Paricalcitol (Oral)

Paricalcitol is used to treat and prevent hyperparathyroidism in patients with chronic kidney disease who are on dialysis. Hyperparathyroidism happens when the parathyroid glands in the neck produce too much parathyroid hormone (PTH). This hormone regulates the levels of calcium and phosphorus in your blood. Paricalcitol helps reduce the amount of PTH, which lowers the levels of calcium and phosphorus.

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

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

Do not take other medicines unless you have discussed them 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.

This medicine may increase the aluminum in your blood and may harm your bones if used with any products containing aluminum (e.g., antacids or phosphate binders). Ask your doctor before you take any of these products.

In deciding to use a medicine, it is important to think about the risks of taking it compared to the benefits it may provide. This is a choice you and your doctor will make together. For this medicine, consider the following:

Allergies

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

Pediatric

Suitable studies have not been conducted on the effects of paricalcitol in children younger than 10 years old. Safety and effectiveness have not been established for this age group.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the usefulness of paricalcitol in this age group.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

While some medicines should not be taken together at all, in other situations, two different medicines may be used together even if there is a chance of interaction. In these cases, your doctor may need to adjust the dose, or take other precautions. When you are taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are highlighted for their potential importance and may not include all possibilities.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to prescribe this medication or may change some of the other medicines you take.

• Burosumab-twza

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best treatment for you. If both medicines are prescribed, your doctor may adjust the dose or the frequency of use for one or both.

• Ketoconazole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around mealtime, as interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Bone disease or
• Heart rhythm problems (e.g., arrhythmia) or
• Hypercalciuria (high calcium in the urine) or
• Hyperphosphatemia (high phosphate in the blood) or
• Seizures—Use with caution. May worsen these conditions.

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

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

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 suddenly from a lying or sitting position
• 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

Incidence not known

• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• slow or irregular breathing

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 with 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.

In the U.S.

• Zemplar

Available Dosage Forms:

• Capsule, Liquid Filled

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Vitamin D Analog

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.

Your doctor may tell you to limit your dietary intake of phosphate. Foods that are high in phosphate include beans, beer, chocolate, cheese, cola soft drinks, ice cream, milk, nuts, peas, whole grain products, and yogurt.

If you are also taking cholestyramine or mineral oil, do not take it at the same time that you take this medicine. Take paricalcitol capsules at least 1 hour before or 4 to 6 hours after taking cholestyramine or mineral oil.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

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 form (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 3 times a week (taken not more than every other day) as directed by your doctor. Your doctor may adjust your dose as needed. Children 10 to 16 years of age—1 mcg 3 times a week (taken not more than every other day) as directed by your doctor. Your doctor may adjust your dose as needed. Children younger than 10 years of age—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.