AIMOVIG- erenumab-aooe injection AIMOVIG- erenumab-aooe injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ERENUMAB (UNII: I5I8VB78VT) (ERENUMAB - UNII:I5I8VB78VT)

Available from:

Amgen Inc

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

AIMOVIG is indicated for the preventive treatment of migraine in adults. AIMOVIG is contraindicated in patients with serious hypersensitivity to erenumab-aooe or to any of the excipients. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.1)] . 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/. Risk Summary There are no adequate data on the developmental risk associated with the use of AIMOVIG in pregnant women. No adverse effects on offspring were observed when pregnant monkeys were administered erenumab-aooe throughout gestation [see Data]. Serum erenumab-aooe exposures in pregnant monkeys were greater than those in humans at clinical doses. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recogni

Product summary:

AIMOVIG (erenumab-aooe) injection is a sterile, clear to opalescent, colorless to light yellow solution for subcutaneous administration. AIMOVIG prefilled autoinjectors and prefilled syringes are not made with natural rubber latex. Each single-dose prefilled SureClick® autoinjector or single-dose prefilled syringe of AIMOVIG contains a Type 1 glass syringe and stainless steel needle and delivers 1 mL of 70 mg/mL or 140 mg/mL solution. AIMOVIG is supplied as follows: SureClick® Autoinjector Syringe

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

AIMOVIG- ERENUMAB-AOOE INJECTION
AIMOVIG- ERENUMAB-AOOE INJECTION, SOLUTION
AMGEN INC
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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.
AIMOVIG (ERENUMAB-AOOE) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2018
RECENT MAJOR CHANGES
Dosage and Administration (2.2)
9/2022
INDICATIONS AND USAGE
AIMOVIG is a calcitonin gene-related peptide receptor antagonist
indicated for 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 benefit
from a dosage of 140 mg
once monthly (2.1)
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: 140 mg/mL solution in a single-dose prefilled SureClick
autoinjector (3)
Injection: 70 mg/mL solution in a single-dose prefilled syringe (3)
Injection: 140 mg/mL solution in a single-dose prefilled syringe (3)
CONTRAINDICATIONS
AIMOVIG is contraindicated in patients with serious hypersensitivity
to erenumab-aooe or to any of the
excipients. (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions: If a serious hypersensitivity reaction
occurs, discontinue administration of
AIMOVIG and initiate appropriate therapy. Hypersensitivity reactions
can occur within hours to more
than one week after administration. (5.1)
Constipation with Serious Complications: Serious complications of
constipation may occur. (5.2)
Hypertension: New-onset or worsening of pre-existing hypertension may
occur. (5.3)
ADVERSE REACTIONS
The most common adverse reactions in AIMOVIG clinical studies
(occurring in at least 3% of treated
patients and more often than placebo) are injection site reactions and
constipation. (6.1)
TO REPORT SUSPECTED ADVER