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Stelara (ustekinumab) Approved by the U.S.

STELARA 45 mg solution for injection in pre-filled syringe

Package leaflet: Information for the user.

Medpage Today News: Biologics Storage: Getting It Just Right Medpage Today.

Stelara (ustekinumab) Janssen Biotech, Inc.

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The dosage and frequency of administration depend on the condition being treated.Īfter appropriate training, people can be taught how to self-administer Stelara or caregivers shown how to give it to another person.

Keep out skin#

Stelara is administered by injection, under the skin (subcutaneous).

Moderate-to-severe ulcerative colitis in adults.

Moderate-to-severe Crohn's disease in adults after other medicines have failed.

Active psoriatic arthritis in children who are at least 6 years old.

Psoriatic arthritis in adults, sometimes in combination with methotrexate.

Plaque psoriasis in adults and children who are at least 6 years old.

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

If you are traveling for longer than this, you may need to arrange a cool box or ask for it to be kept in a refrigerator on the plane.

Stelara can be kept at room temperature for up to 30 days.

Keep the injection away from sunlight and heat.

Put it in a purse or briefcase, and bring the box label.

Remove the agent from the refrigerator, and wrap the injectable syringe in bubble wrap or light insulation.

If you are traveling for an extended period of time and your dose of Stelara falls during your time away, then follow these steps. Never shake Stelara as prolonged vigorous shaking can damage the medicine. Discard the syringe if it has not been used with 30 days or by the original expiry date. Once a syringe has been stored at room temperature, it should not be returned to the refrigerator. The discard date (30 days from that date) should also be written on the carton. 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. 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☏ (25☌). 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. Unfortunately, it is unknown how much these missteps in storage impact on the effectiveness and absorption of these biologics.

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☌) and 11.4% were stored for more than 30 minutes below 32° F (0☌). Injecting yourself with cold Stelara can be uncomfortable, so this improves the comfort associated with administration.Ī few studies have identified problems with storing biologics, such as Stelara.

The temperature of the room should be less than 77☏ (25☌). Just leave it sitting on top of its carton. Do not warm in any other way, such as rubbing between your hands, dropping in hot water, or heating in the microwave. Stelara (ustekinumab) comes as a prefilled syringe and should be stored in a refrigerator between 35.6☏ and 46.4° F (2☌ and 8☌) and not frozen.īefore 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 put Stelara that has already been allowed to warm up to room temperature back in the refrigerator.Individual Stelara syringes can be left out of a refrigerator for up to 30 days, so long as the room temperature is less than 77☏ (25☌), and the Stelara does not expire within that time.Before using, the injection may be taken out of the refrigerator and its carton and allowed to warm to room temperature for 30 minutes.Stelara needs to be stored in a refrigerator.