Consumer Information for: APO-CINACALCET
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication is used for
-
APO-CINACALCET is used:
- to treat secondary hyperparathyroidism (high-perpear-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. APOCINACALCET 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. APO-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 APO-CINACALCET if you are hypersensitive (allergic) to any of the ingredients in the tablet.
You should not take APO-CINACALCET if your blood calcium level is below the normal range.
What the medicinal ingredient is
Cinacalcet (as cinacalcet hydrochloride)
What the non-medicinal ingredients are
Mannitol, microcrystalline cellulose, sodium starch glycolate, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, yellow iron oxide, brilliant blue FCF AL LAKE, and black iron oxide.
What dosage form it comes in
APO-CINACALCET is available as small, light green tablets packaged in bottles of 30 tablets and blister packs of 100 tablets. Each tablet contains 30 mg, 60 mg, or 90 mg of cinacalcet (as cinacalcet hydrochloride)
Warnings and precautions
BEFORE you use APO-CINACALCET talk to your doctor or pharmacist if:
- You have or had seizures (convulsions). The risk of having a seizure is greater if you have had seizures before.
- You have or had heart problems (low blood pressure or worsening heart failure).
- You have or had liver problems.
- You have lower blood calcium levels.
- 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 heartbeat, if you have heart rhythm problems, or if you take medicines known to cause heart rhythm problems, while taking APO-CINACALCET. APO-CINACALCET is not recommended for patients with CKD not receiving dialysis.
APO-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 APO-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 APO-CINACALCET exactly as your doctor has instructed you. Your doctor will tell you how much APO-CINACALCET to take. Your doctor will order regular blood tests to measure how you are responding to APO-CINACALCET and may increase or decrease your dose based on your PTH, calcium, and phosphate levels.
Usual Dose
If you have secondary hyperparathyroidism the usual starting dose for APO-CINACALCET is one 30 mg tablet once daily.
If you have parathyroid cancer or primary hyperparathyroidism, the usual starting dose for APOCINACALCET is one 30 mg tablet twice daily. APO-CINACALCET is taken with food or right after a meal. APO-CINACALCET tablets must be taken whole and are not to be chewed, crushed, or divided. It’s best to take APO-CINACALCET at the same time each day. APO-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 APO-CINACALCET.
If you think you have taken too much APOCINACALCET, 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 APOCINACALCET, you should take your next daily dose as normal.
Side effects and what to do about them
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All medicines have side effects.
If you have any of the following side effects while
taking APO-CINACALCET, you should tell your doctor
right away.
- Nausea and vomiting. These are the most common side effects seen with APO-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).
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Common | |||
| Diarrhea | ✔ | ||
| Hypocalcemia/ low calcium level (symptoms may include: unusually fast or pounding heart beat, numbness/ tingling around mouth, muscle aches/ cramps, seizures) | ✔ | ||
| Uncommon | |||
| Seizures (convulsions) | ✔ | ||
| Hypersensitivity/ allergic reactions (symptoms may include: skin rash, hives, itching, difficulty breathing, swelling of face, tongue or throat) | ✔ | ||
| Very Rare | |||
| Low blood pressure (symptoms may include: dizziness, feeling lightheaded, feeling tired) | ✔ | ||
| Worsening heart failure (symptoms may include: increased difficulty breathing, swelling of the legs, ankles and feet, feeling more tired) | ✔ | ||
| Angioedema (swelling of the face, lips, mouth, tongue or throat) | ✔ | ||
| Severe hypersensitivity/ allergic reactions (symptoms may include: skin rash, hives, itching, difficulty breathing or swallowing, swelling of face, tongue or throat) | ✔ | ||
How to store
Store APO-CINACALCET tablets at room temperature (15ºC to 30ºC). Keep in a safe place out of the reach and sight of children.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at MedEffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701D
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available at MedEffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
- Talk to your doctor or pharmacist.
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer’s website ***
This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9. Last revised: January 6, 2020
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