Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution Auto-injector, Subcutaneous [preservative free]:
Aimovig: erenumab-aooe 70 mg/mL (1 mL); erenumab-aooe 140 mg/mL (1 mL) [contains polysorbate 80]
Aimovig (140 MG Dose): erenumab-aooe 70 mg/mL (1 mL [DSC]) [contains polysorbate 80]
Pharmacology
Mechanism of Action
Erenumab is a human monoclonal antibody that antagonizes calcitonin gene-related peptide (CGRP) receptor function.
Pharmacokinetics/Pharmacodynamics
Distribution
Vz: 3.86 L
Metabolism
Via a nonspecific, nonsaturable proteolytic pathway
Time to Peak
~6 days
Half-Life Elimination
28 days
Use: Labeled Indications
Migraine prophylaxis: Preventive treatment of migraine in adults
Contraindications
Serious hypersensitivity to erenumab or any component of the formulation.
Dosage and Administration
Dosing: Adult
Migraine prophylaxis: SubQ: Initial: 70 mg once a month; some patients may benefit from 140 mg once a month
Missed dose: Administer missed dose as soon as possible, and schedule next dose for 1 month from date of the last dose.
Dosing: Geriatric
Refer to adult dosing.
Administration
SubQ: For subcutaneous use only; intended for self-administration. Keep out of direct sunlight and allow to come to room temperature for 30 minutes before administration. Do not warm using a heat source (eg, hot water, microwave) and do not shake. Administer in abdomen (avoiding 2 inches around the navel), thigh or upper arm, avoiding areas of skin that are tender, bruised, red or hard. Deliver entire contents of single-use autoinjector or prefilled syringe.
Storage
Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton. Protect from light until time of use. If removed from the refrigerator, should be kept at room temperature (up to 25°C [77°F]) in the original carton and used within 7 days. Do not freeze or shake.
Drug Interactions
There are no known significant interactions.
Adverse Reactions
1% to 10%:
Gastrointestinal: Constipation (3%; with serious complications)
Immunologic: Antibody development (3% to 6%; neutralizing: <1%)
Local: Injection site reaction (5% to 6%)
Neuromuscular & skeletal: Muscle cramps (≤2%), muscle spasm (≤2%)
Frequency not defined:
Dermatologic: Injection site pruritus
Local: Erythema at injection site, pain at injection site
<1%, postmarketing, and/or case reports: Anaphylaxis, angioedema, hypersensitivity reaction
Warnings/Precautions
Concerns related to adverse effects:
- Constipation: Constipation, including cases with serious complications resulting in hospitalization and surgery, has been reported. Constipation has generally occurred after the first dose; however, a later onset has also been observed. Concurrent use of medications that decrease GI motility may increase the risk for more severe constipation and the potential for constipation-related complications.
- Hypersensitivity: Hypersensitivity reactions, including rash, angioedema, and anaphylaxis, have been reported. Most reactions are mild to moderate and occur within hours after administration, but some may be delayed for >1 week. If a hypersensitivity reaction occurs, discontinue treatment and institute appropriate therapy.
Dosage form specific issues:
- Latex: The packaging (needle shield of auto-injector and needle cap of prefilled syringe) may contain latex.
Monitoring Parameters
Number of monthly migraine days
Pregnancy
Pregnancy Considerations
Adverse events were not observed in animal reproduction studies.
Patient Education
What is this drug used for?
- It is used to prevent migraine headaches.
Frequently reported side effects of this drug
- Injection site redness, swelling, or pain
- Constipation
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
