ARX-SUNITINIB

ARX-SUNITINIB

Active ingredient(s): SUNITINIB MALATE

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Consumer Medicine Information (CMI)

This leaflet provides important information about using ARX-SUNITINIB. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using ARX-SUNITINIB.

Where to find information in this leaflet:

1. Why am I using ARX-SUNITINIB?
2. What should I know before I use ARX-SUNITINIB?
3. What if I am taking other medicines?
4. How do I use ARX-SUNITINIB?
5. What should I know while using ARX-SUNITINIB?
6. Are there any side effects?
7. Product details

1. Why am I using ARX-SUNITINIB?

ARX-SUNITINIB contains the active ingredient sunitinib. ARX-SUNITINIB is an indolinone derivative and tyrosine kinase inhibitor with potential antineoplastic activity. It interferes with the growth of cancer cells, which are eventually destroyed.

ARX-SUNITINIB is used for treatment of

• advanced renal cell carcinoma (RCC), a type of renal cancer
• gastrointestinal stromal tumour (GIST) GIST is a cancer of the stomach and bowels. It is caused by the uncontrolled growth of cells in the wall of the stomach or bowel. ARX-SUNITINIB slows down the growth of these cells.
• pancreatic neuroendocrine tumours. This is a rare cancer in the cells of the pancreas that release hormones.

Ask your doctor if you have any questions about why ARX-SUNITINIB has been prescribed for you.

Your doctor may have prescribed it for another purpose.

ARX-SUNITINIB is only available with a doctor’s prescription. It is not addictive.

Use in children

The safety and efficacy of ARX-SUNITINIB have not been established in children.

2. What should I know before I use ARX-SUNITINIB?

Warnings

Do not use ARX-SUNITINIB if:

• you are allergic to sunitinib or any of the ingredients listed at the end of this leaflet.
  Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.
• Do not use ARX-SUNITINIB after the expiry date printed on the pack.
• Do not use ARX-SUNITINIB if the packaging shows signs of tampering.

Check with your doctor if you:

• have high blood pressure
• have or have had an aneurysm (abnormal balloon-like swelling in the wall of an artery)
• have problems with your heart
• have or have ever had problems with your liver or kidneys

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

ARX-SUNITINIB should not be used during pregnancy. Your doctor will discuss the risks with you.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

You should not breastfeed while taking ARX-SUNITINIB.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with ARX-SUNITINIB and affect how it works. Some of these medicines include:

• ketoconazole, a medicine to treat fungal infections
• itraconazole, a medicine to treat fungal infections
• ritonavir, a medicine to treat HIV infection
• erythromycin, a medicine to treat infections
• clarithromycin, a medicine to treat infections
• rifampicin, a medicine to treat tuberculosis and some other infections
• dexamethasone, a medicine to treat dermatitis, asthma and some other conditions
• phenytoin, a medicine to treat seizures
• carbamazepine, a medicine to treat seizures
• phenobarbital (phenobarbitone), a medicine to treat seizures
• St. John’s wort (a herbal medicine, also called Hypericum perforatum) to treat anxiety
• medicines used to treat irregular heart beat
• medicines called bisphosphonates, such as zoledronic acid, alendronate pamidronate or ibandronate to treat osteoporosis and some types of cancers medicines to treat diabetes.

You may need to take different amounts of your medicines or you may need to use different medicines. Your doctor will advise you.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect ARX-SUNITINIB.

4. How do I use ARX-SUNITINIB?

How much to take / use

Your doctor will tell you the dose that you should take. The dose depends on the type of cancer.

For renal cell carcinoma and GIST, the usual dose is 50 mg taken once a day for 4 weeks followed by no medicine for 2 weeks, making a 6-week cycle. Your doctor will let you know how many cycles of treatment you will need.

For pancreatic neuroendocrine tumours, the usual recommended dose is 37.5 mg taken once daily.

Your doctor may change your dose or dosing schedule during treatment.

Follow all the directions given to you by your doctor carefully. These directions may differ from the information contained in this leaflet.

If you do not understand the instructions on the label, ask your doctor or pharmacist for help.

How to take ARX-SUNITINIB

Swallow the capsules with a glass of water. ARX-SUNITINIB can be taken with or without food.

When to take / use ARX-SUNITINIB

Take the capsules at about the same time each day. Taking them at the same time each day will help you to remember to take them.

How long to take ARX-SUNITINIB

Continue taking ARX-SUNITINIB for as long as your doctor prescribes it.

If you forget to use ARX-SUNITINIB

ARX-SUNITINIB should be used regularly at the same time each day as per your cycles of treatment. If you miss your dose at the usual time do not take an additional dose. Take your usual dose on the next day.

Do not take a double dose to make up for the dose you missed.

If you are not sure what to do, ask your doctor or pharmacist.

If you use too much ARX-SUNITINIB

If you think that you have used too much ARX-SUNITINIB, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using ARX-SUNITINIB?

Things you should do

Make sure you follow your doctor’s instructions and keep all appointments.

You will need regular follow-up to make sure the treatment is working.

Your doctor will measure your blood pressure. You will also have blood tests to check for side effects.

Use a proven method of birth control (contraception) to prevent pregnancy while being treated with ARX-SUNITINIB and for at least 4 weeks after finishing treatment with ARX-SUNITINIB.

Call your doctor straight away if you:

If you become pregnant while taking ARX-SUNITINIB.

If you are going to have surgery, an operation or dental treatment while taking ARX-SUNITINIB.

Remind any doctor, dentist or pharmacist you visit that you are using ARX-SUNITINIB.

Things you should not do

• Do not take this medicine to treat any other complaints unless your doctor tells you to.
• Do not give this medicine to anyone else, even if their condition seems similar to yours.

Things to be careful of

Avoid drinking grapefruit juice while you are being treated with ARX-SUNITINIB.

Grapefruit juice may interact with ARX-SUNITINIB and affect how your body uses this medicine.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how ARX-SUNITINIB affects you.

ARX-SUNITINIB may make some people feel very tired and dizzy.

Looking after your medicine

• Store below 25°C. Keep your capsules in the original container until it is time to take them.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Heat and dampness can destroy some medicines.

Keep it where young children cannot reach it.

A locked cupboard at least one-and-a half meters above the ground is a good place to store medicines.

Getting rid of any unwanted medicine

If you doctor tells you to stop taking this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects

What to do

tiredness diarrhoea nausea (feeling sick) or vomiting change in sense of taste, loss of taste loss of appetite, weight loss change in skin colour change in hair colour tingling or rash on palms of hands or soles of feet rash, dry skin, skin redness, scaly skin, itchy skin, blisters; skin infections, pus formation, skin ulcers headache constipation sore tongue, sore mouth, dry mouth, difficulty swallowing, cold sores cough upset stomach, stomach pain, wind, heart burn, indigestion pain in fingers, arms or legs weakness muscle pain, joint pain, back pain dizziness hair loss nose bleed increased tears, watery eyes tingling or numbness of hands or feet; pins and needles difficulty sleeping depression unusual urine colour, frequency or pain passing urine swelling, weight gain, enlargement of thyroid gland feeling overheated, increased sweating fast or irregular heart beat.

Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects

What to do

Tell your doctor immediately if you get any of the following side effects: shortness of breath, wheezing or trouble breathing, chest pain swelling of feet or legs, leg pain swollen face, eyelids, lip, tongue or voice box; swelling under the skin bleeding or bruising under the skin; coughing blood flu-like symptoms (chills, fever, sore throat, swollen glands) high blood pressure very bad stomach pain leaking or discharge near anus fits, seizures infection swelling, dark marks or blisters on any part of the body muscle pain, weakness or wasting decrease in amount of urine yellowing of skin and eyes (jaundice) numbness or tingling on one side of the body; weakness of face, arm or leg; trouble speaking, seeing or swallowing; headache, confusion, dizziness, loss of co-ordination or balance pain or numbness in the jaw, teeth or gums decreased blood sugar level, feeling hungry, shaky or anxious pain in the neck, shoulder or arm pressure in the chest.

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

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

What ARX-SUNITINIB contains

Active ingredient (main ingredient)	sunitinib malate
Other ingredients (inactive ingredients)	mannitol, croscarmellose sodium, povidone, magnesium stearate, gelatin, titanium dioxide (E171), red iron oxide CI77491 (E172), (12.5 mg, 25 mg and 50 mg), yellow iron oxide CI77492 (E172) (25 mg, 37.5 mg and 50 mg), black iron oxide CI77499 (E172) (25 mg and 50 mg).
Potential allergens	ARX-SUNITINIB capsules do not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Do not take this medicine if you are allergic to any of these ingredients.

What ARX-SUNITINIB looks like

ARX-SUNITINIB 12.5 mg (blister pack AUST R 331640) have opaque reddish brown cap and body and are printed with “RM53” on the cap and “RM53” on the body in white ink.

ARX-SUNITINIB 25 mg (blister pack AUST R 332967) have opaque caramel-coloured cap and opaque reddish brown body and are printed with “RM54” on the cap and “RM54” on the body in white ink.

ARX-SUNITINIB 37.5 mg (blister pack AUST R 332994) have opaque yellow cap and opaque yellow body and are printed with “RM55” on the cap and “RM55” on the body in black ink.

ARX-SUNITINIB 50 mg (blister pack AUST R 342659) opaque caramel-coloured cap and opaque caramel-colored body and are printed with “RM56” on the cap and “RM56” on the body in white ink.

Each blister pack contains 28 capsules.

Who distributes ARX-SUNITINIB

Arrotex Pharmaceuticals Pty Ltd
15-17 Chapel Street
Cremorne VIC 3121
Australia

This leaflet was prepared in January 2023.