Evenity · 4.8 Undesirable effects · 1

HOS-098375 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile The most common adverse reactions were nasopharyngitis (13.6%) and arthralgia (12.4%). Hypersensitivity-related reactions occurred in 6.7% of patients treated with romosozumab. Hypocalcaemia was reported uncommonly (0.4% of patients treated with romosozumab). In randomised controlled studies, an increase in serious cardiovascular events (myocardial infarction and stroke) has been observed in romosozumab treated patients compared to controls (see section 4.4 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. 5  Frequency MedDRA System Organ Class Adverse reaction category Nasopharyngitis Very common Infections and infestations Sinusitis Common Hypersensitivitya Common Rash Common Dermatitis Common Immune system disorders Urticaria Uncommon Angioedema Rare Erythema multiforme Rare Metabolism and nutrition disorders Hypocalcaemiab Uncommon Headache Common Nervous system disorders Strokec Uncommon Eye d

Auszug; vollständigen Abschnitt im Original lesen.

HOS-098371 · has-contraindication-information · PDF-Seite 3

- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.4) - Hypocalcaemia (see section 4.4) - History of myocardial infarction or stroke (see section 4.4)

HOS-098370 · has-indication-information · PDF-Seite 2

EVENITY is indicated in treatment of severe osteoporosis in postmenopausal women at high risk of fracture (see section 5.1).

HOS-098373 · has-interaction-information · PDF-Seite 5

No drug interaction studies have been performed with romosozumab. No pharmacokinetic drug interactions are expected with romosozumab.

HOS-098374 · has-pregnancy-information · PDF-Seite 5

Pregnancy Romosozumab is not indicated for use in women of child-bearing potential or in pregnant women. There are no data from the use of romosozumab in pregnant women. Skeletal malformations (including syndactyly and polydactyly) were observed at a low incidence in a single study with romosozumab in rats (see section 5.3). A risk for malformations of developing digits in the human foetus is low following romosozumab exposure due to the timing of digit formation in the first trimester in humans, a period when placental transfer of immunoglobulins is limited. Breast-feeding Romosozumab is not indicated for use in breast-feeding women. No data are available on excretion of romosozumab in human milk. Human IgGs are known to be excreted in breast milk during the first few days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to the breast-fed infant cannot be excluded during this short period. Fertility No data are available on the effect of romosozumab on human fertility. Animal studies in female and Draft male rats did not show any effects on fertility endpoints (see section 5.3).

HOS-098372 · has-warning-information · PDF-Seite 3

Myocardial infarction and stroke In randomised controlled studies, an increase in serious cardiovascular events (myocardial infarction and stroke) has been observed in romosozumab treated patients compared to controls (see section 4.8). Romosozumab is contraindicated in patients with previous myocardial infarction or stroke (see section 4.3). When determining whether to use romosozumab for an individual patient, consideration should be given to her fracture risk over the next year and her cardiovascular risk based on risk factors (e.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. 3 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. If any patient presents with suspected symptoms of hypocalcaemia during treatment (see section 4.8), calcium levels should be measured. Patients should be adequately supplemented with calcium and vitamin D (see sections 4.3 and 4.8). 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 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. If an anaphylactic or other clinically significant allergic reaction occurs, appropriate therapy should be initiated and use of romosozumab should be discontinued (see sections 4.3 and 4.8). 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 thera

Auszug; vollständigen Abschnitt im Original lesen.