FORTEO® (teriparatide [rDNA origin] injection): Use Beyond the 28-Day In-Use Period

Detailed Information

Teriparatide should only be used for a total of 28 days once the delivery device is used for the first time.¹

Teriparatide has only been tested for use through 28 days. Therefore, do not use a teriparatide delivery device beyond 28 days from the first injection.²

Discard the teriparatide delivery device after the 28-day in-use period, even if there is still medication left.¹

Use of Teriparatide Beyond 28 Days

Accidental use of teriparatide beyond 28 days is not likely to cause harm; however, is not recommended because

• it contains preservatives which help protect against germs

• beyond 28 days, the preservatives may not work as well, potentially allowing germs to grow in the liquid medicine in the delivery device, and

• it is possible that teriparatide may not work as well after 28 days as growth of germs may cause the medicine to begin to breakdown.²

Therefore, products with preservative, such as teriparatide, should not be used beyond 28 days.¹

European Medicines Agency Recommendation

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommends that in-use sterile solutions be used within 28 days due to the potential for reduced sterility of the medication after this time interval.³

Enclosed Prescribing Information

FORTEO® (teriparatide [rDNA origin] injection), Lilly

Reference

1. Forteo [package insert]. Indianapolis IN: Eli Lilly and Company; 2019.

2. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

3. The European Medicines Agency: Committee for Medicinal Products for Human Use. Available at: www.ema.europa.eu http://www.ema.europa.eu/ . Accessed December 10, 2019.