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Cinacalcet (Oral route)

Pronunciation:

sin-a-KAL-set

Brand Names:

  • Sensipar

Dosage Forms:

  • Tablet

Classifications:

Therapeutic—

Calcium Regulator

Pharmacologic—

Calcimimetic

Uses of This Medicine:

Cinacalcet is used to treat 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 helps to control the concentrations of calcium and phosphorus in your blood. Cinacalcet lowers the amount of PTH which lowers the calcium and phosphorus concentrations. Cinacalcet is also used to lower calcium in the blood of patients with parathyroid cancer.

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 cinacalcet 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 cinacalcet in the elderly.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal 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.

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 is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Clozapine
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Fluoxetine

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.

  • Desipramine
  • Itraconazole
  • 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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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 disease or
  • Heart failure or
  • Heart rhythm problems (e.g., arrhythmia) or
  • Hypotension (low blood pressure) or
  • Seizures, history of—Use with caution. May make these conditions worse.
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

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.

It is best to take this medicine with food or shortly after a meal.

Swallow the tablet whole. Do not crush, break, or chew it.

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 (tablets):
    • For hypercalcemia associated with parathyroid cancer:
      • Adults—At first, 30 milligrams (mg) two times a day. Your doctor may adjust your dose every 2 to 4 weeks.
      • Children—Use and dose must be determined by your doctor.
    • For hyperparathyroidism with chronic kidney disease:
      • Adults—At first, 30 milligrams (mg) once a day. Your doctor may adjust your dose every 2 to 4 weeks.
      • 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 together with cinacalcet may require your doctor to change the dose of one of the medicines or cinacalcet.

This medicine may lower the calcium in your blood. If you have any of these symptoms, check with your doctor right away: abdominal or stomach cramps; confusion; convulsions; difficulty with breathing; irregular heartbeats; mood or mental changes; muscle cramps in the hands, arms, feet, legs, or face; numbness and tingling around the mouth, fingertips, or feet; shortness of breath; or tremors.

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
chest pain
dizziness
headache
nervousness
pounding in the ears
slow or fast heartbeat
Less common
Convulsions
cough or hoarseness
fever or chills
loss of bladder control
lower back or side pain
muscle spasm or jerking of all extremities
painful or difficult urination
sudden loss of consciousness
Incidence not known
Abdominal or stomach cramps
confusion
decreased urine output
difficulty with breathing
difficulty with moving
dilated neck veins
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
extreme fatigue
fainting
irregular breathing
irregular heartbeats
joint pain
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
low bone turnover
mood or mental changes
muscle aching or cramping
muscle cramps in the hands, arms, feet, legs, or face
muscle pains or stiffness
numbness and tingling around the mouth, fingertips, or feet
shortness of breath
sweating
swelling of the face, fingers, feet, or lower legs
swollen joints
tightness in the chest
tremor
troubled breathing
unusual tiredness or weakness
weight gain
wheezing

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:

More common
Diarrhea
lack or loss of strength
loss of appetite
nausea
vomiting
weight loss
Incidence not known
Hives or welts
itching
rash
redness of the skin

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.


Last Updated: 4/4/2014

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