Romosozumab

EVENITY

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Pronunciation: roe-moe-SOZ-yoo-mab

Romosozumab ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Romosozumab ballicule

Romosozumab EVENITY mascot mnemonic cartoon — Visual mnemonic: Romosozumab mascot
**“Bone’s bein’ laid, but Even Rome wasn’t built in a day”**

What it isSclerostin antibody that both builds bone and inhibits resorption; severe osteoporosis.

Why this oneOnly dual anabolic-antiresorptive; prevents more fractures than alendronate and raises hip BMD more than teriparatide.

What limits it⚑ Myocardial infarction, stroke or cardiovascular death can occur; do not start within a year of infarction or stroke, then follow with an antiresorptive.

Pearls

Monthly injections, limited to 12 months.
Reasonable first-line in women at high fracture risk.
Arthralgia, headache; rare ONJ and atypical femoral fracture.

Romosozumab molecular structure (skeletal formula) — Molecular structure: Romosozumab

Romosozumab prescription history

Animated chart of estimated U.S. prescriptions per year, Osteoporosis meds (1975–2026). Romosozumab enters in 2019.

FDA-approved for

postmenopausal osteoporosis at high fracture risk (2019)

Classes and tags

Clinical profile

Therapeutic safety burden3 / 4

Overdose danger1 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk2 / 4

Legacy pregnancy categoryNot assigned — PLLR-era drug

Defining liabilityGenerally tolerated at therapeutic doses; clinically important risks are agent-specific and increase with interactions or organ impairment.

FDA label

Read the full label on DailyMed ↗

BOXED WARNING May increase risk of MI, stroke, and cardiovascular death; do not initiate within 1 year of an MI or stroke; discontinue if either occurs.

FDA dosing	Population	Start	Target	Max
Osteoporosis (postmenopausal women at high fracture risk)	Adults	210 mg SC monthly	210 mg SC monthly	210 mg SC monthly x 12 doses

Renal Severe impairment or on dialysis: increased hypocalcemia risk; monitor serum calcium and supplement calcium/vitamin D.

Hepatic Undefined

Treatment duration is 12 monthly doses; if a dose is missed, administer as soon as possible then resume monthly from the last dose.

Instructions

Administer as two separate 105 mg/1.17 mL SC injections (total 210 mg), one after the other
Given by a healthcare provider
Inject in abdomen, thigh, or upper arm
Supplement calcium and vitamin D during treatment
Allow syringes to reach room temperature >=30 min before injecting

Available strengths

inj 105 mg/1.17 mL

Contraindications

Hypocalcemia (correct before initiating therapy)

Cautions

Major adverse cardiac events (MI, stroke, CV death)
Hypersensitivity (angioedema, erythema multiforme, rash, urticaria)
Hypocalcemia
Osteonecrosis of the jaw
Atypical femoral fracture

Adverse reactions

Arthralgia
Headache

Pregnancy Not indicated in women of reproductive potential; animal data show skeletal abnormalities.

Lactation Not indicated in women of reproductive potential.

Cost

Romosozumab (EVENITY)

Strength		#/mo	generic $/unit	CostPlus
105 mg/1.17 mL	inj	per unit		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Romosozumab is administered under clinical supervision and dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

Generic entry2035 est. (biosimilar)

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