By clicking on "Continue" below, you will leave TREMFYAhcp.com. TREMFYA® is administered as a 100 mg subcutaneous injection once every 8 weeks, after starter doses at weeks 0 and 4. 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. 0000003908 00000 n TREMFYA® may cause serious side effects. You are solely responsible for your interactions with that website. Inspect TREMFYA visually for particulate matter and discoloration prior to administration. h�b```b``>�������A��bl,;8X���L>�,k���m|����Ïe��N���Xv�qn�Ѥ��[�%��&K��nB2�A��Ua��̡C)_oD8��49j�&�m��e, e��t'_K,�dI��P:�S蟘z$%�Ce17gkK�`��R��71�n��_g|l2t�"3�5�Ui(F6�K(q�,:��b�С"�m�&WY�|��Ͳ�Z ����j �`�@�����D%��X#D12�`с��h@�ettU����{��$+���0�rUli�#;A����:��E jz��0���vޠ?q���7%�2�b+``��y��X����ln�y W�.� ��g endstream endobj 109 0 obj <>>> endobj 110 0 obj <>/Font<>/ProcSet[/PDF/Text]>>/Rotate 0/TrimBox[0.0 0.0 612.0 792.0]/Type/Page>> endobj 111 0 obj <> endobj 112 0 obj <> endobj 113 0 obj <> endobj 114 0 obj <> endobj 115 0 obj <>stream 0000000856 00000 n Instruct patients receiving TREMFYA® to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. Infections. 0000006501 00000 n The ultimate responsibility for patient care resides with a healthcare professional. If a serious hypersensitivity reaction occurs, discontinue TREMFYA® and initiate appropriate therapy. Patients may self-inject with TREMFYA® after physician approval and proper training. 0000013957 00000 n ImmunizationsPrior to initiating TREMFYA®, consider completion of all age-appropriate immunizations according to current immunization guidelines. You should avoid receiving live vaccines during treatment with TREMFYA, are pregnant or plan to become pregnant. Initiate treatment of latent TB prior to administering TREMFYA®. We encourage you to read the Privacy Policy of every website you visit. Do not administer TREMFYA® to patients with active TB infection. Consider the risks and benefits of treatment prior to prescribing TREMFYA® in patients with a chronic infection or a history of recurrent infection. It is not known if TREMFYA, are breastfeeding or plan to breastfeed. Treatment with TREMFYA ® should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated. The Prescribing Information included here may not be appropriate for use outside the United States and Puerto Rico. Avoid use of live vaccines in patients treated with TREMFYA®. We would like to show you a description here but the site won’t allow us. The information contained in this section of the site is intended for US healthcare professionals only. TREMFYA® is a prescription medicine used to treat adults with active psoriatic arthritis. 0000020310 00000 n These are not all the possible side effects of TREMFYA®. 0000008874 00000 n See “What is the most important information I should know about TREMFYA®?”. 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.
TREMFYA is a clear and colorless to light yellow solution that may contain small translucent particles. U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA 0000003796 00000 n 0000009982 00000 n Treatment with TREMFYA® should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated. have an infection that does not go away or that keeps coming back.
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. 0000009868 00000 n The links of TREMFYAhcp.com are provided for informational purposes only and do not represent any endorsement, direct or implied, of the websites to which you will be directed. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Our Privacy Policy is located at tremfya.com/privacy-policy.
TREMFYA is a clear, colourless to light yellow solution. 0000012200 00000 n Please read the full Prescribing Information and Medication Guide for TREMFYA®.
H�\��n�0E��~l��d)B��J. 0000004590 00000 n The material on this site is intended only as informational or as an educational aid and it is not intended to be taken as medical advice. WARNINGS AND PRECAUTIONSHypersensitivity ReactionsSerious hypersensitivity reactions, including anaphylaxis, have been reported with postmarket use of TREMFYA®. What is the most important information I should know about TREMFYA®?
Provide the Medication Guide to your patients and encourage discussion. 4.2 DOSE AND METHOD OF ADMINISTRATION Dosage (dose and interval) The Prescribing Information included here may not be appropriate for use outside the United States and Puerto Rico. 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).
0000024733 00000 n %PDF-1.4 %���� 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. All rights reserved. 0000005080 00000 n 0000007929 00000 n 0000007292 00000 n This site is published by Janssen Biotech, Inc., which is solely responsible for its contents. TREMFYA® is a prescription medicine that may cause serious side effects, including: Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including: Do not take TREMFYA® if you have had a serious allergic reaction to guselkumab or any of the ingredients in TREMFYA®. 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. TREMFYA® is indicated for the treatment of adult patients with active psoriatic arthritis.
Please read the full Prescribing Information, including Medication Guide for TREMFYA®, and discuss any questions that you have with your doctor. 0000013021 00000 n TREMFYA® is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. 0000014908 00000 n TREMFYA ® may lower the ability of your immune system to fight infections and may increase your risk of infections.
108 0 obj <> endobj xref Before using TREMFYA®, tell your healthcare provider about all of your medical conditions, including if you: Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. 0000002613 00000 n Lek ten działa poprzez blokowanie czynności białka zwanego interleukiną 23 (IL-23), która występuje w zwiększonej ilości u osób z łuszczycą. Immunisations: Consider completing all appropriate immunisations prior to Tremfya. 0000000016 00000 n InfectionsTREMFYA® may increase the risk of infection. Use TREMFYA® exactly as your healthcare provider tells you to use it. In active psoriatic arthritis, TREMFYA® may be administered alone or in combination with a cDMARD (e.g., methotrexate). Requires Adobe® Reader®. 0000011668 00000 n 108 28 Your are solely responsible for your interactions with such websites. CONTRAINDICATIONSTREMFYA® is contraindicated in patients with a history of serious hypersensitivity reaction to guselkumab or to any of the excipients. 0000006609 00000 n 0000003263 00000 n What are the possible side effects of TREMFYA®? © Janssen Biotech, Inc. 2020. have TB or have been in close contact with someone with TB. TREMFYA to reach room temperature (30 minutes) without removing the needle cap. Third party trademarks used herein are trademarks of their respective owners.
Tremfya zawiera substancję czynną guselkumab, która jest rodzajem białka zwanym przeciwciałem monoklonalnym. Clicking on "Continue" below will take you to a website to which our site's Privacy Policy does not apply.
Laws, regulatory requirements, and medical practices for pharmaceutical products vary from country to country. Some cases required hospitalization. Now approved for adult patients with active psoriatic arthritis, Need Help?Chat With Medical Information Need Help?Chat Live With Medical Information. This information is intended for the use of patients and caregivers in the United States and Puerto Rico only. Third party trademarks used herein are trademarks of their respective owners. 0000001831 00000 n 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. Legal Notice | Privacy Policy | Medical Information Center. have recently received or are scheduled to receive an immunization (vaccine).
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