vascular headache suppressants
calcitonin gene-related peptide receptor antagonists
Monoclonal antibody that binds to the calcitonin gene-related peptide (CGRP) receptor, which reduces the neuroinflammatory and vasodilatory effects of CGRP.
Reduction in frequency of migraines.
Distribution: Minimal distribution to tissues.
Metabolism and Excretion: Degraded by enzymatic proteolysis into small peptides and amino acids.
Half-life: 31 days.
TIME/ACTION PROFILE (plasma concentrations)
|Subcut||unknown||5–7 days||1 mo|
Use Cautiously in:
- OB: Safety and effectiveness not established in pregnancy;
- Lactation: Use only if potential maternal benefit justifies potential risk to infant;
- Pedi: Safety and effectiveness not established in children.
Adverse Reactions/Side Effects
Local: injection site reactions
Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA)
* CAPITALS indicate life-threatening.
Underline indicate most frequent.
SC (Adults): 225 mg once monthly or 675 mg every 3 mo.
Solution for injection (prefilled syringes and autoinjectors): 225 mg/1.5 mL
- 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.
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.
- 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 breast feeding. 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.
Decrease in frequency of migraines.
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