Description
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.
This product is available in the following dosage forms:
- Capsule, Liquid Filled
Before Using
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.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of paricalcitol in children younger than 10 years of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of paricalcitol in the elderly.
Breastfeeding
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.
Drug Interactions
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 is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Burosumab-twza
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 (eg, arrhythmia) 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
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.
- For hyperparathyroidism in patients with chronic kidney disease:
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
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine 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.
This medicine may increase the aluminum in your blood and may cause harm to your bones if used in combination with any products containing aluminum (eg, antacids or phosphate binders). Ask your doctor before you take any of these products.
Side Effects
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
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.
DRG-20073059
