erenumab (Rx)

Brand and Other Names:Aimovig
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

single-dose prefilled syringe

  • 70mg/mL
  • 140mg/mL

single-dose prefilled SureClick autoinjector

  • 70mg/mL
  • 140mg/mL

Migraine Prophylaxis

Indicated for preventive treatment of migraines

70 mg SC once monthly

Some patients may need 140 mg SC once monthly (administered as 2 consecutive 70-mg SC doses)

Dosage Modifications

Renal or hepatic impairment is not expected to affect pharmacokinetics of erenumab

Hepatic impairment: Not studied

Renal impairment

  • Mild-to-moderate: Clinical studies did not reveal a difference in pharmacokinetics
  • Severe (eGFR <30 mL/min/1.73 m²): Not studied

Safety and efficacy not established

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Adverse Effects

1-10%

Injection site pain (5-6%)

Constipation (1-3%)

Cramps, muscle spasms (<3%)

Postmarketing Reports

Hypersensitivity

Constipation with serious complications

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Warnings

Contraindications

Hypersensitivity to drug or excipients

Cautions

Hypersensitivity reactions (eg, rash, angioedema, anaphylaxis) reported; may occur within hours or one week following administration; discontinue administration and initiate appropriate therapy if serious reaction occurs

Constipation

  • Constipation with serious complications reported in the postmarketing setting; cases that required hospitalization, including cases where surgery was necessary reported
  • In majority cases, onset of constipation was reported after first dose; however, patients have also presented with constipation later on in treatment
  • Monitor patients for severe constipation and manage as clinically appropriate
  • Concurrent use of medications associated with decreased gastrointestinal motility may increase risk for more severe constipation and potential for constipation-related complications
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Pregnancy

Pregnancy

Data are not available regarding fetal risk if used in pregnant women

Animal studies

  • No adverse effects on offspring were observed when pregnant monkeys were administered erenumab-aooe throughout gestation

Clinical considerations

  • Data suggest that women with migraine may be at increased risk of preeclampsia during pregnancy

Lactation

Data are not available on the presence in human milk, the effects on the breastfed infant, or the effects on milk production

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Human monoclonal antibody; binds to the calcitonin gene-related peptide (CGRP) receptor, which is thought to be causally involved in migraine pathophysiology

Absorption

Absolute bioavailability: 82%

Peak plasma time: ~6 days

Peak plasma concentration: 6.1 mcg/mL (70 mg); 15.8 mcg/mL (140 mg)

AUC: 159 day·mcg/mL (70 mg); 505 day·mcg/mL (140 mg)

Bioavailability: 82%

Distribution

Vd: 3.86 L

Elimination

Half-life: 28 days

2 elimination phases observed

  • Low concentrations: Predominantly through saturable binding to target (CGRP receptor)
  • Higher concentrations: Largely through a nonspecific, nonsaturable proteolytic pathway
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Administration

SC Administration

For SC use only

Needle shield within the cap of prefilled autoinjector and the cap of prefilled syringe contain dry natural rubber (a derivative of latex) may cause allergic reactions in individuals sensitive to latex

Intended for patient self-administration; provide proper training to patients and/or caregivers on preparation and administration, including aseptic technique

Instructions

  • Prior to SC administration, allow syringe to sit at room temperature for at least 30 minutes protected from direct sunlight
  • Do not warm by using a heat source (eg, hot water, microwave)
  • Do not shake product
  • Visually inspect for particulate matter and discoloration; do not use if solution is cloudy or discolored or contains flakes or particles
  • Administer SC in the abdomen, thigh, or upper arm; 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

Missed dose

  • If a dose is missed, administer as soon as possible
  • Thereafter, reschedule monthly dose from date of last dose

Storage

Refrigerate at 2-8°C (36-46°F) in original carton to protect from light

If removed from refrigerator, keep at room temperature (up to 25°C [77°F]) in the original carton; must be used within 7 days; discard if left at room temperature for >7 days

Do not freeze

Do not shake

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Images

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.