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Pharmacology of Monoclonal Antibodies and Gepants
Eili Tranheim Kase, PhD, Associate Professor, Department of Pharmacy, University of Oslo.
Anti-CGRP monoclonal antibodies probably cross the placenta but there is no evidence of harm in humans as a result; levels in breast milk are very low, especially after one week. There are no data on human exposure to gepants during pregnancy but animal studies at doses comparable with clinical doses suggest any risk is low.
References
- Pham-Huy A, Sadarangani M, Huang V, et al. From mother to baby: antenatal exposure to monoclonal antibody biologics. Expert Rev Clin Immunol. 2019;15:221-229.
- Gisbert JP, Chaparro M. Safety of new biologics (vedolizumab and ustekinumab) and small molecules (tofacitinib) during pregnancy: a review. Drugs. 2020l;80:1085-1100.
- Bussiere JL, Davies R, Dean C, et al. Nonclinical safety evaluation of erenumab, a CGRP receptor inhibitor for the prevention of migraine. Regul Toxicol Pharmacol. 2019;106:224-238.
- Cohen-Barak O, Weiss S, Rasamoelisolo M, et al. A phase 1 study to assess the pharmacokinetics, safety, and tolerability of fremanezumab doses (225 mg, 675 mg and 900 mg) in Japanese and Caucasian healthy subjects. Cephalalgia. 2018;38:1960-1971.
- Do TP, Guo S, Ashina M. Therapeutic novelties in migraine: new drugs, new hope? J Headache Pain. 2019;20:37. doi: 10.1186/s10194-019-0974-3.
- de Vries T, Villalón CM, MaassenVanDenBrink A. Pharmacological treatment of migraine: CGRP and 5-HT beyond the triptans. Pharmacol Ther. 2020;211:107528. doi: 10.1016/j. pharmthera.2020.107528.
- Palmeira P, Quinello C, Silveira-Lessa AL, et al. IgG placental transfer in healthy and pathological pregnancies. Clin Dev Immunol. 2012;2012:985646. doi: 10.1155/2012/985646.
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By TEVAEili Tranheim Kase, PhD, Associate Professor, Department of Pharmacy, University of Oslo.
Anti-CGRP monoclonal antibodies probably cross the placenta but there is no evidence of harm in humans as a result; levels in breast milk are very low, especially after one week. There are no data on human exposure to gepants during pregnancy but animal studies at doses comparable with clinical doses suggest any risk is low.
References
- Pham-Huy A, Sadarangani M, Huang V, et al. From mother to baby: antenatal exposure to monoclonal antibody biologics. Expert Rev Clin Immunol. 2019;15:221-229.
- Gisbert JP, Chaparro M. Safety of new biologics (vedolizumab and ustekinumab) and small molecules (tofacitinib) during pregnancy: a review. Drugs. 2020l;80:1085-1100.
- Bussiere JL, Davies R, Dean C, et al. Nonclinical safety evaluation of erenumab, a CGRP receptor inhibitor for the prevention of migraine. Regul Toxicol Pharmacol. 2019;106:224-238.
- Cohen-Barak O, Weiss S, Rasamoelisolo M, et al. A phase 1 study to assess the pharmacokinetics, safety, and tolerability of fremanezumab doses (225 mg, 675 mg and 900 mg) in Japanese and Caucasian healthy subjects. Cephalalgia. 2018;38:1960-1971.
- Do TP, Guo S, Ashina M. Therapeutic novelties in migraine: new drugs, new hope? J Headache Pain. 2019;20:37. doi: 10.1186/s10194-019-0974-3.
- de Vries T, Villalón CM, MaassenVanDenBrink A. Pharmacological treatment of migraine: CGRP and 5-HT beyond the triptans. Pharmacol Ther. 2020;211:107528. doi: 10.1016/j. pharmthera.2020.107528.
- Palmeira P, Quinello C, Silveira-Lessa AL, et al. IgG placental transfer in healthy and pathological pregnancies. Clin Dev Immunol. 2012;2012:985646. doi: 10.1155/2012/985646.