Monoclonal antibody that binds to the calcitonin gene-related peptide (CGRP) receptor, which reduces the neuroinflammatory and vasodilatory effects of CGRP.
Therapeutic effects:
Reduction in frequency of migraines.
Pharmacokinetics⬆⬇
Absorption: Unknown.
Distribution: Minimal distribution to tissues.
Metabolism/Excretion: Degraded by enzymatic proteolysis into small peptides and amino acids.
Half-Life: 31 days.
Time/Action Profile⬆⬇
(plasma concentrations)
ROUTE
ONSET
PEAK
DURATION
SUBQ
unknown
5–7 days
1 mo
Contraind./Precautions⬆⬇
Contraindicated in:
Hypersensitivity.
Use Cautiously in:
OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Safety and effectiveness not established in children.
SC (Adults ): 225 mg once monthly or 675 mg every 3 mo.
Availability⬆⬇
Solution for injection (prefilled syringes and autoinjectors): 225 mg/1.5 mL
Assessment⬆⬇
Assess frequency and intensity of migraines.
Monitor for signs and symptoms of hypersensitivity reactions (rash, pruritus, drug hypersensitivity, urticaria) during therapy. May occur up to 1 mo after administration. If reaction is severe, discontinue fremanezumab and treat as needed.
Implementation⬆⬇
SC: Prior to use allow vial to sit at room temperature for at least 30 min, protect from direct sunlight. Do no use other methods to warm solution (hot water or microwave). Do not shake. Solution is clear to opalescent, colorless to light yellow; do not administer solutions that are discolored, cloudy, or contain particulate matter. Store in refrigerator in original carton to protect from light; do not freeze. May be stored up to 7 days at room temperature; discard if at room temperature >7 days.
Inject entire contents into abdomen, thigh, or upper arm. Do not inject into areas where the skin is tender, bruised, red, or hard.
Patient/Family Teaching⬆⬇
Instruct patient to take as directed. Administer missed doses as soon as possible and schedule next dose from date last dose administered. Educate patient and/or caregiver on correct technique for injection and disposal of equipment. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
Instruct patient to notify health care professional immediately if signs and symptoms of hypersensitivity reaction (itching, rash, hives, swelling of face, mouth, tongue or throat, trouble breathing) occur.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Rep: Advise female patients to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy. Inform patient of pregnancy exposure registry that monitors pregnancy outcomes in women exposed to fremanezumab during pregnancy. Enrollment can be done by health care professional or patient by calling 1-833-927-2605 or visiting www.tevamigrainepregnancyregistry.com.
