Darunavir Mylan

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

darunavir

Available from:

Mylan Pharmaceuticals Limited

ATC code:

J05AE10

INN (International Name):

darunavir

Therapeutic group:

Antivirals for systemic use

Therapeutic area:

HIV Infections

Therapeutic indications:

Darunavir, 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 (see section 4.2).Darunavir Mylan 75 mg, 150 mg, 300 mg and 600 mg tablets may be used to provide suitable dose regimens (see section 4.2):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 darunavir 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 darunavir (see sections 4.2, 4.4 and 5.1).Darunavir 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. Darunavir 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). Darunavir Mylan 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 (see section 4.2). 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 darunavir in such ART-experienced patients, genotypic testing should guide the use of darunavir (see sections 4.2, 4.3, 4.4 and 5.1).

Product summary:

Revision: 13

Authorization status:

Authorised

Authorization date:

2017-01-03

Patient Information leaflet

126
B. PACKAGE LEAFLET
127
PACKAGE LEAFLET: INFORMATION FOR THE USER
DARUNAVIR MYLAN 75 MG FILM-COATED TABLETS
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 Darunavir Mylan is and what it is used for
2.
What you need to know before you take Darunavir Mylan
3.
How to take Darunavir Mylan
4.
Possible side effects
5.
How to store Darunavir Mylan
6.
Contents of the pack and other information
1.
WHAT DARUNAVIR MYLAN IS AND WHAT IT IS USED FOR
WHAT IS DARUNAVIR MYLAN?
Darunavir Mylan contains the active substance darunavir. Darunavir is
an antiretroviral medicine used
in the treatment of Human Immunodeficiency Virus (HIV) infection. It
belongs to a group of
medicines called protease inhibitors. Darunavir 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?
Darunavir is used to treat adults and children of 3 years of age and
above, and at least 15 kilogram
body weight who are infected by HIV and who have already used other
antiretroviral medicines.
Darunavir must be taken in combination with a low dose of 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 DARUNAVIR MYLAN
DO NOT TAKE DARUNAVIR MYLAN
-
if you are
ALLERGIC
to darunavir or any of the other ingredients of this medicine (listed
in section
6) or to ritonavir.
-
if you have
SEVERE LIVE

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Darunavir Mylan 75 mg film-coated tablets
Darunavir Mylan 150 mg film-coated tablets
Darunavir Mylan 300 mg film-coated tablets
Darunavir Mylan 600 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Darunavir Mylan 75 mg film-coated tablets
Each film-coated tablet contains 75 mg of darunavir.
Darunavir Mylan 150 mg film-coated tablets
Each film-coated tablet contains 150 mg of darunavir.
Darunavir Mylan 300 mg film-coated tablets
Each film-coated tablet contains 300 mg of darunavir.
Darunavir Mylan 600 mg film-coated tablets
Each film-coated tablet contains 600 mg of darunavir.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Darunavir Mylan 75 mg film-coated tablets
Film-coated tablet.
White to off-white, oval shaped, biconvex film-coated tablets
approximately 9.7 mm by 4.6 mm,
debossed with ‘M’ on one side and ‘DV1' on the other side.
Darunavir Mylan 150 mg film-coated tablets
Film-coated tablet.
White to off-white, capsule shaped, biconvex film-coated tablets
approximately 12.75 mm by 6.3 mm
debossed with ‘M’ on one side and ‘DV2’ on the other side.
Darunavir Mylan 300 mg film-coated tablets
Film-coated tablet.
White to off-white, oval shaped, biconvex film coated tablets
approximately 16.5 mm by 8.2 mm,
debossed with 'M' on one side of the tablet and 'DV3' on other side.
Darunavir Mylan 600 mg film-coated tablets
Film-coated tablet.
White to off-white, oval shaped, biconvex film-coated tablets
approximately 21.2 mm by 10.6 mm,
debossed with ‘M’ on one side and ‘DV5’ on the other side.
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Darunavir, 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 (see section 4.2).
Darunavir Mylan 75 mg, 150 mg, 300 mg and 600 mg tablets may be used
to provide suitable dose
regimens (see secti