Pazopanib Viatris

Leaflet accompanying the packaging: Patient information

Pazopanib Viatris, 200 mg, film-coated tablets

Pazopanib Viatris, 400 mg, film-coated tablets

pazopanib

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Pazopanib Viatris and what is it used for
• 2. Important information before taking Pazopanib Viatris
• 3. How to take Pazopanib Viatris
• 4. Possible side effects
• 5. How to store Pazopanib Viatris
• 6. Contents of the packaging and other information

1. What is Pazopanib Viatris and what is it used for

Pazopanib Viatris belongs to a group of medicines called protein kinase inhibitors. The action of the medicine is based on inhibiting the activity of proteins involved in the growth and spread of cancer cells.
Pazopanib Viatris is used in adult patients to treat:

• advanced or metastatic kidney cancer.
• certain types of soft tissue sarcoma, which is a type of tumor that attacks connective tissue in the body. It can occur in muscles, blood vessels, fat tissue, or other tissues that support, surround, and protect internal organs.

2. Important information before taking Pazopanib Viatris

When not to take Pazopanib Viatris

• if the patient is allergicto pazopanib or any of the other ingredients of this medicine (listed in section 6).

Consult a doctorif the patient believes the above statement applies to them.

Warnings and precautions

Before starting to take Pazopanib Viatris, the patient should discuss with their doctor:

• if the patient has heart disease.
• if the patient has liver disease.
• if the patient has had heart failure or a heart attack.
• if the patient has a history of pneumothorax.
• if the patient has bleeding, blood clots, or arterial stenosis.
• if the patient has had stomach or intestinal diseases, such as perforation(puncture) or fistula(formation of abnormal connections between different parts of the intestine).
• if the patient has thyroid diseases.
• if the patient has kidney function disorders.
• if the patient has or has had an aneurysm(enlargement and weakening of the wall of a blood vessel) or a rupture of a blood vessel.

Tell the doctorif any of these circumstances occur. The doctor will decide whether Pazopanib Viatris is suitable for the patient. It may be necessary to perform additional tests on the patient to check if the kidneys, heart, and liver are functioning properly.
High blood pressure and taking Pazopanib Viatris
Pazopanib Viatris may cause high blood pressure. Before starting to take Pazopanib Viatris and during treatment, the patient's blood pressure will be monitored.
If the patient has high blood pressure, the doctor will prescribe blood pressure-lowering medications.

• Tell the doctorif the patient has high blood pressure.

If the patient is scheduled for surgery

The doctor will recommend stopping Pazopanib Viatris at least 7 days before surgery, as the medicine may affect the wound healing process after surgery. Treatment will be resumed after the wound has healed.

Conditions that require special attention

Pazopanib Viatris may exacerbate certain disorders or cause severe side effects. During treatment with Pazopanib Viatris, it is essential to pay attention to certain symptoms to minimize the risk of adverse effects. See section 4.

Children and adolescents

Pazopanib Viatris is not recommended for patients under 18 years of age. It has not been established how the medicine works in this group of patients. Additionally, for safety reasons, the medicine should not be used in children under 2 years of age.

Pazopanib Viatris and other medicines

Tell the doctor or pharmacist about all medicines currently being taken or recently taken, as well as those planned to be taken. This includes herbal preparations and other medicines available without a prescription.
Some medicines may affect the action of Pazopanib Viatris or increase the likelihood of side effects in the patient.
Pazopanib Viatris may also affect the action of other medicines. These include:

• clarithromycin, ketoconazole, itraconazole, rifampicin, telithromycin, voriconazole (used to treat infections).
• atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (used to treat HIV infections).
• nefazodone (used to treat depression).
• simvastatin and possibly other statins (used to treat high cholesterol in the blood).
• medicines that reduce stomach acid secretion. Medicines taken to reduce stomach acid secretion (e.g., proton pump inhibitors, H2 receptor antagonists, or antacids) may affect the absorption of Pazopanib Viatris. For advice, consult a doctor or nurse. Tell the doctoror pharmacist if the patient is taking any of these medicines.

Pazopanib Viatris with food and drink

Do not take Pazopanib Viatris with food, as it affects the absorption of the medicine. The medicine should be taken at least 2 hours after a meal or 1 hour before a meal (see section 3).
Do not drink grapefruit juice during treatment with Pazopanib Viatris, as it may increase the risk of side effects.

Pregnancy, breastfeeding, and fertility

Pazopanib Viatris is not recommended during pregnancy. It is not known how Pazopanib Viatris affects pregnancy.

• Tell the doctor if the patient is pregnantor plans to become pregnant.
• During treatment with Pazopanib Viatris and for at least 2 weeks after the end of treatment, an effective method of contraception should be usedto prevent pregnancy.
• Tell the doctor if the patient becomes pregnant while taking Pazopanib Viatris.

Do not breastfeed while taking Pazopanib Viatris. It is not known whether the ingredients of Pazopanib Viatris pass into human milk. Consult the attending doctor.
Men(including men after vasectomy), whose partners are pregnant or are able to become pregnant (including women using other contraceptive methods), should use condoms during sexual intercourse while taking Pazopanib Viatris and for at least 2 weeks after taking the last dose.
Treatment with Pazopanib Viatris may affect fertility. Consult the attending doctor.

Driving and operating machinery

While taking Pazopanib Viatris, side effects may occur that can affect the ability to drive and operate machinery.

• Avoid driving and operating machinery if the patient feels dizzy, tired, or weak, or if they have low energy levels.

Pazopanib Viatris contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to take Pazopanib Viatris

This medicine should always be taken as directed by the doctor. In case of doubts, consult a doctor or pharmacist.

How many tablets to take

The usual dose is 800 mg taken once a day. The dose can be taken as two 400 mg tablets or four 200 mg tablets. The 800 mg dose is the maximum daily dose. The doctor may recommend reducing the dose if the patient experiences side effects.

When to take the medicine

Do not take Pazopanib Viatris with food. The medicine should be taken at least 2 hours after a meal or 1 hour before a meal. For example, the medicine can be taken 2 hours after breakfast or 1 hour before lunch. Pazopanib Viatris should be taken every day at the same time.
Tablets should be swallowed whole, one after the other, with water. Do not break or crush the tablets, as this affects the absorption of the medicine and may increase the risk of side effects.

Taking a higher dose of Pazopanib Viatris than recommended

In case of swallowing too many tablets, consult a doctor or pharmacist. If possible, show the packaging of the medicine or this leaflet.

Missing a dose of Pazopanib Viatris

Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.

Stopping treatment with Pazopanib Viatris

Pazopanib Viatris should be taken for as long as the doctor recommends. Do not stop taking the medicine unless the doctor recommends it.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible serious side effects
Brain swelling(reversible posterior leukoencephalopathy syndrome). Rarely, Pazopanib Viatris may cause brain swelling, which can be life-threatening. Symptoms include:

• loss of speech
• vision disturbances
• seizures
• disorientation
• high blood pressure

Stop taking Pazopanib Viatris and seek medical help immediately

if any of these symptoms occur or if the patient experiences a headache with any of these symptoms.
Hypertensive crisis(sudden and severe increase in blood pressure)
Pazopanib Viatris may rarely cause a sudden and severe increase in blood pressure. This condition is known as a hypertensive crisis. The doctor will monitor the patient's blood pressure while taking Pazopanib Viatris. Symptoms of a hypertensive crisis may include:

• severe chest pain
• severe headache
• blurred vision
• disorientation
• nausea
• vomiting
• severe anxiety
• shortness of breath
• seizures
• fainting

Stop taking Pazopanib Viatris and seek medical help immediately

if a hypertensive crisis occurs.

Heart rhythm disorders

The risk of these disorders may be higher in people with existing heart disease or those taking other medicines. While taking Pazopanib Viatris, the patient will be monitored for heart rhythm disorders.
Heart function disorders/heart failure, heart attack
Pazopanib Viatris may affect the heart's ability to pump blood or increase the risk of a heart attack. Symptoms include:

• irregular or rapid heartbeat
• rapid palpitations
• fainting
• chest pain or tightness
• arm, back, neck, or jaw pain
• shortness of breath
• swelling of the legs

Seek medical help immediatelyif any of these symptoms occur.
QT interval prolongation (heart rhythm disorder)
Pazopanib Viatris may affect the heart rhythm, which can lead to heart rhythm disorders called torsades de pointesin some people. These can cause very rapid heartbeat, leading to loss of consciousness.
Tell the doctorif the patient experiences any unusual heart rhythm changes, such as too fast or too slow heartbeat.

Stroke

Pazopanib Viatris may increase the risk of stroke. Symptoms of a stroke may include:

• numbness or weakness on one side of the body
• difficulty speaking
• headache
• dizziness

Seek medical help immediatelyif any of these symptoms occur.

Bleeding

Pazopanib Viatris may cause severe bleeding from the digestive tract (stomach, esophagus, intestine, or rectum), lungs, kidneys, vagina, or bleeding into the brain, although this is not very common. Symptoms of bleeding may include:

• blood in the stool or black stool
• blood in the urine
• abdominal pain
• coughing up blood or vomiting blood

Seek medical help immediatelyif any of these symptoms occur.

Perforation and fistula

Pazopanib Viatris may cause a rupture (perforation) of the stomach or intestinal wall or the formation of an abnormal connection between two parts of the digestive tract (fistula). Symptoms of this condition may include:

• severe abdominal pain
• nausea and (or) vomiting
• fever
• formation of a hole (perforation) in the stomach, large intestine, or small intestine, with bloody or foul-smelling pus discharge

Seek medical help immediatelyif any of these symptoms occur.

Liver diseases

Pazopanib Viatris may cause liver disorders, which can lead to serious diseases such as liver function disorders or liver failure, which can be fatal. The doctor will monitor the patient's liver enzyme activity while taking Pazopanib Viatris. Symptoms of liver dysfunction may include:

• yellowing of the skin or whites of the eyes (jaundice)
• dark urine
• feeling tired
• nausea
• vomiting
• loss of appetite
• pain on the right side of the abdomen
• easy bruising

Seek medical help immediatelyif any of these symptoms occur.

Blood clots

Deep vein thrombosis and pulmonary embolism
Pazopanib Viatris may cause blood clots in the veins, especially in the veins of the legs (deep vein thrombosis), which can also move to the lungs (pulmonary embolism). Symptoms of this condition may include:

• sudden chest pain
• shortness of breath
• rapid breathing
• leg pain
• swelling of the arms and hands or feet and ankles

Microangiopathic hemolytic anemia
Pazopanib Viatris may cause blood clots in the small blood vessels in the kidneys and brain, accompanied by a decrease in the number of red blood cells and blood cells involved in clotting (microangiopathic hemolytic anemia). Symptoms include:

• easy bruising
• high blood pressure
• fever
• disorientation
• drowsiness
• seizures
• decreased urine output

Seek medical help immediatelyif any of these symptoms occur.

Tumor lysis syndrome

Pazopanib Viatris may cause rapid breakdown of cancer cells, leading to tumor lysis syndrome, which can be fatal in some people. Symptoms may include irregular heartbeat, seizures, disorientation, muscle cramps, or decreased urine output. Seek medical help immediatelyif any of these symptoms occur.

Infections

Infections that occur while taking Pazopanib Viatris can become severe. Symptoms of infections may include:

• fever
• flu-like symptoms such as cough, fatigue, and body aches that do not go away
• shortness of breath and (or) wheezing
• pain while urinating
• cuts, scratches, or wounds that are red, warm, swollen, or painful

Seek medical help immediatelyif any of these symptoms occur.

Pneumonitis

Pazopanib Viatris may rarely cause pneumonitis (interstitial lung disease, pneumonia), which can be fatal in some patients. Symptoms include shortness of breath or cough that does not go away. While taking Pazopanib Viatris, the patient will be monitored for any lung problems.
Seek medical help immediatelyif any of these symptoms occur.

Thyroid diseases

Pazopanib Viatris may decrease the production of thyroid hormones in the body. This can cause weight gain and fatigue. While taking Pazopanib Viatris, the doctor will monitor the patient's thyroid hormone levels.
Tell the doctorif the patient notices significant weight gain or fatigue.

Blurred vision or vision disturbances

Pazopanib Viatris may cause separation or tearing of the membrane on the back surface of the eye (retinal detachment or retinal tear). This can cause blurred vision or vision disturbances. Tell the doctorif the patient notices any changes in vision.

Possible side effects (including possible serious side effects in the relevant frequency categories).

Very common side effects(may occur in more than 1 in 10patients):

• high blood pressure
• diarrhea
• nausea (nausea or vomiting)
• abdominal pain
• loss of appetite
• weight loss
• taste disturbances or loss of taste
• mouth pain
• headache
• cancer pain
• lack of energy, feeling weak or tired
• hair color changes
• excessive hair loss or thinning
• skin discoloration
• skin rash with possible peeling
• redness and swelling of the hands or soles of the feet

Tell the doctor or pharmacistif any of these symptoms become troublesome.

Very common side effect that may be detected in blood or urine tests

• increased liver enzyme activity
• decreased albumin levels in the blood
• protein in the urine
• decreased platelet count (a blood component that enables clotting)
• decreased white blood cell count

Common side effects (may occur in less than 1 in 10patients):

• indigestion, bloating, gas
• nosebleeds
• dry mouth or mouth sores
• infections
• excessive sleepiness
• sleep disturbances
• chest pain, shortness of breath, leg pain, or swelling of the legs or feet. These may be symptoms of blood clots in the body (thromboembolism). If a clot breaks loose, it can move to the lungs, which can be life-threatening or fatal.
• decreased heart function (heart failure)
• slow heartbeat
• bleeding from the mouth, rectum, or lungs
• dizziness
• blurred vision
• hot flashes
• swelling of the face, hands, feet, or ankles due to fluid accumulation
• tingling, weakness, or numbness of the hands, arms, legs, or feet
• skin disorders, redness, itching, dryness of the skin
• nail disorders
• burning, tingling, itching, or numbness of the skin
• feeling cold with accompanying chills
• excessive sweating
• dehydration
• muscle, joint, tendon, or chest pain, muscle cramps
• hoarseness
• shortness of breath
• coughing
• hemoptysis
• hiccups
• pneumothorax with air trapped in the space between the lung and the chest cavity, often causing shortness of breath (pneumothorax)

Tell the doctoror pharmacist if any of these symptoms become troublesome.

Common side effects that may be detected in blood or urine tests:

• hypothyroidism
• abnormal liver function
• increased bilirubin levels (a substance produced by the liver)
• increased lipase activity (an enzyme involved in digestion)
• increased creatinine levels (a substance produced in the muscles)
• changes in the levels or activity of various substances or enzymes in the blood. The doctor will inform the patient about the results of the blood tests.

Uncommon side effects(may occur in less than 1 in 100patients):

• stroke
• transient reduction in blood flow to the brain (transient ischemic attack)
• interruption of blood flow to a part of the heart or heart attack (myocardial infarction)
• partial interruption of blood flow to a part of the heart (myocardial ischemia)
• blood clots accompanied by a decrease in the number of red blood cells and blood cells involved in clotting (microangiopathic hemolytic anemia). This can damage organs such as the brain and kidneys.
• increased red blood cell count
• sudden shortness of breath, especially if accompanied by sudden chest pain and (or) rapid breathing (pulmonary embolism)
• severe bleeding from the digestive tract (stomach, esophagus, or intestine), kidneys, vagina, or bleeding into the brain
• heart rhythm disorders (QT interval prolongation)
• perforation (perforation) of the stomach or intestine
• formation of abnormal connections between different parts of the intestine (fistula)
• excessive or irregular menstrual bleeding
• sudden, severe increase in blood pressure (hypertensive crisis)
• pancreatitis
• inflammation, abnormal function, or damage to the liver
• yellowing of the skin or whites of the eyes (jaundice)
• inflammation of the lining of the abdominal cavity (peritonitis)
• runny nose
• rashes that may be itchy or inflamed (flat or raised patches or blisters)
• diarrhea
• increased sensitivity of the skin to sunlight
• weakness or decreased sensitivity, especially of the skin
• skin wound that does not heal (skin ulcer)

Rare side effects(may occur in less than 1 in 1000patients):

• pneumonitis
• enlargement and weakening of the wall of a blood vessel or rupture of a blood vessel (aneurysm and arterial dissection)

Frequency not known(frequency cannot be estimated from the available data)

• tumor lysis syndrome due to rapid breakdown of cancer cells
• liver failure

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, tell the doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Al. Jerozolimskie 181C,
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Pazopanib Viatris

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiration date stated on the blister, bottle, and carton after "Expiration Date (EXP)". The expiration date refers to the last day of the month stated.
There are no special storage instructions for the medicine.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Pazopanib Viatris contains

• The active substance is pazopanib (as hydrochloride). Each 200 mg film-coated tablet of Pazopanib Viatris contains 200 mg of pazopanib. Each 400 mg film-coated tablet of Pazopanib Viatris contains 400 mg of pazopanib.
• The other ingredients of the 200 mg and 400 mg tablets are: microcrystalline cellulose, sodium carboxymethylcellulose (type A), povidone (K30), magnesium stearate, hypromellose (6 mPas), titanium dioxide (E 171), macrogol 400, polysorbate 80. The 200 mg tablets also contain iron oxide red (E 172).

What Pazopanib Viatris looks like and contents of the pack

Pazopanib Viatris, 200 mg film-coated tablets are pink film-coated tablets in the shape of a capsule, with "200" engraved on one side. The medicine is available in blisters of 30, 60, or 90 tablets, multipacks of 60 or 60 x 1 (2 cartons of 30 or 2 cartons of 30 x 1) tablets, 90 or 90 x 1 (3 cartons of 30 or 3 cartons of 30 x 1) tablets, and in plastic bottles of 30 or 90 tablets or multipacks of 90 (3 bottles of 30) tablets.
Pazopanib Viatris, 400 mg film-coated tablets are white film-coated tablets in the shape of a capsule, with "400" engraved on one side. The medicine is available in blisters of 30, 60, or 90 tablets, multipacks of 60 or 60 x 1 (2 cartons of 30 or 2 cartons of 30 x 1) tablets, 90 or 90 x 1 (3 cartons of 30 or 3 cartons of 30 x 1) tablets, and in plastic bottles of 30 or 60 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Viatris Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
DUBLIN
Ireland
(logo of the marketing authorization holder)

Manufacturer:

Remedica Ltd
Aharnon Street
Limassol Industrial Estate
3056 Limassol
Cyprus
PharOS MT Ltd.
HF62X, Hal Far Industrial Estate
Birzebbugia BBG3000
Malta
Pharos Pharmaceutical Oriented Services Ltd.
Lesvou Street End
Thesi Loggos Industrial Zone
Metamorfossi 14452
Greece
Logiters Logistica Portugal S.A.
Estrada Dos Arneiros 4
2050-306 Lisbon
Portugal
Mylan Germany GmbH
Benzstrasse 1
61352 Bad Homburg
Germany
To obtain more detailed information about this medicine, contact the local representative of the marketing authorization holder:
Viatris Healthcare Sp. z o.o.
Phone: +48 22 54 66 400

This medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium
Pazopanib Viatris 200 mg, 400 mg film-coated tablets
Denmark
Pazopanib Viatris
Estonia
Pazopanib Viatris
France
Pazopanib Viatris 200 mg, 400 mg film-coated tablets
Netherlands
Pazopanib Viatris 200 mg, 400 mg film-coated tablets
Iceland
Pazopanib Viatris
Lithuania
Pazopanib Viatris 200 mg, 400 mg film-coated tablets
Luxembourg
Pazopanib Viatris 200 mg, 400 mg film-coated tablets
Latvia
Pazopanib Viatris
Germany
Pazopanib Viatris 200 mg, 400 mg film-coated tablets
Norway
Pazopanib Viatris
Poland
Pazopanib Viatris
Portugal
Pazopanib Viatris
Czech Republic
Pazopanib Viatris
Hungary
Pazopanib Viatris 200 mg, 400 mg film-coated tablets
Italy
Pazopanib Mylan

Date of last revision of the leaflet: