NEW
Nubeqa

Nubeqa Use In Pregnancy & Lactation

Manufacturer:

Bayer

Distributor:

Zuellig
Full Prescribing Info
Use In Pregnancy & Lactation
This medicinal product is not indicated in women of childbearing potential. It is not to be used in women who are, or may be, pregnant or breast-feeding (see Indications/Uses and Contraindications).
Women of childbearing potential / contraception in males and females: It is not known whether darolutamide or its metabolites are present in semen. If the patient is engaged in sexual activity with a woman of childbearing potential, a highly effective contraceptive method (<1% failure rate per year) should be used during and for 1 week after completion of treatment with NUBEQA to prevent pregnancy.
Pregnancy: Based on its mechanism of action, darolutamide may cause foetal harm. No non-clinical reproductive toxicity studies have been conducted (see Pharmacology: Toxicology: Preclinical safety data under Actions).
It is not known whether darolutamide or its metabolites are present in semen. If the patient is engaged in sexual activity with a pregnant woman, a condom should be used during and for 1 week after completion of treatment with NUBEQA. Exposure of the foetus to an androgen receptor inhibitor through seminal transfer to the pregnant woman has to be avoided, as this could affect development of the foetus.
Breast-feeding: It is unknown whether darolutamide or its metabolites are excreted in human milk. No studies in animals have been conducted to evaluate the excretion of darolutamide or its metabolites into milk (see Pharmacology: Toxicology: Preclinical safety data under Actions). A risk to the breast-fed child cannot be excluded.
Fertility: There are no human data on the effect of darolutamide on fertility.
Based on animal studies, NUBEQA may impair fertility in males of reproductive potential (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $768 a year.
Sign up for free
Already a member? Sign in