8.1 Pregnancy
Additions and/or revisions
underlined:
…
Risk Summary
Available data from a randomized,
controlled trial with lenacapavir use during pregnancy in individuals without
HIV-1 have not identified a drug-associated risk for miscarriage, or adverse maternal
or fetal outcomes
when compared to an active control (see Data). The rate of major birth defects in lenacapavir-exposed
pregnancies did not exceed the background prevalence rates. The risk estimates
are imprecise due to small numbers of exposed pregnancies (see Data). In animal reproduction
studies, no adverse developmental effects were observed when lenacapavir was
administered to rats and rabbits at exposures (AUC) ?16 times the exposure in
humans at the recommended human dose (RHD) of
SUNLENCA (see Data).
The background risk of major birth
defects and miscarriage for the indicated population is unknown. The background
rate of major birth defects in a U.S. reference population of the Metropolitan Atlanta Congenital
Defects Program (MACDP) is 2.7%. The rate of miscarriage is not reported
in the APR. The estimated background rate of miscarriage in clinically recognized pregnancies in
the U.S. general population is 15 to 20%.
Data
Human Data
In a randomized, controlled trial
of individuals without HIV-1 in Uganda and South Africa, there were 208 pregnancies exposed
to lenacapavir with known outcomes
and 132 deliveries (both
live and non-live). In the active
control arm of this trial,
there were 109 pregnancies with known outcomes
and 61 deliveries (both live and non-live). The adverse pregnancy outcomes of spontaneous abortion, stillbirth, preterm
birth, and small for
gestational age were similar across both treatment groups.
There were two major
birth defects in the lenacapavir arm. Both were ventricular septal defects. This resulted in a rate of
major birth defects that fell within the background prevalence rate for major
birth defects.
Concentrations of lenacapavir during
each trimester of pregnancy and postpartum were comparable to those in non-pregnant
participants.
…
8.2 Lactation
Additions and/or revisions underlined:
Risk Summary
Lenacapavir is present in human milk. Lenacapavir was detected at
very low levels in
infants who were breastfed by individuals who became pregnant while
receiving lenacapavir (see Data).
No adverse effects of lenacapavir in breastfed infants have been observed.
It is not known if lenacapavir affects milk production.
Potential risks of breastfeeding include: (1) HIV-1 transmission (in infants without
HIV-1), (2) developing viral resistance (in infants with HIV-1), and (3) adverse
reactions in a breastfed infant similar to those seen in adults.
Data
Human data
The median lenacapavir concentration in human breast milk to maternal plasma ratio in participants (n=8) who received lenacapavir was 0.63 (range:
0.29 to 1.90).
The median infant-to-mother
plasma ratio for lenacapavir in infants (n=10) who were breastfed by
individuals receiving lenacapavir from 0 to less than 13 weeks after delivery
was 0.06 (range: 0.01 to 0.20).
Additions and/or
revisions underlined:
What is SUNLENCA?
…
OR,
…
Before receiving or taking
SUNLENCA, tell your healthcare provider
about all your medical conditions, including if you:
are pregnant
or plan to become pregnant.
Tell your healthcare provider
if you become pregnant during
treatment with SUNLENCA.
Pregnancy Exposure Registry: There
is a pregnancy exposure registry for women who receive or take
SUNLENCA during pregnancy. The purpose of this registry
is to collect information about the health
of you and your baby. Talk with
your healthcare provider about how you can take part in this registry.
are
breastfeeding or plan to breastfeed. A small amount of SUNLENCA is
present in breast milk. Talk with your healthcare provider about the following risks to your baby from breastfeeding during
treatment with SUNLENCA:
…
…
How should
I receive and take SUNLENCA?
If you are receive
or take SUNLENCA for the treatment
of HIV-1 (not for starting
treatment with BIXLENVO):
…
…
If you take SUNLENCA
tablets for starting
treatment with BIXLENVO:
Your treatment includes
SUNLENCA tablets, for the first 2 days only, and another medicine
called BIXLENVO tablets.
Take BIXLENVO tablets
and SUNLENCA tablets
by mouth, with or without
food.
You dosing schedule
will start as follows:
On Day 1,
you will take 1 BIXLENVO tablet and 2 SUNLENCA
tablets.
On Day 2,
you will take 1 BIXLENVO tablet and 2 SUNLENCA
tablets.
It is very important that you take BIXLENVO with SUNLENCA on these first 2 days. Contact
your healthcare provider if you have questions
If you miss a dose of SUNLENCA on Day 1 or Day 2, take it as soon as possible.
Do not take Day 1 and Day 2 doses of SUNLENCA on the same day.
…
How should
I store SUNLENCA?
…
…
Additions and/or revisions underlined:
…
Missed Injection Dose: Treatment
of HIV-1 in Heavily Treatment-Experienced Adults
Inform patients that SUNLENCA can
remain in the body for up to 12 months or longer after receiving their last injection.
Advise patients to contact their healthcare provider if they miss or plan to
miss a scheduled injection visit and that oral SUNLENCA therapy may be used for
up to 6 months to replace missed injections. Advise patients that oral dosing
should be used on an interim
basis only and that the
maintenance injection dosage should be resumed at the earliest
possible opportunity [see Dosage and Administration (2.2, 2.4)
and Warnings and Precautions (5.2)].
Missed Oral Initiation Dose: Oral Loading
for Initiation of BIXLENVO
Inform patients that if they miss one of
the two days of oral initiation doses of SUNLENCA given with BIXLENVO
to take it as soon as possible [see Dosage and Administration (2.4)].
…
Get Email Alerts |
Guide
