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Does growth hormone need to be refrigerated before mixing?

5 min read

As a highly sensitive protein-based medication, growth hormone (GH) can quickly lose its effectiveness if not stored correctly. A common and critical question for patients is, does growth hormone need to be refrigerated before mixing? For most formulations, strict refrigeration is required both before and after reconstitution to ensure the medication remains potent and safe.

Quick Summary

Before reconstitution, most growth hormone formulations must be kept refrigerated to preserve their efficacy. Exposure to improper temperatures or light can degrade the sensitive protein, rendering the medication less effective. Always follow the specific storage instructions provided by your healthcare provider and the manufacturer.

Key Points

  • Refrigerate Unmixed Growth Hormone: Most growth hormone formulations, including lyophilized powder vials and pre-filled cartridges, require refrigeration before mixing to maintain potency.

  • Protect from Heat and Light: As a sensitive protein, growth hormone is susceptible to degradation from both heat and light. Keep the medication in its original, protective packaging in the refrigerator.

  • Avoid Shaking Vigorously: During the mixing process, gently swirl the vial to dissolve the powder. Shaking can damage the protein structure and decrease the medication's effectiveness.

  • Check Expiration After Mixing: Mixed growth hormone has a significantly shorter shelf life, typically a few weeks, and must remain refrigerated. Check the manufacturer's specific instructions for the exact duration.

  • Understand Product-Specific Rules: Some brands, like Genotropin MINIQUICK, have different rules for room temperature storage before reconstitution. Always follow the instructions for your specific product.

  • Consult Your Provider: If you are unsure about any aspect of storage or handling, consult your healthcare provider or pharmacist to ensure the medication remains safe and effective.

In This Article

The Crucial Role of Cold Storage for Unmixed Growth Hormone

When you receive a prescription for growth hormone (somatropin), it typically arrives as a lyophilized (freeze-dried) powder in a vial or as a pre-filled cartridge. Regardless of the form, this sensitive protein requires specific storage conditions to maintain its therapeutic properties. The strict requirement for refrigeration, even before the medication is mixed, is based on the inherent instability of protein-based drugs. Environmental factors like heat and light can cause the growth hormone molecules to break down, a process known as degradation. Once degraded, the medication may not work as intended, leading to inadequate treatment outcomes.

Protecting a Sensitive Protein

Growth hormone is a delicate, naturally occurring hormone produced in the body, and its synthetic counterpart is engineered to mimic its function precisely. This complex molecular structure is highly susceptible to damage from heat. Just as food can spoil when left out of the refrigerator, HGH can lose its potency. Keeping the unmixed product in the refrigerator at a consistent, cool temperature (typically between 36°F and 46°F or 2°C and 8°C) significantly slows down this degradation process, ensuring the medication's integrity until its expiration date. Freezing the medication, however, is also detrimental and should be avoided, as it can irreversibly damage the protein structure.

Storage Guidelines for Different Growth Hormone Products

Different brands and forms of growth hormone have unique storage requirements, and it is vital to read the specific instructions provided by the manufacturer. For example, some self-contained injector systems, like the Genotropin MINIQUICK, may offer a limited period of room temperature storage for the unmixed product. However, this is an exception, not the rule.

Lyophilized Powder Vials

For products that come as a powder in a vial with a separate diluent, the unmixed powder must be refrigerated. The vial is often stored in its original carton to protect it from light, another factor that can cause degradation. Once reconstituted with the liquid diluent, the mixed solution must also be stored in the refrigerator, and it will have a shorter expiration window, typically a few weeks.

Pre-filled Cartridges and Pens

Many modern growth hormone therapies are dispensed in pre-filled cartridges or pens. Unused cartridges must be refrigerated until their first use to maintain efficacy. After the first injection, some pens can be stored at room temperature for a limited period, but they must be discarded after a specified number of days, even if medication remains. Other brands, like Omnitrope, require the pen containing the cartridge to be stored in the refrigerator between every use.

The Mixing and Handling Process

Following proper procedures during mixing is just as important as correct storage. A careless or rushed reconstitution can damage the growth hormone, even if it has been stored correctly.

Preparing for Mixing

  • Gather all necessary supplies, including the growth hormone vial or cartridge, diluent, and sterile mixing syringes.
  • Wash your hands thoroughly with soap and water.
  • Clean the rubber stoppers of both the growth hormone and diluent vials with alcohol swabs.

Safe Reconstitution

  • Draw the specified amount of diluent into a sterile syringe.
  • Carefully inject the diluent into the vial containing the growth hormone powder, directing the stream toward the vial's side rather than directly onto the powder.
  • Gently swirl the vial to dissolve the powder completely. Never shake the vial vigorously, as this can denature the protein and reduce the medication's effectiveness.
  • Once the powder is fully dissolved, the solution should be clear and colorless. If it appears cloudy or contains particles, it should be discarded.

Consequences of Improper Storage

Failing to refrigerate growth hormone or exposing it to extreme temperatures can have several negative consequences:

  • Reduced Efficacy: The primary risk is a decrease in the medication's potency. If the growth hormone degrades, a patient may not receive the full therapeutic effect, potentially compromising treatment goals.
  • Wasted Medication: Given the high cost of growth hormone therapy, improper storage can lead to the loss of expensive medication that must be discarded.
  • Inadequate Treatment: A weakened medication can result in an inconsistent or ineffective treatment, which can be frustrating and even dangerous for patients dependent on a stable dosage. This can affect blood glucose levels and other metabolic processes.

Comparison of HGH Product Storage

Product Type Storage Before Mixing Storage After Mixing Short-Term Room Temp Exposure
Lyophilized Powder Vial Refrigerate at 36-46°F (2-8°C) Refrigerate at 36-46°F (2-8°C) Not recommended; only for handling
Pre-filled Cartridge (e.g., Omnitrope) Refrigerate at 36-46°F (2-8°C) Refrigerate at 36-46°F (2-8°C) Up to 30 mins before injection
Self-contained Injector (e.g., Genotropin MINIQUICK) Refrigerate until expiration OR Store at ≤77°F for up to 3 months Refrigerate for up to 24 hours OR Use immediately Up to 3 months before mixing

Special Handling and Travel Considerations

When traveling with growth hormone, it is crucial to maintain the cold chain to prevent spoilage. A portable medicine cooler with ice packs is essential. Never place the pens or vials directly on ice to avoid freezing them. Always carry the medication in your carry-on luggage, not in checked bags, where temperature extremes can occur. Be sure to keep the medication in its original packaging to protect it from light. If you have any questions about storing your specific growth hormone product while traveling, consult your healthcare provider or pharmacist.

Conclusion: Prioritizing Potency and Safety

In summary, the short answer to "Does growth hormone need to be refrigerated before mixing?" is overwhelmingly yes for most products. Proper refrigeration is the cornerstone of effective growth hormone therapy, preserving the medication's potency and ensuring it delivers the intended therapeutic benefits. While some specific formulations allow for temporary room temperature storage, these are exceptions that must be strictly followed according to manufacturer guidelines. Improper storage is not just an inconvenience; it can render the treatment ineffective. Therefore, patients must always prioritize careful handling and adhere to their prescribed storage protocols to get the most out of their medication.

It is strongly advised to consult with a healthcare professional or pharmacist if there is any doubt about the storage or handling of growth hormone. Your doctor will provide the most accurate instructions for your specific product and situation. For comprehensive information on your medication, always review the product's prescribing information provided by the manufacturer, such as this guide for Omnitrope: https://www.omnitrope.com/pro/why-omnitrope/faq/.

Frequently Asked Questions

If unmixed growth hormone is left out of the refrigerator, its effectiveness will likely decrease over time due to temperature sensitivity. The duration of safe use outside refrigeration varies by product, so consult your pharmacist to determine if the medication is still viable.

Most growth hormone products require refrigeration between 36°F and 46°F (2°C and 8°C). The exact temperature range is specified in the package insert for each product.

Some manufacturers recommend letting the medication reach room temperature for about 30 minutes before mixing or injecting for patient comfort. However, the vial should be returned to refrigeration immediately after the short exposure.

After mixing, the storage duration varies by brand. Some products, like Omnitrope vials, must be used within 21 days, while Genotropin pens can last up to 28 days. Always check your specific product's instructions.

Shaking the vial or pen vigorously can damage the sensitive protein structure of the growth hormone, rendering it less effective. Always swirl the vial gently to dissolve the powder.

If growth hormone freezes, it should be discarded immediately. The freezing process can irreversibly damage the protein, and using it could lead to ineffective treatment.

For the majority of growth hormone products, storing them at room temperature before mixing is not safe and will compromise the medication's potency. Certain products like Genotropin MINIQUICK are an exception, allowing for limited room temperature storage before reconstitution.

References

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Medical Disclaimer

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