Registered Kenya · PPB

PIFELTRO 100 MG FILM-COATED TABLET

DORAVIRINE

H2022/CTD10177/21536 EACH FILM-COATED TABLET CONTAINS 100 MG OF DORAVIRINE NEW/INNOVATOR antiinfectives for systemic use INN generic

What it does

Doravirine is a medication used to help manage HIV (human immunodeficiency virus) infection.

Commonly used for: HIV infection

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
H2022/CTD10177/21536
Registration date
-
Expiry date
2028 September 26
Status
Registered
Active ingredient
DORAVIRINE
Strength
-
Pack size
1 BOTTLE WITH 30 FILM-COATED TABLETS
Therapeutic class
NEW/INNOVATOR
ATC class (WHO)
J05AG - Non-nucleoside reverse transcriptase inhibitors
RxNorm RxCUI
2055755
Manufacturer / MAH
Imperial Managed Solutions
Applicant / LTR
MSD (PTY) LTD
Country of origin
FOREIGN
Manufacturer location
JW8Q+7R3, kutch Rd, Mlolongo, Kenya

Source: Pharmacy and Poisons Board · fetched 2026-01-28 19:34:38 · updated 2026-10-20 02:21:41

Drug Interactions

7
Check interactions

Severe (1)

Doravirine - decreases exposure

Lumacaftorispredictedtodecreasetheexposureto doravirine.Avoid.rTheoretical

Severe Theoretical

Moderate (2)

Sirolimus - decreases exposure

Doravirine is predicted to decrease the exposure to sirolimus. Monitor sirolimus concentration and adjust dose, p. 919.

Moderate Theoretical

Tacrolimus - decreases exposure

Doravirine is predicted to decrease the exposure to tacrolimus. Monitor tacrolimus concentration and adjust dose, p. 920.

Moderate Theoretical

Unknown (4)

Doravirine - decreases exposure

Dabrafenib is predicted to decrease the exposure to doravirine. Avoid or adjust doravirine p. 708 or lamivudine with tenofovir disoproxil and doravirine p. 718 dose.

Unknown Theoretical

Doravirine - decreases exposure

Mitotaneispredictedtodecreasetheexposuretodoravirine. Avoid.rStudy

Unknown Study

Doravirine - decreases exposure

Modafinil is predicted to decrease the exposure to doravirine. Avoid or adjust doravirine p. 708 or lamivudine with tenofovir disoproxil and doravirine p. 718 dose.

Unknown Theoretical

Doravirine - decreases exposure

Telotristat ethyl is predicted to decrease the exposure to doravirine. Avoid or adjust doravirine p. 708 or lamivudine with tenofovir disoproxil and doravirine p. 718 dose.

Unknown Theoretical

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: exact

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About this medicine

Doravirine is a medication used to help manage HIV (human immunodeficiency virus) infection.

What it treats

  • HIV infection

How it works

It works by preventing the virus from multiplying in the body, helping to control the infection.

Who it's for

Doravirine is for adults and children who are infected with HIV.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Doravirine

BNF-referenced

Doravirine is a pyridinone non-nucleoside reverse transcriptase inhibitor (NNRTI) used for the treatment of HIV-1 infection. It works by inhibiting the reverse transcriptase enzyme, which is crucial for the replication of the virus. By blocking this enzyme, doravirine prevents the conversion of viral RNA into DNA, thereby hindering the virus's ability to replicate within the host's cells. It is typically used in combination with other antiretroviral drugs to enhance treatment efficacy.

Indications

  • HIV-1 infection

Dosage

Children: Refer to the BNF for Children for specific paediatric dosing guidelines.

Adults: 600 mg once daily.

Mechanism of action

Doravirine inhibits HIV-1 replication by non-competitively inhibiting the reverse transcriptase enzyme that HIV uses to generate complementary DNA (cDNA) from its RNA genome. This cDNA is then integrated into the host cell genome, allowing for viral replication. Importantly, doravirine does not inhibit human DNA polymerases, ensuring a selective action against HIV-1.

Pharmacodynamics

In clinical trials, doravirine demonstrated efficacy in reducing viral load in HIV-1 infected individuals. A phase 2 trial assessed doses ranging from 0.25 to 2 times the recommended dose and found no significant exposure-response relationship for efficacy, indicating that higher doses do not necessarily equate to better outcomes. Furthermore, doravirine does not significantly affect the QT interval, even at doses significantly higher than the recommended dosage.

Pharmacokinetics

Doravirine is well absorbed after oral administration, with peak plasma concentrations occurring within 1 to 4 hours. The drug has a half-life that allows for once-daily dosing. It is primarily metabolized in the liver via the cytochrome P450 system, particularly CYP3A, and is eliminated mainly through feces, with renal excretion accounting for a minor portion. The presence of certain medications can interact with doravirine, potentially necessitating dose adjustments.

Adverse effects

  • Abdominal pain
  • Anxiety
  • Asthenia
  • Diarrhoea
  • Dizziness
  • Drowsiness
  • Gastrointestinal discomfort
  • Nausea
  • Skin reactions
  • Sleep disorders
  • Vomiting
  • Behavioural abnormality
  • Confusion
  • Flushing
  • Headache
  • Hepatocellular injury
  • Gynaecomastia
  • Hallucination
  • Memory reactions
  • Mood altered
  • Pancreatitis
  • Psychosis
  • Seizure
  • Suicidal behaviours
  • Thinking confusion
  • Constipation
  • Depression
  • Electrolyte abnormality
  • Tinnitus
  • Tremor
  • Vertigo
  • Blurred vision
  • Hypertension
  • Malaise
  • Memory loss
  • Myalgia
  • Paresthesia
  • Delusions
  • Photosensitivity reaction
  • Acute kidney injury

Interactions

  • Doravirine can decrease the exposure of lumacaftor
  • Doravirine can decrease the exposure of sirolimus
  • Doravirine can decrease the exposure of tacrolimus
  • Doravirine can decrease the exposure of dabrafenib
  • Doravirine can decrease the exposure of mitotane
  • Doravirine can decrease the exposure of modafinil
  • Doravirine can decrease the exposure of telotristatethyl

Precautions

  • Caution in patients with acute porphyrias
  • Caution in elderly patients
  • History of psychiatric disorders
  • History of seizures
  • Risk of QT interval prolongation in certain individuals
  • Caution in patients with abnormal hepatic function
  • Monitor liver function if receiving other hepatotoxic drugs
  • Caution in renal impairment, particularly severe renal failure

Pregnancy

Manufacturer advises to avoid use due to potential risks, including reports of neural tube defects when used in the first trimester.

Breast-feeding

No information available regarding excretion in breast milk and the effects on the

BNF 85 (British National Formulary) p.728 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: Doravirine

PubChem CID 58460047

Molecular formula: C17H11ClF3N5O3

Mechanism of action

Doravirine is a pyridinone non-nucleoside reverse transcriptase inhibitor of HIV-1. Reverse transcriptase is the enzyme with which HIV generates complementary DNA (cDNA) to its RNA genome - this cDNA is then inserted into the host cell genome, where it can be transcribed into viral RNA for the purposes of replication. Doravirine inhibits HIV-1 replication by non-competitively inhibiting HIV-1 reverse transcriptase. Doravirine does not, however, inhibit the human cellular DNA polymerases α, ß, and mitochondrial DNA polymerase γ.

Pharmacodynamics

In a clinical phase 2 trial evaluating a dose range of 0.25-2x the recommended dose of doravirine (in combination with emtricitabine/tenofovir) in HIV-1 infected subjects with no antiretroviral treatment history, no exposure-response relationship for efficacy was identified for doravirine. Furthermore, at a dose of 1200 mg, which provides approximately 4 times the peak concentration observed following the recommended dose, doravirine does not prolong the QT interval to any clinically relevant extent.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.