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 EMGALITY, 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. EMGALITY was discontinued in many
of the reported cases.
Monitor patients treated
with EMGALITY for new-onset hypertension or worsening of pre-existing
hypertension, and consider whether discontinuation of EMGALITY 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 EMGALITY. In reported cases with monoclonal antibody CGRP
antagonists, symptom onset occurred after 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.
EMGALITY 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 Contraindications (4) and
Warnings and Precautions (5.1)]
- Hypertension [see
Warnings and Precautions (5.2)]
- Raynaud's Phenomenon [see Warnings and Precautions (5.3)]
6.3 Postmarketing
Experience
Additions and/or
revisions underlined:
The following adverse
reactions have been identified during post-approval use of EMGALITY. 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 EMGALITY exposure.
Immune
System Disorders — Anaphylaxis, angioedema [see Contraindications (4) and Warnings and
Precautions (5.1)].
Skin
and Subcutaneous Tissue Disorders — Rash.
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:
. . .
Hypersensitivity
Reactions: Inform patients about the signs and symptoms of
hypersensitivity reactions and that these reactions can occur with EMGALITY.
Advise patients to seek immediate medical attention if they experience any
symptoms of serious or severe hypersensitivity reactions [see Warnings and Precautions (5.1)].
Hypertension: Inform
patients that hypertension can develop or pre-existing hypertension can worsen
with EMGALITY, and that they should contact their healthcare provider 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 EMGALITY.
Advise patients to discontinue EMGALITY 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 use EMGALITY, tell your healthcare provider if you:
- have
high blood pressure.
- have
circulation problems in your fingers and toes.
. . .
What
are the possible side effects of EMGALITY?
EMGALITY
may cause serious side effects, including:
. . .
- High blood pressure. High
blood pressure or worsening of high blood pressure can happen after receiving
EMGALITY. Contact your healthcare provider if you have an increase in blood
pressure.
- Raynaud’s phenomenon. A
type of circulation problem can worsen or happen after receiving EMGALITY.
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)
8
Use in Specific Populations
8.1 Pregnancy
Additions underlined
Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors
pregnancy outcomes in women exposed to EMGALITY during pregnancy. Healthcare
providers are encouraged to register pregnant patients, or pregnant women may
enroll themselves in the registry by calling 1-833-464-4724 or by contacting
the company at www.migrainepregnancyregistry.com.
…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Additions
underlined
…
Pregnancy
Exposure Registry:
Advise patients that there is a pregnancy exposure registry that monitors
pregnancy outcomes in women exposed to EMGALITY during pregnancy [see Use in Specific Populations (8.1)].
…
PATIENT INFORMATION
Additions
underlined
…
Before
you use EMGALITY, tell your healthcare provider if you:
Approved Drug Label (PDF)
5
Warnings and Precautions
5.1Hypersensitivity Reactions
(additions
underlined)
Hypersensitivity
reactions, including dyspnea, urticaria, and rash, have occurred with
EMGALITY in clinical studies and the
postmarketing setting. Cases of anaphylaxis and angioedema have also been
reported in the postmarketing setting. If a serious or severe
hypersensitivity reaction occurs, discontinue administration of EMGALITY and
initiate appropriate therapy. Hypersensivity
reactions can occur days after administration and may be prolonged.
6
Adverse Reactions
6.3 Postmarketing Experience
(newly added
subsection)
The
following adverse reactions have been identified during post-approval use of
EMGALITY. 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 EMGALITY exposure.
Immune System
Disorders —
Anaphylaxis, angioedema . Skin and
Subcutaneous Tissue Disorders — Rash.
Approved Drug Label (PDF)
6
Adverse Reactions
6.1 Clinical Trials Experience
Addition
of the heading Migraine (to delineate separate indications) above the text
beginning with:
The safety of EMGALITY has been evaluated
in 2586 patients with migraine …
Newly
added information on new approved indication:
Episodic Cluster Headache
EMGALITY was studied for up to 2 months in
a placebo-controlled trial in patients with episodic cluster headache (Study 4).
A total of 106 patients were studied (49 on EMGALITY and 57 on placebo). Of the
EMGALITY-treated patients, approximately 84% were male, 88% were white, and the
mean age was 47 years at study entry. Two EMGALITY-treated patients
discontinued double-blind treatment because of adverse events. Overall, the
safety profile observed in patients with episodic cluster headache treated with
EMGALITY 300 mg monthly is consistent with the safety profile in migraine
patients.
8
Use in Specific Populations
8.1 Pregnancy
Additions
and/or revisions underlined:
Data
Animal
Data
… The highest dose tested (250 mg/kg) was
associated with a plasma exposure (Cave, ss) 38 or 18
times that in humans at the recommended human dose (RHD) for migraine
(120 mg) or episodic cluster headache (300 mg), respectively.
Administration of galcanezumab-gnlm (0, 30, or 100 mg/kg) by subcutaneous
injection to pregnant rabbits throughout the period of organogenesis produced
no adverse effects on embryofetal development. The higher dose tested was
associated with a plasma Cave, ss 64 or 29 times that in humans at 120
mg or 300 mg, respectively.
… The higher dose tested was associated
with a plasma Cave, 34 or 16 times that in humans at 120 mg or 300
mg, respectively.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT INFORMATION
What
is EMGALITY?
EMGALITY is a prescription medicine used
in adults for the:
Newly
added:
treatment
of episodic cluster headache.
How
should I use EMGALITY?
Additions
and/or revisions underlined:
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