Aimovig

AIMOVIG is indicated for the preventive treatment of migraine in adults.

• For subcutaneous use only (
  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/Storage and Handling (16.2)]. 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 (3)]
    . 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.
  )
• Recommended dosage is 70 mg once monthly; some patients may benefit from a dosage of 140 mg once monthly (
  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.
  )
• Administer in the abdomen, thigh, or upper arm subcutaneously (
  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/Storage and Handling (16.2)]. 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 (3)]
    . 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.
  )
• See Dosage and Administration for important administration instructions (
  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/Storage and Handling (16.2)]. 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 (3)]
    . 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.
  )

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

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/.