AIMOVIG
Clinical safety rating: caution
Comprehensive clinical and safety monograph for AIMOVIG (AIMOVIG).
AIMOVIG (erenumab) is a human monoclonal antibody that binds to the calcitonin gene-related peptide (CGRP) receptor and antagonizes CGRP receptor function. CGRP is a neuropeptide involved in the pathophysiology of migraine; its release leads to vasodilation and activation of pain pathways.
| Metabolism | Erenumab is degraded into small peptides and amino acids via general protein catabolism pathways. It is not metabolized by cytochrome P450 enzymes. |
| Excretion | Elimination via proteolytic catabolism; no renal or biliary excretion of intact antibody. |
| Half-life | 28 days (range 23-31 days) in healthy volunteers; supports monthly subcutaneous dosing. |
| Protein binding | No specific protein binding; 100% bound to target (CGRP receptor) and cleared via target-mediated disposition. |
| Volume of Distribution | Approximately 3.8 L, indicating limited extravascular distribution, consistent with a monoclonal antibody. |
| Bioavailability | 82% after subcutaneous administration. |
| Onset of Action | Reduction in migraine days observed as early as 1 week after first subcutaneous dose. |
| Duration of Action | Sustained effect over 1 month; clinical trials show efficacy maintained through monthly dosing. |
70 mg subcutaneously once monthly; some patients may benefit from 140 mg subcutaneously once monthly.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required for renal impairment. Not studied in patients requiring dialysis. |
| Liver impairment | No dose adjustment required for mild to moderate hepatic impairment (Child-Pugh A or B). Not studied in severe hepatic impairment (Child-Pugh C). |
| Pediatric use | Safety and efficacy not established in pediatric patients. |
| Geriatric use | No dose adjustment required; limited data in patients aged ≥65 years, but no overall differences observed. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for AIMOVIG (AIMOVIG).
| Breastfeeding | No human data on erenumab in breast milk. Monoclonal antibodies are likely excreted in breast milk at low levels. M/P ratio unknown. Caution recommended; consider developmental benefits of breastfeeding vs maternal need. Weight risk of infant exposure. |
| Teratogenic Risk | Aimovig (erenumab) is a monoclonal antibody. Based on mechanism of action (CGRP receptor antagonist) and animal studies, there is potential for fetal harm. Insufficient human data; avoid in pregnancy unless benefit outweighs risk. First trimester: unknown risk. Second/third trimester: IgG1 crosses placenta; potential fetal exposure increases with gestational age. |
■ FDA Black Box Warning
No boxed warning.
| Serious Effects |
["Hypersensitivity to erenumab or any excipient in the formulation."]
| Precautions | ["Hypersensitivity reactions, including rash, angioedema, and anaphylaxis have been reported.","Constipation with serious complications (e.g., intestinal perforation, obstruction) in postmarketing reports; monitor for severe constipation.","Risk of antibody development and potential loss of efficacy.","May cause fetal harm based on animal studies; consider reproductive potential and need for contraception."] |
| Food/Dietary | No specific food interactions. |
| Clinical Pearls |
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| Fetal Monitoring | Monitor for fetal growth abnormalities if used during pregnancy. No specific monitoring guidelines; routine prenatal care with ultrasound as indicated. Assess for maternal adverse effects (e.g., hypertension, injection site reactions). |
| Fertility Effects | No data on human fertility effects. In animal studies, no impairment of fertility at doses up to 300 mg/kg. Potential for reversible hormonal effects via CGRP receptor blockade? Unknown clinical significance. |
| Administer subcutaneously monthly; no dose adjustment needed for renal or hepatic impairment. Onset of efficacy may take several months. Contraindicated in patients with hypersensitivity to any component. |
| Patient Advice | Inject once monthly on the same day each month. · Store in refrigerator at 2°C to 8°C; do not freeze. · Allow to reach room temperature for 30 minutes before injecting. · Rotate injection sites to reduce injection site reactions. · Report any signs of allergic reaction, such as rash, itching, or difficulty breathing. |