romosozumab

REMS

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.

Contraind./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.

Adv. 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)

Interactions ⬆ ⬇

Drug-drug:

None reported.

Availability ⬆ ⬇

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

Route/Dosage ⬆ ⬇

SC (Adults ): 210 mg once monthly for 12 mo.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Inhibits sclerostin, which leads to increased bone formation and decreased bone resorption.

Therapeutic effects:

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

Classifications ⬆ ⬇

Therapeutic Classification: bone resorption inhibitors

Pharmacologic Classification: sclerostin inhibitors

Pharmacokinetics ⬆ ⬇

Absorption: Unknown.

Distribution: Minimally distributed to tissues.

Metabolism/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

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.

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Indications ⬇