PARSABIV 5 mg/mL
etelcalcetide · INJECTION, SOLUTION · Amgen, Inc
PARSABIV is a injection, solution containing etelcalcetide at 5 mg/mL, taken intravenous. Manufactured by Amgen, Inc.
Key Facts
- Brand Name
- PARSABIV
- Generic Name
- etelcalcetide
- NDC Code (Product)
55513-741- Manufacturer
- Amgen, Inc
- Strength
- 5 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA208325
- Marketing Start
- 04/03/2017
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE PARSABIV is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. 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. 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 .
Dosage & Administration
2 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 hyp…
Contraindications
4 CONTRAINDICATIONS PARSABIV is contraindicated in patients with known hypersensitivity to etelcalcetide or any of its excipients. ( 4 ) 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) ] .
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Hypocalcemia [see Warnings and Precautions (5.1) ] Worsening Heart Failure [see Warnings and Precautions (5.2) ] Upper Gastrointestinal Bleeding [see Warnings and Precautions (5.3) ] Adynamic Bone [see Warnings and Precautions (5.4) ] The most common adverse reactions (≥ 5%) were blood calcium decreased, muscle spasms, diarrhea, nausea, vomiting, headache, hypocalcemia, and paresthesia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The data in Table 2 are derived from two placebo-controlled clinical studies in patients with chronic kidney disease and secondary hyperparathyroidism on hemodialysis. The data reflect exposure of 503 patients to PARSABIV with a mean du…
Frequently Asked Questions
What is PARSABIV used for?
PARSABIV contains etelcalcetide. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is PARSABIV a controlled substance?
PARSABIV is not classified as a controlled substance by the DEA.
What is the generic name for PARSABIV?
The generic name for PARSABIV is etelcalcetide. There are no other listed brand versions of etelcalcetide.
What is the NDC code for PARSABIV 5 mg/mL?
The NDC (National Drug Code) for PARSABIV 5 mg/mL is 55513-741, listed by Amgen, Inc.
Other PARSABIV Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)