Evrysdi

Evrysdi Use In Pregnancy & Lactation

Manufacturer:

Roche

Distributor:

DKSH

Marketer:

Roche
Full Prescribing Info
Use In Pregnancy & Lactation
Patients of reproductive potential: Contraception in male and female patients: Male and female patients of reproductive potential should adhere to the following contraception requirements: Female patients of childbearing potential should use highly effective contraception during treatment and for at least 1 month after the last dose.
Male patients, with female partners of childbearing potential, should both use highly effective contraception during treatment and for at least 4 months after his last dose.
Pregnancy testing: The pregnancy status of female patients of reproductive potential should be verified prior to initiating Evrysdi therapy. Pregnant women should be clearly advised of the potential risk to the foetus.
Pregnancy: There are no data from the use of Evrysdi in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Evrysdi is not recommended during pregnancy and in women of childbearing potential not using contraception (see Precautions).
Breast-feeding: It is not known whether risdiplam is excreted in human breast milk. Studies in rats show that risdiplam is excreted into milk (see Pharmacology: Toxicology: Preclinical safety data under Actions). As the potential for harm to the breastfed infant is unknown, it is recommended not to breastfeed during treatment.
Fertility: Male patients: Male fertility may be compromised while on treatment, based on nonclinical findings. In rat and monkey reproductive organs, sperm degeneration and reduced sperm numbers were observed (see Pharmacology: Toxicology: Preclinical safety data under Actions). Based on observations from animal studies, the effects on sperm cells are expected to be reversible upon discontinuation of risdiplam.
Male patients may consider sperm preservation prior to treatment initiation or after a treatment-free period of at least 4 months. Male patients who wish to father a child should stop treatment for a minimum of 4 months. Treatment may be re-started after conception.
Female patients: Based on nonclinical data (see Pharmacology: Toxicology: Preclinical safety data under Actions), an impact of risdiplam on female fertility is not expected.
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