Phoslyra

Hyperphosphataemia, Communicable Diseases, Dialysis therapy + 4 more

Treatment

3 FDA approvals

3 Active Studies for Phoslyra

What is Phoslyra

Calcium acetate

The Generic name of this drug

Treatment Summary

Calcium acetate is a compound made from calcium and acetic acid. It's also known as the acetate of lime. The anhydrous form of this compound is very absorbent, so it usually comes in the form of the monohydrate.

ProcalAmine

is the brand name

Phoslyra Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

ProcalAmine

Calcium acetate

1982

77

Approved as Treatment by the FDA

Calcium acetate, otherwise known as ProcalAmine, is approved by the FDA for 3 uses which include Kidney Failure, Chronic and End-stage Renal Failure (ESRF) .

Kidney Failure, Chronic

Helps manage End-stage Renal Failure (ESRF)

End-stage Renal Failure (ESRF)

Helps manage End-stage Renal Failure (ESRF)

Hyperphosphataemia

Helps manage Hyperphosphataemia

Effectiveness

How Phoslyra Affects Patients

Patients with serious kidney problems may build up phosphate in their bodies, which can lead to high blood levels of parathyroid hormone and calcium deposits in the body. To help control this, dietary phosphate needs to be reduced, as well as using a medication called calcium acetate to bind to any dietary phosphate and remove it from the body. This helps keep the level of phosphorus in the blood below 6.0 mg/dl. Calcium acetate dissolves easily and helps bind phosphate in the small intestine before it is absorbed.

How Phoslyra works in the body

Calcium acetate and other calcium salts help manage phosphate levels in the body. They do this by binding to the phosphate found in food, preventing it from being absorbed into your bloodstream.

When to interrupt dosage

The prescribed dosage of Phoslyra is contingent upon the diagnosed condition, including Kidney, Hyperphosphataemia and Kidney Failure, Chronic. The amount of dosage is dependent on the mode of administration (e.g. Intravenous or Topical) specified in the table below.

Condition

Dosage

Administration

Hyperphosphataemia

667.0 mg, , 667.0 mg/mL, 0.839 mg/mg, 0.952 mg/mg, 952.0 mg, 5.95 mg/mL, 450.0 mg, 300.0 mg, 668.0 mg, 0.26 mg/mL, 22.0 mg/mL, 6.67 mg/mg, 44.0 mg/mL

, Oral, Tablet - Oral, Tablet, Capsule - Oral, Capsule, Solution, Solution - Oral, Powder, for solution - Topical, Topical, Powder, for solution, Solution - Topical, Injection - Intravenous, Injection, Intravenous, Injection, solution, concentrate - Intravenous, Injection, solution, concentrate, Liquid, Solution - Intravenous, Liquid - Intravenous, Tablet, coated, Tablet, coated - Oral

Kidney

667.0 mg, , 667.0 mg/mL, 0.839 mg/mg, 0.952 mg/mg, 952.0 mg, 5.95 mg/mL, 450.0 mg, 300.0 mg, 668.0 mg, 0.26 mg/mL, 22.0 mg/mL, 6.67 mg/mg, 44.0 mg/mL

, Oral, Tablet - Oral, Tablet, Capsule - Oral, Capsule, Solution, Solution - Oral, Powder, for solution - Topical, Topical, Powder, for solution, Solution - Topical, Injection - Intravenous, Injection, Intravenous, Injection, solution, concentrate - Intravenous, Injection, solution, concentrate, Liquid, Solution - Intravenous, Liquid - Intravenous, Tablet, coated, Tablet, coated - Oral

high phosphate levels

667.0 mg, , 667.0 mg/mL, 0.839 mg/mg, 0.952 mg/mg, 952.0 mg, 5.95 mg/mL, 450.0 mg, 300.0 mg, 668.0 mg, 0.26 mg/mL, 22.0 mg/mL, 6.67 mg/mg, 44.0 mg/mL

, Oral, Tablet - Oral, Tablet, Capsule - Oral, Capsule, Solution, Solution - Oral, Powder, for solution, Powder, for solution - Topical, Topical, Solution - Topical, Injection - Intravenous, Injection, Intravenous, Injection, solution, concentrate - Intravenous, Injection, solution, concentrate, Liquid, Solution - Intravenous, Liquid - Intravenous, Tablet, coated, Tablet, coated - Oral

Astringent

667.0 mg, , 667.0 mg/mL, 0.839 mg/mg, 0.952 mg/mg, 952.0 mg, 5.95 mg/mL, 450.0 mg, 300.0 mg, 668.0 mg, 0.26 mg/mL, 22.0 mg/mL, 6.67 mg/mg, 44.0 mg/mL

, Oral, Tablet - Oral, Tablet, Capsule - Oral, Capsule, Solution, Solution - Oral, Powder, for solution, Powder, for solution - Topical, Topical, Solution - Topical, Injection - Intravenous, Injection, Intravenous, Injection, solution, concentrate - Intravenous, Injection, solution, concentrate, Liquid, Solution - Intravenous, Liquid - Intravenous, Tablet, coated, Tablet, coated - Oral

Communicable Diseases

667.0 mg, , 667.0 mg/mL, 0.839 mg/mg, 0.952 mg/mg, 952.0 mg, 5.95 mg/mL, 450.0 mg, 300.0 mg, 668.0 mg, 0.26 mg/mL, 22.0 mg/mL, 6.67 mg/mg, 44.0 mg/mL

, Oral, Tablet - Oral, Tablet, Capsule - Oral, Capsule, Solution, Solution - Oral, Powder, for solution - Topical, Topical, Powder, for solution, Solution - Topical, Injection - Intravenous, Injection, Intravenous, Injection, solution, concentrate - Intravenous, Injection, solution, concentrate, Liquid, Solution - Intravenous, Liquid - Intravenous, Tablet, coated, Tablet, coated - Oral

Dialysis therapy

667.0 mg, , 667.0 mg/mL, 0.839 mg/mg, 0.952 mg/mg, 952.0 mg, 5.95 mg/mL, 450.0 mg, 300.0 mg, 668.0 mg, 0.26 mg/mL, 22.0 mg/mL, 6.67 mg/mg, 44.0 mg/mL

, Oral, Tablet - Oral, Tablet, Capsule - Oral, Capsule, Solution, Solution - Oral, Powder, for solution - Topical, Topical, Powder, for solution, Solution - Topical, Injection - Intravenous, Injection, Intravenous, Injection, solution, concentrate - Intravenous, Injection, solution, concentrate, Liquid, Solution - Intravenous, Liquid - Intravenous, Tablet, coated, Tablet, coated - Oral

Kidney Failure, Chronic

667.0 mg, , 667.0 mg/mL, 0.839 mg/mg, 0.952 mg/mg, 952.0 mg, 5.95 mg/mL, 450.0 mg, 300.0 mg, 668.0 mg, 0.26 mg/mL, 22.0 mg/mL, 6.67 mg/mg, 44.0 mg/mL

, Oral, Tablet - Oral, Tablet, Capsule - Oral, Capsule, Solution, Solution - Oral, Powder, for solution - Topical, Topical, Powder, for solution, Solution - Topical, Injection - Intravenous, Injection, Intravenous, Injection, solution, concentrate - Intravenous, Injection, solution, concentrate, Liquid, Solution - Intravenous, Liquid - Intravenous, Tablet, coated, Tablet, coated - Oral

Warnings

Phoslyra Contraindications

Condition

Risk Level

Notes

Hypercalcemia

Do Not Combine

Pulse Frequency

Do Not Combine

There are 20 known major drug interactions with Phoslyra.

Common Phoslyra Drug Interactions

Drug Name

Risk Level

Description

Technetium Tc-99m oxidronate

Major

Calcium acetate may decrease effectiveness of Technetium Tc-99m oxidronate as a diagnostic agent.

Dobutamine

Minor

The therapeutic efficacy of Dobutamine can be decreased when used in combination with Calcium acetate.

3-Aza-2,3-Dihydrogeranyl Diphosphate

Moderate

Calcium acetate can cause a decrease in the absorption of 3-Aza-2,3-Dihydrogeranyl Diphosphate resulting in a reduced serum concentration and potentially a decrease in efficacy.

Acebutolol

Moderate

The therapeutic efficacy of Acebutolol can be decreased when used in combination with Calcium acetate.

Acetyldigitoxin

Moderate

Calcium acetate may increase the arrhythmogenic and cardiotoxic activities of Acetyldigitoxin.

Phoslyra Toxicity & Overdose Risk

The lowest toxic dose of oral rat is 4280mg/kg. Symptoms of overdose may include constipation, lack of appetite, nausea, vomiting, confusion, loss of consciousness, and difficulty speaking.

Phoslyra Novel Uses: Which Conditions Have a Clinical Trial Featuring Phoslyra?

There are currently 5 active studies evaluating the potential of Phoslyra to reduce Kidney-related high phosphate levels and Hyperphosphataemia.

Condition

Clinical Trials

Trial Phases

high phosphate levels

0 Actively Recruiting

Kidney Failure, Chronic

0 Actively Recruiting

Communicable Diseases

0 Actively Recruiting

Hyperphosphataemia

0 Actively Recruiting

Dialysis therapy

3 Actively Recruiting

Not Applicable, Phase 3, Phase 4

Astringent

0 Actively Recruiting

Kidney

0 Actively Recruiting

Patient Q&A Section about phoslyra

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is Phoslyra used for?

"Phoslyra is a medication indicated for reducing the serum phosphorus levels in patients with end stage renal disease. It works by binding to phosphate in the gastrointestinal tract, thus preventing its absorption."

Answered by AI

What is calcium acetate used for?

"Calcium acetate is a medication used to treat hyperphosphatemia (too much phosphate in the blood) in patients with end stage kidney disease who are on dialysis. Calcium acetate works by binding with the phosphate in the food you eat, so that it is eliminated from the body without being absorbed."

Answered by AI

How do you take Phoslyra?

"You should take this medication with each meal, and the dosage will be based on your medical condition and how you respond to treatment. If you're using the liquid form, make sure to use a medication-measuring device or spoon to get the correct dose. Don't use a household spoon, because you might not get the right amount."

Answered by AI

Does calcium acetate come in liquid?

"Take calcium acetate with each meal, as directed by your doctor."

Answered by AI

Clinical Trials for Phoslyra

Image of Rocky Mountain Kidney Care - Lone Tree in Lone Tree, United States.

AP301 for High Phosphate Levels

Any Age
All Sexes
Lone Tree, CO

The goal of this clinical trial is to learn if AP301 could work in the patients receiving maintenance dialysis with elevated blood phosphate. The main questions it aims to answer are: * Does AP301 lower blood phosphate levels? * Does AP301 works on serum calcium level, calcium times phosphate level, and intact parathyroid hormone level? * What discomfort or medical problem do the patients have when taking AP301? * Does AP301 improve quality of life in Chinese patients? The researchers will compare AP301 to an ineffective comparator (a look-alike substance that contains low dose AP301) to see if AP301 works to treat elevated blood phosphate. In the study, the patients will experience the following stages in a chronicle order: * Stop all using blood phosphate-lowering drugs, * Take AP301 or the comparator three times a day for 8 weeks, * Take AP301 three times a day for 24 weeks, and * Take AP301 or the comparator three times a day for 3 weeks. In the first 32 weeks, the dose of AP301 will be adjusted upwards or downwards based on the patient's blood phosphate level and the study doctor's judgment. If the participant has a blood phosphate level above or below a certain level, they may receive additional treatment to lower the blood phosphate level.

Phase 3
Recruiting

Rocky Mountain Kidney Care - Lone Tree (+18 Sites)

Alebund Pharmaceuticals