romosozumab

General

Pronunciation:
roe-moe-soz-ue-mab


Trade Name(s)

  • Evenity

Ther. Class.
bone resorption inhibitors

Pharm. Class.
temporary class sclerostin inhibitors

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

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

Absorption: Unknown.

Distribution: Not widely 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)

ROUTEONSETPEAKDURATION
Subcutunknown5 days4 wk

Contraindication/Precautions

Contraindicated in:

  • Hypersensitivity;
  • Hypocalcemia (correct before administration);
  • MI or stroke in past year (↑ risk of cardiovascular death, MI, or stroke)
  • OB:  Pregnancy (may cause fetal harm);
  • Lactation.

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);
  • Pedi:   Safety and effectiveness not established in children;
  • Geri:  Older adults may be more sensitive to drug effects.

Adverse Reactions/Side Effects

CNS: STROKE, headache, insomnia

CV: CARDIOVASCULAR DEATH, MI, peripheral edema

F and E: hypocalcemia

MS: arthralgia, atypical femoral fracture, muscle spasm, osteonecrosis of the jaw

Local: injection site reactions

Neuro: paresthesia

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA)

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

Interactions

Drug-Drug

None reported.

Route/Dosage

SC (Adults): 210 mg every month for 12 months.

Availability

Solution for injection (prefilled syringes): 105 mg/1.17 mL

Assessment

  • Assess patients for low bone mass before and periodically during therapy.
  • Assess cardiac history. Avoid administration in patients who have had an MI or stroke within the preceding year. Discontinue romosozumab if MI or stroke occurs.
  • Monitor for signs and symptoms of hypocalcemia (spasms, twitches, or cramps in muscles; numbness or tingling in fingers, toes, or around mouth) periodically during therapy.
  • Perform a routine oral exam prior to initiation of therapy. Dental exam with appropriate preventative dentistry should be considered prior to therapy. Patients with history of tooth extraction, poor oral hygiene, gingival infections, diabetes, cancer, receiving radiation, anemia, coagulopathy, or use of a dental appliance or those taking immunosuppressive therapy, angiogenesis inhibitors, or systemic corticosteroids are at greater risk for osteonecrosis of the jaw.

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.
  • SC 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

  • Explain purpose of romosozumab to patient.
  • Advise patient to notify health care professional immediately if signs and symptoms of MI or hypersensitivity occur.
  • Advise patient to eat a balanced diet and consult health care professional about the need for supplemental calcium and vitamin D.
  • Encourage patient to participate in regular exercise and to modify behaviors that increase the risk of osteoporosis (stop smoking, reduce alcohol consumption).
  • Advise patient to notify health care professional if signs and symptoms if osteonecrosis of the jaw (pain, numbness, swelling of or drainage from the jaw, mouth, or teeth) or hypocalcemia (spasms, twitches, or cramps in muscles; numbness or tingling in fingers, toes, or around mouth) or thigh, hip, or groin pain occur.
  • Advise parents to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
  • Rep:  Not indicated for women of reproductive potential.

Evaluation/Desired Outcomes

Reduction in vertebral and non-vertebral fractures and improvement in bone mineral density.

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