INDICATIONS

WEZLANA is indicated for the treatment of:

  • patients 6 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
  • patients 6 years or older with active psoriatic arthritis...Read more
  • adult patients with moderately to severely active Crohn’s disease.
  • adult patients with moderately to severely active ulcerative colitis.
  • patients 6 years or older with moderate to severe plaque psoriasis who are candidates...Read more for phototherapy or systemic therapy.
  • patients 6 years or older with active psoriatic arthritis.
  • adult patients with moderately to severely active Crohn’s disease.
  • adult patients with moderately to severely active ulcerative colitis.

Current STELARA® patients do not need to repeat their loading dose1,2

WEZLANA has the same dosing as STELARA, and patients currently receiving STELARA should transition to WEZLANA at their next scheduled dose. New patients not currently on STELARA can initiate WEZLANA as prescribed by their healthcare provider.3,4

  • MODERATE TO SEVERE Plaque psoriasis

    Patients can initiate WEZLANA as their next scheduled dose of ustekinumab.1,2

    ADULT3

    Subcutaneous injection

    ≤ 100 kg (≤ 220 lb)

    45 mg

    week 0, week 4, and every 12 weeks thereafter

    > 100 kg (> 220 lb)*

    90 mg

    week 0, week 4, and every 12 weeks thereafter

    *In subjects weighing more than 100 kg (220 lb), 45 mg was also shown to be efficacious. However, 90 mg resulted in greater efficacy in these subjects.

    PEDIATRIC3

    Subcutaneous injection

    < 60 kg (< 132 lb)

    0.75 mg/kg

    week 0, week 4, and every 12 weeks thereafter

    60 kg to 100 kg (132 lb to 220 lb)

    45 mg

    week 0, week 4, and every 12 weeks thereafter

    > 100 kg (> 220 lb)

    90 mg

    week 0, week 4, and every 12 weeks thereafter

  • MODERATE TO SEVERE Crohn’s disease & ulcerative colitis

    Patients can initiate WEZLANA as their next scheduled dose of ustekinumab (loading dose is not repeated when patients switch from STELARA to WEZLANA).1,2

    Intravenous injection
    Initial IV induction dose3

    ≤ 55 kg (≤ 121 lb)

    260 mg

    (130 mg/26 mL vial x2)

    Initial IV induction dose3

    > 55 kg to ≤ 85 kg (> 121 lb to ≤ 187 lb)

    390 mg

    (130 mg/26 mL vial x3)

    > 85 kg (> 187 lb)

    520 mg

    (130 mg/26 mL vial x4)

    Subcutaneous injection

    Maintenance dose3

    90 mg

    8 weeks after initial IV dose and every 8 weeks thereafter

    IV = intravenous.

  • Psoriatic arthritis

    Patients can initiate WEZLANA as their next scheduled dose of ustekinumab (loading dose is not repeated when patients switch from STELARA to WEZLANA).1,2

    ADULT3

    Subcutaneous injection

    45 mg

    week 0, week 4, and every 12 weeks thereafter

    Patients with coexistent moderate to severe plaque PsO weighing > 100 kg (> 220 lb)

    90 mg

    week 0, week 4, and every 12 weeks thereafter

    PEDIATRIC3

    Subcutaneous injection

    < 60 kg (< 132 lb)

    0.75 mg/kg

    week 0, week 4, and every 12 weeks thereafter

    ≥ 60 kg (≥ 132 lb)

    45 mg

    week 0, week 4, and every 12 weeks thereafter

    > 100 kg (> 220 lb) with coexistent moderate to severe plaque psoriasis

    90 mg

    week 0, week 4, and every 12 weeks thereafter

    PsO = psoriasis.

WEZLANA is available as a prefilled subcutaneous syringe or single-dose vial3
Prefilled syringe

45 mg/0.5 mL

single-dose prefilled syringe

(for subcutaneous use)

Prefilled syringe

90 mg/mL

single-dose prefilled syringe

(for subcutaneous use)

Click here to view the patient video and injection resource, which provide an overview and supplemental injection information for your patients prescribed the prefilled syringe. They do not replace the Instructions for Use and it is important to review the Instructions for Use with your patients.

Single-dose vial

45 mg/0.5 mL

single-dose vial

(for subcutaneous use)

Single-dose vial

130 mg/26 mL (5 mg/mL)

single-dose vial

(for intravenous infusion)

Click here to view the patient video and injection resource, which provide an overview and supplemental injection information for your patients prescribed the prefilled syringe. They do not replace the Instructions for Use and it is important to review the Instructions for Use with your patients.

The WEZLANA prefilled syringe is not made with natural rubber or latex

  • WEZLANA is intended for use under the guidance and supervision of a physician with patients who wiII be closely monitored and have regular follow-up
  • The appropriate dose should be determined by a healthcare provider using the patient’s current weight at the time of dosing
  • In pediatric patients with psoriatic arthritis or moderate to severe plaque psoriasis, it is recommended that WEZLANA be administered by a healthcare provider
  • If a physician determines that it is appropriate, a patient may self-inject, or a caregiver may inject WEZLANA after proper training in subcutaneous injection technique

IMPORTANT SAFETY INFORMATION

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.

INDICATIONS

WEZLANA is indicated for the treatment of patients 6 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

WEZLANA is indicated for the treatment of patients 6 years or older with active psoriatic arthritis.

WEZLANA is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease.

WEZLANA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.

WHAT IS WEZLANA™ (ustekinumab-auub)?

WEZLANA is a prescription medicine used to treat:

  • adults and children 6 years and older with moderate to severe psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills).
  • adults and children 6 years and older with active psoriatic arthritis.
  • 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.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

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

STELARA® is a registered trademark of Janssen Biotech, Inc.

WEZLANA is a trademark of Amgen Inc.

References: 1. Blauvelt A, Papp K, Trivedi M, et al. Efficacy and safety of the biosimilar candidate ABP 654 in the treatment of moderate-to-severe plaque psoriasis: results from a phase 3, multicenter, randomized, double-blinded study. Poster Presented at: European Academy of Dermatology and Venerology 2023 Spring Symposium; May 18-20, 2023; Seville, Spain. 2. US National Library of Medicine. A study to investigate ABP 654 for the treatment of participants with moderate to severe plaque psoriasis. https://clinicaltrials.gov/study/NCT04607980. Updated December 15, 2023. Accessed October 21, 2024. 3. WEZLANA™ (ustekinumab-auub) prescribing information, Amgen. 4. STELARA® (ustekinumab) prescribing information, Janssen Biotech, Inc.

This material is for discussion and informational purposes only. WEZLANA is currently not available commercially and will be commercially available in the US no later than January 1, 2025.