Bleomycin Side Effects

Not all side effects for bleomycin may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to bleomycin: injection powder for solution

In addition to its needed effects, some unwanted effects may be caused by bleomycin. In the event that any of these side effects do occur, they may require 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.

You should check with your doctor immediately if any of these side effects occur when 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)

If any of the following side effects occur while taking bleomycin, check with your doctor or nurse as soon as possible:

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

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

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
  • Changes in fingernails or toenails
  • weight loss

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 taking this drug, it is possible that you may still experience side effects that need medical attention. If you notice any of the following side effects check with your doctor immediately:

  • Cough
  • shortness of breath

For Healthcare Professionals

Applies to bleomycin: injectable powder for injection

Respiratory

Pulmonary toxicity occurs most frequently in patients over 70 years of age and in those receiving over 400 units of total dosage. Patients often present with dry cough, dyspnea, rales, and infiltrate. One case of fatal pulmonary fibrosis has been reported in a patient (with normal renal function) who received a total cumulative dose of only 20 units.

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

The earliest sign and symptom of pulmonary toxicity are fine rales and dyspnea. A specific clinical syndrome has not been defined. Radiographically, the pneumonitis produces nonspecific patchy opacities, usually of the lower lung field. The most common changes in pulmonary function tests are decreases in total lung volume and vital capacity. However, these changes are not predictive of the development of pulmonary fibrosis.

Microscopic tissue changes 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 Hamman-Rich syndrome. These microscopic findings are nonspecific. (Similar changes are seen in radiation pneumonitis and pneumocystic pneumonitis.)[Ref]

Respiratory side effects (10%) are potentially the most serious. The most frequent respiratory presentation has been pneumonitis, which has sometimes progressed to pulmonary fibrosis. Approximately 1% of treated patients have died of pulmonary fibrosis. Two cases of fatal pneumothorax and one case reported of fatal diffuse alveolar injury have also been reported.[Ref]

Dermatologic

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]

Dermatologic side effects including erythema, rash, striae, vesiculation, hyperpigmentation, and skin tenderness are the most frequent (50%) type of side effect. Hyperkeratosis, nail changes, alopecia, and pruritus have also been reported. One case of fatal fulminant angioedema involving the skin and lungs has been reported. A case of bleomycin-induced flagellate dermatitis has also been reported.[Ref]

Gastrointestinal

Relative to other chemotherapeutic agents, bleomycin is felt to have low emetogenic potential.[Ref]

Gastrointestinal side effects have frequently included vomiting, which can generally be controlled with oral phenothiazines. Anorexia and weight loss have also been frequently reported and may persist long after discontinuation of treatment. Mucosal lesions including stomatitis and ulceration of the lips and tongue have been reported rarely.[Ref]

Hypersensitivity

Hypersensitivity side effects have included an idiosyncratic reaction (hypotension, mental confusion, fever, chills, and wheezing) in approximately 1% of lymphoma patients.[Ref]

The reaction may be immediate or delayed for several hours. It usually occurs after the first or second dose. Treatment is symptomatic and can include volume expansion, epinephrine, antihistamines and corticosteroids.

Two known cases have been reported of fatal hyperpyrexia in patients with lymphoma who had previously received bleomycin (without prior hyperpyrexia). One of the patients had previously received multiple doses. There has also been a case report of fatal hyperpyrexia in a patient premedicated with high-dose dexamethasone, to an initial 7.5 mg dose for a poorly differentiated metastatic carcinoma.[Ref]

Cardiovascular

Cardiovascular side effects (myocardial infarction, cerebrovascular accident, thrombotic microangiopathy (HUS)) have been reported rarely (in combination antineoplastic therapy).[Ref]

Other

Other side effects include fever (up to 50%), and chills which have frequently been reported. Cerebral arteritis and Raynaud's phenomenon have also been reported. Three known cases of scleroderma have been reported.[Ref]

Local

Local side effects including pain at the tumor site and phlebitis have been reported infrequently.[Ref]

Oncologic

Oncologic side effects have been reported. Bleomycin has tested positive in the great majority of genetic toxicity assays. These genotoxic effects are similar to those induced by ionizing radiation.[Ref]

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

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

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

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

6. 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

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

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

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

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

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

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

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

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

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

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

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

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

19. Rosenfelt F, Palmer J, Weinstein I, Rosenbloom B "A fatal hyperpyrexial response to bleomycin following prior therapy: a case report and literature review." Yale J Biol Med 55 (1982): 529-31

20. Carter JJ, McLaughlin ML, Bern MM "Bleomycin-induced fatal hyperpyrexia." Am J Med 74 (1983): 523-5

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

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

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