Mometasone / olopatadine nasal Pregnancy and Breastfeeding Warnings

Brand names: Ryaltris

Medically reviewed by Drugs.com. Last updated on Dec 8, 2022.

Mometasone / olopatadine nasal Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned.

Risk summary: No data available on use of this combination drug or mometasone in pregnant women to inform a drug-related risk; postmarketing experience with antihistamines (with similar mechanism of action to olopatadine) has not identified a drug-related risk, but no published human data are specific to olopatadine.

Comments:
-Infants born of mothers who received corticosteroids during pregnancy should be carefully observed for hypoadrenalism.

Animal studies have not been reported with this combination drug. There are no controlled data in human pregnancy.

MOMETASONE: Animal studies have revealed evidence of fetotoxicity, teratogenicity, and fetolethality. In pregnant mice dosed throughout organogenesis, cleft palate occurred at a dose about equal to the maximum recommended human daily intranasal dose (MRHDID) (on a mcg/m2 basis with maternal subcutaneous doses of at least 60 mcg/kg) and decreased fetal survival was seen at about 4 times the MRHDID (on a mcg/m2 basis with maternal subcutaneous dose of 180 mcg/kg); no toxicity was observed at an exposure about one-half of the MRHDID (on a mcg/m2 basis with maternal topical dermal doses of at least 20 mcg/kg). In pregnant rats dosed throughout organogenesis, fetal umbilical hernia occurred at exposures about 20 times the MRHDID (on a mcg/m2 basis with maternal topical dermal doses of at least 600 mcg/kg) and delays in fetal ossification were seen at a dose about 12 times the MRHDID (on a mcg/m2 basis with maternal topical dermal doses of at least 300 mcg/kg). In another study, pregnant rats were dosed throughout pregnancy or late in gestation which caused prolonged and difficult labor, fewer live births, lower birth weight, and reduced early pup survival at a dose about equal to the MRHDID (on a mcg/m2 basis with maternal subcutaneous dose of 15 mcg/kg); there were no findings at a dose about equal to or less than the MRHDID (on a mcg/m2 basis with maternal subcutaneous dose of 7.5 mcg/kg). Pregnant rabbits were dosed by either the topical dermal or oral route throughout organogenesis; using the topical dermal route, multiple malformations were observed in fetuses at doses about 12 times the MRHDID (on a mcg/m2 basis with maternal topical dermal doses of at least 150 mcg/kg), and using the oral route, increased fetal resorptions and cleft palate and/or head malformations occurred at a dose about 60 times the MRHDID (on a mcg/m2 basis with maternal oral dose of 700 mcg/kg). In rabbits, at about 220 times the MRHDID (on a mcg/m2 basis with maternal oral dose of 2800 mcg/kg), most litters were aborted or resorbed; no effects were seen at a dose about 12 times the MRHDID (on a mcg/m2 basis with maternal oral dose of 140 mcg/kg). In animal studies, small amounts of mometasone crossed the placental barrier. There are no controlled data in human pregnancy.

OLOPATADINE: Animal studies have revealed evidence of fetotoxicity, teratogenicity, and fetolethality. In pregnant rats dosed orally throughout organogenesis, maternal toxicity (producing death and reduced maternal body weight gain), decreased embryofetal viability, and reduced fetal weight were observed at 600 mg/kg/day (about 1200 times the MRHDID on a mg/m2 basis); cleft palate occurred at 60 mg/kg/day (about 120 times the MRHDID on a mg/m2 basis). In pregnant rats dosed orally throughout organogenesis, a decreased number of live fetuses was seen at 400 mg/kg/day (about 1600 times the MRHDID on a mg/m2 basis). There are no controlled data in human pregnancy.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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

Mometasone / olopatadine nasal Breastfeeding Warnings

This drug should be used only if the benefit to the patient outweighs the risks to the infant.
-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 and the benefit of breastfeeding for the child.

Excreted into human milk: Unknown (mometasone, olopatadine)
Excreted into animal milk: Yes (mometasone, olopatadine [both after oral administration])

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.
-Mometasone levels in plasma after nasal therapeutic doses are low; levels in human breast milk are likely to be correspondingly low.
-It is unknown whether topical nasal administration of olopatadine could result in sufficient systemic absorption to produce detectable quantities in human breast milk.
-Patients should be advised that antihistamines may affect milk production of a nursing mother.

Neither inhaled mometasone nor mometasone nasal implants have been studied during breastfeeding. Although not measured, the amounts of inhaled and nasal corticosteroids absorbed into the maternal bloodstream and excreted into breast milk are most likely too small to affect a breastfed infant. According to expert opinion, inhaled and oral corticosteroids are considered acceptable to use during breastfeeding.

See references

Further information

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