and non-Hodgkin's lymphoma, testicular cancer, and malignant pleural effusion (a build-up of fluid in the outer tissues of the lungs, caused by certain types of cancer). Blenoxane treats only the symptoms of cancer but does not treat the cancer itself. The brand name Blenoxane is discontinued, but generic versions may be available. Common side effects of Blenoxane (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. Other side effects of Blenoxane (bleomycin sulfate) include temporary hair. Normal hair growth should return after treatment has ended.

To treat squamous cell carcinoma, non-Hodgkin's lymphoma, testicular carcinoma and Hodgkin's disease the dose of Blenoxane is 0.25 to 0.50 units/kg (10 to 20 units/m²) given intravenously, intramuscularly, or subcutaneously weekly or twice weekly. Blenoxane may interact with other cancer treatments. Tell your doctor all medications and supplements you use. Blenoxane is not recommended for use during pregnancy. It may harm a fetus. If you become pregnant or think you may be pregnant, tell your doctor. It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding while using this drug is not recommended.

Our Blenoxane (bleomycin sulfate) for Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Blenoxane Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Bleomycin can cause breathing problems. While you are being treated with this medicine, be sure you can get medical help quickly in case you have any serious side effects.

Call your doctor at once if you have:

  • sudden chest pain or discomfort, wheezing, dry cough or hack;
  • shortness of breath;
  • confusion, feeling weak or tired, loss of appetite, rapid weight loss;
  • fever or chills;
  • a light-headed feeling, feeling like you might pass out;
  • white patches or sores inside your mouth or on your lips;
  • severe redness, itching, rash, blistering, or tenderness of your skin; or
  • unusual hardening or thickening of your skin.

Some side effects may be more likely in older adults.

Common side effects may include:

  • dark streaks or discoloring on your skin;
  • fingernail or toenail changes;
  • temporary hair loss;
  • mild itching;
  • vomiting;
  • pain near your tumor; or
  • redness, warmth, itching, or swelling around the IV needle.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Blenoxane (Bleomycin Sulfate Injection)

Blenoxane Professional Information

SIDE EFFECTS

Pulmonary

The most serious side effects are pulmonary adverse reactions, occurring in approximately 10% of treated patients. The most frequent presentation is pneumonitis occasionally progressing to pulmonary fibrosis. Approximately 1% of patients treated have died of pulmonary fibrosis. Pulmonary toxicity is both dose and age related, being more common in patients over 70 years of age and in those receiving over 400 units total dose. This toxicity, however, is unpredictable and has been seen in young patients receiving low doses. Some published reports have suggested that the risk of pulmonary toxicity may be increased when bleomycin is used in combination with G-CSF (filgrastim) or other cytokines. However, randomized clinical studies completed to date have not demonstrated an increased risk of pulmonary complications in patients treated with bleomycin and G-CSF.

Because of lack of specificity of the clinical syndrome, the identification of patients with pulmonary toxicity due to BLENOXANE (bleomycin sulfate injection) has been extremely difficult. The earliest symptom associated with BLENOXANE (bleomycin sulfate injection) pulmonary toxicity is dyspnea. The earliest sign is fine rales.

Radiographically, BLENOXANE (bleomycin sulfate injection) -induced pneumonitis produces nonspecific patchy opacities, usually of the lower lung fields. The most common changes in pulmonary function tests are a decrease in total lung volume and a decrease in vital capacity. However, these changes are not predictive of the development of pulmonary fibrosis.

The microscopic tissue changes due to BLENOXANE (bleomycin sulfate injection) toxicity include bronchiolar squamous metaplasia, reactive macrophages, atypical alveolar epithelial cells, fibrinous edema, and interstitial fibrosis. The acute stage may involve capillary changes and subsequent fibrinous exudation into alveoli producing a change similar to hyaline membrane formation and progressing to a diffuse interstitial fibrosis resembling the Hamman-Rich syndrome. These microscopic findings are nonspecific; eg, similar changes are seen in radiation pneumonitis and pneumocystic pneumonitis.

To monitor the onset of pulmonary toxicity, roentgenograms of the chest should be taken every 1 to 2 weeks (see WARNINGS). If pulmonary changes are noted, treatment should be discontinued until it can be determined if they are drug related. Recent studies have suggested that sequential measurement of the pulmonary diffusion capacity for carbon monoxide (DLCO) during treatment with BLENOXANE (bleomycin sulfate injection) may be an indicator of subclinical pulmonary toxicity. It is recommended that the DLCO be monitored monthly if it is to be employed to detect pulmonary toxicities, and thus the drug should be discontinued when the DLCO falls below 30% to 35% of the pretreatment value.

Because of bleomycin's sensitization of lung tissue, patients who have received bleomycin are at greater risk of developing pulmonary toxicity when oxygen is administered in surgery. While long exposure to very high oxygen concentrations is a known cause of lung damage, after bleomycin administration, lung damage can occur at lower concentrations that are usually considered safe. Suggested preventive measures are:

  1. Maintain FIO2 at concentrations approximating that of room air (25%) during surgery and the postoperative period.
  2. Monitor carefully fluid replacement, focusing more on colloid administration rather than crystalloid.

Sudden onset of an acute chest pain syndrome suggestive of pleuropericarditis has been reported during BLENOXANE (bleomycin sulfate injection) infusions. Although each patient must be individually evaluated, further courses of BLENOXANE (bleomycin sulfate injection) do not appear to be contraindicated.

Pulmonary adverse events which may be related to the intrapleural administration of BLENOXANE (bleomycin sulfate injection) have been reported.

Idiosyncratic Reactions

In approximately 1% of the lymphoma patients treated with BLENOXANE (bleomycin sulfate injection) , an idiosyncratic reaction, similar to anaphylaxis clinically, has been reported. The reaction may be immediate or delayed for several hours, and usually occurs after the first or second dose (see WARNINGS). It consists of hypotension, mental confusion, fever, chills, and wheezing. Treatment is symptomatic including volume expansion, pressor agents, antihistamines, and corticosteroids.

Integument and Mucous Membranes

These adverse reactions have been reported in approximately 50% of treated patients. They consist of erythema, rash, striae, vesiculation, hyperpigmentation, and tenderness of the skin. Hyperkeratosis, nail changes, alopecia, pruritus, and stomatitis have also been reported. It was necessary to discontinue BLENOXANE (bleomycin sulfate injection) therapy in 2% of treated patients because of these toxicities.

Scleroderma-like skin changes have been reported.

Skin toxicity is a relatively late manifestation usually developing in the second and third week of treatment after 150 to 200 units of BLENOXANE (bleomycin sulfate injection) have been administered and appears to be related to the cumulative dose.

Intrapleural administration of BLENOXANE (bleomycin sulfate injection) has been associated with local pain. Hypotension possibly requiring symptomatic treatment has been reported. Death has been reported in association with BLENOXANE (bleomycin sulfate injection) pleurodesis in seriously ill patients.

Other

Vascular toxicities coincident with the use of BLENOXANE (bleomycin sulfate injection) in combination with other antineoplastic agents have been reported. The events are clinically heterogeneous and may include myocardial infarction, cerebrovascular accident, thrombotic microangiopathy (HUS), or cerebral arteritis. Various mechanisms have been proposed for these vascular complications. There are also reports of Raynaud's phenomenon occurring in patients treated with BLENOXANE (bleomycin sulfate injection) in combination with vinblastine with or without cisplatin or, in a few cases, with BLENOXANE (bleomycin sulfate injection) as a single agent. It is currently unknown if the cause of Raynaud's phenomenon in these cases is the disease, underlying vascular compromise, BLENOXANE (bleomycin sulfate injection) , vinblastine, hypomagnesemia, or a combination of any of these factors.

Fever, chills, and vomiting have been reported. Anorexia and weight loss have been reported and may persist long after termination of this medication. Pain at tumor site, phlebitis, and other local reactions have been reported.

Malaise has been reported.

Read the entire FDA prescribing information for Blenoxane (Bleomycin Sulfate Injection)

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© Blenoxane Patient Information is supplied by Cerner Multum, Inc. and Blenoxane Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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