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What is Rayaldee
CalcifediolThe Generic name of this drug
Treatment SummaryCalcifediol is a metabolite of vitamin D3 that is produced in the liver and is used to measure the amount of vitamin D in a person's body. It is used to treat conditions like rickets and osteomalacia and helps to mineralize bones.
Rayaldeeis the brand name
Rayaldee Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Rayaldee
Calcifediol
2016
1
Approved as Treatment by the FDA
Calcifediol, also known as Rayaldee, is approved by the FDA for 6 uses including Secondary Hyperparathyroidism (SHPT) and Chronic Kidney Disease, Stage 3 (Moderate) .Secondary Hyperparathyroidism (SHPT)
Chronic Kidney Disease, Stage 3 (Moderate)
Hyperparathyroidism, Secondary
Vitamin D Deficiency (10 ng/mL to 30 ng/mL)
Renal Insufficiency, Chronic
Stage 4 Chronic Kidney Disease
Effectiveness
How Rayaldee Affects PatientsCalcidiol is a precursor of vitamin D3, which is a hormone that helps the body regulate calcium and phosphorus levels, and helps with the absorption of vitamin A. Not getting enough vitamin D can lead to two diseases: rickets in children, which causes bone deformities, and osteomalacia in adults. Causes of vitamin D deficiency can include not getting enough sunlight, not getting enough from your diet, and some genetic defects. Vitamin D helps the body keep calcium balanced and control the parathyroid hormone. It also helps the body absorb calcium and phosphorus, and move them from bones to the bloodstream.
How Rayaldee works in the bodyCalcidiol is a precursor to the active form of vitamin D, called calcitriol. When calcitriol enters the cell, it binds to receptors which then act as a switch to turn on or off certain genes. This gene switch helps to increase calcium absorption from the gut and kidneys, helping to raise levels of calcium in the bloodstream. Calcitriol also binds to receptors in the intestine, which helps to absorb more calcium from the food we eat.
When to interrupt dosage
The quantity of Rayaldee is dependent upon the diagnosed disorder, including Chronic Kidney Disease, Stage 3 (Moderate), Stage 4 Chronic Kidney Disease and Hyperparathyroidism, Secondary. The dosage varies, contingent upon the procedure of delivery (e.g. Capsule - Oral or Oral) featured in the table beneath.Condition
Dosage
Administration
Hyperparathyroidism, Secondary
, 0.03 mg, 0.02 mg
, Oral, Capsule, extended release, Capsule, extended release - Oral, Capsule - Oral, Capsule
Vitamin D Deficiency (10 ng/mL to 30 ng/mL)
, 0.03 mg, 0.02 mg
, Oral, Capsule, extended release, Capsule, extended release - Oral, Capsule - Oral, Capsule
Renal Insufficiency, Chronic
, 0.03 mg, 0.02 mg
, Oral, Capsule, extended release, Capsule, extended release - Oral, Capsule - Oral, Capsule
Stage 4 Chronic Kidney Disease
, 0.03 mg, 0.02 mg
, Oral, Capsule, extended release, Capsule, extended release - Oral, Capsule - Oral, Capsule
Warnings
There are 20 known major drug interactions with Rayaldee.Common Rayaldee Drug Interactions
Drug Name
Risk Level
Description
Sucralfate
Major
The serum concentration of Sucralfate can be increased when it is combined with Calcifediol.
1alpha,24S-Dihydroxyvitamin D2
Moderate
The risk or severity of adverse effects can be increased when Calcifediol is combined with 1alpha,24S-Dihydroxyvitamin D2.
1alpha-Hydroxyvitamin D5
Moderate
The risk or severity of adverse effects can be increased when Calcifediol is combined with 1alpha-Hydroxyvitamin D5.
Acetyldigitoxin
Moderate
The risk or severity of ventricular arrhythmias and Cardiac Arrhythmia can be increased when Calcifediol is combined with Acetyldigitoxin.
Acetyldigoxin
Moderate
The risk or severity of ventricular arrhythmias and Cardiac Arrhythmia can be increased when Calcifediol is combined with Acetyldigoxin.
Rayaldee Toxicity & Overdose RiskOverdosing on cefazolin may cause bone pain, constipation, diarrhea, drowsiness, dry mouth, headaches, increased thirst, frequent urination (especially at night), irregular heartbeat, itchy skin, loss of appetite, a metallic taste in the mouth, muscle pain, nausea or vomiting (especially in children or adolescents), and fatigue.
Rayaldee Novel Uses: Which Conditions Have a Clinical Trial Featuring Rayaldee?
Currently, there are 10 active studies evaluating the potential of Rayaldee to ameliorate Chronic Kidney Disease Stage 3 (Moderate), Secondary Hyperparathyroidism and Vitamin D Deficiency (10 ng/mL to 30 ng/mL).Condition
Clinical Trials
Trial Phases
Hyperparathyroidism, Secondary
6 Actively Recruiting
Phase 3, Not Applicable
Renal Insufficiency, Chronic
2 Actively Recruiting
Phase 2, Phase 1
Vitamin D Deficiency (10 ng/mL to 30 ng/mL)
0 Actively Recruiting
Stage 4 Chronic Kidney Disease
5 Actively Recruiting
Phase 4, Phase 1, Phase 2, Not Applicable
Rayaldee Reviews: What are patients saying about Rayaldee?
5Patient Review
10/27/2018 I have chronic kidney disease and parathyroid hormone. My vitamin D was extremely low, but after taking this medication for the past six months, it is now normal. My co-pay is $75.00 per month, which isn't too bad considering the cost without insurance would be around one thousand dollars.
Patient Q&A Section about rayaldee
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.Is Rayaldee vitamin D?
"RAYALDEE is a treatment for hyperparathyroidism that comes as a result of chronic kidney disease. It is for stage 3 or 4 adult patients who have a serum total 25-hydroxyvitamin D level that is less than 30 ng/mL."
Answered by AI
What is Rayaldee used for?
"Rayaldee is an extended-release capsule taken by mouth that is prescribed to treat adults with secondary hyperparathyroidism, stage 3 or 4 chronic kidney disease, and low vitamin d levels."
Answered by AI
Is there a generic for Rayaldee?
"Currently, there is no drug in the United States that is the same as Rayaldee. However, there are fake versions of Rayaldee being sold online by unlicensed pharmacies. These drugs may not be safe, as they are not regulated."
Answered by AI
Who manufactures Rayaldee?
"OPKO, a company based in Miami, announced today that the FDA has approved their drug Rayaldee for chronic kidney disease. This approval comes only three months after OPKO received a complete response letter from the FDA, due to concerns that the FDA had about the plant where the drug was being produced."
Answered by AI