AJOVY 225 mg/1.5mL
fremanezumab-vfrm · INJECTION · Teva Pharmaceuticals USA, Inc.
AJOVY is a injection containing fremanezumab-vfrm at 225 mg/1.5mL, taken subcutaneous. Manufactured by Teva Pharmaceuticals USA, Inc..
Key Facts
- Brand Name
- AJOVY
- Generic Name
- fremanezumab-vfrm
- NDC Code (Product)
51759-202- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Strength
- 225 mg/1.5mL
- Dosage Form
- INJECTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- BLA761089
- Marketing Start
- 03/29/2020
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE AJOVY is indicated for: the preventive treatment of migraine in adults, and the preventive treatment of episodic migraine in pediatric patients who are 6 to 17 years of age and who weigh 45 kg or more. AJOVY is a calcitonin gene-related peptide antagonist indicated for: the preventive treatment of migraine in adults, and the preventive treatment of episodic migraine in pediatric patients who are 6 to 17 years of age and who weigh 45 kg or more. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For subcutaneous use only. Recommended dosage: Adults : Two subcutaneous dosing options of AJOVY are available to administer the recommended dosage; 225 mg monthly or 675 mg every 3 months (quarterly). The 675 mg quarterly dosage is administered as three consecutive injections of 225 mg each. ( 2.1 ) Pediatric patients 6 to 17 years of age and who weigh 45 kg or more : 225 mg monthly ( 2.1 ) Administer in the abdomen, thigh, or upper arm subcutaneously. ( 2.2 ) See Dosage and Administration for important administration instructions. ( 2.2 ) 2.1 Recommended Dosage Adults The recommended dosage in adults for the preventive treatment of migraine is administered by subcutaneous injection as one of the following options: 225 mg monthly, or 675 mg every 3 months (quarterly), which is administered as three consecutive subcutaneous injections of 225 mg each. When switching dosage options, administer the first dose of the new regimen on the next scheduled date of administration. Pediatric Patients who are 6 to 17 Years of Age and who Weigh 45 kg or More: The recommended dosage for the preventive treatment of episodic migraine in pediatric patients who are 6 to 17…
Contraindications
4 CONTRAINDICATIONS AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions ( 5.1 )]. AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Constipation with Serious Complications [see Warnings and Precautions ( 5.2 )] Hypertension [see Warnings and Precautions ( 5.3 )] Raynaud’s Phenomenon [see Warnings and Precautions ( 5.4 )] The most common adverse reactions (≥5% and greater than placebo) were injection site reactions. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in clinical practice. Adults The safety of AJOVY was evaluated in 2512 patients with migraine who received at least 1 dose of AJOVY, representing 1279 patient-years of exposure. Of these, 1730 patients were exposed to AJOVY 225 mg monthly or AJOVY 675 mg quarterly for at least…
Frequently Asked Questions
What is AJOVY used for?
AJOVY contains fremanezumab-vfrm. It is a injection taken subcutaneous. Consult your doctor for specific uses.
Is AJOVY a controlled substance?
AJOVY is not classified as a controlled substance by the DEA.
What is the generic name for AJOVY?
The generic name for AJOVY is fremanezumab-vfrm. There are no other listed brand versions of fremanezumab-vfrm.
What is the NDC code for AJOVY 225 mg/1.5mL?
The NDC (National Drug Code) for AJOVY 225 mg/1.5mL is 51759-202, listed by Teva Pharmaceuticals USA, Inc..
Other AJOVY Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)