Stelara dosage, forms, and strengths

Stelara (ustekinumab) is a brand-name drug used for treating moderate to severe plaque psoriasis, active psoriatic arthritis, hidradenitis suppurativa, Crohn’s disease, and ulcerative colitis. All are autoimmune conditions that cause inflammation and damage to the body’s tissues. The active ingredient in the injection is a monoclonal antibody that inhibits two proteins critical to the inflammatory response. Unlike similar biologic drugs, Stelara injections are spread far apart, from one dose every eight weeks (for inflammatory bowel disease) to one dose every 12 weeks (for psoriasis and psoriatic arthritis). 

Stelara forms and strengths

Stelara can be purchased at a pharmacy as a prefilled syringe for subcutaneous injections in two dosage strengths. Stelara vials are used for intravenous injections. 

• Prefilled syringe: 0.5 milliliters (mL) of 45 mg/0.5 mL, 1 mL of 0.9 mg/mL

• Vial: 26 mL of 5 mg/mL (130 mg total)

Stelara dosage for adults

Stelara is prescribed as a maintenance treatment for plaque psoriasis. For other FDA-approved conditions, such as psoriatic arthritis and inflammatory bowel disease (IBD), Stelara is initiated during an active flare-up to achieve control of the condition and is subsequently transitioned to long-term maintenance treatment. Doses are self-administered. Sometimes, the first dose is given by a healthcare professional as an intravenous infusion.

Stelara dosage for moderate to severe plaque psoriasis

The FDA has approved Stelara to treat moderate to severe plaque psoriasis in people who are candidates for systemic therapy or phototherapy. Stelara works by blocking interleukin 12 and interleukin 23 cytokines, substances that provoke the immune and inflammatory responses that cause the symptoms of psoriasis. After two initial doses are taken four weeks apart, Stelara injections are self-administered under the skin (subcutaneous) once every three months as a maintenance treatment. Doses are based on body weight. People weighing less than 100 kg (220 pounds) receive 45 mg injections. People at a higher weight take 90 mg injections. The recommended dosage is the maximum dosage.

• Initial Stelara dosage for moderate to severe plaque psoriasis: 45 mg (for people weighing less than 100 kg) or 90 mg (for people weighing more than 100 kg) subcutaneous injection followed by a second 45 mg or 90 mg subcutaneous injection four weeks later

• Standard Stelara dosage for moderate to severe plaque psoriasis: 45 mg (for people weighing less than 100 kg) or 90 mg (for people weighing more than 100 kg) subcutaneous injection followed by a second 45 mg or 90 mg subcutaneous injection four weeks later

Stelara dosage for active psoriatic arthritis (PsA)

Psoriatic arthritis is a joint manifestation of psoriasis. Stelara acts as an immunosuppressant to prevent the immune system from attacking healthy joint tissues. The first doses are given four weeks apart. After that, maintenance doses are injected subcutaneously every 12 weeks.

• Initial Stelara dosage for psoriatic arthritis: 45 mg subcutaneous injection followed by a second 45 mg subcutaneous injection four weeks later

• Standard Stelara dosage for psoriatic arthritis: 45 mg subcutaneous injection followed by a second 45 mg subcutaneous injection four weeks later

Stelara dosage for active psoriatic arthritis in people with moderate to severe plaque psoriasis

In people with psoriatic arthritis and moderate to severe plaque psoriasis, the dosages are identical to those for plaque psoriasis. This is true even if the initial reason for treatment is psoriatic arthritis. People will receive 45 mg or 90 mg doses based on their body weight.

Stelara dosage for inflammatory bowel disease

Healthcare professionals also use Stelara to treat active Crohn’s disease and active ulcerative colitis in adult patients. The FDA has approved Stelara only after corticosteroids or immunomodulators like methotrexate have been tried and failed. It is not necessary for healthcare providers to use TNF blockers or biologic drugs before prescribing Stelara. 

• Standard Stelara dosage for psoriatic arthritis: 90 mg first dose given as an IV infusion with follow-up doses of 90 mg given as subcutaneous injections every eight weeks

Stelara dosage for children

Children as young as 6 years old can be treated with Stelara for plaque psoriasis or psoriatic arthritis. Dosing for children and adolescents is based on body weight. Doses will be calculated precisely for children weighing less than 60 kilograms (132 pounds). To do this, healthcare professionals will use single-dose vials following a chart provided in the manufacturer’s prescribing information. As with adults, the first dose will be followed by a second four weeks later. All follow-up doses are taken every 12 weeks.

Stelara dosage restrictions

The FDA has not recommended dosage reductions or restrictions for people with liver dysfunction or kidney problems or in people older than 65.

How to take Stelara

Except for the first dose in people with ulcerative colitis or Crohn’s disease, patients or their caregivers will inject a dose at home every eight or 12 weeks. A healthcare professional will give proper training in administering injections using the pre-filled syringe. Ask the healthcare provider for clarification if there are any questions or confusion. The Instructions for use included with the syringe have detailed step-by-step instructions. The Stelara website has an instructional video that goes through each step of the self-injection process.

General tips

• Read the medication guide and instructions for use that come with this medicine.

• You will inject this medicine under the skin.

• The prescriber will specify the exact dose and how often it should be taken.

• Review the instructions included with the medicine before administering each injection.

• Before administering an injection, check the Stelara package to ensure the dose is correct and the medicine has not expired.

• Contact the prescribing healthcare provider for medical advice if a dose is missed.

Preparing for the injection

• The shot can be injected under the skin on the abdomen, buttocks, or upper thighs.

• Caregivers can inject the medicine under the skin in the upper arms if they choose to do so.

• Pick a different area of the body for each injection.

• Do not inject through skin that is red, hard, or bruised.

• Clean the injection site with an antiseptic wipe before giving the injection. 

How to inject Stelara

• Carefully remove the pre-filled syringe from the package without touching the plunger.

• Do not shake the syringe.

• Inspect the medicine in the syringe to make sure it is clear to light yellow. Do use the syringe if the medicine is discolored, cloudy, or contains large particles. Do not use the syringe if it appears damaged.

• Carefully remove the needle cover. Do not touch the plunger while removing the needle cover.

• Pinch the skin at the injection site.

• Holding the syringe with the index finger and thumb, quickly insert the needle at a 45-degree angle into the pinched skin.

• Push the plunger down fully to inject the medicine.

• Make sure to inject all the medicine.

• Keep pushing down the plunger and remove the needle from the skin.

• When the thumb is removed from the plunger, the needle guard will automatically cover the needle.

• Dispose of the syringe in a sharps container that is out of the reach of children and pets.

Storing this medicine

• Store Stelara in the refrigerator in its original package, protected from light.

• Do not freeze Stelara.

• Stelara can also be stored in its original package at room temperature for up to 30 days. Once Stelara is at room temperature, do not return it to the refrigerator.

• Do not remove the pre-filled syringe from the package until ready to give an injection.

• Do not shake the carton.

Stelara dosage FAQs

How long does it take Stelara to work?

In clinical trials, between 60% and 70% of people taking Stelara for plaque psoriasis had significantly clearer skin from their initial baseline after 12 weeks. 

For psoriatic arthritis, it took about 24 weeks for half of the participants in one clinical study to see symptom improvement. 

For inflammatory bowel disease, the goal is to have remission of symptoms eight weeks after the intravenous induction dose. Not all patients will experience these results.

How long does Stelara stay in your system?

The half-life of Stelara ranges from a minimum of 9 days to a maximum of 125 days but is 19 days in most people. However, in people taking continuous doses every eight or twelve weeks, Stelara hits a steady concentration in the blood after 28 weeks of therapy.

What happens if I miss a dose of Stelara?

Do not miss a dose of Stelara. If a dose is missed, contact the prescribing healthcare provider for advice. 

How long can you take Stelara?

Stelara is intended as a long-term, even multi-year treatment. People can take Stelara for as long as it works, and the side effects of Stelara are under control. Adverse effects are a concern. People may quit the medication voluntarily or be taken off it because of serious side effects. Because Stelara blocks the immune system, people are vulnerable to serious infections, malignancies, and skin cancer. Stelara can also cause swelling in the brain, called posterior reversible encephalopathy syndrome (PRES). Stelara may also be discontinued if people develop antibodies to the drug, making the drug less effective. Stelara will also be discontinued if people have hypersensitivity reactions to the drug or need to receive live vaccines . Examples of live vaccines are chicken pox, intransal flu, MMR, and Japanese encephalitis vaccine.

What is the maximum dosage for Stelara?

The recommended dose is the maximum dosage for Stelara. It is difficult to overdose on Stelara because doses are taken at wide intervals. People will usually not have enough medicine for an overdose. If the dose of Stelara given exceeds the maximum dose, call a poison helpline or go to an emergency room.

Is it safe to take Stelara during pregnancy?

Stelara is prescribed to pregnant women. Animal studies suggest there is little risk of birth defects or other pregnancy problems. For the mother, there is an increased risk of infection. Ustekinumab has been discovered in at least one infant born to a mother taking Stelara, though there were no adverse effects reported. 

Is it safe to take Stelara while breastfeeding?

Healthcare providers prescribe Stelara to women who are breastfeeding. Ustekinumab is present in breast milk, according to clinical and case studies. No adverse effects or increased risk of infections have been reported for the infants.

Sources

• Crohn’s disease treatments and medications, SingleCare

• Psoriasis treatments and medications, SingleCare

• Stelara, Janssen Biotech, Inc

• Stelara medical information: Use of Stelara in nursing mothers, Janssen Biotech, Inc

• Stelara prescribing information, NIH National Library of Medicine

• Ulcerative colitis treatments and medications, SingleCare