DELSTRIGO FILM-COATED TABLETS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL AS FUMARATE

Available from:

MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL

ATC code:

J05AR24

Pharmaceutical form:

FILM COATED TABLETS

Composition:

DORAVIRINE 100 MG; LAMIVUDINE 300 MG; TENOFOVIR DISOPROXIL AS FUMARATE 245 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

MERCK SHARP & DOHME LLC, USA

Therapeutic area:

LAMIVUDINE,TENOFOVIR DISOPROXIL AND DORAVIRINE

Therapeutic indications:

Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) is indicated as a complete regimen for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults without past or present evidence of viral resistance to doravirine, lamivudine, or tenofovir.

Authorization date:

2020-09-21

Patient Information leaflet

1
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS
(PREPARATIONS) 1986
This medicine is marketed upon doctor's prescription only
DELSTRIGO
®
FILM-COATED TABLETS
Each film coated tablet contains:
Doravirine 100 mg
Lamivudine 300mg
Tenofovir disoproxil (as fumarate) 245mg
For a list of inactive ingredients see section 6 "Further Informtion".
See also section 2.9 “Important
information about some of the ingredients of the medicine".
Read all of this leaflet carefully before you start using the
medicine.
•
This leaflet contains concise information about Delstrigo. If you have
any further questions, refer to
the doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if
their medical condition seems similar to yours.
1.
WHAT DELSTRIGO IS INTENDED FOR?
Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) is
indicated as a complete regimen for
the treatment of human immunodeficiency virus-1 (HIV-1) infection in
adults without past or present
evidence of viral resistance to doravirine, lamivudine, or tenofovir.
Therapeutic group:
•
Doravirine - a non-nucleoside reverse transcriptase inhibitor (NNRTI)
•
Lamivudine - a nucleoside analogue reverse transcriptase inhibitor
(NRTI)
•
Tenofovir disoproxil - a nucleoside analogue reverse transcriptase
inhibitor (NRTI)
How Delstrigo works
Delstrigo works by preventing HIV from making more viruses in your
body. This will help by:
•
reducing the amount of HIV in your blood (this is called your ‘viral
load’).
•
increasing the number of white blood cells called ‘CD4
+
T’. This can make your immune
system stronger. This may reduce your risk of early death or catching
infections because
your immune system is weak.
2.
BEFORE USING DELSTRIGO
2.1 Do not use Delstrigo:
•
if you are sensitive (allergic) to doravirine, lamivudine or tenofovir
disoproxil or
any of the other ingredients of this medicine listed in section 6.
•
if you are taking any of the following medicine

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Delstrigo Film-Coated Tablets
2.
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.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Yellow, oval-shaped tablet, debossed with the corporate logo and 776
on one side and plain on the
other side.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) is
indicated as a complete regimen for the
treatment of human immunodeficiency virus type 1 (HIV-1) infection in
adults without past or present
evidence of viral resistance to doravirine, lamivudine, or tenofovir.
4.2
Posology and method of administration
Therapy should be initiated by a physician experienced in the
management of HIV infection.
Posology
The recommended dose of Delstrigo is one tablet taken orally once
daily with or without food.
_Dose adjustment _
If Delstrigo is co-administered with rifabutin, the doravirine dose
should be increased to 100 mg twice
daily. This is achieved by adding one 100 mg tablet of doravirine (as
a single agent), to be taken
approximately 12 hours apart from the dose of Delstrigo (see section
4.5).
Co-administration of doravirine with other moderate CYP3A inducers has
not been evaluated, but
decreased doravirine concentrations are expected. If co-administration
with other moderate CYP3A
inducers (e.g., dabrafenib, lesinurad, bosentan, thioridazine,
nafcillin, modafinil, telotristat ethyl)
cannot be avoided, one 100 mg tablet of doravirine should be taken
daily, approximately 12 hours
after the dose of Delstrigo (see section 4.5).
_Missed dose _
If the patient misses a dose of Delstrigo within 12 hours of the time
it is usually taken, the patient
should take Delstrigo as soon as possible and resume