AIMOVIG

1 Dosing Considerations  Aimovig is administered subcutaneously through single-dose pre-filled autoinjector or single-dose pre-filled syringe.  Aimovig is intended for patient self-administration.  Administration should be performed by an individual who has been trained to ad minister the product  Aimovig should be initiated by health professionals experienced in the diagnosis and treatment of migraine.

2 Recommended Dose and Dosage Adjustment The recommended dose of Aimovig is 70 mg administered once monthly. Some patients may benefit from a dose of 140 mg once monthly administered as one subcutaneous injection of 140 mg. See Part II- 14 CLINICAL TRIALS.

Aimovig is not approved for pediatric use. 4 Administration To administer the recommended dose of 70 mg, give one subcutaneous injection. To administer the recommended dose of 140 mg, give one subcutaneous injection of 140 mg. Prior to subcutaneous administration, allow Aimovig to sit at room temperature for at least 30 minutes and protect from direct sunlight.

Do not warm by using a heat source such as hot water or microwave. Do not shake the product. Visually inspect the solution for particles and discolouration. Aimovig is a clear to opalescent, colourless to light yellow solution. Do not use if the solution is cloudy, discoloured or if flakes or particles are present.

Administer Aimovig subcutaneously in the abdomen, thigh, or upper arm. Injection sites should be rotated and injections should not be given into areas where the skin is tender, bruised, red, or hard. Both the pre-filled syringe and the pre-filled SureClick® autoinjector are single-dose and designed to deliver the entire contents with no residual content.

The grey needle cover of the Aimovig pre-filled syringe and the needle shield within the white or orange cap of the Aimovig pre-filled autoinjector contains dry natural rubber (a derivative of latex), which may cause allergic reactions in individuals sensitive to latex.

Comprehensive instructions for the administration of Aimovig are provided in the Patient Medication Information. 5 Missed Dose If an Aimovig dose is missed, administer as soon as possible. Thereafter, Aimovig can be scheduled monthly from the date of the last dose.

1 Adverse Reaction Overview A total of over 2,500 patients (more than 2,600 patient years) have been treated with AIMOVIG in registration studies. Of these, more than 1,300 patients were exposed for at least 12 months. The adverse reactions reported in the placebo-controlled trials of Aimovig were injection site reactions, constipation, muscle spasm and pruritus.

5%) AIMOVIG® (erenumab) Page 9 of 63 System Organ Class Preferred Term Aimovig 70 mg N = 893 n (%) Aimovig 140 mg N = 507 n (%) Placebo N = 1043 n (%) a Injection Site Reactions includes multiple preferred terms, such as injection site pain and injection site erythema.

b Pruritus includes generalized pruritus, pruritus, and pruritic rash. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.

Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. 2%) muscle spasm was reported in subjects treated with Aimovig 140 mg. This subject had a history of muscle spasms and experienced worsening of back spasms.

All other adverse reactions were grade 1 (mild) or moderate (grade 2) in severity. In the pivotal studies, the following adverse events were observed to occur at or above 1% during the double-blind treatment phase. 7) Upper […]

, Constipation with Serious Complications 09/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 1 Pregnant Women ..........................................................................................

2 Breast-feeding............................................................................................... 3 Pediatrics ...................................................................................................... 4 Geriatrics ......................................................................................................

3 Less Common Clinical Trial Adverse Reactions .................................................... 5 Post-Market Adverse Reactions.......................................................................... 15 9 DRUG INTERACTIONS..................................................................................................

2 Drug Interactions Overview................................................................................ 4 Drug-Drug Interactions ...................................................................................... 5 Drug-Food Interactions ......................................................................................

6 Drug-Herb Interactions ...................................................................................... 7 Drug-Laboratory Test Interactions ...................................................................... 16 10 CLINICAL PHARMACOLOGY .........................................................................................

1 Mechanism of Action.................................................................................... 2 Pharmacodynamics ...................................................................................... 3 Pharmacokinetics.........................................................................................

 Aimovig is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.