What are the storage requirements for Apretude (cabotegravir)?

Storage Requirements for Apretude (Cabotegravir)

Apretude (cabotegravir) must be stored below 30°C (86°F) according to the FDA label. 1

Storage Temperature Requirements

Apretude is an extended-release injectable suspension containing cabotegravir, which is used for HIV-1 pre-exposure prophylaxis (PrEP). As the first long-acting injectable option approved for PrEP, proper storage is essential to maintain its efficacy.

The specific storage requirements for Apretude are:

• Store below 30°C (86°F) 1
• Do not freeze
• Protect from light by keeping in the original packaging

Handling Considerations

When handling Apretude, healthcare providers should be aware of the following:

• The medication is supplied as a pre-filled syringe containing the extended-release injectable suspension
• No reconstitution is required before administration
• The medication should be inspected visually for particulate matter before administration
• If the medication has been exposed to temperatures outside the recommended range, it should not be used

Administration Schedule

While not directly related to storage, it's important to note the administration schedule as it affects how long the medication needs to be stored:

• Apretude is administered as a 600 mg (3 mL) gluteal intramuscular injection 2
• Initial dosing: First two injections are separated by 4 weeks
• Maintenance dosing: Subsequent injections are administered every 8 weeks 2

Practical Considerations for Healthcare Settings

Healthcare facilities storing Apretude should:

• Use dedicated medication refrigerators or storage areas that maintain temperatures below 30°C
• Implement temperature monitoring with documentation twice daily 2
• Keep temperature logs for at least 3 years 2
• Take immediate action if storage temperatures exceed recommended ranges 2

Common Pitfalls to Avoid

1. Temperature excursions: Unlike some medications that require strict refrigeration (2-8°C), Apretude can be stored at room temperature (below 30°C). However, exposure to temperatures above 30°C may compromise potency.

2. Freezing: While some medications are stored frozen, Apretude should never be frozen as this could affect the suspension properties and drug delivery characteristics.

3. Improper handling during administration: The medication should be brought to room temperature naturally before administration for patient comfort.

4. Delayed administration: If injections are delayed by 8 or more weeks, a "reloading" schedule is required with two injections 4 weeks apart before resuming the regular 8-week schedule 2.

By following these storage requirements, healthcare providers can ensure that Apretude maintains its efficacy for HIV-1 prevention, which is critical for reducing morbidity and mortality associated with HIV infection.