|
f gestation. Drug-related maternal toxicity occurred at doses of 0.1 and 0.75 mg/kg/day (0.6 and 4.5 mg/m 2 ). Teratogenic effects were observed at 0.75 mg/kg/day (4.5 mg/m 2 ) manifested by increased incidence of various skeletal malformations. In a dose range-finding study, pentostatin was administered intravenously to rats at doses of 0, 0.05, 0.1, 0.5, 0.75, or 1 mg/kg/day (0, 0.3, 0.6, 3, 4.5, 6 mg/m 2 ) on days 6 through 15 of gestation. Fetal malformations that were observed were an omphalocele at 0.05 mg/kg (0.3 mg/m 2 ), gastroschisis at 0.75 mg/kg and 1 mg/kg (4.5 and 6 mg/m 2 ), and a flexure defect of the hindlimbs at 0.75 mg/kg (4.5 mg/m 2 ). Pentostatin was also shown to be teratogenic in mice when administered as a single 2 mg/kg (6 mg/m 2 ) intraperitoneal injection on day 7 of gestation. Pentostatin was not teratogenic in rabbits when administered intravenously on days 6 through 18 of gestation at doses of 0, 0.005, 0.01, or 0.02 mg/kg/day (0, 0.015, 0.03, or 0.06 mg/m 2 ); however, maternal toxicity, abortions, early deliveries, and deaths occurred in all drug-treated groups. There are no adequate and well-controlled studies in pregnant women. If NIPENT is used during pregnancy, or if the patient becomes pregnant while taking (receiving) this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential receiving NIPENT should be advised to avoid becoming pregnant.
|
Type of Infection
|
Percent of Patients |
|
Frontline,
Treated
With NIPENT
N=180
|
Frontline,
Treated
With IFN
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
|
|
|
