Romosozumab

EVENITY

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

Why this oneIt is the only agent with dual anabolic and antiresorptive action, giving the fastest density gain.

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.

FDA-approved for

postmenopausal osteoporosis at high fracture risk (2019)

FDA label

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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

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.

⚠ BOXED WARNING

Myocardial infarction, stroke and cardiovascular death

Cost, est. cash$300–$5,000/dose or month

Generic entry2035 est. (biosimilar)

Classes and tags

Clinical profile

Therapeutic safety burden1 / 4

Overdose danger1 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 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.