DOVATO FILM-COATED TABLET 50MG300MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Dolutegravir sodium eqv Dolutegravir; Lamivudine

Available from:

GLAXOSMITHKLINE PTE LTD

ATC code:

Pending

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Dolutegravir sodium eqv Dolutegravir 50 mg; Lamivudine 300 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

GlaxoSmithKline LLC

Authorization status:

ACTIVE

Authorization date:

2020-08-13

Patient Information leaflet

PATIENT INFORMATION LEAFLET
DOVATO 50 MG/300 MG FILM-COATED TABLETS
DOLUTEGRAVIR/LAMIVUDINE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
Keep this leaflet. You may need to read it again. If you have any
questions, ask your
doctor or pharmacist.
This medicine has been prescribed for you personally. Don’t pass it
on to other people - it
may harm them even if their symptoms seem to be the same as yours.
IN THIS LEAFLET
1.
WHAT DOVATO IS AND WHAT IT IS USED FOR
2.
BEFORE YOU TAKE DOVATO
3.
HOW TO TAKE DOVATO
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE DOVATO
6.
FURTHER INFORMATION
1. WHAT DOVATO IS AND WHAT IT IS USED FOR
DOVATO IS USED TO TREAT HIV (HUMAN IMMUNODEFICIENCY VIRUS) INFECTION
IN ADULTS
AND IN CHILDREN OVER THE AGE OF 12 YEARS.
DOVATO contains two active ingredients that are used to treat HIV
infection:
dolutegravir and lamivudine. Dolutegravir belongs to a group of
anti-retroviral medicines
called
_integrase inhibitors _
(INIs). Lamivudine belongs to a group of anti-retroviral
medicines called
_nucleoside analogue reverse transcriptase inhibitors (NRTIs)_
.
DOVATO does not cure HIV infection; it reduces the amount of virus in
your body, and
keeps it at a low level. It also increases the CD4 cell count in your
blood. CD4 cells are a
type of white blood cells that are important in helping your body to
fight infection.
Not everyone responds to treatment with DOVATO in the same way. Your
doctor will
monitor the effectiveness of your treatment.
2. BEFORE YOU TAKE DOVATO
DON’T TAKE DOVATO
•
if you are
ALLERGIC
(HYPERSENSITIVE) TO DOLUTEGRAVIR OR LAMIVUDINE
, or any other
ingredients of DOVATO (listed in
SECTION 6
)
•
if you’re taking another medicine called
DOFETILIDE
or PILSICANIDE
(to treat heart
conditions), or
FAMPRIDINE
(also known as dalfampridine; used in multiple sclerosis).

If you think either of these applies to you, DON’T TAKE DOVATO
until you have
checked with your doctor
.
TAKE SPECIAL CARE WITH DOVATO
Before you take DOVATO your doctor needs to know:
•

Summary of Product characteristics

DOVATO
DOLUTEGRAVIR/LAMIVUDINE
QUALITATIVE AND QUANTITATIVE COMPOSITION
Oval, biconvex, white, film-coated tablet debossed with “SV 137”
on one face.
Each film-coated tablet contains 50 mg of dolutegravir as dolutegravir
sodium and
300 mg of lamivudine.
CLINICAL INFORMATION
INDICATIONS
_DOVATO _is indicated for the treatment of Human Immunodeficiency
Virus (HIV)
infection in adults and adolescents from 12 years of age weighing at
least 40 kg, who
have no known or suspected resistance to either antiretroviral
component.
DOSAGE AND ADMINISTRATION
Pharmaceutical form: Film-coated tablet
Therapy should be initiated by a physician experienced in the
management of HIV
infection.
_DOVATO _can be taken with or without food.
_DOVATO _is a fixed-dose tablet and should not be prescribed for
patients requiring dosage
adjustments, such as those with creatinine clearance less than 30
mL/min.
A separate preparation of dolutegravir (_TIVICAY_) is available where
a dose adjustment is
required due to drug-drug interactions (_see Interactions_).
For patients with integrase inhibitor resistance, _DOVATO _is not
recommended. In this
case the physician should refer to the dolutegravir (_TIVICAY_)
product information.
ADULTS AND ADOLESCENTS
The recommended dose of _DOVATO _in adults and adolescents weighing at
least 40 kg is
one tablet once daily.
CHILDREN
_DOVATO _is not currently recommended for the treatment of children
less than 12 years
of age as the necessary dose adjustment cannot be made. Clinical data
is currently not
available for this combination. Physicians should refer to the
individual product
information for dolutegravir and lamivudine.
ELDERLY
There are limited data available on the use of dolutegravir and
lamivudine in patients
aged 65 years and over. However, there is no evidence that elderly
patients require a
different dose than younger adult patients (_see Pharmacokinetics _
_–_
_ Special Patient _
_Populations_). When treating elderly patients, consideration needs to
be given to the
greater frequency of decr