Doravirine

What is Doravirine?

Doravirine (PIFELTRO), a non-nucleoside reverse transcriptase inhibitor (NNRTI) used together with other HIV-1 medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection.

What are the uses of this medicine?

This medicine is used together with other HIV-1 medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults:

• who have not received HIV-1 medicines in the past, or
• to replace their current HIV-1 medicines for people whose healthcare provider determines that they meet certain requirements.

How does this medicine work?

• Doravirine is an antiretroviral drug.
• Doravirine is a pyridinone non-nucleoside reverse transcriptase inhibitor of HIV-1 and inhibits HIV-1 replication by non-competitive inhibition of HIV-1 reverse transcriptase (RT).
• Doravirine does not inhibit the human cellular DNA polymerases α, β, and mitochondrial DNA polymerase γ.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who use:

• the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin
• the androgen receptor inhibitor enzalutamide
• the antimycobacterials rifampin, rifapentine
• the cytotoxic agent mitotane
• St. John's wort (Hypericum perforatum)

What drug interactions can this medicine cause?

• Co-administration of PIFELTRO with a CYP3A inducer decreases doravirine plasma concentrations, which may reduce PIFELTRO efficacy.
• Co-administration of PIFELTRO is contraindicated with enzalutamide.
• Co-administration of PIFELTRO is contraindicated with Anticonvulsants carbamazepine,oxcarbazepine,phenobarbital,phenytoin.
• Co-administration of PIFELTRO is contraindicated with rifampin or rifapentine.
• Co-administration of PIFELTRO is contraindicated with mitotane.
• Co-administration of PIFELTRO is contraindicated with St. John's wort.

Is this medicine FDA approved?

• It was approved for use in the United States in 2018.

How should this medicine be used?

Recommended Dosage

• The recommended dosage regimen of PIFELTRO in adults is one 100 mg tablet taken orally once daily with or without food.

Dosage Adjustment with Rifabutin:

• One tablet taken twice daily (approximately 12 hours apart).

Administration

• Take PIFELTRO every day exactly as your doctor tells you to take it.
• Take PIFELTRO 1 time each day, at about the same time every day.
• If you take the medicine rifabutin during treatment with PIFELTRO, take PIFELTRO 2 times each day, about 12 hours apart, as prescribed by your doctor. You may not have enough doravirine in your blood if you take rifabutin during treatment with PIFELTRO.
• Take PIFELTRO with or without food.
• Do not change your dose or stop taking PIFELTRO without talking to your doctor. Stay under a doctor's care when taking PIFELTRO.
• It is important that you do not miss or skip doses of PIFELTRO.
• If you miss a dose of PIFELTRO, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at your regular time. Do not take 2 doses of PIFELTRO at the same time.
• If you have any questions, call your doctor or pharmacist.
• When your PIFELTRO supply starts to run low, get more from your doctor or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to PIFELTRO and become harder to treat.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 100 mg doravirine

This medicine is available in fallowing brand namesː

• PIFELTRO

What side effects can this medication cause?

The most common side effects of this medicine include:

• nausea
• dizziness
• headache
• tiredness
• diarrhea
• stomach (abdominal) pain
• abnormal dreams

PIFELTRO can cause serious side effects, including:

• Changes in your immune system (Immune Reconstitution Syndrome)

What special precautions should I follow?

• Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy.
• Autoimmune disorders (such as Graves' disease, polymyositis, Guillain-Barré syndrome, and autoimmune hepatitis) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable and can occur many months after initiation of treatment.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• No adequate human data are available to establish whether or not PIFELTRO poses a risk to pregnancy outcomes.
• There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to PIFELTRO during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263.

Can this medicine be used in children?

• Safety and efficacy of PIFELTRO have not been established in pediatric patients less than 18 years of age.

What are the active and inactive ingredients in this medicine?

• Active ingredient: doravirine.
• Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablet film coating contains hypromellose, lactose monohydrate, titanium dioxide and triacetin. The coated tablets are polished with carnauba wax.

Who manufactures and distributes this medicine?

• Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of
• MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

What should I know about storage and disposal of this medication?

• Store PIFELTRO tablets at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep PIFELTRO in the original bottle.
• Do not take the tablets out of the bottle to store in another container, such as a pill box.
• Keep the bottle tightly closed to protect PIFELTRO from moisture.
• The PIFELTRO bottle contains a desiccant to help keep your medicine dry (protect it from moisture). Keep the desiccant in the bottle. Do not eat the desiccant.
• Keep PIFELTRO and all medicines out of the reach of children.

• Dailymed label info on Doravirine
• FDA Doravirine

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