TIVICAY 5 MG DISPERSIBLE TABLETS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DOLUTEGRAVIR AS SODIUM

Available from:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC code:

J05AX12

Pharmaceutical form:

DISPERSIBLE TABLETS

Composition:

DOLUTEGRAVIR AS SODIUM 5 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

VIIV HEALTHCARE UK LIMITED, UK

Therapeutic area:

DOLUTEGRAVIR

Therapeutic indications:

Tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children of at least 4 weeks of age or older and weighing at least 3 kg.

Authorization date:

2023-07-30

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a physician's prescription only
TIVICAY 5 MG DISPERSIBLE TABLETS
Each tablet contains:
Tivicay 5 mg: DOLUTEGRAVIR (AS SODIUM) 5 MG
For the list of inactive and allergenic ingredients in the
preparation, see section
2 –
Important information regarding some of the ingredients of the
medicine
and section 6 - Further information.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This
leaflet contains concise information about the medicine. If you have
further
questions, refer to the physician or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them even if it seems to you that their medical condition is
similar.
1.
WHAT IS THE MEDICINE INTENDED FOR?
Tivicay is used as combination therapy (in combination with other
anti-retroviral
medicines) to treat HIV (HUMAN IMMUNODEFICIENCY VIRUS) INFECTION in
adults,
adolescents and children of at least 4 weeks of age or older, and who
weigh at
least 3 kg.
Tivicay does not cure HIV infection; it reduces the amount of virus in
your body,
and keeps it at a low level. As a result of this, 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 fight infection.
Not everyone responds to treatment with Tivicay in the same way. Your
physician will monitor the effectiveness of your treatment.
Tivicay is always used in combination with other anti-retroviral
medicines
(
combination therapy
). To control your HIV infection and to stop your illness
from getting worse, you must keep taking all your medicines, unless
your
physician tells you to stop taking any.
THERAPEUTIC GROUP
Tivicay contains the active ingredient dolutegravir. This medicine
belongs to a
group of anti-retroviral medicines called
integrase inhibitors (INIs).
2.
BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE:

if you (or your child, if he/she is the pa

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Tivicay 5 mg dispersible tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dispersible tablet contains dolutegravir sodium equivalent to 5
mg dolutegravir.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Dispersible tablet.
White, round, biconvex tablets approximately 6 mm in diameter debossed
with ‘SV H7S’ on one side and ‘5’
on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tivicay is indicated in combination with other anti-retroviral
medicinal products for the treatment of Human
Immunodeficiency Virus (HIV) infected adults, adolescents and children
of at least 4 weeks of age or older
and weighing at least 3 kg.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Tivicay should be prescribed by physicians experienced in the
management of HIV infection.
_ _
Posology
_Adults _
_ _
_Patients infected with HIV-1 without documented or clinically
suspected resistance to the integrase class _
The recommended dose of dolutegravir is 30 mg (six 5 mg dispersible
tablets) orally once daily.
Dolutegravir should be administered twice daily in this population
when co-administered with some
medicines (e.g. efavirenz, nevirapine, tipranavir/ritonavir, or
rifampicin). Please refer to section 4.5.
_Patients infected with HIV-1 with resistance to the integrase class
(documented or clinically suspected) _
The recommended dose of dolutegravir is 30 mg (six 5 mg dispersible
tablets) twice daily.
In the presence of documented resistance that includes Q148 +

2 secondary mutations from G140A/C/S,
E138A/K/T, L74I, modelling suggests that an increased dose may be
considered for patients with limited
treatment options (less than 2 active agents) due to advanced multi
class resistance (see section 5.2).
The decision to use dolutegravir for such patients should be informed
by the integrase resistance pattern (see
section 5.1).
2
_Adolescents, children and infants aged 4 weeks and above and weighing
at least 3 kg _
_Patients infected with HIV-1 without