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. This site is published by Janssen Biotech, Inc., which is solely responsible for its contents. 0000001436 00000 n TREMFYA® is administered as a 100 mg subcutaneous injection once every 8 weeks, after starter doses at weeks 0 and 4. InfectionsTREMFYA® may increase the risk of infection. 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. The ultimate responsibility for patient care resides with a healthcare professional. 0000003263 00000 n Now approved for adult patients with active psoriatic arthritis, Need Help?Chat With Medical Information Need Help?Chat Live With Medical Information. WARNINGS AND PRECAUTIONSHypersensitivity ReactionsSerious hypersensitivity reactions, including anaphylaxis, have been reported with postmarket use of TREMFYA®. If occurs, discontinue Tremfya immediately and initiate appropriate therapy. Click here to download. Tremfya zawiera substancję czynną guselkumab, która jest rodzajem białka zwanym przeciwciałem monoklonalnym. 0000005791 00000 n

Patients may self-inject with TREMFYA® after physician approval and proper training. 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 a clear, colourless to light yellow solution. Infections. Consider the risks and benefits of treatment prior to prescribing TREMFYA® in patients with a chronic infection or a history of recurrent infection. 0000013957 00000 n 0000011668 00000 n 0000001322 00000 n Please read the full Prescribing Information and Medication Guide for TREMFYA®.

Clicking on "Continue" below will take you to a website to which our site's Privacy Policy does not apply. This information is intended for the use of patients and caregivers in the United States and Puerto Rico only. ADVERSE REACTIONSMost 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. have an infection that does not go away or that keeps coming back. Requires Adobe® Reader®. Our Privacy Policy is located at tremfya.com/privacy-policy. 0000005080 00000 n Lek ten działa poprzez blokowanie czynności białka zwanego interleukiną 23 (IL-23), która występuje w zwiększonej ilości u osób z łuszczycą. 4.2 DOSE AND METHOD OF ADMINISTRATION Dosage (dose and interval)
0000020310 00000 n This site is published by Janssen Biotech, Inc., which is solely responsible for its contents.

have recently received or are scheduled to receive an immunization (vaccine). Third party trademarks used herein are trademarks of their respective owners. The Prescribing Information included here may not be appropriate for use outside the United States and Puerto Rico.

0000000856 00000 n Immunisations: Consider completing all appropriate immunisations prior to 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. Some cases required hospitalization.
TREMFYA to reach room temperature (30 minutes) without removing the needle cap. Initiate treatment of latent TB prior to administering TREMFYA®. %PDF-1.4 %���� By clicking on "Continue" below, you will leave TREMFYAhcp.com. TREMFYA® is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Legal Notice | Privacy Policy | Contact Us. 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. These are not all the possible side effects of TREMFYA®. Your are solely responsible for your interactions with such websites. This site is intended for use by healthcare professionals of the United States and Puerto Rico.

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. Use TREMFYA® exactly as your healthcare provider tells you to use it. 0000001831 00000 n Laws, regulatory requirements, and medical practices for pharmaceutical products vary from country to country. Avoid use of live vaccines in patients treated with TREMFYA®. Call your doctor for medical advice about side effects. TREMFYA® is intended for use under the guidance and supervision of a physician. TREMFYA® is indicated for the treatment of adult patients with active psoriatic arthritis. Legal Notice | Privacy Policy | Medical Information Center. We encourage you to read the Privacy Policy of every website you visit. 0000006501 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. CONTRAINDICATIONSTREMFYA® is contraindicated in patients with a history of serious hypersensitivity reaction to guselkumab or to any of the excipients. In active psoriatic arthritis, TREMFYA® may be administered alone or in combination with a cDMARD (e.g., methotrexate). 0000006609 00000 n Instruct patients receiving TREMFYA® to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. Consider the risks and benefits of treatment prior to prescribing TREMFYA ® in patients with … What are the possible side effects of TREMFYA®? Do not use if the liquid contains large particles, is discolored or cloudy. We would like to show you a description here but the site won’t allow us. 0000011051 00000 n 108 28 Treatment with TREMFYA® should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated. What is the most important information I should know about TREMFYA®? 0000003908 00000 n Do not administer TREMFYA® to patients with active TB infection. 0000000016 00000 n 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. 0000013021 00000 n 0000003796 00000 n

0000009868 00000 n It is not known if. TREMFYA is a clear and colorless to light yellow solution that may contain small translucent particles. 0000024733 00000 n Provide the Medication Guide to your patients and encourage discussion. Monitor patients for signs and symptoms of active TB during and after TREMFYA® treatment. 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�.� 0000008874 00000 n © Janssen Biotech, Inc. 2020. 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®. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA 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. 0000004590 00000 n You should avoid receiving live vaccines during treatment with TREMFYA, are pregnant or plan to become pregnant. 108 0 obj <> endobj xref 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. trailer <<8C324D2679F14FDF94A56A9EDAD57479>]/Prev 724778>> startxref 0 %%EOF 135 0 obj <>stream 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. Pre-Treatment Evaluation for Tuberculosis (TB)Evaluate patients for TB infection prior to initiating treatment with TREMFYA®.

TREMFYA® may cause serious side effects. 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. H�\��n�0E��~l��d)B��J. 0000007929 00000 n 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. Please read the full Prescribing Information, including Medication Guide for TREMFYA®, and discuss any questions that you have with your doctor. 0000014908 00000 n

Tremfya® is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. 0000009982 00000 n 0000012200 00000 n ImmunizationsPrior to initiating TREMFYA®, consider completion of all age-appropriate immunizations according to current immunization guidelines. 0000007292 00000 n Inspect TREMFYA visually for particulate matter and discoloration prior to administration. The information contained in this section of the site is intended for US healthcare professionals only.

Third party trademarks used herein are trademarks of their respective owners.

It is not known if TREMFYA, are breastfeeding or plan to breastfeed. have TB or have been in close contact with someone with TB. See “What is the most important information I should know about TREMFYA®?”. If a serious hypersensitivity reaction occurs, discontinue TREMFYA® and initiate appropriate therapy. The Prescribing Information included here may not be appropriate for use outside the United States and Puerto Rico. You are solely responsible for your interactions with that website. You are encouraged to report negative side effects of prescription drugs to the FDA.

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