6 Interactions found for:

The following applies to the ingredients: Tirzepatide (found in Mounjaro)

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
According to some authorities: Use of this drug is not recommended during pregnancy or in women of childbearing potential not using contraception.

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

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

Comments:
-There are risks to mother and fetus associated with poorly controlled diabetes in pregnancy.
-Use of this drug may reduce the efficacy of oral hormonal contraceptives due to delayed gastric emptying; this delay is largest after the first dose and diminishes over time. Patients using oral hormonal contraceptives should be advised to switch to a non-oral contraceptive method or add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each dose escalation with this drug.

Animal studies have revealed evidence of teratogenicity, fetotoxicity, and abortion when this drug was administered in pregnant animals during organogenesis at clinically relevant exposures based on AUC. These adverse embryo-fetal effects in animals coincided with pharmacological effects on maternal weight and food consumption. Animal studies with this drug did not indicate direct 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, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications; poorly controlled diabetes increase the fetal 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: Metformin

Benefit should outweigh risk

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

Risk Summary: Data are not sufficient to inform a drug-associated risk for major birth defects or miscarriage; published studies have not reported an increased risk. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy.

Comments:
-Maternal glucose levels should be well controlled prior to conception and throughout pregnancy to avoid maternal and fetal diabetes-associated risks.
-Premenopausal women should understand the potential for unintended pregnancy with use of this drug as ovulation may occur in some anovulatory women.

Animal studies do not indicate harmful effects with respect to pregnancy, embryo or fetal development, birth or postnatal development. Poorly-controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth and delivery complications. Poorly controlled maternal diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. Published evidence suggests this drug has a good safety profile in women with no increased long-term effects in offspring up to 18 months; however, much of the evidence is from observational, small, and/or nonrandomized studies, and therefore data must be interpreted cautiously.

Many experts continue to recommend insulin as the drug of choice for type 1, type 2, and gestational diabetes when diet alone is unsuccessful in controlling blood sugars. The estimated background risk for major birth defects in women with pre-gestational diabetes mellitus with an HbA1C greater than 7 is 6% to 10% and for women with a HbA1C greater than 10, this risk has been reported to be as high as 20% to 25%. In the US, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The estimated risk of miscarriage for pregnant women with diabetes is unknown. There are no adequate and well-controlled studies in pregnant women.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. 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: Metformin

Benefit should outweigh risk

Excreted into human milk: Yes

Comments:
-Available data have not reported adverse effects in breastfed infants, however, this data is limited.
-Due to this limited data, product manufacturers recommend a decision should be made to discontinue nursing or discontinue the drug, considering the importance of the drug to the mother.
-Published data suggest this drug is compatible with breastfeeding; they recommend caution when nursing a newborn or premature infant, and those with renal impairment.

Drug levels are expected to be 0.5% (range 0.11% to 1%) of the mother's weight-adjusted dosage and milk/plasma ratio range between 0.13 and 1. Since milk levels are expected to be relatively constant, timing of breastfeeding with drug administration is expected to be of little benefit. One large prospective study found no adverse effects in breastfed infants. Low detectable serum levels were found in some breastfed infants.

The following applies to the ingredients: Tirzepatide (found in Mounjaro)

Benefit should outweigh risk.
According to some authorities: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

Comments:
-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 side effects in the breastfed child due to this drug or the mother's underlying condition should be considered.
-The quantity of this drug in breast milk or absorbed by the breastfed child is expected to be low due to the large molecular weight of this drug and its probable partial destruction within the infant gastrointestinal tract.