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Evenity is a brand name for Romosozumab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: EVENITY is indicated in treatment of severe osteoporosis in postmenopausal women at high risk of fracture (see section 5.1).
Verbatim from this product's EMA label. Tap a section to expand.
Treatment should be initiated and supervised by specialist physicians experienced in the management of osteoporosis. Posology The recommended dose is 210 mg romosozumab (administered as two subcutaneous injections of 105 mg each) once monthly for 12 months.
4). Patients treated with EVENITY should be given the package leaflet and the patient alert card. Draft 3 Following completion of romosozumab therapy, transition to antiresorptive therapy is recommended in order to extend the benefit achieved with romosozumab beyond 12 months.
Missed doses If the romosozumab dose is missed, it should be administered as soon as it can be feasible. Thereafter, the next romosozumab dose should not be given earlier than one month after the last dose. 2). 2). 4). 2). Paediatric population The safety and efficacy of romosozumab in paediatric patients (age <18 years) have not yet been established.
No data are available. Method of administration Subcutaneous use To administer the 210 mg dose, 2 subcutaneous injections of romosozumab should be given into the abdomen, thigh, or upper arm. The second injection should be given immediately after the first one, but at a different injection site.
Administration should be performed by an individual who has been trained in injection techniques. 6.
4%). 7% of patients treated with romosozumab. 4% of patients treated with romosozumab). 4 and information below). Tabulated list of adverse reactions The following convention has been used for the classification of the adverse reactions: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000).
Within each frequency grouping and system organ class, adverse reactions are presented in order of decreasing seriousness. Draft 6 MedDRA System Organ Class Adverse reaction Frequency category Infections and infestations Nasopharyngitis Very common Sinusitis Common Immune system disorders Hypersensitivitya Rash Dermatitis Urticaria Angioedema Erythema multiforme Common Common Common Uncommon Rare Rare Metabolism and nutrition disorders Hypocalcaemiab Uncommon Nervous system disorders Headache Common Strokec Uncommon Eye disorders Cataract Uncommon Cardiac disorders Myocardial infarctionc Uncommon Musculoskeletal and connective tissue disorders Arthralgia Very common Neck pain Common Muscle spasms Common General disorders and administration site conditions Injection site reactionsd Common a.
4. b. Defined as albumin adjusted serum calcium that was below the lower limit of normal. 4. c. See section “Myocardial infarction and stroke” below. d. Most frequent injection site reactions were pain and erythema. 9% (58 of 6244) for neutralizing antibodies.
The earliest onset of anti-romosozumab antibodies was 3 months after first dosing. The majority of antibody responses were transient. The presence of anti-romosozumab binding antibodies decreased romosozumab exposure by up to 25%. No impact on the efficacy of romosozumab was observed in the presence of antiromosozumab antibodies.
Limited safety data show that the incidence of injection site reactions was numerically higher in female patients with neutralizing antibodies. 3%) in the alendronate arm. These events occurred in patients with and without a history of myocardial infarction or stroke.
8). 3). g. established cardiovascular disease, hypertension, hyperlipidaemia, diabetes mellitus, smoking, severe renal impairment, age). Romosozumab should only be used if the prescriber and patient agree that the benefit outweighs the risk.
If a patient experiences a myocardial infarction or stroke during therapy, treatment with romosozumab should be discontinued. Draft 4 Hypocalcaemia Transient hypocalcaemia has been observed in patients receiving romosozumab. Hypocalcaemia should be corrected prior to initiating therapy with romosozumab and patients should be monitored for signs and symptoms of hypocalcaemia.
8), calcium levels should be measured. 8). 73 m2) or receiving dialysis are at greater risk of developing hypocalcaemia and the safety data for these patients is limited. Calcium levels should be monitored in these patients. Hypersensitivity Clinically significant hypersensitivity reactions, including angioedema, erythema multiforme, and urticaria occurred in the romosozumab group in clinical trials.
8). Osteonecrosis of the jaw Osteonecrosis of the jaw (ONJ), has been reported rarely in patients receiving romosozumab. The following risk factors should be considered when evaluating a patient’s risk of developing ONJ: - potency of the medicinal product that inhibits bone resorption (the risk increases with the antiresorptive potency of the compound), and cumulative dose of antiresorptive therapy.
g. anaemia, coagulopathies, infection), smoking. - concomitant therapies: corticosteroids, chemotherapy, angiogenesis inhibitors, radiotherapy to head and neck. g. tooth extractions. All patients should be encouraged to maintain good oral hygiene, receive routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling or non-healing of sores or discharge during treatment with romosozumab.
Patients who are suspected of having or who develop ONJ while on romosozumab should receive care by a dentist or an oral surgeon with expertise in ONJ. Discontinuation of romosozumab therapy should be considered until the condition resolves and contributing risk factors are mitigated where possible.
4)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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6%) women in the alendronate group. 14]) for romosozumab compared to alendronate. 1%) women in the alendronate group. 8%) in the placebo group. 7%) women in the placebo group. Draft 7 Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Atypical femoral fractures Atypical low-energy or low trauma fracture of the femoral shaft, which can occur spontaneously, has been reported rarely in patients receiving romosozumab. Any patient who presents with new or unusual thigh, hip, or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture.
Patient presenting with an atypical femur fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Interruption of romosozumab therapy should be considered, based on an individual benefit-risk assessment.
070 mg of polysorbate 20 in each pre-filled pen and each pre-filled syringe. Polysorbates may cause allergic reactions. This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium-free.
Draft 5