Details for: MAR-CINACALCET
Company: MARCAN PHARMACEUTICALS INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02480298 | MAR-CINACALCET | CINACALCET (CINACALCET HYDROCHLORIDE) | 30 MG | TABLET | ORAL |
| 02480301 | MAR-CINACALCET | CINACALCET (CINACALCET HYDROCHLORIDE) | 60 MG | TABLET | ORAL |
| 02480328 | MAR-CINACALCET | CINACALCET (CINACALCET HYDROCHLORIDE) | 90 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
MAR-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. MAR-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. MAR-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 MAR-CINACALCET if you are
hypersensitive (allergic) to any of the ingredients in
the tablet.
You should not take MAR-CINACALCET if your
blood calcium level is below the normal range.
What the medicinal ingredient is
Cinacalcet hydrochloride
What the non-medicinal 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 form it comes in
MAR-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 MAR-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 heart beat, if you have heart
rhythm problems, or if you take medicines known to
cause heart rhythm problems, while taking MARCINACALCET.
MAR-CINACALCET is not recommended for
patients with CKD not receiving dialysis.
MAR-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 MAR-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 MAR-CINACALCET exactly as your doctor has instructed you. Your doctor will tell you how much MAR-CINACALCET to take. Your doctor will order regular blood tests to measure how you are responding to MAR-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 MAR-CINACALCET is one 30 mg
tablet once daily.
If you have parathyroid cancer or primary
hyperparathyroidism, the usual starting dose for
MAR-CINACALCET is one 30 mg tablet twice daily.
MAR-CINACALCET is taken with food or right after
a meal. MAR-CINACALCET tablets must be taken
whole and are not to be chewed, crushed, or divided.
It's best to take MAR-CINACALCET at the same time
each day.
MAR-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 MARCINACALCET.
Missed Dose
Do not take a double dose to make up for forgotten daily doses. If you have forgotten a dose of MARCINACALCET, 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 MAR-CINACALCET, you should tell your
doctor right away.
- Nausea and vomiting. These are the most common side effects seen with MAR-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 with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and get immedia te 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) | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking MAR-CINACALCET, contact your doctor or pharmacist.
How to store
Store MAR-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 adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/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 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/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
If you want more information about MarCinacalcet:
- 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); Marcan Pharmaceuticals Inc.’s website www.marcanpharma.com, or by calling 1-855- 627-2261.
Marcan Pharmaceuticals Inc.
2 Gurdwara Road, Suite #112,
Ottawa, ON, K2E 1A2
Date of Revision: December 9, 2019