Impairment of Fertility: No fertility studies have been conducted in animals; however, in a 5-day intravenous toxicity study in dogs, mild seminiferous tubular degeneration was observed with doses of 1 and 4 mg/kg. The possible adverse effects on fertility in humans have not been determined.

Pregnancy
Pregnancy Category D: (See WARNINGS)

Nursing Mothers
It is not known whether NIPENT is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from pentostatin, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of NIPENT to the mother.

Pediatric Use
Safety and effectiveness in children or adolescents have not been established.

ADVERSE REACTIONS
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 Swe