Rayaldee

Rayaldee is a vitamin D3. Vitamin D is important for absorbing calcium from the stomach and for how calcium works in the body.

Rayaldee is used to treat secondary hyperparathyroidism (overactive parathyroid glands) in adults who have stage 3 or 4 chronic kidney failure and low vitamin D levels. This medicine is not for people who are receiving dialysis.

Rayaldee may also be used for other reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may sometimes adjust your dose. Use the medicine exactly as directed.

Take Rayaldee at bedtime each day.

Swallow the extended-release capsule whole and do not crush, chew, break, or open it.

You will need frequent medical tests.

Store at room temperature, away from moisture and heat.

Follow all instructions on your medicine label and package. Inform each of your healthcare providers about all your medical conditions, allergies, and all medicines you are taking.

Tell your doctor if you have ever had:

• heart problems; or
• high levels of calcium in your blood (hypercalcemia).

Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether Rayaldee will harm an unborn baby. However, having chronic kidney disease during pregnancy may cause complications such as miscarriage, premature birth, low birth weight, stillbirth, or eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of treating kidney disease may outweigh any risks to the baby.

If you are breastfeeding, tell your doctor if you notice vomiting, constipation, weight loss, or seizures in the nursing baby.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Rayaldee may cause serious side effects. Call your doctor right away if you have:

• shortness of breath (even with mild effort), swelling, rapid weight gain;
• high calcium levels--confusion, tiredness, nausea, vomiting, loss of appetite, constipation, increased thirst or urination, weight loss; or
• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common side effects of Rayaldee may include:

• constipation; or
• runny or stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Skip the missed dose and take your next dose at the usual time. Do not take two doses at the same time.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Signs of an overdose may include vomiting, constipation, loss of appetite, feeling tired or irritable, muscle weakness, feeling very thirsty or hot, or urinating less than usual.

Talk to a doctor or pharmacist before using any vitamins or mineral supplements. Many over-the-counter dietary supplements have calcium or vitamin D. Taking certain products together can lead to getting too much of these ingredients.

Sometimes, it is not safe to use certain medicines together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medicines less effective.

Tell your doctor about all your other medicines, especially:

• cholestyramine;
• digoxin, digitalis;
• phenobarbital or other seizure medications;
• an antibiotic or antifungal medicine;
• antiviral medicine to treat hepatitis C or HIV/AIDS;
• a diuretic or "water pill";
• heart medication; or
• medications or mineral supplements that contain calcium or vitamin D.

This list is not complete and many other drugs may affect Rayaldee. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.