Palopegteriparatide

YORVIPATH is indicated for the treatment of hypoparathyroidism in adults. YORVIPATH is a parathyroid hormone analog (PTH(1-34)) indicated for the treatment of hypoparathyroidism in adults. Limitations of Use: Not studied for acute post-surgical hypoparathyroidism. Titration scheme only evaluated in adults who first achieved an albumin-corrected serum calcium of at least 7.8 mg/dL using calcium and active vitamin D treatment. Limitations of Use YORVIPATH was not studied for acute post-surgical hypoparathyroidism. YORVIPATH's titration scheme was only evaluated in adults who first achieved an albumin-corrected serum calcium of at least 7.8 mg/dL using calcium and active vitamin D treatment.

At physiological conditions, palopegteriparatide releases PTH(1-34) to maintain a continuous systemic exposure. Endogenous PTH maintains extracellular calcium and phosphate homeostasis by increasing serum calcium and decreasing serum phosphate. These effects are mediated by stimulating bone turnover to mobilize calcium and phosphate from bone, promoting renal calcium reabsorption and phosphate excretion, and facilitating active vitamin D synthesis, in turn increasing intestinal absorption of calcium and phosphate. Similar to endogenous PTH, PTH(1-34) released from palopegteriparatide exerts these effects through its main receptor, parathyroid hormone 1 receptor (PTH1R), which is highly expressed on osteoblasts, osteocytes, renal tubular cells, and in several other tissues.

Use only one injection to achieve the once daily recommended dosage. Maximum recommended YORVIPATH dosage is 30 mcg subcutaneously once daily. Individualize YORVIPATH dosage based on serum calcium. Refer to the Full Prescribing Information for complete dosage and administration information.

YORVIPATH is contraindicated in patients with a history of severe hypersensitivity to palopegteriparatide or any of the inactive ingredients of YORVIPATH. Reactions have included anaphylaxis, angioedema, and urticaria. Severe hypersensitivity to palopegteriparatide or any of the inactive ingredients of YORVIPATH.

Hypersensitivity Reactions: Anaphylaxis, angioedema, and urticaria have been reported in patients treated with parathyroid hormone analogs, including YORVIPATH. If signs or symptoms of a hypersensitivity reaction occur, discontinue treatment with YORVIPATH, initiate supportive care, and monitor until signs and symptoms resolve. Discontinue YORVIPATH permanently in patients with a severe hypersensitivity reaction to YORVIPATH. Unintended Changes in Serum Calcium Levels Related to Number of Daily Injections: Use only one daily YORVIPATH injection. Using two YORVIPATH injections to achieve the recommended once daily dosage increases the variability of the total delivered dose. Serious Hypercalcemia and Hypocalcemia: Have occurred with YORVIPATH. Periodically measure serum calcium and monitor for signs and symptoms of hypercalcemia and hypocalcemia.

The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions Risk of Unintended Changes in Serum Calcium Levels Related to Number of Daily Injections Serious Hypercalcemia Serious Hypocalcemia Potential Risk of Osteosarcoma Orthostatic Hypotension Risk of Digoxin Toxicity with Concomitant Use of Digitalis Compounds Adverse reactions occurring in ≥ 5% of patients: injection site reactions, vasodilatory signs and symptoms, headache, diarrhea, back pain, hypercalcemia, and oropharyngeal pain.

Drugs Known to Affect Calcium: When used concomitantly with YORVIPATH, measure serum calcium levels more frequently. Drugs Affected by Serum Calcium Digoxin YORVIPATH increases serum calcium, therefore, concomitant use with digoxin (which has a narrow therapeutic index) may predispose patients to digitalis toxicity if hypercalcemia develops. Digoxin efficacy may be reduced if hypocalcemia is present. When YORVIPATH is used concomitantly with digoxin, measure serum calcium and digoxin levels, and monitor for signs and symptoms of digoxin toxicity. Adjustment of the digoxin and/or YORVIPATH dose may be needed. Drugs Known to Affect Serum Calcium Drugs that affect serum calcium may alter the therapeutic response to YORVIPATH.

Until first use, store YORVIPATH in the refrigerator between 2°C to 8°C (36°F to 46°F). After first use, store YORVIPATH for 14 days at room temperature below 30°C (86°F). Store away from heat. Keep YORVIPATH in the packaging to protect from light. After each use, remove the needle and put the pen cap on to protect from light.