Important Safety Information

CONTRAINDICATIONS

TREMFYA^® is contraindicated in patients with a history of serious hypersensitivity reaction to guselkumab or to any of the excipients.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylaxis, have been reported with postmarket use of TREMFYA^®. Some cases required hospitalization. If a serious hypersensitivity reaction occurs, discontinue TREMFYA^® and initiate appropriate therapy.

Infections

TREMFYA^® may increase the risk of infection. Treatment with TREMFYA^® 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 prescribing TREMFYA^® in patients with a chronic infection or a history of recurrent infection. Instruct patients receiving TREMFYA^® to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a clinically important or serious infection, or is not responding to standard therapy, closely monitor and discontinue TREMFYA^® until the infection resolves.

Pre-Treatment Evaluation for Tuberculosis (TB)

Evaluate patients for TB infection prior to initiating treatment with TREMFYA^®. Initiate treatment of latent TB prior to administering TREMFYA^®. Monitor patients for signs and symptoms of active TB during and after TREMFYA^® treatment. Do not administer TREMFYA^® to patients with active TB infection.

Immunizations

Prior to initiating TREMFYA^®, consider completion of all age-appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with TREMFYA^®.

ADVERSE REACTIONS

Most common (≥1%) adverse reactions associated with TREMFYA^® include upper respiratory infections, headache, injection site reactions, arthralgia, bronchitis, diarrhea, gastroenteritis, tinea infections, and herpes simplex infections.

The overall safety profile observed in patients with psoriatic arthritis is generally consistent with the safety profile in patients with plaque psoriasis, with the addition of bronchitis and neutrophil count decreased.

Please read the full Prescribing Information and Medication Guide for TREMFYA^®. Provide the Medication Guide to your patients and encourage discussion.

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Indication

TREMFYA^® is indicated for the treatment of adults with moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.

Study Designs

VOYAGE 1 (n=837) and VOYAGE 2 (n=992) were phase 3, multicenter, double-blind, placebo-controlled trials in adult patients with moderate to severe plaque PsO. Patients were randomized to TREMFYA^® 100 mg subcutaneous (SC) injection at Weeks 0, 4, and 12, then every 8 weeks (q8w); placebo at Weeks 0, 4, and 12, followed by crossover to TREMFYA^® at Week 16, Week 20, and q8w; or active comparator through Week 47 (VOYAGE 1) or Week 23 (VOYAGE 2). In VOYAGE 1, patients initially randomized to active comparator entered a washout period after their final dose at Week 47 and entered open-label TREMFYA^® from Week 52-252. VOYAGE 2 incorporated a randomized withdrawal and re-treatment from Week 28-72, followed by open-label TREMFYA^® from Week 76-252. Safety was assessed through Week 264.^1-3

IGA=Investigator Global Assessment, IGA score of cleared (0) or minimal (1) using a 5-point scale of overall disease severity; PASI=Psoriasis Area and Severity Index; ss-IGA=scalp-specific Investigator Global Assessment; ss-IGA 0/1=proportion of patients who achieved an ss-IGA score of absence of disease (0) or very mild (1) using a 5-point scale where scalp lesions were assessed in terms of clinical signs of redness, thickness, and scaliness on a scale of 0 to 4: absence of disease (0), very mild (1), mild (2), moderate (3), or severe (4).

References: 1. TREMFYA^® (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Blauvelt A, Papp KA, Griffiths CEM, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: results from the phase III, double-blinded, placebo- and active comparator–controlled VOYAGE 1 trial. J Am Acad Dermatol. 2017;76(3):405-417. 3. Reich K, Armstrong AW, Foley P, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: results from the phase III, double-blind, placebo- and active comparator–controlled VOYAGE 2 trial. J Am Acad Dermatol. 2017;76(3):418-431.