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CONTRAINDICATIONS

WEZLANA is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients.

INFECTIONS

Ustekinumab products may increase the risk of infections and reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections requiring hospitalization or otherwise clinically significant infections were reported. In patients with plaque psoriasis, these included diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis, and urinary tract infections. In patients with psoriatic arthritis, this included cholecystitis. In patients with Crohn’s disease, these included anal abscess, gastroenteritis, ophthalmic herpes zoster, pneumonia, and Listeria meningitis. In patients with ulcerative colitis, these included gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeriosis.

Treatment with WEZLANA should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to initiating use of WEZLANA in patients with a chronic infection or a history of recurrent infection. Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur while on treatment with WEZLANA and discontinue WEZLANA for serious or clinically significant infections until the infection resolves or is adequately treated.

THEORETICAL RISK FOR VULNERABILITY TO PARTICULAR INFECTIONS

Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria, Salmonella, and Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and fatal outcomes have been reported in such patients. It is not known whether patients with pharmacologic blockade of IL-12/IL-23 from treatment with ustekinumab products may be susceptible to these types of infections. Consider diagnostic testing, eg, tissue culture, stool culture, as dictated by clinical circumstances.

PRE-TREATMENT EVALUATION FOR TUBERCULOSIS (TB)

Evaluate patients for TB prior to initiating treatment with WEZLANA. Do not administer WEZLANA to patients with active tuberculosis infection. Initiate treatment of latent TB before administering WEZLANA. Closely monitor patients receiving WEZLANA for signs and symptoms of active TB during and after treatment.

MALIGNANCIES

Ustekinumab products are immunosuppressants and may increase the risk of malignancy. Malignancies were reported among patients who received ustekinumab in clinical trials. The safety of ustekinumab products has not been evaluated in patients who have a history of malignancy or who have a known malignancy. There have been reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving ustekinumab products who had risk factors for developing non-melanoma skin cancer (NMSC). All patients receiving WEZLANA, especially those >60 years or those with a history of PUVA or prolonged immunosuppressant treatment, should be monitored for the appearance of NMSC.

HYPERSENSITIVITY REACTIONS

Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with ustekinumab products. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue WEZLANA.

POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME (PRES)

Two cases of posterior reversible encephalopathy syndrome (PRES), also known as Reversible Posterior Leukoencephalopathy Syndrome (RPLS), were reported in clinical trials. Cases have also been reported in postmarketing experience in patients with psoriasis, psoriatic arthritis and Crohn’s disease. Clinical presentation included headaches, seizures, confusion, visual disturbances, and imaging changes consistent with PRES a few days to several months after ustekinumab product initiation. A few cases reported latency of a year or longer. Patients recovered with supportive care following withdrawal of ustekinumab products.

Monitor all patients treated with WEZLANA for signs and symptoms of PRES. If PRES is suspected, promptly administer appropriate treatment and discontinue WEZLANA.

IMMUNIZATIONS

Prior to initiating therapy with WEZLANA, patients should receive all age-appropriate immunizations as recommended by current immunization guidelines. Patients being treated with WEZLANA should not receive live vaccines. BCG vaccines should not be given during treatment with WEZLANA 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 WEZLANA because of the potential risk for shedding from the household contact and transmission to patient. Non-live vaccinations received during a course of WEZLANA may not elicit an immune response sufficient to prevent disease.

CONCOMITANT THERAPIES

In clinical studies of psoriasis, the safety of ustekinumab products in combination with other biologic immunosuppressive agents or phototherapy was not evaluated. Ultraviolet-induced skin cancers developed earlier and more frequently in mice genetically manipulated to be deficient in both IL-12 and IL-23 or IL-12 alone.

NONINFECTIOUS PNEUMONIA

Cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been reported during post-approval use of ustekinumab products. Clinical presentations included cough, dyspnea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalization. Patients improved with discontinuation of therapy and, in certain cases, administration of corticosteroids. If diagnosis is confirmed, discontinue WEZLANA and institute appropriate treatment.

ALLERGEN IMMUNOTHERAPY

Ustekinumab products 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.

MOST COMMON ADVERSE REACTIONS

• The most common adverse reactions (≥3% and higher than that with placebo) in adults from plaque psoriasis clinical trials for ustekinumab 45 mg, ustekinumab 90 mg, or placebo were: nasopharyngitis (8%, 7%, 8%), upper respiratory tract infection (5%, 4%, 5%), headache (5%, 5%, 3%), and fatigue (3%, 3%, 2%), respectively. The safety profile in pediatric patients with plaque psoriasis was similar to that of adults with plaque psoriasis.
• In psoriatic arthritis (PsA) trials, a higher incidence of arthralgia and nausea was observed in patients treated with ustekinumab when compared with placebo (3% vs 1% for both).
• In Crohn’s disease induction trials, common adverse reactions (3% or more of patients treated with ustekinumab and higher than placebo) reported through Week 8 for ustekinumab 6 mg/kg intravenous single infusion or placebo included: vomiting (4% vs 3%). In the Crohn’s disease maintenance trial, common adverse reactions (3% or more of patients treated with ustekinumab and higher than placebo) reported through Week 44 for ustekinumab 90 mg subcutaneous injection or placebo were: nasopharyngitis (11% vs 8%), injection site erythema (5% vs 0%), vulvovaginal candidiasis/mycotic infection (5% vs 1%), bronchitis (5% vs 3%), pruritus (4% vs 2%), urinary tract infection (4% vs 2%) and sinusitis (3% vs 2%).
• In the ulcerative colitis induction trial, common adverse reactions (3% or more of patients treated with ustekinumab and higher than placebo) reported through Week 8 for ustekinumab 6 mg/kg intravenous single infusion or placebo included: nasopharyngitis (7% vs 4%). In the ulcerative colitis maintenance trial, common adverse reactions (3% or more of patients treated with ustekinumab and higher than placebo) reported through Week 44 for ustekinumab 90 mg subcutaneous injection or placebo included: nasopharyngitis (24% vs 20%), headache (10% vs 4%), abdominal pain (7% vs 3%), influenza (6% vs 5%), fever (5% vs 4%), diarrhea (4% vs 1%), sinusitis (4% vs 1%), fatigue (4% vs 2%), and nausea (3% vs 2%).

Please see the accompanying WEZLANA full Prescribing Information, including Medication Guide.