Approved Drug Label (PDF)
6
Adverse Reactions
6.1 Clinical
Trials Experience
Additions and/or revisions
underlined:
. . .
Adults
. . .
Pediatric Patients 6 to 17 Years of Age
The safety of AJOVY was evaluated in 225 pediatric
patients 6 to 17 years of age with episodic migraine who received at least one
dose of AJOVY. Of these patients, 209 received AJOVY monthly for at least 6
months and 100 received AJOVY for at least 12 months. In the placebo-controlled
trial (Study 3), 123 pediatric patients with episodic migraine were treated
with AJOVY [see Clinical Studies (14)]. The most common adverse
reactions of AJOVY observed in Study 3 were injection site reactions.
Hypersensitivity reactions were also observed. Overall, the safety profile in
pediatric patients is similar to the known safety profile in adults.
. . .
8
Use in Specific Populations
8.4 Pediatric Use
Additions and/or
revisions underlined:
Episodic
Migraine
The
safety and effectiveness of AJOVY have been established in an adequate and
well- controlled study for the preventive treatment of episodic migraine in
pediatric patients who are 6 to 17 years of age and who weigh 45 kg or more
(Study 3). The safety and efficacy profile of AJOVY in these patients was
similar to the safety and efficacy profile seen in clinical trials in adults
with migraine [see Adverse Reactions
(6.1), Clinical Pharmacology (12.3), and Clinical Studies (14)].
AJOVY
is not approved in pediatric patients weighing less than 45 kg because of the
lack of an appropriate strength presentation.
The
safety and effectiveness of AJOVY for the preventive treatment of episodic
migraine in pediatric patients younger than 6 years of age have not been
established.
Chronic
Migraine
The
safety and effectiveness of AJOVY for the preventive treatment of chronic
migraine in pediatric patients have not been established.
Juvenile
Animal Toxicity Data
Subcutaneous
administration of fremanezumab-vfrm (0, 50, 150, or 450 mg/kg) to juvenile rats
once weekly from postnatal day (PND) 28 to PND 63 resulted in no adverse
effects on growth, sexual maturation, or neurobehavioral or reproductive
function. The highest dose tested was associated with plasma drug exposures
(AUC) approximately 58 times that in pediatric patients at the recommended
human dose (225 mg), when calculated on a monthly basis.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING
INFORMATION
Additions and/or
revisions underlined:
.
. .
Information
on Preparation and Administration
Instruct patients who
are 13 years and older and/or caregivers on proper subcutaneous
administration technique, including aseptic technique, and how to use the
single-dose prefilled syringe [see Dosage
and Administration (2.2)]. Instruct patients and/or caregivers to read and
follow the Instructions for Use each time they use AJOVY.
Instruct
patients who are prescribed the regimen of 675 mg every 3 months to
administer the dosage as three consecutive subcutaneous injections of 225 mg
each [see Dosage and Administration
(2.1)].
Hypersensitivity
Reactions
Inform
patients about the signs and symptoms of hypersensitivity reactions and that
these reactions can occur up to 1 month after administration. Advise patients
to contact their healthcare provider if signs or symptoms of hypersensitivity
reactions occur and to seek immediate medical attention if they experience
serious or severe hypersensitivity reactions [see Warnings and Precautions (5.1)].
.
. .
PATIENT
INFORMATION
Additions and/or
revisions underlined:
What is AJOVY?
AJOVY
is a prescription medicine used for the preventive treatment of:
.
. .
.
. .
What are the
possible side effects of AJOVY? AJOVY may cause serious side effects,
including:
. . .
. . .
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 AJOVY, 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. AJOVY was discontinued in many of the reported
cases.
Monitor patients treated with AJOVY for new-onset
hypertension or worsening of pre-existing hypertension, and consider whether
discontinuation of AJOVY 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 AJOVY.
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.
AJOVY 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 discussed in greater detail in other sections of
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)]
6.3 Postmarketing
Experience
Additions and/or
revisions underlined:
The
following adverse reactions have been identified during postapproval use of
AJOVY. 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: Anaphylactic reactions and angioedema [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 AJOVY,
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 AJOVY. Advise patients to
discontinue AJOVY 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 AJOVY, 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 AJOVY?
AJOVY may cause serious
side effects, including:
. . .
- High blood pressure. High
blood pressure or worsening of high blood pressure can happen after receiving
AJOVY. 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 AJOVY.
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
(Additions and/or
revisions underlined)
AJOVY
is contraindicated in patients with serious hypersensitivity to
fremanezumab-vfrm or to any of the excipients. Reactions have included
anaphylaxis and angioedema [see
Warnings and Precautions (5.1)].
5
Warnings and Precautions
5.1 Hypersensitivity Reactions
(Additions and/or
revisions underlined)
Hypersensitivity reactions, including rash,
pruritus, drug hypersensitivity, and urticaria, were reported with AJOVY in
clinical trials. Most reactions were mild to moderate, but some led to
discontinuation or required corticosteroid treatment. Most reactions were reported
from within hours to one month after administration. Cases of anaphylaxis
and angioedema have been reported in the postmarketing setting.
If a hypersensitivity reaction occurs, consider
discontinuing AJOVY, and institute appropriate therapy [see Contraindications (4)].
6
Adverse Reactions
6.3 Postmarketing Experience
(Newly added
subsection)
The
following adverse reactions have been identified during postapproval use of
AJOVY. 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 –
Anaphylactic reactions and angioedema [see
Contraindications (4) and Warnings and Precautions (5.1)].
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 AJOVY during pregnancy. Healthcare providers are encouraged to
register pregnant patients, or pregnant women may enroll themselves in the
registry by calling 1-833-927-2605 or visiting www.tevamigrainepregnancyregistry.com.
…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
(Additions and/or
revisions underlined)
Advise
the patient and/or caregiver 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 syringe [see Dosage and
Administration (2.2)]. Instruct patients and/or caregivers to read and
follow the Instructions for Use each time they use AJOVY.
Instruct
patients prescribed the regimen of 675 mg every 3 months to administer the
dosage as three consecutive subcutaneous injections of 225 mg each [see Dosage and Administration (2.1)].
Hypersensitivity
Reactions
Inform
patients about the signs and symptoms of hypersensitivity reactions and that
these reactions can occur up to 1 month after administration. Advise patients
to contact their healthcare provider immediately if signs or symptoms of hypersensitivity
reactions occur [see Warnings and
Precautions (5.1)].
Pregnancy
Advise
women that there is a pregnancy exposure registry that monitors pregnancy
outcomes in women exposed to AJOVY during pregnancy [see Use in Specific Populations (8.1)].
PATIENT INFORMATION
(Additions and/or
revisions underlined)
…
Before you use
AJOVY, tell your healthcare provider if you:
are pregnant or
plan to become pregnant. It is not known if AJOVY will harm your unborn baby.
Pregnancy
Registry: There
is a registry for women who become pregnant during treatment with AJOVY. The
purpose of this registry is to collect information about the safety of AJOVY
during pregnancy. Contact the registry as soon as you learn that you are pregnant,
or ask your doctor to contact the registry for you. You or your doctor can get
information and enroll you in the registry by calling 1-833-927-2605 or
visiting
www.tevamigrainepregnancyregistry.com.
- are breastfeeding
or plan to breastfeed. It is not known if AJOVY passes into your breast milk.
Talk to your healthcare provider about the best way to feed your baby while
using AJOVY.
Tell your
healthcare provider about all the medicines you take, including
prescription and over-the-counter medicines, vitamins, and herbal supplements.
Know
the medicines you take. Keep a list of your medicines with you to show your
healthcare provider and pharmacist when you get a new medicine.
…
Approved Drug Label (PDF)
8
Use in Specific Populations
(Additions and/or
revisions underlined)
Published
data have suggested that women
with migraine may be at increased
risk of preeclampsia and gestational
hypertension during pregnancy.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
Patient Information
(Additions and/or
revisions underlined)
If your prescribed dose is AJOVY 675 mg every 3 months, you
must use 3 separate autoinjectors or 3 separate syringes. You will give
3 separate injections one time every 3 months.
If you are giving 3 injections of AJOVY for your prescribed
dose, you may use the same injection area for all 3 injections, but not
the same spot.
Throw away (dispose of) AJOVY in a sharps disposal or
puncture-resistant container if it has been out of the refrigerator for 24
hours or longer.
Keep AJOVY prefilled autoinjector and AJOVY prefilled
syringe out of the reach of small children.
AJOVY prefilled syringe and prefilled autoinjector are
not made with natural rubber latex.
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