LUMIVO TABLET

País: República de Sud-àfrica

Idioma: anglès

Font: South African Health Products Regulatory Authority (SAHPRA)

Disponible des:

Adcock Ingram Limited

Dosis:

See ingredients

formulario farmacéutico:

TABLET

Composición:

EACH TABLET CONTAINS DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg

Estat d'Autorització:

Renewal -In Progress

Data d'autorització:

2018-10-10

Informació per a l'usuari

Page 1 of 18
PATIENT INFORMATION LEAFLET FOR LUMIVO
SCHEDULING STATUS
S4
LUMIVO, 300 MG, 300 MG, 50 MG, FILM-COATED TABLETS
LAMIVUDINE, TENOFOVIR, DOLUTEGRAVIR SODIUM
CONTAINS SUGAR (140,4 MG MANNITOL PER TABLET)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING LUMIVO_ _
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other healthcare
provider.
•
LUMIVO has been prescribed for you personally and you should not share
your medicine
with other people. It may harm them, even if their symptoms are the
same as yours.
WHAT IS IN THIS LEAFLET
1. What LUMIVO is and what it is used for
2. What you need to know before you take LUMIVO
3. How to take LUMIVO
4. Possible side effects
5. How to store LUMIVO
6. Contents of the pack and other information
WARNING:
LACTIC ACIDOSIS (BUILD-UP OF ACID IN THE BLOOD); HEPATOMEGALY WITH
STEATOSIS (SWOLLEN
AND FATTY LIVER):
Page 2 of 18
Two components LUMIVO (Tenofovir and lamivudine) belong to a class of
medicines (NRTIs)
that can cause a condition called lactic acidosis (excess of lactic
acid in your blood), together
with an enlarged liver. Signs and symptoms of lactic acidosis include
deep, rapid breathing;
drowsiness, nausea, vomiting and stomach pain.
If you have liver disease you may also be more at risk of getting this
condition. While you are
being treated with LUMIVO your doctor will monitor you closely for any
signs that you may
be developing lactic acidosis.
Worsening of hepatitis B virus infection in people who have HIV-1
infection:
LUMIVO is not indicated for the treatment of long-term (chronic)
hepatitis B virus infection.
Patients with liver disease including chronic hepatitis B virus
infection, who are treated with
combination antiretrovirals, have a higher risk of severe and
potentially life-threatening liver
problems.
If you have hepatitis B virus infection, you should not stop LUMIVO
without instructions from
your doctor, as you may have recurrence of your hepatitis. This ma

Fitxa tècnica

Page 1 of 54
PROFESSIONAL INFORMATION FOR LUMIVO
SCHEDULING STATUS
S4
1. NAME OF THE MEDICINE
LUMIVO, 300 mg, 300 mg, 50 mg, film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each LUMIVO film-coated tablet contains:
Lamivudine 300 mg
Tenofovir disoproxil fumarate 300 mg
Dolutegravir sodium equivalent to dolutegravir 50 mg
Contains sugar (140,4 mg mannitol per tablet).
For the full list of excipients, see section 6.1
WARNING:
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING
FATAL
CASES,
HAVE
BEEN
REPORTED
WITH
THE
USE
OF
NUCLEOSIDE
ANALOGUES ALONE OR IN COMBINATION WITH OTHER ANTIRETROVIRALS
(SEE SECTION 4.4). LUMIVO IS NOT INDICATED FOR THE TREATMENT OF
CHRONIC HEPATITIS B VIRUS (HBV) INFECTION. SAFETY AND EFFICACY OF
LUMIVO HAS NOT BEEN ESTABLISHED IN PATIENTS CO-INFECTED WITH HBV
AND
HIV.
SEVERE
ACUTE
EXACERBATIONS
OF
HEPATITIS
B
HAVE
BEEN
REPORTED IN PATIENTS WHO ARE CO-INFECTED WITH HBV AND HIV AND HAVE
Page 2 of 54
DISCONTINUED THE COMBINATION TABLET. HEPATIC FUNCTION SHOULD BE
MONITORED CLOSELY WITH BOTH CLINICAL AND LABORATORY FOLLOW-UP
FOR AT LEAST SEVERAL MONTHS IN PATIENTS WHO DISCONTINUE LUMIVO
AND ARE CO-
INFECTED WITH HIV AND HBV IF APPROPRIATE, INITIATION OF
ANTI-HEPATITIS B THERAPY MAY BE WARRANTED (SEE SECTION 4.4).
3. PHARMACEUTICAL FORM
Film-coated tablets
Orange coloured, modified capsule shaped, biconvex film-coated tablets
debossed with 'H'
on one side, and 'D 17' on the other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
LUMIVO is indicated for the treatment of HIV-1 infection in adults
aged 18 years and older.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a medical practitioner experienced in
the management of HIV
infection.
LUMIVO can be taken with or without food.
_ADULTS: _
For
treatment-naïve
and
treatment-experienced
patients,
the
recommended
dose
of
LUMIVO is one tablet daily.
Page 3 of 54
SPECIAL POPULATIONS
RENAL IMPAIRMENT
Significantly
increased
exposure
occurred
when
tenofovir
disoproxil
fumarate
,
as
in
LUMIV