Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
doravirine
Merck Sharp & Dohme B.V.
J05AG06
doravirine
Antivirals for systemic use
HIV Infections
Pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults, and adolescents aged 12 years and older weighing at least 35 kg infected with HIV 1 without past or present evidence of resistance to the NNRTI class.
Revision: 9
Authorised
2018-11-22
34 B. PACKAGE LEAFLET 35 PACKAGE LEAFLET: INFORMATION FOR THE USER PIFELTRO 100 MG FILM-COATED TABLETS doravirine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist , or nurse. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Pifeltro is and what it is used for 2. What you need to know before you take Pifeltro 3. How to take Pifeltro 4. Possible side effects 5. How to store Pifeltro 6. Con tents of the pack and other information 1. WHAT PIFELTRO IS AND WHAT IT IS USED FOR WHAT PIFELTRO IS Pifeltro is used to treat HIV (‘human immunodeficiency virus’) infection. It belongs to a group of medicines called ‘antiretroviral medicines’. Pifeltro contains the active substance doravirine - a non- nucleoside reverse transcriptase inhibitor (NNRTI). WHAT PIFELTRO IS USED FOR Pifeltro is used to treat HIV infection in adults, and adolescents aged 12 years and older weighing at least 35 kg . HIV is the virus that causes AIDS (‘ acquired immune deficiency s yndrome’). You should not take Pifeltro if your doctor has told you that the virus causing your infection is resistant to doravirine. Pifeltro must be used in combinatio n with other medicines for HIV. HOW PIFELTRO WORKS When used with othe r medicines, Pifeltro works by preventing HIV from making more viruses in your body. This will help by : • reducing the amount of HIV in your blood (this is called your ‘ viral load ’ ) • increasing the number of white blood cells called ‘CD4 + T’. This can make yo ur immune system stronger. This may reduce your risk of early death or Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Pifeltro 100 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film- coated tablet contains 100 mg of doravirine. Excipient with known effect Each film- coated tablet contains 222 mg lactose (as monohydrate ). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film- coated tablet (tablet). White, oval- shaped, tablet of dimensions 19.00 mm x 9.50 mm , debossed with the corporate logo and 700 on one side and plain on the other side. 4. C LINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults, and adolescents aged 12 years and older weighing at least 35 kg infected with human immunodeficiency virus type 1 (HIV-1) without past or present evidence of resistance to the non- nucleoside reverse transcriptase inhibitors (NNRTI) class (see sections 4.4 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy should be initiated by a physician experienced in the management of HIV infection . Posology The recommended dose is one 100 mg tablet taken orally once daily with or without food. Dose adjustment If Pifeltro is co- administered with rifabutin, one 100 mg tablet of Pifeltro should be taken twice daily (approximately 1 2 hours apart) (see section 4.5). Co- administration of doravirine with other moderate CYP3A inducers has not been evaluated, but decreased doravirine concentrations are expected. If co - administration with other moderate CYP3A inducers (e.g ., dabrafenib, lesinurad, bosentan, thioridazine, nafcillin, modafinil, telotristat ethyl) cannot be avoided, one 100 mg tablet of Pifeltro should be taken twice daily (approximately 12 hours apart). Missed dose If the patient misses a dose of Pifeltro within 12 hours of the time it is usually taken, the patient should take as soon as possible and resume the normal dosing schedule. If a patient misses a dose by more than 12 hours, the pat Aqra d-dokument sħiħ