Is Frozen Testosterone Still Safe To Use?
In our latest question and answer, the pharmacist discusses if it is safe to use testosterone injection if it has been frozen.
I take testosterone cypionate and it froze. Is it wasted now?
Nov 13, 2022- Frozen testosterone should not be used because it has been stored outside the required temperature range and may be degraded or ineffective.
- Liquid medications that freeze can break down or change, similar to what happens with insulin and vaccines, potentially causing loss of effectiveness or side effects.
- You should discard frozen testosterone and work with your doctor and pharmacy to get a replacement vial.
Answer
If your testosterone cypionate solution for injection accidentally froze, you should not use it since it has been stored outside the required storage conditions for the drug.
The prescribing information for testosterone cypionate states the drug should be stored as follows:
Store at 15°C to 25°C (59°F to 77°F); excursions permitted to 2°C to 30°C (36°F to 86°F). Store product in carton to protect contents from light.
Although I couldn't find any specific information regarding testosterone, studies have shown that medications in a liquid dosage form that have been frozen (and aren't intended to be) can degrade and/or be altered. This could potentially lead to serious side effects and a loss of effect.
One type of drug where this has been demonstrated is with insulin. One study showed that when certain types of insulin are frozen and thawed, there is evidence of drug degradation and "particle clumping".
Another example is with protein-based drugs, where freezing and thawing can produce 'shearing' forces on the drug molecules, rendering them ineffective. One such study stated the following:
During thawing, additional damage to proteins is caused by recrystallization process. Recrystallization exerts additional interfacial tension or shear on the entrapped proteins and hence causes additional damage to the latter.
A number of studies have also shown that several vaccines can be made ineffective by inadvertent freezing. The World Health Organization (WHO) has even provided guidance on how to avoid this.
What To Do If Your Testosterone Has Frozen
If the drug you are taking has accidentally frozen or was otherwise stored outside of the required storage conditions, you should discard the medication and not use it. This is the case for testosterone cypionate injection.
Even when we don't have specific information on a particular drug and how freezing could affect it, it should not be used. It could be ineffective or increase the risk of side effects if it were used.
Manufacturers base their storage requirements on stability tests, and if we don't know how a drug could be affected when stored outside the requirements, it is best not to use it. When it comes to using medication, it is important they are safe and effective, something that can't be guaranteed if the medication wasn't stored properly.
Be sure to work with your doctor and pharmacy regarding how to get a replacement vial.
Final Words
Thanks for reaching out!
References & sources
- Aide-memoire for prevention of freeze damage to vaccines — World Health Organization
- Impact of Freeze/Thaw Process on Drug Substance Storage of Therapeutics — PubMed
- The effects of freezing on commercial insulin suspensions — ScienceDirect
- The Stability of Insulin in Crystalline and Amorphous Solids: Observation of Greater Stability for the Amorphous Form — Springer
- Effect of freezing and thawing rates on denaturation of proteins in aqueous solutions — PubMed
- Drugs and Drug Administration in Extreme Environments — Oxford Academic
- TESTOSTERONE CYPIONATE INJECTION Prescribing Information — AccessFDA
Glossary — Terms in This Answer
- Testosterone cypionate
- A form of the male hormone testosterone given by injection that is used to treat low testosterone levels.
- Dosage form
- The physical form in which a medication is prepared and given to a patient, such as a liquid, pill, or injection.
- Drug degradation
- The breakdown or chemical breakdown of a medication into less effective or potentially harmful substances over time.
- Insulin
- A hormone that helps control blood sugar levels in the body, commonly used to treat diabetes.
- Particle clumping
- The sticking together of tiny particles in a liquid medication, which can make it less effective.
- Recrystallization
- The formation of new crystal structures in a frozen substance during thawing that can damage the medication.
- Shearing forces
- Stress or pressure that tears or separates molecules apart, causing damage to medication molecules.
- Stability tests
- Scientific studies performed by manufacturers to determine how a medication breaks down or changes under different storage conditions.
Dr. Brian Staiger, PharmD
Doctor of Pharmacy, board certified clinical pharmacist (BCPS), American Herbalist Guild, Medication Therapy Management certified
Brian Staiger, PharmD, BCPS, is a licensed pharmacist with more than 13 years of experience across retail pharmacy, clinical pharmacy, medication safety, pharmacy program development, and healthcare administration. He is the founder of HelloPharmacist.com, where he helps patients...
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