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Prescribing Information

(Please consult the Summary of Product Characteristics (SmPC) before prescribing)

EVENITY® (Romosozumab) 
Active Ingredient: Romosozumab – solution for injection: 105 mg of romosozumab in 1.17 mL of solution (90 mg/mL).
Indications: Severe osteoporosis in postmenopausal women at high risk of fracture. 
Dosage and Administration: Treatment should be initiated and supervised by specialist physicians experienced in the management of osteoporosis. Dosage: 210 mg administered as two equal subcutaneous injections of 105 mg each once monthly for 12 months. 
Patients to be adequately supplemented with calcium and vitamin D before and during treatment. 
Following completion of therapy, transition to antiresorptive therapy is recommended. Renal impairment: No dose adjustment is needed. Serum calcium to be monitored in patients with severe renal impairment or receiving dialysis. Elderly: No dose adjustment needed. Discontinuation: see SmPC for guidance. 
Contraindications, Warnings, Precautions for use: Contraindications: Hypersensitivity to romosozumab or to any of the excipients listed in the SmPC; Hypocalcaemia; History of myocardial infarction or stroke. 
Warnings and Precautions: Myocardial infarction and stroke: An increase in serious cases of cardiovascular events has been observed in romosozumab treated patients compared to controls. Consideration should be given to fracture risk over the next year and cardiovascular risk factors. If a patient experiences a myocardial infarction or stroke during therapy, treatment should be discontinued. Hypocalcemia: Transient hypocalcaemia has been observed. Hypocalcaemia should be corrected prior to initiating romosozumab. Limited safety data in patients with severe renal impairment or receiving dialysis - calcium levels should be monitored in these patients. Hypersensitivity: Erythema multiforme, angioedema and urticaria have been reported. Osteonecrosis of the jaw (ONJ): Consider risk factors when evaluating risk of developing ONJ. Atypical femoral fractures: Atypical low-energy or low trauma fracture of the femoral shaft have been reported rarely. Consider interruption of romosozumab in patients presenting with an atypical femur fracture, based on an individual benefit-risk assessment. 
Refer to SmPC for full information. 
Interactions: No data available. 
Fertility, pregnancy and lactation: Not to be used in child-bearing potential, pregnant or breastfeeding women. Risk for malformations of developing digits in the human foetus in the first trimester, a period when placental transfer of immunoglobulins is limited. No data available on human fertility. 
Driving and use of machines: No or negligible influence on ability to drive and use machines. 
Adverse Effects: Very Common (≥ 1/10): Nasopharyngitis, arthralgia. Common (≥ 1/100 to < 1/10): Sinusitis, hypersensitivity, rash, dermatitis, headache, neck pain, muscle spasms, injection site reactions. Uncommon (≥ 1/1,000 to < 1/100): Urticaria, hypocalcaemia, stroke, cataract, myocardial infarction. Rare (≥ 1/10,000 to < 1/1,000): angioedema, erythema multiforme. See SmPC for further details. 
Pharmaceutical Precautions: Store in a refrigerator (2ºC – 8ºC) in original container, do not freeze. Keep pre-filled pen in the outer carton in order to protect from light. Do not return to refrigerator after use; EVENITY can be kept at up to 25ºC for up to 30 days in original container. Product should be discarded after this period. 
Legal Category: POM 
Marketing Authorisation Numbers: EU/1/19/1411/001 
UK NHS Costs: 2 pre-filled pens (£427.75) 
Marketing Authorisation Holder: UCB Pharma S.A., Allée de la Recherche 60, B-1070 Brussels, Belgium. 
Further information is available from: UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire, SL1 3WE. Tel: +44 (0)1753 777100 
Email: ucbcares.uk@ucb.com 
UCB (Pharma) Ireland Ltd, United Drug House, Magna Drive, Magna Business Park, City West Road, Dublin 24, Ireland.
Tel: +353 1463 2371 Email: ucbcares.ie@ucb.com 
Date of Revision: December 2019 (IE-P-RM-OP-1900010) EVENITY is a registered trademark. 

 

UK: Adverse events should be reported. Reporting forms and information can be found at
www.mhra.gov.uk/yellowcard.
Ireland: Adverse events should be reported to the HPRA Pharmacovigilance either by phone
+353 1 6764971 or via the website at www.hpra.ie 

Adverse events should also be reported to UCB Pharma Ltd.