YORVIPATH is indicated for the treatment of hypoparathyroidism in adults.

Injection: Clear, colorless solution in single-patient-use prefilled pens in three presentations

Table 2 displays the YORVIPATH prefilled pen presentations, strengths, labeled doses, and deliverable dose ranges.

YORVIPATH is contraindicated in patients with severe hypersensitivity to palopegteriparatide or to any of its excipients. Hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria, have been observed with parathyroid hormone (PTH) analogs.

The following clinically significant adverse reactions are described elsewhere in the labeling:

Accidental overdose of YORVIPATH may cause hypercalcemia that can be severe and require medical intervention. One subject in Study 1 accidentally received approximately 3-fold the prescribed dose of YORVIPATH for more than 7 consecutive days and developed albumin-corrected serum calcium as high as 16.1 mg/dL, requiring hospitalization.

YORVIPATH (palopegteriparatide injection) is a parathyroid hormone analog (PTH(1-34)). Palopegteriparatide is a prodrug of teriparatide (PTH(1-34)) consisting of PTH(1-34) transiently conjugated to an inert carrier via a proprietary TransCon Linker. PTH(1-34) is identical to the 34 N-terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone. The carrier is a branched 40 kDa (2×20 kDa) methoxypolyethylene glycol (mPEG) moiety. The average molecular weight of palopegteriparatide is approximately 47.4 kDa.

The structure of palopegteriparatide drug substance is shown in Figure 2. The theoretical molecular formula is C

YORVIPATH is a sterile, clear, and colorless solution in a glass cartridge which is pre-assembled in a single-patient-use prefilled pen for subcutaneous administration. The prefilled pen is co-packaged with disposable needles to administer 14 doses of YORVIPATH. YORVIPATH is available in three presentations containing 0.56 mL, 0.98 mL, or 1.4 mL of YORVIPATH solution, and each pen presentation can deliver one of three distinct doses for 14 days of therapy.

Each mL of YORVIPATH solution contains 3456 mcg of palopegteriparatide, equivalent to 300 mcg of teriparatide (PTH(1-34)), and the following inactive ingredients: 41.7 mg mannitol, 2.5 mg metacresol, 0.13 mg sodium hydroxide, 1.18 mg succinic acid, and water for injection. YORVIPATH has a pH of 3.7 to 4.3.

Each pen of 0.56 mL contains 168 mcg teriparatide equivalent to 1935 mcg palopegteriparatide.

Each pen of 0.98 mL contains 294 mcg teriparatide equivalent to 3387 mcg palopegteriparatide.

Each pen of 1.4 mL contains 420 mcg teriparatide equivalent to 4838 mcg palopegteriparatide.

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

Yorvipath

168 mcg/0.56 mL prefilled pens

For 6 mcg, 9 mcg or 12 mcg doses only

For subcutaneous use

Dispense in this sealed carton

Important:

Rx Only

Yorvipath

294 mcg/0.98 mL prefilled pens

For 15 mcg, 18 mcg or 21 mcg doses only

For subcutaneous use

Dispense in this sealed carton

Important:

Rx Only

Yorvipath

420 mcg/1.4 mL prefilled pens

For 24 mcg, 27 mcg or 30 mcg doses only

For subcutaneous use

Dispense in this sealed carton

Important:

Rx Only