- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
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Solution for injection of romosozumab.
Romosozumab is a humanised IgG2 monoclonal antibody produced using recombinant DNA technology in Chinese hamster ovary cells.
Treatment of osteoporosis in postmenopausal women to prevent fractures
Treatment of severe osteoporosis in postmenopausal women at high risk of fracture.
210mg given as two subcutaneous injections of 105mg once a month for 12 months.
It is recommended that a transition to antiresorptive therapy, to extend the benefit achieved with romosozumab, follows the completion of romosozumab therapy.
Additional Dosage Information
If a patient misses a dose of romosozumab, administer the missed dose as soon as practical. The next dose of romosozumab should not be given earlier than one month after the last dose.
To be administered by subcutaneous injection only.
Children under 18 years
Females of childbearing potential
History of cerebrovascular accident
History of myocardial infarction
Precautions and Warnings
Severe renal impairment
Discontinue if cerebrovascular accident occurs
Monitor serum calcium in patients with severe renal impairment
Treatment to be initiated and supervised by a specialist
For subcutaneous use only
Ensure patient's dietary intake of calcium and vitamin D is adequate
Monitor serum calcium in patients with signs or symptoms of hypocalcaemia
Advise patient to report any new thigh, hip or groin pain
Advise patient to report signs of hypocalcaemia
Consider discontinuation if atypical femoral fracture occurs
Consider withholding treatment if osteonecrosis of the jaw occurs
Discontinue if myocardial infarction occurs
Advise patient on need for adequate dental hygiene & regular dental checks
Advise patient to report any dental mobility, pain or swelling
Give patient package leaflet and patient reminder card
Patient to inform dentist of romosozumab use: avoid invasive procedures
Myocardial infarction and stroke
When determining whether to use romosozumab, consideration should be given to the fracture risk over the next year and the cardiovascular risk of the patient. Romosozumab should only be used if the prescriber and patient agree that the benefit outweighs the risk.
Osteonecrosis of the jaw
Patients suspected of having or who develop osteonecrosis of the jaw whilst on romosozumab should receive care by a dentist or an oral surgeon with expertise in osteonecrosis of the jaw. Risk factors for developing osteonecrosis of the jaw, to be considered, are the potency and cumulative dose of bone resorption therapy, cancer, co-morbidities, smoking, concomitant therapies, poor oral hygiene and dental problems.
Pregnancy and Lactation
Romosozumab is contraindicated during pregnancy.
The manufacturer does not indicate for the use of romosozumab during pregnancy. There is no data from the use of romosozumab in pregnancy. Animal studies observed a low incidence of skeletal malformations. Following romosozumab exposure, a risk for malformations of developing digits in the human foetus is low due to the timing of digit formation in the first trimester in humans, a period when placental transfer of immunoglobulins is limited.
Romosozumab is contraindicated during breastfeeding.
The manufacturer does not indicate for the use of romosozumab during breastfeeding. There is no data available on the excretion of romosozumab in human milk. It is known that human IgGs are excreted in breast milk during the first few days after birth, which decreases to low concentrations soon afterwards. Therefore, a risk to the breast-fed infant cannot be excluded in this time.
Atypical femoral fracture
Erythema at injection site
Injection site reactions
Osteonecrosis (primarily of the jaw)
Pain / soreness (injection site)
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: April 2020
Summary of Product Characteristics: Evenity 105mg solution for injection in pre-filled pen. UCB Pharma Limited. Revised December 2019.
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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