PARSABIV Injection
Etelcalcetide
5mg
Amgen Europe B.V
| Pack size | 6 Glass Vials (1ml) |
|---|---|
| Dispensing mode | POM |
| Source | NETHERLANDS |
| Agent | CITY MEDICAL STORE |
| Retail Price | 761.50 AED |
Available as:
Indications
PARSABIV Injection is used for:
Secondary hyperparathyroidism (SHPT), in adult patients w/, chronic kidney disease (CKD), on haemodialysis therapy.
Adult Dose
Hyperparathyroidism
Indicated for secondary hyperparathyroidism (SHPT) for patients with chronic kidney disease (CKD) on hemodialysis
Initial dose
Ensure corrected serum calcium is at or above the lower limit of normal prior to initiation, a dose increase, or reinitiation of therapy after a dosing interruption
5 mg IV push 3 times/week at the end of hemodialysis treatment
Maintenance dose
Individualize and determine by titration based on parathyroid hormone (PTH) and corrected serum calcium response
2.5 mg IV 3 times/week; titrate dose by 2.5- or 5-mg increments not more frequently than q4Weeks to maintain PTH levels within target range and corrected serum calcium within the normal range; maximum dose of 15 mg 3 times/week
Child Dose
Renal Dose
Administration
IV Preparation
Do not mix or dilute prior to administration
Solution is clear and colorless
Inspect for particulate matter and discoloration prior to administration
Do not use vial if particulate matter or discoloration is observed
IV Administration
Administer IV push into venous line of the dialysis circuit during rinse back or IV after rinse back; only administer at the end of hemodialysis treatment
Administered during rinse back: Administer a sufficient volume of 0.9% NaCl (eg, 150 mL) of rinse back into dialysis tubing
Administered after rinse back: Flush line with at least 10 mL of 0.9% NaCl
Contra Indications
Hypersensitivity. Do not initiate if corrected serum Ca is less than the lower limit of the normal range.
Precautions
Risk of hypocalcaemia; adynamic bone in patients w/ PTH levels <100 pg/mL. Measure serum Ca levels prior to treatment, w/in 1 wk of initiation or dose adjustment & every 4 wk during treatment. Ventricular arrhythmia & QT prolongation secondary to hypocalcaemia. Patients w/ history of convulsion disorder or CHF. Monitor for positive binding Abs in SHPT patients treated w/ Parsabiv for up to 6 mth. Co-administration w/ drugs lowering serum Ca. Certain potential manifestations of hypocalcaemia may affect ability to drive or operate machinery. Pregnancy & lactation. Childn & adolescents <18 yr.
Pregnancy-Lactation
Pregnancy
There are no available data on the use in pregnant women
Lactation
Unknown if distributed in human breast milk
Studies in rats showed distribution in milk at concentrations similar to plasma
Because of the potential for etelcalcetide to cause adverse effects in breastfed infants, including hypocalcemia, use is not recommended while breastfeeding
Interactions
Increased risk of severe hypocalcaemia w/ drugs reducing serum Ca. Cinacalcet
Adverse Effects
Side effects of Etelcalcetide :
>10%
Decreased serum calcium, asymptomatic reductions in calcium <7.5 mg/dL or clinically significant asymptomatic reductions in corrected serum calcium between 7.5 and <8.3 mg/dL that required medical management (64%)
Muscle spasms (12%)
Diarrhea (11%)
Nausea (11%)
1-10%
Vomiting (9%)
Headache (8%)
Hypocalcemia (7%)
Paresthesia (6%)
Hypersensitivity (4.4%)
Hyperkalemia (4%)
Hospitalization for heart failure (2%)
Myalgia (2%)
QTc prolongation secondary to hypocalcemia (1.2%)
Hypophosphatemia (1%)
<1%
Hypocalcemia, symptomatic reductions in corrected serum calcium <8.3 mg/dL (0.2%)
Mechanism of Action
Calcimimetic agent that allosterically modulates the calcium-sensing receptor (CaSR)
Etelcalcetide binds to the CaSR and enhances activation of the receptor by extracellular calcium
Activation of the CaSR on parathyroid chief cells decreases PTH secretion
Note
PARSABIV 5mg Injection manufactured by Amgen Europe B.V. Its generic name is Etelcalcetide. PARSABIV is availble in United Arab Emirates.
Farmaco UAE drug index information on PARSABIV Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.