Aimovig (Erenumab-Aooe) Injection, Solution [Amgen, Inc]

AIMOVIG is indicated for the preventive treatment of migraine in adults.

AIMOVIG is contraindicated in patients with serious hypersensitivity to erenumab-aooe or to any of the excipients. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.1)].

The following serious adverse reactions are described below and elsewhere in 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: If a serious hypersensitivity reaction occurs, discontinue administration of AIMOVIG and initiate appropriate therapy. Hypersensitivity reactions can occur within hours to more than one week after administration. (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, angioedema, and anaphylaxis, have been reported with AIMOVIG in postmarketing experience. Most hypersensitivity reactions were not serious and occurred within hours of administration, although some occurred more than one week after administration. If a serious or severe hypersensitivity reaction occurs, discontinue administration of AIMOVIG and initiate appropriate therapy [see Contraindications (4), and Patient Counseling Information (17)].5.2 Constipation with Serious ComplicationsConstipation with serious complications has been reported following the use of AIMOVIG in the postmarketing setting. There were cases 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 of AIMOVIG; however, patients have also presented with constipation later on in treatment. AIMOVIG was discontinued in most reported cases of constipation with serious complications. Constipation was one of the most common (up to 3%) adverse reactions reported in clinical studies [see Adverse Reactions (6.1)].Monitor patients treated with AIMOVIG for severe constipation and manage as clinically appropriate [see Patient Counseling Information (17)]. The concurrent use of medications associated with decreased 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 AIMOVIG in the postmarketing setting. Many of the patients had pre-existing hypertension or risk factors for hypertension. There were cases requiring pharmacological treatment and, in some cases, hospitalization. Hypertension may occur at any time during treatment but was most frequently reported within seven days of dose administration. In the majority of the cases, the onset or worsening of hypertension was reported after the first dose. AIMOVIG was discontinued in many of the reported cases.Monitor patients treated with AIMOVIG for new-onset hypertension, or worsening of pre-existing hypertension, and consider whether discontinuation of AIMOVIG is warranted if evaluation fails to establish an alternative etiology.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 AIMOVIG. 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.AIMOVIG 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 (2.1, 2.2)Recommended dosage is 70 mg once monthly; some patients may benefit from a dosage of 140 mg once 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 DosingThe recommended dosage of AIMOVIG is 70 mg injected subcutaneously once monthly. Some patients may benefit from a dosage of 140 mg injected subcutaneously once monthly.If a dose of AIMOVIG is missed, administer as soon as possible. Thereafter, AIMOVIG can be scheduled monthly from the date of the last dose.2.2 Important Administration InstructionsAIMOVIG is for subcutaneous use only.AIMOVIG is intended for patient self-administration. Prior to use, provide proper training to patients and/or caregivers on how to prepare and administer AIMOVIG using the single-dose prefilled autoinjector or single-dose prefilled syringe, including aseptic technique [see Instructions for Use]:Prior to subcutaneous administration, allow AIMOVIG to sit at room temperature for at least 30 minutes protected from direct sunlight [see How Supplied/Storage and Handling (16.2)]. This is important for administering the entire dose and helps minimize discomfort. Do not warm by using a heat source such as hot water or a microwave. Do not shake the product. Inspect visually for particulate matter and discoloration prior to administration [see Dosage Forms and Strengths (3)]. Do not use if the solution is cloudy or discolored or contains flakes or particles. Administer AIMOVIG in the abdomen, thigh, or upper arm subcutaneously. Do not inject into areas where the skin is tender, bruised, red, or hard. Both prefilled autoinjector and prefilled syringe are single-dose and deliver the entire contents.

AIMOVIG is a sterile, clear to opalescent, colorless to light yellow solution available as follows: Injection: 70 mg/mL in a single-dose prefilled SureClick® autoinjector Injection: 140 mg/mL in a single-dose prefilled SureClick® autoinjector Injection: 70 mg/mL in a single-dose prefilled syringe Injection: 140 mg/mL in a single-dose prefilled syringe

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