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PIFELTRO 100 mg FILM-COATED TABLETS

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About the medicine

How to use PIFELTRO 100 mg FILM-COATED TABLETS

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the User

Pifeltro100mg 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.

Contents of the pack

  1. What is Pifeltro and what is it used for
  2. What you need to know before you take Pifeltro
  3. How to take Pifeltro
  4. Possible side effects
  5. Storage of Pifeltro
  6. Contents of the pack and other information

1. What is Pifeltro and what is it used for

What isPifeltro

Pifeltro is used to treat HIV infection (Human Immunodeficiency Virus). It belongs to a group of medicines called antiretrovirals.

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 from 12 years of age and weighing at least 35 kg. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). Do 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 HIV medicines.

How Pifeltro works

When used with other medicines, Pifeltro works by preventing HIV from producing more viruses in your body by:

  • reducing the amount of HIV in the blood (this is called "viral load")
  • increasing the number of white blood cells called "CD4+ T cells". This can strengthen your immune system and reduce the risk of early death or acquiring infections because your immune system is weak.
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2. What you need to know before you take Pifeltro

Do not takePifeltro

  • if you are allergic to doravirine or any of the other ingredients of this medicine (listed in section 6).
  • if you are taking the following medicines:
  • carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines to treat seizures)
  • rifampicin, rifapentine (medicines to treat tuberculosis)
  • St. John's Wort (Hypericum perforatum, a herbal remedy used for depression and anxiety) or products that contain it
  • mitotane (a medicine to treat cancer)
  • enzalutamide (a medicine to treat prostate cancer)
  • lumacaftor (a medicine to treat cystic fibrosis)

Do not take Pifeltro if you are in any of the above situations. If you are unsure, consult your doctor, pharmacist, or nurse before taking Pifeltro. Also, read the section "Other medicines and Pifeltro".

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start taking Pifeltro.

Severe skin reactions

Severe skin reactions, including Stevens-Johnson syndrome/toxic epidermal necrolysis, have been reported with Pifeltro treatment. Stop taking Pifeltro and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Immune Reconstitution Syndrome

This syndrome may occur when you start treatment with any HIV medicine, including this medicine. Your immune system may become stronger and start to fight infections that have been hidden in your body for a long time. Tell your doctor immediately if you start to have new symptoms after starting HIV medicine.

Autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you have started 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 starting in the hands and feet and rising to the trunk of the body, palpitations, tremors, or hyperactivity, tell your doctor immediately to receive the necessary treatment.

Children and adolescents

Do not give this medicine to children under 12years of age or weighing less than 35kg.The use of Pifeltro in children under 12 years of age or weighing less than 35 kg has not been studied.

Other medicines andPifeltro

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 the way Pifeltro works and Pifeltro may affect the way other medicines work.

There are some medicines that you should not take with Pifeltro. Read the list in the section "Do not take Pifeltro".

Talk to your doctor before taking the following medicines with Pifeltro, as your doctor may need to adjust the dose of your medicines:

  • bosentan (a medicine to treat lung diseases)
  • dabrafenib (a medicine to treat skin cancer)
  • lesinurad (a medicine to treat gout)
  • modafinil (a medicine to treat excessive sleepiness)
  • nafcillin (a medicine to treat certain bacterial infections)
  • rifabutin (a medicine to treat certain bacterial infections, such as tuberculosis)
  • telotristat ethyl (a medicine to treat diarrhea in people with carcinoid syndrome)
  • thioridazine (a medicine to treat psychiatric disorders such as schizophrenia)

If your doctor decides that you should take these medicines with Pifeltro, you should take one doravirine tablet twice a day (with approximately 12 hours between each dose).

Your doctor may check your blood levels or monitor side effects if you take the following medicines with Pifeltro:

  • sirolimus (a medicine used to control the immune response of your body after a transplant)
  • tacrolimus (a medicine used to control the immune response of your body after a transplant)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. It is recommended to avoid the use of this medicine during pregnancy, as it has not been studied during pregnancy and it is not known whether it will harm your baby while you are pregnant.

It is not recommended that HIV-infected women breastfeed their babies because HIV infection can be passed to the baby through breast milk.

If you are breastfeeding or think you may want to breastfeed, talk to your doctor as soon as possible.

Driving and using machines

Be careful when driving, cycling, or using machines if you feel tired, dizzy, or drowsy after taking this medicine.

Pifeltro tablets contain lactose

If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Pifeltro

Always take this medicine exactly as your doctor, pharmacist, or nurse has told you. If you are unsure, talk to your doctor, pharmacist, or nurse. This medicine must be used in combination with other HIV medicines.

How much to take

The recommended dose is one tablet once a day. If you are taking certain medicines, your doctor may need to adjust the amount of doravirine you take. Read the section "Other medicines and Pifeltro" to see the list of medicines.

How to take this medicine

  • Swallow the tablet whole (do not crush or chew it).
  • This medicine can be taken with or without food.

If you take more Pifeltro than you should

Do not take a higher dose than recommended. If you accidentally take more than the recommended dose, contact your doctor.

If you forget to takePifeltro

  • It is important that you do not miss or skip any dose of this medicine.
  • If you forget to take a dose, take it as soon as you remember. However, if it is less than 12 hours until the time of your next dose, skip the missed dose and take the next dose at the usual time. Then continue with your treatment as usual.
  • Do not take a double dose to make up for forgotten doses.
  • If you are unsure what to do, talk to your doctor or pharmacist.

If you stop takingPifeltro

Do not stop taking this medicine without talking to your doctor. If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

Medicine questions

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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Do not stop taking this medicine without talking to your doctor.

Stop taking Pifeltro and seek medical attention immediately if you notice any of the following symptoms: red patches, target-like marks or circular patches on the trunk, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can start with fever and symptoms similar to flu (Stevens-Johnson syndrome/toxic epidermal necrolysis). The frequency of these reactions cannot be estimated from the available data.

Other side effects that may occur

Common:may affect up to 1 in 10 people:

  • abnormal dreams, difficulty sleeping (insomnia)
  • headache, dizziness, drowsiness
  • nausea, diarrhea, stomach pain, vomiting, gas (flatulence)
  • rash
  • feeling tired

Blood tests may also show:

  • increased levels of liver enzymes (ALT)

Uncommon:may affect up to 1 in 100 people:

  • nightmares, depression, anxiety, irritability, confusion, suicidal thoughts
  • concentration problems, memory problems, tingling in hands and feet, muscle stiffness, poor quality sleep
  • high blood pressure
  • constipation, stomach upset, bloating or swelling of the stomach (abdominal distension), indigestion, soft stools
  • itching
  • muscle pain, joint pain
  • feeling weak, general feeling of being unwell

Blood tests may also show:

  • decreased levels of phosphate
  • increased levels of liver enzymes (AST)
  • increased levels of lipase
  • increased levels of amylase
  • decreased levels of hemoglobin

Rare:may affect up to 1 in 1,000 people:

  • aggression, hallucinations, difficulty adapting to changes, mood changes, sleepwalking
  • difficulty breathing, swelling of the tonsils
  • feeling of incomplete defecation
  • skin inflammation due to an allergy, redness of the cheeks, nose, chin, or forehead, bumps or pimples on the face
  • kidney damage, kidney problems, kidney stones
  • chest pain, feeling cold, pain, thirst

Blood tests may also show:

  • decreased levels of magnesium
  • increased levels of creatine phosphokinase

Reporting of side effects

If you experience 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 national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pifeltro

  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the bottle after EXP. This medicine should be used within 35 days of first opening the bottle.
  • The bottle contains a desiccant that protects the tablets from moisture. Keep the desiccant in the bottle and do not throw it away until you have finished taking all the medicine.
  • Keep the bottle tightly closed to protect it from moisture.
  • This medicine does not require any special storage conditions.
  • Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Additional Information

Pifeltro Composition

  • The active ingredient is doravirine 100 mg.
  • The other components are sodium croscarmellose E468; hypromellose acetate succinate; lactose monohydrate; magnesium stearate E470b; microcrystalline cellulose E460 and anhydrous colloidal silica E551. The tablets are coated with a film that contains the following components: carnauba wax E903; hypromellose E464; lactose monohydrate; titanium dioxide E171 and triacetin E1518.

Product Appearance and Package Contents

Pifeltro is presented in film-coated tablets, white, oval, engraved with the corporate logo and 700 on one side and smooth on the other side.

The following package sizes are available:

  • 1 bottle with 30 film-coated tablets
  • 90 film-coated tablets (3 bottles of 30 film-coated tablets)

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, Netherlands

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Belgium

MSD Belgium

Tel: +32(0)27766211

[email protected]

Lithuania

UAB Merck Sharp & Dohme

Tel: + 370 5 278 02 47

[email protected]

Text in Bulgarian language with contact information of Merck Sharp & Dohme Bulgaria including phone and email

Luxembourg

MSD Belgium

Tel: +32(0)27766211

[email protected]

Czech Republic

Merck Sharp & Dohme s.r.o.

Tel: +420 233 010 111

[email protected]

Hungary

MSD Pharma Hungary Kft.

Tel.: +36 1 888 5300

[email protected]

Denmark

MSD Danmark ApS

Tlf.: + 45 4482 4000

[email protected]

Malta

Merck Sharp & Dohme Cyprus Limited

Tel: 8007 4433 (+356 99917558)

[email protected]

Germany

MSD Sharp & Dohme GmbH

Tel: 0800 673 673 673 (+49 (0) 89 4561 0)

[email protected]

Netherlands

Merck Sharp & Dohme B.V.

Tel: 0800 9999000

(+31 23 5153153)

[email protected]

Estonia

Merck Sharp & Dohme OÜ

Tel.: +372 6144 200

[email protected]

Norway

MSD (Norge) AS

Tlf: +47 32 20 73 00

[email protected]

Greece

MSD Α.Φ.Ε.Ε.

Τηλ: +30 210 98 97 300

[email protected]

Austria

Merck Sharp & Dohme Ges.m.b.H.

Tel: +43 (0) 1 26 044

[email protected]

Spain

Merck Sharp & Dohme de España, S.A.

Tel: +34 91 321 06 00

[email protected]

Poland

MSD Polska Sp. z o.o.

Tel: +48 22 549 51 00

[email protected]

France

MSD France

Tél: + 33 (0) 1 80 46 40 40

Portugal

Merck Sharp & Dohme, Lda

Tel: +351 21 4465700

[email protected]

Croatia

Merck Sharp & Dohme d.o.o.

Tel: + 385 1 6611 333

[email protected]

Romania

Merck Sharp & Dohme Romania S.R.L.

Tel: +40 21 529 29 00

[email protected]

Ireland

Merck Sharp & Dohme Ireland (Human Health) Limited

Tel: +353 (0)1 2998700

[email protected]

Slovenia

Merck Sharp & Dohme, inovativna zdravila d.o.o.

Tel: +386 1 5204 201

[email protected]

Iceland

Vistor hf.

Sími: + 354 535 7000

Slovak Republic

Merck Sharp & Dohme, s. r. o.

Tel: +421 2 58282010

[email protected]

Italy

MSD Italia S.r.l.

Tel: 800 23 99 89 (+39 06 361911)

[email protected]

Finland

MSD Finland Oy

Puh/Tel: +358 (0)9 804 650

[email protected]

Cyprus

Merck Sharp & Dohme Cyprus Limited

Τηλ.: 800 00 673 (+357 22866700)

[email protected]

Sweden

Merck Sharp & Dohme (Sweden) AB

Tel: +46 77 5700488

[email protected]

Latvia

SIA Merck Sharp & Dohme Latvija

Tel: + 371 67364224

[email protected]

United Kingdom (Northern Ireland)

Merck Sharp & Dohme Ireland (Human Health) Limited

Tel: +353 (0)1 2998700

[email protected]

Date of Last Revision of this Leaflet:{MM/YYYY}.

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu.

Online doctors for PIFELTRO 100 mg FILM-COATED TABLETS

Discuss questions about PIFELTRO 100 mg FILM-COATED TABLETS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

5.0 (3)
Doctor

Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques. For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance. Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults. In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions. Patients commonly seek his care for: 

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Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.

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Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

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If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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Daniel Cichi

Family medicine 24 years exp.

Dr Daniel Cichi is a family medicine doctor with over 20 years of clinical experience. He provides online consultations for adults, supporting patients with acute symptoms, chronic conditions, and everyday health concerns that require timely medical guidance. His background includes work in emergency care, ambulance services, and family medicine, which allows him to assess symptoms quickly, identify warning signs, and help patients choose the safest next steps – whether that means home care, treatment adjustment, or in-person evaluation. Patients commonly consult Dr Daniel Cichi for: 

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Svetlana Kolomeeva

Cardiology 18 years exp.

Dr. Svetlana Kolomeeva is a general practitioner and internal medicine doctor providing online consultations for adults. She helps patients manage acute symptoms, chronic conditions, and preventive care. Her clinical focus includes cardiovascular health, hypertension control, and managing symptoms like fatigue, weakness, sleep issues, and overall low energy.

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Frequently Asked Questions

Is a prescription required for PIFELTRO 100 mg FILM-COATED TABLETS?
PIFELTRO 100 mg FILM-COATED TABLETS requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in PIFELTRO 100 mg FILM-COATED TABLETS?
The active ingredient in PIFELTRO 100 mg FILM-COATED TABLETS is doravirine. This information helps identify medicines with the same composition but different brand names.
Who manufactures PIFELTRO 100 mg FILM-COATED TABLETS?
PIFELTRO 100 mg FILM-COATED TABLETS is manufactured by Merck Sharp & Dohme B.V.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of PIFELTRO 100 mg FILM-COATED TABLETS online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether PIFELTRO 100 mg FILM-COATED TABLETS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to PIFELTRO 100 mg FILM-COATED TABLETS?
Other medicines with the same active substance (doravirine) include EDURANT 25 mg FILM-COATED TABLETS, EFAVIRENZ AUROVITAS 600 mg FILM-COATED TABLETS, Efavirenz Teva 600 mg film-coated tablets. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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