romosozumab

Contraindicated in:

Hypersensitivity;
Hypocalcemia (correct before administration);
MI or stroke in past year (↑ risk of cardiovascular death, MI, or stroke)
.

Use Cautiously in:

Risk factors for cardiovascular disease
;
Severe renal impairment 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 nonvertebral 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 and side effects of romosozumab to patient. Do not stop receiving drug without consulting health care provider. If an appointment is missed, contact health care provider as soon as possible to reschedule. Advise patient to read Medication Guide before starting and periodically during therapy in case of changes.
Advise patients and family to call 911 and seek urgent treatment for signs and symptoms of hypersensitivity reactions (difficulty breathing; chest tightness; hives; rash; feeling light-headed; itching; swelling of the face, lips, tongue, or throat).
Advise patients and family to call 911 and seek urgent treatment if signs and symptoms of MI or stroke (chest pain, dizziness, nausea, weakness, slurred speech, confusion, trouble breathing) occur.
Advise patient to eat a balanced diet and consult health care provider about the need for supplemental calcium and vitamin D.
Encourage patient to participate in regular exercise and to modify behaviors that ↑ risk of osteoporosis (stop smoking, ↓ alcohol consumption).
Advise patient to notify health care provider if signs and symptoms if osteonecrosis of the jaw (pain, numbness, swelling of, or drainage from the jaw, mouth, or teeth); 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 provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care provider before taking other medications.
Rep: Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected or if breastfeeding.

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Indications ⬇

Contraind./Precautions ⬆ ⬇