Evenity Special Precautions

Hypocalcaemia: Transient hypocalcaemia has been observed in patients receiving romosozumab (EVENITY). Correct hypocalcaemia prior to initiating therapy with romosozumab (EVENITY) (see Contraindications and Adverse Reactions).
Monitor patients for signs and symptoms of hypocalcaemia. Patients should be adequately supplemented with calcium and vitamin D (see Pharmacology: Pharmacodynamics: Clinical trials under Actions).
Hypersensitivity: Clinically significant hypersensitivity reactions, including angioedema, erythema multiforme, and urticaria occurred in the romosozumab (EVENITY) group in clinical trials. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of romosozumab (EVENITY) (see Contraindications and Adverse Reactions).
Myocardial infarction and stroke: In two large, controlled fracture trials of romosozumab (EVENITY) for the treatment of osteoporosis in postmenopausal women, cardiovascular events of myocardial infarction (MI) and stroke were prospectively adjudicated.
During the 12-month double-blind treatment period of the active-controlled trial (ARCH), MI occurred in 16 women (0.8%) in the romosozumab (EVENITY) arm and 5 (0.2%) in the alendronate arm; stroke occurred in 13 women (0.6%) in the romosozumab (EVENITY) arm and 7 (0.3%) in the alendronate arm. These events occurred in patients with and without a history of MI or stroke.
During the 12-month double-blind treatment period of the placebo-controlled trial (FRAME), MI occurred in 9 women (0.3%) in the romosozumab (EVENITY) arm and 8 (0.2%) in the placebo arm; stroke occurred in 8 women (0.2%) in the romosozumab (EVENITY) arm and 10 (0.3%) in the placebo arm. These events occurred in patients with and without a history of MI or stroke.
A causal relationship between romosozumab (EVENITY) and these events has not been established. In both trials, most participants had common risk factors for cardiovascular disease, and within each trial, cardiovascular risk factors were balanced between treatment arms. Romosozumab (EVENITY) should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year.
Consider the benefit-risk in patients at increased risk for MI or stroke. Patients should be instructed to watch for symptoms of MI and stroke and to seek prompt medical attention if symptoms occur.
Cardiovascular risk factors should be assessed by the treating physician prior to treatment. A patient's suitability for treatment should be based on individual benefit-risk assessment.
In patients at high cardiovascular risk, consider relative benefits and risks of treatment. If a patient experiences a myocardial infarction or stroke during therapy, romosozumab (EVENITY) should be discontinued.
Osteonecrosis of the jaw: Osteonecrosis of the jaw (ONJ), which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing and has occurred rarely in patients receiving romosozumab (EVENITY) in the clinical trials.
Prior to treatment, a dental examination with appropriate preventative dentistry should be considered in patients with possible risk factors.
Before commencing invasive dental procedures, patients and their dentist should be advised of the risks and reports of osteonecrosis of the jaw so that dental symptoms, including toothache, developing during treatment can be fully assessed for cause before treatment of the tooth commences.
Patients who are suspected of having or who develop ONJ while on romosozumab (EVENITY) should receive care by a dentist or an oral surgeon. Discontinuation of romosozumab (EVENITY) therapy should be considered based on individual benefit-risk assessment.
Atypical femoral fracture: Atypical low-energy or low-trauma fracture of the femoral shaft, which can occur spontaneously, has occurred rarely in patients receiving romosozumab (EVENITY) in the clinical trials. 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. Patients presenting with an atypical femur fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Interruption of romosozumab (EVENITY) therapy should be considered based on individual benefit-risk assessment.
Effects on laboratory tests: No interactions with laboratory and diagnostic tests have been identified.
Effects on ability to drive and use machines: The effects of this medicine on a person's ability to drive and use machines were not assessed as part of this registration.
Use in hepatic impairment: No clinical studies have been conducted to evaluate the effect of hepatic impairment.
Use in renal impairment: No dose adjustment is required in patients with renal impairment. There is limited experience in patients with eGFR <30 mL/min.
Patients with severe renal impairment (estimated glomerular filtration rate [eGFR] 15 to 29 mL/min/1.73 m²) or receiving dialysis are at greater risk of developing hypocalcaemia (see Contraindications and Precautions). Monitoring of calcium levels is highly recommended. Adequate intake of calcium and vitamin D is important in patients with severe renal impairment or receiving dialysis.
Use in Children: The safety and efficacy of romosozumab (EVENITY) have not been established in paediatric patients. There have been no studies in adolescents or children less than 18 years. Romosozumab (EVENITY) should not be used in paediatric patients.
Use in the Elderly: Of the 6525 postmenopausal women with osteoporosis treated with romosozumab (EVENITY) in clinical studies, 5222 (80%) were ≥65 years old and 2385 (36.6%) were ≥75 years old. Of the 163 men with osteoporosis treated with romosozumab (EVENITY) in clinical studies, 132 (80.9%) were ≥65 years old and 70 (42.9%) were ≥75 years old. No overall differences in safety or efficacy were observed among these patients and younger patients.