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Does omnitrope need to be refrigerated after mixing?

See the DrugPatentWatch profile for omnitrope

Does Omnitrope Need Refrigeration After Mixing?


Omnitrope, a somatropin (human growth hormone) injection, requires refrigeration after reconstitution. Once mixed with the provided diluent, store the solution at 36°F to 46°F (2°C to 8°C) in a refrigerator. Do not freeze it, and protect it from light by keeping it in the original carton.[1][2]

How Long Does Reconstituted Omnitrope Last?


A single 5 mg vial stays stable for up to 21 days refrigerated after first puncture. For cartridge or pen formats (like 5 mg/1.5 mL), use within 28 days from first use when refrigerated. Discard if left unrefrigerated for more than 24 hours or if it appears cloudy/particulate.[1][2]

What If Omnitrope Is Left Out of the Fridge?


Unrefrigerated reconstituted solution remains usable for up to 24 hours at room temperature (up to 77°F or 25°C). Beyond that, potency drops, so discard it. Travel tips: Use a cooler pack for short trips, but avoid direct ice contact to prevent freezing.[1][3]

Storage Rules Before Mixing


Unopened Omnitrope vials, cartridges, or pens must be refrigerated at 36°F to 46°F (2°C to 8°C). Do not freeze or expose to heat/light. Shelf life pre-mixing varies: Check expiration on packaging, typically 2-3 years from manufacture.[1][2]

Patient Tips for Handling and Errors


Mix gently by swirling—do not shake, as it can denature the protein. Inspect for clarity before each dose. If accidentally frozen post-mixing, thaw in fridge and discard if unchanged after 24 hours. Common errors like exposure to heat shorten usability.[3]

Sources:
[1] Omnitrope Prescribing Information, Sandoz (https://www.omnitrope.com/)
[2] FDA Label for Omnitrope, DailyMed (https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=...)
[3] Sandoz Patient Instructions for Use (https://www.sandoz.com/)



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