AIMOVIG 70MG/ML INJECTION

AIMOVIG 70MG/ML INJECTION
AIMOVIG 70 MG / ML 1 PRE-FILLED PEN
Aimovig is the first FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide, or CGRP, a molecule that is involved in migraine attacks.
NDICATIONS
AIMOVIG is indicated for the preventive treatment of migraine in adults.
DOSAGE AND ADMINISTRATION
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.
Important Administration Instructions
AIMOVIG is for subcutaneous use only.
The needle shield within the white or orange cap of the AIMOVIG prefilled autoinjector and gray needle cap of the AIMOVIG prefilled syringe contain dry natural rubber (a derivative of latex), which may cause allergic reactions in individuals sensitive to latex.
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]. This is important for administering the entire dose and helps minimize discomfort. Do not warm by using a heat source such as hot water or a microwave.
Do not shake the product.
Inspect visually for particulate matter and discoloration prior to administration [see Dosage Forms And Strengths]. Do not use if the solution is cloudy or discolored or contains flakes or particles.
Administer AIMOVIG in the abdomen, thigh, or upper arm subcutaneously. Do not inject into areas where the skin is tender, bruised, red, or hard.
Both prefilled autoinjector and prefilled syringe are single-dose and deliver the entire contents.
HOW SUPPLIED
Dosage Forms And Strengths
AIMOVIG is a sterile, clear to opalescent, colorless to light yellow solution available as follows:
Injection
70 mg/mL in a single-dose prefilled SureClick® autoinjector
Injection
140 mg/mL in a single-dose prefilled SureClick® autoinjector
Injection
70 mg/mL in a single-dose prefilled syringe
Injection
140 mg/mL in a single-dose prefilled syringe
AIMOVIG (erenumab-aooe) injection is a sterile, clear to opalescent, colorless to light yellow solution for subcutaneous administration.
The needle shield within the white or orange cap of the AIMOVIG prefilled autoinjector and gray needle cap of the AIMOVIG prefilled syringe contain dry natural rubber (a derivative of 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
NDC PRODUCT CODE 55513-840
NDC CODE: 55513-840 
Proprietary Name: Aimovig 
Non-Proprietary Name: Erenumab-aooe 
 Drug Use Information
 
This medication is used to help prevent migraine. This medication may work by changing the amounts of certain natural substances in the brain. Erenumab belongs to a class of drugs known as monoclonal antibodies. Preventing frequent migraine attacks can help improve your ability to concentrate and do your usual tasks. This monograph is about the following erenumab product: erenumab-aooe.
 NDC Code Structure
55513 - Amgen Inc
55513-840 - Aimovig
55513-840-01
NDC 55513-840-01 
Package Description: 1 SYRINGE, GLASS in 1 CARTON > 1 mL in 1 SYRINGE, GLASS
NDC PRODUCT INFORMATION
Aimovig with NDC 55513-840 is a a human prescription drug product labeled by Amgen Inc. The generic name of Aimovig is erenumab-aooe. The product's dosage form is injection and is administered via subcutaneous form. The RxNorm crosswalk for this NDC code includes the following unique RxCUI concept(s): 2045627, 2045632, 2045636, 2045638, 2056669, 2056670, 2056680, 2056681, 2120193, 2120195, 2120198 and 2120199
Dosage Form: Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.

Product Type: Human Prescription Drug 
AIMOVIG ACTIVE INGREDIENT(S)
 
ERENUMAB 70 mg/mL