Anti-Sclerostin Monoclonal Antibody — Anabolic Osteoporosis Treatment Pregnancy: Not indicated for use in women of reproductive potential. In animal reproduction studies, weekly administration to pregnant rats during organogenesis at exposures greater than 31 times the clinical exposure produced skeletal abnormalities in the offspring; administration prior to mating and through the end of lactation produced minimal to slight decreases in femoral bone mineral density and/or cortical circumferences in the offspring at 1.4 to 54 times the expected human exposure.

Romosozumab

Brand names: Evenity

Romosozumab is a monoclonal antibody used to treat severe osteoporosis in postmenopausal women at high risk of fracture.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 210 mg, given as two separate 105 mg/1.17 mL prefilled syringes injected one after the other (two separate subcutaneous injections are needed to deliver the total 210 mg dose)

Route: Subcutaneous injection into the abdomen, thigh or upper arm; should be administered by a healthcare provider

Frequency: Once every month

Max: The treatment duration is 12 monthly doses

No UK SPC (eMC) record was fetched for this drug — the figures above are from the US prescribing information for EVENITY (Amgen, label date 2026-07-16, https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1b60403e-86c5-4694-8cb5-2fc19f46dc49) and must be verified against the UK SPC before use. Patients should be adequately supplemented with calcium and vitamin D during treatment. If a dose is missed, administer as soon as it can be rescheduled, and thereafter schedule every month from the date of the last dose. Allow the syringes to sit at room temperature for at least 30 minutes before injecting and do not warm in any other way; prepare and clean two injection sites, one for each injection, avoiding a two-inch area around the navel; do not use if the solution is cloudy, discoloured or contains particles. The label carries a boxed warning on major adverse cardiac events: EVENITY should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year, and the benefit-risk balance should be considered in patients with other cardiovascular risk factors. PAEDIATRIC: safety and effectiveness have not been established in paediatric patients — no paediatric dose is stated, so none is recorded here.

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypocalcaemia — pre-existing hypocalcaemia must be corrected prior to initiating therapy
A history of systemic hypersensitivity to romosozumab or to any component of the product formulation; reactions have included angioedema, erythema multiforme and urticaria

Side effects

Arthralgia (most common, 5% or more)
Headache (most common, 5% or more)
Major adverse cardiac events — cardiovascular death, nonfatal myocardial infarction and nonfatal stroke (boxed warning)
Hypersensitivity reactions including angioedema, erythema multiforme, dermatitis, rash and urticaria
Hypocalcaemia; osteonecrosis of the jaw; atypical subtrochanteric and diaphyseal femoral fracture

Clinical monograph

How it works

It binds and inhibits sclerostin, which both increases bone formation and decreases bone resorption, producing a dual anabolic and antiresorptive effect.

Prescribing in practice

It carries an MHRA warning of an increased risk of myocardial infarction, stroke and cardiovascular death, and is contraindicated in patients with a history of myocardial infarction or stroke.
It is given as a course over a limited period, after which patients should transition to an antiresorptive agent to maintain bone density gains.
Hypocalcaemia must be corrected before starting, and adequate calcium and vitamin D intake maintained throughout.

Monitoring

Check calcium status before and during treatment and reassess cardiovascular risk before initiation.

Counselling the patient

Seek urgent help if you develop chest pain, weakness on one side of the body or difficulty speaking.
This is a time-limited course and will usually be followed by another bone-protecting medicine.
Continue your calcium and vitamin D as advised.

Evidence & guidelines

The FRAME and ARCH trials showed reduced fracture risk, while ARCH highlighted a cardiovascular safety signal.

Reference: ARCH Trial (NEJM 2017); FRAME Trial (NEJM 2017); MHRA DSU 2019 (Cardiovascular Risk); NICE TA791 (Romosozumab); Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways