6 Interactions found for:

The following applies to the ingredients: Atorvastatin

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According to some authorities: Use is contraindicated during pregnancy or in patients of childbearing potential not using contraception.

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

Risk summary: Based on its mechanism of action, this drug may cause fetal harm when administered during pregnancy.
-Available data on the use of statins in pregnant women have not identified a drug-related risk of major congenital malformations and are insufficient to inform a drug-related risk of miscarriage.

Comments:
-If the patient becomes pregnant while taking this drug, therapy should be discontinued and the patient should be apprised of the potential harm to the fetus.
---According to some authorities: Alternatively, the ongoing needs of the individual patient should be considered.
-According to some authorities: Patients of childbearing potential should use effective contraception during therapy; this drug should be used in patients of childbearing potential only when they are highly unlikely to conceive and have been informed of the potential risks to a fetus.

Animal studies have failed to reveal evidence of teratogenicity; however, some of the following effects were observed in rats at a non-maternotoxic dose: increased incidence of stillbirths, decreased birthweight, increased incidence of dilated renal pelvis, increased postnatal mortality, suppressed pup growth, delayed physical development, and abnormal behavioral development. No adverse developmental effects were observed in pregnant rats or rabbits administered oral doses that resulted in up to 30 and 20 times, respectively, the human exposure at the maximum recommended human dose (MRHD) of 80 mg (based on body surface area [mg/m2]); in rats administered this drug during gestation and lactation, decreased postnatal growth and development delay were observed at doses at least 6 times the MRHD. This drug crosses the rat placenta and reaches levels in the fetal liver equivalent to that of maternal plasma. A study of statin-exposed pregnant women compared to controls did not find a significant teratogenic effect from maternal use of statins in the first trimester, after adjusting for potential confounders. In cases involving pregnant women who took a HMG-CoA reductase inhibitor during the first trimester of pregnancy, serious fetal abnormalities occurred in several instances. There are no controlled data in human pregnancy.

Cholesterol and other products of cholesterol biosynthesis are essential components for fetal development (including synthesis of steroids and cell membranes). Because this drug decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol, it may cause fetal harm when used during pregnancy.

Treatment of hyperlipidemia is not generally necessary during pregnancy. Since atherosclerosis is a chronic process, discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term primary hypercholesterolemia therapy for most patients.

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)

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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: Atorvastatin

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Until more data are available, an alternate agent may be preferred, particularly while breastfeeding newborn or preterm infants.
-According to some authorities: Breastfeeding is not recommended during use of this drug.
-According to some authorities: Use is contraindicated.

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

Comments:
-Another drug in this class is excreted into human milk.
-Statins (including this drug) decrease synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; they may cause harm to the breastfed infant.
-The effects in the nursing infant are unknown; based on the mechanism of action, there is the potential for serious adverse reactions in nursing infants.

Due to a concern over disruption of infant lipid metabolism, it is generally agreed that women taking a statin should not breastfeed; however, others have argued that children homozygous for familial hypercholesterolemia are treated with statins starting at 1 year of age, statins have low oral bioavailability, and risks to the breastfed infant are low. Some evidence indicates that this drug can be taken by nursing mothers with no obvious developmental problems in their infants.

In cases of patients with homozygous familial hypercholesterolemia, 6 patients breastfed 11 infants after restarting statin therapy postpartum; the specific statin was not reported, but most of the women on statin therapy were using this drug (40 or 80 mg/day). Normal early child development was reported for all offspring; children started school at the appropriate age with no learning difficulties reported.

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

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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.