Version May 2024
Migraine, prevention (alternative agent):
Note: Avoid use in patients with recent cardiovascular or cerebrovascular ischemic events (Ref). Limit use to patients with significant disability from frequent migraines who are unable to tolerate or do not respond to adequate trials of at least 2 other preventive therapies (Ref). An adequate trial for assessment of effect is considered to be at least 3 months at a therapeutic dose (Ref).
SUBQ: Initial: 70 to 140 mg once monthly (Ref).
Missed dose: Administer missed dose as soon as possible, and schedule next dose for 1 month from date of the last dose.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); renal impairment is not expected to change the pharmacokinetics of erenumab.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); hepatic impairment is not expected to change the pharmacokinetics of erenumab.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults.
1% to 10%:
Gastrointestinal: Constipation (3%; with serious complications)
Immunologic: Antibody development (3% to 6%; of which 3% were neutralizing)
Local: Injection site reaction (5% to 6%; including erythema at injection site, injection-site pruritus, pain at injection site)
Neuromuscular & skeletal: Muscle cramps (≤2%), muscle spasm (≤2%)
Postmarketing:
Cardiovascular: Hypertension (including exacerbation of hypertension)
Dermatologic: Alopecia, skin rash
Gastrointestinal: Oral mucosal ulcer
Hypersensitivity: Hypersensitivity reaction (including anaphylaxis and angioedema)
Serious hypersensitivity (eg, angioedema, anaphylaxis) to erenumab or any component of the formulation.
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.
• Hypertension: New-onset and worsening of preexisting hypertension, including cases requiring pharmacological treatment or hospitalization, have been reported. Onset most frequently reported after the initial dose and within 7 days of administration but may occur at any time. Monitor patients and consider discontinuing treatment in patients whom an alternative etiology is not established.
Disease related concerns:
• Cardiovascular disease: May cause hypertension; use with caution in patients with hypertension or risk factors for hypertension.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Auto-injector, Subcutaneous [preservative free]:
Aimovig: Erenumab-aooe 70 mg/mL (1 mL); Erenumab-aooe 140 mg/mL (1 mL) [contains polysorbate 80]
No
Solution Auto-injector (Aimovig Subcutaneous)
70 mg/mL (per mL): $903.14
140 mg/mL (per mL): $903.14
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Auto-injector, Subcutaneous:
Aimovig: Erenumab-aooe 70 mg/mL (1 mL); Erenumab-aooe 140 mg/mL (1 mL) [contains polysorbate 80]
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.
Migraine, prevention: Preventive treatment of migraine in adults
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
In general, preventive treatment for migraine in patients trying to become pregnant should be avoided. Options for patients planning a pregnancy should be considered as part of a shared decision-making process. Nonpharmacologic interventions should be considered initially. When needed, preventive treatment should be individualized considering the available safety data and needs of the patient should pregnancy occur. A gradual discontinuation of preventive medications is generally preferred when the decision is made to stop treatment prior to conception (ACOG 2022; AHS [Ailani 2021]). IV calcitonin gene-related peptide receptor antagonists are not currently recommended for the prevention of migraine in patients planning to become pregnant due to lack of data. Due to the long half-life, use is not recommended for 6 months prior to conception, and use should be avoided in patients at high risk of unintended pregnancy due to theoretical concerns for potential adverse fetal effects (ACOG 2022; Loder 2018).
Erenumab is a humanized monoclonal antibody (IgG2). Human IgG crosses the placenta. Exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009).
Outcome data following maternal use of erenumab during pregnancy are limited (Fofi 2021; Kanaan 2020; Noseda 2021; Vig 2022).
Erenumab is a calcitonin gene-related peptide (CGRP) receptor antagonist. Based on animal data, CGRP may help regulate placental blood flow, uterine relaxation, and maintain BP; CGRP antagonists could potentially increase the risk of gestational hypertension and preeclampsia (Dodick 2019). The risk of hypertensive disorders, including preeclampsia and eclampsia, are also increased in pregnant patients with migraine (ACOG 2022; Dodick 2019).
In general, preventive treatment for migraine should be avoided during pregnancy. Options for pregnant patients should be considered as part of a shared decision-making process. Nonpharmacologic interventions should be considered initially. When needed, preventive treatment should be individualized considering the available safety data, the potential for adverse maternal and fetal events, and needs of the patient (ACOG 2022; AHS [Ailani 2021]). IV CGRP receptor antagonists are not currently recommended for the prevention of migraine in pregnant patients due to lack of data (ACOG 2022).
Data collection to monitor pregnancy and infant outcomes following exposure to erenumab is ongoing. Patients should be encouraged to enroll in the Pregnancy Registry (833-244-4083 or http://www.genesispregnancyregistry.com/).
It is not known if erenumab is present in breast milk.
Erenumab is a humanized monoclonal antibody (IgG2). Human IgG is present in breast milk; concentrations are dependent upon IgG subclass and postpartum age (Anderson 2021). Outcome data following use of erenumab during lactation are limited (Henze 2019; Noseda 2021; Vig 2022).
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. In general, preventive treatment for migraine in lactating patients should be avoided. When needed, therapy should be individualized considering the available safety data and needs of the patient (AHS [Ailani 2021]). IV calcitonin gene-related peptide receptor antagonists are not currently recommended for the prevention of migraine in lactating patients due to lack of data (ACOG 2022).
Blood pressure.
Erenumab is a human monoclonal antibody that antagonizes calcitonin gene-related peptide (CGRP) receptor function.
Distribution: Vz: 3.86 L
Metabolism: Via a nonspecific, nonsaturable proteolytic pathway
Bioavailability: 82%
Half-life elimination: 28 days
Time to peak: ~6 days
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