This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
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Pifeltro 100 mg film-coated tablets
Pifeltro® 100 mg film-coated tablets
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
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. Contents of the pack and other information
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).
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 syndrome’). 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 combination with other medicines for HIV.
When used with other medicines, Pifeltro works by preventing HIV from making more viruses in your body. This will help by:
Do not take Pifeltro if the above applies to you. If you are not sure, talk to your doctor, pharmacist, or nurse before taking Pifeltro. See also “Other Medicines and Pifeltro” section.
Talk to your doctor, pharmacist, or nurse before taking Pifeltro.
This can happen when you start taking any HIV medicine, including this medicine. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your doctor right away if you start having any new symptoms after starting your HIV medicine.
Autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.
Do not give this medicine to children aged less than 12 years or weighing less than 35 kg. The use of Pifeltro in children aged less than 12 years or weighing less than 35 kg has not yet been studied.
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken or might take any other medicines. This is because other medicines may affect how Pifeltro works, and Pifeltro might affect the way some other medicines work.
There are some medicines you must not take with Pifeltro. See list under “Do not take Pifeltro” section.
Talk to your doctor before taking the following medicines with Pifeltro, as your doctor may need to change the dose of your medicines:
If your doctor decides you should take these medicines with Pifeltro, one tablet of doravirine should be taken twice daily (approximately 12 hours apart).
Your doctor may check your blood levels or monitor for side effects if you take the following medicines with Pifeltro:
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, talk to your doctor about the risks and benefits of taking Pifeltro. It is preferable to avoid the use of this medicine during pregnancy. This is because it has not been studied in pregnancy and it is not known if it will harm your baby while you are pregnant.
Breast-feeding is not recommended in women living with HIV because HIV infection can be passed on to the baby in breast milk.
If you are breast-feeding, or thinking about breast-feeding, you should discuss it with your doctor as soon as possible.
Use caution when driving or riding a bicycle, or operating machines if you feel dizzy, tired, or sleepy after taking this medicine.
If you have been told by your doctor that you have an intolerance to lactose, talk to your doctor before taking this medicine.
Always take this medicine exactly as your doctor, pharmacist, or nurse has told you. Check with your doctor, pharmacist, or nurse if you are not sure. This medicine must be used in combination with other medicines for HIV.
The recommended dose is 1 tablet once a day. If you take certain medicines, your doctor may need to change the amount of doravirine you take. See “Other medicines and Pifeltro” section for a list of medicines.
Do not take more than the recommended dose. If you accidentally take more, contact your doctor.
Do not run out of this medicine. Refill your prescription or talk to your doctor before it is all gone.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Do not stop taking this medicine without first talking to your doctor.
Common: may affect up to 1 in 10 people:
Blood tests may also show:
Uncommon: may affect up to 1 in 100 people:
Blood tests may also show:
Rare: may affect up to 1 in 1,000 people:
Blood tests may also show:
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
Pifeltro is available as a white, oval-shaped, film-coated tablet, and is debossed with the corporate logo and 700 on one side and plain on the other side.
The following pack sizes are available:
Not all pack sizes may be available in your country.
Marketing Authorisation Holder:
For any information about this medicine, please contact:
This leaflet was last revised in September 2022
© 2022 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved.