Vitekta

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

elvitegravir

Available from:

Gilead Sciences International Ltd

ATC code:

J05AX11

INN (International Name):

elvitegravir

Therapeutic group:

Antivirals for systemic use

Therapeutic area:

HIV Infections

Therapeutic indications:

Vitekta co-administered with a ritonavir-boosted protease inhibitor and with other antiretroviral agents, is indicated for the treatment of human-immunodeficiency-virus-1 (HIV-1) infection in adults who are infected with HIV-1 without known mutations associated with resistance to elvitegravir.

Product summary:

Revision: 4

Authorization status:

Withdrawn

Authorization date:

2013-11-13

Patient Information leaflet

50
B. PACKAGE LEAFLET
Medicinal product no longer authorised
51
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VITEKTA 85 MG FILM-COATED TABLETS
Elvitegravir
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Vitekta is and what it is used for
2.
What you need to know before you take Vitekta
3.
How to take Vitekta
4.
Possible side effects
5.
How to store Vitekta
6.
Contents of the pack and other information
1.
WHAT VITEKTA IS AND WHAT IT IS USED FOR
Vitekta contains the active substance elvitegravir.
Vitekta is a TREATMENT FOR HUMAN IMMUNODEFICIENCY VIRUS (HIV)
INFECTION in adults aged 18 years
and over.
VITEKTA MUST ALWAYS BE TAKEN WITH CERTAIN OTHER HIV MEDICINES. See
section 3,
_How to take _
_Vitekta_
.
The HIV virus produces an enzyme called HIV integrase. This enzyme
helps the virus to multiply in
the cells in your body. Vitekta stops this enzyme working and reduces
the amount of HIV in your
body. This will improve your immune system and reduce the risk of
developing illnesses linked to
HIV infection.
This medicine is not a cure for HIV infection. While taking Vitekta
you may still develop infections
or other illnesses associated with HIV infection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VITEKTA
DO NOT TAKE VITEKTA
•
IF YOU ARE ALLERGIC TO ELVITEGRAVIR or any of the o

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Vitekta 85 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 85 mg of elvitegravir.
Excipient with known effect: Each tablet contains 6.2 mg lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Green, pentagon-shaped, film-coated tablet of dimensions 8.9 mm x 8.7
mm, debossed with “GSI” on
one side of the tablet and “85” on the other side of the tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vitekta co-administered with a ritonavir-boosted protease inhibitor
and with other antiretroviral
agents, is indicated for the treatment of human immunodeficiency
virus-1 (HIV-1) infection in adults
who are infected with HIV-1 without known mutations associated with
resistance to elvitegravir (see
sections 4.2 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
management of HIV infection.
Posology
Vitekta must be administered in combination with a ritonavir-boosted
protease inhibitor.
The Summary of Product Characteristics for the co-administered
ritonavir-boosted protease inhibitor
should be consulted.
The recommended dose of Vitekta is one 85 mg tablet or one 150 mg
tablet taken orally once daily
with food. The choice of dose of Vitekta depends on the
co-administered protease inhibitor (see
Table 1 and sections 4.4 and 4.5). For use of the 150 mg tablet,
please refer to the Summary of
Product Characteristics for Vitekta 150 mg tablets.
Vitekta should be administered once daily as follows:
-
Either at the same time as a once daily ritonavir-boosted prot