Cinacalcet (Sanis Health): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

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 be a risk factor for heart disease and abnormal calcification of blood vessels and other parts of the body. CINACALCET treats secondary hyperparathyroidism by lowering PTH. This helps keep calcium and phosphorus within proper levels.

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. 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 CINACALCET if you are hypersensitive (allergic) to any of the ingredients in the tablet.

You should not take CINACALCET if your blood calcium level is below the normal range.

What the medicinal ingredient is:

Cinacalcet hydrochloride

What the important nonmedicinal ingredients are:

Microcrystalline cellulose, Low Substituted Hydroxy Propyl Cellulose, Lactose Monohyrate, Colloidal silicon dioxide, Magnesium stearate and Purified water. Tablets are coated with colour (Opadry® II green).

What dosage forms it comes in:

CINACALCET is available as small, light green tablets packaged in bottles of 30’s, 100’s and 500’s tablets. Each tablet contains 30 mg, 60 mg, or 90 mg of cinacalcet.

WARNINGS AND PRECAUTIONS

BEFORE you use 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.
2. 2. You have or had heart problems (low blood pressure or worsening heart failure).
3. 3. You have or had liver problems.
4. 4. You have lower blood calcium levels.
5. 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 CINACALCET.

CINACALCET is not recommended for patients with CKD not receiving dialysis.

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 CINACALCET include: ketoconazole, erythromycin, itraconazole, metoprolol, flecainide, vinblastine, thioridazine, rifampin, phenytoin, or medicines such as tricyclic antidepressants (desipramine, amitriptyline).

PROPER USE OF THIS MEDICATION

It is important to take CINACALCET exactly as your doctor has instructed you. Your doctor will tell you how much CINACALCET to take. Your doctor will order regular blood tests to measure how you are responding to 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 CINACALCET is one 30 mg tablet once daily.

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

CINACALCET is taken with food or right after a meal. CINACALCET tablets must be taken whole and are not to be chewed, crushed, or divided. It's best to take CINACALCET at the same time each day.

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 CINACALCET.

If you think you have taken too much 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 CINACALCET, you should take your next daily dose as normal.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

All medicines have side effects.

If you have any of the following side effects while taking CINACALCET, you should tell your doctor right away.

• Nausea and vomiting. These are the most common side effects seen with 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)

This is not a complete list of side effects. For any unexpected effects while taking CINACALCET,

contact your doctor or pharmacist.

HOW TO STORE IT

Store CINACALCET tablets at room temperature (15°C to 30°C). Keep in a safe place out of the reach and sight of children.

REPORTING SIDE EFFECTS You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the web page on Adverse Reaction

  Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-

  products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or

• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

If you want more information about CINACALCET:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://health- products.canada.ca/dpd-bdpp/index-eng.jsp); contacting Sanis Health Inc. at 1-866-236-4076 or quality@sanis.com.

Sanis Health Inc.

1 President's Choice Circle

Brampton, Ontario

L6Y 5S5

Date of Revision: January 31, 2022