Nipent Side Effects

Generic name: pentostatin

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

Some side effects of Nipent may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to pentostatin: intravenous powder for injection

Get emergency medical help if you have any of these signs of an allergic reaction while taking pentostatin (the active ingredient contained in Nipent) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• fever, swollen glands, cold or flu symptoms, blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;

• pale skin, weakness, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• swelling, rapid weight gain, little or no urinating, pain in your side or lower back;

• red or pink urine;

• skin sores, severe skin rash;

• anxiety, sweating, severe shortness of breath, wheezing, gasping for breath, chest pain, fast or uneven heart rate;

• cough with foamy mucus, cough with yellow or green mucus;

• eye pain, vision problems; or

• numbness, tingling, or burning pain.

Common side effects may include:

• loss of appetite, nausea, vomiting;

• constipation, diarrhea;

• joint or muscle pain;

• headache, dizziness, drowsiness, depressed mood; or

• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to pentostatin: intravenous powder for injection

Hematologic

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

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.

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.

General

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.

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.

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.

Hepatic

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

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

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.

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.

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.

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.

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.

Hypersensitivity

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

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.

One study reported keratoconjunctivitis in four of 50 patients.

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.

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.

Metabolic

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

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