Isentress HD

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Raltegravir potassium 651.6mg equivalent to raltegravir 600 mg;  

Available from:

Merck Sharp & Dohme (New Zealand) Limited

Dosage:

600 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Raltegravir potassium 651.6mg equivalent to raltegravir 600 mg   Excipient: Carnauba wax Croscarmellose sodium Hypromellose Magnesium stearate Microcrystalline cellulose Opadry yellow 39K170005

Prescription type:

Prescription

Therapeutic indications:

Indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection.

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, HDPE with PP CR closure - 60 tablets - 24 months from date of manufacture stored at or below 30°C

Authorization date:

2018-02-13

Patient Information leaflet

ISENTRESS
® AND ISENTRESS HD
®
_raltegravir _
THE FOLLOWING INFORMATION IS APPLICABLE TO ISENTRESS (400 MG TABLET)
AND
ISENTRESS HD (600 MG TABLET)
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about the ISENTRESS product
range. It
does not contain all the available information. It does not take the
place of talking to your
doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking
ISENTRESS against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor
or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
WHAT ISENTRESS IS USED FOR
ISENTRESS works against the Human Immunodeficiency Virus (HIV), the
virus that
causes AIDS (Acquired Immune Deficiency Syndrome). ISENTRESS blocks
HIV
integrase, an enzyme that is needed for HIV to make more virus.
ISENTRESS is used in combination with other antiretroviral medicinal
products to treat
HIV infection.
Your doctor has prescribed ISENTRESS to help control your HIV
infection. ISENTRESS
is not a cure for HIV infection.
When used with other anti-HIV medicines, ISENTRESS may reduce the
amount of HIV in
your blood (called "viral load") and increase the number of CD4 (T)
cells. Reducing the
amount of HIV in the blood may keep your immune system healthy, so it
can help fight
infection. ISENTRESS may not have these effects in all patients.
ISENTRESS DOES NOT CURE HIV INFECTION OR AIDS. It is very important
that you stay
under the care of your doctor during treatment with ISENTRESS.
HIV
HIV is a blood-borne disease spread by contact with blood or sexual
contact with an
infected individual.
BEFORE YOU TAKE ISENTRESS
WHEN YOU MUST NOT TAKE IT
Do not take ISENTRESS if:
•
you are allergic to any of the ingredients in ISENTRESS
•
you are breast-feeding or plan to breast-feed.
ISENTRESS is not recommended for use when breast-feeding. It is
recommended that
HIV-infected women should not breast-feed their infants because of t

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Page 1 of 29
1 PRODUCT NAME
ISENTRESS
®
400 mg tablet
ISENTRESS HD
®
600 mg tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet of ISENTRESS contains 400 mg of raltegravir
(as potassium salt).
Each film-coated tablet of ISENTRESS HD contains 600 mg of raltegravir
(as potassium
salt).
3 PHARMACEUTICAL FORM
ISENTRESS (raltegravir) 400 mg is a film-coated pink tablet with 227
on one side and plain
on the other. Dimensions are 15.88 mm x 8.81 mm.
ISENTRESS HD (raltegravir) 600 mg is a film-coated yellow, oval tablet
with the MSD logo
and “242” debossed on one side and plain on the other. Dimensions
are 19.1 mm x 9.7 mm
x 6.1 mm.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ISENTRESS or ISENTRESS HD is indicated in combination with other
antiretroviral agents
for the treatment of human immunodeficiency virus (HIV-1) infection.
4.2
DOSE AND METHOD OF ADMINISTRATION
ISENTRESS or ISENTRESS HD is to be given in a combination regimen with
other
antiretroviral agents.
ISENTRESS or ISENTRESS HD can be administered with or without food.
ISENTRESS is available in the following dose strength:
•
400 mg film coated tablet for twice daily use
ISENTRESS HD is available in the following dose strength:
•
600 mg film-coated tablet for once daily use
THE FORMULATIONS HAVE DIFFERENT PHARMACOKINETIC PROFILES, THEREFORE DO
NOT SUBSTITUTE
THE 400 MG TABLET FOR THE 600 MG TABLET TO CREATE A 1200 MG ONCE DAILY
DOSE.
It is not recommended to chew, crush or split the 400 mg tablet or 600
mg tablet.
NEW ZEALAND DATA SHEET
Page 2 of 29
For the treatment of adult patients with HIV-1 infection, the dosage
of ISENTRESS or
ISENTRESS HD is as follows:
DOSING RECOMMENDATIONS IN ADULTS WITH HIV 1 INFECTION
POPULATION
RECOMMENDED DOSE
Treatment-naïve patients or patients who are
virologically suppressed on an initial regimen of
ISENTRESS 400 mg twice daily
*1200 mg (2 x 600 mg) once daily
or
400 mg twice daily
Treatment-experienced patients
400 mg twice daily
*Do not substitute the 400 mg tab