The Importance of Proper TAKHZYRO Storage
TAKHZYRO (lanadelumab-flyo) is a biological medicine used to prevent hereditary angioedema (HAE) attacks. Like many biologics, it is susceptible to degradation from temperature extremes, which can alter its therapeutic properties and render it ineffective. The manufacturer provides explicit temperature guidelines to ensure the drug's stability and safety. Proper storage is a key part of your treatment regimen, as it guarantees you receive the full benefit of each dose.
General Storage Requirements
Before you are ready to administer a dose, all TAKHZYRO products—whether prefilled syringes or vials—must be stored in their original carton in the refrigerator at 36°F to 46°F (2°C to 8°C). This protects the medication from both heat and light. Under no circumstances should TAKHZYRO be frozen or vigorously shaken.
Room Temperature Rules for Unopened TAKHZYRO
The length of time an unopened TAKHZYRO product can be left out of the refrigerator varies depending on the product type (prefilled syringe or vial) and the specific regional labeling. These distinctions are crucial for safe handling.
Prefilled Syringes (US Labeling)
The most common instruction for TAKHZYRO prefilled syringes in the United States is that if they are left out of the refrigerator, they must be discarded. There is no authorized window for extended room temperature storage for the prefilled syringe under US labeling. This highlights the importance of immediate administration after the initial 15-minute warming period, and discarding the product if it was left out for an extended time.
Unopened Vials (EU/Other Regional Labeling)
In some regions, labeling for unopened TAKHZYRO vials may differ. For instance, European labeling specifies that vials removed from refrigeration can be stored, unopened, below 25°C (77°F) for up to 14 days. Important: Once stored at room temperature, the vial should not be returned to the refrigerator. The total cumulative storage time out of the refrigerator should also not exceed 14 days. Because of this discrepancy, patients must always follow the specific instructions on their product's packaging and provided by their healthcare provider.
Preparing for Your Injection: The 15-Minute Warm-up
Before administration, you should remove the prefilled syringe or vial from the refrigerator and let it sit for approximately 15 minutes to allow it to reach room temperature. This makes the injection more comfortable. You should never use a microwave, hot water, or other heating methods to speed up this process.
Timing for Prepared Doses from Vials
When using the single-dose vial presentation, there are specific timeframes for handling the medication after drawing it into a syringe:
- Immediate Use (Room Temperature): After a dose has been drawn from the vial into a syringe, it must be administered within 2 hours if left at room temperature.
- Refrigerated Use: If not used immediately, a prepared syringe can be refrigerated and used within 8 hours.
Storage Rules at a Glance: Prefilled Syringe vs. Vial
| Storage Condition | Prefilled Syringe (US Labeling) | Unopened Vial (EU/Other Labeling) | Prepared Vial Dose (US/EU) |
|---|---|---|---|
| Recommended Storage | Refrigerate at 36°F–46°F (2°C–8°C) in original carton. | Refrigerate at 36°F–46°F (2°C–8°C) in original carton. | Refrigerate at 36°F–46°F (2°C–8°C). |
| Room Temperature (Unopened) | Discard if left out of the refrigerator. | Up to 14 days below 25°C (77°F); do not re-refrigerate. | Not applicable. |
| Room Temperature (After Preparation) | 15-minute warm-up only. | N/A (Administer within 2 hours of drawing dose). | Administer within 2 hours. |
| Refrigerated (After Preparation) | N/A | N/A | Use within 8 hours. |
| Freezing | Do not freeze. | Do not freeze. | Do not freeze. |
What to Do If TAKHZYRO is Left Out
If you find your TAKHZYRO has been accidentally left out of the refrigerator, follow these steps:
- Check the product type and local instructions. As noted, prefilled syringes under US labeling should be discarded if left out. Unopened vials in regions with more flexible rules may still be usable within the 14-day window.
- Inspect the solution. Before use, visually inspect the TAKHZYRO solution. It should be clear to slightly opalescent and colorless to slightly yellow. Do not use it if it appears discolored, cloudy, or contains visible particles.
- When in doubt, throw it out. The stability and effectiveness of the medication cannot be guaranteed if it has been exposed to improper storage conditions, especially if you are unsure of the duration. Using a compromised dose could mean you are not adequately protected against HAE attacks.
- Contact your pharmacist or healthcare provider. If you have any questions or concerns about the integrity of your medication, contact your pharmacy or physician for guidance.
Conclusion: Adherence is Key to Safety
Adhering to the specific storage and handling guidelines for TAKHZYRO is not merely a suggestion—it is an essential part of your treatment regimen for preventing HAE attacks. The length of time TAKHZYRO can be safely left out of the refrigerator depends on the product type and your region's labeling, but the guiding principle is caution. Always check your specific product's packaging and, when in doubt, consult a healthcare professional. By following these precise instructions, you can ensure that each dose is as effective and safe as possible. For the most authoritative and up-to-date information, refer to the full prescribing information for TAKHZYRO provided by the manufacturer.
Frequently Asked Questions
Q: What should I do if my prefilled syringe of TAKHZYRO was left out of the refrigerator for more than 15 minutes? A: According to US labeling, you must discard the prefilled syringe if it was left out of the refrigerator for an extended period, beyond the short warming time before administration. You should use a new, properly stored syringe for your dose.
Q: How long can a dose drawn from a TAKHZYRO vial be left at room temperature? A: A dose drawn from a TAKHZYRO vial into a syringe must be administered within 2 hours if left at room temperature.
Q: Can I put TAKHZYRO back in the refrigerator after it has been at room temperature? A: For prefilled syringes and for unopened vials under certain regional labeling, once the product is stored at room temperature, it should not be returned to refrigeration. Always follow your specific product's instructions.
Q: Is it okay to use TAKHZYRO if it looks different after being left out? A: No. You should never use TAKHZYRO if it appears discolored, contains particles, or looks different than described. Always inspect the solution before injection.
Q: Can I travel with TAKHZYRO? A: Yes, you can travel with TAKHZYRO. It requires careful planning to maintain the cold chain. Use a cooler or insulated travel bag with ice packs, ensuring the medication does not freeze. Discuss travel plans with your healthcare provider to ensure you have enough medication and proper storage during transit.
Q: What happens if I use TAKHZYRO that has been improperly stored? A: Using improperly stored TAKHZYRO could mean the medication is less potent or completely ineffective, potentially leaving you vulnerable to an HAE attack. It is not recommended to use compromised medication.
Q: What is the warming time for TAKHZYRO before injection? A: TAKHZYRO should be removed from the refrigerator and allowed to warm to room temperature for approximately 15 minutes before administering the injection.
Q: Does exposure to light affect TAKHZYRO? A: Yes, TAKHZYRO should be stored in its original carton to protect it from light, which can degrade the medication.
Q: How do I dispose of improperly stored TAKHZYRO? A: Discard improperly stored medication according to local regulations for biological waste. Do not dispose of it in regular household trash.
Q: What should I do if I am unsure about TAKHZYRO's storage and need to take a dose? A: If you are in doubt, do not use the medication. Contact your healthcare provider or pharmacist immediately for guidance on using a new, properly stored dose.
Q: Can I extend my dose if my TAKHZYRO was left out and I am traveling? A: No. If a dose is compromised due to improper storage, you should not extend your dosing interval. You should obtain a replacement dose and adhere to your regular schedule as prescribed by your doctor.
