PARSABIV- etelcalcetide injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ETELCALCETIDE HYDROCHLORIDE (UNII: 72PT5993DU) (ETELCALCETIDE - UNII:60ME133FJB)

Available from:

Amgen Inc

INN (International Name):

ETELCALCETIDE HYDROCHLORIDE

Composition:

ETELCALCETIDE 2.5 mg in 0.5 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PARSABIV is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. Limitations of Use: PARSABIV has not been studied in adult patients with parathyroid carcinoma, primary hyperparathyroidism, or with chronic kidney disease who are not on hemodialysis and is not recommended for use in these populations. Hypersensitivity PARSABIV is contraindicated in patients with known hypersensitivity to etelcalcetide or any of its excipients. Hypersensitivity reactions, including face edema and anaphylactic reaction, have occurred with PARSABIV [see Adverse Reactions (6)] . Risk Summary There are no available data on the use of PARSABIV in pregnant women. In animal reproduction studies, effects were seen at doses associated with maternal toxicity that included hypocalcemia. In a pre- and post-natal study in rats administered etelcalcetide during organogenesis through delivery and weaning, there was a slight increase in perinatal pup mortality,

Product summary:

PARSABIV (etelcalcetide) injection is supplied in a single-dose vial (type I glass) with stopper (fluoropolymer laminated elastomeric) and an aluminum seal with flip-off dust cover containing 5 mg/mL of etelcalcetide as a ready-to-use clear and colorless solution in the following strengths: Storage Store in the original carton in refrigerator at 2°C to 8°C (36°F to 46°F) to protect from light. Once removed from the refrigerator:

Authorization status:

New Drug Application

Summary of Product characteristics

PARSABIV- ETELCALCETIDE INJECTION, SOLUTION
AMGEN INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PARSABIV SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PARSABIV.
PARSABIV (ETELCALCETIDE) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2017
INDICATIONS AND USAGE
PARSABIV is a calcium-sensing receptor agonist indicated for:
Secondary hyperparathyroidism (HPT) in adult patients with chronic
kidney disease (CKD) on
hemodialysis. (1)
Limitations of Use:
PARSABIV has not been studied in adult patients with parathyroid
carcinoma, primary
hyperparathyroidism, or with CKD who are not on hemodialysis and is
not recommended for use in these
populations.
DOSAGE AND ADMINISTRATION
Ensure corrected serum calcium is at or above the lower limit of
normal prior to initiation, dose
increase, or re-initiation. (2.1)
The recommended starting dose is 5 mg administered by intravenous
bolus injection three times per
week at the end of hemodialysis treatment. (2.1)
The maintenance dose is individualized and determined by titration
based on parathyroid hormone
(PTH) and corrected serum calcium response. The dose range is 2.5 to
15 mg three times per week.
(2.1)
The dose may be increased in 2.5 mg or 5 mg increments no more
frequently than every 4 weeks. (2.2)
Measure serum calcium within 1 week after initiation or dose
adjustment and every 4 weeks for
maintenance. (2.2)
Measure PTH after 4 weeks from initiation or dose adjustment. (2.2)
Decrease or temporarily discontinue PARSABIV in individuals with PTH
levels below the target range.
(2.2)
Consider decreasing or temporarily discontinuing PARSABIV or use
concomitant therapies to increase
corrected serum calcium in patients with a corrected serum calcium
below the lower limit of normal but
at or above 7.5 mg/dL without symptoms of hypocalcemia. (2.2)
Stop PARSABIV and treat hypocalcemia if the corrected serum calcium
falls below 7.5 mg/dL or patients
report symptoms of hypocalcemia. (2.2)
Do not m