Prezista

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

darunavir

Available from:

Janssen-Cilag International NV

ATC code:

J05AE10

INN (International Name):

darunavir

Therapeutic group:

Antivirals for systemic use

Therapeutic area:

HIV Infections

Therapeutic indications:

PREZISTA, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight.PREZISTA, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg).In deciding to initiate treatment with PREZISTA co administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of PREZISTA.PREZISTA, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV 1) infection.PREZISTA 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens:For the treatment of HIV 1 infection in antiretroviral treatment (ART) experienced adult patients, including those that have been highly pre treated.For the treatment of HIV 1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight.In deciding to initiate treatment with PREZISTA co administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of PREZISTA.PREZISTA, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV 1) infection.PREZISTA, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg).PREZISTA 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV 1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (ART) naïve.ART experienced with no darunavir resistance associated mutations (DRV RAMs) and who have plasma HIV 1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 106/L. In deciding to initiate treatment with PREZISTA in such ART experienced patients, genotypic testing should guide the use of PREZISTA.

Product summary:

Revision: 54

Authorization status:

Authorised

Authorization date:

2007-02-11

Patient Information leaflet

144
B. PACKAGE LEAFLET
145
PACKAGE LEAFLET: INFORMATION FOR THE USER
PREZISTA 100 MG/ML ORAL SUSPENSION
darunavir
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What PREZISTA is and what it is used for
2.
What you need to know before you take PREZISTA
3.
How to take PREZISTA
4.
Possible side effects
5.
How to store PREZISTA
6.
Contents of the pack and other information
1.
WHAT PREZISTA IS AND WHAT IT IS USED FOR
WHAT IS PREZISTA?
PREZISTA contains the active substance darunavir. PREZISTA is an
antiretroviral medicine used in
the treatment of Human Immunodeficiency Virus (HIV) infection. It
belongs to a group of medicines
called protease inhibitors. PREZISTA works by reducing the amount of
HIV in your body. This will
improve your immune system and reduces the risk of developing
illnesses linked to HIV infection.
WHAT IT IS USED FOR?
PREZISTA is used to treat HIV infected adults as well as HIV infected
children of 3 years of age and
above, and at least 15 kilogram body weight (see HOW TO TAKE
PREZISTA).
PREZISTA must be taken in combination with a low dose of cobicistat or
ritonavir and other anti-HIV
medicines. Your doctor will discuss with you which combination of
medicines is best for you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PREZISTA
DO NOT TAKE PREZISTA
-
if you are ALLERGIC to darunavir or any of the other ingredients of
this medicine (listed in section
6) or to cobicistat or ritonavir.
-
if you have SEVERE LIVER PROBLEMS. Ask your doctor if you are unsure
about the severity of

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
PREZISTA 100 mg/ml oral suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oral suspension contains 100 mg of darunavir (as
ethanolate).
Excipient with known effect: sodium methyl parahydroxybenzoate (E219)
3.43 mg/ml.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension
White to off-white opaque suspension
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PREZISTA, co-administered with low dose ritonavir is indicated in
combination with other
antiretroviral medicinal products for the treatment of human
immunodeficiency virus (HIV-1)
infection in adult and paediatric patients from the age of 3 years and
at least 15 kg body weight (see
section 4.2).
PREZISTA, co-administered with cobicistat is indicated in combination
with other antiretroviral
medicinal products for the treatment of human immunodeficiency virus
(HIV-1) infection in adults
and adolescents (aged 12 years and older, weighing at least 40 kg)
(see section 4.2).
In deciding to initiate treatment with PREZISTA co-administered with
cobicistat or low dose ritonavir,
careful consideration should be given to the treatment history of the
individual patient and the patterns
of mutations associated with different agents. Genotypic or phenotypic
testing (when available) and
treatment history should guide the use of PREZISTA (see sections 4.2,
4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a healthcare provider experienced in
the management of HIV infection.
After therapy with PREZISTA has been initiated, patients should be
advised not to alter the dosage,
dose form or discontinue therapy without discussing with their
healthcare provider.
The interaction profile of darunavir depends on whether ritonavir or
cobicistat is used as
pharmacokinetic enhancer. Darunavir may therefore have different
contraindications and
recommendations for concomitant medications depending on whether the
compound is