Migraine, prevention (alternative agent):
Note: Avoid use in patients with recent cardiovascular or cerebrovascular ischemic events (Schwedt 2022). 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 (AHS [Ailani 2021]; Loder 2018). An adequate trial for assessment of effect is considered to be at least 3 months at a therapeutic dose (AHS [Ailani 2021]).
SUBQ: Initial: 70 to 140 mg once monthly (Goadsby 2021; Reuter 2018; manufacturer’s labeling).
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.
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]
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Auto-injector, Subcutaneous:
Aimovig: 70 mg/mL (1 mL); 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
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.
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
In general, preventive treatment for migraine in patients trying to become pregnant should be avoided; treatment should be individualized considering the available safety data and needs of the patient should pregnancy occur (AHS [Ailani 2021]). Consider the long half-life prior to use in patients who may become pregnant until information related to pregnancy is available (Tepper 2018).
Adverse events were not observed in animal reproduction studies.
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).
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. The risk of preeclampsia is also increased in pregnant patients with migraine (Dodick 2019; Parikh 2020).
In general, preventive treatment for migraine in pregnant patients should be avoided; treatment during pregnancy should be individualized considering the available safety data, the potential for adverse maternal and fetal events, and needs of the patient (AHS [Ailani 2021]). Based on available data, other agents may be preferred for the prevention of migraine in pregnant patients; use of CGRP receptor antagonists should be avoided until additional data are available (Burch 2019; Parikh 2020).
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).
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; treatment should be individualized considering the available safety data and needs of the patient (AHS [Ailani 2021]). Use of CGRP receptor antagonists should be avoided until additional data are available (Parikh 2020).
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
Solution Auto-injector (Aimovig Subcutaneous)
70 mg/mL (per mL): $836.10
140 mg/mL (per mL): $836.10
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