Ustekinumab

What is Ustekinumab?

• Ustekinumab (STELARA) is a human interleukin-12 and -23 antagonist used for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis.

What are the uses of this medicine?

Ustekinumab (STELARA) is a prescription medicine used to treat:

• adults and children 6 years and older with moderate or severe psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills).
• adults 18 years and older with active psoriatic arthritis. STELARA can be used alone or with the medicine methotrexate.
• adults 18 years and older with moderately to severely active Crohn's disease.
• adults 18 years and older with moderately to severely active ulcerative colitis.

How does this medicine work?

Ustekinumab is a human IgG1қ monoclonal antibody that binds with specificity to the p40 protein subunit used by both the IL-12 and IL-23 cytokines. IL-12 and IL-23 are naturally occurring cytokines that are involved in inflammatory and immune responses, such as natural killer cell activation and CD4+ T-cell differentiation and activation.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with clinically significant hypersensitivity to ustekinumab or to any of the excipients.

What drug interactions can this medicine cause?

• In psoriasis studies the safety of STELARA® in combination with immunosuppressive agents or phototherapy has not been evaluated.
• Upon initiation of STELARA® in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, monitoring for therapeutic effect (e.g., for warfarin) or drug concentration (e.g., for cyclosporine) should be considered and the individual dose of the drug adjusted as needed.
• STELARA® has not been evaluated in patients who have undergone allergy immunotherapy. Caution should be exercised in patients receiving or who have received allergen immunotherapy, particularly for anaphylaxis.

Is this medicine FDA approved?

• Ustekinumab was approved for use in psoriasis United States in 2010, and current indications include moderate-to-severe plaque psoriasis and active psoriatic arthritis.
• Ustekinumab has been evaluated in other autoimmune diseases including Crohn disease, but does not have official approval for use in other conditions.

How should this medicine be used?

Recommended dosage:

• Psoriasis:

Subcutaneous Adult Dosage Regimen

• For patients weighing 100 kg or less, the recommended dose is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks.
• For patients weighing more than 100 kg, the recommended dose is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks.
• In subjects weighing more than 100 kg, 45 mg was also shown to be efficacious. However, 90 mg resulted in greater efficacy in these subjects.

Subcutaneous Pediatric Dosage Regimen

• Administer STELARA® subcutaneously at Weeks 0 and 4, then every 12 weeks thereafter.

The recommended dose of STELARA® for pediatric patients (6–17 years old) based on body weight is shown below:

Weight Range (kilogram)	Dosage Regimen
less than 60 kg	0.75 mg/kg
60 kg to 100 kg	45 mg
greater than 100 kg	90 mg

• Psoriatic Arthritis Adult Subcutaneous Recommended Dosage:
• The recommended dosage is 45 mg administered subcutaneously initially and 4 weeks later, followed by 45 mg administered subcutaneously every 12 weeks.
• For patients with co-existent moderate-to-severe plaque psoriasis weighing greater than 100 kg, the recommended dosage is 90 mg administered subcutaneously initially and 4 weeks later, followed by 90 mg administered subcutaneously every 12 weeks.

• Crohn's Disease and Ulcerative Colitis Initial Adult Intravenous Recommended Dosage:

Weight Range (kilogram)	Recommended Dosage
up to 55 kg	(2 vials)
greater than 55 kg to 85 kg	(3 vials)
greater than 85 kg	(4 vials)

Crohn's Disease and Ulcerative Colitis Maintenance Adult Subcutaneous Recommended Dosage:

• A subcutaneous 90 mg dose 8 weeks after the initial intravenous dose, then every 8 weeks thereafter.

Administration:

• Use STELARA exactly as your doctor tells you to.
• The needle cover on the STELARA prefilled syringe contains latex. Do not handle the needle cover if you are sensitive to latex.
• Adults with Crohn's disease and ulcerative colitis will receive the first dose of STELARA through a vein in the arm (intravenous infusion) in a healthcare facility by a healthcare provider. It takes at least 1 hour to receive the full dose of medicine. You will then receive STELARA as an injection under the skin (subcutaneous injection) 8 weeks after the first dose of STELARA, as described below.
• Adults with psoriasis or psoriatic arthritis and children 6 years and older with psoriasis will receive STELARA as an injection under the skin (subcutaneous injection) as described below.
• Injecting STELARA under your skin
• STELARA is intended for use under the guidance and supervision of your doctor. In children 6 years and older, it is recommended that STELARA be administered by a healthcare provider. If your doctor decides that you or a caregiver may give your injections of STELARA at home, you should receive training on the right way to prepare and inject STELARA. Your doctor will determine the right dose of STELARA for you, the amount for each injection, and how often you should receive it. Do not try to inject STELARA yourself until you or your caregiver have been shown how to inject STELARA by your doctor or nurse.
• Inject STELARA under the skin (subcutaneous injection) in your upper arms, buttocks, upper legs (thighs) or stomach area (abdomen).
• Do not give an injection in an area of the skin that is tender, bruised, red or hard.
• Use a different injection site each time you use STELARA.
• If you inject more STELARA than prescribed, call your doctor right away.
• Be sure to keep all of your scheduled follow-up appointments.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Subcutaneous Injection:

• Injection: 45 mg/0.5 mL or 90 mg/mL solution in a single-dose prefilled syringe
• Injection: 45 mg/0.5 mL solution in a single-dose vial

Intravenous Infusion:

• Injection: 130 mg/26 mL (5 mg/mL) solution in a single-dose vial

This medicine is available in fallowing brand namesː

• Zevalin

What side effects can this medication cause?

The most common side effects of this medicine include:

• nasal congestion, sore throat, and runny nose
• upper respiratory infections
• fever
• headache
• tiredness
• itching
• nausea and vomiting
• redness at the injection site
• vaginal yeast infections
• urinary tract infections
• sinus infection
• bronchitis
• diarrhea
• stomach pain

STELARA may cause serious side effects, including:

• Serious infections
• Cancers
• Posterior Reversible Encephalopathy Syndrome (PRES)
• Serious allergic reactions
• Lung inflammation

What special precautions should I follow?

• Serious infections have occurred. Do not start STELARA® during any clinically important active infection. If a serious infection or clinically significant infection develops, consider discontinuing STELARA® until the infection resolves.
• Serious infections from mycobacteria, salmonella and Bacillus Calmette-Guerin (BCG) vaccinations have been reported in patients genetically deficient in IL-12/IL-23. Diagnostic tests for these infections should be considered as dictated by clinical circumstances.
• Evaluate patients for TB prior to initiating treatment with STELARA®. Initiate treatment of latent TB before administering STELARA®.
• STELARA® may increase risk of malignancy. The safety of STELARA® in patients with a history of or a known malignancy has not been evaluated.
• Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with STELARA. Anaphylaxis or other clinically significant hypersensitivity reactions may occur.
• Two cases of posterior reversible encephalopathy syndrome (PRES), also known as Reversible Posterior Leukoencephalopathy Syndrome (RPLS), were reported. If PRES is suspected, treat promptly and discontinue STELARA®.
• Cases of interstitial pneumonia, eosinophilic pneumonia and cryptogenic organizing pneumonia have been reported during post-approval use of STELARA®. If diagnosis is confirmed, discontinue STELARA® and institute appropriate treatment.
• In clinical studies of psoriasis the safety of STELARA® in combination with other biologic immunosuppressive agents or phototherapy was not evaluated.

What to do in case of emergency/overdose?

Management of overdosage:

• In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment be instituted immediately.

Can this medicine be used in pregnancy?

• Limited data on the use of STELARA® in pregnant women are insufficient to inform a drug associated risk.
• It is not known if STELARA can harm your unborn baby.
• You and your doctor should decide if you will receive STELARA.

Can this medicine be used in children?

• It is not known if STELARA is safe and effective in children less than 6 years of age.
• The safety and effectiveness of STELARA® have been established in pediatric patients 6 to 17 years old with moderate to severe plaque psoriasis.
• The safety and effectiveness of STELARA® have not been established in pediatric patients with psoriatic arthritis, Crohn's disease or ulcerative colitis.

What are the active and inactive ingredients in this medicine?

• Active ingredient: ustekinumab
• Inactive ingredients: Single-dose prefilled syringe for subcutaneous use contains L-histidine, L-histidine monohydrochloride monohydrate, Polysorbate 80, and sucrose. Single-dose vial for subcutaneous use contains L-histidine, L-histidine hydrochloride monohydrate, Polysorbate 80 and sucrose. Single-dose vial for intravenous infusion contains EDTA disodium salt dihydrate, L-histidine, L-histidine hydrochloride monohydrate, L-methionine, Polysorbate 80, and sucrose.

Who manufactures and distributes this medicine?

Manufactured by:

• Janssen Biotech, Inc., Horsham, PA
• © 2012, 2016, 2019 Janssen Pharmaceutical Companies

What should I know about storage and disposal of this medication?

• Store STELARA vials and prefilled syringes in a refrigerator between 36°F to 46°F (2°C to 8°C).
• Store STELARA vials standing up straight.
• Store STELARA in the original carton to protect it from light until time to use it.
• Do not freeze STELARA.
• Do not shake STELARA.
• If needed, individual STELARA prefilled syringes may also be stored at room temperature up to 30°C (86ºF) for a maximum single period of up to 30 days in the original carton to protect from light.
• Once a syringe has been stored at room temperature, it should not be returned to the refrigerator.
• Discard the syringe if not used within 30 days at room temperature storage.
• Do not use STELARA after the expiration date on the carton or on the prefilled syringe.

antirheumatic agents

• gold preparations
  • auranofin, gold salts, gold sodium thiomalate

• interleukin receptor antagonists
  • anakinra, canakinumab, rilonacept, sarilumab, tocilizumab

• major immunosuppressive agents (also used in transplant medicine)
  • cyclosporine, mycophenylate, sirolimus, tacrolimus

• monoclonal antibodies
  • adalimumab, canakinumab, certolizumab, golimumab, infliximab, rituximab, sarilumab, tocilizumab, ustekinumab

• thiopurines
  • azathioprine, mercaptopurine, thioguanine

• tumor necrosis factor antagonists
  • adalimumab, certolizumab, etanercept, golimumab, infliximab

• tyrosine (janus) kinase inhibitors
  • baricitinib, tofacitinib

• miscellaneous
  • abatacept, flavocoxid, hydroxychloroquine, leflunomide, methotrexate, penicillamine

• Dailymed label info on Ustekinumab
• FDA Ustekinumab

Ustekinumab Resources
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