6 Interactions found for:

The following applies to the ingredients: Empagliflozin (found in Jardiance)

Use should be avoided, especially during the second and third trimesters of pregnancy.

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

Risk Summary: There is limited data in pregnant women to determine a drug-associated risk for major birth defects and miscarriage. Based on animal data, this drug may cause adverse renal effects in the developing fetus.

Comments:
-Poorly controlled diabetes in pregnancy increases the risk of adverse maternal and fetal outcomes.

Animal studies have revealed evidence of adverse renal changes and embryofetal toxicity. Administration of this drug to pregnant animals during the period of organogenesis at doses up to 154 times the maximum clinical dose based on AUC resulted in maternal/fetal toxicity, malformations, and reduced offspring body weights. In juvenile rats, direct exposure to this drug at doses approximately 13 times the maximum clinical dose caused increased kidney weights and renal tubular/pelvic dilatations. These findings occurred during a period of renal development in rats corresponding to the late second and third trimester of human renal development. Animal studies do not indicate direct or indirect harmful effects with respect to fertility. There are no controlled data in human pregnancy.

Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth, and delivery complications. Fetal risks of poorly controlled diabetes in pregnancy include an increased risk for major birth defects, stillbirth, and macrosomia-related morbidity.

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.

The following applies to the ingredients: Semaglutide (found in Ozempic)

Noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH): This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
Type 2 diabetes mellitus: This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
-According to some authorities: Use is not recommended.
Weight management: Use is not recommended.

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

Risk summary: Limited and insufficient data are available on the use of this drug in pregnant women to inform a drug-related risk; based on animal data, this drug may cause fetal harm.

Comments:
-According to some authorities: Contraception use is recommended during therapy for patients of childbearing potential.
-This drug should be discontinued at least 2 months before a planned pregnancy due to the long half-life.
-Additionally for Wegovy:
---A pregnancy exposure registry is available.
---When a pregnancy is recognized, the patient should be apprised of the potential harm to the fetus and discontinue the drug.

Animal studies have revealed evidence of embryofetal mortality, early pregnancy losses, structural abnormalities, and growth alterations. After subcutaneous dosing in rats, rabbits, and cynomolgus monkeys during organogenesis, pharmacologically mediated maternal toxicity (reduced body weight gain and food consumption) was observed at all dose levels. In rats, reduced growth and fetal abnormalities (visceral and skeletal) were observed at the human exposure. In rabbits, early pregnancy losses and increased rates of minor fetal abnormalities (visceral and skeletal) were seen at clinically relevant exposures. In monkeys, sporadic abnormalities (vertebra, sternebra, ribs) occurred at exposures above the human exposure. Exposures at the no observed adverse effect level in all species were subclinical or only slightly higher than the plasma AUC at the maximum recommended human dose; a direct effect of this drug on the fetus cannot be excluded. Salcaprozate sodium (SNAC), an absorption enhancer in the oral tablet, has been shown to cross the placenta and reach fetal tissues in rats; SNAC was associated with increased gestation length, stillbirths, and decreased pup viability following oral dosing in pregnant rats during gestation and lactation. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Pregnant women exposed to Wegovy and health care providers are encouraged to contact the manufacturer at wegovypregnancyregistry.com.

Clinical considerations:
-Noncirrhotic MASH: There may be risks to the mother and fetus related to MASH with advanced liver fibrosis (e.g., increased risks of gestational diabetes, hypertensive complications, preterm birth, postpartum hemorrhage); the effect of this drug on these risks is unknown.
-Type 2 diabetes mellitus: Hypoglycemia and hyperglycemia occur more often during pregnancy in patients with pregestational diabetes; poorly controlled diabetes during pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications and increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity.
-Weight management: 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.

The following applies to the ingredients: Empagliflozin (found in Jardiance)

Use is not recommended

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

Comments:
-A risk to the breastfed infant cannot be excluded; there is a potential for serious adverse effects on postnatal renal development.
-An alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Drug accumulation was observed in the milk of lactating animals. Studies in juvenile rats with direct exposure demonstrated pelvic and tubular dilations of the kidney during maturation. Human kidney maturation occurs in utero and during the first 2 years of life; thus, a potential for serious harm to the developing kidney may exist for infants exposed to this drug during breastfeeding. However, some experts anticipate low amounts of this drug in human breastmilk due to high levels of plasma protein binding.

The following applies to the ingredients: Semaglutide (found in Ozempic)

Only injectable forms of this drug should be used during breastfeeding.
-According to some authorities: Use is not recommended.
-According to some authorities: Breastfeeding is not recommended during use of the oral form of this drug.

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

Comments:
-Injectable formulations: Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug. The effects in the nursing infant are unknown; potential adverse effects in the breastfed child due to this drug or the mother's underlying condition should be considered.
---According to some authorities: A risk to a breastfed child cannot be excluded.
-Oral formulations: The absorption enhancer (salcaprozate sodium [SNAC]) and/or its metabolites are present in human milk; enzyme activity involved in SNAC clearance may be lower in infants compared to adults, leading to higher SNAC plasma levels in neonates and infants.
---There is the potential for serious adverse reactions in breastfed infants due to possible SNAC accumulation.

This drug was not detectable in the milk of mothers receiving the subcutaneous formulation. Data from a lactation study with the oral tablet formulation reported drug levels below the lower limit of quantification in human milk.

In a study involving nursing mothers using subcutaneous doses of this drug, milk samples showed no measurable drug levels. If present at the detection limit, the relative infant dose was estimated to be very low. Additionally, breastfed infants of these mothers showed normal growth and development during the period of exposure through breast milk. This drug has poor oral absorption, with a maximum bioavailability of approximately 1% in adults.

Milk samples were collected (at 0, 12, and 24 hours after dosing) from 8 nursing mothers using this drug subcutaneously (0.25 to 1 mg/week); their infants (4 to 23 months old) were mixed fed, receiving breast milk for 3 to 9 weeks during maternal dosing. None of the milk samples contained any measurable drug (less than 1.7 mcg/L), and the mothers reported normal growth and development for their infants. According to author calculation, if drug milk levels were at the detection limit, the relative infant dose would have averaged 1.12%; this did not account for the poor oral absorption of the drug and maximum bioavailability of 1% in adults.