Semaglutide Pregnancy and Breastfeeding Warnings

Brand names: Ozempic, Rybelsus, Wegovy

Semaglutide Pregnancy Warnings

Benefit should outweigh risk

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned

Risk summary: Available data are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other maternal or fetal outcomes; based on animal data, there may be potential risks to the fetus from exposure during pregnancy. Additionally weight loss offers no benefit to a pregnant patient and may cause fetal harm.

Comments:
-Poorly controlled diabetes during pregnancy is associated with both maternal and fetal risks.
-When pregnancy is recognized for a women on Wegovy, this drug should be discontinued and the patient should be advised of the risk to a fetus.
-Women of childbearing potential should be encouraged to use contraception during therapy; if pregnancy is desired, stop treatment at least 2 months prior to a planned pregnancy due to its long washout period.
-A pregnancy registry has been created to monitor pregnancy outcomes in women exposed to semaglutide (Wegovy) during pregnancy; pregnant women exposed to Wegovy and healthcare providers are encourage to contact Novo Nordisk at 1-800-727-6500.

Studies in pregnant rats have shown embryofoetal mortality, structural abnormalities, and alterations to growth when administered during organogenesis at maternal exposures below the maximum recommended human dose (MRHD). Early pregnancy losses and structural abnormalities were observed in rabbits at doses below the MRHD. In cynomolgus monkeys, early pregnancy losses and structural abnormalities were observed at exposures of 10-fold or higher that of the MRHD. In rabbits and monkeys, these finding coincided with marked maternal body weight loss. Salcaprozate sodium (SNAC), an absorption enhancer in the oral tablet has been shown to cross the placenta and reach fetal tissue in rats. Administration of SNAC to pregnant rats has shown an increase in number of stillbirths and a decrease in pup viability. There are no adequate and well-controlled studies in pregnant women.

Clinical considerations:
-Poorly controlled diabetes during pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, stillbirth and delivery complications and increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. In the US, the estimated background risk of major birth defects in women with pregestational diabetes with an HbA1c greater than 7 is 6% to 10%; in women with pregestational diabetes and a HbA1c greater than 10, this risk has been reported as 20% to 25%.
-Appropriate weight gain based on pre-pregnancy weight is recommended for all pregnant patients because of the obligatory weight gain that occurs in maternal tissues during pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Semaglutide Breastfeeding Warnings

Oral Administration: Not recommended
Subcutaneous Administration: Benefit should outweigh risk

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-Oral tablets: Breastfeeding is not recommended with maternal use of the oral tablet due to the possible accumulation of the absorption enhancer (salcaprozate sodium) in breastfed infant; if therapy is necessary, the subcutaneous injection should be used.
-Subcutaneous injection: The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need and any potential adverse effects on the breastfed infant from this drug or from the underlying maternal condition.
-Some authorities advise against semaglutide use during lactation as a risk to the breastfed child cannot be excluded.

Subcutaneous formulation: In lactating rats, this drug was detected in milk at levels 3 to 12-fold lower than maternal plasma. There are no data on the presence of this drug in human milk, the effects on milk production, or the effects on the breastfed infant. It is assumed that because this drug is a peptide molecule and is over 99% protein bound, if excreted, the amount in milk would be low. Additionally, it is believed that if excreted in milk, infant absorption would be unlikely as it would probably be destroyed in the infant's gastrointestinal tract.

Oral Tablet: Salcaprozate sodium (SNAC) is present in the oral formulation as an absorption enhancer. SNAC and/or its metabolites have been found in concentrated quantities in the milk of lactating rats. There are no data in the presence of SNAC in human milk, however, the enzyme needed to clear SNAC (UGT2B7) is lower in infants compared to adults and therefore higher SNAC plasma levels may occur in breastfed infants. The potential for serious adverse reactions due to accumulation of SNAC are unknown.

See references

Further information

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