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The Storage Rules: Do I Need to Keep Rekovelle in the Fridge?

4 min read

Proper storage is crucial for the effectiveness of medications like Rekovelle. While unopened pens require refrigeration, the storage rules change once you begin treatment, leaving many users to question, "Do I need to keep rekovelle in the fridge?" during their daily routine. The answer depends on its usage status.

Quick Summary

Rekovelle requires refrigeration at 2–8°C before its first use and may be stored at or below 25°C for up to 3 months including the 28-day in-use period. After the first injection, store the pen at or below 25°C for up to 28 days before discarding.

Key Points

  • Initial Refrigeration: Unopened Rekovelle pens must be stored in a refrigerator at 2–8°C.

  • Post-First-Use Storage: After the first injection, the pen is stable for up to 28 days when stored at or below 25°C.

  • Limited Room Temperature Storage: Unopened pens can be stored out of the fridge for a single period of up to 3 months, which includes the 28-day in-use period.

  • Never Re-refrigerate: Once an unopened pen has been at room temperature for the 3-month period, it cannot be put back in the fridge.

  • Discard After Limits: Discard any unused medicine after the 28-day in-use period or if the 3-month room temperature window is exceeded.

  • Protect from Light: Keep the pen in its original box and use the cap to protect the medicine from light.

In This Article

The Core Answer: Initial vs. In-Use Storage

For anyone prescribed Rekovelle (follitropin delta), the storage requirements are divided into two main phases: before the first use and after the first injection. Initially, and before the pen is used for the first time, refrigeration is essential to maintain the medication's stability and efficacy. However, once the pen is in use, it does not require constant refrigeration, offering some flexibility for patients.

Pre-First-Use Storage: The Cold Chain

Your pharmacist will dispense Rekovelle to you cold, and it is your responsibility to keep it that way until you are ready to begin treatment. The manufacturer's instructions are very clear about the initial storage conditions to ensure the integrity of the active ingredients:

  • Store in a refrigerator: Unopened Rekovelle pens must be kept in a refrigerator at a temperature between 2°C and 8°C.
  • Do not freeze: Freezing can damage the medication and render it ineffective.
  • Protect from light: Always store the pen in its original packaging with the cap on to protect it from light.

After the First Injection: A Shift in Protocol

After you have given yourself the first injection with the Rekovelle pre-filled pen, the storage rules change significantly. This is to accommodate the practical needs of daily injections during an IVF cycle, where constant refrigeration might be inconvenient.

  • Room Temperature Storage (In-Use): Once the pen is in use, it can be stored at or below 25°C for a maximum of 28 days.
  • Discard After 28 Days: After this 28-day period, any unused portion of the medication must be discarded, even if it is still within the expiry date.

The 3-Month Room Temperature Exception

There is an additional, important storage rule that provides flexibility for travel or short-term storage outside a refrigerator.

  • Single Removal Period: An unopened Rekovelle pen can be removed from the refrigerator and stored at or below 25°C for a single continuous period of up to 3 months.
  • No Re-refrigeration: Crucially, once the pen has been stored at room temperature for any length of time (up to 3 months), it must not be refrigerated again.
  • Includes In-Use Period: The 3-month room temperature storage includes the 28-day period after the first injection.
  • Track the Date: To avoid confusion, it is recommended to write the date you first remove the pen from the fridge on the box.

A Practical Storage Comparison

Storage Phase Temperature Range Maximum Duration Notes
Before First Use 2°C to 8°C (Refrigerated) Until expiry date Store in original package; Do not freeze
Optional Unopened At or below 25°C (Room Temp) Up to 3 months A single, continuous period; Do not re-refrigerate
After First Use At or below 25°C (Room Temp) 28 days Discard any remaining medicine after 28 days

Understanding the 'Why': Stability and Active Ingredients

Rekovelle contains follitropin delta, a biological medication that is sensitive to heat and light. The strict temperature control and protection from light are essential to ensure the medication remains stable and effective. If the active ingredient degrades due to improper storage, the medication may not work as intended, potentially impacting the success of your fertility treatment.

Proper Storage Guidelines

Following these steps can help ensure your Rekovelle is stored correctly throughout your treatment:

  1. Read the Instructions: Always read the full package leaflet and instructions for use provided in your Rekovelle box.
  2. Initial Refrigeration: Store the pen in the refrigerator (2–8°C) in its original packaging until you are ready to start.
  3. Keep Track of Time: If you decide to store an unopened pen at room temperature for up to 3 months, make sure to write the date you removed it from the fridge on the box.
  4. Manage Your In-Use Period: Once you give your first injection, record the date. The pen must be used within 28 days and stored at or below 25°C.
  5. Protect from Light: Always keep the pen cap on and store it in its original box between injections.
  6. Discard Safely: At the end of your treatment, or if your medication reaches its storage limit, dispose of it properly. Ask your pharmacist for guidance on safe disposal.

Conclusion: Your Medication, Your Responsibility

In summary, the question "Do I need to keep rekovelle in the fridge?" has a nuanced answer based on the stage of use. While unopened pens require refrigeration, they can be stored at room temperature (up to 25°C) for a limited time. After the first injection, the pen is stable at room temperature for 28 days. Always adhere strictly to the storage instructions provided by the manufacturer and consult your healthcare provider with any questions to ensure the medication's effectiveness. For more detailed product information, refer to the resources from the European Medicines Agency.

Frequently Asked Questions

No, once an unopened Rekovelle pen has been stored at room temperature (at or below 25°C) for any length of time within its 3-month window, it must not be refrigerated again.

If the pen was unopened and the room temperature was at or below 25°C, it is likely fine, but you must now track the 3-month room temperature limit. Consult your pharmacist or doctor if you have concerns about high temperature exposure.

After the first injection, the opened pen can be stored at or below 25°C for up to 28 days.

Yes, you must always store the pen in its original packaging with the pen cap on to protect it from light.

You should never freeze Rekovelle. Freezing can damage the medication and render it ineffective. If it has been frozen, it must be discarded.

For Rekovelle, room temperature is defined as at or below 25°C (77°F).

No, you should not use the pen if the solution is not clear or contains particles. If you notice this, contact your healthcare provider or pharmacist immediately.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.