fremanezumab (Rx)

Brand and Other Names:Ajovy, fremanezumab-vfrm
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 225mg/1.5mL (single-dose prefilled syringe or autoinjector)

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

Dosage Modifications

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

Renal impairment

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

Safety and efficacy not established

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Adverse Effects

1-10%

Injection site pain (5%)

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Warnings

Contraindications

History of serious hypersensitivity reactions to drug or excipients

Cautions

Use caution in patients with cardiovascular disease; not studied

Hypersensitivity reactions

  • 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

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Pregnancy

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 and gestational hypertension 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

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

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

Absorption

Peak plasma time: 5-7 days

Time to steady state: 168 days (~6 months)

Distribution

Vd: ~6 L

Metabolism

Enzymatic proteolysis

Elimination

Half-life: ~31 days

Clearance: ~0.141 L/day

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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

Do not coadminister with other injectable drugs at same injection site

Missed dose

  • If dose missed, administer as soon as possible
  • Thereafter, reschedule dose from date of last dose

Storage

Refrigerate at 2-8°C (36-46°F) in original carton to protect from light

If necessary, keep in original carton at room temperature (up to 25°C [77°F]) for up to 24 hr or discard

Do not freeze; do not shake

Do not expose to extreme heat or direct sunlight

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Images

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.