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Stelara

Generic Name: Ustekinumab
Drug Category: Monoclonal Antibody
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 6 years old for a maximum duration of 5 years.

Approved Uses

Indicated for:

Psoriasis (Ps):

• The treatment of patients 6 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Psoriatic Arthritis (PsA):

• The treatment of adult patients with active psoriatic arthritis. STELARA can be used alone or in combination with methotrexate (MTX).

Crohn’s Disease (CD):

• The treatment of adult patients with moderately to severely active Crohn’s disease.

Ulcerative Colitis:

• The treatment of adult patients with moderately to severely active ulcerative colitis. 

The safety and effectiveness of STELARA have not been established in pediatric patients with psoriatic arthritis, Crohn’s disease or ulcerative colitis.

Evaluate patients for tuberculosis infection prior to initiating treatment with STELARA. Do not administer STELARA to patients with active tuberculosis infection. 

STELARA may increase the risk of infections and reactivation of latent infections. Serious bacterial, fungal, and viral infections were observed in subjects receiving STELARA. Treatment with STELARA should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.

In patients with psoriasis, serious infections included diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis and urinary tract infections. In patients with psoriatic arthritis, serious infections included cholecystitis. In patients with Crohn’s disease, serious or other clinically significant infections included anal abscess, gastroenteritis, ophthalmic herpes, pneumonia, and listeria meningitis.

Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria (including nontuberculous, environmental mycobacteria), salmonella (including non-typhi strains), and Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and fatal outcomes have been reported in such patients.

STELARA is an immunosuppressant and may increase the risk of malignancy. There have been postmarketing reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving STELARA who had pre-existing risk factors for developing non-melanoma skin cancer. The safety of STELARA has not been evaluated in patients who have a history of malignancy or who have a known malignancy.

There have been post-marketing reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving STELARA who had pre-existing risk factors for developing non melanoma skin cancer. All patients receiving STELARA should be monitored for the appearance of non-melanoma skin cancer. Patients greater than 60 years of age, those with a medical history of prolonged immunosuppressant therapy and those with a history of PUVA treatment should be followed closely.

Prior to initiating therapy with STELARA, patients should receive all age-appropriate immunizations as recommended by current immunization guidelines. Patients being treated with STELARA should not receive live vaccines. BCG vaccines should not be given during treatment with STELARA or for one year prior to initiating treatment or one year following discontinuation of treatment. Caution is advised when administering live vaccines to household contacts of patients receiving STELARA because of the potential risk for shedding from the household contact and transmission to patient.

The safety of STELARA in combination with other immunosuppressive agents or phototherapy was not evaluated.

Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with STELARA.

One case of reversible posterior leukoencephalopathy syndrome (RPLS) was observed in clinical studies of psoriasis and psoriatic arthritis.

Cases of interstitial pneumonia, eosinophilic pneumonia and cryptogenic organizing pneumonia have been reported during post-approval use of STELARA.

STELARA may decrease the protective effect of allergen immunotherapy (decrease tolerance) which may increase the risk of an allergic reaction to a dose of allergen immunotherapy. Therefore, caution should be exercised in patients receiving or who have received allergen immunotherapy, particularly for anaphylaxis.

The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g., IL-1, IL-6, IL-10, TNFα, IFN) during chronic inflammation. Thus, STELARA, an antagonist of IL-12 and IL-23, could normalize the formation of CYP450 enzymes. 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.

Limited data on the use of STELARA in pregnant women are insufficient to inform a drug associated risk.

There are no data on the presence of ustekinumab in human milk, the effects on the breastfed infant, or the effects on milk production. Ustekinumab was present in the milk of lactating monkeys administered ustekinumab.

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Off-label Uses

• Use in patients under the age of 6. GoToSource

• Spondyloarthropathy. GoToSource

• Type I pityriasis rubra pilaris. GoToSource

• Asthma. GoToSource

• Inflammatory bowel disease. GoToSource

Adverse Events

Hepatitis B virus reactivation. GoToSource

Major adverse cardiovascular events. GoToSource

Infections and reactivation of latent infections including bacterial, fungal and viral infections such as cellulitis, diverticulitis, osteomyelitis gastroenteritis, pneumonia, urinary tract infections and reversible posterior leukoencephalopathy syndrome (syndrome characterized by headache, confusion, seizures and visual loss). GoToSource

Nasopharyngitis (swelling of nasal passages and back of throat) and upper respiratory tract infection. GoToSource

Non-melanoma skin cancer, prostate, colorectal and breast cancer and melanoma. GoToSource

Tuberculosis. GoToSource

Worsening of crohn’s disease, pneumothorax (collapsed lung) and small intestinal obstruction. GoToSource

Cholecystitis (gallbladder inflammation). GoToSource

Nephrolithiasis (kidney stone), pancreatitis (inflammation of pancreas) psychotic disorder and hypertension (high blood pressure). GoToSource

Bullous pemphigoid (skin condition causing fluid-filled blisters). GoToSource

Small-vessel vasculitis (inflammation of blood vessels). GoToSource

Flares of psoriatic arthritis or unmasked previously occult joint disease. GoToSource

Litigation

Lawsuits filed for development of cutaneous squamous cell carcinoma, prostate, melanoma or breast cancer.

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

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Site Last Updated March 29, 2024