Aimovig Drug Information
Generic name: ERENUMAB-AOOE
Uses of Aimovig
is indicated for the preventive treatment of migraine in adults. AIMOVIG is a calcitonin gene-related peptide receptor antagonist indicated for the preventive treatment of migraine in adults.
Dosage & Administration of Aimovig
Recommended Dosing
The 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.
Important
Administration Instructions AIMOVIG 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 : Prior to subcutaneous administration, allow AIMOVIG to sit at room temperature for at least 30 minutes protected from direct sunlight.
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 . 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.
Side Effects of Aimovig
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. The safety of AIMOVIG has been evaluated in 2537 patients with migraine who received at least one dose of AIMOVIG, representing 3040.2 patient-years of exposure. Of these, 2271 patients were exposed to 70 mg or 140 mg once monthly for at least 6 months, 1305 patients were exposed for at least 12 months, and 216 patients were exposed through 5 years.
In placebo-controlled clinical studies (Studies 1, 2, and 3) of 2184 patients, 787 patients received at least one dose of AIMOVIG 70 mg once monthly, 507 patients received at least one dose of AIMOVIG 140 mg once monthly, and 890 patients received placebo during 3 months or 6 months of double-blind treatment . Approximately 84% were female, 91% were white, and the mean age was 42 years at study entry. The most common adverse reactions (incidence ≥ 3% and more often than placebo) in the migraine studies were injection site reactions and constipation. Table 1 summarizes the adverse reactions that occurred during the first 3 months in the migraine studies (Studies 1, 2, and 3). Table 1: Adverse Reactions Occurring with an Incidence of at Least 2% for Either Dose of AIMOVIG and at Least 2% Greater than Placebo During the First 3 Months in Studies 1, 2, and 3 Adverse Reaction AIMOVIG 70 mg Once Monthly N = 787 % AIMOVIG 140 mg Once Monthly N = 507 % Placebo N = 890 % Injection site reactions Injection site reactions include multiple adverse reactions related terms, such as injection site pain and injection site erythema., The rate of injection site reactions reported in Table 1 is with the prefilled syringe. 6 5 3 Constipation 1 3 1 Cramps, muscle spasms < 1 2 < 1 In Studies 1, 2, and 3, 1.3% of patients treated with AIMOVIG 70 mg or 140 mg discontinued double-blind treatment because of adverse events.
The most frequent injection site reactions were injection site pain, injection site erythema, and injection site pruritus.
Postmarketing Experience
The following adverse reactions have been identified during postapproval use of AIMOVIG. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune System Disorders: Hypersensitivity reactions, including rash, angioedema, and anaphylaxis. Gastrointestinal Disorders: Constipation with serious complications , oral mucosal ulceration.
Skin and Subcutaneous Tissue Disorders: Rash, alopecia. Vascular Disorders: Hypertension , Raynaud's Phenomenon.
Warnings & Cautions for Aimovig
Hypersensitivity Reactions Hypersensitivity 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 .
Constipation with Serious Complications Constipation 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 . Monitor patients treated with AIMOVIG for severe constipation and manage as clinically appropriate . 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.
Hypertension Development 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.
Raynaud's Phenomenon Development 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.
Pregnancy Safety for Aimovig
Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AIMOVIG during pregnancy. Patients should be encouraged to enroll by calling 1-833-244-4083 or visiting https://www.genesispregnancyregistry.com/. Risk Summary There are no adequate data on the developmental risk associated with the use of AIMOVIG in pregnant women. No adverse effects on offspring were observed when pregnant monkeys were administered erenumab-aooe throughout gestation.
Serum erenumab-aooe exposures in pregnant monkeys were greater than those in humans at clinical doses. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. The estimated rate of major birth defects (2.2%-2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine.
Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy. Data Animal Data In a study in which female monkeys were administered erenumab-aooe (0 or 50 mg/kg) twice weekly by subcutaneous injection throughout pregnancy (gestation day 20-22 to parturition), no adverse effects on offspring were observed. Serum erenumab-aooe exposures (AUC) in pregnant monkeys were approximately 20 times that in humans at a dose of 140 mg once monthly.
Pediatric Use of Aimovig
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
Contraindications for Aimovig
is contraindicated in patients with serious hypersensitivity to erenumab-aooe or to any of the excipients. Reactions have included anaphylaxis and angioedema . AIMOVIG is contraindicated in patients with serious hypersensitivity to erenumab-aooe or to any of the excipients.
Clinical Studies of Aimovig
Difference from placebo −1.4 −1.9 p- value < 0.001 < 0.001 ≥
50% MMD responders % Responders 43.3% 50.0% 26.6% Difference from placebo 16.7% 23.4% Odds ratio relative to placebo 2.1 2.8 p- value < 0.001 < 0.001 Monthly acute migraine-specific medication days Change from baseline −1.1 −1.6 −
Difference from placebo −0.9 −1.4 p- value < 0.001 < 0.001 Figure
1: Change from Baseline in Monthly Migraine Days in Study 1 Least-square means and 95% confidence intervals are presented. Figure 2 shows the distribution of change from baseline in mean monthly migraine days over months 4 to 6 in bins of 2 days by treatment group. A treatment benefit over placebo for both doses of AIMOVIG is seen across a range of changes from baseline in monthly migraine days.
Figure 2: Distribution of Change from Baseline in Mean Monthly Migraine Days Over Months 4 to 6 by Treatment Group in Study 1 Figure excludes patients with missing data. Compared to placebo, patients treated with AIMOVIG 70 mg once monthly and 140 mg once monthly showed greater reductions from baseline in mean monthly MPFID everyday activity scores averaged over months 4 to 6, and in mean monthly MPFID physical impairment scores averaged over months 4 to 6. Study 2 (NCT 02483585) was a randomized, multi-center, 3-month, placebo-controlled, double-blind study evaluating AIMOVIG for the preventive treatment of episodic migraine. A total of 577 patients with a history of episodic migraine were randomized to receive either AIMOVIG 70 mg (N = 286) or placebo (N = 291) by subcutaneous injection once monthly for 3 months.
Patients were allowed to use acute headache treatments including migraine-specific medications (i.e., triptans, ergotamine derivatives) and NSAIDs during the study. The study excluded patients with medication overuse headache as well as patients with myocardial infarction, stroke, transient ischemic attacks, unstable angina, coronary artery bypass surgery, or other revascularization procedures within 12 months prior to screening. The primary efficacy endpoint was the change from baseline in monthly migraine days at month 3. Secondary endpoints included the achievement of a ≥ 50% reduction from baseline in monthly migraine days ("≥ 50% MMD responders"), the change from baseline in monthly acute migraine-specific medication days at month 3, and the proportion of patients with at least a 5-point score reduction from baseline in MPFID at month 3. A total of 546 (95%) patients completed the 3-month double-blind study.
Patients had a median age of 43 years (range: 18 to 65 years), 85% were female, and 90% were white. Six to seven percent of patients were taking concomitant preventive migraine treatment. The mean migraine frequency at baseline was approximately 8 migraine days per month and was similar between treatment groups.
AIMOVIG treatment demonstrated statistically significant improvements for key efficacy endpoints compared to placebo, as summarized in Table 4. Table 4: Efficacy Endpoints at Month 3 for Study 2 AIMOVIG 70 mg Once Monthly Placebo N = 282 N = 288 Monthly Migraine Days (MMD) Change from baseline −2.9 −
Difference from placebo −1.0 p- value < 0.001 ≥ 50%
MMD responders % Responders 39.7% 29.5% Difference from placebo 10.2% Odds ratio relative to placebo 1.6 p- value 0.010 Monthly acute migraine-specific medication days Change from baseline −1.2 −
Difference from placebo −0.6 p- value 0.002 Figure 3: Change from Baseline
in Monthly Migraine Days in Study 2 Least-square means and 95% confidence intervals are presented. Figure 4 shows the distribution of change from baseline in monthly migraine days at month 3 in bins of 2 days by treatment group. A treatment benefit over placebo for AIMOVIG is seen across a range of changes from baseline in monthly migraine days.
Figure 4: Distribution of Change from Baseline in Monthly Migraine Days at Month 3 by Treatment Group in Study 2 Figure excludes patients with missing data. The pre-specified analysis for the MPFID was based on at least a 5-point reduction within-patient responder definition. AIMOVIG 70 mg once monthly was not significantly better than placebo for the proportion of responders for everyday activity and physical impairment.
In an exploratory analysis of the change from baseline in the mean MPFID scores at month 3, patients treated with AIMOVIG 70 mg, as compared to placebo, showed nominally greater reductions of physical impairment scores, but not of everyday activities scores. Figure 1 Figure 2 Figure 3 Figure 4 Chronic Migraine Study 3 (NCT 02066415) was a randomized, multi-center, 3-month, placebo-controlled, double-blind study evaluating AIMOVIG as a preventive treatment of chronic migraine. A total of 667 patients with a history of chronic migraine with or without aura were randomized to receive AIMOVIG 70 mg (N = 191), AIMOVIG 140 mg (N = 190), or placebo (N = 286) by subcutaneous injections once monthly for 3 months.
Patients were allowed to use acute headache treatments including migraine-specific medications (i.e., triptans, ergotamine derivatives) and NSAIDs during the study. The study excluded patients with medication overuse headache caused by opiate overuse and patients with concurrent use of migraine preventive treatments. Patients with myocardial infarction, stroke, transient ischemic attacks, unstable angina, coronary artery bypass surgery, or other revascularization procedures within 12 months prior to screening were also excluded.
The primary efficacy endpoint was the change from baseline in monthly migraine days at month 3. Secondary endpoints included the achievement of a ≥ 50% reduction from baseline in monthly migraine days ("≥ 50% MMD responders") and change from baseline in monthly acute migraine-specific medication days at month 3. A total of 631 (95%) patients completed the 3-month double-blind study. Patients had a median age of 43 years (range: 18 to 66 years), 83% were female, and 94% were white. The mean migraine frequency at baseline was approximately 18 migraine days per month and was similar across treatment groups.
AIMOVIG treatment demonstrated statistically significant improvements for key efficacy outcomes compared to placebo, as summarized in Table 5. Table 5: Efficacy Endpoints at Month 3 in Study 3 AIMOVIG 70 mg Once Monthly AIMOVIG 140 mg Once Monthly Placebo N = 188 N = 187 N = 281 Monthly Migraine Days (MMD) Change from baseline −6.6 −6.6 −
Difference from placebo −2.5 −2.5 p- value < 0.001 < 0.001 ≥
50% MMD responders % Responders 39.9% 41.2% 23.5% Difference from placebo 16.4% 17.7% Odds ratio relative to placebo 2.2 2.3 p- value < 0.001 < 0.001 Monthly acute migraine-specific medication days Change from baseline −3.5 −4.1 −
Difference from placebo −1.9 −2.6 p- value < 0.001 < 0.001 Figure
5: Change from Baseline in Monthly Migraine Days in Study 3 Least-square means and 95% confidence intervals are presented. Figure 6 shows the distribution of change from baseline in monthly migraine days at month 3 in bins of 3 days by treatment group. A treatment benefit over placebo for both doses of AIMOVIG is seen across a range of changes from baseline in migraine days.
Figure 6: Distribution of Change from Baseline in Monthly Migraine Days at Month 3 by Treatment Group in Study 3 Figure excludes patients with missing data. Figure 5 Figure 6
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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