Tibsovo Use In Pregnancy & Lactation

Women of childbearing potential/Contraception: Women of childbearing potential should have a pregnancy test prior to starting treatment with Tibsovo and should avoid becoming pregnant during therapy (see Precautions).
Women of childbearing potential and males with female partners of childbearing potential should use effective contraception during treatment with Tibsovo and for at least 1 month after the last dose.
Ivosidenib may decrease the systemic concentrations of hormonal contraceptives and, therefore, concomitant use of an alternative contraceptive method such as barrier contraceptives is recommended (see Precautions and Interactions).
Pregnancy: There are no adequate data on the use of ivosidenib in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Tibsovo is not recommended for use during pregnancy and in women of childbearing potential not using effective contraception. Patients should be informed of the potential risk to the foetus if it is used during pregnancy or if a patient (or female partner of a treated male patient) becomes pregnant during treatment or during the one-month period after the last dose.
Breast-feeding: It is unknown whether ivosidenib and its metabolites are excreted in human milk. No studies in animals have been conducted to evaluate the excretion of ivosidenib and its metabolites in milk. A risk to the newborns/infants cannot be excluded.
Breast-feeding should be discontinued during treatment with Tibsovo and for at least 1 month after the last dose.
Fertility: There are no human data on the effect of ivosidenib on fertility. No fertility studies in animals have been conducted to evaluate the effect of ivosidenib. Undesirable effects on reproductive organs were observed in a 28-day repeat-dose toxicity study (see Pharmacology: Toxicology: Preclinical safety data under Actions). The clinical relevance of these effects is unknown.