PARSABIV SOLUTION FOR INJECTION 10 MG/2 ML [SIN15452P]

Product Info

PARSABIV SOLUTION FOR INJECTION 10 MG/2 ML

[SIN15452P]

4.1 Therapeutic indications

Parsabiv is indicated for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on haemodialysis therapy.

4.2 Posology and method of administration

Posology

The recommended initial dose of etelcalcetide is 5 mg administered by bolus injection 3 times per week. Corrected serum calcium should be at or above the lower limit of the normal range prior to administration of first dose of Parsabiv, a dose increase, or reinitiation after a dose stop (see also dose adjustments based on serum calcium levels). Parsabiv should not be administered more frequently than 3 times per week.

Dose titration
Parsabiv should be titrated so that doses are individualised between 2.5 mg and 15 mg. The dose may be increased in 2.5 mg or 5 mg increments no more frequently than every 4 weeks to a maximum dose of 15 mg 3 times per week to achieve the desired parathyroid hormone (PTH) target.

Dose adjustments based on PTH levels
PTH should be measured after 4 weeks from initiation or dose adjustment of Parsabiv, and approximately every 1–3 months during maintenance. Dose adjustment may be necessary at any time during treatment including the maintenance phase.

If PTH is below 100 pg/mL (10.6 pmol/L), the dose should be reduced or temporarily stopped. If PTH does not return to > 100 pg/mL following dose reduction, the dose should be stopped. For patients in whom the dose is stopped, Parsabiv should be reinitiated at a lower dose once PTH returns to > 150 pg/mL (15.9 pmol/L) and pre-dialysis serum corrected calcium (cCa) ≥ 8.3 mg/dL (2.08 mmol/L). If the patient’s last administered dose was 2.5 mg, Parsabiv may be reinitiated at the 2.5 mg dose level if PTH is > 300 pg/mL (31.8 pmol/L), and the most recent pre-dialysis serum cCa ≥ 8.3 mg/dL (2.08 mmol/L).

Additional recommendations related to the management of low calcium are provided in the table below.

Parsabiv may be used as part of a therapeutic regimen including phosphate binders and/or vitamin D sterols, as appropriate (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Dose adjustments based on serum calcium levels
Serum calcium should be measured within 1-week of initiation or dose adjustment of Parsabiv. Once the maintenance phase has been established for a patient, corrected serum calcium should be measured approximately every 4 weeks. In the studies total serum calcium was measured using Roche modular analysers. The lower limit of the normal range for corrected serum calcium was 8.3 mg/dL (2.08 mmol/L). Other laboratory assays may have different cut-offs for the lower limit of the normal range.

In the event that clinically meaningful decreases in corrected serum calcium levels below the lower limit of the normal range occur and/or symptoms of hypocalcaemia occur, the following management is recommended:

Switch from cinacalcet to etelcalcetide
Etelcalcetide should not be initiated in patients until 7 days after the last dose of cinacalcet and the corrected serum calcium is at or above the lower limit of the normal range (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Missed doses
If a regularly scheduled haemodialysis treatment is missed, do not administer any missed doses. Parsabiv should be administered at the next haemodialysis treatment at the same dose. If doses are missed for more than 2 weeks, then Parsabiv should be administered at 5 mg, (or 2.5 mg if that was the patients last administered dose), and titrated to achieve the desired PTH.

Special population

Elderly
Dosing recommendations for elderly patients are the same as for adult patients.

Paediatric population
The safety and efficacy of etelcalcetide in children and adolescents less than 18 years have not yet been established. No data are available.

Method of administration

Parsabiv is administered into the venous line of the dialysis circuit at the end of the haemodialysis treatment during rinse-back or intravenously after rinse-back. When given during rinse-back at least 150 mL of rinse-back volume should be administered after injection. If rinse-back is completed and Parsabiv was not administered, then it may be administered intravenously followed by at least 10 mL sodium chloride 9 mg/mL (0.9%) solution for injection flush volume.

Parsabiv should not be diluted.

Parenteral medicinal products should be inspected visually for particulate matter and change in colour prior to administration.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Parsabiv should not be initiated if corrected serum calcium is less than the lower limit of the normal range (see sections 4.2 and 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).