Calcitriol Injection: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

• The management of hypocalcemia (low calcium levels)

  in patients undergoing chronic renal dialysis.

What it does:

Calcitriol Injection helps to regulate calcium levels in the blood.

When it should not be used:

You should not use Calcitriol Injection if you:

• are allergic to calcitriol, or vitamin D or its analogues

  and derivatives, or any of the non-medicinal ingredients in Calcitriol Injection

• have high calcium levels (hypercalcemia)
• have high vitamin D levels (vitamin D toxicity).

What the medicinal ingredient is:

calcitriol

What the important non-medicinal ingredients are: Edetate disodium, Polysorbate 20, Sodium chloride, Sodium ascorbate, Dibasic sodium phosphate, Monobasic sodium phosphate and Water for Injection.

What dosage forms it comes in:

Calcitriol Injection is supplied in 1 mL amber ampoules containing 1 mcg or 2 mcg of calcitriol.

BEFORE you use Calcitriol Injection talk to your doctor or pharmacist if:

• you are allergic to vitaminD or to any ingredient

  of Calcitriol Injection

• you are on digitalis

• you are pregnant or nursing

• you are taking other vitamin D product or its derivatives.

The safety and effectiveness of Calcitriol Injection in children under 18 years of age have not been established.

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with Calcitriol Injection include:

• digitalis
• anti-seizure medications (e.g., diphenylhydantoin and barbiturates)
• antacids containing magnesium
• corticosteroids
• thiazide diuretics (e.g., hydrochlorothiazide)

PROPER USE OF THIS MEDICATION

The effectiveness of Calcitriol Injection therapy is based on the assumption that each patient is receiving an adequate daily intake of calcium.

To ensure that each patient receives an adequate daily intake of calcium, the physician may either prescribe a calcium supplement or instruct the patient in appropriate dietary measures.

Usual dose:

The dose will be decided by your doctor and be given through a catheter three times per week at the end of hemodialysis. You should also take your prescribed daily dose of calcium and follow the instructions on diet and supplement intake.

Overdose:

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

The most common side effect of Calcitriol Injection is hypercalcemia (high calcium levels).

Early symptoms (within first few months of use of drug) of hypercalcemia and vitamin D toxicity include: weakness, headache, feeling sleepy, nausea, irregular heart beat, excessive thirst, vomiting, dry mouth, constipation, abdominal pain, loss of appetite, discomfort or unpleasant sensation in the upper abdomen, muscle pain, bone pain, and metallic taste.

Late symptoms (with continued [chronic] use of drug): too much protein in your urine, loss of appetite, feeling WARNINGS AND PRECAUTIONS

If you think you have taken too much Calcitriol Injection, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. IMPORTANT: PLEASE READ

Calcitriol Injection –Product Monograph Page 23 of 23

indifferent or lack of emotion, abnormal heart beat, swelling

or infection near your eyelid, decreased sex drive, loss of

water/not enough water in your body, abnormal changes in

bone and muscle development, deposit of calcium salt in

tissues, excessive nitrogen in your urine, elevated liver

function tests, high cholesterol, high blood pressure, feeling

too hot, too much calcium in your kidneys, needing to urinate

at night, inflammation of the pancreas, sensitivity to light,

excessive thirst, increased need to urinate, itching, loss of

contact with reality, runny nose, changes in sensation such as

pain, touch, pressure and temperature sensation, urinary tract

infections, and weight loss.

If these side effects do not go away or if you experience

other side effects which are not listed above, talk to your

doctor right away.

This is not a complete list of side effects. For any

unexpected effects while taking Calcitriol Injection, contact your doctor or pharmacist.

HOW TO STORE IT

Store at room temperature between 15 °C and 30 °C. Protect from light, freezing or excessive heat.

Keep out of 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

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Fresenius Kabi Canada Ltd., at 1-877-821-7724.

Fresenius Kabi Canada Ltd.

165 Galaxy Blvd, Suite 100

Toronto, ON, M9W 0C8

Last Revised: November 16, 2017