September 2018 Pharmacy Update
EpiPen Generic– Prescribing Tips
As you may be aware, the FDA has approved the first generic epinephrine auto-injector for the emergency treatment of allergic reactions, such as anaphylaxis.
- On 8/16/18, the FDA approved the first generic version of EpiPen® for both the adult (0.3mg) and pediatric (0.15mg) strengths1
- On 8/21/18, the FDA extended the expiration dates on some EpiPen® products in an effort to remediate the recent national EpiPen® shortage:
- Recommendation: Safe to use up to 4 months beyond the labeled expiration dates
- This affects only specific lots of the adult dose (0.3mg) EpiPens® and its approved generics: https://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm563360.htm
1. The EpiPen® generic alternative that has been on the market ≠ new EpiPen® generic
- The EpiPen® alternative is the generic version of Adrenaclick®, which differs from EpiPen® for the following reasons:
- EpiPen® has 1 cap to remove before injection, whereas the alternative generic has 2 caps
- The needle of the EpiPen® retracts automatically after use, whereas the alternative does not
- One may hold the injection in the site for 3-10 seconds for the EpiPen®, whereas the alternative must be held for 10 seconds
- The new EpiPen® generic works just like the brand EpiPen® (i.e., 1 cap, needle retraction, etc.)
2. Writing your prescription as “epinephrine auto-injector” will allow the pharmacist to substitute for any covered version, brand or generic.
3. Encourage the patient to ask the pharmacist how to use the pens when picking up their medications. Most products come with a trainer pen included for demonstration.
4. Calling the pharmacy before prescribing is recommended to verify what is in stock, as some pharmacies may not be able to retrieve the medication due to the shortage and/or high demand.