Nipent Side Effects

Generic Name: pentostatin

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

Side Effects of Nipent - for the Consumer

Nipent

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Nipent:

Diarrhea; fatigue; headache; loss of appetite; muscle pain; nausea; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Nipent:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chills; cough; eye pain or changes in vision; fever; hoarseness; itching; pain, redness, or swelling at the injection site; sore throat; sores on the mouth or lips; unusual bruising or bleeding; unusual tiredness or weakness

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Nipent Side Effects - for the Professional

Nipent

Most patients treated for hairy cell leukemia in the five NCI-sponsored Phase 2 studies and the Phase 3 SWOG study experienced an adverse event. The following table lists the most frequently occurring adverse events in patients treated with Nipent (both frontline and IFN-refractory patients) compared with IFN (frontline only), regardless of drug association. The drug association of some adverse events is uncertain as they may be associated with the disease itself (eg, infection, hematologic suppression), but other events, such as the gastrointestinal symptoms, rashes, and abnormal liver function tests, can in many cases be attributed to the drug. Most adverse events that were assessed for severity were either mild or moderate, and diminished in frequency with continued therapy.

	Percent of Patients
All Adverse Eventsa	Frontline,	Frontline,	IFN-Refractory,
	Treated	Treated	Treated With
	With Nipent	With IFN	Nipent
	N=180	N=176	N=197
Nausea and/or Vomiting	63	22	53b
Fever	46	59	42
Rash	43	30	26
Fatigue	42	55	29
Leukopenia	22	15	60
Pruritus	21	6	10
Coughing/Increased Cough	20	15	17
Myalgia	19	36	11
Chills	19	34	11
Headache	17	29	13
Diarrhea	17	17	15
Abdominal Pain	16	15	4
Anorexia	13	10	16
Upper Respiratory Infection	13	8	16
Asthenia	12	13	10
Stomatitis	12	7	5
Rhinitis	11	15	10
Dyspnea	11	13	8
Anemia	8	5	35
Pain	8	19	20
Pharyngitis	8	11	10
Sweating/Increased Sweating	8	21	10
Viral Infection	8	17	NR
Infection	7c	2c	36
Arthralgia	6	14	3
Thrombocytopenia	6	6	32
Skin Disorder	4	5	17
Allergic Reaction	2	1	11
Hepatic Disorder/Elevated Liver Function Testsd	2	2	19
Neurologic Disorder, CNS/CNS Toxicity	1	NR	11
Lung Disorder/Disease	NR	1	12
Nausea	NR	NR	22
Genitourinary Disorder	NR	NR	15

NR = Not Reported

a Occurring in more than 10% of patients, in any group, regardless of drug association

b Includes only nausea with vomiting

c These figures represent only unspecified infections. Refer to infection table.

d Elevated liver enzymes and liver disorder for SWOG

The total incidence for all types of infections is considerably higher for both treatment groups in the SWOG 8691 study than is listed in the table above. An intent-to-treat analysis of infections found that 38% of patients treated with Nipent and 34% of patients treated with IFN averaged 2.4 and 1.9 documented infections during treatment, respectively. The following table lists the different types of infections that were reported as adverse events during the initial phase of the SWOG study. There were no apparent differences in the types of infection between the 2 treatment groups, with the possible exception of herpes zoster which was reported more frequently for Nipent (8%) than for IFN (1%).

	Percent of Patients
Type of Infection	Frontline, Treated	Frontline, Treated
	With Nipent	With IFN
	N=180	N=176
Upper Respiratory Infection	13	8
Rhinitis	11	15
Herpes Zoster	8	1
Pharyngitis	8	11
Viral Infection	8	17
Infection (Unspecified)	7	2
Sinusitis	6	4
Cellulitis	6	3
Bacterial Infection	5	4
Pneumonia	5	7
Conjunctivitis	4	2
Furunculosis	4	<1
Herpes Simplex	4	1
Bronchitis	3	2
Sepsis	3	2
Urinary Tract Infection	3	3
Abscess, Skin	2	4
Moniliasis, Oral	2	<1
Mycotic Infection, Skin	<1	3
Osteomyelitis	1	0

The drug relatedness of the adverse events listed below cannot be excluded. The following adverse events occurred in 3% to 10% of Nipent-treated patients in the initial phase of the SWOG study:

Body as a Whole—Chest Pain, Death, Face Edema, Peripheral Edema

Cardiovascular System—Hemorrhage, Hypotension

Digestive System—Dental Abnormalities, Dyspepsia, Flatulence, Gingivitis

Hemic and Lymphatic System—Agranulocytosis

Laboratory Deviations—Elevated Creatinine

Musculoskeletal System—Arthralgia

Nervous System—Confusion, Dizziness, Insomnia, Paresthesia, Somnolence

Psychobiologic Function—Anxiety, Depression, Nervousness

Respiratory System—Asthma

Skin & Appendages—Skin Dry, Urticaria

The remaining adverse events which occurred in less than 3% of Nipent-treated patients during the initial phase of the SWOG study:

Body as a Whole—Flu-like Symptoms, Hangover Effect, Neoplasm

Cardiovascular System—Angina Pectoris, Arrhythmia, A-V Block, Bradycardia, Extrasystoles Ventricular, Heart Arrest, Heart Failure, Hypertension, Pericardial Effusion, Phlebitis, Pulmonary Embolus, Sinus Arrest, Tachycardia, Thrombophlebitis Deep, Vasculitis

Digestive System—Constipation, Dysphagia, Glossitis, Ileus

Hemic and Lymphatic System—Acute Leukemia, Anemia-Hemolytic, Aplastic Anemia

Laboratory Deviations—Hypercalcemia, Hyponatremia

Musculoskeletal System—Arthritis, Gout

Nervous System—Amnesia, Ataxia, Convulsions, Dreaming Abnormal, Dysarthria, Encephalitis, Hyperkinesia, Meningism, Neuralgia, Neuritis, Neuropathy, Paralysis, Syncope, Twitching, Vertigo

Psychobiologic Function—Decrease/Loss Libido, Emotional Lability, Hallucination, Hostility, Neurosis, Thinking Abnormal

Respiratory System—Bronchospasm, Larynx Edema

Skin and Appendages—Acne, Alopecia, Eczema, Petechial Rash, Photosensitivity Reaction

Special Senses—Amblyopia, Deafness, Earache, Eyes Dry, Labyrinthitis, Lacrimation Disorder, Nonreactive Eye, Photophobia, Retinopathy, Tinnitus, Unusual Taste, Vision Abnormal, Watery Eyes

Urogenital System—Amenorrhea, Breast Lump, Impotence, Kidney Function Abnormal, Nephropathy, Renal Failure, Renal Insufficiency, Renal Stone

One patient with hairy cell leukemia treated with Nipent during another clinical study developed unilateral uveitis with vision loss.

Nineteen (5%) patients withdrew from the Phase 3 SWOG 8691 study because of adverse events; 9 during initial Nipent treatment, 4 during Nipent crossover, 5 during initial IFN treatment, and 1 during both initial IFN treatment and Nipent crossover. In the Phase 2 studies in IFN-refractory hairy cell leukemia, 11% of patients withdrew from treatment with Nipent due to an adverse event.

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Side Effects by Body System - for Healthcare Professionals

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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