TREMFYA® is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. TREMFYA is a clear and colorless to light yellow solution that may contain small translucent particles. © Janssen Biotech, Inc. 2020. Tremfya® is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Laws, regulatory requirements, and medical practices for pharmaceutical products vary from country to country. WARNINGS AND PRECAUTIONSHypersensitivity ReactionsSerious hypersensitivity reactions, including anaphylaxis, have been reported with postmarket use of TREMFYA®. TREMFYA® is a prescription medicine used to treat adults with active psoriatic arthritis. Use TREMFYA® exactly as your healthcare provider tells you to use it. 0000002613 00000 n Some cases required hospitalization. 0000003908 00000 n InfectionsTREMFYA® may increase the risk of infection. 0000004590 00000 n Instruct patients receiving TREMFYA® to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. 0000001831 00000 n TREMFYA is a clear, colourless to light yellow solution. By clicking on "Continue" below, you will leave TREMFYAhcp.com. What are the possible side effects of TREMFYA®? The most common side effects of TREMFYA® include: upper respiratory infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, herpes simplex infections, and bronchitis. TREMFYA ® may lower the ability of your immune system to fight infections and may increase your risk of infections. 0000009868 00000 n 108 28 In active psoriatic arthritis, TREMFYA® may be administered alone or in combination with a cDMARD (e.g., methotrexate). Your are solely responsible for your interactions with such websites. Janssen Biotech, Inc., recognizes that the Internet is a global communications medium; however, laws, regulatory requirements, and medical practices for pharmaceutical products vary from country to country. TREMFYA ® is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.. TREMFYA ® is indicated for the treatment of adult patients with active psoriatic arthritis.. TREMFYA ® is administered as a 100 mg subcutaneous injection once every 8 weeks, after starter doses at weeks 0 and 4. Do not use live vaccines concurrently with Tremfya; no data available; before live vaccination, withhold Tremfya for at least 12 weeks and resume at least 2 weeks after vaccination. Please read the full Prescribing Information, including Medication Guide for TREMFYA®, and discuss any questions that you have with your doctor. Patients may self-inject with TREMFYA® after physician approval and proper training. 0000006609 00000 n have an infection that does not go away or that keeps coming back. Immunisations: Consider completing all appropriate immunisations prior to Tremfya. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with TREMFYA ® and may treat you for TB before you begin treatment with TREMFYA ® if you have a history of TB or have active TB. We encourage you to read the Privacy Policy of every website you visit. Pre-Treatment Evaluation for Tuberculosis (TB)Evaluate patients for TB infection prior to initiating treatment with TREMFYA®. H�\��n�0E��~l��d)B��J. 0000003263 00000 n U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA Inspect TREMFYA visually for particulate matter and discoloration prior to administration. See “What is the most important information I should know about TREMFYA®?”. Call your doctor for medical advice about side effects. TREMFYA® is intended for use under the guidance and supervision of a physician. 0000020310 00000 n You should avoid receiving live vaccines during treatment with TREMFYA, are pregnant or plan to become pregnant. CONTRAINDICATIONSTREMFYA® is contraindicated in patients with a history of serious hypersensitivity reaction to guselkumab or to any of the excipients. It is not known if. The ultimate responsibility for patient care resides with a healthcare professional. By clicking "OK" below, you will be taken to [extlink:external-url], a website that may contain links or references to other websites to which our Privacy Policy may not apply. 0000011051 00000 n 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TREMFYA is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The information contained in this section of the site is intended for US healthcare professionals only. Sign up to receive information about TREMFYA® (guselkumab), fainting, dizziness, feeling lightheaded (low blood pressure), swelling of your face, eyelids, lips, mouth, tongue or throat, warm, red, or painful skin or sores on your body different from your psoriasis, burning when you urinate or urinating more often than normal, have any of the conditions or symptoms listed in the section. 0000013021 00000 n Legal Notice | Privacy Policy | Contact Us. 0000004472 00000 n 0000000016 00000 n 0000024733 00000 n trailer <<8C324D2679F14FDF94A56A9EDAD57479>]/Prev 724778>> startxref 0 %%EOF 135 0 obj <>stream ImmunizationsPrior to initiating TREMFYA®, consider completion of all age-appropriate immunizations according to current immunization guidelines. TREMFYA® is a prescription medicine used to treat adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light). 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