Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Prefilled Syringe, Subcutaneous [preservative free]:
Ajovy: fremanezumab-vfrm 225 mg/1.5 mL (1.5 mL) [contains edetate disodium dihydrate, polysorbate 80]
Mechanism of Action
Fremanezumab is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.
Vd: ~6 L
Degraded by enzymatic proteolysis into small peptides and amino acids
Clearance: 0.141 L/day
Time to Peak
5 to 7 days
Use: Labeled Indications
Migraine prophylaxis: Preventive treatment of migraine in adults
Serious hypersensitivity to fremanezumab or any component of the formulation
Dosage and Administration
Migraine prophylaxis: SubQ: 225 mg monthly or 675 mg every 3 months. When switching dosage options, administer the first dose of the new regimen on the next scheduled date of administration.
Refer to adult dosing.
SubQ: For subcutaneous use only. Keep out of direct sunlight and allow prefilled syringe to come to room temperature for 30 minutes before administration. Do not warm by using a heat source (eg, hot water, microwave). Do not shake. Administer in the abdomen, thigh, or upper arm, avoiding areas that are tender, bruised, red, or indurated. The 675 mg dose should be administered as 3 consecutive 225 mg injections. For multiple injections, use the same body site, but not the exact location of the previous injection.
Store at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. If necessary, may keep in the original carton at room temperature up to 25°C (77°F) for a maximum of 24 hours. Do not expose to extreme heat or direct sunlight. After removal from the refrigerator, administer within 24 hours or discard.
There are no known significant interactions.
>10%: Local: Injection site reaction (43% to 45%)
1% to 10%: Immunologic: Antibody development (≤2%; neutralizing <1%)
Frequency not defined: Hypersensitivity: Hypersensitivity reaction
Concerns related to adverse effects:
- Hypersensitivity: Hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria, have been reported. Most reactions were mild to moderate and were reported from within hours to 1 month after administration. If a hypersensitivity reaction occurs, consider discontinuing treatment and institute appropriate therapy.
- Cardiovascular disease: Patients with a history of significant cardiovascular disease, vascular ischemia, or thrombotic events, such as cerebrovascular accident, transient ischemic attacks, deep vein thrombosis, or pulmonary embolism were excluded from clinical trials; use with caution in these patients.
Dosage form specific issues:
- Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.
- Immunogenicity: Anti-fremanezumab antibodies and neutralizing antibodies may develop.
Number of monthly migraine days.
Adverse events were not observed in animal reproduction studies.
Fremanezumab is a humanized monoclonal antibody (IgG2). Potential placental transfer of human IgG is dependent upon the IgG subclass and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009).
Consider the long half-life prior to use in females who are or may become pregnant until information related to pregnancy is available (Tepper 2018).
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Have patient report immediately to prescriber severe injection site irritation (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.