Approved Drug Label (PDF)
5
Warnings and Precautions
Newly added subsection:
5.4
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 AIMOVIG. In reported cases with monoclonal antibody CGRP
antagonists, symptom onset occurred a median of 71 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.
AIMOVIG 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 serious
adverse reactions are described below and elsewhere in the labeling:
- Hypersensitivity
Reactions [see Warnings and Precautions
(5.1)]
- Constipation
with Serious Complications [see Warnings
and Precautions (5.2)]
- Hypertension
[see Warnings and Precautions (5.3)]
- Raynaud’s
Phenomenon [see Warnings and Precautions
(5.4)]
6.2 Postmarketing
Experience
Additions and/or
revisions underlined:
The following adverse
reactions have been identified during postapproval use of AIMOVIG. 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.
. . .
Vascular
Disorders: Hypertension [see Warnings and Precautions (5.3)], Raynaud’s
Phenomenon [see Warnings and Precautions
(5.4)].
8
Use in Specific Populations
8.1 Pregnancy
Additions and/or revisions underlined:
Pregnancy Exposure Registry
There is a pregnancy exposure registry
that monitors pregnancy outcomes in women exposed to AIMOVIG during pregnancy.
Patients should be encouraged to enroll by calling 1-833-244-4083 or visiting
https://www.genesispregnancyregistry.com/.
. . .
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Additions and/or
revisions underlined:
. . .
Pregnancy
Advise patients that
there is a pregnancy exposure registry that monitors pregnancy outcomes in
women exposed to AIMOVIG during pregnancy [see
Use in Specific Populations (8.1)].
Raynaud’s Phenomenon
Inform patients that
Raynaud’s phenomenon can develop or worsen with AIMOVIG. Advise patients to
discontinue AIMOVIG and contact their healthcare provider if they experience
signs or symptoms of Raynaud’s phenomenon [see
Warnings and Precautions (5.4)].
PATIENT INFORMATION
Additions and/or
revisions underlined:
. . .
Before you start using AIMOVIG, tell your healthcare
provider about all your medical conditions, including if you:
- have high blood pressure
- have circulation problems in your fingers and toes
- are pregnant or plan to become pregnant. It is not known if
AIMOVIG will harm your unborn baby.
- Pregnancy Registry: There is a pregnancy registry for
women who take AIMOVIG. The purpose of this registry is to collect information
about your health and your baby’s health. You may enroll yourself by calling 1-833-244-4083
or visiting https://www.genesispregnancyregistry.com/. Or you may talk
to your healthcare provider about how you can take part in this registry.
- are breastfeeding or plan to breastfeed. It is not known if
AIMOVIG passes into your breast milk. Talk to your healthcare provider about
the best way to feed your baby while using AIMOVIG.
Tell your pharmacist or healthcare provider about all
the medicines you take, including any prescription and over-the-counter
medicines, vitamins, or herbal supplements.
. . .
What are possible side
effects of AIMOVIG?
AIMOVIG may cause serious
side effects, including:
. . .
- Raynaud’s phenomenon. A type of
circulation problem can worsen or happen after receiving AIMOVIG. 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)
6
Adverse Reactions
6.1 Clinical
Trials Experience
Additions and/or
revisions underlined:
…
The safety of AIMOVIG has
been evaluated in 2537 patients with migraine who received at least one dose of
AIMOVIG, representing 3040.2 patient-years of exposure. Of these, 2271
patients were exposed to 70 mg or 140 mg once monthly for at least 6 months, 1305
patients were exposed for at least 12 months, and 216 patients were
exposed through 5 years.
…
In Studies 1, 2, and 3,
1.3% of patients treated with AIMOVIG 70 mg or 140 mg discontinued
double-blind treatment because of adverse events. The most frequent injection
site reactions were injection site pain, injection site erythema, and injection
site pruritus.
…
8
Use in Specific Populations
8.1 Pregnancy
Additions and/or revisions underlined:
…
Clinical Considerations
Disease-Associated
Maternal and/or Embryo/Fetal Risk
Published data have suggested that women with migraine
may be at increased risk of preeclampsia and gestational hypertension
during pregnancy.
…
Approved Drug Label (PDF)
6
Adverse Reactions
6.3 Postmarketing Experience
Additions
and/or revisions underlined:
Immune System
Disorders: Hypersensitivity
reactions, including rash, angioedema, and anaphylaxis [see Warnings and Precautions (5.1)].
Gastrointestinal
Disorders: Constipation
with serious complications [see Warnings
and Precautions (5.2)], oral mucosal ulceration.
Skin and
Subcutaneous Tissue Disorders: Rash, alopecia.
Vascular
Disorders: Hypertension
[see Warnings and Precautions (5.3)].
Approved Drug Label (PDF)
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
Patient Counseling Information
(Newly
added information)
Advise patients
to let AIMOVIG sit at room temperature
for at
least 30 minutes prior to administration
[see Dosage and Administration (2.2)].
Patient Information
(Newly
added information)
• Also, before you inject, leave AIMOVIG at room temperature
for at least 30 minutes protected from direct sunlight.
Approved Drug Label (PDF)
5
Warnings and Precautions
5.3 Hypertension
(new subsection added)
Development
of hypertension and worsening of pre-existing hypertension have been reported
following the use of AIMOVIG in the postmarketing setting. Many of the patients
had pre-existing hypertension or risk factors for hypertension. There were cases
requiring pharmacological treatment and, in some cases, hospitalization.
Hypertension may occur at any time during treatment but was most frequently
reported within seven days of dose administration. In the majority of the
cases, the onset or worsening of hypertension was reported after the first
dose. AIMOVIG was discontinued in many of the reported cases.
Monitor
patients treated with AIMOVIG for new-onset hypertension, or worsening of
pre-existing
hypertension, and consider whether discontinuation of AIMOVIG is warranted if
evaluation fails to establish an alternative etiology.
6
Adverse Reactions
(addition underlined)
6.3 Postmarketing Experience
(addition
underlined)
…
Vascular
Disorders: Hypertension
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
(additions
underlined)
…
Hypertension:
Advise
patients that development of hypertension and worsening of pre-existing
hypertension can occur with AIMOVIG and that they should contact their
healthcare providers if they experience elevation in their blood pressure.
…
PATIENT INFORMATION
(additions
underlined)
…
What are possible
side effects of AIMOVIG?
AIMOVIG may cause
serious side effects, including:
…
…
Approved Drug Label (PDF)
5
Warnings and Precautions
5.2 Constipation with Serious Complications
(newly added
subsection)
Constipation
with serious complications has been reported following the use of
AIMOVIG in the postmarketing setting. There were cases that required hospitalization,
including cases where surgery was necessary. In
a majority of these cases, the onset of constipation was reported after the first dose of AIMOVIG; however, patients have also presented
with constipation later on in treatment. AIMOVIG was discontinued in most reported
cases of constipation with serious
complications. Constipation was one of the most
common (up to 3%) adverse reactions reported
in clinical studies.
Monitor patients treated with AIMOVIG for severe constipation and manage as
clinically appropriate. The concurrent
use of medications associated with decreased gastrointestinal
motility may increase the
risk for more severe constipation
and the potential for
constipation-related complications.
6
Adverse Reactions
(additions and/or
revisions are underlined)
The following serious adverse reactions are described below and elsewhere
in the labeling:
6.3 Postmarketing Experience
(additions and/or
revisions are underlined)
The following adverse
reactions have been identified during postapproval use of AIMOVIG.
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.
Skin and Appendages: Hypersensitivity reactions, including rash, angioedema, and
anaphylaxis.
Gastrointestinal Disorders: Constipation with serious complications.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
(additions and/or
revisions are underlined)
Advise the patient
to read the FDA-approved patient labeling (Patient Information
and
Instructions for Use).
Information
on Preparation and Administration:
Provide guidance to
patients and caregivers on proper
subcutaneous administration technique, including aseptic
technique, and how to use
the single-dose prefilled autoinjector or single-dose prefilled syringe. Instruct patients and/or caregivers to read and follow the Instructions
for Use each time they use AIMOVIG.
Advise latex-sensitive patients that
the needle shield within the white or orange cap
of the AIMOVIG prefilled autoinjector
and gray needle cap of
the AIMOVIG prefilled
syringe contain dry natural rubber (a derivative of latex)
that may cause allergic reactions in individuals
sensitive to latex.
Hypersensitivity Reactions:
Advise patients to seek immediate medical
attention if they experience any symptoms of serious or severe hypersensitivity reactions.
Constipation
with Serious Complications:
Advise patients that
constipation with serious complications
can occur with AIMOVIG
and that they should contact
their healthcare providers
if they experience severe constipation.
PATIENT INFORMATION
(additions and/or
revisions are underlined)
What are possible side effects of AIMOVIG? AIMOVIG may cause serious side effects, including:
Allergic reactions. Allergic reactions, including
rash or swelling
can happen after receiving AIMOVIG. This can happen within hours
to days after using AIMOVIG.
Call your healthcare provider or get emergency
medical help right away if
you have any of the following symptoms
of an allergic reaction:
Constipation with serious
complications. Severe constipation can happen after receiving AIMOVIG.
In some cases, people have been hospitalized or needed
surgery. Contact your healthcare provider if you have severe constipation.
The most common side effects of AIMOVIG include:
pain, redness, or swelling
at the injection site and constipation. Tell your healthcare provider
if you have any side effect
that bothers you or that does not go away.
These are not all of the possible side effects
of AIMOVIG. Ask your pharmacist or healthcare provider for more information.
Call your healthcare provider for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report
side effects to Amgen at 1-800-77-AMGEN (1-800-772-6436).
Approved Drug Label (PDF)
4
Contraindications
(Additions and/or revisions are underlined)
AIMOVIG is contraindicated in patients with serious hypersensitivity
to erenumab-aooe or to any of the excipients. Reactions have included
anaphylaxis and angioedema.
5
Warnings and Precautions
5.1 Hypersensitivity Reactions
(Additions and/or revisions are underlined)
Hypersensitivity
reactions, including rash, angioedema, and anaphylaxis, have been reported with
AIMOVIG in postmarketing experience. Most hypersensitivity reactions were not serious
and occurred within hours of administration, although some occurred more than one
week after administration. If a serious or severe hypersensitivity reaction occurs,
discontinue administration of AIMOVIG and initiate appropriate therapy.
6
Adverse Reactions
(Additions and/or revisions are underlined)
The following serious adverse reactions are described below
and elsewhere in the labeling:
6.3 Postmarketing Experience
(Additions and/or revisions are underlined)
The following adverse reactions have been identified during
postapproval use of AIMOVIG. 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.
Skin and Appendages:
Hypersensitivity reactions, including rash, angioedema, and
anaphylaxis
8
Use in Specific Populations
Patient Information
(Extensive changes;
please refer to labeling)
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
17 PATIENT COUNSELING INFORMATION
(Additions and/or
revisions are underlined)
Hypersensitivity Reactions:
Advise patients to seek immediate medical attention if
they experience any symptoms of serious or severe hypersensitivity reactions
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