Etelcalcetide Injection
Etelcalcetide is a calcium-sensing receptor agonist injection used to treat secondary hyperparathyroidism in adults with chronic kidney disease on hemodialysis.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Etelcalcetide Injection: Patient Information Guide
A plain-language walkthrough of Etelcalcetide Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Etelcalcetide injection is approved for one indication across its supported product:
- Parsabiv (intravenous injection) is indicated for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease (CKD) who are on hemodialysis.
- Parsabiv has not been studied in — and is not recommended for — adults with CKD who are not on hemodialysis, those with primary hyperparathyroidism, or those with parathyroid carcinoma.
⚙️How it works▾
Etelcalcetide is a calcimimetic agent, meaning it works by mimicking calcium's effect on the body. It binds to and activates a protein called the calcium-sensing receptor (CaSR) on the parathyroid gland cells. This activation signals the glands to produce less parathyroid hormone (PTH) — the hormone that, when overproduced, disrupts calcium and phosphate balance in people with kidney disease. By reducing PTH, etelcalcetide helps bring these mineral levels closer to the normal range.
💊How it's taken▾
Parsabiv is given exclusively as an intravenous (IV) bolus injection by a healthcare provider — it is not taken by mouth. It is administered three times per week, always at the end of a hemodialysis session, after blood is no longer flowing through the dialyzer. Your dose will be adjusted over time based on your PTH and calcium levels.
- Do not take a missed dose — if a dialysis session is skipped, simply resume Parsabiv at the next scheduled session.
- If doses are missed for more than 2 weeks, your prescriber will re-start you at the beginning dose.
- Calcium and PTH levels are checked regularly to guide dose adjustments.
🤒Side effects — in detail▾
The most commonly reported side effects with Parsabiv include:
- Decreased blood calcium (often detected by lab tests, sometimes with symptoms)
- Muscle spasms
- Diarrhea
- Nausea
- Vomiting
- Headache
- Tingling or numbness (paresthesia)
- Myalgia (muscle aching)
Serious reactions to act on immediately include symptomatic low calcium (muscle spasms, tingling, seizures), irregular or rapid heartbeat, worsening heart failure symptoms, signs of GI bleeding (bloody or dark stools), and allergic reactions such as facial swelling or hives.
⚠️Warnings & precautions▾
- Low blood calcium (hypocalcemia): The most significant risk. Can cause muscle cramps, tingling, seizures, and dangerous heart rhythm changes (QT prolongation and ventricular arrhythmias). Calcium is monitored before starting and regularly throughout treatment. Do not start Parsabiv if calcium is already below normal.
- Heart failure: Reductions in calcium may be linked to worsening congestive heart failure. Parsabiv should be used with close monitoring in patients with existing heart failure.
- Upper GI bleeding: Patients with stomach ulcers, esophagitis, or severe vomiting may be at higher risk. Report any signs of GI bleeding promptly.
- Adynamic bone disease: Over-suppression of PTH can lead to adynamic bone — a condition where the skeleton stops remodeling properly. Dose reduction or discontinuation may be needed if PTH falls too low.
- Hypersensitivity: Serious allergic reactions, including anaphylaxis and facial swelling, have been reported. Parsabiv is contraindicated in anyone with a known allergy to etelcalcetide or its ingredients.
🔀What it interacts with▾
Etelcalcetide has a limited drug interaction profile based on lab studies, but a critical clinical interaction exists:
- Cinacalcet (Sensipar): Using cinacalcet at the same time as Parsabiv can cause severe, life-threatening low calcium. Stop cinacalcet for at least 7 days before starting Parsabiv.
- Other calcium-lowering products (e.g., denosumab): Combining these with Parsabiv increases the risk of serious hypocalcemia. Close monitoring is required if used together.
- CYP450 enzymes and common drug transporters: Etelcalcetide is not metabolized by, and does not interact with, CYP450 enzymes or common drug transporter proteins — so typical medication-metabolism interactions are not a concern.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Allergy to etelcalcetide: Parsabiv is contraindicated if you have a known hypersensitivity to etelcalcetide or any component of the injection.
- Low calcium at baseline: Do not start Parsabiv if your corrected serum calcium is already below the normal lower limit.
- History of seizures: Low calcium caused by Parsabiv may lower the seizure threshold — close monitoring is needed.
- Heart rhythm problems (long QT syndrome or family history): Low calcium can worsen heart rhythm disorders; careful monitoring of calcium and QT interval is required.
- Heart failure: Parsabiv has been associated with worsening heart failure in clinical studies; monitor closely.
- Stomach ulcers or GI conditions: May increase the risk of upper GI bleeding.
- Pregnancy: No human data are available. Animal studies showed fetal effects related to maternal low calcium at high doses. Discuss risks with your doctor.
- Breastfeeding: Parsabiv is not recommended while breastfeeding due to potential risk of low calcium in the infant.
- Children: Safety and effectiveness in pediatric patients have not been established.
- Older adults (65+): No significant differences in safety or effectiveness were seen compared to younger adults in clinical studies.
🚑If you take too much▾
There is no clinical experience with Parsabiv overdose. Taking too much could cause low blood calcium, with or without symptoms such as muscle spasms, tingling, or heart rhythm changes. If an overdose is suspected, calcium levels should be checked and the patient monitored for hypocalcemia symptoms, with appropriate treatment started as needed.
📡Pharmacodynamics — effects in the body▾
After a single intravenous dose of etelcalcetide, PTH levels begin to fall within 30 minutes. The degree and duration of PTH reduction increases with higher doses. As PTH drops, blood calcium levels also decrease and post-dialysis phosphate rises are reduced. When given three times a week, the PTH-lowering effect is maintained over at least six months of treatment.
🔬Pharmacokinetics — how your body processes it▾
Etelcalcetide reaches steady-state blood levels within 7 to 8 weeks of three-times-weekly dosing, with an effective half-life of 3 to 4 days. It is not broken down by liver enzymes (CYP450); instead, it undergoes reversible chemical changes in the blood, primarily binding to albumin. In patients on hemodialysis, the drug is cleared mainly through dialysis — about 60% is recovered in the dialysate — which is why it must always be given after the dialysis session ends, not before or during.
📦How to store it▾
Store in the original carton in refrigerator at 2°C to 8°C (36°F to 46°F) to protect from light. refrigerator: Do not expose to temperatures above 25°C (77°F). stored in the original carton.
📄 Written from Etelcalcetide Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Etelcalcetide Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Parsabiv used for? ▾
How will I receive this medication? Do I take it as a pill? ▾
What side effects should I watch out for? ▾
I was previously on cinacalcet. Can I just switch over to Parsabiv right away? ▾
What happens if I miss a dialysis session and don't get my Parsabiv dose? ▾
Is it safe to use Parsabiv if I'm pregnant or breastfeeding? ▾
Is Etelcalcetide Injection available over the counter? ▾
When was Etelcalcetide Injection first available? ▾
Who makes Etelcalcetide Injection? ▾
💬 Answers drafted from Etelcalcetide Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Etelcalcetide Injection comes
Etelcalcetide Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Parsabiv is used to treat secondary hyperparathyroidism in adult patients with chronic kidney disease who are on hemodialysis
- Parsabiv is not recommended for adults with CKD not on hemodialysis, or for those with primary hyperparathyroidism or parathyroid cancer
- Parsabiv is administered by a healthcare provider as an intravenous bolus injection three times per week at the end of each hemodialysis session
- Parsabiv must be given after blood is no longer circulating through the dialyzer — either during rinse back or after rinse back with a saline flush of at least 10 mL
- Parsabiv should not be mixed or diluted before administration; inspect the solution for particles or discoloration and do not use if either is present
- If a hemodialysis session is missed, do not give the missed Parsabiv dose — resume at the next scheduled session
📊 Etelcalcetide Injection across the U.S. market
How Etelcalcetide Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Etelcalcetide Injection is used
A general measure of how commonly Etelcalcetide Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Etelcalcetide Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Etelcalcetide Injection prescribed? Of the 1,596 medications we measure, Etelcalcetide Injection ranks #865 by Medicaid prescriptions — more than 46% of them.
Utilization by Etelcalcetide Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
0.5 ML etelcalcetide 5 MG/ML Injection Most dispensed
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1876137
1 ML etelcalcetide 5 MG/ML Injection
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1876135
2 ML etelcalcetide 5 MG/ML Injection
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1876127
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Etelcalcetide Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 3 of 9 listed Etelcalcetide Injection NDCs with Medicaid activity.
🔍 Compare Etelcalcetide Injection products
A representative set of FDA-listed product records for Etelcalcetide Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 2.5 mg/0.5 mL | Intravenous | Amgen, Inc | NDA | View NDC → |
| 5 mg/mL | Intravenous | Amgen, Inc | NDA | View NDC → |
| 10 mg/2 mL | Intravenous | Amgen, Inc | NDA | View NDC → |
| 2.5 mg/0.5 mL | Intravenous | Amgen Inc | NDA | View NDC → |
| 5 mg/mL | Intravenous | Amgen Inc | NDA | View NDC → |
| 10 mg/2 mL | Intravenous | Amgen Inc | NDA | View NDC → |
Showing 6 of 6 products — FDA National Drug Code Directory. See every product, package size and price: browse all 6 Etelcalcetide Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Etelcalcetide Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Etelcalcetide Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Etelcalcetide Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1876119 1 dose form · 3 strengths
-
Dose form (SCDF) Injection RxCUI 1876126In current FDA listingsClinical drug / strength (SCD) 0.5 ML etelcalcetide 5 MG/MLRxCUI 18761371 ML etelcalcetide 5 MG/MLRxCUI 18761352 ML etelcalcetide 5 MG/MLRxCUI 1876127
Look up RxCUI 1876119 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Etelcalcetide Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Etelcalcetide Injection belongs to the Calcium-sensing Receptor Agonist class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Amgen Inc is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.