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  • CLASSES

    Calcitonin Gene-Related Peptide (CGRP) Antagonists

    DEA CLASS

    Rx

    DESCRIPTION

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

    HOW SUPPLIED

    Fremanezumab Subcutaneous Inj Sol: 1.5mL, 225mg

    DOSAGE & INDICATIONS

    For migraine prophylaxis.
    Subcutaneous dosage
    Adults

    225 mg subcutaneously once monthly or 675 mg subcutaneously every 3 months.

    MAXIMUM DOSAGE

    Adults

    225 mg/month or 675 mg every 3 months subcutaneously.

    Geriatric

    225 mg/month or 675 mg every 3 months subcutaneously.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

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

    Renal Impairment

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

    ADMINISTRATION

    Injectable Administration

    Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. Do not use if the fremanezumab solution is cloudy, discolored, or contains particles. Fremanezumab is a clear to opalescent, colorless to slightly yellow solution.

    Subcutaneous Administration

    Fremanezumab is intended for patient self-administration. Provide proper training to patients and/or caregivers on how to prepare and administer fremanezumab, including aseptic technique.
    Prior to administration, allow fremanezumab 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 use if the product has been at room temperature for 24 hours or more.
    Do not shake.
    Clean injection site on the abdomen, thigh, or upper arm with an alcohol wipe, and allow skin to dry.
    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 3 separate injections needed for the 675 mg dose, ensure the injections are not at same location used for the previous injection.
    Do not coadminister fremanezumab with other injectable drugs at the same injection site.
    When switching between monthly and quarterly dosage options, administer the first dose of the new regimen on the next scheduled date of administration.
    If a dose is missed, give the next dose as soon as possible. Subsequently, schedule from the date of the last dose.
    Storage: After removing fremanezumab from the refrigerator, it can be stored at room temperature up to 77 degrees F (25 degrees C) for up to 24 hours. Discard if not used within 24 hours after removal from refrigerator.
     
    Single-dose, Prefilled Syringe
    Always hold syringe by the barrel.
    Pull 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.
    Discard the prefilled syringe in a FDA-cleared sharps disposal container. Do not discard in household trash.
    Storage: After removing fremanezumab from the refrigerator, it can be stored at room temperature up to 77 degrees F (25 degrees C) for up to 24 hours. Discard if not used within 24 hours after removal from refrigerator.

    STORAGE

    Generic:
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Discard product if stored above 77 degrees F for more than 24 hours
    - Do not freeze
    - Protect from direct sunlight
    - Protect from extreme heat
    - Protect from light
    - Store in original carton in refrigerator (35 to 46 degrees F) until time of use

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    Fremanezumab is contraindicated in patients with serious hypersensitivity to fremanezumab or any of the excipients.

    Pregnancy

    There are no adequate data on the developmental risk associated with fremanezumab use during human pregnancy. Fremanezumab has a half-life of approximately 31 days, which should be taken into consideration for women who are pregnant or who intend to become pregnant while using the drug. No adverse developmental effects were observed when rabbits were given fremanezumab throughout organogenesis or when rats were given fremanezumab prior to and during mating and throughout pregnancy and lactation at doses associated with exposures approximately 2 to 3 times that in humans at a dose of 675 mg. Women with migraine may be at increased risk of preeclampsia during pregnancy.

    Breast-feeding

    There are no data on the presence of fremanezumab 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 fremanezumab and any potential adverse effects on the breast-fed infant from fremanezumab or the underlying maternal condition.

    ADVERSE REACTIONS

    Moderate

    antibody formation / Delayed / 0.4-1.6
    erythema / Early / Incidence not known
    constipation / Delayed / Incidence not known

    Mild

    injection site reaction / Rapid / 43.0-45.0
    urticaria / Rapid / Incidence not known
    pruritus / Rapid / Incidence not known
    rash / Early / Incidence not known
    alopecia / Delayed / Incidence not known

    DRUG INTERACTIONS

    There are no drug interactions associated with Fremanezumab products.

    PREGNANCY AND LACTATION

    Pregnancy

    There are no adequate data on the developmental risk associated with fremanezumab use during human pregnancy. Fremanezumab has a half-life of approximately 31 days, which should be taken into consideration for women who are pregnant or who intend to become pregnant while using the drug. No adverse developmental effects were observed when rabbits were given fremanezumab throughout organogenesis or when rats were given fremanezumab prior to and during mating and throughout pregnancy and lactation at doses associated with exposures approximately 2 to 3 times that in humans at a dose of 675 mg. Women with migraine may be at increased risk of preeclampsia during pregnancy.

    There are no data on the presence of fremanezumab 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 fremanezumab and any potential adverse effects on the breast-fed infant from fremanezumab or the underlying maternal condition.

    MECHANISM OF ACTION

    Fremanezumab is a human immunoglobulin G2 (IgG2) monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor. 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.[63169] [63551]

    PHARMACOKINETICS

    Fremanezumab is administered subcutaneously. Steady-state is achieved by 6 months after both monthly and quarterly dosing regimens. Fremanezumab has an apparent volume of distribution of 6 L, suggesting minimal distribution to extravascular tissues. Fremanezumab is degraded by enzymatic proteolysis into small peptides and amino acids. Fremanezumab apparent clearance is approximately 0.141 L/day. The half-life of fremanezumab is 31 days.[63551] Affected cytochrome P450 isoenzymes and drug transporters: none

    Subcutaneous Route

    After single fremanezumab doses of 225, 675, or 900 mg, the median Tmax was 5 to 7 days. Dose-proportionality was observed between 225 to 900 mg. The median accumulation ratio based on once-monthly and once-quarterly dosing regimens is approximately 2.3 and 1.2, respectively.