Usual Adult Dose for Secondary Hyperparathyroidism

Initial dose: 5 mg IV 3 times per week

• Adjust dose in increments of 2.5 or 5 mg no more frequently than every 4 weeks to achieve a dose that maintains parathyroid hormone levels within the target range and corrected serum calcium within the normal range

• If switching from cinacalcet, discontinue cinacalcet at least 7 days prior to starting this drug.
• Ensure corrected serum calcium is at or above the lower limit of normal prior to initiating therapy; a dose increase, or re-initiation after a dose interruption.
• Dose should be administered by IV bolus at the end of hemodialysis treatment.
• If a hemodialysis treatment is missed, do not give this drug; resume this drug at the end of the next hemodialysis session at the prescribed dose; if more than 2 weeks of hemodialysis treatments are missed, reinitiate this drug at the recommended starting dose (5 mg) or 2.5 mg if that was the patient's last dose.

Renal Dose Adjustments

This drug is not recommended for patients with chronic kidney disease (CKD) not on hemodialysis

Liver Dose Adjustments

No adjustment recommended

Dose Adjustments

At Maintenance Dose:

• PTH levels should be within the recommended target range
• Corrected serum calcium should be within the normal range

• If PTH levels are above the recommended target range and corrected serum calcium is within the normal range; do not exceed maximum dose

• If PTH levels are below target range
• If corrected serum calcium falls below 7.5 mg/dL or patient reports symptoms of hypocalcemia, stop therapy and treat hypocalcemia; investigate and address factors for hypocalcemia.
• If corrected serum calcium is below the lower limit of normal but at or above 7.5 mg/dL without symptoms of hypocalcemia, consider decreasing or temporarily holding this drug or use concomitant therapies to increase corrected serum calcium.
• If corrected serum calcium falls below 7.5 mg/dL or patient reports symptoms of hypocalcemia, stop therapy and treat hypocalcemia; then, when corrected serum calcium is within normal limits, symptoms of hypocalcemia have resolved, and predisposing factors for hypocalcemia have been addressed, reinitiate at a dose 5 mg lower than the last administered dose; if last administered dose was 2.5 mg or 5 mg, reinitiate at 2.5 mg dose

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active substance or any product excipients; hypersensitivity reactions have included face edema and anaphylactic reaction

Dialysis

See Adult Dosage

Other Comments

Administration advice:

• Administer by IV bolus injection at the end of hemodialysis treatment

• If dialysis treatment is missed, do not administer any missed doses
• If doses are missed for more than 2 weeks, reinitiate at recommended starting dose (5 mg) or 2.5 mg if that was the patient's last dose

• Store refrigerated 36F to 46F (2C to 8C) in original carton
• Once removed from refrigerator: Do not expose to temperatures above 77F (25C); use within 7 days if kept in the original carton; use within 4 hours if removed from original carton (do not expose to direct sunlight)

• Do not dilute or mix prior to administration
• This drug is removed by the dialyzer membrane and therefore must be administered after blood is no longer circulating through the dialyzer
• Administer by IV bolus injection into the venous line of the dialysis circuit after hemodialysis, during rinse back or intravenously after rinse back
• Administer a sufficient volume of saline (e.g., 150 mL of rinse back) after injecting drug into dialysis tubing
• If drug is administered after rinse back, follow with at least 10 mL of saline flush

• This drug has not been studied in patients with parathyroid carcinoma, primary hyperparathyroidism, or with chronic kidney disease not on hemodialysis and is therefore, not recommended in these patients.

• Obtain corrected serum calcium level at time of dose initiation and dose adjustment, and repeat in 1 week; then every 4 weeks during maintenance
• Obtain parathyroid (PTH) levels at time of dose initiation and dose adjustment, and repeat in 4 weeks; then per clinical practice
• Monitor patients with heart failure for worsening of heart failure

• Patients should be instructed to report symptoms of hypocalcemia.
• Patients with heart failure should be instructed to reports worsening of their heart failure.
• Patients should be instructed to report symptoms of gastrointestinal bleeding.
• Patients should understand the importance of laboratory monitoring and should adhere to the laboratory monitoring schedule.

Frequently asked questions

• What is Parsabiv used to treat?