YORVIPATH

/ Neopharm (Israel) 1996 Ltd.

Dose recommendations of this medical product refer to micrograms of PTH(1-34). The dose should be individualised based on serum calcium. The optimal dose after titration is the minimum dose required to prevent hypocalcaemia. This is the dose that maintains serum calcium within the normal range without the need for active forms of vitamin D or calcium supplementation beyond recommended nutritional supplementation for the general population (generally less than 600 mg per day). Doses of active forms of vitamin D and calcium supplements will need to be adjusted
prior to initiating and during treatment with this medical product based on serum calcium value.
Patients receiving the maximum dose of 60 mcg per day who experience ongoing hypocalcaemia may require co-administration of therapeutic calcium and/or active forms of vitamin D.
Before initiation
Serum 25(OH) vitamin D should be within the normal range and serum calcium should be stable within or slightly below the normal range (1.95 – 2.64 mmol/L [7.8 – 10.6 mg/dL]) on at least 1 laboratory value at least two weeks prior to first dose of treatment.
Initiation
The recommended starting dose is 18 mcg once daily with dose adjustments in 3 mcg increments thereafter every 7 days. The dose range is 6 to 60 mcg per day.
See prescribing information for full details.

Parathyroid hormone (PTH) replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism.

* Hypersensitivity to the active substance or to any of the excipients
* Patients with pseudohypoparathyroidism

Hypercalcaemia
Serious events of hypercalcaemia have been reported. The risk is
highest when starting or increasing the dose. During treatment, serum calcium should be measured.
Hypocalcaemia
Serious events of hypocalcaemia have been reported. The risk is highest when treatment is abruptly discontinued but may occur at any time. During treatment, serum calcium should be measured and patients should be monitored for signs and symptoms of hypocalcaemia.
Concomitant use with cardiac glycosides
Hypercalcaemia of any cause may predispose to digitalis toxicity. In patients using this medical product concomitantly with cardiac glycosides (such as digoxin or digitoxin), serum calcium and cardiac glycoside levels should be monitored and patients should be observed for signs and symptoms of digitalis toxicity.
Severe renal or hepatic disease
No studies have been performed. Patients with eGFR of < 45 mL/min may
be more susceptible for hypercalcaemic reactions and transient eGFR decrease, particularly when initiating treatment. If treatment is initiated in these patients, it is recommended to closely monitor serum calcium levels.
Use in patients at increased risk of osteosarcoma
* Should be used with caution in patients with skeletal malignancies and bone metastases
* Should be used with caution in patients who are receiving or who have received radiation therapy to the skeleton
* Should be used with caution in patients with unexplained elevations of bone-specific alkaline phosphatase
* Should be used with caution in patients with metabolic bone diseases who are at increased baseline risk for osteosarcoma (e.g.,
Paget’s disease of the bone)
Use in patients with osteoporosis
Screening for and monitoring of osteoporosis should be for any patient at increased risk of fragility fractures.
See prescribing information for full details.

Very common: Headache, Paraesthesia, Nausea, Injection site reactions, Fatigue
Common: Hypercalcaemia, Hypocalcaemia, Dizzinessa, Syncope, Presyncope, Palpitations, Postural orthostatic, tachycardia syndrome, Orthostatic hypotension, Oropharyngeal pain, Diarrhoea, Constipation, Vomiting, Abdominal discomfort, Abdominal pain, Rash, Photosensitivity reaction, Arthralgia, Myalgia, Muscle twitching, Musculoskeletal pain, Asthenia, Thirst.

No interaction studies have been performed.
Cardiac glycosides (such as digoxin or digitoxin) have a narrow therapeutic index and are affected by calcium. Patients should be monitored for signs and symptoms of digitalis toxicity when taking this medical product and cardiac glycosides.
Other medicinal products can exert effects on serum calcium and may alter the therapeutic response to this medical product, including but not limited to bisphosphonates, denosumab, romosozumab, thiazide and loop diuretics, systemic corticosteroids, and lithium. Patients should be monitored for changes in serum calcium when treated concomitantly with these medicinal products.

Pregnancy: There are no or limited amount of data from the use of palopegteriparatide in pregnant females. However, a risk to the pregnant female or developing foetus cannot be excluded. A decision to initiate or discontinue treatment with palopegteriparatide during pregnancy should take into account the possible risks versus the benefits for the pregnant female. It is recommended to closely monitor maternal serum calcium levels in pregnant females with hypoparathyroidism, including if treated with this medical product.
Lactation: It is unknown whether palopegteriparatide is excreted in human milk. As palopegteriparatide is not orally absorbed, it is unlikely to adversely affect the breast-fed child. A decision to discontinue breast-feeding or palopegteriparatide therapy should take into account the benefit of breastfeeding for the child and the benefit of therapy for the female. It is recommended to closely monitor maternal serum calcium levels if breast-feeding with hypoparathyroidism, including if treated with this medical product.
See prescribing information for full details.

Overdose can cause hypercalcaemia, the manifestations of which may include dehydration, heart palpitations, ECG changes, hypotension, nausea, vomiting, dizziness, muscle weakness, and confusion. Severe hypercalcaemia may require medical care and careful monitoring.
One instance of accidental overdose of approximately 3-fold the prescribed dose lasting more than 7 consecutive days resulted in serum calcium as high as 16.1 mg/dL, the patient was symptomatic and required medical intervention. After withholding palopegteriparatide, calcium, and active vitamin D, the patient recovered and restarted on the correct dose.

After first opening store below 30 °C. Keep the pen cap on the pre-filled pen in order to protect from light. Must be discarded after 14 days.