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AJOVY is a brand name for Fremanezumab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: PrAJOVY® (fremanezumab solution for subcutaneous injection) is indicated for: • the prevention of migraine in adults who have at least 4 migraine days per month. • the prevention of episodic migraine (fewer than 15 migraine days per month) in pediatric patients aged 6 to 17 years and weighing at least 45 kg. AJOVY…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations AJOVY is administered subcutaneously through single dose prefilled syringes or single dose prefilled autoinjectors. AJOVY may be self-administered by patients 13 years of age and older, or administered by healthcare professionals and/or adult caregivers.
In pediatric patients 6 to 12 years of age, AJOVY must be administered by a healthcare professional or adult caregiver. Administration should be performed by an individual who has been trained to administer the product. 2 Recommended Dose and Dosage Adjustment • Adults Two subcutaneous dosing options of AJOVY are available to administer the recommended dosage (See Clinical Trials): • 225 mg (1 subcutaneous injection) once a month (monthly dosing), or • 675 mg (3 separate subcutaneous injections of 225 mg one after another) every 3 months (quarterly dosing).
The dose regimen must be followed as prescribed. Patients should be advised that monthly dosing consists of a single subcutaneous injection. When switching dosage options, the first dose of the new regimen should be given on the next scheduled dosing date of the prior regimen.
• Pediatrics (6 to 17 years of age) and weighing at least 45 kg The recommended dosage in pediatric patients aged 6 to 17 years, weighing at least 45 kg is: - 225 mg (1 subcutaneous injection) once a month (monthly dosing) Do not administer AJOVY to pediatric patients weighing less than 45 kg as an appropriate strength presentation is not available.
(see CLINICAL TRIALS). For both adult and pediatric patients, the treatment benefit should be assessed within 3 months after initiation of the treatment. Any further decision to continue treatment should be taken on an individual patient basis.
Evaluation of the need to continue treatment is recommended regularly thereafter. (See CLINICAL TRIALS). 4 Administration AJOVY is for subcutaneous use only. AJOVY may be administered by healthcare professionals, patients and/or caregivers.
Only healthcare professionals and/or caregivers may administer AJOVY to pediatric patients aged 12 years and younger. Prior to use, provide proper training to patients and/or caregivers on the preparation and administration of AJOVY prefilled syringe or prefilled autoinjector, including aseptic technique [see respective Instructions for Use].
1 Adverse Reaction Overview Adults Hypersensitivity reactions, including rash, pruritus and urticaria were reported with fremanezumab in less than 1% of patients 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. Hypersensitivity reactions, including urticaria, pruritus, rash and swelling/edema have also been reported with fremanezumab in post-marketing experience.
Very common reported adverse drug reactions (ADRs) from the clinical trials were local reactions at the injection site pain, induration, erythema and pruritus. The adverse reactions that most commonly led to discontinuations were injection site reactions.
Pediatrics No new clinical trial safety findings were noted for AJOVY use in the pediatric population compared to the known safety profile from the adult clinical trials. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
Therefore, the frequencies of adverse reactions observed in the clinical trials may not reflect frequencies observed in clinical practice and should not be compared to frequencies reported in clinical trials of another drug. The safety of AJOVY was evaluated in 2512 adult patients with migraine who received at least one dose of AJOVY 225 mg monthly or AJOVY 675 mg quarterly for at least six months; 775 patients for at least 12 months; and 138 patients for at least 15 months.
In placebo- controlled clinical trials (Studies 1 and 2), 662 patients received AJOVY 225 mg monthly for 12 weeks (with or without a loading dose of 675 mg), and 663 patients received AJOVY 675 mg quarterly for 12 weeks (See CLINICAL TRIALS) .
In the controlled trials, 87% of patients were female, 80% were White, and the mean age was 41 years. The most common adverse reactions in the clinical trials for the preventive treatment of migraine were injection site reactions. The adverse reactions that most commonly led to discontinuations were injection site reactions.
Cardiovascular No safety data are available in these populations. Patients with significant cardiovascular disease, vascular ischemia, or thrombotic events, such as cerebrovascular accident, transient ischemic attacks, deep vein thrombosis, or pulmonary embolism were excluded from the clinical trials.
(See CLINICAL TRIALS). Hepatic/Biliary/Pancreatic/Renal No safety data are available in these populations. Fremanezumab as a monoclonal antibody is not expected to undergo hepatic metabolism or renal clearance. 73 m2) have not been studied in AJOVY clinical trials.
(See CLINICAL TRIALS). Sensitivity/Resistance Serious hypersensitivity reactions, including rash, angioedema, and anaphylactic reactions, were reported with the CGRP- class products including AJOVY in clinical trials and in post- market experience.
These reactions may occur within minutes, although some may occur up to one month after administration. If a hypersensitivity reaction occurs, consider discontinuing AJOVY, and institute appropriate therapy. 1 Pregnancy There are no adequate data on the developmental risk associated with the use of AJOVY in pregnant individuals.
AJOVY has a long half-life (see CLINICAL PHARMACOLOGY). This should be taken into consideration for individuals who are pregnant or plan to become pregnant while using AJOVY. (See Non-Clinical Toxicology). 2 Breast-feeding It is unknown if the drug is excreted in human milk.
Because many drugs are excreted in human milk, precaution should be exercised. There are no data on the presence of fremanezumab in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for AJOVY and any potential adverse effects on the breastfed infant from AJOVY or from the underlying maternal condition.
AJOVY (fremanezumab) is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, (see DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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• 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 STORAGE, STABILITY AND DISPOSAL). • Follow aseptic injection technique every time AJOVY is administered. Inspect AJOVY for particles or discolouration prior to administration. Do not use if the solution is cloudy, discoloured, or contains particles.
(See DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING). • 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.
5 Missed Dose If an AJOVY injection is missed on the planned date, the missed dose should be administered as soon as possible. The regular dosing regimen should resume from the new dosing day. A double dose must not be administered to make up for a missed dose.
5 OVERDOSE In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse effects and given appropriate symptomatic treatment if necessary. For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669).
Patients with significant cardiovascular disease, vascular ischemia, or thrombotic events, such as cerebrovascular accident, transient ischemic attacks, deep vein thrombosis, or pulmonary embolism were excluded from the clinical trials.
(See CLINICAL TRIALS) Table 2: Adverse Reactions Occurring with an Incidence of ≥ 1% and Greater Than Placebo in Episodic and Chronic Migraine Studies System Organ Class Preferred Term AJOVY 225 mg monthly N=290 AJOVY 675 mg quarterly N=667 Placebo N=668 Injection site reactions* 43 % 45 % 38 % *Injection site reactions include multiple related adverse event terms, such as injection site pain, induration, and erythema Table 3: Treatment Emergent adverse events occurring with an incidence of ≥1% in the Placebo Controlled Studies System Organ Class Preferred Term AJOVY 225 mg monthly N=290 n= (%) AJOVY 675 mg quarterly N=667 n= (%) Placebo N=668 n= (%) Patients with at least 1 AE 192 (66) 458 (69) 411 (62) System Organ Class Preferred Term AJOVY 225 mg monthly N=290 n= (%) AJOVY 675 mg quarterly N=667 n= (%) Placebo N=668 n= (%) Gastrointestinal Disorders Nausea 4 (1) 11 (2) 16 (2) Diarrhoea 2 (<1) 5 (<1) 8 (1) General disorders and administration site conditions Injection site pain 87 (30) 200 (30) 180 (27) Injection site induration 71 (24) 131 (20) 113 (17) Injection site erythema 52 (18) 135 (20) 101 (15) Injection site haemorrhage 3 (1) 16 (2) 16 (2) Injection site pruritus 4 (1) 10 (1) 2 (<1) Fatigue 2 (<1) 9 (1) 9 (1) Injection site rash 3 (1) 5 (<1) 0 Injection site swelling 3 (1) 4 (<1) 0 Infections and infestations Upper respiratory tract infection 16 (6) 29 (4) 30 (4) Nasopharyngitis 11 (4) 30 (4) 29 (4) Urinary tract infection 7 (2) 14 (2) 11 (2) Bronchitis 6 (2) 9 (1) 6 (<1) Sinusitis 4 (1) 12 (2) 18 (3) Influenza 2 (<1) 8 (1) (1) Gastroenteritis 4 (1) 4 (<1) 5 (<1) Cystitis 3 (1) 1 (<1) 1 (<1) System Organ Class Preferred Term AJOVY 225 mg monthly N=290 n= (%) AJOVY 675 mg quarterly N=667 n= (%) Placebo N=668 n= (%) Herpes zoster 3 (1) 0 1 (<1) Injury, poisoning and procedural complications Ligament sprain 1 (<1) 3 (<1) 2 (<1) Investigations Blood creatine phosphokinase increased 1 (<1) 3 (<1) 7 (1) Alanine aminotransferase increased 1 (<1) 3 (<1) 1 (<1) Aspartate aminotransferase increased 1 (<1) 3 (<1) 1 (<1) Musculoskeletal and connective tissue disorders Back pain 3 (1) 11 (2) 9 (1) Musculoskeletal pain 3 (1) 4 (<1) 0 Arthralgia 3 (1) 2 (<1) 1 (<1) Nervous system disorders Dizziness 3 (1) 9 (1) 9 (1) Paraesthesia 2 (<1) 9 (1) 4 (<1) Migraine 1 (<1) 6 (<1) 11 (2) Respiratory, thoracic and mediastinal disorders Cough 1 (<1) 8 (1) 6 (<1) Skin and subcutaneous tissue disorders Pruritus 0 8 (1) 1 (<1) Injection site reactions The most frequently observed local reactions at the injection site were pain, induration and erythema.
Most local injection site reactions were transient and predominantly mild to moderate in severity. Pain, induration and erythema were typically observed immediately after injection while pruritus and rash appeared within a median of 24 and 48 hours, respectively.
Most injection site reactions resolved, generally within a few hours or days. If the intensity of Injection site reactions is severe, discontinuation of fremanezumab should be considered. 1 Clinical Trial Adverse Reactions – Pediatrics Over 400 pediatric patients with migraine, 6 to 17 years of age, have been treated with AJOVY in registration studies.
This included 123 pediatric patients in the placebo-controlled trial with episodic migraine (EM). The only adverse reactions of AJOVY observed in this study were injection site reactions, which is similar to the overall safety profile observed in adult clinical studies.
The injection site reactions reported were injection site erythema, injection site pain, and injection site swelling. Table 4 summarizes adverse reactions reported in the 3- month […]
3 Pediatrics Episodic migraine Safety and efficacy of AJOVY in patients aged 6-17 years and older, suffering from episodic migraine and weighing at least 45 kg have been established, and are similar to the safety and efficacy profile seen in clinical trials in adults with migraine.
The safety and efficacy of AJOVY in children below 6 years of age have not been established. Chronic migraine The safety and efficacy of AJOVY in pediatric patients (<18 years of age) with chronic migraine have not been established.
Bone growth and development (pediatrics):
Longterm effects of CGRP pathway inhibition on skeletal growth and maturation in children are unknown. , height/weight; Tanner staging); however, clinical exposure is limited in duration, which may be insufficient to detect delayed changes.
, height z-scores and Tanner staging), and reassess therapy if concerns arise. 4 Geriatrics Geriatrics (≥ 65 years of age): Clinical studies of AJOVY did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.