Fremanezumab

Indications

Fremanezumab is used for: Migraine Prophylaxis

Adult Dose

Migraine Prophylaxis Indicated for preventive treatment of migraine 225 mg SC once monthly Alternatively, 675 mg every 3 months (quarterly), administered as 3 consecutive 225-mg SC doses When switching dosage options, administer first dose of new regimen on next scheduled date of administration Hepatic impairment Not expected to affect pharmacokinetics of fremanezumab; dedicated hepatic impairment studies not performed Mild: Population pharmacokinetic analysis of integrated data from clinical studies indicated no difference in pharmacokinetics

Child Dose

Renal Dose

Renal impairment Not expected to affect pharmacokinetics of fremanezumab; dedicated renal impairment studies not performed

Administration

SC Preparation Before use, allow syringe to sit at room temperature for 30 minutes protected from direct sunlight Do not warm by using a heat source such as hot water or a microwave Do not use if it has been at room temperature ?24 hr Follow aseptic injection technique Inspect solution for particles or discoloration prior to administration; do not use if solution cloudy, discolored, or contains particles SC Administration Therapy may be administered by healthcare professionals, patients, and/or caregivers; provide proper training to patients and/or caregivers on preparation and administration of prefilled syringe, including aseptic technique Administer SC into areas of abdomen, thigh, or upper arm that are not tender, bruised, red, or indurated; for multiple injections, use the same body site, but not the exact location of previous injection

Contra Indications

History of serious hypersensitivity reactions to drug or excipients

Precautions

Hypersensitivity reactions (eg, rash, pruritus, drug hypersensitivity, urticaria) reported within hours to 1 month following administration in clinical trials; some reactions led to discontinuation or required corticosteroid treatment; consider discontinuing therapy, and institute appropriate therapy if hypersensitivity reaction occurs

Pregnancy-Lactation

Pregnancy There are no adequate data on developmental risk associated with therapy in pregnant women; drug has a long half-life, which should be taken into consideration for women who are pregnant or plan to become pregnant while receiving therapy Clinical considerations Published data have suggested that women with migraine may be at increased risk of preeclampsia during pregnancy Animal data Administration to rats and rabbits during the period of organogenesis or to rats throughout pregnancy and lactation at doses resulting in plasma levels greater than those expected clinically did not result in adverse effects on development Lactation There are no data on presence in human milk, effects on breastfed infant, or on milk production Consider developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on breastfed infant from the drug or from the underlying maternal condition

Interactions

Adverse Effects

Side effects of Fremanezumab :

Mechanism of Action

Human monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to receptor, which is involved in migraine pathophysiology