Label: information for the user

Pifeltro100film-coated tablets

doravirine

Read this label carefully before starting to take this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse,even if they do not appear in this label. See section4.

What isPifeltro

Pifeltro is used to treat HIV infection ("human immunodeficiency virus"). It belongs to a group of medications called "antiretrovirals".

Pifeltro contains the active ingredient doravirina, a non-nucleoside reverse transcriptase inhibitor (NNRTI).

For what it is usedPifeltro

Pifeltro is used to treat HIV infection in adults and adolescents 12 years of age or older with a weight of 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 doravirina.

Pifeltro must be used in combination with other HIV medications.

How Pifeltro works

When used with other medications, Pifeltro acts by preventing HIV from generating more virus in your body through:

• reducing the amount of HIV in the blood (known as "viral load")
• increasing the number of white blood cells called "T CD4+". This may strengthen your immune system and reduce the risk of early death or acquiring infections due to a weakened immune system.

Do not takePifeltro

• if you are allergic to doravirine or any of the other components of this medication (listed in section6).
• if you are taking the following medications:

• carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medications for treating seizures)
• rifampin, rifapentine (medications for treating tuberculosis)
• St. John's Wort (Hypericum perforatum, a plant-based remedy used for depression and anxiety) or products containing it
• mitotane (a medication for treating cancer)
• enzalutamide (a medication for treating prostate cancer)
• lumacaftor (a medication for treating cystic fibrosis)

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Pifeltro.

Severe skin reactions

Severe skin reactions, including Stevens-Johnson syndrome/toxic epidermal necrolysis, have been reported in association with Pifeltro treatment. Stop taking Pifeltro and seek medical attention immediately if you notice any symptoms related to these severe skin reactions described in section4.

Immune reconstitution syndrome

This syndrome may occur when you start treatment with any HIV medication, including this one. Your immune system may become stronger and start fighting infections that had been hidden in your body for a long time. Inform your doctor immediately if you start experiencing new symptoms after starting HIV medication.

You may also develop autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) after starting HIV treatment. Autoimmune disorders may appear many months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and ascending to the body trunk, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive necessary treatment.

Children and adolescents

Do not administer this medication to children under 12years or weighing less than 35kg.This medication has not yet been studied in children under 12years or weighing less than 35kg.

Other medications andPifeltro

Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may need to take any other medication. This is because other medications may affect the mechanism of action of Pifeltro and Pifeltro may affect the mechanism of action of those other medications.

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

Consult your doctor before taking the following medications with Pifeltro, as your doctor may need to modify the dose of your medications:

• bosentan (a medication for treating pulmonary diseases)
• dabrafenib (a medication for treating skin cancer)
• lesinurad (a medication for treating gout)
• modafinil (a medication for treating excessive sleepiness)
• nafcillin (a medication for treating some bacterial infections)
• rifabutin (a medication for treating some bacterial infections, such as tuberculosis)
• telotristat etyl (a medication for treating diarrhea in people with carcinoid syndrome)
• thioridazine (a medication for treating psychiatric disorders such as schizophrenia)

If your doctor decides that you should take these medications with Pifeltro, you should take one doravirine tablet twice a day (with an approximate 12-hour difference between each dose).

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

• sirolimus (a medication used to control your body's immune response after a transplant)
• tacrolimus (a medication used to control your body's immune response after a transplant)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor about the risks and benefits of taking Pifeltro. It is preferable to avoid using this medication during pregnancy, as it has not been studied during pregnancy and its effects on the fetus are unknown.

It is not recommended that women with HIV breastfeed, as the infection can be transmitted to the baby through breast milk.

If you are breastfeeding or plan to breastfeed, you should consult your doctor as soon as possible.

Driving and operating machinery

Be cautious when driving, riding a bike, or using machines if you feel tired, dizzy, or drowsy after taking this medication.

Pifeltro tablets contain lactose

If your doctor has told you that you have lactose intolerance, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse again. This medication should be used in combination with other medications against HIV.

How much to take

The recommended dose is one tablet once a day. If you take certain medications, your doctor may need to modify the amount of doravirine you take. See the section "Other medications and Pifeltro" to view the list of medications.

How to take this medication

• Swallowthe tablet whole (do not crush or chew it).
• This medication can be taken with food or between meals.

If you take more Pifeltro than you should

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

If you forget to takePifeltro

• It is essential not to forget or miss any dose of this medication.
• If you forget to take a dose, take it as soon as you remember. However, if less than 12hours remain until the scheduled time for the next dose, skip the missed dose and take the next dose at the usual time. Continue with your treatment as usual.
• Do not take a double dose to compensate for the missed doses.
• If unsure of what to do, consult your doctor or pharmacist.

If you interrupt the treatment withPifeltro

Do not run out of this medication. Reorder your prescription or speak with your doctor before your supply runs out.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Do not stop taking this medicine without first consulting your doctor.

Stop taking Pifeltro and seek medical attention immediately if you notice any of the following symptoms: red spots without swelling, in the shape of a target or circular on the trunk, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions may start with fever and symptoms similar to the 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 10people:

• abnormal dreams, difficulty sleeping (insomnia)
• headache, dizziness, drowsiness
• nausea, diarrhea, stomach pain, vomiting, gas (flatulence)
• eruption
• sense of fatigue

Blood tests may also indicate:

• increased levels of liver enzymes (ALT)

Uncommon:may affect up to 1 in 100people:

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

Blood tests may also indicate:

• 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 10,000people:

• aggression, hallucinations, difficulty adapting to changes, mood changes, somnambulism
• difficulty breathing, enlargement of the tonsils
• sense of incomplete defecation
• skin inflammation due to an allergy, flushing 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 indicate:

• decreased levels of magnesium
• increased levels of creatine phosphokinase

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse,even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through theAppendixV. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the bottle after CAD. This medication must be used within 35 days after the first opening of the bottle.
• The bottle contains a desiccant that protects the tablets from moisture. Keep the desiccant inside the bottle and do not discard it until you have finished taking all the medication.
• Keep the bottle perfectly closed to protect it from moisture.
• This medication does not require any special storage temperature.
• Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the containers and medication that you no longer need. This will help protect the environment.

Composition of Pifeltro

• The active ingredient is doravirine 100 mg.
• The other components are sodium croscarmellose E468; acetate succinate of hypromellose; 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.

Appearance of the product and contents of the package

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

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 commercially available.

Holder of the marketing authorization and responsible for manufacturing

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

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

Last date of revision of this leaflet:{MM/YYYY}.

Other sources of information

More detailed information on this medicine is available on the website of the European Medicines Agency:https://www.ema.europa.eu.