Ajovy (Fremanezumab-Vfrm) Injection [Teva Pharmaceuticals Usa, Inc.]

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 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)].

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)]

Hypersensitivity Reactions: Most reactions were reported from within hours to one month after administration. If hypersensitivity occurs, consider discontinuing AJOVY and institute appropriate therapy. (5.1)Constipation with Serious Complications: Serious complications of constipation may occur. (5.2)Hypertension: New-onset or worsening of pre-existing hypertension may occur. (5.3)Raynaud's Phenomenon: New-onset or worsening of pre-existing Raynaud’s phenomenon may occur. (5.4)5.1 Hypersensitivity ReactionsHypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria, were reported with AJOVY in clinical trials. Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment. Most reactions were reported from within hours to one month after administration. Cases of anaphylaxis and angioedema have been reported in the postmarketing setting.If a hypersensitivity reaction occurs, consider discontinuing AJOVY, and institute appropriate therapy [see Contraindications (4)].5.2 Constipation with Serious ComplicationsConstipation with serious complications has been reported following the use of monoclonal antibody CGRP antagonists, including AJOVY, in the postmarketing setting. There were cases with monoclonal antibody CGRP antagonists that required hospitalization, including cases where surgery was necessary. In a majority of these cases, the onset of constipation was reported after the first dose; however, patients have also presented with constipation later in treatment. The monoclonal antibody CGRP antagonist was discontinued in many of the reported cases of constipation with serious complications. Monitor patients treated with AJOVY for severe constipation and manage as clinically appropriate [see Patient Counseling Information (17)]. The concurrent use of medications that reduce gastrointestinal motility may increase the risk for more severe constipation and the potential for constipation-related complications.5.3 HypertensionDevelopment of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including AJOVY, in the postmarketing setting. Some of the patients who developed new-onset hypertension had risk factors for hypertension. There were cases requiring initiation of pharmacological treatment for hypertension and, in some cases, hospitalization. Hypertension may occur at any time during treatment, but was most frequently reported within 7 days of therapy initiation. AJOVY was discontinued in many of the reported cases. Monitor patients treated with AJOVY for new-onset hypertension or worsening of pre-existing hypertension, and consider whether discontinuation of AJOVY is warranted if evaluation fails to establish an alternative etiology or blood pressure is inadequately controlled.5.4 Raynaud's PhenomenonDevelopment of Raynaud’s phenomenon and recurrence or worsening of pre-existing Raynaud’s phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists, including AJOVY. In reported cases with monoclonal antibody CGRP antagonists, symptom onset occurred a median of 71 days following dosing. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain.In most reported cases, discontinuation of the CGRP antagonist resulted in resolution of symptoms.AJOVY should be discontinued if signs or symptoms of Raynaud’s phenomenon develop and patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of Raynaud’s phenomenon should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms.

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 DosageAdultsThe 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 years of age and who weigh 45 kg or more is administered by subcutaneous injection as follows:225 mg monthly.AJOVY is not approved in pediatric patients weighing less than 45 kg because of the lack of an appropriate strength presentation [see Clinical Studies (14) and How Supplied/Storage and Handling (16.1)].Missed DoseIf a dose of AJOVY is missed, administer as soon as possible. Thereafter, AJOVY can be scheduled from the date of the last dose.2.2 Important Administration InstructionsAJOVY is for subcutaneous use only.AJOVY may be administered by healthcare providers, patients 13 years of age and older, and/or caregivers. In pediatric patients 6 to 12 years of age, AJOVY must be administered by a healthcare provider or adult caregiver. Prior to use, provide proper training to patients and/or caregivers on the preparation and administration of AJOVY prefilled syringe, including aseptic technique [see Instructions for Use]: Remove AJOVY from the refrigerator. Prior to use, allow AJOVY 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 AJOVY if it has been at room temperature for 7 days or longer [see How Supplied/Storage and Handling (16.2)]. Follow aseptic injection technique every time AJOVY is administered.Inspect AJOVY for particles or discoloration prior to administration [see Dosage Forms and Strengths (3)]. Do not use if the solution is cloudy, discolored, or contains particles. Administer AJOVY by subcutaneous injection into areas of the abdomen, thigh, or upper arm that are not tender, bruised, red, or indurated. For multiple injections, you may use the same body site, but not the exact location of the previous injection.Do not co-administer AJOVY with other injectable drugs at the same injection site.

AdultsThe 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 years of age and who weigh 45 kg or more is administered by subcutaneous injection as follows:225 mg monthly.AJOVY is not approved in pediatric patients weighing less than 45 kg because of the lack of an appropriate strength presentation [see Clinical Studies (14) and How Supplied/Storage and Handling (16.1)].Missed DoseIf a dose of AJOVY is missed, administer as soon as possible. Thereafter, AJOVY can be scheduled from the date of the last dose.

AJOVY is a sterile, clear to opalescent, colorless to slightly yellow solution, available as follows:Injection: 225 mg/1.5 mL single-dose prefilled autoinjectorInjection: 225 mg/1.5 mL single-dose prefilled syringe

Source: DailyMed, U.S. National Library of Medicine. Additional information compiled from online sources.