romosozumab

General

Pronunciation:
roe-moe-soz-ue-mab

Trade Name(s)

Evenity

Ther. Class.

bone resorption inhibitors

Pharm. 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 nonvertebral fractures and improvement in bone mineral density.

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

Contraindicated in:

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

Use Cautiously in:

Black Box: 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.

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

Drug-Drug

None reported.

Route/Dosage

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

Availability

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

Assessment

Assess bone density before and periodically during therapy.
Monitor for new or unusual thigh, hip, or groin pain, which may indicate an incomplete femur fracture.
Assess cardiac history. Avoid administration in patients who have had an MI or stroke within the preceding year. Monitor patients for signs and symptoms of emerging cardiovascular disease such as MI (chest pain, dyspnea, diaphoresis, dizziness, nausea) and stroke (unilateral weakness, slurred speech, confusion, dizziness). If MI or stroke occurs, permanently discontinue romosozumab.
Monitor for signs/symptoms of hypocalcemia (muscle spasms, twitches, or cramps; peripheral or circumoral paresthesia) periodically during therapy. Correct hypocalcemia before initiating 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 antiresorptive 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 provider. Allow romosozumab to warm to room temperature for ≥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 two injections in separate sites: thigh, abdomen, or 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 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.

Evaluation/Desired Outcomes