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Blenoxane Side Effects

Generic Name: bleomycin

Note: This document contains side effect information about bleomycin. Some of the dosage forms listed on this page may not apply to the brand name Blenoxane.

For the Consumer

Applies to bleomycin: injection powder for solution

Along with its needed effects, bleomycin (the active ingredient contained in Blenoxane) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer, such as leukemia. Discuss these possible effects with your doctor.

Check with your doctor immediately if any of the following side effects occur while taking bleomycin:

More Common

  • Fever and chills (occurring within 3 to 6 hours after a dose)

Less Common

  • Confusion
  • faintness
  • wheezing

Rare

  • Chest pain (sudden severe)
  • weakness in arms or legs (sudden)

Check with your doctor as soon as possible if any of the following side effects occur while taking bleomycin:

More Common

  • Cough
  • shortness of breath
  • sores in mouth and on lips

Some side effects of bleomycin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  • Darkening or thickening of skin
  • dark stripes on skin
  • itching of skin
  • skin rash or colored bumps on fingertips, elbows, or palms
  • skin redness or tenderness
  • swelling of fingers
  • vomiting and loss of appetite

Less Common

Bleomycin may cause a temporary loss of hair in some people. After treatment has ended, normal hair growth should return, although it may take several months.

Side effects that affect your lungs (for example, cough and shortness of breath) may be more likely to occur if you smoke.

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

  • Cough
  • shortness of breath

For Healthcare Professionals

Applies to bleomycin: injectable powder for injection

Respiratory

Very common (10% or more): Interstitial pneumonia (10%), pulmonary fibrosis (10%)

Common (1% to 10%): Wheezing[Ref]

Dermatologic

Very common (10% or more): Sclerosis of the skin (41%), pigmentation disorder (41%), alopecia (30%), nail deformation (11%), nail discoloration, skin hypertrophy, flagellate dermatitis

Common (1% to 10%): Rash, urticaria, exfoliative dermatitis[Ref]

Skin toxicity is a relatively late manifestation, usually developing in the 2nd and 3rd week of treatment, after a cumulative dose of 150 to 200 units.[Ref]

Gastrointestinal

Very common (10% or more): Nausea (15%), vomiting (15%), stomatitis (13%)

Common (1% to 10%): Angular cheilitis

Uncommon (0.1% to 1%): Diarrhea[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Shock, vein wall hypertrophy, venous stenosis

Frequency not reported: Myocardial infarction, hypotension, Raynaud's phenomenon, embolism, thrombosis, peripheral ischemia, cerebral infarction, chest pain[Ref]

Other

Very common (10% or more): Fever/pyrexia (40%), malaise (16%)[Ref]

Local

Uncommon (0.1% to 1%): Injection site induration

Frequency not reported: Injection site thrombosis (IV), injection site pain[Ref]

Oncologic

The most frequent mutations produced in mammalian cells are large multilocus deletions, which probably arise by misrepair of (DNA) double strand breaks.[Ref]

Uncommon (0.1% to 1%): Tumor pain[Ref]

Hematologic

Common (1% to 10%): Hemorrhage

Uncommon (0.1% to 1%): Leucopenia

Frequency not reported: Pancytopenia, thrombocytopenia, anemia, neutropenia

Postmarketing reports:

Immunologic

Frequency not reported: Sepsis

Musculoskeletal

Very common (10% or more): Scleroderma, chills

Metabolic

Very common (10% or more): Anorexia (29%), weight loss (29%)

Psychiatric

Common (1% to 10%): Mental confusion

Genitourinary

Uncommon (0.1% to 1%): Oliguria, dysuria, pollakiuria, urinary retention, polyuria, feeling of residual urine

Hepatic

Uncommon (0.1% to 1%): Hepatocellular injury

Nervous system

Very common (10% or more): Rigors (40%)

Common (1% to 10%): Headache

Uncommon (0.1% to 1%): Dizziness

References

1. Wilson KS, Worth A, Richards AG, Ford HS "Low-dose bleomycin lung." Med Pediatr Oncol 10 (1982): 283-8

2. Zucker PK, Khouri NF, Rosenshein NB "Bleomycin-induced pulmonary nodules: a variant of bleomycin pulmonary toxicity." Gynecol Oncol 28 (1987): 284-91

3. Maher J, Daly PA "Severe bleomycin lung toxicity: reversal with high dose corticosteroids." Thorax 48 (1993): 92-4

4. Chisholm RA, Dixon AK, Williams MV, Oliver RTD "Bleomycin lung: the effect of different chemotherapeutic regimens." Cancer Chemother Pharmacol 30 (1992): 158-60

5. "Product Information. Blenoxane (bleomycin)." Bristol-Myers Squibb, Princeton, NJ.

6. Bennett WM, Pastore L, Houghton DC "Fatal pulmonary bleomycin toxicity in cisplatin-induced acute renal failure." Cancer Treat Rep 64 (1980): 921-4

7. Jones AW "Bleomycin lung damage: the pathology and nature of the lesion." Br J Dis Chest 72 (1978): 321-6

8. Brown WG, Hasan FM, Barbee RA "Reversibility of severe bleomycin-induced pneumonitis." JAMA 239 (1978): 2012-4

9. Hartmann LC, Frytak S, Richardson RL, Coles DT, Cupps RE "Life-threatening bleomycin pulmonary toxicity with ultimate reversibility." Chest 98 (1990): 497-9

10. Bechard DE, Fairman RP, DeBlois GG, Via CT "Fatal pulmonary fibrosis from low-dose bleomycin therapy." South Med J 80 (1987): 646-9

11. Sleijfer S "Bleomycin-induced pneumonitis." Chest 120 (2001): 617+

12. Khansur T, Little D, Tavassoli M "Fulminant and fatal angioedema caused by bleomycin treatment." Arch Intern Med 144 (1984): 2267

13. Dalgleish AG, Woods RL, Levi JA "Bleomycin pulmonary toxicity: its relationship to renal dysfunction." Med Pediatr Oncol 12 (1984): 313-7

14. Wolkowicz J, Sturgeon J, Rawji M, Chan CK "Bleomycin-induced pulmonary function abnormalities." Chest 101 (1992): 97-101

15. McLeod BF, Lawrence HJ, Smith DW, Vogt PJ, Gandara DR "Fatal bleomycin toxicity from a low cumulative dose in a patient with renal insufficiency." Cancer 60 (1987): 2617-20

16. Doll DC "Fatal pneumothorax associated with bleomycin-induced pulmonary fibrosis." Cancer Chemother Pharmacol 17 (1986): 294-5

17. Leeser JE, Carr D "Fatal pneumothorax following bleomycin and other cytotoxic drugs." Cancer Treat Rep 69 (1985): 344-5

18. Arseculeratne G, Berroeta L, Meiklejohn D, et al. "Bleomycin-induced "flagellate dermatitis"." Arch Dermatol 143 (2007): 1461-2

19. Kerr LD, Spiera H "Scleroderma in association with the use of bleomycin: a report of 3 cases." J Rheumatol 19 (1992): 294-6

20. "Multum Information Services, Inc. Expert Review Panel"

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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