It’s advisable to refrigerate compounded tirzepatide. Warmer temperatures can alter the chemical structure and break down the molecular structure of the medication. This causes the drug to lose its efficiency and become risky for people.
Proper storage is always mandatory when it comes to medication.
It’s the same for compounded tirzepatide.
Compounded tirzepatide is primarily prescribed for type 2 diabetes. Its use for weight management should be determined by a licensed provider.
However, one factor that heavily influences its efficiency is temperature. Keeping it at the right temperature ensures the drug stays stable and potent.
That’s why you must know how to store it, the right temperature, and related factors.
Tirzepatide: Branded vs. Compounded
What Is Tirzepatide?
A novel medication.
Tirzepatide is a once-weekly injectable drug for the treatment of type 2 diabetes. It’s a dual-action agonist of—
- The glucagon-like peptide-1 (GLP-1) receptor and
- The glucose-dependent insulinotropic polypeptide (GIP) receptor
Both GLP-1 and GIP are peptide hormones secreted in our intestines. The difference is that—
GLP-1 helps stimulate insulin release and suppresses glucagon secretion to regulate blood sugar levels. OTOH, GIP adjusts glucose-induced insulin secretion and boosts “below normal” glucagon secretion to keep sugar levels well-regulated.
Tirzepatide is primarily an anti-diabetic medication. While it affects appetite and metabolism, its use for weight management should be determined by a licensed provider.
This controls hunger and reduces overeating, which leads to weight management benefits.
However, tirzepatide isn’t a weight-loss medication, and it won’t work for everyone.
Difference Between Tirzepatide and Compounded Tirzepatide
The branded version of tirzepatide is different from the compounded one. There are a few factors that make the two different.
Formulation and Strengths
Branded tirzepatide is generally produced for patients with type 2 diabetes.
It has a standardized formulation. This means each solution contains the same amount of tirzepatide and inactive ingredients.
Each 0.5mL solution can contain:
- 2.5 mg/5 mg/7.5 mg/10 mg/12.5 mg/15 mg of tirzepatide
- 4.1 mg of sodium chloride
- 0.7 mg Sodium phosphate dibasic heptahydrate
Moreover, the injection has gone through a strict, uniform process to ensure consistency in potency, purity, and efficiency.
Compounded tirzepatide is prepared by compounding pharmacies. It may contain customized formulations based on individual patient needs.
Variations may include:
- Different strengths
- Dosages, or
- Additives like vitamin B12 or B6
Regulatory Status
Branded tirzepatide has gone through rigorous testing and extensive clinical trials. This shows its safety and efficacy.
That’s why the medication is FDA-approved.
This approval ensures that tirzepatide meets strict manufacturing and quality standards.
Compounded tirzepatide isn’t FDA-approved.
The reason is that it’s not produced following the same process and formulation. Instead, it’s prepared differently depending on the individual case.
Storage Implications
Manufacturers provide specific storage instructions when it comes to branded tirzepatide. It typically needs refrigeration—
- Between 36°F and 46°F (2°C to 8°C)
This helps maintain its stability and potency.
Storage requirements for compounded tirzepatide can vary. It depends on the–
- Formulation and
- Pharmaceutical institutions
To ensure efficiency, follow the storage guidelines the tirzepatide compounding pharmacy provides.
The Science Behind Refrigeration
Why Does Temperature Matter?
It helps maintain the stability and integrity of compounded drugs. That’s why temperature matters.
Compounded drugs are specially prepared medications that aren’t typically available in standard forms. They need specific storage conditions to remain effective.
When tirzepatide is exposed to higher temperatures, its chemical and physical structure may change.
Result: Reduced potency. This means the drug may not work as intended.
Problems
One study found that peptide-based drugs can have fibril issues. It’s when the peptides stick together and form fiber.
Factors like the following can cause this effect:
- Temperature
- Acidity (pH)
- Salt levels, and
- Shaking
However, experts say that, temperature plays a big role.
Such medication can also create byproducts.
Another research mentions:
Diketopiperazine, a side product, was formed in the tirzepatide. This was due to factors like chemicals and improper temperature.
This caused instability in the medication and made it inefficient. The experts suggested proper storage at cooler temperatures to keep it stable.
The U.S. Pharmacopeia (USP) recommends storage of certain medication—
- 2°C and 8°C (36° and 46° F).
It’s standard for compounded tirzepatide. However, it can vary based on personalization.
Do check the guidelines or consult the manufacturer to know about it.
This cold storage helps ensure that the drug remains stable and effective.
Compounded Tirzepatide At Different Temperatures
Refrigerated Temperatures
The ideal refrigerated temperature for the compounded tirzepatide is 2°C to 8°C. It’s usable until the expiry date or up to 21 or 28 days.
- Disclaimer: Talk to an expert to learn more about the expiry date.
A study says it may remain the most stable for at least 14 days when refrigerated at 4°C.
Room Temperature
The compounded tirzepatide may stay good at temps below 30°C or 86°F.
But how long can compounded tirzepatide be at room temperature?
The drug may start degrading and breaking down molecular structures once it crosses 21 days.
Experts suggest throwing it away after 21 days if it stays unused and out of the fridge.
High and Freezing Temperatures
Extreme temperatures, like when it’s higher and lower than the recommended range, are bad for the compounded tirzepatide.
This can alter the chemical composition and traits of the drug. Moreover, side products can form as a result.
One study found that peptide-based drugs lost stability and formed deposits at 50°C.
There isn’t any research on the impact of freezing temperatures.
Suppliers and experts suggest you don’t freeze it. The consequences can be similar or worse.
What Happens If Tirzepatide Is Not Refrigerated?
It’s not advisable to keep the tirzepatide at room temperature.
There isn’t any specific research regarding the effects of temperature on tirzepatide. However, different studies say peptide-based drugs can change their composition under improper temperatures.
Although the solution can stay good out of the fridge for around 21 days, experts discourage storing it that way.
Consequence Of Tirzepatide If Not Refrigerated
- Breakdown of molecular structure
- Aggregation like Fibrils
- Microbial growth
- Side product
- Oxidation
- Reduction
All these instabilities make the medication less efficient and risky for use.
Storage Guidelines: Packaging, Refrigeration & Ideal Spot
Compounded Tirzepatide Storage Best Practices
Refrigerate The Medication
As we mentioned countless times, compounded tirzepatide should be refrigerated.
Cold storage can help keep the medication stable.
Store your tirzepatide in a refrigerator. Your fridge temperature should stay in the 2°C to 8°C range (36° to 46°F).
Ensure it’s not set too cold.
This ensures that its critical components remain intact and don’t cause any chemical reactions. Plus, it preserves its overall efficiency.
Designate A Storage Area
Figure out where you can keep your compounded tirzepatide.
Your fridge should have a specific spot solely for medications, particularly tirzepatide.
Avoid placing it near foods. This helps prevent cross-contamination if vials or pens leak.
Consider keeping it in the center of the refrigerator. Make sure it’s away from the freezer compartment.
This spot maintains a consistent temperature. Plus, it protects the drug from freezing and warming.
Ensure Proper Packaging
The original packaging is the best.
Keep your compounded tirzepatide vial or pen in its original packaging. This protects the drug from external factors.
Before each use, check for any damage or leaks in the vial or pen. Store the medication properly in the fridge.
Also, keep the compounded tirzepatide away from heat sources like:
- Light or sunlight
- Radiator
- Stoves
They can degrade the medication and reduce its efficiency. Ensure you store it in a dark container or packet.
Check Expiry Dates
Always check the expiry dates before use.
Administering the expired drug can lead to inefficient treatment and risks like:
- Nausea
- Headaches
- Digestive discomfort
- And many more unpredictable side effects
There are two expiry dates:
- The "official" expiration date: You see it labeled on the pen or vial by the manufacturer. It indicates the time until when tirzepatide is good if consistently stored in a refrigerator.
- The expiry after 21 days: It happens when the chemical structure breaks down, and the drug loses its potency after 3 weeks.
Check specifics for compounded tirzepatide from your pharmacy, as these may vary.
Keep track of both expiry dates. Throw away the drug if it goes past them,
Safety Tips
Wash your hands
Always wash your hands with soap and water. It helps prevent contamination.
Use Isopropyl Alcohol
Clean your fingers and the area with an alcohol pad. It eliminates the bacteria and other microbes.
Follow Dosage Instructions
Consult an expert like a GobyMeds telehealth provider to determine whether compounded tirzepatide is right for you. Also, discuss the dosage and strength.
Stick to the dosage the experts prescribe. Taking the wrong, too much, or too little dosage can cause unpredictable problems.
Report Any Side Effects
If you experience any side effects or unusual reactions, rush to the hospital.
Report these to your healthcare provider immediately. It helps:
- Ensure your safety and
- Allow for proper management
