Drugs List

Therapeutic Indications

Uses

Treatment of osteoporosis in postmenopausal women to prevent fractures

Treatment of severe osteoporosis in postmenopausal women at high risk of fracture.

Administration

To be administered by subcutaneous injection only.

Contraindications

Children under 18 years
Females of childbearing potential
Breastfeeding
History of cerebrovascular accident
History of myocardial infarction
Hypocalcaemia
Pregnancy

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

Pregnancy

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.

Lactation

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.

Side Effects

Angioedema
Antibody formation
Arthralgia
Atypical femoral fracture
Cataracts
Dermatitis
Erythema at injection site
Erythema multiforme
Headache
Hypersensitivity reactions
Hypocalcaemia
Injection site reactions
Muscle spasm
Myocardial infarction
Nasopharyngitis
Neck pain
Osteonecrosis (primarily of the jaw)
Pain / soreness (injection site)
Rash
Sinusitis
Stroke
Urticaria

Presentation

Solution for injection of romosozumab.

Romosozumab is a humanised IgG2 monoclonal antibody produced using recombinant DNA technology in Chinese hamster ovary cells.

Drugs List

Therapeutic Indications

Uses

Treatment of osteoporosis in postmenopausal women to prevent fractures

Treatment of severe osteoporosis in postmenopausal women at high risk of fracture.

Dosage

Adults

Additional Dosage Information

Administration

To be administered by subcutaneous injection only.

Contraindications

Children under 18 years
Females of childbearing potential
Breastfeeding
History of cerebrovascular accident
History of myocardial infarction
Hypocalcaemia
Pregnancy

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

Pregnancy

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.

Lactation

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.

Side Effects

Angioedema
Antibody formation
Arthralgia
Atypical femoral fracture
Cataracts
Dermatitis
Erythema at injection site
Erythema multiforme
Headache
Hypersensitivity reactions
Hypocalcaemia
Injection site reactions
Muscle spasm
Myocardial infarction
Nasopharyngitis
Neck pain
Osteonecrosis (primarily of the jaw)
Pain / soreness (injection site)
Rash
Sinusitis
Stroke
Urticaria

Overdosage

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 ).

Further Information

Last Full Review Date: April 2020

Reference Sources

Summary of Product Characteristics: Evenity 105mg solution for injection in pre-filled pen. UCB Pharma Limited. Revised December 2019.