Brand Name
Pifeltro
Generic Name
Doravirine
View Brand Information FDA approval date: July 20, 2018
Classification: Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor
Form: Tablet
What is Pifeltro (Doravirine)?
PIFELTRO ™ is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients: with no prior antiretroviral treatment history; OR to replace the current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine. PIFELTRO, a non-nucleoside reverse transcriptase inhibitor , is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients: with no prior antiretroviral treatment history, OR to replace the current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine.
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A Clinical Study to Evaluate the Breast Milk and Plasma Pharmacokinetics of MK-8591A in Healthy Lactating Female Participants
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Brand Information
PIFELTRO (doravirine)
1INDICATIONS AND USAGE
PIFELTRO
- with no prior antiretroviral treatment history;
- to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine
2DOSAGE FORMS AND STRENGTHS
PIFELTRO film-coated tablets are white, oval-shaped tablets, debossed with the corporate logo and 700 on one side and plain on the other side. Each tablet contains 100 mg doravirine.
3CONTRAINDICATIONS
PIFELTRO is contraindicated when co-administered with drugs that are strong cytochrome P450 (CYP)3A enzyme inducers as significant decreases in doravirine plasma concentrations may occur, which may decrease the effectiveness of PIFELTRO
- the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin
- the androgen receptor inhibitor enzalutamide
- the antimycobacterials rifampin, rifapentine
- the cytotoxic agent mitotane
- St. John's wort (
4ADVERSE REACTIONS
The following adverse reactions are discussed in other sections of the labeling:
- Immune Reconstitution Syndrome
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
4.2Postmarketing Experience
The following adverse reactions have been identified during postmarketing experience in patients receiving doravirine-containing regimens. Because postmarketing reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Skin and Subcutaneous Tissue Disorders: Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN)
Hepatobiliary Disorders: hepatitis
Investigations: hepatic enzyme increased
5DESCRIPTION
PIFELTRO is a film-coated tablet containing doravirine for oral administration.
Doravirine is an HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI).
Each tablet contains 100 mg of doravirine as the active ingredient. The tablets include the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablets are film coated with a coating material containing the following inactive ingredients: hypromellose, lactose monohydrate, titanium dioxide, and triacetin. The coated tablets are polished with carnauba wax.
The chemical name for doravirine is 3-chloro-5-[[1-[(4,5-dihydro-4-methyl-5-oxo-1
It has a molecular formula of C
It has the following structural formula:
Doravirine is practically insoluble in water.
6HOW SUPPLIED/STORAGE AND HANDLING
Each PIFELTRO tablet contains 100 mg of doravirine, is white, oval-shaped and film-coated, and is debossed with the corporate logo and 700 on one side and plain on the other side. Each bottle contains 30 tablets (NDC 0006-3069-01) with silica gel desiccant and is closed with a child-resistant closure.
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
8PRINCIPAL DISPLAY PANEL - 100 mg Bottle Label
NDC 0006-3069-01
Pifeltro
100 mg
Each tablet contains 100 mg doravirine.
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Rx only
30 Tablets
