romosozumab at a glance
Medicine class
Sclerostin-inhibiting monoclonal antibody
Licensed use
Severe osteoporosis in postmenopausal women at high fracture risk
Administration
Subcutaneous injection given by someone trained in the injection technique
Key safety checks
Calcium status, cardiovascular history and risk, kidney function and dental health
What is romosozumab used for?
Licensed for:
Treatment of severe osteoporosis in postmenopausal women who are at high risk of fracture.
How does romosozumab work?
Romosozumab binds to and blocks sclerostin, a protein made mainly by bone cells that restrains bone formation. This increases new bone formation and reduces bone resorption, improving bone mass and structure.
romosozumab preparations and strengths
Injection
Route: Parenteral
Strengths: 105 mg
How to take romosozumab
Romosozumab is injected under the skin of the abdomen, thigh or outer upper arm by a trained person. Allow the pen to reach room temperature naturally before use; do not shake or heat it. Do not inject solution that is cloudy, discoloured or contains particles, or into tender, bruised, red or hardened skin.
Use a different spot for each injection.
Follow the supplied instructions for use and use an appropriate sharps container.
Take calcium and vitamin D as directed by the treating clinician.
romosozumab side effects
Common or expected effects
- Common-cold symptoms or sinusitis
- Joint or neck pain
- Headache
- Muscle spasms
- Rash or dermatitis
- Pain or redness at the injection site
Get urgent medical advice
- Possible heart attack or stroke: chest pain, breathlessness, sudden weakness or numbness, speech or vision changes, or loss of balance
- Serious allergy: facial or throat swelling, hives, breathing or swallowing difficulty, or a severe target-like rash
- Low calcium: muscle cramps, spasms or twitching, or tingling around the mouth or in the fingers or toes
- Jaw problems: dental mobility, jaw pain or swelling, discharge, or a mouth sore that does not heal
- Possible atypical thigh-bone fracture: new or unusual thigh, hip or groin pain
romosozumab in pregnancy
Romosozumab is intended for postmenopausal women and is not indicated during pregnancy or for women who could become pregnant. Human pregnancy data are unavailable; contact the prescriber if pregnancy exposure is suspected.
romosozumab while breastfeeding
Romosozumab is not indicated while breastfeeding. It is unknown whether it enters human milk, and a risk to a breastfed infant cannot be excluded, particularly soon after birth.
romosozumab interactions
Formal interaction studies have not been performed, although pharmacokinetic interactions are not expected. Tell the specialist about all prescribed, over-the-counter and complementary products you use.
Common questions about romosozumab
Answers are fully visible for fast scanning and source review.
What is romosozumab used for?
It is licensed for severe osteoporosis in postmenopausal women who have a high risk of fracture.
Is romosozumab a bisphosphonate?
No. It is a monoclonal antibody that blocks the bone protein sclerostin.
How does romosozumab strengthen bones?
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.