Rayaldee 30mcg Capsules

Calcifediol (25-hydroxyvitamin D3) is a prohormone of calcitriol (1,25-dihydroxyvitamin D3). In the kidney, calcifediol is converted by 1-alpha-hydroxylase (CYP27B1) to calcitriol, the active form of vitamin D. Calcitriol then binds to the vitamin D receptor (VDR) in target tissues, including the parathyroid glands, intestine, and bone. Activation of the VDR suppresses parathyroid hormone (PTH) synthesis and secretion, regulates calcium and phosphate homeostasis by promoting intestinal absorption of calcium and phosphate, and influences bone mineralization.

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high calcium levels, including:
+ Weakness
+ Confusion
+ Feeling tired
+ Headache
+ Upset stomach and vomiting
+ Constipation
+ Bone pain
Signs of high potassium levels, such as:
+ Abnormal heartbeat
+ Confusion
+ Weakness
+ Lightheadedness or dizziness
+ Feeling like passing out
+ Numbness or tingling
+ Shortness of breath
Abnormal heartbeat
Seizures
Decreased appetite
Unusual thirst
Frequent urination
Weight loss
Shortness of breath, significant weight gain, or swelling in the arms or legs

Other Possible Side Effects

Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor or seek medical help:

* Nose or throat irritation

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before taking this medication, it is essential to inform your doctor about the following:

Any allergies you have, including allergies to this drug, any of its components, or other substances, such as foods or medications. Be sure to describe the symptoms you experienced as a result of the allergy.
If you have elevated calcium levels, as this medication may interact with this condition.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to ensure safe use and avoid potential interactions.
Any existing health problems, as this medication may interact with other medical conditions.
* You should also consult with your doctor and pharmacist to verify that it is safe to take this medication in conjunction with your other medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions you have with your doctor. If you are taking cholestyramine, consult with your pharmacist to determine the best way to take it in conjunction with this drug. Additionally, if you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor immediately. You and your doctor will need to carefully weigh the benefits and risks of this medication to both you and your baby.

• Thiazide diuretics (increased risk of hypercalcemia)
• Digitalis (increased risk of cardiac arrhythmias due to hypercalcemia)
• Other vitamin D analogs or vitamin D supplements (increased risk of hypercalcemia and hyperphosphatemia)

• Corticosteroids (may reduce the effects of vitamin D analogs)
• CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir) - may increase calcifediol exposure
• CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital) - may decrease calcifediol exposure
• Bile acid sequestrants (e.g., cholestyramine, colestipol) - may impair intestinal absorption of calcifediol
• Mineral oil, Orlistat - may impair intestinal absorption of calcifediol
• Phosphate binders (e.g., sevelamer, lanthanum carbonate) - concomitant use may require careful monitoring of serum phosphorus

• Symptoms of hypercalcemia (e.g., nausea, vomiting, constipation, muscle weakness, fatigue, confusion, polyuria, polydipsia, bone pain)
• Symptoms of hyperphosphatemia (e.g., pruritus, bone pain, vascular calcification symptoms)

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects at doses higher than human therapeutic doses.

It is not known whether calcifediol is excreted in human milk. Other vitamin D analogs are excreted in human milk. The decision to discontinue breastfeeding or discontinue the drug should consider the importance of the drug to the mother.

Safety and effectiveness in pediatric patients have not been established. Rayaldee is not indicated for use in pediatric patients.

No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.

• Rayaldee is a prohormone of calcitriol, offering a more physiological approach to vitamin D repletion and PTH suppression compared to direct calcitriol administration, especially in early CKD stages.
• Always administer Rayaldee with food to optimize absorption and exposure.
• Close monitoring of serum calcium, phosphorus, and PTH is crucial, especially during dose titration, to prevent hypercalcemia and hyperphosphatemia.
• Patients should be educated on the symptoms of hypercalcemia and instructed to report them immediately.
• Avoid concomitant use of other vitamin D supplements or analogs to prevent excessive vitamin D levels and hypercalcemia.
• Consider the long half-life of calcifediol when making dose adjustments; effects may not be fully apparent for several weeks.

• Cholecalciferol (Vitamin D3) or Ergocalciferol (Vitamin D2) for vitamin D insufficiency/deficiency (though Rayaldee is specifically for SHPT in CKD 3/4 with low 25[OH]D).
• Calcitriol (Rocaltrol, Calcijex) - active vitamin D analog, often used in later stages of CKD or dialysis.
• Paricalcitol (Zemplar) - selective vitamin D receptor activator, used for SHPT in CKD.
• Doxercalciferol (Hectorol) - vitamin D analog, used for SHPT in CKD.
• Cinacalcet (Sensipar) - calcimimetic, directly lowers PTH by increasing calcium sensing receptor sensitivity to calcium, used for SHPT in CKD (especially Stage 5) and primary hyperparathyroidism.

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.