TREMFYA- guselkumab injection
Janssen Biotech, Inc.
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Medication Guide
TREMFYA ®(trem fye' ah) (guselkumab) injection, for subcutaneous use |
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This Medication Guide had been approved by the U.S. Food and Drug Administration. | Revised: 11/2023 | ||||
What is the most important information I should know about TREMFYA?
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See " What are the possible side effects of TREMFYA?" for more information about side effects. | |||||
What is TREMFYA? | |||||
TREMFYA is a prescription medicine used to treat adults: | |||||
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It is not known if TREMFYA is safe and effective in children under 18 years of age. | |||||
Do not use TREMFYAif you have had a serious allergic reaction to guselkumab or any of the other ingredients in TREMFYA. See the end of this Medication Guide for a complete list of ingredients in TREMFYA. | |||||
Before using TREMFYA, tell your healthcare provider about all of your medical conditions, including if you: | |||||
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Tell your healthcare provider about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements. | |||||
How should I use TREMFYA? | |||||
See the detailed "Instructions for Use" that comes with TREMFYA for information on how to prepare and inject a dose of TREMFYA, and how to properly throw away (dispose of) used TREMFYA prefilled syringes or One-Press injectors. | |||||
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If you inject more TREMFYA than prescribed, call your healthcare provider right away. | |||||
What are the possible side effects of TREMFYA?
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The most common side effects of TREMFYA include: | |||||
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These are not all the possible side effects of TREMFYA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. | |||||
General information about the safe and effective use of TREMFYA | |||||
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use TREMFYA for a condition for which it was not prescribed. Do not give TREMFYA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about TREMFYA that is written for health professionals. | |||||
What are the ingredients in TREMFYA?
Active ingredient: guselkumab Inactive ingredients:L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, sucrose and water for injection Not made with natural rubber latex. |
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Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044, USA, U.S. License Number 1864
For patent information: www.janssenpatents.com © 2017 Janssen Pharmaceutical Companies For more information, call 1-800-526-7736 or go to www.tremfya.com. |