Patients with non-Hodgkin�s Lymphoma and Chronic Lymphocytic Leukaemia

RIXIMYO
for the treatment of non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukaemia

rituximab (rch)


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about RIXIMYO.

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

The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available.

You should ensure that you speak to your pharmacist or doctor to obtain the most up-to-date information on the medicine. You can also download the most up-to- date leaflet from www.tga.gov.au Those updates may contain important information about the medicine and its use of which you should be aware.

All medicines have risks and benefits. Your doctor has weighed the risks of you being given this medicine against the benefits they expect it will 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.

What RIXIMYO is used for

RIXIMYO contains the active ingredient rituximab.

Rituximab belongs to a group of medicines known as anti-cancer agents. There are many different classes of anti-cancer agents.

Rituximab belongs to a class called monoclonal antibodies.

Monoclonal antibodies are proteins which specifically recognise and bind to other unique proteins in the body.

RIXIMYO is used to treat non- Hodgkin's lymphoma and chronic lymphocytic leukaemia.

Rituximab works by binding to a protein on the surface of certain white blood cells known as B lymphocytes. During the process of binding to the protein, the abnormal growth of the B lymphocytes is stopped.

It is the abnormally growing B lymphocytes that are responsible for certain types of non-Hodgkin's lymphoma and chronic lymphocytic leukaemia.

RIXIMYO may be used on its own or together with chemotherapy.

If your doctor thinks it is appropriate for your circumstances, you may continue to receive RIXIMYO after the initial course of treatment.

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

This medicine is available only with a doctor's prescription.

Before you start on RIXIMYO

When it must not be given to you

RIXIMYO is not suitable for you:

  • if you have had an allergic reaction to rituximab or any of the ingredients listed at the end of this leaflet.
  • if you have had an allergic reaction to any other proteins that are of mouse origin.

Some of the symptoms of an allergic reaction may include severe skin rash, itching, hives, swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing, swelling of the hands, feet or ankles.

If you are not sure if you should start receiving RIXIMYO, talk to your doctor.

Before you are given it

Your doctor must know about all of the following before you are given RIXIMYO.

Tell your doctor if:

  • you have an infection, or a history of a recurring or long- term infection such as hepatitis B
  • you are taking or have previously taken medicines which may affect your immune system, such as chemotherapyor immunosuppressive medicines
    If you are taking or have taken medicines which affect your immune system, you may have an increased risk of infections. There have been reports of a rare, serious brain infection called PML (progressive multifocal leuko-encephalopathy) usually affecting people with a weakened immune system. Your chance of getting PML may be higher if you are treated with RIXIMYO and/or other medicines that weaken the immune system. PML can cause severe disability or even death.
  • you have a history of heart disease with:
    – angina
    – cardiac arrhythmias (abnormal beating of the heart)
    – congestive heart failure
    Your doctor will supervise you closely during treatment with RIXIMYO.
  • you are taking medicine to control blood pressure
    RIXIMYO may cause a reduction in blood pressure at the beginning of treatment. Because RIXIMYO may cause a temporary drop in your blood pressure, your doctor may advise you to temporarily stop taking your blood pressure medicine before you are given RIXIMYO.
  • you have pre-existing lung disease
    You may have a greater chance of breathing difficulties during treatment with RIXIMYO.
  • you intend to have or have had immunisation with any vaccine (e.g. measles, rubella, flu, vaccines for travel purposes)
    Some vaccines should not be given at the same time as RIXIMYO or in the months after you receive RIXIMYO. Your doctor will check if you should have any vaccines before you receive RIXIMYO.

you are allergic to any other medicines or any other substances such as foods, preservatives or dyes

  • you are pregnant or intend to become pregnant
    It is not known whether rituximab is harmful to an unborn baby. It is not recommended that you are given RIXIMYO while you are pregnant.
    If you are a woman of child- bearing potential, you must use effective contraceptive methods to prevent pregnancy during treatment and for 12 months after completing treatment with RIXIMYO.
  • you are breastfeeding or plan to breastfeed
    It is not known if rituximab passes into breast milk. It is recommended that you discontinue breast feeding while you are treated with RIXIMYO.

If you have not told your doctor about any of the above, tell him/ her before you are given RIXIMYO. Your doctor will decide whether it is safe for you to receive RIXIMYO.

Use in children

The safety and effectiveness of rituximab have not been established in children.

Your doctor will discuss the risks and benefits of using this medicine in children.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. As RIXIMYO may cause a temporary drop in your blood pressure at the beginning of treatment, your doctor may advise you to temporarily stop taking your blood pressure medicine before you are given RIXIMYO.

It is not known if RIXIMYO will affect your normal response to a vaccine.

It is possible that after treatment with RIXIMYO you may experience allergic reactions if you are treated with other medications containing monoclonal antibodies.

Your doctor and pharmacist will have more information on medicines to be careful with or to avoid while undergoing treatment with RIXIMYO.

How RIXIMYO is given

RIXIMYO concentrated solution is diluted with sterile saline (sodium chloride) or dextrose solution before it is given as a slow infusion into a vein (intravenous infusion) by a healthcare professional.

Your doctor will decide how much RIXIMYO and how long you will be given it. The dose of RIXIMYO depends on your body weight and height.

RIXIMYO may be given with or without chemotherapy. When given in combination with chemotherapy, 1 infusion of RIXIMYO is usually given on day 1 of each chemotherapy cycle.

Depending on the circumstances of your disease or response to the drug your doctor may decide to change your treatment.

Maintenance treatment

If you respond to initial treatment, your doctor may decide to continue your treatment with RIXIMYO for up to 2 years.

If you are given too much (overdose)

As RIXIMYO 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 effe
cts after being given RIXIMYO, tell your doctor immediately.

While you are receiving RIXIMYO

Things you must do

If you are a woman of child bearing potential, you must use effective contraceptive methods to prevent pregnancy during treatment with RIXIMYO and for 12 months after completing treatment.

Tell your doctor if you become pregnant while receiving RIXIMYO.

Tell all doctors, dentists and pharmacists who are treating you that you are receiving RIXIMYO.

Tell your partner or caregiver you are receiving RIXIMYO and ask them to tell you if they notice any changes in your movement or behaviour. If they notice any changes you should tell your doctor about them immediately. Your doctor may need to perform some tests and alter your treatment.

Be sure to keep all of your appointments with your doctor so that your progress can be checked. Your doctor will perform regular blood tests.

Things you must not do

Do not breast feed your infant during treatment with RIXIMYO. It is not known whether rituximab crosses into human milk.

Do not take any other medicines whether they require a prescription or not without first telling your doctor or consulting with a pharmacist.

Things to be careful of

Be careful driving or operating machinery until you know how RIXIMYO affects you. RIXIMYO generally does not cause any problems with your ability to drive or operate machinery.However, as with many other medicines, RIXIMYO may cause dizziness in some people.

Side effects

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.

RIXIMYO helps many people who have either non-Hodgkin's lymphoma or chronic lymphocytic leukaemia but it may have unwanted side effects.

Do not be alarmed by the lists of possible side effects. You may not experience any of them.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are receiving RIXIMYO.

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

The following is a list of the more common side effects.

During or after an infusion

Tell your doctor if you notice any of the following during or after receiving an infusion (particularly during the first 2 hours of receiving the first infusion) and they worry you:

  • fever, chills and severe shivering (most likely to occur)
  • swelling of the tongue, face, lips, mouth or throat which may cause difficulty breathing or swallowing
  • itchy rash and/or pinkish, itchy swellings on the skin
  • difficulty breathing and/or shortness of breath
  • wheezing or coughing
  • dizziness or light-headedness, especially on standing up
  • nausea (feeling sick) or vomiting
  • headache
  • fatigue (feeling tired) and/or feeling weak
  • rhinitis (a runny nose)
  • flushing
  • fast heart beat
  • chest pain which may spread to the neck and shoulders
  • pain where the cancer is located
  • muscle and joint pain
  • stomach pain or discomfort
  • throat irritation.

These side effects are temporary and less likely to occur after the first infusion.

Your doctor may recommend that you take medication to prevent pain or allergy before you receive your RIXIMYO infusion.

The following is a list of other common side effects. Tell your doctor if you notice any of the following and they worry you:

  • sore mouth or mouth ulcers
  • bleeding or bruising more easily than normal
  • shingles (herpes zoster infection)
  • diarrhoea
  • increased blood pressure
  • indigestion
  • loss of appetite
  • muscle stiffness
  • nervousness, feeling anxious or agitated
  • increased cough
  • inability to sleep
  • pins and needles, or decreased feeling in the skin
  • stuffy nose or chest
  • sweating or night sweats
  • watery, itchy or crusty eyes
  • changes to sense of taste
  • weight loss
  • ear pain and/or buzzing, hissing, whistling, ringing or other persistent noise in the ears
  • constipation
  • a general feeling of being unwell
  • unusual hair loss or thinning

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

  • severe skin rash, itching, hives
  • swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing, swelling of the hands, feet or ankles
  • one or a combination of the following: severe shortness of breath, severe difficulty breathing, severe wheezing, severe coughing
  • vision loss associated with headaches, confusion and seizures
  • one or a combination of the following: confusion, disorientation or memory loss, changes in the way you move, walk or talk, decreased strength or progressive weakness in your body, blurred or loss of vision.
  • yellowing of skin and eyes, light coloured bowel motions, dark coloured urine

These are serious side effects. You may need urgent medical attention. Serious side effects are rare.

In combination with chemotherapy

If you have been given RIXIMYO in combination with chemotherapy, as well as the side effects listed above, the following additional side effect may also occur:

  • bronchitis (inflammation in the lungs)

If you are 65 years of age or over and have been given RIXIMYO in combination with chemotherapy, the following side effects may occur more commonly:

  • frequent infections with symptoms such as fever, severe chills, sore throat or mouth ulcers

These events may be related to RIXIMYO, but you may get other side effects from your chemotherapy. Please consult your doctor for possible side effects that may be caused by your chemotherapy.

This is not a complete list of all possible side effects. Your doctor or pharmacist has a more complete list. Others may occur in some people and there may be some side effects not yet known.

Tell your doctor if you notice anything else that is making you feel unwell.

Ask your doctor or pharmacist if you don't understand anything in these lists.

After receiving RIXIMYO

Keep all of your appointments with your doctor so that your progress can be checked, any tests are made and further infusions can be given when needed.

Storage

RIXIMYO should be stored in the pharmacy or on the hospital ward. Each vial is intended for use in one patient on one occasion only.

The concentrated solution should be kept in a refrigerator at 2-8°C, but must not be frozen. The vial should be kept in the carton to protect it from light.

If the diluted solution is not immediately given for infusion, it may be stored in a refrigerator at 2- 8°C for up to 24 hours.

Any unused portion in the vial or infusion bag should be discarded.

Product description

What it looks like

RIXIMYO is a clear, colourless to slightly yellowish, concentrated solution in 10 mL or 50 mL glass vials. It is available in packs of:

  • Two or three 100 mg/10 mL single-use vials;
  • One or two 500 mg/50 mL single- use vials.

Ingredients

RIXIMYO vials contain 10 mg of the active ingredient, rituximab (rch), per mL of concentrated solution. The solution also contains the following inactive ingredients:

  • citric acid monohydrate
  • sodium chloride
  • polysorbate 80
  • sodium hydroxide and/or hydrochloric acid (for pH adjustment)
  • water for injections.

Sponsor

RIXIMYO is supplied in Australia by:

Sandoz Pty Ltd
ABN 60 075 449 553
54 Waterloo Road Macquarie Park NSW 2113
Telephone: 1800 634 500
We
b site: www.sandoz.com.au

This leaflet was prepared in September 2019

Australian Registration Numbers:

100mg/10mL vial – AUST R 281782

500mg/50mL vial – AUST R 281781

Internal document code:

(190926-riximyo-onc-cmi) based on PI (190926-riximyo-onc-pi)

Published by MIMS November 2019

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