Doravirine, Lamivudine, And Tenofovir Disoproxil Fumarate (Delstrigo)

Trade Name : DELSTRIGO

Merck Sharp & Dohme Corp.

TABLET, FILM COATED

Strength 100300300 mg/1mg/1mg/1

DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Non-Nucleoside Analog [EXT],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]

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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, Lamivudine, And Tenofovir Disoproxil Fumarate (Delstrigo) which is also known as DELSTRIGO and Manufactured by Merck Sharp & Dohme Corp.. It is available in strength of 100; 300; 300 mg/1; mg/1; mg/1 per ml. Read more

Doravirine, Lamivudine, And Tenofovir Disoproxil Fumarate (Delstrigo) 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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  • Severe acute exacerbations of hepatitis B (HBV) have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued lamivudine or tenofovir disoproxil fumarate (TDF), which are components of DELSTRIGO. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue DELSTRIGO. If appropriate, initiation of anti-hepatitis B therapy may be warranted .
  • WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B
  • See full prescribing information for complete boxed warning.
  • Severe acute exacerbations of hepatitis B (HBV) have been reported in patients coinfected with HIV-1 and HBV who have discontinued lamivudine or tenofovir disoproxil fumarate (TDF), two of the components of DELSTRIGO. Closely monitor hepatic function in these patients. If appropriate, initiation of anti-hepatitis B therapy may be warranted. ()
  • No data
  • DELSTRIGOu2122 is indicated as a complete regimen for the treatment of HIV-1 infection in adult patients:
  • DELSTRIGO is a three-drug combination of doravirine (a non-nucleoside reverse transcriptase inhibitor [NNRTI]), lamivudine, and tenofovir disoproxil fumarate (both nucleoside analogue reverse transcriptase inhibitors) and is indicated as a complete regimen for the treatment of HIV-1 infection in adult patients:
  • with no 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 the individual components of DELSTRIGO. ()
  • No data
  • Testing: Prior to or when initiating DELSTRIGO, test for HBV infection. Prior to or when initiating DELSTRIGO, and during treatment with DELSTRIGO, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus ()
  • Recommended dosage: One tablet taken orally once daily with or without food in adult patients. ()
  • Renal impairment: Not recommended in patients with estimated creatinine clearance below 50 mL per minute. ()
  • Dosage adjustment with rifabutin: Take one tablet of DELSTRIGO once daily, followed by one tablet of doravirine 100 mg (PIFELTRO) approximately 12 hours after the dose of DELSTRIGO. ()
  • DELSTRIGO film-coated tablets are yellow, oval-shaped tablets, debossed with the corporate logo and 776 on one side and plain on the other side. Each tablet contains 100 mg doravirine, 300 mg lamivudine, and 300 mg tenofovir disoproxil fumarate (equivalent to 245 mg of tenofovir disoproxil).
  • Tablets: 100 mg of doravirine, 300 mg of lamivudine, and 300 mg of tenofovir disoproxil fumarate. ()
  • No data
  • DELSTRIGO 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 DELSTRIGO. ()
  • DELSTRIGO is contraindicated in patients with a previous hypersensitivity reaction to lamivudine.
  • No data
  • New onset or worsening renal impairment: Prior to or when initiating DELSTRIGO, and during treatment with DELSTRIGO, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. Avoid administering DELSTRIGO with concurrent or recent use of nephrotoxic drugs. ()
  • Bone loss and mineralization defects: Consider monitoring BMD in patients with a history of pathologic fracture or other risk factors of osteoporosis or bone loss. ()
  • Monitor for Immune Reconstitution Syndrome. ()
  • The following adverse reactions are discussed in other sections of the labeling:
  • Most common adverse reactions (incidence greater than or equal to 5%, all grades) are dizziness, nausea, 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.
  • No data
  • Because DELSTRIGO is a complete regimen, co-administration with other antiretroviral medications for treatment of HIV-1 infection is not recommended. ()
  • Consult the full prescribing information prior to and during treatment for important potential drug-drug interactions. (, , )
  • No data
  • Lactation: Breastfeeding is not recommended due to the potential for HIV-1 transmission. ()
  • No data are available on overdose of DELSTRIGO in patients and there is no known specific treatment for overdose with DELSTRIGO. If overdose occurs, the patient should be monitored and standard supportive treatment applied as required.
  • DELSTRIGO is a fixed-dose combination, film-coated tablet, containing doravirine, lamivudine, and TDF for oral administration.
  • Doravirine is an HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI).
  • Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine and is an HIV-1 nucleoside analogue reverse transcriptase inhibitor.
  • TDF (a prodrug of tenofovir) is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. TDF is converted to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate. Tenofovir is an HIV-1 reverse transcriptase inhibitor.
  • Each tablet contains 100 mg of doravirine, 300 mg of lamivudine, and 300 mg of TDF (equivalent to 245 mg of tenofovir disoproxil) as active ingredients. The tablets include the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, and sodium stearyl fumarate. The tablets are film coated with a coating material containing the following inactive ingredients: hypromellose, iron oxide yellow, lactose monohydrate, titanium dioxide, and triacetin. The coated tablets are polished with carnauba wax.
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  • Each DELSTRIGO tablet contains 100 mg of doravirine, 300 mg of lamivudine, and 300 mg of tenofovir disoproxil fumarate (equivalent to 245 mg of tenofovir disoproxil), is yellow, oval-shaped, film-coated, and is debossed with the corporate logo and 776 on one side and plain on the other side. Each bottle contains 30 tablets (NDC 0006-5007-01) and silica gel desiccants, and is closed with a child-resistant closure.
  • Store DELSTRIGO in the original bottle. Keep the bottle tightly closed to protect from moisture. Do not remove the desiccants.
  • Store DELSTRIGO 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 of n 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-mk1439a-t-1910r002
  • No data
  • NDC 0006-5007-01
  • Delstrigou2122(doravirine, lamivudine, andtenofovir disoproxil fumarate) tablets
  • 100mg/300mg/300mg
  • Each tablet contains 100 mg doravirine, 300 mglamivudine, and 300 mg tenofovir disoproxil fumarate(equivalent to 245 mg tenofovir disoproxil).
  • ALERT: Find out about medicines thatshould NOT be taken with Delstrigou2122.
  • Rx only
  • 30 Tablets

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