Reproduced with permission from Therapeutic Goods Administration (TGA) Medicines Safety Update 1 December 2025.

 

Summary

The Therapeutic Goods Administration's investigation into the potential for reduced effectiveness of oral contraception during initiation or dose escalations with Mounjaro (tirzepatide) has found that this association could not be ruled out.

As a precautionary measure, the Product Information (PI) and Consumer Medicine Information (CMI) for tirzepatide has been updated to include further advice for patients using oral contraceptives. Patients are advised to switch to a non-oral contraceptive or add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each dose escalation with tirzepatide.

Tirzepatide is a dual glucose-dependent insulinotropic polypeptide (GIP)/glucagon-like-peptide-1 receptor agonist (GLP-1 RA). It is approved in the treatment of type 2 diabetes mellitus (T2DM), chronic weight management and for the treatment of obstructive sleep apnoea in adults with obesity.

It belongs to the GLP-1 RA class of prescription medicines used primarily to manage T2DM and obesity. None of these medicines are recommended for use during pregnancy.

What health professionals should do

Be alert to the PI update for tirzepatide and advise patients taking oral contraceptives to switch to a non-oral contraceptive or add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each dose escalation.

Advise patients that GLP-1 RAs should not be used during pregnancy and individuals of childbearing potential are advised to use effective contraception during treatment with a GLP-1 RA.

See the full article on the TGA website.