Axitinib Accord

Package leaflet: Information for the patient

Axitinib Accord 1 mg film-coated tablets, 3 mg film-coated tablets, 5 mg film-coated tablets

axitinib
Read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor. See section 4.

Contents of this leaflet

1. What Axitinib Accord is and what it is used for
2. What you need to know before taking Axitinib Accord
3. How to take Axitinib Accord
4. Possible side effects
5. How to store Axitinib Accord
6. Contents of the pack and other information

1. What Axitinib Accord is and what it is used for

Axitinib Accord is a medicine containing the active substance axitinib. Axitinib reduces the amount of blood reaching the tumour, thereby slowing down its growth.
Axitinib Accord is indicated for the treatment of advanced renal cell cancer (advanced kidney cancer) in adults, in cases where another medicine (sunitinib or a cytokine) is no longer able to stop the progression of the disease.
If you have any doubts about how this medicine works or why it has been prescribed for you, consult your doctor.

2. What you should know before taking Axitinib Accord

Do not take Axitinib Accord:
If you are allergic to axitinib or to any of the other ingredients of this medicine (listed in
section 6). If you think you may be allergic, consult your doctor.
Warnings and precautions
Tell your doctor or nurse before taking Axitinib Accord

• If you have high blood pressure. Axitinib Accord can cause an increase in blood pressure. It is important that your doctor checks your blood pressure before you start taking this medicine, and regularly during treatment. If you have high blood pressure (hypertension), you may need to take medicines to

reduce it. Your doctor must ensure that your blood pressure is under control both before and during
treatment with Axitinib Accord.

• If you have thyroid problems. Axitinib Accord can cause thyroid problems. Inform your doctor if, while taking Inlyta, you become more easily fatigued, generally feel colder than other people, or your voice becomes deeper. Thyroid function should be checked before starting Axitinib Accord and regularly during treatment. If your thyroid gland does not produce enough thyroid hormone, either before or during treatment with this medicine, you will need to take a thyroid hormone replacement.
• If you have recently had problems due to blood clots forming in veins and arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis. Go immediately to the emergency room and inform your doctor if, during treatment with Axitinib Accord, you experience symptoms such as chest tightness or pain; pain in the arms, back, neck, or jaw/mandible; shortness of breath; numbness or weakness on one side of the body; difficulty speaking; headache; vision changes; dizziness.
• If you have bleeding problems. Treatment with Axitinib Accord may increase the risk of bleeding. Inform your doctor if bleeding occurs during treatment with this medicine, coughing up blood, or coughing with blood-streaked sputum.
• If you have or have had an aneurysm (a bulging and weakening of the wall of a blood vessel) or a tear in the wall of a blood vessel.
• If you have severe stomach (abdominal) pain during treatment with this medicine, or if stomach pain does not go away. Treatment with Axitinib Accord may increase the risk of stomach or intestinal perforation or the formation of fistulas (an abnormal passage that forms between two body cavities or with the skin). Inform your doctor if you experience severe abdominal pain during treatment with this medicine.
• If you are about to undergo surgery or have non-healing wounds. Axitinib Accord may affect wound healing, so your doctor should stop treatment at least 24 hours before surgery. Once the wound has adequately healed, treatment with this medicine should be restarted.
• If during treatment with this medicine you develop symptoms such as headache, confusion, seizures, or vision changes, with or without concomitant high blood pressure. Go immediately to the emergency room and inform your doctor. This could be a rare neurological side effect called reversible posterior encephalopathy syndrome.
• If you have liver problems. Your doctor should perform blood tests to check liver function before and during treatment with Axitinib Accord.
• If during treatment with this medicine you develop symptoms such as excessive fatigue, swelling in the abdomen, legs, or ankles, shortness of breath, or distended neck veins. Axitinib Accord may increase the risk of developing heart failure events. Your doctor should periodically monitor for signs or symptoms of heart failure events throughout treatment with axitinib.

Use in children and adolescents
Axitinib Accord is not recommended for patients under 18 years of age. This medicine has not been studied in children and adolescents.
Other medicines and Axitinib Accord
Some medicines may affect Axitinib Accord, or may be affected by it. Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription, vitamins, and herbal preparations. The medicines listed in this leaflet may not be the only ones that interact with Axitinib Accord.
The following medicines may increase the risk of side effects with Axitinib Accord:

• ketoconazole or itraconazole, used to treat fungal infections;
• clarithromycin, erythromycin, or telithromycin, antibiotics used to treat bacterial infections;
• atazanavir, indinavir, nelfinavir, ritonavir, or saquinavir, used to treat HIV and AIDS infections;
• nefazodone, used to treat depression.

The following medicines may reduce the effectiveness of Axitinib Accord:

• rifampicin, rifabutin, or rifapentine, used to treat tuberculosis (TB);
• dexamethasone, a corticosteroid used for various conditions, including some serious diseases;
• phenytoin, carbamazepine, or phenobarbital, medicines used to treat epilepsy, particularly in cases of seizures;
• St. John’s wort ( Hypericum perforatum ), a herbal preparation used to treat depression.

During treatment with Axitinib Accord, you must not take these medicines. If you are taking any of these medicines, inform your doctor, pharmacist, or nurse. Your doctor may decide to adjust the dose of these medicines, adjust the dose of Axitinib Accord, or switch to another medicine.
Axitinib Accord may increase the side effects associated with theophylline, used to treat asthma and other lung diseases.
Axitinib Accord with food and drink
Consumption of grapefruit or grapefruit juice should be avoided during treatment with this medicine, as it may increase the likelihood of side effects.
Pregnancy and breastfeeding

• If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor, pharmacist, or nurse before taking this medicine.
• Axitinib Accord could harm the unborn baby or a breastfed infant.
• This medicine must not be used during pregnancy. Consult your doctor before taking the medicine if you are pregnant or could become pregnant.
• During treatment with Axitinib Accord, you must use a reliable method of contraception for at least one week after taking the last dose of the medicine to avoid pregnancy.
• You must not breastfeed during treatment with Axitinib Accord. If you are breastfeeding, consult your

doctor to decide whether to discontinue breastfeeding or the treatment with Axitinib
Accord.
Driving and using machines
If you experience dizziness and/or unusual tiredness during treatment with Axitinib Accord, exercise particular caution when driving or operating machinery.
Axitinib Accord contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
Axitinib Accord contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially ‘sodium-free’.

3. How to take Axitinib Accord

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor, pharmacist, or nurse.
The recommended dose is 5 mg twice daily. Your doctor may later decide to increase or reduce the dose based on your tolerance to treatment with Axitinib Accord. Other products are available for the increased dose of 7 mg.
The tablets must be swallowed whole with water, with or without food. Take doses of Axitinib Accord approximately 12 hours apart.
If you take more Axitinib Accord than you should
If you have accidentally taken too many tablets or a higher dose than prescribed, contact your doctor immediately. If possible, show the doctor the medicine package or this leaflet. Medical intervention may be necessary.
If you forget to take Axitinib Accord
Take the next dose at your usual time. Do not take a double dose to make up for the forgotten dose.
If you vomit while taking Axitinib Accord
If you vomit, do not take an additional dose. Take the next prescribed dose at your usual time.
If you stop treatment with Axitinib Accord
If you are unable to take the medicine prescribed by your doctor or if you think you no longer need it, contact your doctor immediately.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects could be serious. Contact your doctor immediately if you experience any of
the following serious side effects (see also section 2 “What you need to know before taking Axitinib Accord”):

• Heart failure events. Inform your doctor if you experience excessive tiredness, swelling in the abdomen, legs or ankles, shortness of breath, or swelling of the neck veins.
• Blood clots in veins and arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis. Go immediately to the emergency room and contact your doctor if you experience symptoms such as chest tightness or pain; pain in the arms, back, neck, or jaw; shortness of breath; numbness or weakness on one side of the body; difficulty speaking; headache; vision changes; or dizziness.

Bleeding. Contact your doctor immediately if, during treatment with Axitinib Accord, you experience any of the following symptoms or have severe bleeding: black, tarry stools; coughing up blood or blood-streaked sputum; or changes in mental status.

• Stomach or intestinal perforation or formation of a fistula (an abnormal passageway that develops between two body cavities or between a body cavity and the skin). Contact your doctor immediately if you experience severe abdominal pain.

Severe increase in blood pressure (hypertensive crisis). Contact your doctor immediately if you experience very high blood pressure, or severe headache or chest pain.
Reversible swelling of the brain (reversible posterior encephalopathy syndrome).
Go immediately to the emergency room and contact your doctor if you experience any of the following symptoms: headache, confusion, seizures, or vision changes, with or without high blood pressure.

Other possible side effects of Axitinib Accord include:
Very common: may affect more than 1 in 10 people

• High blood pressure or increases in blood pressure
• Diarrhea, feeling unwell or general malaise (nausea or vomiting), stomach ache, indigestion, mouth, tongue or throat pain, constipation
• Shortness of breath, cough, hoarseness
• Loss of strength, feeling weak or tired
• Reduced activity of the thyroid gland (may be detected in blood tests)
• Redness and swelling of the palms of the hands and soles of the feet (hand-foot syndrome), skin rash, dry skin
• Joint pain, pain in hands or feet
• Loss of appetite
• Presence of protein in the urine (can be detected in blood tests)
• Weight loss
• Headache, taste disturbances or loss of taste

Common: may affect up to 1 in 10 people

• Dehydration (loss of body fluids)
• Kidney failure
• Flatulence (gas), hemorrhoids, bleeding gums, rectal bleeding, burning or irritation in the mouth
• Overactivity of the thyroid gland (can be detected in blood tests)
• Sore throat or nasal irritation, throat irritation
• Muscle pain
• Nosebleeds
• Itching, skin redness, hair loss
• Ringing or buzzing in the ears (tinnitus)
• Reduced number of red blood cells (can be detected in blood tests)
• Reduced number of platelets (cells that help blood to clot) (can be detected in blood tests)
• Presence of red blood cells in the urine (can be detected in urine tests)
• Changes in levels of various chemicals/enzymes in the blood (can be detected in blood tests)
• Increased number of red blood cells (can be detected in blood tests)
• Swelling of the abdomen, legs or ankles, swelling of neck veins, excessive tiredness, shortness of breath (signs of heart failure events)
• Fistula (an abnormal passageway that develops between two body cavities or between a body cavity and the skin)
• Dizziness
• Inflammation of the gallbladder

Uncommon: may affect up to 1 in 100 people

• Reduced number of white blood cells (can be detected in blood tests)

Not known: frequency cannot be estimated from the available data

• Widening and weakening of the wall of a blood vessel or a tear in the wall of a blood vessel (aneurysms and arterial dissections).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Axitinib Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister label, or bottle after "EXP". The expiry date refers to the last day of the month.
This medicine does not require any special storage temperature.
OPA/Aluminum/PVC/Aluminum blister:
Store in the original packaging to protect from moisture.
HDPE bottle:
Keep the bottle tightly closed to protect from moisture.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Bottle:
After first opening of the bottle:
1 mg: use within 45 days
3 mg and 5 mg: use within 30 days.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Axitinib Accord contains

• The active substance is axitinib. Axitinib Accord film-coated tablets are available in different strengths.
  Axitinib Accord 1 mg: each tablet contains 1 mg of axitinib.
  Axitinib Accord 3 mg: each tablet contains 3 mg of axitinib.
  Axitinib Accord 5 mg: each tablet contains 5 mg of axitinib.

The other components are: lactose, microcrystalline cellulose (E460), anhydrous colloidal silica,
hydroxypropylcellulose (300–600 mPa*s), sodium croscarmellose (E468), talc, magnesium stearate (E
470b), hypromellose 2910 (15 mPas) (E464), monohydrate lactose, titanium dioxide (E171), triacetin, and
iron oxide red (E172) (see section 2 Axitinib Accord contains lactose).

Description of the appearance of Axitinib Accord and package contents
Axitinib Accord 1 mg is available as red, modified capsule-shaped, biconvex, film-coated tablets,
imprinted with "S14" on one side and plain on the other. The tablet dimensions are approximately 9.1 ± 0.2 mm x 4.6 ± 0.2 mm. Axitinib Accord 1 mg is available in bottles containing 180 tablets and in blister packs of 14 tablets. Each blister pack contains 28 or 56 tablets, or perforated blisters divided into single-dose units of 28 x 1 or 56 x 1 tablets.

Axitinib Accord 3 mg is available as red, round, biconvex, film-coated tablets, imprinted with "S95" on one side and plain on the other. The tablet dimensions are approximately 5.3 ± 0.3 mm x 2.6 ± 0.3 mm. Axitinib Accord 3 mg is available in bottles containing 60 tablets and in blister packs of 14 tablets. Each blister pack contains 28 or 56 tablets, or perforated blisters divided into single-dose units of 28 x 1 or 56 x 1 tablets.

Axitinib Accord 5 mg is available as red, triangular, biconvex, film-coated tablets, imprinted with "S15" on one side and plain on the other. The tablet dimensions are approximately 6.4 ± 0.3 mm x 6.3 ± 0.3 mm. Axitinib Accord 5 mg is available in bottles containing 60 tablets and in blister packs of 14 tablets. Each blister pack contains 28 or 56 tablets, or perforated blisters divided into single-dose units of 28 x 1 or 56 x 1 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est, 6a Planta,
08039 Barcelona,
Spain

Manufacturer
APIS Labor GmbH
Resslstraβe 9
9065 Ebenthal in Kärnten,
Austria

Accord Healthcare Polska Sp.z.o.o
ul Lutomierska 50, 95-200
Pabianice, Poland

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
AT / BE / BG / CY / CZ / DE / DK / EE / ES / FI / FR / HR / HU / IE / IS / IT / LT / LV / LX / MT /
NL / NO / PL / PT / RO / SE / SI / SK
Accord Healthcare S.L.U.
Tel: +34 93 301 00 64
EL
Win Medica Α.Ε.
Τηλ: +30 210 74 88 821

More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.