AIMOVIG 140 mg/mL
erenumab-aooe · INJECTION, SOLUTION · Amgen Inc
AIMOVIG is a injection, solution containing erenumab-aooe at 140 mg/mL, taken subcutaneous. Manufactured by Amgen Inc.
Key Facts
- Brand Name
- AIMOVIG
- Generic Name
- erenumab-aooe
- NDC Code (Product)
55513-842- Manufacturer
- Amgen Inc
- Strength
- 140 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- BLA761077
- Marketing Start
- 03/15/2019
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE AIMOVIG is indicated for the preventive treatment of migraine in adults. AIMOVIG is a calcitonin gene-related peptide receptor antagonist indicated for the preventive treatment of migraine in adults. ( 1 )
Dosage & Administration
2 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 ) 2.1 Recommended Dosing The recommended dosage of AIMOVIG is 70 mg injected subcutaneously once monthly. Some patients may benefit from a dosage of 140 mg injected subcutaneously once monthly. If a dose of AIMOVIG is missed, administer as soon as possible. Thereafter, AIMOVIG can be scheduled monthly from the date of the last dose. 2.2 Important Administration Instructions AIMOVIG is for subcutaneous use only. AIMOVIG is intended for patient self-administration. Prior to use, provide proper training to patients and/or caregivers on how to prepare and administer AIMOVIG using the single-dose prefilled autoinjector or single-dose prefilled syringe, including aseptic technique [see Instructions for Use] : Prior to subcutaneous administration, allow AIMOVIG to sit at room temperature for at least 30 minutes protected from direct sunlight [see How Supplied/Storag…
Contraindications
4 CONTRAINDICATIONS 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) ] . AIMOVIG is contraindicated in patients with serious hypersensitivity to erenumab-aooe or to any of the excipients. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS 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) ] 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 ADVERSE REACTIONS, contact Amgen Medical Information at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. 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 pati…
Frequently Asked Questions
What is AIMOVIG used for?
AIMOVIG contains erenumab-aooe. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.
Is AIMOVIG a controlled substance?
AIMOVIG is not classified as a controlled substance by the DEA.
What is the generic name for AIMOVIG?
The generic name for AIMOVIG is erenumab-aooe. There are no other listed brand versions of erenumab-aooe.
What is the NDC code for AIMOVIG 140 mg/mL?
The NDC (National Drug Code) for AIMOVIG 140 mg/mL is 55513-842, listed by Amgen Inc.
Other AIMOVIG Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)