Dosing & Uses
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
Adverse Effects
1-10%
Injection site pain (5%)
Postmarketing Reports
Immune system disorders: Anaphylactic reactions and angioedema
Warnings
Contraindications
History of serious hypersensitivity reactions to drug or excipients
Cautions
Use caution in patients with cardiovascular disease; not studied
Hypersensitivity reactions
- Cases of anaphylaxis, angioedema, 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
Pregnancy
There is pregnancy exposure registry that monitors pregnancy outcomes in women exposed to drug during pregnancy; healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in registry by calling 1-833-927-2605 or visiting www.tevamigrainepregnancyregistry.com
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.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
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
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Ajovy Syringe subcutaneous - | 225 mg/1.5 mL solution |  | |
| Ajovy Autoinjector subcutaneous - | 225 mg/1.5 mL syringe |  |
Copyright © 2010 First DataBank, Inc.
Formulary
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.
