Risk Summary
There are no adequate and well-controlled studies in pregnant women. There is a limited amount of data from the use of ATGAM in pregnant women. It is also not known whether ATGAM can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. The outcome of pregnancies cannot be determined. Use ATGAM during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcome. 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.
Data
In embryo-fetal toxicity studies, ATGAM was administered to rats and cynomolgus monkeys for 11 and 16 days, respectively during organogenesis. In rats, hypoplastic cervical vertebrae, a finding consistent with delayed skeletal development, were observed in fetuses whose dams received ATGAM at doses of 100 mg/kg/day during organogenesis. In monkey reproduction studies, maternal toxicity (vaginal bleeding, decreased body weight and loss of appetite) was observed with ATGAM doses ≥20 mg/kg/day after 16 days of dosing. Fetal deaths occurred in dams treated with 20 mg/kg/day ATGAM earlier in organogenesis (days 20‑35), but not when treatment was given at a later part of organogenesis (days 35-50). The maternal and fetal deaths were attributed to maternal anemia due to red blood cell antigen that humans do not share. Therefore, this toxicity is not considered relevant to human fetal development.
Risk Summary
It is not known if ATGAM is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in breast-feeding neonates and infants from ATGAM, a decision should be made whether to discontinue breast-feeding or to discontinue the drug taking into account the importance of the drug to the mother.
Data
In animal studies, a single dose of ATGAM up to 40 mg/kg was not detected at the limit of quantification in the milk of lactating cynomolgus monkeys.
Contraception
Females
It is not known if ATGAM can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)]. Advise females of reproductive potential to use effective contraception during treatment with ATGAM and for at least 10 weeks after cessation of therapy.
Males
Advise males with a female partner of reproductive potential to use effective contraception during treatment with ATGAM and for at least 10 weeks after cessation of therapy.
Infertility
In fertility studies, ATGAM at doses 10, 20 and 40 mg/kg/day was administered to cynomolgus monkeys (Macaca fascicularis) for 14 days either before (male monkeys) or before and after (female monkeys) cohabitation with untreated mates. ATGAM treatment was not associated with male or female hormonal or copulation behavior changes. A decrease in fertility index in female monkeys receiving ATGAM was seen. Female toxicity, including death, was observed with ATGAM doses of ≥20 mg/kg/day. While the etiology of this toxicity is uncertain, it may be attributed to hemolytic anemia due to cross-reactivity of ATGAM to a monkey red blood antigen.
Experience with children has been limited. ATGAM has been administered safely to a small number of pediatric renal allograft recipients and pediatric aplastic anemia patients at dosage levels comparable to those in adults.
Clinical experience in a limited number of elderly patients (≥65 years of age) has not identified differences in responses between the elderly and younger patients. Select the dose for an elderly patient with caution, starting at the low end of the dosage range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of comorbidities or other drug therapy in this age group.
Risk Summary
There are no adequate and well-controlled studies in pregnant women. There is a limited amount of data from the use of ATGAM in pregnant women. It is also not known whether ATGAM can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. The outcome of pregnancies cannot be determined. Use ATGAM during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcome. 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.
Data
In embryo-fetal toxicity studies, ATGAM was administered to rats and cynomolgus monkeys for 11 and 16 days, respectively during organogenesis. In rats, hypoplastic cervical vertebrae, a finding consistent with delayed skeletal development, were observed in fetuses whose dams received ATGAM at doses of 100 mg/kg/day during organogenesis. In monkey reproduction studies, maternal toxicity (vaginal bleeding, decreased body weight and loss of appetite) was observed with ATGAM doses ≥20 mg/kg/day after 16 days of dosing. Fetal deaths occurred in dams treated with 20 mg/kg/day ATGAM earlier in organogenesis (days 20‑35), but not when treatment was given at a later part of organogenesis (days 35-50). The maternal and fetal deaths were attributed to maternal anemia due to red blood cell antigen that humans do not share. Therefore, this toxicity is not considered relevant to human fetal development.
Risk Summary
It is not known if ATGAM is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in breast-feeding neonates and infants from ATGAM, a decision should be made whether to discontinue breast-feeding or to discontinue the drug taking into account the importance of the drug to the mother.
Data
In animal studies, a single dose of ATGAM up to 40 mg/kg was not detected at the limit of quantification in the milk of lactating cynomolgus monkeys.
Contraception
Females
It is not known if ATGAM can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)]. Advise females of reproductive potential to use effective contraception during treatment with ATGAM and for at least 10 weeks after cessation of therapy.
Males
Advise males with a female partner of reproductive potential to use effective contraception during treatment with ATGAM and for at least 10 weeks after cessation of therapy.
Infertility
In fertility studies, ATGAM at doses 10, 20 and 40 mg/kg/day was administered to cynomolgus monkeys (Macaca fascicularis) for 14 days either before (male monkeys) or before and after (female monkeys) cohabitation with untreated mates. ATGAM treatment was not associated with male or female hormonal or copulation behavior changes. A decrease in fertility index in female monkeys receiving ATGAM was seen. Female toxicity, including death, was observed with ATGAM doses of ≥20 mg/kg/day. While the etiology of this toxicity is uncertain, it may be attributed to hemolytic anemia due to cross-reactivity of ATGAM to a monkey red blood antigen.
Experience with children has been limited. ATGAM has been administered safely to a small number of pediatric renal allograft recipients and pediatric aplastic anemia patients at dosage levels comparable to those in adults.
Clinical experience in a limited number of elderly patients (≥65 years of age) has not identified differences in responses between the elderly and younger patients. Select the dose for an elderly patient with caution, starting at the low end of the dosage range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of comorbidities or other drug therapy in this age group.
Risk Summary
There are no adequate and well-controlled studies in pregnant women. There is a limited amount of data from the use of ATGAM in pregnant women. It is also not known whether ATGAM can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. The outcome of pregnancies cannot be determined. Use ATGAM during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcome. 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.
Data
In embryo-fetal toxicity studies, ATGAM was administered to rats and cynomolgus monkeys for 11 and 16 days, respectively during organogenesis. In rats, hypoplastic cervical vertebrae, a finding consistent with delayed skeletal development, were observed in fetuses whose dams received ATGAM at doses of 100 mg/kg/day during organogenesis. In monkey reproduction studies, maternal toxicity (vaginal bleeding, decreased body weight and loss of appetite) was observed with ATGAM doses ≥20 mg/kg/day after 16 days of dosing. Fetal deaths occurred in dams treated with 20 mg/kg/day ATGAM earlier in organogenesis (days 20‑35), but not when treatment was given at a later part of organogenesis (days 35-50). The maternal and fetal deaths were attributed to maternal anemia due to red blood cell antigen that humans do not share. Therefore, this toxicity is not considered relevant to human fetal development.
Risk Summary
It is not known if ATGAM is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in breast-feeding neonates and infants from ATGAM, a decision should be made whether to discontinue breast-feeding or to discontinue the drug taking into account the importance of the drug to the mother.
Data
In animal studies, a single dose of ATGAM up to 40 mg/kg was not detected at the limit of quantification in the milk of lactating cynomolgus monkeys.
Contraception
Females
It is not known if ATGAM can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)]. Advise females of reproductive potential to use effective contraception during treatment with ATGAM and for at least 10 weeks after cessation of therapy.
Males
Advise males with a female partner of reproductive potential to use effective contraception during treatment with ATGAM and for at least 10 weeks after cessation of therapy.
Infertility
In fertility studies, ATGAM at doses 10, 20 and 40 mg/kg/day was administered to cynomolgus monkeys (Macaca fascicularis) for 14 days either before (male monkeys) or before and after (female monkeys) cohabitation with untreated mates. ATGAM treatment was not associated with male or female hormonal or copulation behavior changes. A decrease in fertility index in female monkeys receiving ATGAM was seen. Female toxicity, including death, was observed with ATGAM doses of ≥20 mg/kg/day. While the etiology of this toxicity is uncertain, it may be attributed to hemolytic anemia due to cross-reactivity of ATGAM to a monkey red blood antigen.
Experience with children has been limited. ATGAM has been administered safely to a small number of pediatric renal allograft recipients and pediatric aplastic anemia patients at dosage levels comparable to those in adults.
Clinical experience in a limited number of elderly patients (≥65 years of age) has not identified differences in responses between the elderly and younger patients. Select the dose for an elderly patient with caution, starting at the low end of the dosage range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of comorbidities or other drug therapy in this age group.
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