HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
AIMOVIG safely and effectively. See full prescribing information for
AIMOVIG.
AIMOVIGTM (erenumab-aooe) injection, for subcutaneous use
Initial U.S. Approval: 2018
----------------------------INDICATIONS AND USAGE--------------------------
AIMOVIG is a calcitonin gene-related peptide receptor antagonist indicatedfor the preventive treatment of migraine in adults (1)
---------------------------DOSAGE AND ADMINISTRATION------------------
For subcutaneous use only (2.1, 2.2)
Recommended dosage is 70 mg once monthly; some patients may benefitfrom a dosage of 140 mg once monthly (2.1)
The 140 mg dose is administered once monthly as two consecutiveinjections of 70 mg each (2.1)
The needle shield within the white cap of the prefilled autoinjector and thegray needle cap of the prefilled syringe contain dry natural rubber (aderivative of latex), which may cause allergic reactions in individuals
sensitive to latex (2.2)
Administer in the abdomen, thigh, or upper arm subcutaneously (2.2)
See Dosage and Administration for important administration instructions(2.2)
-----------------------DOSAGE FORMS AND STRENGTHS------------------
Injection: 70 mg/mL solution in a single-dose prefilled SureClick®autoinjector (3)
Injection: 70 mg/mL solution in a single-dose prefilled syringe (3)
------------------------------CONTRAINDICATIONS----------------------------
None (4)
------------------------------ADVERSE REACTIONS-----------------------------
The most common adverse reactions in AIMOVIG clinical studies (occurringin at least 3% of treated patients and more often than placebo) are injection
site reactions and constipation (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact AmgenMedical Information at 1-800-77-AMGEN (1-800-772-6436) or FDA at1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and
FDA-approved Patient Labeling.
Revised: 5/2018
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FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing
2.2 Important Administration Instructions
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Immunogenicity
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage and Handling
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing information are
not listed
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
AIMOVIG is indicated for the preventive treatment of migraine in adults.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing
