Timothy grass pollen allergen extract Pregnancy and Breastfeeding Warnings

Brand names: Grastek

Medically reviewed by Drugs.com. Last updated on Jun 14, 2023.

Timothy grass pollen allergen extract Pregnancy Warnings

Use is recommended only if clearly needed and the benefit outweighs the risk.

AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned.

Risk Summary: Available data do not establish the presence or absence of risk associated with use of this drug during human pregnancy; no evidence of fetal harm has been observed in animal studies.

Comments:
-Some authorities advise against initiating allergy immunotherapy during pregnancy;, if pregnancy occurs, a full evaluation (including lung function) should occur before continuing treatment.
- This drug should be used during pregnancy only if clearly needed as systemic and local adverse reactions may be poorly tolerated; if used, close supervision is recommended, especially for patients with preexisting asthma.

Animal studies with doses estimated to be approximately 6.7 times the human sublingual dose, have failed to reveal evidence of fetotoxicity. In 2 different studies, mice were administered this drug to the buccal cavity. In the first study, administration was from day 6 of gestation to day 17 of lactation and in the second, from 14 days prior to mating until day 15 of the gestation period. These studies revealed no evidence of harm to the mother or the fetus. There are no controlled data in human pregnancy.

AU TGA pregnancy category B2: 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 are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

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

Timothy grass pollen allergen extract Breastfeeding Warnings

Safety has not been established

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-Some authorities advise against initiating allergy immunotherapy while breast feeding, but for those who have already initiated therapy who need to breastfeed, close monitoring is advised.

See references

Further information

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