Patient Medication Information: uses, side effects, how to take - Rayaldee
What is RAYALDEE used for?
RAYALDEE is used to treat Secondary Hyperparathyroidism (SHPT) in adults with Stage 3 or 4 chronic kidney disease, who do not have enough Vitamin D.
How does RAYALDEE work?
When people have chronic kidney disease, their kidneys do not change enough Vitamin D to its active form and they do not excrete enough phosphate. Low levels of the active form of vitamin D decreases the amount of calcium taken into the body from food. When there is not enough calcium in the blood, a gland known as the parathyroid gland will make too much parathyroid hormone. This causes Secondary Hyperparathyroidism (SHPT). The medicinal ingredient in RAYALDEE is changed in the kidney to the active form of Vitamin D. This form of Vitamin D causes changes in the body that allow for more calcium to be absorbed in the intestine. When this happens, less parathyroid hormone is made.
What are the ingredients in RAYALDEE?
Medicinal ingredients: calcifediol
Non-medicinal ingredients: butylated hydroxytoluene, carrageenan, dehydrated alcohol, dibasic sodium phosphate, FD&C blue #1, hypromellose, lauroyl polyoxylglycerides, medium chain triglycerides, mineral oil, modified corn starch, mono- and di-glycerides, paraffin, propylene glycol, sorbitol sorbitan solution, titanium dioxide and water.
RAYALDEE comes in the following dosage forms:
Capsules (slow release): 30 mcg
Do not use RAYALDEE if you:
are allergic to calcifediol or to any of the other ingredients (see What are the ingredients in
RAYALDEE)
- have high levels of calcium in your blood (hypercalcemia).
- are showing signs of vitamin D toxicity (nausea, vomiting, weakness, increased urination).
- have Stage 5 kidney disease
- are on dialysis
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take RAYALDEE. Talk about any health conditions or problems you may have, including if you:
- have a history of high levels of calcium in your blood.
- are taking digitalis, a medicine used to treat heart problems.
are taking any medicines or supplements that contain calcium and/or phosphate, including
“water pills” used for high blood pressure called thiazide diuretics.
- are taking any medicines or supplements that contain vitamin D.
are pregnant or planning to become pregnant.
- are breastfeeding or planning to breastfeed.
Other warnings you should know about:
Taking RAYALDEE can cause you to have high levels of calcium in your blood (hypercalcemia). If you feel tired, have difficulty thinking clearly, experience loss of appetite, nausea, vomiting, constipation, increased thirst, increased urination or weight loss while you are taking RAYALDEE talk to your healthcare professional immediately.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with RAYALDEE:
- Medicines used to treat fungal infections such as: ketoconazole, itraconazole, voriconazole
- Medicines used to treat HIV/AIDS such as; atazanavir, indinavir, nelfinavir, ritonavir, saquinavir, cobicistat containing products
- Medicines used to treat bacterial infections such as; clarithromycin, telithromycin
- Nefazodone; used to treat depression
- Thiazide diuretics; “water pills” used to treat high blood pressure
- Cholestyramine used to lower cholesterol
- Phenobarbital and other medicines used to treat seizures
- Vitamin D supplements
How to take RAYALDEE:
- Take RAYALDEE at bedtime, exactly as prescribed by your healthcare professional.
- Swallow RAYALDEE capsules whole, do not split or chew them.
Usual adult dose:
One capsule taken orally every day at bedtime.
Overdose:
Overdose of RAYALDEE may cause higher than normal levels of calcium in the blood (hypercalcemia), higher than normal levels of phosphate in the blood (hyperphosphatemia), higher than normal levels of calcium in the urine (hyperuricemia), or cause very low levels of intact parathyroid hormone.
If you think you have taken too much RAYALDEE, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
Missed Dose:
- If you miss a dose of RAYALDEE, skip that dose.
- Take your next dose at your usual time the next day.
- Do not take more than one dose of RAYALDEE to make up for a missed dose.
What are possible side effects from using RAYALDEE?
These are not all the possible side effects you may feel when taking RAYALDEE. If you experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
- Constipation
- Nausea
- Abdominal discomfort, abdominal pain, indigestion, frequent bowel movements, vomiting
- Decreased appetite
- Thirst
- Change in weight
- Weakness or lack of energy, fatigue
- Common cold (stuffy or runny nose, coughing, sore throat etc.)
- Cough
- Nosebleed
- Pain
- Muscle stiffness, weakness and twitching
- Headache
- Light-headedness
- Rash, itching
- Hot flashes
- Increased urination
RAYALDEE can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| COMMON | |||
| Anemia: fatigue, loss of energy, weakness, shortness of breath | |||
| Heart failure: shortness of breath when you exert yourself or lie down, fatigue, weakness, swelling in your legs, ankles and feet, fast or irregular heartbeat, cough | |||
| Lung infections (bronchitis, pneumonia): shortness of breath, chest pain, cough, trouble breathing, fever, chills, fatigue | |||
| Bruising | ✓ | ||
| High levels of creatinine in the blood: feeling dehydrated, fatigue, swelling in the arms or legs, shortness of breath, confusion | |||
High levels of potassium in the blood (hyperkalemia): tiredness, weakness, numbness and tingling, nausea or vomiting, trouble breathing, chest pain, irregular heartbeat | |||
| High levels of uric acid in the blood (hyperuricemia): redness, pain, swelling and tenderness in the big toe, knees or other joints | |||
Osteoarthritis: pain, tenderness and stiffness of the joints | |||
Chronic obstructive pulmonary disease: shortness of breath, especially during activity, wheezing, chest tightness, chronic cough with phlegm | |||
| Edema: swelling in the arms or legs | |||
| UNCOMMON | |||
| Vertigo: dizziness, feeling of losing the balance | |||
| Cataract: clouded, blurred or dim vision | |||
| Infection of the glands around the anus | |||
| Gastroenteritis: severe diarrhea, vomiting, stomach pain | |||
High levels of phosphate in the blood (hyperphosphatemia): muscle cramps, joint and bone pain, itching, red eyes, numbness and tingling around the mouth, nausea, vomiting | |||
High levels of calcium in the blood (hypercalcemia): feeling tired, difficulty thinking clearly, loss of appetite, nausea, vomiting, constipation, increased thirst, increased urination, and weight loss. | |||
| Migraine | |||
| Kidney problems (including kidney failure): decreased urination, inability to empty the bladder, nausea, vomiting, swelling of extremities, fatigue | |||
| Asthma: coughing especially at night, wheezing, shortness of breath | |||
| Angioedema: stomach cramps, red rash or patches on the hands, arms and feet, swelling of the throat, trouble breathing | |||
| High blood pressure: headache, fatigue, vision problems, chest pain, trouble breathing, irregular heartbeat | |||
| Phlebitis: Swelling of a vein with pain, tenderness, redness | |||
| Adynamic bone disease (increased risk of breaking a bone due to very low levels of parathyroid hormone): sudden pain in any location which may be a broken bone |
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
Visiting the Web page on Adverse Reaction Reporting
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Store RAYALDEE at room temperature between 15°C to 30°C. Do not freeze.
Keep out of reach and sight of children.
If you want more information about RAYALDEE:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (www.canada.ca/en/health-canada.html)) or by calling 1-844-729-2539 or medicalinformation@opko.com.