Anti-Sclerostin Monoclonal Antibody (Dual Anabolic/Anti-Resorptive) Pregnancy: US label §8.1: EVENITY is 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 to the end of lactation produced minimal to slight decreases in femoral bone mineral density and/or cortical circumferences in offspring at 1.4 to 54 times the expected human exposure. (US labelling — verify against the UK SPC §4.6.)

Romosozumab (Anti-Sclerostin — Severe Osteoporosis)

Brand names: Evenity

Romosozumab is a subcutaneously administered anti-sclerostin monoclonal antibody used for severe osteoporosis at high fracture risk in postmenopausal women, given as a time-limited course.

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 subcutaneously once every month, administered as TWO separate 105 mg/1.17 mL prefilled syringes (two separate subcutaneous injections given one after the other) to make up the total 210 mg dose

Route: Subcutaneous injection into the abdomen, thigh or upper arm. Should be administered by a healthcare provider. Do not administer into muscle or a blood vessel.

Frequency: Once every month; treatment duration is 12 monthly doses

NO UK SPC (eMC) WAS RETRIEVED IN THIS BUNDLE — the regimen above is taken from the US FDA prescribing information for EVENITY (Amgen, Inc; label date 2026-07-16; https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1b60403e-86c5-4694-8cb5-2fc19f46dc49). VERBATIM (§2.2 Recommended Dosage): 'The recommended dose of EVENITY is 210 mg administered subcutaneously in the abdomen, thigh or upper arm. Administer EVENITY once every month. The treatment duration for EVENITY is 12 monthly doses.' VERBATIM (§2.1): 'Two separate syringes (and two separate subcutaneous injections) are needed to administer the total dose of 210 mg of EVENITY. Inject two 105 mg/1.17 mL prefilled syringes, one after the other. EVENITY should be administered by a healthcare provider.' CALCIUM/VITAMIN D: 'Patients should be adequately supplemented with calcium and vitamin D during treatment with EVENITY.' MISSED DOSE: 'If the EVENITY dose is missed, administer as soon as it can be rescheduled. Thereafter, EVENITY can be scheduled every month from the date of the last dose.' PREPARATION: allow to sit at room temperature for at least 30 minutes before injecting; do not warm in any other way; do not remove the gray needle cap until ready to inject and do not leave the cap off for more than 5 minutes; prepare and clean two separate injection sites, one for each injection; rotate sites and do not inject into skin that is tender, bruised, red or hard, or into scars/stretch marks. BOXED/CARDIOVASCULAR CAUTION (§5.1): 'EVENITY should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year.' PAEDIATRIC (§8.4): 'Safety and effectiveness of EVENITY have not been established in pediatric patients' — no paediatric dose is stated, so paedDose is null; verify any under-18 use against a children's formulary. ELDERLY (§8.5): no overall differences in safety or efficacy observed in patients 65 years and over versus younger subjects, but greater sensitivity of some older individuals cannot be ruled out; no separate dose is stated. NO §7 DRUG INTERACTIONS SECTION AND NO RENAL DOSING SECTION WERE RETRIEVED IN THIS BUNDLE. Several sections of the fetched US label were truncated at the source-fetch limit — clinician to confirm against the full label and the UK SPC before publication.

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 and headache — the most common adverse reactions (≥ 5%) reported in clinical trials
Major adverse cardiac events (MACE) — a higher rate of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke was seen versus alendronate; monitor for symptoms of MI and stroke
Hypersensitivity reactions including angioedema, erythema multiforme, dermatitis, rash and urticaria — discontinue if a clinically significant allergic reaction occurs
Hypocalcaemia — supplement calcium and vitamin D adequately during treatment
Osteonecrosis of the jaw — monitor for symptoms; consider discontinuation based on benefit-risk assessment
Atypical subtrochanteric and diaphyseal femoral fracture — evaluate new or unusual thigh, hip or groin pain to rule out an incomplete femur fracture

Clinical monograph

How it works

By inhibiting sclerostin it both increases bone formation and decreases bone resorption, producing a dual anabolic and antiresorptive effect that rapidly raises bone mineral density.

Prescribing in practice

It is contraindicated in patients with a history of myocardial infarction or stroke because trials showed an excess of cardiovascular events, so cardiovascular risk must be assessed before starting.
Correct hypocalcaemia and ensure adequate calcium and vitamin D before and during treatment.
Rare osteonecrosis of the jaw and atypical femoral fracture can occur, and a subsequent antiresorptive agent is needed afterwards to maintain bone-density gains.

Monitoring

Monitor calcium levels and fracture/cardiovascular risk, and review for jaw symptoms and new thigh or groin pain during the treatment course.

Counselling the patient

Tell us about any history of heart attack or stroke before starting.
Maintain adequate calcium and vitamin D intake.
Report new jaw, thigh or groin pain, and dental problems.

Evidence & guidelines

Efficacy in reducing vertebral fractures is supported by randomised trials, with NICE recommending it for severe osteoporosis after careful cardiovascular risk assessment.

Reference: Saag et al. NEJM 2017 (ARCH trial); MHRA Approval Evenity 2020; MHRA Drug Safety Update 2019 (CV risk); NICE TA791 (Romosozumab for Osteoporosis); NOF Guidelines 2023; 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