Rayaldee

Rayaldee is a prescription medication used to treat secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL.

Rayaldee belongs to a group of drugs called vitamin D3 analogs. These help to regulate serum calcium levels by increasing intestinal absorption of calcium and mobilization of calcium from bone.

This medication is available as an extended-release capsule and is taken once daily at bedtime with or without food.

Do not chew, divide, or break Rayaldee capsules. Swallow capsules whole.

Common side effects include anemia, cold symptoms, and difficulty breathing.

Rayaldee is a prescription medication used to treat secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Rayaldee. See the “Rayaldee Precautions” section.

Common side effects of Rayaldee include the following:

• anemia (low red blood cell count)
• cold symptoms
• increased levels in lab that measures kidney functions
• difficulty breathing
• cough
• congestive heart failure
• constipation
• inflammation of the bronchioles
• high potassium blood levels

This is not a complete list of Rayaldee side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone
• thiazide or thiazide-like diuretics such as hydrochlorothiazide (Microzide, HCTZ), chlorothiazide (Diuril), chlorthalidone (Thalitone), and metolazone (Zaroxolyn)
• cholestyramine (Questran)
• phenobarbital or other anticonvulsants

This is not a complete list of Rayaldee drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Rayaldee including:

• Hypercalcemia (high levels of calcium in blood). Excessive administration of vitamin D compounds, including Rayaldee, can cause hypercalcemia and hypercalciuria. Severe hypercalcemia due to substantial overdosage of vitamin D and its metabolites may require emergency attention. Patients should be informed about the symptoms of elevated calcium. Tell your healthcare provider right away if you have some or all of the following symptoms of hypercalcemia:
  • Pain in the abdomen or bones
  • dehydration or excessive thirst
  • fatigue (tiredness)
  • appetite loss
  • constipation
  • nausea
  • excessive urination
  • confusion
  • weight loss
• Digitalis toxicity. This risk is increased by hypercalcemia of any cause. Serum calcium and signs and symptoms of digitalis toxicity should be monitored more frequently when starting Rayaldee or changing the dose. Tell your healthcare provider right away if you have some or all of the following symptoms of digitalis toxicity:
  • Confusion
  • Irregular pulse
  • Loss of appetite
  • Nausea, vomiting, diarrhea
  • Fast heartbeat
  • Vision changes
• Adynamic Bone Disease. Monitor for abnormally low levels of intact PTH levels when using Rayaldee, and adjust dose if needed. Tell your healthcare provider right away if you have some or all of the following symptoms of Adynamic Bone Disease:
  • Bone pain
  • Joint pain
  • Bone deformation
  • Bone fracture
• Congestive Heart Failure: Tell your healthcare provider right away if you have some or all of the following symptoms of Congestive Heart Failure:
  • chest pain
  • cough
  • dizziness
  • fatigue
  • loss of appetite
  • fast breathing
  • shortness of breath at night or lying down
  • water retention or bloating
  • swollen legs or feet
  • weight gain
  • sensation of an abnormal heartbeat

Do not take Rayaldee if you are allergic to Rayaldee or to any of its ingredients.

Grapefruit and grapefruit juice may interact with Rayaldee and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before taking Rayaldee, tell your doctor about all of your medical conditions. Especially tell your doctor if you are:

• allergic to Rayaldee or to any of its ingredients.
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Rayaldee falls into category C.

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Rayaldee crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with the use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Rayaldee.

Take Rayaldee exactly as prescribed.

Rayaldee comes in an extended-release capsule form and is taken once daily at bedtime with or without food.

Do not chew, divide, or break Rayaldee capsules. Swallow capsules whole.

If you miss a dose, take Rayaldee at the next scheduled time. Do not take an extra dose to make up for the missed dose.
 

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose range of Rayaldee for the treatment of secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL is 30 mcg to 60 mcg once daily.

The maximum daily dose of Rayaldee is 60 mcg.

If you take too much Rayaldee, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store at 20-25°C (68-77°F)
• While taking Rayaldee, you will need routine monitoring of laboratory parameters such as calcium, iPTH and total 25-hydroxyvitamin D