Romosozumab
EVENITY
Pronunciation: roe-moe-SOZ-yoo-mab
“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 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
Read the full label on DailyMed ↗
| 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
| Strength | #/mo | generic $/unit | CostPlus | |
|---|---|---|---|---|
| 105 mg/1.17 mL | inj | per unit | not offered |
Generic entry2035 est. (biosimilar)
⚠ BOXED WARNING
- Myocardial infarction, stroke and cardiovascular death
Classes and tags
Clinical profile
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.
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