Lorviqua Use In Pregnancy & Lactation

Women of childbearing potential/Contraception in males and females: Women of childbearing potential should be advised to avoid becoming pregnant while receiving lorlatinib. A highly effective non-hormonal method of contraception is required for female patients during treatment with lorlatinib, because lorlatinib can render hormonal contraceptives ineffective (see Precautions and Interactions). If a hormonal method of contraception is unavoidable, then a condom must be used in combination with the hormonal method. Effective contraception must be continued for at least 35 days after completing therapy.
During treatment with lorlatinib and for at least 14 weeks after the final dose, male patients with female partners of childbearing potential must use effective contraception, including a condom, and male patients with pregnant partners must use condoms.
Pregnancy: Studies in animals have shown embryo-foetal toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). There are no data from the use of lorlatinib in pregnant women. Lorlatinib may cause foetal harm when administered to a pregnant woman.
Lorlatinib is not recommended during pregnancy or for women of childbearing potential not using contraception.
Breast-feeding: It is unknown whether lorlatinib and its metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded.
Lorlatinib should not be used during breast-feeding. Breast-feeding should be discontinued during treatment with lorlatinib and for 7 days after the final dose.
Fertility: Based on non-clinical safety findings, male fertility may be compromised during treatment with lorlatinib (see Pharmacology: Toxicology: Preclinical safety data under Actions). It is not known whether lorlatinib affects female fertility. Men should seek advice on effective fertility preservation before treatment.