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How long can you keep Stelara in or out of the fridge?

Medically reviewed by Carmen Pope, BPharm. Last updated on Aug 6, 2024.

Official Answer by Drugs.com

Stelara (ustekinumab) comes as a prefilled syringe and should be stored in a refrigerator between 35.6°F and 46.4° F (2°C and 8°C) and not frozen.

Before using, the injection should be taken out of the refrigerator and its carton and allowed to warm to room temperature for 30 minutes. Do not warm in any other way, such as rubbing between your hands, dropping in hot water, or heating in the microwave. Just leave it sitting on top of its carton. The temperature of the room should be less than 77°F (25°C).

Injecting yourself with cold Stelara can be uncomfortable, so this improves the comfort associated with administration.

A few studies have identified problems with storing biologics, such as Stelara. One study showed that only 11.6% of injections were stored correctly; 33.2% were stored for over a week above 46.4° F (8°C) and 11.4% were stored for more than 30 minutes below 32° F (0°C). Unfortunately, it is unknown how much these missteps in storage impact on the effectiveness and absorption of these biologics. Some experts suggest changes in the protein structure of biologics brought about by freeze-thawing or prolonged storage at elevated temperatures may lead to a breakdown in protein structure, the irreversible formation of protein complexes, and a loss of biological activity.

If needed, individual Stelara syringes may be left out of the refrigerator for up to 30 days, as long as the temperature of the room does not exceed 77°F (25°C). Syringes should be left in their original carton to protect from light and the date recorded on the carton that the syringe was taken out of the fridge. The discard date (30 days from that date) should also be written on the carton.

Once a syringe has been stored at room temperature, it should not be returned to the refrigerator. Discard the syringe if it has not been used with 30 days or by the original expiry date.

Never shake Stelara as prolonged vigorous shaking can damage the medicine.

Related questions

How do you travel with Stelara?

If you are traveling for an extended period of time and your dose of Stelara falls during your time away, then follow these steps.

What is Stelara?

Stelara (ustekinumab) is a targeted treatment that reduces inflammation and may be used in the treatment of:

Stelara is administered by injection, under the skin (subcutaneous). The dosage and frequency of administration depend on the condition being treated.

After appropriate training, people can be taught how to self-administer Stelara or caregivers shown how to give it to another person.

References

Read next

Who is the actress in the Stelara commercial?

The 2022 advertising campaign for Stelara, called “Move towards Relief” features an unknown actress because the campaign aimed to include authentic and diverse adults living with moderately to severely active Crohn’s disease and ulcerative colitis to represent a real community. Continue reading

Does Stelara treat ulcerative colitis?

Yes, Stelara was approved by the FDA on October 21, 2019 for the treatment of adult patients with moderately to severely active ulcerative colitis (UC). UC is a serious and long-term inflammatory disease that affects the large intestine (colon) and rectum. Stelara works by targeting proteins called interleukins (IL)-12 and IL-23 to lower inflammation, a main feature of ulcerative colitis. Continue reading

Is Stelara an immunosuppressant?

Yes, Stelara (ustekinumab) is an immunosuppressant. It is approved to treat certain forms of psoriasis, psoriatic arthritis and moderate to severe Crohn's disease and ulcerative colitis. Continue reading

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