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Pentostatin Side Effects

In Summary

Commonly reported side effects of pentostatin include: skin rash. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to pentostatin: intravenous powder for solution

Along with its needed effects, pentostatin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Along with its needed effects, pentostatin may cause some unwanted effects. Some side effects will have signs or symptoms that you can see or feel. Your doctor may watch for others by doing certain tests.

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. Discuss these possible effects with your doctor.

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

More Common

  • Cough or hoarseness
  • fever or chills
  • lower back or side pain
  • pain
  • painful or difficult urination
  • skin rash or itching (sudden)
  • unusual tiredness or weakness

Less Common

  • Anxiety or nervousness
  • black, tarry stools
  • blood in the urine or stools
  • changes in vision
  • chest pain
  • confusion
  • cramps in lower legs
  • mental depression
  • nosebleed
  • numbness or tingling of the hands or feet
  • pinpoint red spots on the skin
  • shortness of breath
  • sleepiness
  • sore, red eyes
  • sores in the mouth or on the lips
  • stomach pain
  • swelling of the feet or lower legs
  • trouble with sleeping
  • unusual bleeding or bruising

Some side effects of pentostatin 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

Less Common

For Healthcare Professionals

Applies to pentostatin: intravenous powder for injection

Hematologic

One study reported life-threatening neutropenia in 35 of 50 patients.[Ref]

Hematologic side effects including leukopenia (60%), anemia, (35%), and thrombocytopenia (32%) have been reported. Ecchymosis, lymphadenopathy, and petechiae have been reported in 3% to 10% of patients. Abnormal erythrocytes, leukocytosis, pancytopenia, purpura, splenomegaly, eosinophilia, hematologic disorders, hemolysis, lymphoma-like reactions, and thrombocythemia have been reported in less than 3% of patients.[Ref]

Gastrointestinal

Gastrointestinal side effects including nausea with vomiting (50% to 53%), nausea (22%), anorexia (16%), diarrhea (15%), and vomiting (9%) have been reported. Constipation, flatulence, and stomatitis have also been reported in 3% to 10% of patients. Colitis, dysphagia, eructation, gastritis, gastrointestinal hemorrhage, gum hemorrhage, hepatitis, hepatomegaly, intestinal obstruction, jaundice, leukoplakia, melena, periodontal abscess, proctitis, abnormal stools, dyspepsia, esophagitis, gingivitis, hepatic failure, and mouth disorders have been reported in less than 3% of patients.[Ref]

General

According to the manufacturer, 11% of patients were withdrawn from treatment due to adverse events which primarily included hematologic toxicity, infection, and rash or pruritus.[Ref]

General side effects including fever (42%), infection (36%), fatigue (29%), pain (20%), increased cough (17%), headache (13%), myalgia (11%), chills (11%), asthenia (10%), sweating (10%), and malaise (9%) have been reported. Death, sepsis, chest pain, abdominal pain, back pain, flu syndrome, and neoplasm have been reported in 3% to 10% of patients. Abscess, enlarged abdomen, ascites, cellulitis, cyst, face edema, fibrosis, granuloma, hernia, injection-site hemorrhage, injection-site inflammation, moniliasis, neck rigidity, pelvic pain, photosensitivity reaction, anaphylactic reaction, immune system disorder, mucous membrane disorder, and neck pain have been reported in less than 3% of patients.[Ref]

Dermatologic

Dermatologic side effects including rash (26%) and skin disorder (17%) have been reported. Eczema, dry skin, herpes simplex, herpes zoster, macropapular rash, pruritus, seborrhea, skin discoloration, sweating, and vesiculobullous rash have been reported in 3% to 10% of patients. Acne, alopecia, contact dermatitis, exfoliative dermatitis, fungal dermatitis, psoriasis, benign skin neoplasm, subcutaneous nodule, skin hypertrophy, and urticaria have been reported in less than 3% of patients.[Ref]

Hepatic

One study reported severe liver toxicity in two of 50 patients.[Ref]

Hepatic side effects including hepatic disorders and/or elevated LFTs (19%) have been reported.[Ref]

Genitourinary

Genitourinary side effects (15%) have been reported. Hematuria and dysuria, increased BUN, and increased creatinine have been reported in 3% to 10% of patients. Albuminuria, fibrocystic breast, glycosuria, gynecomastia, hydronephrosis, kidney failure, oliguria, polyuria, pyuria, toxic nephropathy, urinary frequency, urinary retention, urinary tract infection, urinary urgency, impaired urination, urolithiasis, and vaginitis have been reported in less than 3% of patients.[Ref]

Respiratory

Respiratory side effects including upper respiratory infection (16%) and lung disorders (12%) have been reported. Pharyngitis, pneumonia, rhinitis, bronchitis, dyspnea, epistaxis, lung edema, and sinusitis have been reported in 3% to 10% of patients. Asthma, atelectasis, hemoptysis, hyperventilation, hypoventilation, laryngitis, larynx edema, lung fibrosis, pleural effusion, pneumothorax, pulmonary embolus, and increased sputum have been reported in less than 3% of patients.[Ref]

Nervous system

Nervous system side effects (11%) have been reported. Death following the onset of progressive neuropathy has been reported in one patient. Anxiety, confusion, depression, dizziness, insomnia, nervousness, paresthesia, somnolence, and abnormal thinking have also been reported in 3% to 10% of patients. Agitation, amnesia, apathy, ataxia, central nervous system depression, coma, convulsions, abnormal dreams, depersonalization, emotional lability, facial paralysis, abnormal gait, hyperesthesia, hypoesthesia, hypertonia, incoordination, decreased libido, neuropathy, postural dizziness, decreased reflexes, stupor, tremor, and vertigo have been reported in less than 3% of patients.[Ref]

Cardiovascular

During a 4 year period including over 1,100 patients, eleven patients had significant cardiac events as their major toxicity. The events recorded could be grouped into three categories: 1) angina and myocardial infarction, 2) congestive heart failure and 3) acute arrhythmias. All eleven patients were over 59 years of age. Ten of the eleven patients were males.[Ref]

Cardiovascular side effects including arrhythmia, abnormal electrocardiogram, thrombophlebitis, and hemorrhage have been reported in 3% to 10% of patients. Aortic stenosis, arterial anomaly, cardiomegaly, congestive heart failure, flushing, cardiac arrest, hypertension, myocardial infarct, palpitation, shock, and varicose veins have been reported in less than 3% of patients.[Ref]

Hypersensitivity

Hypersensitivity side effects including allergic reactions (11%) have been reported.[Ref]

Ocular

Ocular side effects including abnormal vision, conjunctivitis and eye pain have been reported in 3% to 10% of patients. Blepharitis, cataract, diplopia, exophthalmos, lacrimation disorder, optic neuritis and retinal detachment have been reported in less than 3% of patients. One patient developed unilateral uveitis with loss of vision.[Ref]

One study reported keratoconjunctivitis in four of 50 patients.[Ref]

Musculoskeletal

Musculoskeletal side effects including arthralgia have been reported. Arthritis, bone pain, osteomyelitis, and pathological fractures have been reported in less than 3% of patients.[Ref]

Other

Other side effects including ear pain have been reported. Peripheral edema, weight loss, and increased lactate dehydrogenase (LDH) have been reported in 3% to 10% of patients. Deafness, otitis media parosmia, taste perversion, tinnitus, acidosis, increased creatine phosphokinase, dehydration, diabetes mellitus, increased gamma globulins, gout, abnormal healing, hypercholesterolemia, weight gain, and hyponatremia have been reported in less than 3% of patients.[Ref]

Metabolic

Metabolic side effects including a case of possible pentostatin-induced symptomatic hyponatremia have been reported.[Ref]

References

1. "Product Information. Nipent (pentostatin)." Parke-Davis, Morris Plains, NJ.

2. Cheson BD "Infectious and immunosuppressive complications of purine analog therapy." J Clin Oncol 13 (1995): 2431-48

3. Kraut EH, Neff JC, Bouroncle BA, Gochnour D, Grever MR "Immunosuppressive effects of pentostatin." J Clin Oncol 8 (1990): 848-55

4. Sorensen JM, Chun HG, Vena D, Fallavollita A, Cheson BD "PENTOSTATIN (DCF) THERAPY FOR HAIRY CELL LEUKEMIA (HCL): UPDATE OF A GROUP C PROTOCOL OF 208 PATIENTS (PTS) WHO HAVE FAILED INTERFERON ALPHA (IFNA) (MEETING ABSTRACT)." Proc Annu Meet Am Soc Clin Oncol 10 (1991): a7871991

5. Cassileth PA, Cheuvart B, Spiers AS, Harrington DP, Cummings FJ, Neiman RS, Bennett JM, O'Connell MJ "Pentostatin induces durable remissions in hairy cell leukemia." J Clin Oncol 9 (1991): 243-6

6. Grem JL, King SA, Chun HG, Grever MR "Cardiac complications observed in elderly patients following 2'- deoxycoformycin therapy." Am J Hematol 38 (1991): 245-7

7. Bruno JJ, Canada TW "Possible pentostatin-induced symptomatic hyponatremia." Pharmacotherapy 27 (2007): 164-9

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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