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paricalcitol injection Use in Specific Populations

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Limited data with Paricalcitol Injection in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with chronic kidney disease in pregnancy (see Clinical Considerations).

In animal reproduction studies, slightly increased embryofetal loss was observed in pregnant rats and rabbits administered another paricalcitol product intravenously during the period of organogenesis at doses 2 and 0.5 times, respectively, a human dose of 14 mcg (equivalent to 0.24 mcg/kg), based on body surface area (mg/m2). Adverse reproductive outcomes were observed at doses that caused maternal toxicity (see Data).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations

Disease-Associated Maternal and/or Embryo/Fetal Risk

Chronic kidney disease in pregnancy increases the risk for maternal hypertension and preeclampsia, miscarriage, preterm delivery, polyhydramnios, still birth, and low birth weight infants.

Data

Animal Data

Pregnant rats and rabbits were treated with another paricalcitol product by once-daily intravenous injection during the period of organogenesis (in rats, from gestation day [GD] 6 to 17; in rabbits, from GD 6 to 18). Rats were dosed at 0, 0.3, 1, or 3 mcg/kg/day and rabbits at 0, 0.03, 0.1, or 0.3 mcg/kg/day, representing up to 2 or 0.5 times, respectively, a human dose of 0.24 mcg/kg, based on body surface area (mg/m2). Slightly decreased fetal viability was observed in both studies at the highest doses representing 2 and 0.5 times, respectively, a human dose of 0.24 mcg/kg, in the presence of maternal toxicity (decreased body weight and food consumption). Pregnant rats were administered another paricalcitol product by intravenous injection 3 times per week at doses of 0, 0.3, 3, or 20 mcg/kg/day throughout gestation, parturition, and lactation (GD 6 to lactation day [LD] 20) representing exposures up to 13 times a human dose of 0.24 mcg/kg. A small increase in stillbirths and pup deaths from parturition to LD 4 were observed at the high dose when compared to the control group (9.2% versus 3.3% in controls) at 13 times a human dose of 0.24 mcg/kg, which occurred at a maternally toxic dose known to cause hypercalcemia in rats. Surviving pups were not adversely affected; body weight gains, developmental landmarks, reflex ontogeny, learning indices, and locomotor activity were all within normal parameters. F1 reproductive capacity was unaffected.

8.2 Lactation

Risk Summary

There is no information available on the presence of paricalcitol in human milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production. Studies in rats have shown that paricalcitol and/or its metabolites are present in the milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk (see Data). Infants exposed to Paricalcitol Injection through breast milk should be monitored for signs and symptoms of hypercalcemia (see Clinical Considerations). The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Paricalcitol Injection and any potential adverse effects on the breastfed child from Paricalcitol Injection or from the underlying maternal condition.

Clinical Considerations

Infants exposed to Paricalcitol Injection through breast milk should be monitored for signs and symptoms of hypercalcemia, including seizures, vomiting, constipation, and weight loss. Monitoring of serum calcium in the infant should be considered.

Data

Following a single oral administration of 20 mcg/kg of radioactive [3H] paricalcitol to lactating rats, the concentrations of total radioactivity was determined. Lower levels of total radioactivity were present in the milk compared to that in the plasma of the dams indicating that low levels of [3H] paricalcitol and/or its metabolites are secreted into milk. Exposure of the pups to [3H] paricalcitol through milk was confirmed by the presence of radioactive material in the pups' stomachs.

8.4 Pediatric Use

The safety and efficacy of Paricalcitol Injection for the prevention and treatment of secondary hyperparathyroidism associated with CKD have been established in pediatric patients 5 years of age and older with CKD on dialysis. Use of Paricalcitol Injection in pediatric patients 5 years of age and older is supported by evidence from an adequate and well-controlled study with another paricalcitol product in 29 patients, 5 to 19 years of age, with CKD on hemodialysis [see Clinical Studies (14)].

The safety and efficacy of Paricalcitol Injection have not been established in pediatric patients less than 5 years old.

8.5 Geriatric Use

Clinical studies of paricalcitol injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

8.6 Hepatic Impairment

The pharmacokinetics of paricalcitol were studied in patients with mild and moderate hepatic impairment and were similar to that of patients with normal hepatic function. No dose adjustment is required in patients with mild or moderate hepatic function.

Paricalcitol Injection has not been studied in patients with severe hepatic impairment.

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