תפריט
INTRODUCING THE FIRST IV CALCIMIMETIC
You control delivery.
Parsabiv® (etelcalcetide) lowers all sHPT lab values1.
Attains superiority over cinacalcet in PTH reductions2
Switching from cinacalcet to Parsabiv®1
1
7-DAY DISCONTINUATION OF CINACALCET
DAY 1
DAY 2
DAY 3
DAY 4
DAY 5
DAY 6
DAY 7
2
ENSURE cCa IS AT OR ABOVE THE LOWER LIMIT OF THE NORMAL RANGE
≥8.3 mg/dL (2.08 mmol/L)
3
INITIATE Parsabiv®
5 mg
recommended starting dose
3x
per week
During rinse-back
or IV after rinse-back
cCa: Corrected serum calcium
Administering Parsabiv®1
WHEN
At the end of the haemodialysis treatment:
- During rinse-back
or
- IV after rinse-back
HOW
During rinse-back:
- Administer Parsabiv® into the venous line of the dialysis circuit at the end
of the haemodialysis - At least 150 ml of rinse-back volume should be administered after injection
After rinse-back:
- If rinse-back is completed and Parsabiv® was not administered, then it may be administered IV followed by at least 10 ml saline flush volume
SCHEDULE
3 times per week:
- Do not administer Parsabiv® more frequently
- If a regularly scheduled haemodialysis treatment is missed, do not administer any missed doses; administer the prescribed dose of Parsabiv® at the next haemodialysis treatment
- If doses of Parsabiv® are missed for more than 2 weeks, then administer Parsabiv® at 5 mg (or 2.5 mg if that was the patient’s last administered dose) and titrate to achieve the desired PTH
PTH: Parathyroid hormone
Individualising Parsabiv®1
INDIVIDUALISED DOSING
Available in 3 different, ready-to-use, single-use vials
Recommended starting
dose at 5 mg
Dosing range from 2.5 mg
to 15 mg
FLEXIBLE TITRATION
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 PTH target
If PTH is <100 pg/mL (10.6 pmol/L), the dose should be reduced or temporarily stopped.
If PTH does not return to >100 pg/mL, the dose should be stopped. If 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 cCa ≥8.3 mg/dL (2.08 mmol/L).
If 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)
cCa: Corrected serum calcium; PTH: Parathyroid hormone
Managing calcium in patients taking Parsabiv®1
cC a VALUE
RECOMMENDATIONS
≥8.3 mg/dL (2.08 mmol/L)*
- Do not initiate Parsabiv® if cCa is <8.3 mg/dL (2.08 mmol/L)*
- Measure cCa within 1 week after initiation or dose adjustment of Parsabiv®
- Once the maintenance dose has been established, measure cCa
approximately every 4 weeks
if clinically meaningful decreases in cCa levels to <8.3 mg/dL (2.08 mmol/L)
occur and/or symptoms of hypocalcaemia occur, the following management is recommended:
<8.3 mg/dL (2.08 mmol/L)*
and ≥7.5 mg/dL (1.88 mmol/L)
- Consider starting or increasing calcium supplements, calcium-containing phosphate binders, and/or vitamin D sterols, or increasing dialysate
calcium concentration as needed - Consider reducing Parsabiv® dose
<7.5 mg/dL (1.88 mmol/L) or there are symptoms of hypocalcaemia
- Stop Parsabiv® until cCa levels are ≥8.3 mg/dL (2.08 mmol/L)* and symptoms of hypocalcaemia (if present) have resolved
- Consider starting or increasing calcium supplements, calcium-containing phosphate binders, and/or vitamin D sterols, or increasing dialysate calcium concentration as needed
returns to ≥8.3 mg/dL (2.08 mmol/L)* and symptoms of hypocalcaemia have resolved
- Reinitiate Parsabiv® at a dose 5 mg lower than the last administered dose
- If patient’s last administered dose of Parsabiv® was 2.5 mg or 5 mg, reinitiate at 2.5 mg once cCa levels are ≥8.3 mg/dL (2.08 mmol/L)* and symptoms of hypocalcaemia (if present) have resolved
*Lower limit of reference in phase 3 trials; cCa: Corrected serum calcium
Storage & handling of Parsabiv®1
STORE IN A REFRIGERATOR:
• 2°C to 8°C
Once removed from the refrigerator:
• Use within 7 DAYS
if stored in original carton
• Protect from light
by keeping vial in outer carton
• Use within 4 HOURS
if removed from original carton and if protected from direct sunlight
Etelcalcetide Administration Information
HOW?
By intravenous bolus injection1
WHERE?
Into the venous line of the dialysis circuit1
WHEN?
Set up
Haemodialysis treatment
Only at the end of haemodialysis, into the venous line during rinse back or IV after rinse back
Saline Flush Tips
Flush with saline to make sure all medication reaches systemic circulation.
If giving during rinse back, flush the venous line with at least 150 mL of saline
OR
If giving IV after rinse back, flush with at list 10 mL of saline
Note: This is important to prevent the medication from being dialysed. Etelcalcetide is dialysable; it would be significantly eliminated if administered during haemodialysis3
You control delivery.
Parsabiv® (etelcalcetide) lowers all sHPT lab values1
Attains superiority over cinacalcet in PTH reductions2
RESULTS
Lowers PTH, P, and Ca, and helps more patients achieve and sustain lab goals.
CONTROL
Direct IV administration, individualised dosing, and flexible titration allow you to
easily respond to changes in lab parameters
CONFIDENCE
The treatment you seek will be delivered
cCa: Corrected serum calcium; P: Phosphate; PTH: Parathyroid hormone; sHPT: Secondary hyperparathyroidism
indication: Parsabiv® is indicated for the treatment of secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on haemodialysis therapy.
For full details please refer to the PI
license holder: Amgen Europe B.V Israel Branch
Distributor: Medison Pharma
References:
1. Israeli PI.
2. JAMA. 2017;317(2):156-164.Block G, et al.
3. Edson KZ, et al. Kidney Int Rep. 2016;1:24-33
