Calcijex®
Calcitriol
Consumer Medicine Information (CMI)
NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Calcijex. It does not contain all the information that is known about Calcijex. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What Calcijex is used for
Calcijex contains the active ingredient calcitriol. Calcitriol is an active form of Vitamin D3. This vitamin is often lacking in people who are having renal dialysis and are unable to maintain the correct amount of calcium in the blood.
Calcijex increases the amount of calcium in the blood by:
increasing absorption of calcium from the intestines
reducing any loss of calcium from the kidneys
Calcijex reduces levels of serum parathyroid hormone. This hormone is often far too high in patients who are receiving renal dialysis.
Ask your doctor if you have any questions about why it has been prescribed for you.
Your doctor may have prescribed it for another purpose.
This medicine is available only with a doctor's prescription.
Before you are given Calcijex
When you must not be given Calcijex
Do not receive Calcijex if you have had an allergic reaction to:
any medicine containing calcitriol
any other ingredients listed at the end of this leaflet
Some symptoms of an allergic reaction include skin rash, itching, shortness of breath or swelling of the face, lips or tongue, which may cause difficulty in swallowing or breathing.
Do not receive Calcijex if you have a high level of calcium in your blood (hypercalcaemia).
Do not give Calcijex to a child under the age of 18 years.
Safety and effectiveness in children younger than 18 years have not been established.
Do not receive Calcijex after the expiry date printed on the ampoule or if the packaging is damaged or shows signs of tampering.
Before you are given Calcijex
Tell your doctor if you have any allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
a transplant
problems with your bones eg. osteoporosis
Tell your doctor if you are pregnant, intend to become pregnant or are breastfeeding
Your doctor can discuss the risks and benefits involved before Calcijex is administered.
If you have not told your doctor about any of the above, tell them before you are given Calcijex.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food store.
Some medicines and Calcijex may interfere with each other. These include:
magnesium containing antacids (medicines to treat heartburn and indigestion)
any other medicines containing Vitamin D or vitamin D analogues (eg. ergocalciferol and cholecalciferol)
cardiac glycosides (medicines used to treat heart failure eg. Digitalis)
barbiturates and anticonvulsant (medicines used to treat epilepsy)
corticosteroids, medicines such as prednisone and cortisone, (need an example)
diuretics (medicines used to treat high blood pressure or kidney problems)
These medicines may be affected by Calcijex, or may affect how well it works. You may need to use different amounts of your medicine, or take different medicines.
Your doctor or pharmacist has more information on medicines to be careful with or to avoid while taking Calcijex.
How Calcijex should be given
Calcijex is given by intravenous injection and will always be given to you by your doctor or nurse.
The dose of Calcijex will be calculated exactly for you and will be balanced against the level of calcium in your body.
The usual recommended dose of Calcijex is 0.50 micrograms administered three times weekly, approximately every other day.
For Calcijex to work properly it is important that you have enough calcium in your diet.
Your doctor will speak to you about your diet and may also recommend calcium supplements for you to take.
Do not take any other vitamins or supplements without speaking to your doctor first.
Do not stop using Calcijex without first consulting with your doctor.
It is important to keep taking your medicine even if you feel well.
While you are being given Calcijex
Things you must do
Tell your doctor or nurse if you start to feel unwell while you are being given Calcijex.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are receiving Calcijex.
Tell any other doctors, dentists and pharmacists who treat you that you are receiving this medicine.
If you are going to have surgery, tell the surgeon that you are receiving this medicine.
If you become pregnant while you are receiving this medicine, tell your doctor or pharmacist immediately.
If you are about to have any blood tests, tell your doctor that you are receiving this medicine.
It may interfere with the results of some tests.
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side-effects.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are receiving Calcijex.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
headache
sleepiness
nausea
vomiting
constipation
loss of appetite
stomach pain
muscle or bone pain
feeling tired or weak
metallic taste
dry mouth
excessive thirst
you find you need to urinate during the night or pass more urine than normal
conjunctivitis
sensitivity to light or changes in vision
runny nose
itchy rash
high body temperature
decreased sexual drive
irregular heart beat
urinary tract infections
chest pain
high blood pressure (hypertension)
weight loss
anorexia
The above list includes some serious side effects that may require medical attention. Serious side effects are rare.
If any of the following happen, tell your doctor immediately or go to the Emergency Department at your nearest hospital:
skin rash or hives
shortness of breath
swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing
The above list includes very serious side effects. You may need urgent medical attention. These side effects are rare.
Tell your doctor or pharmacist if you notice anything else that is making you feel unwell.
Other side effects not listed above may occur in some people.
Some of these side effects can only be found when your doctor does tests from time to time to check your progress.
Storage
Calcijex should be stored in a cool, dry place, below 25°C away from light.
Product description
What it looks like
Calcijex is an amber-coloured glass ampoule containing a clear, colourless liquid.
Calcijex is available in a pack of twenty five 1 mL ampoules.
Ingredients
Calcijex is available in 1 or 2* micrograms of calcitriol as the active ingredient.
It also contains
polysorbate 20
sodium chloride
sodium ascorbate
sodium phosphate
edetate sodium
water for injections
Calcijex does not contain a preservative.
* Presentation not currently marketed
Supplier
Calcijex is supplied in Australia by:
Abbott Australasia Pty Ltd
32-34 Lord Street
Botany NSW 2019
® Registered Trademark
This leaflet was prepared in October 2011.
Australian Registration Number(s)
1 mcg/mL ampoules: AUST R 54452
2 mcg/mL ampoules: AUST R 54453
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