Liposomal Doxorubicin SUN Concentrate for infusion

Liposomal Doxorubicin SUN Concentrate for infusion is a brand of medicine containing the active ingredient doxorubicin hydrochloride (liposomal).

Find out more about active ingredients.

Consumer medicine information (CMI) leaflet

Developed by the pharmaceutical company responsible for this medicine in Australia, according to TGA regulations.

Liposomal Doxorubicin SUN

Pegylated liposomal Liposomal Doxorubicin hydrochloride


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Liposomal Doxorubicin SUN. It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using Liposomal Doxorubicin SUN against the benefits it is expected to have for you.

If you have any concerns about being given this medicine, ask your doctor or pharmacist.

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

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What is Liposomal Doxorubicin SUN used for

Liposomal Doxorubicin SUN is used to treat cancer of the breast and ovary. It is used to kill cancer cells, shrink the size and delay the growth of the tumour.

Liposomal Doxorubicin SUN is also used in combination with another medicine called bortezomib to treat multiple myeloma, which is a cancer of the plasma cell. Plasma cells are produced in the bone marrow and are a component of the immune system.

Liposomal Doxorubicin SUN is also used to treat Kaposi's sarcoma, another type of cancer. Liposomal Doxorubicin SUN produces an improvement in Kaposi's sarcoma including flattening, lightening and shrinkage of the cancer. Other symptoms of Kaposi's sarcoma, such as swelling around the tumour, may also improve or disappear.

Liposomal Doxorubicin SUN belongs to a group of medicines called antineoplastic or cytotoxic medicines. You may also hear of these being called chemotherapy medicines.

Liposomal Doxorubicin SUN contains a medicine called Liposomal Doxorubicin hydrochloride which is able to interact with cells in such a way as to selectively kill cancer cells. The Liposomal Doxorubicin hydrochloride in Liposomal Doxorubicin SUN is enclosed in tiny spheres called liposomes which help to deliver the medicine from the blood stream to the cancerous tissue rather than healthy normal tissue.

Your doctor, however, may prescribe Liposomal Doxorubicin SUN for another purpose.

Ask your doctor if you have any questions about why Liposomal Doxorubicin SUN has been prescribed for you.

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Before you are given Liposomal Doxorubicin SUN

When you must not be given it

Do not use Liposomal Doxorubicin SUN if you have an allergy to Liposomal Doxorubicin SUN, Liposomal Doxorubicin hydrochloride or any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

  • shortness of breath, wheezing, difficulty breathing or a tight feeling in your chest
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching, hives or flushed, red skin.

Do not use Liposomal Doxorubicin SUN if you are pregnant or breast-feeding.

Before you are given it

Your doctor must know about all of the following before you are given Liposomal Doxorubicin SUN.

Tell your doctor or pharmacist if you have allergies to:

  • any medicines (including other anti-cancer medicines)
  • any other substances, such as foods, preservatives or dyes.

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

  • heart problems
  • liver problems
  • diabetes
  • recent surgery to remove your spleen.

Tell your doctor if you have had any or are on other anti-cancer medicines.

Tell your doctor if you are pregnant/planning to become pregnant or breast-feeding. Liposomal Doxorubicin SUN is not recommended in pregnancy and breast-feeding. Your doctor will discuss the possible risks and benefits of using Liposomal Doxorubicin SUN during pregnancy and breast-feeding.

It is important that you or your partner use a reliable method of contraception to avoid pregnancy during Liposomal Doxorubicin SUN treatment and for 6 months after treatment is stopped. This applies to both female and male patients on Liposomal Doxorubicin SUN treatment.

If you have not told your doctor about any of the above, tell them before you are given Liposomal Doxorubicin SUN.

Taking or being given 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 shop.

Some medicines may affect the way other medicines work. Your doctor or pharmacist will be able to tell you what to do when being given Liposomal Doxorubicin SUN with other medicines.

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How is Liposomal Doxorubicin SUN given

Liposomal Doxorubicin SUN is given by your doctor in a drip (called an infusion) into a vein. Depending on the dose this may take from 30 minutes to more than one hour.

Your doctor will decide how much Liposomal Doxorubicin SUN you will be given and for how long.

The usual dose for cancer of the breast or ovary is 50 mg per square meter of body surface area. This dose is repeated every four weeks for as long as the disease does not progress and you are able to tolerate the treatment.

For multiple myeloma the usual dose is 30 mg per square meter of body surface area. This dose is repeated every three weeks as long as the disease has a satisfactory response and you are able to tolerate the treatment.

For Kaposi's sarcoma the usual dose is 20 mg per square meter of body surface area. This dose is repeated every 2 to 3 weeks for 2-3 months, then as often as necessary to maintain an improvement.

Overdose

As Liposomal Doxorubicin SUN is given to you under the supervision of your doctor, it is very unlikely that you will receive too much. However, if you experience any side effects after being given Liposomal Doxorubicin SUN, tell your doctor immediately. You may need urgent medical attention.

Symptoms of a Liposomal Doxorubicin SUN overdose include the side effects listed below in the 'Side Effects' section, but are usually of a more severe nature.

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While you are using Liposomal Doxorubicin SUN

Things you must do

If the drip stings or hurts while you are receiving a dose of Liposomal Doxorubicin SUN, tell your doctor immediately.

If the medicine starts to upset you or your symptoms become worse, tell your doctor.

Be sure to keep all your doctor's appointments so your progress can be checked. Your doctor may want to check your blood pressure and do some blood and other tests from time to time to check on your progress and detect any unwanted side effects.

Keep follow up appointments with your doctor. It is important to have your follow-up doses of Liposomal Doxorubicin SUN at the appropriate times to get the best effects from your treatments.

Tell any other doctors, dentists, and pharmacists who are treating you that you are on Liposomal Doxorubicin SUN treatment.

If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are on Liposomal Doxorubicin SUN treatment.

If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are on Liposomal Doxorubicin SUN treatment.

Tell your doctor, if you or your partner become pregnant during Liposomal Doxorubicin SUN treatment or 6 months after treatment is stopped.

Liposomal Doxorubicin SUN can lower the number of white blood cells and platelets in your blood. This means that you have an increased chance of getting an infection or bleeding. The following precautions should be taken to reduce your risk of infection or bleeding:

  • Avoid people who have infections. Check with your doctor immediately if you think you may be getting an infection, or if you get a fever, chills, cough, hoarse throat, lower back or side pain or find it painful or difficult to urinate.
  • Be careful when using a toothbrush, toothpick or dental floss. Your doctor, dentist, nurse or pharmacist may recommend other ways to clean your teeth and gums. Check with your doctor before having any dental work.
  • Be careful not to cut yourself when you are using sharp objects such as a razor or nail cutters.
  • Avoid contact sports or other situations where you may bruise or get injured.

Things to be careful of

Be careful driving or operating machinery until you know how Liposomal Doxorubicin SUN affects you. Liposomal Doxorubicin SUN may cause dizziness, tiredness or sleepiness in some people. Make sure you know how you react to Liposomal Doxorubicin SUN before you drive a car, operate machinery, or do anything else that could be dangerous if you are light-headed or sleepy.

Do not drive or operate machinery, if you feel light-headed or sleepy.

If you get reddening painful skin on your hands and feet, any heart problems or mouth sores or if you develop a temperature or any sign of an infection while being given, or soon after stopping Liposomal Doxorubicin SUN, tell your doctor immediately.

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Side Effects

Tell your doctor, nurse, or pharmacist as soon as possible if you do not feel well while you are being given Liposomal Doxorubicin SUN. 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.

Ask your doctor or pharmacist to answer any questions you may have.

During the infusion of Liposomal Doxorubicin SUN the following reactions may occur:

  • Flushing of the face, shortness of breath, headache, chills, back pain, tightness in the chest and/or throat, low blood pressure and possibly dizziness and puffing of the face.
  • Stinging or swelling of the skin at the site of injection may also occur.
  • Convulsions or fits.

Tell your doctor, nurse or pharmacist if you notice any of the above reactions or if the drip stings or hurts while you are receiving Liposomal Doxorubicin SUN.

Tell your doctor if you notice any of the following and they worry you.

These are the more common side effects of Liposomal Doxorubicin SUN:

  • general feeling of tiredness, sleepiness
  • loss of appetite, weight loss
  • stomach pains, sickness (nausea and vomiting), diarrhoea, constipation
  • hair loss, skin rash
  • depression or anxiety
  • sore muscles or back pain
  • taste perversion.

These are some of the more common side effects of Liposomal Doxorubicin SUN.

Tell your doctor immediately if you notice any of the following.

These are the more serious side effects. You may need urgent medical attention.

  • heart problems such as irregular heartbeat, shortness of breath and/or swelling of feet or hands
  • signs of frequent or worrying infections such as fever, severe chills, sore throat or mouth ulcers, persistent cough, pain/difficulty or increased frequency of passing urine, sore or red nose
  • bruising more easily than normal
  • signs of anaemia, such as tiredness, being short of breath, and looking pale
  • redness, swelling and sores on the palms of your hands and feet
  • sores in the mouth, oral thrush (a fungal infection in the mouth), tongue inflammation
  • respiratory problems such as difficulty in breathing which may be linked to infections you have caught as a result of your disease
  • problems with vision, sore or irritated eyes
  • feelings of pins and needles
  • pain, redness and dryness of skin if previously experienced during treatment with radiotherapy may also happen with Liposomal Doxorubicin SUN.

A few people may be allergic to some medicines.

Tell your doctor or nurse immediately if you notice any of the following:

  • swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing
  • shortness of breath
  • skin problems such as rash or itchiness
  • pinkish, itchy swellings on the skin, also called hives or nettle rash
  • dizziness, light-headedness, fainting.

If you have these, you may have had a serious allergic reaction to Liposomal Doxorubicin SUN. You may need urgent medical attention.

Other side effects not listed above may also occur in some patients.

Tell your doctor if you notice any other effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

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After Liposomal Doxorubicin SUN has been stopped

Tell your doctor immediately if you notice any of the following side effects, even if they occur several weeks after stopping treatment with Liposomal Doxorubicin SUN.

  • any heart problems such as shortness of breath or irregular heart beat
  • fever or any other sign of infection
  • redness, swelling or sores on the palms of hands and feet.

Tell your doctor if you notice any other effects.

Tell your doctor, if you or your partner becomes pregnant during the 6 months after Liposomal Doxorubicin SUN treatment is stopped.

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Storage

Liposomal Doxorubicin SUN will be stored in the Pharmacy or on the ward and looked after by your doctor, pharmacist or nurse. This medicine is a concentrated suspension for infusion and is stored at 2°C to 8°C in the refrigerator. Do not freeze.

Do not use Liposomal Doxorubicin SUN if the expiry date (EXP) printed on the pack has passed.

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Product Description

What it looks like

Liposomal Doxorubicin SUN comes as a sterile, translucent red suspension (2 mg per 1 ml) in a glass vial. It is available as 20 mg/10 ml or 50 mg/25 ml vials with one vial inside each pack.

Ingredients

Active ingredient:
Pegylated liposomal Liposomal Doxorubicin hydrochloride (2 mg per 1 ml)

Inactive ingredients:

  • sodium methoxy PEG-40-carbonyl-distearoylphosphatidyl- ethanolamide (MPEG-DSPE)
  • hydrogenated soy phosphatidylcholine (HSPC)
  • cholesterol
  • ammonium sulphate
  • sucrose
  • histidine
  • water for injections
  • hydrochloric acid
  • sodium hydroxide

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Supplier

Liposomal Doxorubicin SUN is supplied in Australia by:
Sun Pharmaceutical Industries Australia Pty Ltd.
Unit 11, 22-30 Wallace Ave
POINT COOK, VIC, 3030
Tel: 1800 267 356

Liposomal Doxorubicin SUN 20mg/10ml concentrated solution for injection
AUSTR 202826

Liposomal Doxorubicin SUN 50mg/25ml concentrated solution for injection
AUSTR 202827

This leaflet was last updated in November 2013.

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CMI provided by MIMS Australia, January 2015  

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