Cinacalcet

Cinacalcet is used to treat high calcium levels in the blood and hyperparathyroidism. It works by controlling the levels of parathyroid hormone (PTH), calcium and phosphorus in your body. Cinacalcet may be used alone or in combination with other medicines. It can be taken with or without food. It should be taken exactly as prescribed by your doctor. Your doctor will decide the dose and how often you should take them. You should take this medicine regularly to get the most benefit from it. Do not stop taking the medicine even if you feel better unless the doctor tells you so. Taking this medicine may cause few common side effects such as nausea, vomiting, dizziness, numbness or tingling sensation, and loss of appetite. Let your doctor know if any of these side effects do not go away with time or get worse, or if you experienced any other symptoms which you think is caused by this medicine. Before using this medicine, inform your doctor if you have any problems with your heart, liver, kidneys, or ever had seizures (fits or convulsions). You should also tell your doctor all the other medications you are taking. If you have low levels of calcium in your body, you should not take this medicine. Your doctor may monitor your blood calcium level while on treatment with this medicine. Pregnant and breastfeeding mothers should ask their doctors' advice before taking this medicine. Cinacalcet works by lowering a chemical (parathyroid hormone), which makes calcium level go back to normal.

• High calcium levels in the blood • Hyperparathyroidism

Cinacalcet is a calcimimetic agent. It lowers parathyroid hormone (PTH) secretion by increasing the sensitivity of the calcium-sensing receptor of the parathyroid gland to activation by extracellular calcium. PTH reduction leads to concomitant decrease in serum calcium and phosphorus concentrations.

Adult Dose: Secondary Hyperparathyroidism (HPT) Indicated for secondary HPT in patients with chronic kidney disease on dialysis Initial dose: 30 mg PO qDay May increase if needed by titrating at 2-4 week intervals through sequential doses of 60, 90, 120, or 180 mg qDay Hypercalcemia in Patients with Parathyroid Carcinoma Initial dose: 30 mg PO q12hr May increase if needed at 2-4 week intervals through sequential doses 60 mg q12hr, 90 mg q12hr, or 90 mg q6-8hr as necessary to normalize serum calcium levels Hypercalcemia With Primary Hyperparathyroidism (HPT) Indicated for severe hypercalcemia in patients with primary HPT who are unable to undergo parathyroidectomy Initial dose: 30 mg PO q12hr May increase if needed at 2-4 week intervals through sequential doses 60 mg q12hr, 90 mg q12hr, or 90 mg q6-8hr as necessary to normalize serum calcium levels Renal Dose: Renal Impairment Dose adjustment not necessary

Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Cinacalcet may be taken with or without food, but it is better to take it at a fixed time.

If you miss a dose of Cinacalcet, skip it and continue with your normal schedule. Do not double the dose.

Common: • Vomiting • Nausea

[UNSAFE] Cinacalcet may cause side effects which could affect your ability to drive. Dizziness and seizures have been reported by patients taking Cinacalcet. This may affect your driving ability. Cinacalcet treats hyperparathyroidism and high calcium levels in the blood. It should be taken with or shortly after food. Cinacalcet may cause dizziness or sleepiness. Do not drive or do anything requiring concentration until you know how it affects you. Inform your doctor if you start or stop smoking during treatment with Cinacalcet. Your doctor may monitor your calcium levels regularly during treatment with Cinacalcet. Inform your doctor if you notice signs of low calcium levels such as numbness or tingling around the mouth or muscle aches. Inform your doctor if you have a history of seizures, heart problems, or liver problems.

Hypersensitivity.

Cinacalcet is a strong CYP2D6 inhibitor and may increase serum concentrations of amitriptyline, nortriptyline and desipramine. Cinacalcet may decrease serum concentrations of tacrolimus. CYP3A4 inhibitors such as ketoconazole, erythromycin may increase plasma concentrations of Cinacalcet.

[CONSULT YOUR DOCTOR] It is not known whether it is safe to consume alcohol with Cinacalcet. Please consult your doctor.

[CONSULT YOUR DOCTOR] Cinacalcet may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.

[CONSULT YOUR DOCTOR] Cinacalcet is probably unsafe to use during breastfeeding. Limited human data suggests that the drug may pass into the breastmilk and harm the baby.

[SAFE IF PRESCRIBED] Cinacalcet is safe to use in patients with kidney disease. No dose adjustment of Cinacalcet is recommended. [CAUTION] Cinacalcet should be used with caution in patients with liver disease. Dose adjustment of Cinacalcet may be needed. Please consult your doctor.

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