romosozumab
General
General
Indications
Indications
Indications
Treatment of osteoporosis in postmenopausal women who are at high risk for a fracture or have failed or are intolerant to other medications used to treat osteoporosis.
Action
Action
Action
Inhibits sclerostin, which leads to increased bone formation and decreased bone resorption.
Therapeutic Effect(s):
Reduction in vertebral and non-vertebral fractures and improvement in bone mineral density.
Pharmacokinetics
Pharmacokinetics
Pharmacokinetics
Absorption: Unknown.
Distribution: Minimally distributed to tissues.
Metabolism and Excretion: Degraded into small peptides and amino acids; elimination pathway unknown.
Half-life: 12.8 days.
TIME/ACTION PROFILE (plasma concentrations)
ROUTE | ONSET | PEAK | DURATION |
---|
SUBQ | unknown | 5 days | 4 wk |
Contraindication/Precautions
Contraindication/Precautions
Contraindication/Precautions
Contraindicated in:
- Hypersensitivity;
- Hypocalcemia (correct before administration);
- MI or stroke in past year (↑ risk of cardiovascular death, MI, or stroke).
Use Cautiously in:
- Patients with risk factors for cardiovascular disease;
- Severe renal impairment (CCr 15–29 mL/min), or receiving dialysis (monitor serum calcium concentrations and calcium and vitamin D intake);
- Invasive dental procedures, cancer, receiving chemotherapy, corticosteroids, or angiogenesis inhibitors, poor oral hygiene, diabetes, gingival infections, periodontal disease, dental disease, anemia, coagulopathy, infection, or poorly fitting dentures (↑ risk of jaw osteonecrosis);
- Geri: Older adults may be more sensitive to drug effects.
Adverse Reactions/Side Effects
Adverse Reactions/Side Effects
Adverse Reactions/Side Effects
CV: CARDIOVASCULAR DEATH, MI, peripheral edema
F and E: hypocalcemia
Local: injection site reactions
MS: arthralgia, atypical femoral fracture, muscle spasm, osteonecrosis of the jaw
Neuro: headache, insomnia, paresthesia, STROKE
Misc: HYPERSENSITIVITY REACTIONS (including anaphylaxis and angioedema)
* CAPITALS indicate life-threatening.
Underline indicate most frequent.
Interactions
Interactions
Interactions
Drug-Drug
None reported.
Route/Dosage
Route/Dosage
Route/Dosage
SUBQ (Adults): 210 mg once monthly for 12 mo.
Availability
Availability
Availability
Solution for injection (prefilled syringes): 105 mg/1.17 mL
Assessment
Assessment
Implementation
Implementation
Implementation
- Duration of therapy is limited to 1 yr due to ↓ effectiveness. If continued therapy is needed, continue therapy with an anti-resorptive agent.
- Supplement patient with calcium and vitamin D during therapy.
- If a dose is missed, administer as soon as possible and reschedule monthly from date of last dose.
- SUBQ Administer by a health care professional. Allow romosozumab to warm to room temperature for at least 30 min; do not warm in any other way. Solution is clear to opalescent, colorless to light yellow; do not administer solutions that are cloudy, discolored, or contain particulate matter. Do not shake. Dose requires 2 injections in separate sites; thigh, abdomen, outer area of upper arm. Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks. Refrigerate solution in original carton to protect from light; do not freeze. Stable for 30 days at room temperature.
Patient/Family Teaching
Patient/Family Teaching
Evaluation/Desired Outcomes
Evaluation/Desired Outcomes
Evaluation/Desired Outcomes
Reduction in vertebral and non-vertebral fractures and improvement in bone mineral density.
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