Cinacalcet
Secondary Hyperparathyroidism, Primary Hyperparathyroidism ... show more
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Drug Status
Government Approvals
US(FDA), UK(BNF)
WHO Essential Medicine
NO
Known Teratogen
No
Pharmaceutical Class
Calcium-sensing Receptor Agonist
Controlled Drug Substance
No
Cinacalcet
Summary
Cinacalcet is used to treat secondary hyperparathyroidism in patients with chronic kidney disease who are on dialysis. It's also used to manage high calcium levels in patients with parathyroid cancer, and severe hypercalcemia in patients with primary hyperparathyroidism who cannot undergo parathyroidectomy.
Cinacalcet works by increasing the sensitivity of the calcium-sensing receptor on the parathyroid gland. This results in reduced production of parathyroid hormone (PTH), which in turn lowers calcium levels in the blood.
For adults, the usual starting dose of Cinacalcet is 30 mg once daily. The dose can be increased every 2 to 4 weeks to a maximum of 180 mg daily. For children aged 3 years and older, the dose is based on body weight and can be adjusted every 4 weeks.
Common side effects of Cinacalcet include nausea, vomiting, and diarrhea. Other side effects can include decreased appetite, headaches, and dizziness.
Cinacalcet can cause low calcium levels, which can lead to serious complications like seizures. It is not recommended for patients with serum calcium levels below the normal range. Additionally, it should not be used in patients with known hypersensitivity to the drug.
Indications and Purpose
How does Cinacalcet work?
Cinacalcet works by increasing the sensitivity of the calcium-sensing receptor on the parathyroid gland. This action reduces the production of parathyroid hormone (PTH), which in turn lowers calcium levels in the blood. By modulating the receptor's response to calcium, Cinacalcet helps manage conditions associated with high PTH and calcium levels.
Is Cinacalcet effective?
Cinacalcet has been shown to effectively reduce parathyroid hormone (PTH) levels in patients with secondary hyperparathyroidism and hypercalcemia. Clinical studies have demonstrated significant reductions in PTH, calcium-phosphorus product, calcium, and phosphorus levels in patients treated with Cinacalcet compared to placebo. These results were consistent across multiple studies, supporting its effectiveness in managing these conditions.
What is Cinacalcet?
Cinacalcet is used to treat secondary hyperparathyroidism in patients with chronic kidney disease on dialysis and to manage high calcium levels in patients with parathyroid cancer. It works by increasing the sensitivity of the calcium-sensing receptor on the parathyroid gland, which reduces the production of parathyroid hormone (PTH) and lowers calcium levels in the blood.
Directions for Use
For how long do I take Cinacalcet?
Cinacalcet is typically used as a long-term treatment to manage conditions like secondary hyperparathyroidism and hypercalcemia. It helps control these conditions but does not cure them, so it is often taken continuously as prescribed by a healthcare provider. The duration of use will depend on the individual's response to the medication and the specific condition being treated.
How do I take Cinacalcet?
Cinacalcet should be taken with food or shortly after a meal to increase its absorption. The tablets should be swallowed whole and not split, chewed, or crushed. There are no specific food restrictions, but patients should talk to their doctor about drinking grapefruit juice while taking this medication, as it may interact with the drug.
How long does it take for Cinacalcet to start working?
Cinacalcet begins to reduce parathyroid hormone (PTH) levels within 2 to 6 hours after taking a dose, with the maximum effect occurring at this time. However, it may take several weeks of regular use to achieve the desired reduction in PTH levels and calcium levels in the blood. Regular monitoring by a healthcare provider is important to assess the medication's effectiveness.
How should I store Cinacalcet?
Cinacalcet should be stored in its original container, tightly closed, and kept out of reach of children. It should be stored at room temperature, away from excess heat and moisture, and not in the bathroom. Unneeded medication should be disposed of through a medicine take-back program, not by flushing down the toilet, to ensure safety for pets, children, and others.
What is the usual dose of Cinacalcet?
For adults, the usual starting dose of Cinacalcet is 30 mg once daily, which can be increased every 2 to 4 weeks to a maximum of 180 mg daily, depending on the condition being treated. For children aged 3 years and older, the starting dose is based on body weight and can be adjusted every 4 weeks. The maximum dose for children is 2.5 mg/kg/day, not exceeding 180 mg daily. Always follow your doctor's instructions for dosing.
Warnings and Precautions
Can Cinacalcet be taken safely while breastfeeding?
There is no data on the presence of Cinacalcet in human milk or its effects on a breastfed infant. However, it is excreted in the milk of lactating rats. The decision to use Cinacalcet while breastfeeding should consider the benefits of breastfeeding, the mother's need for the medication, and any potential risks to the infant. Consult your doctor for personalized advice.
Can Cinacalcet be taken safely while pregnant?
There is limited data on the use of Cinacalcet during pregnancy, and its effects on fetal development are not well established. Animal studies have shown some adverse effects at high doses, but the relevance to humans is unclear. Cinacalcet should only be used during pregnancy if the potential benefits justify the potential risks. Pregnant women should consult their doctor for personalized advice.
Can I take Cinacalcet with other prescription drugs?
Cinacalcet is metabolized by CYP3A4, and its levels can be affected by strong inhibitors or inducers of this enzyme, such as ketoconazole or rifampicin. It is also a strong inhibitor of CYP2D6, which may require dose adjustments for medications metabolized by this enzyme, like desipramine or metoprolol. Patients should inform their doctor of all medications they are taking to avoid potential interactions.
Is Cinacalcet safe for the elderly?
In clinical studies, no overall differences in safety or effectiveness were observed between elderly patients and younger patients. However, greater sensitivity in some older individuals cannot be ruled out. It is important for elderly patients to follow their doctor's instructions carefully and report any unusual symptoms or side effects. Regular monitoring of calcium levels is also recommended to ensure safe use.
Is it safe to exercise while taking Cinacalcet?
Cinacalcet does not specifically limit the ability to exercise. However, some side effects like dizziness, weakness, or muscle spasms could potentially affect physical activity. If you experience these symptoms, it is advisable to discuss them with your doctor. They can provide guidance on managing side effects and advise on safe levels of physical activity while taking this medication.
Who should avoid taking Cinacalcet?
Cinacalcet can cause hypocalcemia (low calcium levels), which can lead to serious complications like seizures and QT interval prolongation. It is contraindicated in patients with serum calcium levels below the normal range. Patients should be monitored for symptoms of hypocalcemia, such as tingling, muscle spasms, or seizures. Cinacalcet should not be used in patients with known hypersensitivity to the drug or its components.
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