Deztron

contains the active ingredient zoledronic acid


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about DEZTRON.

It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you taking DEZTRON against the benefits they expect it will have for you.

If you have any concerns about using this medicine, talk to your doctor or pharmacist.

Keep this leaflet. You may need to read it again.

What DEZTRON is used for

DEZTRON is used to:

  • lower the amount of calcium in the blood when it becomes too high, as may happen in some forms of cancer. Some cancers can speed up normal changes in bone so that the amount of calcium released from the bones into the blood is increased.
  • slow down the spread of cancers in bone, helping to prevent changes to the bones that may cause them to weaken. It is used in people with advanced cancer of the bone marrow (called multiple myeloma) and other advanced cancers that have spread to the bone. This medicine is used in addition to other standard cancer treatments.

DEZTRON belongs to a group of medicines called bisphosphonates, which strongly bind to bone. These medicines work by slowing down the rate of bone change and help to restore the amount of calcium in the blood to normal.

Your doctor may have prescribed DEZTRON for another reason. Ask your doctor if you have any questions about why DEZTRON has been prescribed for you.

DEZTRON is not recommended for use in children, as there have been no studies of its effects in children.

DEZTRON is available only with a doctor's prescription.

There is no evidence that DEZTRON is addictive.

Before you are given DEZTRON

When you must not take it

Do not have DEZTRON if you are allergic to medicines containing zoledronic acid, any other bisphosphonate medicine or any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include skin rash, itching or hives, swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, wheezing or shortness of breath.

Other bisphosphonate medicines can cause breathing difficulties in people with asthma who are allergic to aspirin. It is not known whether ZOLEDRONIC ACID ACTAVIS can have this effect.

Do not have DEZTRON if you are pregnant. There is no information on the use of DEZTRON during pregnancy.

Do not have DEZTRON if you are breastfeeding. It is not known whether DEZTRON passes into breast milk.

Do not have DEZTRON if the expiry date (Exp.) printed on the pack has passed.

Do not have DEZTRON if the packaging is torn or shows signs of tampering.

Before you start to take it

Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.

Tell your doctor if you plan to become pregnant or breastfeed.

Tell your doctor if you have, any medical conditions, especially the following:

  • kidney or liver problems
  • a heart condition
  • asthma and are allergic to aspirin
  • had surgery on your thyroid
  • had or have pain in teeth, gum or jaw, swelling or numbness of the jaw or a ‘heavy jaw feeling’ or loosening of a tooth.

Your doctor may want to take special care if you have any of these conditions.

Your doctor may recommend that you have a dental check-up before starting DEZTRON. Tell your dentist you may be receiving DEZTRON.

Tell your doctor if you need to have any dental treatment or dental surgery. A dental condition called jaw osteonecrosis has been reported in some patients being treated with DEZTRON or with other medicines in the same class. You may need to have any necessary dental treatments completed before starting it.

If you have not told your doctor about any of the above, tell them before you start having DEZTRON.

Ensure sufficient intake of fluid (water) prior to infusions as directed by your doctor as this will help prevent dehydration.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. Some medicines may be affected by DEZTRON, or may affect how well it works. These include:

  • medicines that may have side effects on your kidneys
  • aminoglycoside medicines, used to treat severe infections. The combination of aminoglycoside and bisphonate medicines may cause the level of calcium in the blood to become too low.
  • thalidomide, a medicine used in clinical trials to treat multiple myeloma

Your doctor can tell you what to do if you are taking any of these medicines.

If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while being given DEZTRON.

How DEZTRON will be given

How much you will be given

To lower the amount of calcium in the blood, the usual dose of DEZTRON is 4 mg, given as a single infusion.

To treat cancer in the bone, the usual dose is 4 mg, given as an infusion every 3 to 4 weeks. Your doctor may give you a lower dose if you have a kidney problem. Your doctor may also prescribe a daily calcium supplement and a multiple vitamin containing Vitamin D.

You will have a blood test before each dose of DEZTRON to make sure the medicine is not affecting your kidneys.

Follow all directions given to you by your doctor and pharmacist carefully.

How DEZTRON will be given

DEZTRON is given as a 15 minute infusion into a vein.

You may also be given an infusion of fluids to ensure that you do not become dehydrated.

If you are given too much DEZTRON (overdose)

Tell your doctor if you have any of the following symptoms. They may mean that the level of calcium in your blood has fallen too far.

  • unusual light headedness, dizziness or faintness
  • numbness or tingling sensation
  • muscle cramps

While you are being given DEZTRON

Things you must do

Before starting any new medicine, tell your doctor or pharmacist that you are being given DEZTRON.

Make sure you follow your doctor's instructions carefully and keep all appointments. You will need regular blood tests to make sure the treatment is working. Regular blood tests can also find side effects before they become serious.

Tell all the doctors, dentists and pharmacists who are treating you that you are being given DEZTRON.

If you become pregnant while being given DEZTRON, tell your doctor immediately.

Tell your doctor and dentist immediately about any dental symptoms including pain or unusual feeling in your teeth or gums, or any dental infections. A dental condition called jaw osteonecrosis has been reported in some patients being treated with DEZTRON or other drugs in the same class as DEZTRON.

Tell your dentist that you are being treated with DEZTRON. Your dentist may need to take special precautions.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are being given DEZTRON.

Things to be careful of

Be careful driving, operating machinery or performing jobs that require you to be alert until you know how DEZTRON affects you. If you are returning home immediately after the infusion, arrange to have someone else drive.

Practice good dental hygiene. Your routine dental hygiene should include:

  • brushing your teeth and tongue after every meal and at bedtime
  • gentle flossing once a day to remove plaque
  • keeping your mouth moist by drinking water (many cancer medicines can cause "dry mouth" which can lead to decay and other dental problems)
  • avoiding use of mouthwash that contains alcohol.

Use a mirror to check your teeth and gums regularly for any changes such as sores or bleeding gums. If you notice any problems, tell your doctor or dentist immediately.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are being given DEZTRON.

Like all other medicines, DEZTRON may have unwanted side effects in some people. 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:

  • short-lasting fever, sometimes with flu-like symptoms such as chills, tiredness, weakness and aches and pains
  • redness, swelling or pain where the needle for the infusion was inserted
  • tingling or numbness of the hands or feet
  • upset stomach, abdominal pain, loss of appetite
  • nausea (feeling sick) or vomiting
  • dry or sore mouth
  • constipation or diarrhoea
  • swollen aching joints or muscles, pain in the bones
  • swelling of fingers or lower legs due to fluid build up
  • anxiety, confusion, difficulty sleeping
  • headache, facial pain
  • irritated eyes, blurred vision, eye pain, sensitivity to light, runny, itchy or swollen eyes
  • changes in taste sensation
  • cough
  • slow heart eat
  • increased sweating
  • irregular heart beat
  • difficulty breathing with wheezing or coughing.

Tell your doctor immediately or go to Accident and Emergency at the nearest hospital if you notice any of the following:

  • signs of allergy such as rash, itching or hives on the skin; swelling of the face, lips, tongue or other parts of the body; shortness of breath, wheezing or troubled breathing
  • signs that the level of calcium in your blood may have fallen too far, such as unusual lightheadness, dizziness or faintness, numbness or tingling sensation, muscle cramps
  • constant “flu-like” symptoms (chills, fever, sore throat, sores in mouth, swollen glands, tiredness or lack of energy) that could be a sign of blood problems
  • chest pain
  • passing less urine than normal,blood in the urine
  • pain in the mouth, teeth or jaw, swelling or sores inside the mouth, numbness or a “heavy jaw feeling” or loosening of a tooth. These symptoms could be a sign of a jaw-bone problem known as jaw osteonecrosis.

The above effects can be serious. You may need urgent medical attention.

Unusual fracture of the thigh bone particularly in patients on long- term treatment for osteoporosis may occur. Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early sign of a possible fracture of the thigh bone.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything that is making you feel unwell.

After using DEZTRON

Storage

If you keep DEZTRON at home, keep it where children cannot reach it. A locked cupboard at least one- and-a-half metres above the ground is a good place to store medicines.

Keep your DEZTRON in a cool dry place where the temperature stays below 30°C.

Do not store DEZTRON or any other medicine in the bathroom or near a sink.

Do not leave DEZTRON in the car or on window sills. Heat and dampness can destroy some medicines.

Disposal

If you no longer need DEZTRON, or the expiry date has passed, ask your pharmacist what to do with any that is left over.

Product description

What it looks like

DEZTRON concentrated injection is packaged in plastic vials containing the active ingredient, zoledronic acid, in 5 mL solution.

DEZTRON is a concentrated injection.

Ingredients

The active ingredient in DEZTRON is zoledronic acid. Each DEZTRON vial contains 4 mg of zoledronic acid in a 5 mL solution.

The solution also contains:

  • mannitol
  • sodium citrate
  • water for injections.

Supplier

Medsurge Healthcare Pty Limited
Unit 2, 6-7 Gilda Court
MULGRAVE
VICTORIA 3170

Australian registration numbers:
DEZTRON – AUST R 186527

Date of preparation:
February 2019.

Published by MIMS October 2019


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