Usual Adult Dose for Osteoporosis

210 mg subcutaneously once a month
Duration of therapy: 12 months

This drug should be administered by a healthcare provider; dose is administered as 2 separate injections of 105 mg each (one after the other)

Comments:

• Patients should receive adequate calcium and vitamin D supplementation during therapy.
• The anabolic effect of this drug wanes after 12 months and therefore the duration of therapy should be limited to 12 monthly doses; consider use of anti-resorptive agents if continued therapy for osteoporosis is needed.

Use: For the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.

Renal Dose Adjustments

No adjustment recommended

Severe renal impairment (eGFR less than 30 mL/min/1.73 m2): Monitor calcium concentrations and adequately supplement with calcium and vitamin D

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION (MI), STROKE AND CARDIOVASCULAR DEATH:

• This drug may increase the risk of MI, stroke, and cardiovascular death; it should not be initiated in patients having had MI or stroke within the preceding year.
• Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors.
• If a patient experiences a MI or stroke during therapy, this drug should be discontinued.

CONTRAINDICATIONS:

• Hypocalcemia; preexisting hypocalcemia must be corrected prior to initiating therapy
• Systemic hypersensitivity to active substance or to any product component; reactions have included angioedema, erythema multiforme, and urticaria

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

No adjustment recommended

• Monitor calcium concentrations and adequately supplement with calcium and vitamin D

Other Comments

Administration advice:

• For administration by a healthcare professional
• Subcutaneous administration should be into the abdomen, thigh, or upper arm; rotate injection sites
• Do not inject into areas that are tender, bruised, red, or hard; avoid injecting into areas with scars or stretch marks
• Dose is administered as 2 separate injections of 105 mg each; these are administered one after the other

Missed dose: If a dose is missed, administer as soon as possible; thereafter, administer every month from date of last dose

Storage requirements:

• Store refrigerated 36F to 46F (2C to 8C) in the original carton to protect from light; do not freeze; do not shake
• May be kept at room temperature (up to 77F [25C]) for up to 30 days; discard after 30 days

Reconstitution/preparation techniques:

• Remove prefilled syringe by the syringe barrel from the tray
• Allow this drug to sit at room temperature for at least 30 minutes before injecting; do not warm in any other way
• Do not remove gray needle cap until ready to inject; pull straight off and away from body when ready to inject
• Do not put cap back onto syringe

General:

• In clinical trials, this drug significantly reduced the incidence of new vertebral fractures.
• All women received calcium 500 to 1000 mg and vitamin D 600 to 800 international units per day during trials.

Monitoring:

• Monitor serum calcium in patients with severe renal impairment or receiving dialysis
• Perform and oral examination prior to initiating therapy

Patient advice:

• Patients should be instructed to read the US FDA-approved patient labeling (Medication Guide).
• Patients should understand the potential risk of myocardial infarction (MI), stroke, and cardiovascular death; patients should seek immediate medical attention if they experience signs or symptoms of an MI or stroke.
• Patients should be advised to take calcium and vitamin D supplements to reduce the risk of hypocalcemia; they should seek immediate medical attention if they experience signs/symptoms of hypocalcemia.
• Patients should be advised to practice good oral hygiene during therapy and tell their dentist they are receiving this drug prior to any dental work.
• Patients should understand that hypersensitivity reactions have been reported and they should seek appropriate medical care if these develop.
• Patients should be instructed to report new or unusual thigh, hip, or groin pain as they could signal an impending atypical femoral fracture.

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