Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Zemplar

Descriptions


Paricalcitol injection 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:

  • Solution

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of paricalcitol injection in children 5 years of age and older.

Geriatric

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

Pregnancy

Information about this paricalcitol-intravenous-route
Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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 receiving 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 (e.g., arrhythmia) or
  • Hypercalciuria (high calcium in the urine) or
  • Hyperphosphatemia (high phosphate in the blood)—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

A nurse or other trained health professional will give you this medicine in a hospital or dialysis center. This medicine is given through a needle placed in one of your veins.

Carefully follow your doctor's instructions about any special diet. Do not use antacids or phosphate binders containing aluminum or supplements containing vitamin D, phosphate, or calcium 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.

Precautions

It is very important that your doctor check your progress at regular visits while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood and urine tests may be needed to check for unwanted effects.

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 right away.

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

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.

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 or nurse immediately if any of the following side effects occur:

Less common

  1. Black, tarry stools
  2. bleeding from the rectum or bloody stools
  3. chest pain or discomfort
  4. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  5. fainting
  6. fast, slow, irregular, pounding, or racing heartbeat or pulse
  7. swelling of the face, arms, hands, lower legs, or feet
  8. unusual bleeding or bruising
  9. unusual weight gain
  10. vomiting of blood or material that looks like coffee grounds

Rare

  1. Abdominal or stomach cramps or pain
  2. chills
  3. constipation
  4. cough
  5. depression
  6. difficult or labored breathing
  7. difficulty with swallowing
  8. dry mouth or skin
  9. fever
  10. inability to speak
  11. incoherent speech
  12. increased thirst
  13. increased urination
  14. joint pain
  15. loss of appetite
  16. metallic taste
  17. mood or mental changes
  18. muscle aches and pains
  19. muscle cramps in the hands, arms, feet, legs, or face
  20. muscle spasms or weakness
  21. nausea or vomiting
  22. numbness and tingling around the mouth, fingertips, or feet
  23. pain, redness, or swelling at the injection site
  24. pale skin
  25. pounding in the ears
  26. rapid, shallow breathing
  27. severe or sudden headache
  28. shivering
  29. shortness of breath
  30. slurred speech
  31. sweating
  32. thirst
  33. tightness in the chest
  34. tingling of the hands or feet
  35. tremor
  36. trouble thinking
  37. troubled breathing with exertion
  38. unusual tiredness or weakness
  39. weakness in the arm or leg on one side of the body, sudden and severe
  40. weight loss
  41. wheezing

Incidence not known

  1. Blurred vision
  2. confusion
  3. hoarseness
  4. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  5. slow or irregular breathing
  6. trouble sleeping

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

  1. Abdominal or stomach discomfort
  2. body aches or pain
  3. burning feeling in the chest or stomach
  4. burning sensations on the skin
  5. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  6. burning, dry, or itching eyes
  7. change in the color, amount, or odor of vaginal discharge
  8. change in walking and balance
  9. clumsiness or unsteadiness
  10. confusion as to time, place, or person
  11. decreased vision
  12. difficulty with moving
  13. discharge or excessive tearing
  14. eye pain
  15. hallucinations
  16. holding false beliefs that cannot be changed by fact
  17. increased hair growth, especially on the face
  18. itching skin
  19. lack or loss of strength
  20. loss in sexual ability, desire, drive, or performance
  21. loss of voice
  22. muscle stiffness
  23. muscle twitching or jerking
  24. night sweats
  25. pain in the breasts
  26. rash
  27. redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  28. rhythmic movement of the muscles
  29. sleeplessness
  30. swollen joints
  31. tearing
  32. unusual excitement, nervousness, or restlessness

Incidence not known

  1. Decreased interest in sexual intercourse
  2. diarrhea
  3. hives or welts
  4. inability to have or keep an erection
  5. indigestion
  6. redness of the skin
  7. stomach upset

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.