Reddy-Cinacalcet: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Reddy-Cinacalcet is used:

• to treat secondary hyperparathyroidism (high-per-pear-uh-THIGH-royd-izm) in patients with chronic kidney disease (CKD) receiving dialysis;
• to reduce high levels of calcium in the blood (hypercalcemia) in patients with parathyroid cancer;
• to reduce high levels of calcium in the blood (hypercalcemia) in patients with primary hyperparathyroidism when removal of the gland(s) is not possible.

What it does:

Four small glands located behind the thyroid gland in your neck are called parathyroid glands. They make a hormone called parathyroid hormone (PTH). Normally, PTH makes sure you have just enough calcium and phosphorus in your blood to keep your bones, heart, muscles, nerves and blood vessels working well.

Secondary hyperparathyroidism

When your kidneys are working, PTH keeps your calcium and phosphorus levels normal by moving the right amounts of calcium and phosphorus in and out of your bones. Chronic Kidney Disease (CKD) can cause a condition called secondary hyperparathyroidism.

When your kidneys aren’t working properly, the calcium and phosphorus balance in your body is upset, and your parathyroid glands send out too much PTH to your body. This can cause bone disease and also may

Parathyroid carcinoma/Primary hyperparathyroidism

Primary hyperparathyroidism is caused by an overactive, enlarged parathyroid gland (or glands), occasionally due to cancer of the parathyroid gland. In primary hyperparathyroidism, your parathyroid glands send out too much PTH to your body and your blood level of calcium becomes high. Reddy-Cinacalcet lowers PTH by telling your parathyroid glands to stop releasing too much PTH into your blood. This helps lower your blood calcium levels.

When it should not be used:

You should not take Reddy-Cinacalcet if you are hypersensitive (allergic) to any of the ingredients in the tablet.

You should not take Reddy-Cinacalcet if your blood calcium level is below the normal range.

What the medicinal ingredient is:

Cinacalcet hydrochloride

What the important nonmedicinal ingredients are:

Colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch. Tablets are coated with color (Opadry II green) FD&C blue #2, hypromellose, iron oxide yellow, lactose monohydrate, titanium dioxide and triacetin.

What dosage forms it comes in:

Reddy-Cinacalcet is available as small, light green tablets packaged in bottles of 30 and 500 tablets. Each tablet contains 30 mg, 60 mg, or 90 mg of cinacalcet hydrochloride.

WARNINGS AND PRECAUTIONS

BEFORE you use Reddy-Cinacalcet talk to your doctor or pharmacist if:

1. 1.

   You have or had seizures (convulsions). The risk of

   having a seizure is greater if you have had seizures before.

IMPORTANT: PLEASE READ

1. 2. You have or had heart problems (low blood pressure or worsening heart failure).
2. 3. You have or had liver problems.
3. 4.

   You have lower blood calcium levels.

   If you have parathyroid cancer or primary hyperparathyroidism, the usual starting dose for Reddy-Cinacalcet is one 30 mg tablet twice daily.

   Reddy-Cinacalcet is taken once a day with food or right after a meal. Reddy-Cinacalcet tablets must be taken whole and

4. 5.

   You are pregnant, breastfeeding, or plan to do so.

Low calcium levels can have an effect on your heart rhythm. Tell your doctor if you experience an unusually fast or pounding heart beat, if you have heart rhythm problems, or if you take medicines known to cause heart rhythm problems, while taking REDDY-Cinacalcet.

Reddy-Cinacalcet is not recommended for patients with CKD not receiving dialysis.

Reddy-Cinacalcet should not be used in children. A death was reported in an adolescent clinical trial patient with very low calcium levels in the blood (hypocalcemia).

INTERACTIONS WITH THIS MEDICATION

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.

Drugs that may interact with Reddy-Cinacalcet include: ketoconazole, erythromycin, itraconazole, metoprolol, flecainide, vinblastine, thioridazine, rifampin, phenytoin, or medicines such as tricyclic antidepressants (desipramine, amitriptyline).

PR

PROPER USE OF THIS MEDICATION

O

It is important to take Reddy-Cinacalcet exactly as your doctor has instructed you. Your doctor will tell you how much Reddy-Cinacalcet to take. Your doctor will order regular blood tests to measure how you are responding to Reddy-Cinacalcet and may increase or decrease your dose based on your PTH, calcium, and phosphate levels.

Usual Adult Dose:

If you have secondary hyperparathyroidism the usual starting dose for Reddy-Cinacalcet is one 30 mg tablet once daily. USE THIS MEDICATION

are not to be chewed, crushed, or divided. It’s best to take Reddy-Cinacalcet at the same time each day.

Reddy-Cinacalcet can be used alone or in combination with vitamin D sterols and/or phosphate binders.

Overdose:

Tell your doctor or contact your regional Poison Control Centre immediately if you think you took more than the recommended dose of Reddy-Cinacalcet.

If you think you have taken too much Reddy-Cinacalcet, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Missed Dose:

Do not take a double dose to make up for forgotten daily doses. If you have forgotten a dose of Reddy-Cinacalcet, you should take your next daily dose as normal.

PR

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

All medicines have side effects.

If you have any of the following side effects while taking

Reddy-Cinacalcet, you should tell your doctor right away.

• Nausea and vomiting. These are the most common side effects seen with Reddy-Cinacalcet treatment. This may make it difficult to take your medicines.
• Diarrhea, muscle pain and back pain. These side effects also are commonly reported.
• Rash or hypersensitivity (allergic reactions). Cases of rash have been commonly reported, while cases of hypersensitivity (allergic reactions) have been uncommonly reported.
• Hives (urticaria) is very rarely reported.
• Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema) is also very rarely reported.
• Joint pain (pseudogout).

Joint(

IMPORTANT: PLEASE READ

HOW TO STORE IT

REPORTING SIDE EFFECTS

MORE INFORMATION