Pronunciation:

par-i-KAL-si-tol

Brand Names:

• Zemplar

Dosage Forms:

• Capsule, Liquid Filled

Classifications:

Therapeutic—

Antithyroid Agent

Pharmacologic—

Vitamin D (class)

Uses of This Medicine:

Paricalcitol is used to treat and prevent hyperparathyroidism in patients with chronic kidney disease who are on dialysis. Hyperparathyroidism is a condition that is caused when the parathyroid glands located in the neck make too much parathyroid hormone (PTH). This hormone controls the concentrations of calcium and phosphorus in your blood. Paricalcitol helps lower the amount of PTH which lowers the calcium and phosphorus concentrations.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of paricalcitol in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of paricalcitol in the elderly.

Pregnancy—

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ketoconazole

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bone disease or
• Heart rhythm problems or
• Hypercalciuria (high calcium in the urine) or
• Hyperphosphatemia (high phosphate in the blood) or
• Seizures—Use with caution. May make these conditions worse.

• Hypercalcemia (high calcium in the blood) or
• Vitamin D overdose—Should not be used in patients with these conditions.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

You may take this medicine with or without food.

Carefully follow your doctor's instructions about any special diet. Do not use vitamin D, phosphate, or calcium supplements, or antacids containing aluminum without asking your doctor.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules):
  • For hyperparathyroidism in patients with chronic kidney disease:
    • Adults—At first, 1 to 2 micrograms (mcg) once a day or 2 to 4 mcg three times a week (taken not more than every other day) as directed by your doctor. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Do not take other medicines unless they have been discussed with your doctor. Taking other medicines (especially digoxin, Lanoxin®) together with paricalcitol may require your doctor to change the dose of one of the medicines or paricalcitol.

This medicine may increase the calcium in your blood (hypercalcemia). The symptoms of high calcium may include abdominal or stomach pain; confusion; constipation; depression; dry mouth; headache; incoherent speech; increased urination; loss of appetite; metallic taste; muscle weakness; nausea; thirst; unusual tiredness; vomiting; or weight loss. If you have any of these symptoms, check with your doctor immediately.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Blurred vision

cough or hoarseness

difficulty with swallowing

dizziness

fever or chills

headache

hives

itching

lower back or side pain

nervousness

pain

painful or difficult urination

pounding in the ears

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

shortness of breath

skin rash

slow or fast heartbeat

swelling

tightness in the chest

unusual tiredness or weakness

wheezing

Less common

Abdominal or stomach pain

abnormal growth filled with fluid or semisolid material

ammonia-like breath odor

anxiety

bladder pain

bloating or swelling of the face, arms, hands, lower legs, or feet

bloody or cloudy urine

burning, tingling, numbness or pain in the hands, arms, feet, or legs

chest pain or discomfort

cold sweats

coma

confusion

convulsions

cool, pale skin

decreased urine

depression

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

drowsiness

dry mouth

fainting

frequent urge to urinate

general feeling of discomfort or illness

increase in heart rate

increased hunger

increased thirst

irregular heartbeat

joint pain

lightheadedness

loss of appetite

muscle aches and pains

nausea or vomiting

nightmares

numbness or tingling in the hands, feet, or lips

pain or discomfort in the arms, jaw, back, or neck

rapid breathing

rapid weight gain

runny nose

sensation of pins and needles

shakiness

shivering

slurred speech

sneezing

sore throat

stabbing pain

sunken eyes

sweating

thirst

trouble sleeping

troubled breathing

unusual weight gain or loss

weight loss

wrinkled skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Abdominal or stomach cramps

constipation

depression

high urine levels of calcium

incoherent speech

increased urination

metallic taste

muscle cramps in the hands, arms, feet, legs, or face

muscle weakness

tremor

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Acid or sour stomach

back pain

belching

bloody nose

bruising

change in vision

cough producing mucus

difficulty in moving

feeling of constant movement of self or surroundings

heartburn

impaired vision

indigestion

lack or loss of strength

large, flat, blue, or purplish patches in the skin

leg cramps

muscle pain or stiffness

pain or tenderness around the eyes and cheekbones

pain, swelling, or redness in the joints

sensation of spinning

sores on the skin

stomach discomfort, upset, or pain

stuffy nose

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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