Aimovig

Calcitonin Gene-Related Peptide (CGRP) Antagonists

Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. Do not use if the erenumab solution is cloudy or discolored or contains flakes or particles. Erenumab is a clear to opalescent, colorless to light yellow solution.[63162]

Erenumab is intended for patient self-administration. Provide proper training to patients and/or caregivers on how to prepare and administer erenumab, including aseptic technique.
Before administration, allow erenumab to sit at room temperature for at least 30 minutes protected from direct sunlight. Do not warm using a heat source such as hot water or microwave.
Do not shake.
Clean injection site on the abdomen, thigh, or upper arm with an alcohol wipe, and allow skin to dry.
Do not leave cap off the autoinjector or prefilled syringe for more than 5 minutes; this can dry out the medicine.
Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting directly into raised, thick, red, or scaly skin patch or lesion, or areas with scars or stretch marks.
If using the same body area for the 2 separate injections needed for the 140 mg dose, ensure the second injection is not at same location used for the first injection.
Discard the autoinjector or prefilled syringe in a FDA-cleared sharps disposal container. Do not discard in household trash.
Storage: After removing erenumab from the refrigerator, it can be stored at room temperature between 68 to 77 degrees F (20 to 25 degrees C) for up to 7 days. Do not return erenumab to the refrigerator after it has reached room temperature.[63162]
 
Single-dose, Prefilled SureClick Autoinjector
Pull white or orange cap straight off autoinjector.
Do not place fingers into the green or yellow safety guards. The needle is inside the safety guard.
Stretch or pinch skin to create a firm injection site.
Firmly push the autoinjector down onto the skin.
When ready to inject, press the start button; a click will be heard. The injection could take about 15 seconds. When the injection is complete, a click may be heard or felt, and the window will turn yellow.
Remove the autoinjector from the skin.[63162]
 
Single-dose, Prefilled Syringe
Always hold syringe by the barrel.
Pull gray needle cap straight out and away from body.
Pinch injection site skin firmly between thumb and fingers.
Hold the pinch, and insert the syringe into skin at 45 to 90 degrees.
Using slow and constant pressure, push the plunger rod all the way down with thumb until the prefilled syringe stops moving.
When done, release thumb, and gently lift syringe off the skin.[63162]

alopecia / Delayed / 17.0-17.0
angioedema / Rapid / Incidence not known
anaphylactic shock / Rapid / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known
cardiac arrest / Early / Incidence not known
arrhythmia exacerbation / Early / Incidence not known

constipation / Delayed / 1.0-20.0
antibody formation / Delayed / 2.6-11.1
oral ulceration / Delayed / Incidence not known
erythema / Early / Incidence not known
depression / Delayed / Incidence not known
palpitations / Early / Incidence not known
hypertension / Early / Incidence not known
loss of consciousness / Rapid / Incidence not known

injection site reaction / Rapid / 5.0-6.0
muscle cramps / Delayed / 0-2.0
myalgia / Early / Incidence not known
musculoskeletal pain / Early / Incidence not known
arthralgia / Delayed / Incidence not known
rash / Early / Incidence not known
pruritus / Rapid / Incidence not known

Aimovig

Rx

Injectable, selective calcitonin gene-related peptide (CGRP) receptor antagonist
Used for migraine prophylaxis in adults
Significantly reduces monthly migraine days

70 mg subcutaneously once monthly. Some persons may benefit from a dosage of 140 mg subcutaneously once monthly. Guidelines classify erenumab as having established efficacy for migraine prophylaxis.

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

There are no drug interactions associated with Erenumab products.

Aimovig Subcutaneous Inj Sol: 1mL, 70mg, 140mg

140 mg/month subcutaneously.

140 mg/month subcutaneously.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Erenumab is a human immunoglobulin G2 (IgG2) monoclonal antibody that has high affinity binding to the calcitonin gene-related peptide (CGRP) receptor and antagonizes CGRP receptor function. CGRP is distributed throughout the nervous system, and it is concentrated at anatomical sites, such as the trigeminovascular system, which are involved in migraine pathophysiology. Centrally, CGRP is involved in nociceptive transmission through second and third order neurons and pain modulation in the brainstem. Peripherally, CGRP mediates vasodilation through smooth muscle receptors. CGRP concentrations are elevated during acute migraine attacks and may be chronically elevated in chronic migraineurs.

Erenumab is administered subcutaneously. Erenumab exhibits non-linear kinetics. Serum trough concentrations approach steady state by 3 months of dosing. At low concentrations, elimination is predominately through saturable target binding at the calcitonin gene-related peptide (CGRP) receptor; at higher concentrations, elimination is predominantly through a non-specific, non-saturable proteolytic pathway. The half-life of erenumab is 28 days.
 
Affected cytochrome P450 isoenzymes and drug transporters: none

After single doses of 70 or 140 mg, the mean Cmax (SD) of erenumab was 6.1 (2.1) mcg/mL and 15.8 (4.8) mcg/mL, respectively. Median peak serum concentrations occurred in approximately 6 days. The estimated bioavailability was 82%. In patients with episodic migraine, Cmin (SD) was 5.7 (3.1) mcg/mL and 12.8 (6.5) mcg/mL for 70 mg monthly and 140 mg monthly, respectively. In patients with chronic migraine, Cmin was 6.2 (2.9) mcg/mL and 14.9 (6.5) mcg/mL for 70 mg monthly and 140 mg monthly, respectively.

There are no adequate data on the developmental risk associated with erenumab use during human pregnancy. Women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy. No adverse effects on offspring were observed when monkeys were given erenumab throughout pregnancy at exposures approximately 20 times those in humans at a dose of 140 mg once monthly.

There are no data on the presence of erenumab in human milk, the effects on the breast-fed infant, or the effects on milk production. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for erenumab and any potential adverse effects on the breast-fed infant from erenumab or the underlying maternal condition.