DELSTRIGO Film-coated tablet Ref.[28332] Active ingredients: Doravirine Lamivudine Lamivudine, Tenofovir disoproxil and Doravirine Tenofovir disoproxil

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Product name and form

Delstrigo 100 mg/300 mg/245 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Yellow, oval-shaped, tablet of dimensions 21.59 mm x 11.30 mm, debossed with the corporate logo and 776 on one side and plain on the other side.

Qualitative and quantitative composition

Each film-coated tablet contains 100 mg of doravirine, 300 mg of lamivudine (3TC), and 245 mg of tenofovir disoproxil as tenofovir disoproxil fumarate (TDF).

Excipient with known effect: Each film-coated tablet contains 8.6 mg lactose (as monohydrate).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Doravirine

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.

Lamivudine

Lamivudine is a nucleoside analogue which has activity against human immunodeficiency virus (HIV) and hepatitis B virus (HBV). Its main mode of action is as a chain terminator of viral reverse transcription.

Lamivudine, Tenofovir disoproxil and Doravirine

Lamivudine is a nucleoside analogue. Intracellularly, lamivudine is phosphorylated to its active 5'-triphosphate metabolite, lamivudine triphosphate (3TC-TP). The principal mode of action of 3TC-TP is inhibition of HIV-1 reverse transcriptase (RT) via DNA chain termination after incorporation of the nucleotide analogue. Tenofovir diphosphate inhibits the activity of HIV-1 RT by competing with the natural substrate deoxyadenosine 5'-triphosphate and, after incorporation into DNA, by DNA chain termination. Doravirine is a pyridinone non-nucleoside reverse transcriptase inhibitor of HIV-1 and inhibits HIV-1 replication by non-competitive inhibition of HIV-1 RT.

Tenofovir disoproxil

Tenofovir disoproxil is absorbed and converted to the active substance tenofovir, which is a nucleoside monophosphate analogue. Tenofovir is then converted to the active metabolite, tenofovir diphosphate, an obligate chain terminator, by constitutively expressed cellular enzymes. Tenofovir diphosphate inhibits HIV-1 reverse transcriptase and the HBV polymerase by direct binding competition with the natural deoxyribonucleotide substrate and, after incorporation into DNA, by DNA chain termination.

List of Excipients

Tablet core:

Croscarmellose sodium (E468)
Hypromellose acetate succinate
Magnesium stearate (E470b)
Microcrystalline cellulose (E460)
Silica, colloidal anhydrous (E551)
Sodium stearyl fumarate

Film-coating:

Carnauba wax (E903)
Hypromellose (E464)
Iron oxide yellow (E172)
Lactose monohydrate
Titanium dioxide (E171)
Triacetin (E1518)

Pack sizes and marketing

Each carton contains a high density polyethylene (HDPE) bottle with a polypropylene child-resistant closure with silica gel desiccants.

The following pack sizes are available:

  • 1 bottle with 30 film-coated tablets.
  • 90 film-coated tablets (3 bottles of 30 film-coated tablets).

Not all pack sizes may be marketed.

Marketing authorization holder

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Marketing authorization dates and numbers

EU/1/18/1333/001
EU/1/18/1333/002

Date of first authorisation: 22 November 2018

Drugs

Drug Countries
DELSTRIGO Austria, Canada, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom, United States, South Africa

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