Approved Drug Label (PDF)
7
Drug Interactions
7.2 CYP3A4 Inducers
Additions and/or
revisions underlined:
Coadministration of
QULIPTA with steady-state rifampin, a strong CYP3A4 inducer and OATP1B1 and OATP1B3 inhibitor, resulted in a significant decrease
in exposure of atogepant in healthy subjects [see Clinical Pharmacology (12.3)].
Concomitant administration of QULIPTA with moderate inducers of CYP3A4 can also
result in decreased exposure of atogepant.
Coadministration of QULIPTA with steady-state topiramate, a weak CYP3A4 inducer, resulted in decreased exposure of
atogepant in healthy subjects [see
Clinical Pharmacology (12.3)].
For episodic
migraine, the recommended dosage of QULIPTA
with concomitant use of strong
or moderate CYP3A4 inducers is 60 mg once daily. During concomitant
use of QUILIPTA with strong CYP3A4 inducers, monitor monthly for signs of
reduced efficacy, and consider alternative therapies if a reduction in efficacy
is observed. The recommended dosage of QULIPTA with concomitant use of weak
CYP3A4 inducers is 30 mg or 60 mg once daily [see Dosage and Administration (2.2)].
For chronic
migraine, concomitant use of strong
or moderate CYP3A4
inducers with QULIPTA is not recommended. The
recommended dosage of QUILIPTA with concomitant use of weak CYP3A4 inducers
is 60 mg once daily. Monitor monthly for signs of reduced efficacy, and
consider alternative therapies if a reduction in efficacy is observed [see Dosage and Administration (2.2)].
8
Use in Specific Populations
8.6 Renal Impairment
Additions and/or
revisions underlined:
The renal route of elimination plays
a minor role in the clearance of atogepant [see Clinical Pharmacology (12.3)]. For episodic migraine, in patients with
severe renal impairment (CLcr 15-29 mL/min)
and in patients with end-stage renal disease (ESRD)
(CLcr <15 mL/min), the recommended dosage of
QULIPTA is 10 mg once daily; in patients with ESRD undergoing intermittent dialysis, QULIPTA
should preferably be taken after dialysis [see
Dosage and Administration (2.2)]. For chronic
migraine, use of QULIPTA in patients with severe renal impairment and in
patients with ESRD is not recommended. No dose adjustment is recommended for
patients with mild or moderate renal impairment.
8
Use in Specific Populations
8.1 Pregnancy
Additions and/or
revisions underlined:
Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors
outcomes in women who become pregnant while taking QULIPTA. Patients should be encouraged
to enroll by calling 1-833-277-0206 or visiting http://empresspregnancyregistry.com.
.
. .
8.2 Lactation
Additions and/or
revisions underlined:
Risk Summary
Data from a lactation study in twelve healthy adult
females indicate that atogepant is excreted in breast milk in low amounts. The
estimated relative infant dose is approximately 0.19% of the maternal
weight-adjusted dose, and the milk-to-plasma ratio is 0.08 (see Data).
.
. .
Data
A
study was conducted in twelve healthy adult lactating females who were between
23 and
34
years of age and between 1 month and 6 months postpartum. Each subject was
administered a single oral dose of atogepant 60 mg. Maternal plasma and breast
milk were collected for
24
hours after dosing. Using a 150 mL/kg/day estimated infant milk intake, the
mean estimated relative infant dose was approximately 0.19% of the maternal
weight-adjusted dose. The mean milk-to-plasma ratio was 0.08. All subjects had
detectable levels of atogepant in breast milk during the study; by 16 to 24
hours after dosing, 25% of females in the study had detectable levels of
atogepant in breast milk. The mean cumulative amount of atogepant excreted in
breast milk over 24 hours was less than 0.01 mg of a 60 mg dose.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING
INFORMATION
Additions and/or
revisions underlined:
.
. .
Pregnancy
Advise
patients to notify their healthcare provider if they become pregnant during
treatment or plan to become pregnant. Encourage
pregnant patients to enroll in the registry that monitors pregnancy outcomes in
women exposed to QULIPTA during pregnancy [see
Use in Specific Populations (8.1)].
Lactation
Inform
patients to notify their healthcare provider if they are breastfeeding or plan
to breastfeed
[see Use in
Specific Populations (8.2)].
PATIENT
INFORMATION
Additions and/or
revisions underlined:
.
. .
Before you take
QULIPTA tell your healthcare provider about all of your medical conditions,
including if you:
have
high blood pressure.
have
circulation problems in your fingers and toes.
have
kidney problems or are on dialysis.
have
liver problems.
are
pregnant or plan to become pregnant. It is not known if QULIPTA will harm your
unborn baby.
are
breastfeeding or plan to breastfeed. Very small amounts of QULIPTA pass
into breast milk. Talk to your healthcare provider if you plan to breastfeed.
.
. .
Approved Drug Label (PDF)
5
Warnings and Precautions
Newly added subsections:
5.2
Hypertension
Development
of hypertension and worsening of pre-existing hypertension have been reported
following the use of CGRP antagonists, including QULIPTA, in the postmarketing
setting. Some of the patients who developed new-onset hypertension had risk
factors for hypertension. There were cases requiring initiation of
pharmacological treatment for hypertension and, in some cases, hospitalization.
Hypertension may occur at any time during treatment, but was most frequently
reported within 7 days of therapy initiation. QULIPTA was discontinued in many
of the reported cases.
Monitor patients treated
with QULIPTA for new-onset hypertension, or worsening of pre-existing
hypertension, and consider whether discontinuation of QULIPTA is warranted if
evaluation fails to establish an alternative etiology or blood pressure is
inadequately controlled.
5.3 Raynaud’s
Phenomenon
Development of Raynaud’s
phenomenon and recurrence or worsening of pre-existing Raynaud’s phenomenon
have been reported in the postmarketing setting following the use of CGRP
antagonists, including QULIPTA. In reported cases with small molecule CGRP antagonists,
symptom onset occurred a median of 1.5 days following dosing. Many of the cases
reported serious outcomes, including hospitalizations and disability, generally
related to debilitating pain. In most reported cases, discontinuation of the
CGRP antagonist resulted in resolution of symptoms.
QULIPTA should be
discontinued if signs or symptoms of Raynaud’s phenomenon develop, and patients
should be evaluated by a healthcare provider if symptoms do not resolve.
Patients with a history of Raynaud’s phenomenon should be monitored for, and
informed about the possibility of, worsening or recurrence of signs and
symptoms.
6
Adverse Reactions
Additions and/or
revisions underlined:
The following clinically
significant adverse reactions are described elsewhere in the labeling:
- Hypersensitivity
Reactions [see Warnings and
Precautions (5.1)]
- Hypertension
[see Warnings and Precautions (5.2)]
- Raynaud’s Phenomenon
[see Warnings and Precautions (5.3)]
6.2 Postmarketing
Experience
Additions and/or
revisions underlined:
The following adverse
reactions have been identified during post approval use of QULIPTA. Because
these reactions are reported voluntarily from a population of uncertain size,
it is not always possible to estimate their frequency or establish a causal
relationship to drug exposure.
Immune
System Disorders: Hypersensitivity (e.g., anaphylaxis,
dyspnea, rash, pruritus, urticaria, facial edema) [see Contraindications (4)
and Warnings and Precautions (5.1)]
Vascular
Disorders: Hypertension [see Warnings and Precautions (5.2)],
Raynaud’s phenomenon [see Warnings and
Precautions (5.3)]
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Additions and/or
revisions underlined:
. . .
Hypertension
Inform patients that
hypertension can develop or pre-existing hypertension can worsen with QULIPTA,
and that they should contact their healthcare providers if they experience
elevation in their blood pressure [see
Warnings and Precautions (5.2)].
Raynaud’s Phenomenon
Inform patients that
Raynaud’s phenomenon can develop or worsen with QULIPTA. Advise patients to
discontinue QULIPTA and contact their healthcare provider if they experience
signs or symptoms of Raynaud’s phenomenon [see
Warnings and Precautions (5.3)].
. . .
PATIENT INFORMATION
Additions and/or
revisions underlined:
. . .
Before you take QULIPTA
tell your healthcare provider about all of your medical conditions, including
if you:
- have high blood pressure.
- have circulation problems in your
fingers and toes.
. . .
What are the possible
side effects of QULIPTA?
QULIPTA can cause serious
side effects, including:
. . .
- High
blood pressure: High blood pressure or worsening of
high blood pressure can happen when you take QULIPTA. Contact your healthcare
provider if you have an increase in blood pressure.
- Raynaud’s
phenomenon: A type of circulation problem can worsen
or happen when you take QULIPTA. Raynaud’s phenomenon can lead to your fingers
or toes feeling numb, cool, or painful, or changing color from pale, to blue,
to red. Contact your healthcare provider if these symptoms occur.
Approved Drug Label (PDF)
4
Contraindications
Newly added
information:
QULIPTA is contraindicated in patients with
a history of hypersensitivity to atogepant or any of the components of QULIPTA. Reactions have included anaphylaxis and dyspnea [see Warnings and Precautions (5.1)].
5
Warnings and Precautions
Newly added section:
5.1 Hypersensitivity
Reactions
Hypersensitivity reactions, including anaphylaxis, dyspnea,
rash, pruritus, urticaria, and facial edema, have been reported with use of
QULIPTA [see Adverse Reactions (6.2)].
Hypersensitivity reactions can occur days after
administration. If a hypersensitivity reaction occurs,
discontinue QULIPTA and institute appropriate therapy [see Contraindications
(4)].
6
Adverse Reactions
6.1 Clinical Trials Experience
Extensive changes;
please refer to label
6.2 Postmarketing Experience
Newly added subsection
The
following adverse reactions have been identified during post approval use of
QULIPTA. Because these reactions are reported voluntarily from a population of
uncertain size, it is not always possible to estimate their frequency or establish
a causal relationship to drug exposure.
Immune System Disorders: Hypersensitivity
(e.g., anaphylaxis, dyspnea, rash, pruritus, urticaria, facial edema) [see Contraindications (4) and Warnings and Precautions (5.1)]
7
Drug Interactions
7.1 CYP3A4 Inhibitors
Additions and/or revisions
underlined:
Coadministration
of QULIPTA with itraconazole, a strong CYP3A4 inhibitor, resulted in a
significant increase in exposure of atogepant in healthy subjects [see Clinical Pharmacology (12.3)]. For episodic migraine, the recommended
dosage of QULIPTA with concomitant use of strong CYP3A4 inhibitors is 10 mg once
daily. For chronic migraine, avoid concomitant use of strong CYP3A4 inhibitors
with QULIPTA [see Dosage and Administration
(2.2)]. No dosage adjustment of QULIPTA is
needed with concomitant use of moderate or weak CYP3A4 inhibitors.
7.2 CYP3A4 Inducers
Newly added
information:
…
Coadministration of QULIPTA with steady-state
topiramate, a weak CYP3A4 inducer, resulted in decreased exposure of atogepant
in healthy subjects [see Clinical Pharmacology (12.3)].
For episodic migraine, the recommended dosage of QULIPTA
with concomitant use of strong, moderate, or weak CYP3A4 inducers is 30 mg or
60 mg once daily [see Dosage and Administration (2.2)].
For chronic migraine, avoid concomitant use of strong,
moderate, or weak CYP3A4 inducers with QULIPTA [see Dosage and
Administration (2.2)].
7.3 OATP Inhibitors
Additions and/or revisions
underlined:
Coadministration of QULIPTA with single dose
rifampin, an OATP inhibitor, resulted in a significant increase in exposure of
atogepant in healthy subjects [see
Clinical Pharmacology (12.3)]. For episodic
migraine, the recommended dosage of QULIPTA with concomitant use of OATP inhibitors
is 10 mg or 30 mg once daily. For chronic migraine, the recommended dosage
of QULIPTA with concomitant use of OATP inhibitors is 30 mg once daily [see Dosage and Administration
(2.2)].
8
Use in Specific Populations
8.6 Renal Impairment
Additions and/or revisions
underlined:
The renal route of elimination plays a minor role in
the clearance of atogepant [see Clinical
Pharmacology (12.3)]. For episodic migraine, in
patients with severe renal impairment
(CLcr 15-29 mL/min) and in patients with end-stage renal
disease (ESRD) (CLcr <15 mL/min), the recommended dosage of QULIPTA is 10 mg
once daily; in patients with ESRD undergoing intermittent dialysis,
QULIPTA should preferably be taken after dialysis [see Dosage and Administration (2.2)]. For chronic migraine, avoid use of QULIPTA in patients with severe
renal impairment and in patients with ESRD. No dose adjustment is
recommended for patients with mild or moderate renal impairment.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Newly
added information:
…
Hypersensitivity
Reactions
Inform
patients about the signs and symptoms of hypersensitivity reactions and that
these reactions can occur with QULIPTA. Advise patients to discontinue QULIPTA
and seek immediate medical attention if they experience any symptoms of a hypersensitivity
reaction [see Warnings and Precautions (5.1)].
…
PATIENT INFORMATION
Additions and/or revisions
underlined:
…
Do not take QULIPTA
if you:
have
had an allergic reaction to atogepant or any ingredients in QULIPTA. See the end
of this Patient Information leaflet for a complete list of ingredients in
QULIPTA.
…
QULIPTA can cause serious
side effects, including:
Allergic
(hypersensitivity) reactions, including anaphylaxis: Serious allergic
reactions can happen when you take QULIPTA or days after. Stop taking QULIPTA and
get emergency medical help right away if you get any of the following symptoms,
which may be part of a serious allergic reaction:
The
most common side effects of QULIPTA include: nausea, constipation, and fatigue/sleepiness.
…
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