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Doravirine (Pifeltro)

Trade Name : PIFELTRO

Merck Sharp & Dohme Corp.

TABLET, FILM COATED

Strength 100 mg/1

DORAVIRINE Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Non-Nucleoside Analog [EXT]

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Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Doravirine (Pifeltro) which is also known as PIFELTRO and Manufactured by Merck Sharp & Dohme Corp.. It is available in strength of 100 mg/1 per ml. Read more

Doravirine (Pifeltro) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • PIFELTRO is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients:
  • PIFELTRO, a non-nucleoside reverse transcriptase inhibitor (NNRTI), is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients:
  • with no prior antiretroviral treatment history, n
  • 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. ()
  • No data
  • Recommended dosage: One tablet taken orally once daily with or without food in adult patients. ()
  • Dosage adjustment with rifabutin: One tablet taken twice daily (approximately 12 hours apart). ()
  • 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.
  • Tablets: 100 mg doravirine. ()
  • 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 . These drugs include, but are not limited to, the following:
  • 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. ()
  • No data
  • Monitor for Immune Reconstitution Syndrome. ()
  • The following adverse reactions are discussed in other sections of the labeling:
  • 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.
  • Most common adverse reactions (incidence greater than or equal to 5%, all grades) are nausea, dizziness, headache, fatigue, diarrhea, abdominal pain, and abnormal dreams. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Consult the full prescribing information prior to and during treatment for important potential drug-drug interactions. (, , )
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  • Lactation: Breastfeeding is not recommended due to the potential for HIV-1 transmission. ()
  • 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-1-1,2,4-triazol-3-yl)methyl]-1,2-dihydro-2-oxo-4-(trifluoromethyl)-3-pyridinyl]oxy]benzonitrile.
  • It has a molecular formula of CHClFNO and a molecular weight of 425.75.
  • It has the following structural formula:
  • Doravirine is practically insoluble in water.
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  • 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.
  • Store PIFELTRO in the original bottle. Keep the bottle tightly closed to protect from moisture. Do not remove the desiccant.
  • Store PIFELTRO at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F); excursions permitted to 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [see USP Controlled Room Temperature].
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Manufactured for: Merck Sharp & Dohme Corp., a subsidiary ofn Whitehouse Station, NJ 08889, USA
  • For patent information: www.merck.com/product/patent/home.html
  • The trademarks depicted herein are owned by their respective companies.
  • Copyright u00a9 2018-2019 Merck Sharp & Dohme Corp., a subsidiary of n All rights reserved.
  • uspi-mk1439-t-1910r002
  • No data
  • Manufactured by: Merck Sharp & Dohme Corp., a subsidiary ofn , Whitehouse Station, NJ 08889, USA
  • U.S. License No. 0002For patent information: www.merck.com/product/patent/home.htmlThe trademarks depicted herein are owned by their respective companies.Copyright u00a9 2018-2019 Merck Sharp & Dohme Corp., a subsidiary of All rights reserved.usppi-mk1439-t-1909r001For more information, go to www.PIFELTRO.com or call 1-877-888-4231.This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 09/2019
  • NDC 0006-3069-01
  • Pifeltrou2122(doravirine) tablets
  • 100 mg
  • Each tablet contains 100 mg doravirine.
  • ALERT: Find out about medicines thatshould NOT be taken with Pifeltrou2122.
  • Rx only
  • 30 Tablets

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