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.

OVERDOSAGE
No specific antidote for NIPENT overdose is known. NIPENT administered at higher doses (20- 50 mg/m2 in divided doses over 5 days) than recommended was associated with deaths due to severe renal, hepatic, pulmonary, and CNS toxicity. In case of overdose, management would include general supportive measures through any period of toxicity that occurs.

DOSAGE AND ADMINISTRATION
It is recommended that patients receive hydration with 500 to 1,000 mL of 5% Dextrose in 0.5 Normal Saline or equivalent before NIPENT administration. An additional 500 mL of 5% Dextrose or equivalent should be administered after NIPENT is given.

The recommended dosage of NIPENT for the treatment of hairy cell leukemia is 4 mg/m2 every other week. NIPENT may be administered intravenously by bolus injection or