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RIVA-CINACALCET is a brand name for Cinacalcet, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE .............................................................................................................. 3 CONTRAINDICATION ................................................................................................................................. 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
BEFORE you use RIVA-CINACALCET talk to your doctor or pharmacist if: 1. You have or had seizures (convulsions). The risk of having a seizure is greater if you have had seizures before. 2. You have or had heart problems (low blood pressure or worsening heart failure).
3. You have or had liver problems. 4. You have lower blood calcium levels. 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 heartbeat, if you have heart rhythm problems, or if you take medicines known to cause heart rhythm problems, while taking RIVA-CINACALCET.
RIVA-CINACALCET is not recommended for patients with CKD not receiving dialysis. RIVA-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 RIVA-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 RIVA-CINACALCET exactly as your doctor has instructed you. Your doctor will tell you how much RIVA-CINACALCET to take. Your doctor will order regular blood tests to measure how you are responding to RIVA- 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 RIVA-CINACALCET is one 30 mg tablet once daily. If you have parathyroid cancer or primary hyperparathyroidism, the usual starting dose for RIVA-CINACALCET is one 30 mg tablet twice daily.
RIVA-CINACALCET is taken once a day with food or right after a meal. RIVA-CINACALCET tablets must be taken whole and are not to be chewed, crushed, or divided. It’s best to take RIVA- CINACALCET at the same time each day. RIVA-CINACALCET can be used alone or in combination with vitamin D sterols and/or phosphate binders.
Overdose:
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Cinacalcet in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Tell your doctor or contact your regional Poison Control Centre immediately if you think you took more than the recommended dose of RIVA- CINACALCET. If you think you, or a person you are caring for, have taken too much RIVA-CINACALCET, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed Dose:
Do not take a double dose to make up for forgotten daily doses. If you have forgotten a dose of RIVA-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 RIVA-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.
IMPORTANT:
PLEASE READ RIVA-CINACALCET (Cinacalcet Tablets) Product Monograph Page 23 of 24 • 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). SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM Frequency/Side Effect/Symptom Talk to your healthcare professional Stop taking this drug and get immediate medical help Only if severe In all cases Common Diarrhea ✓ Hypocalcemia/ low calcium level (symptoms may include: unusually fast or pounding heartbeat, 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) ✓ SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM Frequency/Side Effect/Symptom Talk to your healthcare professional Stop taking this drug and get immediate medical help Only if severe In all cases Angioedema (swelling of the face, lips, mouth, tongue or throat) ✓ Severe hypersensitivity/alle rgic reactions (symptoms may include: skin rash, hives, itching, difficulty breathing or swallowing, swelling of face, tongue or throat) ✓ This is not a complete list of side effects.
For any unexpected effects while taking RIVA- CINACALCET, contact your doctor or pharmacist. HOW TO STORE IT Store RIVA-CINACALCET tablets at room temperature (15°C to 30°C). Keep in a safe place out of the reach and sight of children.
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 healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
IMPORTANT:
PLEASE READ RIVA-CINACALCET (Cinacalcet Tablets) Product Monograph Page 24 of 24 […]