Omnitrope, a synthetic human growth hormone (somatropin) made by Sandoz Biopharmaceuticals, is an effective treatment for many children and adults with growth hormone deficiencies.
But the effectiveness of this injectable HGH extends beyond its bioengineered formulation. One of the keys to ensuring its efficacy is its storage conditions, particularly refrigeration.
So, here's an in-depth look at the storage requirements for your Omnitrope pens and vials. Why must they be kept refrigerated? What happens when they're left at room temperature?
Understanding these storage instructions is essential for anyone handling Omnitrope. It underscores the interplay between optimal storage conditions and therapeutic effectiveness.
Related article: Growth Hormone, A Comparison of Different Brands.
What is Omnitrope?
Omnitrope is a synthetic version of the human growth hormone (HGH) used to treat various conditions in both children and adults. Produced by Sandoz Biopharmaceuticals through recombinant DNA technology, Omnitrope is indicated in conditions like growth hormone deficiency, Turner syndrome, idiopathic short stature, and Prader-Willi syndrome.
The active ingredient in Omnitrope is somatropin, like in Humatrope, Norditropin, Nutropin, and other HGH treatments.
Human growth hormone, produced by the pituitary gland, stimulates growth during childhood and maintains tissue and organ function throughout life. In cases where the body cannot produce sufficient HGH, Omnitrope can be used as a replacement therapy.
HGH therapy works by stimulating tissue growth, enhancing protein production, and boosting fat breakdown to help provide the energy needed for tissue growth.
Omnitrope is an injectable drug that comes in two forms: a traditional vial with lyophilized powder which is mixed with a solvent before use in a syringe, and a prefilled injector pen with cartridges for easier application.
Omnitrope (somatropin) is a prescription medication. It can cause serious side effects, including local reactions at the injection site, headaches, swelling, joint pain, muscle pain, carpal tunnel syndrome, and others. Never use it without medical advice and supervision. Regular monitoring and dose adjustments are necessary to ensure effective and safe treatment.
Related article: A Practical Guide to Using and Storing Humatrope Pens.
Does Omnitrope Need to Be Refrigerated?
Yes, Omnitrope needs to be refrigerated. Somatropin, its active ingredient, is a very sensitive biologic that quickly deteriorates if not properly stored. Therefore, storing your vials or pens of Omnitrope correctly is essential to maintain its efficacy and safety. Refrigeration is the only way to do so.
Why does Omnitrope need to be refrigerated?
Omnitrope, like other forms of synthetic human growth hormone, is a protein-based medication. Proteins are complex molecules sensitive to conditions like temperature, light, and pH.
Keeping somatropin at a lower temperature slows down the degradation process, helping preserve the medication's structure and function. This way, the quality, safety, and efficacy of the medicine can be ensured throughout its shelf-life.
If Omnitrope is left at room temperature for extended periods, it may degrade more rapidly. This degradation can lead to a loss of potency, meaning it might not work as effectively as expected.
In some cases, if the protein degrades significantly, it could form aggregates - clumps of molecules that could provoke an immune response if injected, although this is rare. This immune response might lead to side effects, and in the worst cases, it could reduce the effectiveness of the therapy or render it completely ineffective.
Therefore, the following storage instructions must be followed to ensure your HGH injections remain potent.
Related article: Why You Should Store Genotropin (Somatropin) in the Fridge.
Storage instructions
According to Sandoz Biopharmaceuticals, the manufacturer of Omnitrope, the injection vials, pens, and cartridges should be stored in the refrigerator between 36°F to 46°F (2°C to 8°C) both before and after reconstitution (mixing).
Additionally, the manufacturer warns that Omnitrope should also be protected from light (kept in its original carton box when possible) and must not be frozen.
How long can it stay out of the fridge?
It is recommended to refrigerate Omnitrope as soon as possible after each injection to maintain its optimal effectiveness. Somatropin should not be kept out of the fridge for more than one hour per day.
How long is Omnitrope good for?
Before use and when adequately kept refrigerated, Omnitrope cartridges and vials are good until the expiration date labeled on the container.
If you’re using Omnitrope injector pens: after the first use of a cartridge, it should remain in the pen and be refrigerated. It must be used within 28 days.
If you’re using Omnitrope vials: after reconstitution of a vial (mixing), it must be kept refrigerated and used within 3 weeks.
Related article: All You Need To Know About Nutropin AQ!
Travel Coolers for Omnitrope
When traveling or transporting Omnitrope, it's important to keep it refrigerated within the required temperature range.
Given somatropin's extreme instability at room temperature, you need a performant and reliable portable cooler. Carrying your Omnitrope injections in insulated lunch bags with ice packs is not recommended because the temperature inside fluctuates too much, which could damage your medicine.
Most people who depend on refrigerated drugs like Omnitrope choose to use 4AllFamily’s portable fridges when traveling.
These medical-grade coolers are designed to maintain a temperature between 36°F to 46°F (2°C to 8°C) for several hours or even days, depending on the model. Our most performant models include a built-in thermostat, anti-freeze safety, and temperature display.
Some of our coolers work with electricity (USB car cigarette lighter, household power, portable solar panel, travel power bank, etc.), while some use biogel freeze pack technology, and others combine both refrigeration methods!
See all our coolers for Omnitrope here! Do not hesitate to contact our support team for further guidance.
Related article: Tips for Storing Norditropin HGH at Home and While Traveling.
Omnitrope vs. Humatrope vs. Genotropin vs. Norditropin vs. Nutropin and Other HGH
Omnitrope isn't the only brand of somatropin. Many HGH injections are made with somatropin as the main active drug, including Humatrope, Genotropin, Norditropin, Nutropin, Saizen, Zomacton, Tev-Tropin, and others.
All these medications are forms of somatropin used to treat growth hormone deficiencies and other conditions.
However, they differ in formulation, method of administration, excipients, solvents, dosage, strength, availability, pricing, injection devices, indications, FDA approvals,
Despite being different brands of the same active drug, they are not interchangeable. Their respective specificities can impact patient preference, ease of use, as well as the success of the therapy.
Always consult a healthcare professional for advice on which medication would be most suitable for you. They will consider several factors, like your condition, overall health, potential side effects, lifestyle, and cost.
Comments
4AllFamily Customer Care Team said:
Dear Franceen,
Thank you for your questions. I will try to answer them as best as I can:
1. Omnitrope is very sensitive to temperature and can only stay unrefrigerated for one hour per day approx. It’s hard to say if it’s been affected by the shipping conditions, because there’s no data about what was the exact temperature inside the package. However, it seems like the refrigeration conditions were not respected, so it could have affected your injections efficacy.
2. When Omnitrope is left unrefrigerated, its starts to degrade and lose potency. However, it should not cause painful side effects. I would recommend asking for your doctor’s advice here.
3. Omnitrope´s manufacturer storage instructions are pretty clear on the fact that it must be refrigerated at all time possible. I would suggest asking for your pharmacist’s advice and contacting the manufacturer to complain about the shipping conditions and request a new batch.
I hope everything goes well,
Warm regards,
4AllFamily
4AllFamily Customer Care Team said:
Dear Franceen,
Thank you for your questions. I will try to answer them as best as I can:
1. Omnitrope is very sensitive to temperature and can only stay unrefrigerated for one hour per day approx. It’s hard to say if it’s been affected by the shipping conditions, because there’s no data about what was the exact temperature inside the package. However, it seems like the refrigeration conditions were not respected, so it could have affected your injections efficacy.
2. When Omnitrope is left unrefrigerated, its starts to degrade and lose potency. However, it should not cause painful side effects. I would recommend asking for your doctor’s advice here.
3. Omnitrope´s manufacturer storage instructions are pretty clear on the fact that it must be refrigerated at all time possible. I would suggest asking for your pharmacist’s advice and contacting the manufacturer to complain about the shipping conditions and request a new batch.
I hope everything goes well,
Warm regards,
4AllFamily
Franceen Hill said:
Three Questions:
(1)My Omnitrope powder vials were sent from Utah to Los Angeles via an overnight 27-hour UPS trip – the ice pack arrived more than 7/8% melted. The package arrived “slightly cool” . Should I expect less potency?
(2)My current nightly injections bring on new and intense body & joint pain that I have never experienced before with many year’s Omnitrope use – could this pain be a side effect brought on by non refrigeration?
(3) Your site seems to be clear on the importance of Omnitrope refrigeration – should I throw this batch out and order new Omnitrope with more prompt delivery specifications?
Thank you.