Land: Singapore
Taal: Engels
Bron: HSA (Health Sciences Authority)
Guselkumab
JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
L04AC16
INJECTION, SOLUTION
Guselkumab 100mg/ml
SUBCUTANEOUS
Prescription Only
Cilag AG
ACTIVE
2020-01-17
Page 1 of 14 TREMFYA ® (GUSELKUMAB) READ ALL OF THIS PACKAGE INSERT CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • Keep this package insert. You may need to read it again. • If you have any questions, ask your doctor or nurse. WHAT IS IN THIS PACKAGE INSERT 1. What TREMFYA ® is and what it is used for 2. What you need to know before you use TREMFYA ® 3. How to use TREMFYA ® 4. What are the possible side effects of TREMFYA ® 5. How to store TREMFYA ® 6. Contents of the pack and other information 1. WHAT TREMFYA ® IS AND WHAT IT IS USED FOR TREMFYA ® contains the active substance guselkumab which is a type of protein called a monoclonal antibody. This medicine works by neutralizing the activity of a protein called IL-23, which is present at increased levels in people with psoriasis. TREMFYA ® is used to treat: • adults with moderate to severe “plaque psoriasis”, an inflammatory condition affecting the skin and nails. TREMFYA ® can improve skin clearance and nail appearance and reduce symptoms of psoriasis, such as scaling, shedding, flaking, itching, pain, and burning. • adults with active psoriatic arthritis, an inflammatory disease of the joints, usually accompanied by psoriasis. If you have active psoriatic arthritis, you will be given TREMFYA ® alone or in combination with a conventional Disease Modifying Anti- Rheumatic Drug (DMARD) such as methotrexate. • adults with moderate to severe palmoplantar pustulosis (PPP), an inflammatory condition causing redness and pustules affecting the palms of the hands and/or soles of the feet. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE TREMFYA ® WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse, before taking TREMFYA ® . If you think you may be allergic to guselkumab or any other ingredients of this medicine, ask your doctor for advice before using TREMFYA ® . Infections BEFORE STARTING TREMFYA ® , TELL YOUR HEALTHCARE PROVIDER IF YOU: • are being treated for an infection • have an infection that does not go away or that keep Lees het volledige document
Page 1 of 37 PRODUCT NAME TREMFYA ® (guselkumab) DOSAGE FORM AND STRENGTHS Guselkumab is a fully human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody (mAb) that binds selectively to the extracellular human interleukin 23 (IL-23) protein with high specificity and affinity. Guselkumab is produced in a mammalian cell line using recombinant DNA technology. TREMFYA ® is available as a solution for injection in the following presentation: PRE-FILLED PEN Each 100mg Prefilled pen contains 100mg of guselkumab per 1mL For excipients, see _List of Excipients_ . CLINICAL INFORMATION INDICATIONS PLAQUE PSORIASIS _ADULTS_ TREMFYA ® is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. PSORIATIC ARTHRITIS TREMFYA ® is indicated for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy. PALMOPLANTAR PUSTULOSIS TREMFYA ® by subcutaneous (SC) administration is indicated for the treatment of moderate to severe palmoplantar pustulosis (PPP) in adult patients who do not adequately respond to conventional therapy. DOSAGE AND ADMINISTRATION DOSAGE – ADULTS (18 YEARS AND OLDER) TREMFYA ® is administered by subcutaneous injection. _PLAQUE PSORIASIS _ The recommended dose of TREMFYA ® is 100 mg to be given as subcutaneous injection at week 0, week 4 and every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment. _PSORIATIC ARTHRITIS_ The recommended dose of TREMFYA ® is 100 mg to be given as subcutaneous injection at weeks 0 and 4 and every 8 weeks thereafter. For patients at high risk for joint damage according to Page 2 of 37 clinical judgement, a dose of 100 mg every 4 weeks may be considered (see _ Clinical studies, _ _Radiographic response_ ). TREMFYA ® may be administered alone or in combination with a conv Lees het volledige document