SUNLENCA lenacapavir (as sodium) 300 mg film coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lenacapavir sodium, Quantity: 306.8 mg (Equivalent: lenacapavir, Qty 300 mg)

Available from:

Gilead Sciences Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: copovidone; poloxamer; mannitol; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black

Administration route:

Oral

Units in package:

5 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

SUNLENCA, in combination with other antiretrovirals, is indicated for the treatment of adults with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.

Product summary:

Visual Identification: LEN tablets are beige, capsule-shaped, filmcoated tablet, debossed with GSI on one side and 62L on the other side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2023-03-27

Patient Information leaflet

SUNLENCA v 1.0 (March 2023)
1
SUNLENCA™
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I USING SUNLENCA?
SUNLENCA contains the active ingredient lenacapavir. SUNLENCA is used
to treat adults who have HIV-1 that are resistant to
many other antiretroviral medicines. SUNLENCA is prescribed in
combination with other antiretroviral medicines. It is used to
treat HIV infection in adults with limited treatment options (for
example when other antiretroviral medicines are not
sufficiently effective or are not suitable). .
For more information, see Section 1. Why am I using SUNLENCA?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE SUNLENCA?
Do not use if you have ever had an allergic reaction to SUNLENCA or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
SUNLENCA?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with SUNLENCA and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE SUNLENCA?
•
Your treatment with SUNLENCA starts with tablets taken on Days 1, 2,
and 8 followed by two injections on Day 15, and
then continues with two injections every six months.
•
Talk to your doctor before taking SUNLENCA tablets.
More instructions can be found in Section 4. How do I use SUNLENCA?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING SUNLENCA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
SUNLENCA.
•
Attend your planned appointments every 6 months to receive your
SUNLENCA injection.

Summary of Product characteristics

SUNLENCA Product Information v 1.0 – 27 March 2023
Page 1
This medicinal product is subject to additional monitoring in
Australia. This will allow quick
identification of new safety information. Healthcare professionals are
asked to report any suspected
adverse events at www.tga.gov.au/reporting-problems
.
AUSTRALIAN PRODUCT INFORMATION
SUNLENCA (LENACAPAVIR (AS SODIUM)) INJECTION, TABLETS
1
NAME OF THE MEDICINE
Lenacapavir sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single-dose vial contains lenacapavir sodium equivalent to 463.5
mg/1.5 mL of
lenacapavir.
Each tablet contains lenacapavir sodium equivalent to 300 mg of
lenacapavir.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Solution for injection.
Clear, yellow to brown solution with an apparent pH of 9.0 to 10.2 and
a viscosity not more
than 300 cP.
Film-coated tablet (tablet).
Beige, capsule-shaped, film-coated tablets, of dimensions 10 mm x 21
mm debossed with
“GSI” on one side of the tablet and “62L” on the other side of
the tablet.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
SUNLENCA, in combination with other antiretrovirals, is indicated for
the treatment of
adults with multidrug resistant HIV-1 infection for whom it is
otherwise not possible to
construct a suppressive anti-viral regimen.
4.2
D
OSE AND METHOD OF ADMINISTRATION
SUNLENCA should be prescribed by physicians experienced in the
treatment of HIV. Prior
to starting SUNLENCA, the healthcare professional should carefully
select patients who
agree to the required injection schedule.
To help maintain viral suppression and reduce the risk of viral
rebound and potential
development of resistance associated with missed doses, the healthcare
professional should
also counsel patients about the importance of adherence to both the
scheduled dosing visits
and the optimised background regimen.
The recommended SUNLENCA treatment regimen in adults consists of an
initiation dosing
period (oral tablets and subcutaneous injections) and onc