Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (0)
Monitor Closely (3)
- efgartigimod alfa
efgartigimod alfa will decrease the level or effect of erenumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.
- efgartigimod/hyaluronidase SC
efgartigimod/hyaluronidase SC will decrease the level or effect of erenumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.
- rozanolixizumab
rozanolixizumab will decrease the level or effect of erenumab by receptor binding competition. Use Caution/Monitor. Rozanolixizumab may lower systemic exposures and reduce effectiveness of medications that bind to the human neonatal Fc receptor (FcRn). Closely monitor for decreased efficacy of such medications. When long-term use of such medications is required, consider discontinuing rozanolixizumab and using alternative therapies.
Minor (0)
Adverse Effects
1-10%
Injection site pain (5-6%)
Constipation (1-3%)
Cramps, muscle spasms (<3%)
Postmarketing Reports
Immune system disorders: Rash, angioedema, anaphylaxis, hypersensitivity
Gastrointestinal disorders: Oral mucosal ulceration, constipation with serious complications
Vascular disorders: Hypertension
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
Hypertension
- Development of hypertension and worsening of pre-existing hypertension reported
- Pre-existing hypertension or of risk factors increases risk
- Pharmacological treatment may be necessary
- May occur at anytime but most frequently within seven days of dose administration
- Onset or worsening of hypertension usually reported after first dose
- Monitor for new onset or worsening of pre-existing hypertension and consider whether discontinuation of therapy warranted if no alternate etiology found
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
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 and gestational hypertension 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.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
Administration
SC Administration
For SC use only
Needle shield within cap of prefilled autoinjector and cap of prefilled syringe contain dry natural rubber (a derivative of latex) may cause allergic reactions in latex-sensitive individuals
Intended for self-administration; properly train on preparation and administration, including aseptic technique
Before SC administration, allow syringe or autoinjector 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 particles
Administer SC in the abdomen, thigh, or upper arm; do not inject into areas where skin is tender, bruised, red, or hard
Prefilled autoinjector and syringe are single-dose and deliver entire contents
Missed dose
- Administer as soon as possible: reschedule monthly dose from date of last dose
Storage
Refrigerate at 2-8ºC (36-46ºF) in original carton to protect from light
If removed from refrigerator, store at room temperature (up to 25ºC [77ºF]) in original carton for up to 7 days; discard if left at room temperature for >7 days
Do not freeze
Do not shake
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Aimovig Autoinjector subcutaneous - | 70 mg/mL syringe |  | |
| Aimovig Autoinjector subcutaneous - | 140 mg/mL syringe |  |
Copyright © 2010 First DataBank, Inc.
Formulary
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