How to take REVOLADE and other practical information for people with chronic immune thrombocytopenia (ITP)

YOUR

TREATMENT

WITH

REVOLADE®

(eltrombopag)

2

GET OFF TO A GOOD START

Your doctor has prescribed REVOLADE to help you treat your chronic immune thrombocytopaenia (ITP).

Take the time to read this practical guide to help you better understand how your treatment works, how to take it correctly, what side effects to watch out for, plus some useful tips to ensure REVOLADE fits as seamlessly into your daily routine as possible.

The answers to some frequently asked questions are found at the back of the booklet, but don’t forget, you should always speak to your doctor or nurse for further advice.

For more information on REVOLADE please read the Consumer Medicine Information leaflet, available from your healthcare professional or at www.novartis.com.au/products/consumer-information. This booklet is not meant to replace the information in the Consumer Medicine Information.

BEFORE YOU START REVOLADE

IMPORTANT FACTS YOUR DOCTOR SHOULD KNOW ABOUT YOU

WHAT IS CHRONIC ITP?

WHAT IS REVOLADE?

HOW TO TAKE REVOLADE

WHAT YOU SHOULD KNOW WHEN TAKING REVOLADE

PLANNING WHEN TO TAKE REVOLADE

WHAT ELSE IS IMPORTANT TO KNOW? THINGS TO BE AWARE OF

SIDE EFFECTS THAT MAY OCCUR WITH REVOLADE

FREQUENTLY ASKED QUESTIONS

CONTENTS5

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15

6

12

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BEFORE

YOU

START

REVOLADE

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Tell your doctor about any medical conditions, including:

Tell your doctor if you are:

Tell your doctor about any medicines you are taking or plan to take, including:

• liver problems or kidney problems• a recent surgery or accident• if a member of your family has had a blood clot• cataracts (a cloudy covering of the eye)• a history of blood cancers• sensitivity to the sun• an allergy to the active ingredient in REVOLADE, eltrombopag olamine, or any of the other ingredients (hypromellose (E464), macrogol 400 (E1521), magnesium stearate (E572), mannitol (E421), microcrystalline cellulose (E460(i)), povidone (E1201), sodium starch glycollate, titanium dioxide (E171), polysorbate 80 (E433), iron oxide red CI77491 (E172), iron oxide yellow CI77492 (E172).

• a smoker• pregnant, think you may be pregnant or plan to get pregnant• breastfeeding or planning to breastfeed• of Asian ancestry (such as Chinese, Japanese, Taiwanese, Korean or Thai), as you may need to start at a lower dose of REVOLADE.

• antacids, used to treat indigestion, heartburn or stomach ulcers• contraceptive pill• hormone replacement therapy• statins, used to lower cholesterol• medicines used to treat HIV such as lopinavir or ritonavir• over-the-counter medicines • complementary medicines or supplements, such as herbal medicines, mineral and multivitamin supplements, and protein shakes• cyclosporin, used for transplantation or immune diseases.

IMPORTANT FACTS YOUR DOCTOR SHOULD KNOW ABOUT YOU

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Chronic immune thrombocytopenia (ITP) is a disease that increases your risk of bleeding because your blood cannot clot properly.

Your blood is made up of lots of different types of cells, including platelets. Platelets are tiny cells that help your blood clot to reduce or stop bleeding, for example when you have a cut or graze. They are made in the bone marrow and are normally removed naturally by the spleen and liver after about seven days.

In people with ITP, the immune system produces proteins called antibodies that mistakenly attack the platelets and stop them from working properly. The platelets are then removed from the body more quickly than usual. Antibodies also interact with the cells that make new platelets, meaning fewer platelets are produced.

When you do not have enough platelets in your body, your blood isn’t able to clot properly. As a result, you may experience symptoms such as bruising, purpura (a type of speckled rash), nosebleeds, bleeding gums or uncontrolled bleeding if cuts or injuries occur. If you have ITP for over six months, it is known as ‘chronic ITP’.

There’s a lot of information about ITP available online. ITP Australia provides easy to understand, accurate and up-to-date information at itpaustralia.org.au*

We hope you find it helpful.LEARN MORE

WHAT IS CHRONIC ITP?

* Inclusion of the Australian website is to provide further resources to patients that are independent and not affiliated to Novartis.

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WHAT IS REVOLADE?

REVOLADE is a treatment for chronic ITP for people aged one year or older. It is called a ‘thrombopoietin (pronounced thrombo-po-eat-in) receptor agonist’, or TPO-R agonist for short.

REVOLADE works in a similar way to your body’s natural thrombopoietin – it increases platelet production in the bone marrow, which, in turn, may increase the number of platelets in your blood.

In the past, you may have had other therapies that work by slowing down platelet destruction. REVOLADE works differently by helping your body to produce more platelets, which should help you better manage your chronic ITP.

How REVOLADE works

HOW

TO

TAKE

REVOLADE

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The time of day (or night) you take REVOLADE is up to you. If you need to take more than one REVOLADE tablet, take them all at the same time.

Your doctor will tell you which one is the right dose for you.

Depending on how you respond to treatment, your doctor may change your dose.1 Do not change the number of REVOLADE tablets you take unless instructed by your doctor.

WHAT YOU SHOULD KNOW WHEN TAKING REVOLADE

25 mg and 50 mg

REVOLADE is available in two tablet strengths

REVOLADE is taken once daily, by mouth with water

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REVOLADE should not be taken with foods, drinks, or other medicines that are high in calcium,* iron,

magnesium, aluminium, selenium or zinc.

The interaction is not harmful, but it does stop your body from being able to absorb REVOLADE properly,

which means it won’t work as well.

Some examples of foods, drinks and medicines that you should avoid around the time you take REVOLADE include:

*High in calcium means foods, drinks or medicines that contain 50 mg or more of calcium. Check the nutritional information on the packet, or if you aren’t sure, speak to your doctor.

Dairy products

Leafy green vegetables

Protein

Nuts and seeds

Milk, yoghurt, cheese, cream, chocolate and buttermilk

Broccoli, cabbages, bok choy and spinach

Canned sardines and chickpeas

Brazil nuts, hazelnuts, almonds, almond milk and sesame seed paste (tahini)

REVOLADE must be taken at least 2 hours before and 4 hours after consuming certain foods, drinks and medicines

If you are unsure about any aspect of taking REVOLADE, speak to your doctor.

IMPORTANT

Certain antacids and some over-the-counter medicines and mineral supplements.

Ask your doctor to suggest an antacid that is less likely to affect your ITP medicine or if you are unsure about your vitamin supplements.

Medicines and supplements:

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Daytime dosing example

Take REVOLADE once every 24 hours, preferably at the same time each day.

Provided you avoid foods and drinks that are high in calcium, you do not need to avoid eating and drinking when taking REVOLADE.

If you choose to eat or drink during the period before and after taking REVOLADE, consider these options:

12am 1am2am

3am

4am

5am

6am

7am

8am

9am

10am

11am12pm

1pm

2pm

3pm

4pm

5pm

6pm

7pm

8pm

9pm

10pm11pm

Have breakfast

6am

TakeREVOLADE

8am

Eat and drink as normal

Limit calcium intake as per

your Revolade Meal Planner

PLANNING WHEN TO TAKE REVOLADE

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Night-time dosing example

Take REVOLADE once every 24 hours, preferably at the same time each day.

REVOLADE should be taken at least 2 hours before and 4 hours after certain foods, drinks, or other medicines that contain high concentrations of calcium, iron, magnesium, aluminium, selenium or zinc.

Eat and drink as n

orm

al

Limit c

alcium

intake as per

12am 1am2am

3am

4am

5am

6am

7am

8am

9am

10am

11am12pm

1pm

2pm

3pm

4pm

5pm

6pm

7pm

8pm

9pm

10pm11pm

your

Re

volade

Meal Planner

Havedinner

11pm

TakeREVOLADE

7pm

Proteins

Fruits and vegetables

Grains

Drinks

Lean beef, chicken, lean ham, white fish, canned tuna, and fresh or smoked salmonApples, bananas, apricots, sultanas, lettuce, tomatoes, peas, potatoes, green beans, carrots

Pasta, rice, bread, oats (made with water or unfortified soy milk)

Water, unfortified* fruit juice, black tea and coffee, soy milk

*Unfortified means no extra minerals have been added.

WHAT

ELSE IS

IMPORTANT

TO KNOW?

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If you are sexually active, use a reliable method of contraception while you are taking REVOLADE

and for at least 7 days after you stop. IMPORTANT

THINGS TO BE AWARE OF

If you are pregnant or breastfeeding

Bleeding (after you stop treatment)

You should not take REVOLADE if you are pregnant or breastfeeding unless your doctor specifically recommends it. It is unknown if REVOLADE has an effect during pregnancy or if it passes into breast milk.

Tell your doctor if you become pregnant or are breastfeeding, or are planning to become pregnant or breastfeed while taking REVOLADE.

After stopping REVOLADE your platelet levels will return to what they were before starting treatment, which increases your risk of bleeding. Tell your doctor if you have any bleeding or bruising in the 4 weeks after you have stopped taking REVOLADE.

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Problems with bone marrow

People with ITP may have problems with their bone marrow (tissue inside bones) and REVOLADE could make this problem worse. Your doctor may carry out tests to check your bone marrow during treatment with REVOLADE.

Worsening of blood cancers

Before you started REVOLADE, your doctor will have carried out tests to ensure that you have ITP and not another condition such as myelodysplastic syndrome (MDS), a type of blood cancer.

High platelet counts

If your platelet count becomes too high, you may have a higher chance of blood clots and your doctor may adjust your tablet strength or tell you to stop taking REVOLADE.

Impact on blood tests

REVOLADE may impact results of blood tests. Ensure that all doctors you see are aware that you take REVOLADE. Repeat tests may be required if results are unexpected.

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Phototoxicity

REVOLADE may cause you to sunburn more easily. While taking REVOLADE, you should wear protective clothing, sunglasses and sunscreen when in the sun, and avoid exposure to high-intensity artificial UV light such as tanning beds.

Regular eye checks

In studies, an increased risk of cataracts (a cloudy covering of the eye) were observed with the use of REVOLADE.

Your doctor may provide a reference for you to have your eyes checked for cataracts by a specialist eye doctor.

Storing REVOLADE

REVOLADE should be stored in a cool, dark, dry place at room temperature. Do not store REVOLADE in the car, in the bathroom, near a sink or on a windowsill. Keep it out of sight and reach of children.

Liver problems

REVOLADE may cause damage to your liver. Your doctor will carry out tests to check your liver before and during treatment with REVOLADE.

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SIDE EFFECTS THAT MAY OCCUR WITH REVOLADE

Adult patients

The following side effects have been associated with REVOLADE treatment in adult patients with ITP.

Very common side effects (affect more than 10% of people):

• Diarrhoea • Nausea • Increase in a liver enzyme called ALT (shown in blood tests) • Back pain

Common side effects (affect 1–10% of people):

• Dry mouth • Vomiting • Unusual hair loss or thinning • Rash • Pain that affects muscles and tendons along with bones, including in your chest • Muscle pain • Sore throat or discomfort when swallowing • Urinary tract infections • Cataract

As with all medicines, you may experience some side effects while taking REVOLADE, although not everybody has them. Tell your doctor, nurse or pharmacist if they arise. Do not stop taking your medication without first consulting your doctor.

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

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Please note that this is not a complete list of side effects that may occur with REVOLADE. For more information on possible side effects, talk to your doctor. You can also review the Consumer Medicine Information, available to download from www.novartis.com.au/products/consumer-informationLEARN MORE

Common side effects that may show up in blood tests: • Increase in other liver enzymes • Increased level of the pigment (bilirubin) in the blood, which may cause a yellow

discolouration of your skin, the whites of your eyes, or body fluids (jaundice).

Patients aged less than 18 years

The following additional side effects have been reported to be associated with treatment with REVOLADE in patients aged less than 18 years with ITP.

Very common side effects (affect more than 10% of people):

• Sore throat, runny nose, nasal congestion and sneezing • Infection in the nose, sinuses, throat and upper airways, common cold

(upper respiratory tract) • Cough • Abdominal pain • Fever

Common side effects (affect 1–10% of people):

• Toothache • Pain in the nose and throat • Itchy, runny or blocked nose

Stop taking REVOLADE and seek medical help immediately if you experience symptoms of the following serious side effects:

• Blood clots (such as swelling, pain or tenderness in one leg)• Loss of liver function (such as unusual tiredness, yellowing of the skin

or whites of the eyes, unusually dark urine or pain in the right upper stomach area)

• Damage to blood vessels in the kidney (such as swollen legs)

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Where can I find more information about ITP?There’s a lot of information about ITP available online. ITP Australia provides easy to understand, accurate and up-to-date information at itpaustralia.org.au

I’ve forgotten to take my dose of REVOLADE, what should I do?Take your next dose at the usual time, and tell your doctor. Do not take a double dose to make up for any forgotten doses.

I have taken too much REVOLADE, what should I do?Immediately telephone your doctor or the Poisons Information Centre on 13 11 26 for advice, or go to Accident and Emergency at the nearest hospital, even if there are no signs of discomfort or poisoning. Take the REVOLADE pack with you.

What do I do if I vomit after taking REVOLADE? Wait until the next day and take your dose at the usual time. If you are often sick from taking REVOLADE, talk to your doctor.

I have eaten dairy products and taken my dose of REVOLADE, what should I do?It is likely that your dose hasn’t been properly absorbed into your body. Take your next dose at the usual time. Talk to your doctor if you are in doubt.

FREQUENTLY ASKED QUESTIONS

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What happens if I find the side effects too hard to manage?If your side effects become too much, talk to your doctor; they may be able to give you some advice on how to manage them better. Remember, do not stop taking REVOLADE without talking to your doctor.

What if I become pregnant while taking REVOLADE?If you become pregnant, tell your doctor immediately. They will be able to advise you on the best course of action.

When will I stop taking REVOLADE?Your doctor will decide with you when it is time to stop taking REVOLADE. Do not stop taking REVOLADE without first talking to your doctor.

What happens when I stop taking REVOLADE?If you and your doctor decide that you should stop taking REVOLADE, your doctor will check your platelet counts for at least 4 weeks after you took your last dose to monitor your condition.

What should I do if I have any extra or expired REVOLADE tablets?If you have extra or expired REVOLADE, you should ask your pharmacist how to dispose of it. Do not flush or throw it in the bin with household waste. Do not use any REVOLADE after the expiry date printed on the carton and blister pack.

If you have any other questions that aren’t answered in this booklet, please speak to your doctor.

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NOTES

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References: 1. REVOLADE Consumer Medicine Information. 2. REVOLADE Approved Product Information. 3. Better Health Channel. Idiopathic thrombocytopenic purpura (ITP). Available at www.betterhealth.vic.gov.au/health/conditionsandtreatments/idiopathic-thrombocytopenic-purpura-itp (accessed March 2019). 4. Patient Immune Thrombocytopaenia. Available at www.patient.info/allergies-blood-immune/blood-clotting-tests/immune-thrombocytopenia (accessed March 2019). 5. Iraqi M et al. Haematologica 2015;100(5):623-32. 6. Williams D et al. Clinical Therapeutics 2009;31(4):764-76.

Novartis Pharmaceuticals Pty Limited. 54 Waterloo Road, Macquarie Park, NSW 2113. Ph (02) 9805 3555. For medical enquiries, please contact 1800 671 203 (phone) or medinfo.phauno@novartis.com (email). ®Registered Trademark. AU-10668. Prepared October 2019. RVD0029.