Important Safety Information

Contraindication: Aimovig® is contraindicated in patients with serious hypersensitivity to erenumab-aooe or to any of the excipients. Reactions have included anaphylaxis and angioedema.

Hypersensitivity Reactions: Hypersensitivity reactions, including rash, angioedema, and anaphylaxis, have been reported with Aimovig® in post marketing experience. Most reactions were not serious and occurred within hours of administration, although some occurred more than one week after administration. If a serious or severe reaction occurs, discontinue Aimovig® and initiate appropriate therapy.

Constipation with Serious Complications: Constipation with serious complications has been reported following the use of Aimovig® in the postmarketing setting. There were cases that required hospitalization, including cases where surgery was necessary. The onset of constipation was reported after the first dose in a majority of these cases, but patients also reported later on in treatment. Aimovig® was discontinued in most reported cases. Constipation was one of the most common (up to 3%) adverse reactions reported in clinical studies.

Monitor patients treated with Aimovig® for severe constipation and manage as clinically appropriate. Concurrent use of medications associated with decreased gastrointestinal motility may increase the risk for more severe constipation and the potential for constipation-related complications.

Adverse Reactions: The most common adverse reactions in clinical studies (≥ 3% of Aimovig®-treated patients and more often than placebo) were injection site reactions and constipation.

Please see Aimovig® full Prescribing Information.


Indication

Aimovig® is indicated for the preventive treatment of migraine in adults.

One injection,
once a month

One injection via self-administered autoinjector1

Image of Aimovig® (erenumab-aooe) SureClick Autoinjector for subcutaneous injection. Image of Aimovig® (erenumab-aooe) SureClick Autoinjector for subcutaneous injection.
 

Single dose at the push of a button1

  • No loading dose1
  • Hidden 27-gauge needle2
  • No dose adjustment required for special populations1
  • Doses may be administered in the upper arm, thigh, or abdomen1
    • Administration in the upper arm requires a caregiver to inject
  • The autoinjector should be kept in the refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light until time of use1
    • After removing Aimovig® from the refrigerator, it can be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 7 days
    • Leave the autoinjector at room temperature for at least 30 minutes before injecting
    • Throw away Aimovig® that has been left at room temperature for more than 7 days

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.1

In clinical trials, the most frequent injection site reactions in patients treated with Aimovig® were injection site pain, injection site erythema, and injection site pruritus. The prefilled syringe was used during Aimovig® pivotal trials.1

These are not the full instructions for the dosage and administration of Aimovig®. Please refer to the full Prescribing Information and the Instructions for Use for complete details.

1.

Why did Amgen and Novartis transition the Aimovig® 140 mg dose from 2 consecutive injections of 70 mg each to a single-dose SureClick® autoinjector of 140 mg/mL?

  • We made this change to reduce the number of injections required for patients to administer the 140 mg dose from 2 injections to 1 injection per month. With either dose, Aimovig® is one injection, once a month.
2.

What is different about the single 140 mg/mL SureClick® autoinjector? Will my patients need to be retrained?

  • The 140 mg/mL autoinjector works the same way as the 70 mg/mL autoinjector. The key difference is the color. The 140 mg/mL Aimovig® SureClick® autoinjector will be a dark blue autoinjector with a gray start button and orange cap.3,4 The package artwork has also been updated to show the image of the single 140 mg/mL SureClick® autoinjector.
  • The 70 mg/mL Aimovig® SureClick® autoinjector and packaging will remain unchanged.3

Click to see the Instructions for Use for the 70 mg/mL autoinjector and the 140 mg/mL autoinjector.

3.

How are Amgen and Novartis notifying patients of the 140 mg/mL SureClick® device?

  • Retail Pharmacies:
    • Amgen and Novartis will be notifying pharmacies of the transition while providing a recommendation to consult with patients when dispensing their Aimovig® prescription.
  • Aimovig Ally:
    • Notifications will be sent to those patients who receive Aimovig® through the Amgen and Novartis fulfillment service once the transition has taken place, in advance of receiving their next prescription. An additional notification will be sent to the patient within their shipment from the McKesson specialty pharmacy highlighting the change.
    • Existing patients receiving 2 x 70 mg/mL SureClick® autoinjectors for the 140 mg dose who enrolled in Aimovig Ally Free Trial Offer (FTO) program or Bridge to Commercial program will be required to obtain a new prescription. Aimovig Ally will be proactively providing a fax to HCPs with a list of their patients that will require a new prescription, which will need to be sent to McKesson Specialty Pharmacy via an electronic or faxed prescription.
  • Additionally, the Aimovig® patient website, injection videos and patient brochures will be updated with this information.
4.

Are there any differences in pharmacokinetics, safety, or adverse events with the Aimovig® 140 mg/mL single-dose SureClick® autoinjector versus the previous 140 mg dose, which was administered as 2 consecutive injections of 70 mg/mL each?

  • Two dedicated studies were conducted to assess the safety profile and pharmacokinetics (PK) of Aimovig® administered as a single 140 mg/mL injection vs 2 x 70 mg/mL injections. Aimovig® administered as a single 140 mg/mL injection was bioequivalent to 2 x 70 mg/mL injections. In both studies, the frequencies of adverse events, serious adverse events, and device-related adverse events were similar between both doses.5
5.

Is there a price difference with the Aimovig® 140 mg/mL single-dose SureClick® autoinjector?

  • There is no price difference. Both the 70 mg and 140 mg doses remain priced the same.
6.

Does the Aimovig Ally Access Card $5 copay offer apply to the 140 mg dose?

  • Yes. Regardless of dose, patients may use the $5 copay offer for each pharmacy fill. All existing terms and conditions apply.
7.

Will my office have to redo any prior authorizations for patients who were using the previous Aimovig® 140 mg dose (2 x 70 mg/mL)?

  • In general, additional prior authorizations are not anticipated since payer systems usually incorporate dosage strengths soon after approval. There could be instances where payer systems have not yet updated with the 140 mg dosage strength, potentially requiring verification with the payer. As always, please contact the relevant payer if you wish to verify coverage criteria.
8.

For my existing Aimovig® 140 mg (2 x 70 mg/mL) patients, do I need to write a new prescription for the Aimovig® 140 mg/mL single-dose SureClick® autoinjector?

  • You may need to provide verbal confirmation with the pharmacy or write a new prescription for the 140 mg/mL single-dose SureClick® autoinjector. Please check with your patient's pharmacist.
9.

What is an example of a prescription for the 140 mg/mL single-dose SureClick® autoinjector?

  • Example: Aimovig® 140 mg—Inject Subcutaneously Once Monthly. Dispense #1 (one)

Prescribing Aimovig®
for your patients

Image of hypothetical prescription Image of hypothetical prescription

Show your patients this overview video on injecting Aimovig®

It is important that you thoroughly review the Instructions for Use. These instructions cover everything you need to know about how to use the Aimovig® SureClick® autoinjector. The information in this website does not replace the Instructions for Use.

Indication

Aimovig® is indicated for the preventive treatment of migraine in adults.

Important Safety Information

Contraindication: Aimovig® is contraindicated in patients with serious hypersensitivity to erenumab-aooe or to any of the excipients. Reactions have included anaphylaxis and angioedema.

Hypersensitivity Reactions: Hypersensitivity reactions, including rash, angioedema, and anaphylaxis, have been reported with Aimovig® in post marketing experience. Most reactions were not serious and occurred within hours of administration, although some occurred more than one week after administration. If a serious or severe reaction occurs, discontinue Aimovig® and initiate appropriate therapy.

Constipation with Serious Complications: Constipation with serious complications has been reported following the use of Aimovig® in the postmarketing setting. There were cases that required hospitalization, including cases where surgery was necessary. The onset of constipation was reported after the first dose in a majority of these cases, but patients also reported later on in treatment. Aimovig® was discontinued in most reported cases. Constipation was one of the most common (up to 3%) adverse reactions reported in clinical studies.

Monitor patients treated with Aimovig® for severe constipation and manage as clinically appropriate. Concurrent use of medications associated with decreased gastrointestinal motility may increase the risk for more severe constipation and the potential for constipation-related complications.

Adverse Reactions: The most common adverse reactions in clinical studies (≥ 3% of Aimovig®-treated patients and more often than placebo) were injection site reactions and constipation.

Please see Aimovig® full Prescribing Information.

References: 1. Aimovig® (erenumab-aooe) prescribing information, Amgen. 2. Data on file, Amgen Inc. AMG 334 70 mg/mL SureClick 1.5 Autoinjector Device Design Input Requirements (DDIR). August 19, 2016. 3. Data on file, Amgen Inc. Device design development [AI/Pen]. 4. Data on file, Amgen Inc. Device design development [140 mg/mL AI/Pen]. 5. Data on file, Amgen Inc. Comparability of 140 mg/mL Aimovig vs 2 x 70 mg/mL PK, safety and AEs. January 25, 2019.