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Question

Does tesamorelin need to be refrigerated? What the current labels say

The two current tesamorelin products are room-temperature drugs. The refrigerator advice you'll still see online belongs to the original 2010 vial.

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The short answer

Not the current products. Egrifta SV and Egrifta WR are kept at room temperature, 68 to 77°F, in the original box away from light, and neither is refrigerated or frozen after mixing. Only the original 1 mg Egrifta vial, under its 2010 label, went in the refrigerator before mixing.

Key takeaways

  • Egrifta SV and Egrifta WR: store unmixed vials at room temperature, 68 to 77°F, in the original box away from light.
  • After mixing, neither is refrigerated or frozen. Egrifta SV is used right away; a mixed Egrifta WR vial stays at room temperature and is thrown away 7 days after mixing.
  • The original 1 mg Egrifta, approved in 2010, was a different formulation, and its label said to refrigerate unmixed vials.
  • Many consumer leaflets still repeat the old refrigerator advice. Check which product your pharmacy gave you.
  • Tesamorelin is not eligible for the 503A or 503B compounding exemptions. The Egrifta instructions do not validate a different, unapproved preparation.

Tesamorelin is the active drug in Egrifta, an FDA-approved prescription for one use: reducing excess belly fat in adults with HIV and lipodystrophy [1]. Two versions carry current labels, Egrifta SV and Egrifta WR, and both are room-temperature products [1] [2]. If a page tells you to keep tesamorelin in the fridge, it may refer to the older 1 mg formulation or an unapproved preparation. For what tesamorelin is and how it is approved, see the tesamorelin overview.

Short answer: room temperature, not the fridge

Both current labels give the same storage range for unmixed vials: 68 to 77°F (20 to 25°C), kept in the original box to protect them from light [1] [2]. Short trips outside that range, between 59 and 86°F (15 to 30°C), are allowed. After mixing, both labels say not to refrigerate or freeze the solution.

The products differ in what happens after mixing. That is one important difference between the formulations, and it is covered in how tesamorelin is taken. This page covers storage only.

Egrifta SV and Egrifta WR storage, as the labels state it
Egrifta SV and Egrifta WR storage, as the labels state it
ItemEgrifta SVEgrifta WRWhere the label says it
Unmixed vialsRoom temperature, 68 to 77°F (20 to 25°C); excursions 59 to 86°F allowed; in the original box, away from lightRoom temperature, 68 to 77°F (20 to 25°C); excursions 59 to 86°F allowed; in the original box, away from light; do not freezeSection 16 [1] [2]
Box of supplies (water, syringes, needles)Room temperature, 68 to 77°FRoom temperature, 68 to 77°FSection 16
After mixingUse right away; do not store, refrigerate or freezeKeep at room temperature in the medication box; do not refrigerate or freezeSection 2, section 16, patient instructions
How long a mixed vial lastsNot stored: discard what isn't usedThrown away 7 days after mixingSection 2, section 16
Routine labeled storageRoom temperature; ask the pharmacist about an accidental excursionRoom temperature; ask the pharmacist about an accidental excursionPatient instructions

Both labels on DailyMed, versions effective July 2026.

The Egrifta SV label: room temperature, and use it right after mixing

The Egrifta SV label says to store the vials at room temperature, 68 to 77°F, in the original box until it's time to use one [1]. The water, syringes and needles come in a separate box that is also kept at room temperature.

Do not store, freeze or refrigerate EGRIFTA SV after it has been mixed with the Sterile Water.[1]

In other words, Egrifta SV isn't kept once it's mixed. The label says to discard any mixed solution that isn't used immediately.

The Egrifta WR label: room temperature for 7 days after mixing

Egrifta WR is the newer version, approved in March 2025 [4]. One mixed vial covers several days, so its label has a rule Egrifta SV doesn't need. After mixing, the vial goes back in the medication box at room temperature, 68 to 77°F, and is thrown away 7 days after it was mixed [2].

Do not freeze or refrigerate EGRIFTA WR after it has been mixed with the Bacteriostatic Water for Injection.[2]

The unmixed vials follow the same room-temperature range and are kept out of the light. The label adds "do not freeze" for unmixed vials too.

Why some pages still say "refrigerate": the original 1 mg vial

Egrifta was first approved in November 2010 as a 1 mg vial [3]. That label said the unmixed vials "must be stored at refrigerated temperature," 36 to 46°F (2 to 8°C) [3]. Consumer leaflets written for that product, and pages copied from them, still give the refrigerator instruction.

The current Egrifta SV label points out that the 1 mg and 2 mg formulations differ in dosage, mixing and storage requirements, and sends 1 mg users to that product's own label [1]. So the storage rule depends on the vial in your hand. Read the carton, or ask the pharmacy which product it dispensed.

How long can tesamorelin be out of the fridge?

For Egrifta SV and Egrifta WR, the question doesn't apply: both are meant to stay out of the fridge. What matters is keeping the vials within the label's temperature range and using them before the expiration date on the carton. For a mixed Egrifta WR vial, the limit is 7 days after mixing [2].

Neither label says what to do if a vial got too hot or froze. That is a question for the dispensing pharmacist, who can tell you whether to replace it.

Compounded or "research" tesamorelin comes with no reviewed storage rules

Since March 23, 2020, FDA has regulated tesamorelin as a biologic, and biologics can't be made under the compounding exemptions [5] [6]. A commercially marketed vial labeled compounded or "for research use" is not thereby covered by those exemptions or by an FDA-reviewed product label. The Egrifta instructions cannot establish the stability of that different preparation.

That is one more reason the status matters. The details are on whether tesamorelin is FDA-approved, and the risks of an unlabeled vial are covered in is tesamorelin safe.

What to ask your pharmacist

  • Which product is this: Egrifta SV, Egrifta WR, or the 1 mg Egrifta vial? The storage rule depends on the answer.
  • What should I do if a vial got hotter than 86°F or froze in transit? The labels give a range, not a remedy.
  • Where do used needles go? Both patient instructions say to put them in an FDA-cleared sharps container right after use [1] [2].

Storage is one small part of the picture. For what the drug does in trials, see does tesamorelin work. For how long it stays in the body, see how long tesamorelin stays in your system. How these pages pick their sources is on how we check.

Frequently asked

Can tesamorelin be refrigerated?
Not Egrifta SV or Egrifta WR. Both labels say to store the vials at room temperature, 68 to 77°F, and never to refrigerate or freeze them after mixing. Only the original 1 mg Egrifta vial's 2010 label called for the refrigerator.
What happens if Egrifta gets too hot?
The labels allow short excursions between 59 and 86°F but don't say what to do beyond that. Ask the dispensing pharmacist whether the vial should be replaced.
Does Egrifta WR need to be refrigerated after mixing?
No. The Egrifta WR label says to keep a mixed vial at room temperature in the medication box, never refrigerated or frozen, and to throw it away 7 days after mixing.
How long does tesamorelin last once mixed?
Egrifta SV is used right after mixing and isn't stored. A mixed Egrifta WR vial is thrown away 7 days after mixing, according to its label.
Is compounded tesamorelin stored the same way?
Tesamorelin does not qualify for the 503A or 503B compounding exemptions. The Egrifta storage instructions do not validate an unapproved compounded or research vial.

Sources

  1. [1] DailyMed. EGRIFTA SV (tesamorelin) for injection, prescribing information and patient instructions (version effective July 29, 2026) (2026). DailyMed label
  2. [2] DailyMed. EGRIFTA WR (tesamorelin) for injection, prescribing information and instructions for use (version effective July 29, 2026) (2026). DailyMed label
  3. [3] FDA. EGRIFTA (tesamorelin) for injection 1 mg, original prescribing information, NDA 022505, 2010. FDA
  4. [4] FDA. Approval letter, NDA 022505/S-020 (Egrifta WR), March 25, 2025. FDA
  5. [5] FDA. Notice to compounders: changes that affect compounding on March 23, 2020. FDA
  6. [6] FDA. List of approved NDAs for biological products that were deemed to be BLAs on March 23, 2020. FDA

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