Approved Drug Label (PDF)
4
Contraindications
ORILISSA is contraindicated
in women:
Who are pregnant [see Use in Specific
Populations (8.1)]. Exposure to ORILISSA early in pregnancy may increase
the risk of early
pregnancy loss.
With known osteoporosis because
of the risk of further
bone loss [see Warnings
and Precautions (5.1)]
With severe hepatic impairment [see Use
in Specific Populations (8.7), Clinical Pharmacology (12.3)]
Taking inhibitors of organic anion transporting polypeptide
(OATP)1B1 (a hepatic
uptake transporter) that are known or
expected to significantly increase
elagolix plasma
concentrations [see
Drug Interactions (7.2)]
With known hypersensitivity reaction to ORILISSA or any of its
inactive components. Reactions have included anaphylaxis and angioedema [see Adverse Reactions (6.2)].
5
Warnings and Precautions
5.1 Bone Loss
(Newly
added information)
ORILISSA is contraindicated in women with known osteoporosis [see Contraindications
(4)].
5.5 Interactions with Hormonal Contraceptives
(Newly
added section)
(Additions and/or revisions underlined)
Advise women to use effective non-hormonal
contraceptives during treatment with ORILISSA and
for 28 days after discontinuing ORILISSA [see Use
in Specific Populations (8.1,
8.3), Drug Interactions (7.1), Clinical
Pharmacology (12.3)].
Increase in Estrogen Exposure and Potential Associated Increased Risks When ORILISSA 200 mg Twice
Daily is Taken With
Combined Hormonal Contraceptives
Co-administration of a combined oral contraceptive (COC)
(containing 20 mcg
ethinyl estradiol/0.1 mg levonorgestrel)
following administration of ORILISSA 200 mg twice daily for 14 days
increases the plasma ethinyl estradiol concentration by 2.2-fold compared
to this COC alone. ORILISSA 200 mg twice daily co-administered
with a COC containing ethinyl estradiol may lead
to increased risk of ethinyl estradiol-related
adverse events including thromboembolic
disorders and vascular
events and is not recommended [see Drug Interactions (7.1), Clinical
Pharmacology (12.3)].
Potential for
Reduced Efficacy of
Progestin-Containing Hormonal Contraceptives Co-administration of ORILISSA 200 mg twice
daily and a COC containing
0.1 mg
levonorgestrel decreases the
plasma concentrations of
levonorgestrel by 27%, potentially affecting contraceptive efficacy. Co-administration of ORILISSA with COCs containing norethindrone
acetate did not show reduction in plasma concentrations of
norethindrone [see Drug
Interactions (7.1), Clinical
Pharmacology (12.3)].
Co-administration of
ORILISSA with progestin-containing intrauterine
contraceptive systems has not been
studied.
Reduced
efficacy of ORILISSA
Based on the mechanism of action of
ORILISSA, estrogen-containing contraceptives are expected
to reduce the efficacy of
ORILISSA. The effect of progestin-only contraceptives on
the efficacy of ORILISSA is unknown.
6
Adverse Reactions
6.2 Postmarketing Experience
(Newly
added section)
The following adverse
reactions have been identified during post-approval use of ORILISSA. Because these reactions are reported voluntarily from
a population of uncertain size, it is not always
possible to reliably estimate their frequency or establish
a causal relationship to drug exposure.
Immune system disorders: hypersensitivity reactions (including anaphylaxis,
angioedema, and urticaria).
7
Drug Interactions
7.1 Potential for ORILISSA to Affect Other Drugs
(Table 7 updated to add interaction with oral
contraceptives; please refer to label)
7.2 Potential for Other Drugs to Affect ORILISSA
(Additions and/or revisions underlined)
Co-administration of
ORILISSA with strong CYP3A inducers may decrease elagolix
plasma concentrations and may result in a decrease of the therapeutic effects of ORILISSA.
Concomitant use of ORILISSA 200 mg twice daily and rifampin
is not recommended. Limit concomitant
use of ORILISSA 150 mg once daily and
rifampin to 6 months.
The effect of concomitant use of P-gp inhibitors
or
inducers on the pharmacokinetics
of ORILISSA
is unknown. OATP1B1
inhibitors that are
known or expected to significantly increase
elagolix plasma concentrations are
contraindicated due to increased
risk of elagolix- associated adverse reactions [see Contraindications (4)].
8
Use in Specific Populations
8.3 Females and Males of Reproductive Potential
(Additions and/or revisions underlined)
Pregnancy Testing
ORILISSA may delay the ability to recognize
the occurrence of a pregnancy because it mayreduce
the intensity, duration,
and amount of menstrual bleeding. Exclude pregnancy before initiating treatment
with ORILISSA. Perform pregnancy testing if pregnancy is suspected during treatment
with ORILISSA and discontinue
treatment if pregnancy is confirmed
[see Contraindications
(4) and Warnings and Precautions (5.2)].
Contraception
Advise women to use effective non-hormonal
contraception during treatment with ORILISSA and
for 28 days after discontinuing ORILISSA [see Warnings and Precautions (5.5)].
8.4 Pediatric Use
(Additions and/or revisions underlined)
Safety and effectiveness of ORILISSA in pediatric patients
have not been established.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
17 PATIENT COUNSELING INFORMATION
(Additions and/or revisions underlined)
Advise patients to read the FDA-approved
patient labeling (Medication
Guide).
Bone Loss
Inform patients about the
risk of bone loss.
Advise patients that supplementary calcium and vitamin D
may be beneficial if dietary intake
of calcium and vitamin D
is not adequate [see Warnings and Precautions (5.1)].
Change in Menstrual Bleeding Pattern,
Contraception and Pregnancy
Advise women that
ORILISSA may delay the
recognition of pregnancy because it may reduce the
amount, intensity, or duration
of menstrual bleeding. Advise patients
to use effective non- hormonal
contraception while taking ORILISSA and
to discontinue ORILISSA if pregnancy is confirmed.
Advise pregnant women that
there is a pregnancy
registry that monitors outcomes
in women
who become pregnant while treated with
ORILISSA. Inform patients they can enroll
by
calling 1-833-782-7241
[see Warnings and Precautions (5.2) and
Use in Specific Populations (8.1)].
Suicidal Ideation, Suicidal Behavior, and Exacerbation of Mood Disorders
Advise patients that
suicidal ideation and
exacerbation of mood diorders may occur with ORILISSA
use. Instruct
patients to seek immediate
medical attention for suicidal ideation and behavior
and for
new onset or worsening depression, anxiety,
or
other mood changes [see Warnings and Precautions (5.3)].
Liver Injury
Advise patients
to promptly seek medical
attention in case of signs or symptoms that may
reflect liver
injury, such as
jaundice [see Warnings
and Precautions (5.4)].
Medication Guide
(Additions and/or revisions underlined)
- If you have bone loss on ORILISSA, your bone
density may improve after you stop taking
ORILISSA but complete recovery may not occur. It is unknown
if these bone changes could
increase your risk for broken bones as you age. For this
reason, your healthcare provider may
limit the length of time you take ORILISSA.
- ORILISSA does
not prevent pregnancy. You will need to use effective methods of birth
control
while taking ORILISSA and for 28 days after you stop
taking ORILISSA. Examples of effective
methods can include condoms or spermicide, which do not
contain hormones.
Do not take ORILISSA if you:
are taking medicines called organic anion transporting
polypeptide (OATP)1B1 inhibitors that are
known or expected to significantly increase the blood
levels of elagolix (the active ingredient in
ORILISSA). Ask your healthcare provider if you are
not sure if you are taking one of these medicines.
• have had a serious allergic reaction to ORILISSA or any
of the ingredients in ORILISSA. See the end
of this Medication Guide for a complete list of
ingredients in ORILISSA. Ask your healthcare provider
if you are not sure.
Especially tell your healthcare provider if you take:
• birth control that contains hormones.
• If you take too much ORILISSA, call your healthcare
provider or go to the nearest hospital
emergency room right away.
Call your healthcare provider or get emergency medical
help right away if
you have any of the following symptoms, especially if
they are new, worse, or bother you:
- thoughts about suicide or dying
- attempts to commit suicide
If no community take-back disposal program is available
go to www.fda.gov/drugdisposal
for more information on how to dispose of ORILISSA
the right way.
Approved Drug Label (PDF)
7
Drug Interactions
7.1 Potential for ORILISSA to Affect Other Drugs
(additions/revisions
are underlined)
Elagolix is a weak to moderate inducer of cytochrome P450 (CYP) 3A. Co-administration
with ORILISSA may decrease
plasma concentrations of drugs that
are substrates of
CYP3A.
Elagolix is a weak inhibitor of CYP 2C19. Co-administration with ORILISSA may increase plasma
concentrations of drugs that are
substrates of CYP2C19 (e.g.,
omeprazole).
Elagolix is an inhibitor of
efflux transporter P-glycoprotein (P-gp).
Co-administration with ORILISSA
may increase plasma concentrations of drugs that
are substrates of P-gp (e.g., digoxin).
7.3 Drug Interactions – Examples and Clinical Management
(extensive changes to table; please refer to labeling)
8
Use in Specific Populations
8.1 Pregnancy
(additions/revisions
are underlined)
Pregnancy Exposure Registry
There is a pregnancy registry that monitors
outcomes in women who become pregnant while treated
with ORILISSA. Patients should be encouraged to enroll by calling
1-833-782-7241.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
(additions/revisions
are underlined)
What is the most important information I should know about ORILISSA? ORILISSA may cause serious side effects, including:
…
effects on pregnancy
Do not take ORILISSA if
you
are trying to become
or are pregnant. It may increase
the risk of early pregnancy
loss.
If you think you are pregnant,
stop taking ORILISSA right away and call your healthcare provider.
PATIENT COUNSELING INFORMATION
(additions/revisions
are underlined)
Advise patients to read the
FDA-approved patient labeling (Medication
Guide).
- There is a pregnancy registry that monitors
outcomes in women who become pregnant while treated with ORILISSA. Inform patients they can enroll by calling
1-833-782-7241.
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