⛔ FDA Black Box Warning
WARNING: CYTOPENIAS, INFUSION-RELATED REACTIONS, AND INFECTIONS WARNING: CYTOPENIAS, INFUSION-RELATED REACTIONS, AND INFECTIONS See full prescribing information for complete boxed warning. Serious, including fatal, cytopenias, infusion-related reactions, and infections can occur (5.1–5.3). Limit doses to 30 mg (single) and 90 mg (cumulative weekly); higher doses increase risk of pancytopenia. ( 2.1 ) Escalate dose gradually and monitor patients during infusion. Withhold therapy for Grade 3 or 4 infusion-related reactions. ( 5.2 ) Administer prophylaxis against Pneumocystis jirovecii pneumonia (PCP) and herpes virus infections. ( 2.2 , 5.3 ) Cytopenias : Serious, including fatal, pancytopenia/marrow hypoplasia, autoimmune idiopathic thrombocytopenia, and autoimmune hemolytic anemia can occur in patients receiving CAMPATH. Single doses of CAMPATH greater than 30 mg or cumulative doses greater than 90 mg per week increase the incidence of pancytopenia [see Warnings and Precautions (5.1) ] . Infusion-Related Reactions : CAMPATH administration can result in serious, including fatal, infusion-related reactions. Carefully monitor patients during infusions and withhold CAMPATH for Grade 3 or 4 infusion-related reactions. Gradually escalate CAMPATH to the recommended dose at the initiation of therapy and after interruption of therapy for 7 or more days [see Dosage and Administration (2.1) and Warnings and Precautions (5.2) ] . Immunosuppression/Infections : Serious, including fatal, bacterial, viral, fungal, and protozoan infections can occur in patients receiving CAMPATH. Administer prophylaxis against Pneumocystis jirovecii pneumonia (PCP) and herpes virus infections [see Dosage and Administration (2.2) and Warnings and Precautions (5.3) ] .
Pregnancy & Breastfeeding
8.1 Pregnancy Risk Summary Based on findings from animal studies, CAMPATH may cause fetal harm when administered to a pregnant woman. Available data from published cohort studies in pregnant women are insufficient to establish a CAMPATH-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Alemtuzumab was embryolethal in pregnant huCD52 transgenic mice when administered during organogenesis (see Data ) . Human IgG antibodies are known to cross the placental barrier; therefore, CAMPATH may be transmitted from the mother to the developing fetus. Advise women of the potential risk to the fetus. Infants born to pregnant women treated with CAMPATH may be at increased risk of infection (see Clinical Considerations ) . The 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 outcomes. 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 Fetal/Neonatal adverse reactions Monoclonal antibodies are transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. Consider the risks and benefits of administering live or live-attenuated vaccines to infants exposed to CAMPATH in utero [see Warnings and Precautions (5.3 , 5.4) ] . Data Animal data When alemtuzumab was administered to pregnant huCD52 transgenic mice during organogenesis (gestation days [GD] 6–10 or GD 11–15) at intravenous doses of 3 or 10 mg/kg, no teratogenic effects were observed. However, there was an increase in embryolethality (increased postimplantation loss and the number of dams with all fetuses dead or resorbed) in pregnant animals dosed during GD 11–15. In a separate study in pregnant huCD52 transgenic mice, administration of alemtuzumab during o