Sunitinib Bluefish

Package Leaflet: Information for the Patient

Sunitinib Bluefish, 12.5 mg, hard capsules

Sunitinib Bluefish, 25 mg, hard capsules

Sunitinib Bluefish, 50 mg, hard capsules

Sunitinib

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for you.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Contents of the Package Leaflet

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

1. What Sunitinib Bluefish is and what it is used for

Sunitinib Bluefish contains the active substance sunitinib, which is a protein kinase inhibitor.
Sunitinib Bluefish is used to treat cancer. It works by blocking the activity of a specific group of proteins, which are thought to be involved in the growth and spread of cancer cells.
Sunitinib Bluefish is used to treat the following types of cancer in adults:

• Gastrointestinal stromal tumor (GIST), a type of stomach and intestine cancer, when imatinib (another anti-cancer medicine) has stopped working or the patient cannot take it;
• Metastatic renal cell carcinoma (MRCC), a type of kidney cancer that has spread to other parts of the body;
• Pancreatic neuroendocrine tumors (pNET), tumors that arise from hormone-producing cells in the pancreas, which are in an advanced stage and cannot be surgically removed.

If you have any questions about how Sunitinib Bluefish works or why it has been prescribed for you, ask your doctor.

2. Important information before taking Sunitinib Bluefish

When not to take Sunitinib Bluefish

• If you are allergic to sunitinib or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Sunitinib Bluefish, you should discuss with your doctor:

• If you have high blood pressure.Sunitinib Bluefish may increase blood pressure. Your doctor may check your blood pressure during treatment with Sunitinib Bluefish, and you may need to take medicines to lower your blood pressure.
• If you have or have had bleeding or blood clotting problems.Treatment with Sunitinib Bluefish may increase the risk of bleeding or changes in the number of certain blood cells, which can cause anemia or affect the blood's ability to clot. If you are taking warfarin or acenocoumarol, blood-thinning medicines used to prevent blood clots, there may be a higher risk of bleeding. You should tell your doctor about any bleeding during treatment with Sunitinib Bluefish.
• If you have heart problems.Sunitinib Bluefish may cause heart problems. You should tell your doctor if you experience tiredness, shortness of breath, or swelling of your feet or ankles.
• If you have irregular heart rhythms.Sunitinib Bluefish may cause irregular heart rhythms. During treatment with Sunitinib Bluefish, your doctor may perform an electrocardiogram to check for these problems. You should tell your doctor if you experience dizziness, fainting, or irregular heart rhythms while taking Sunitinib Bluefish.
• If you have recently had blood clots in your veins and/or arteries (including stroke, heart attack, embolism, or thrombosis).You should contact your doctor immediately if you experience symptoms such as chest pain or tightness, arm, back, neck, or jaw pain, shortness of breath, numbness or weakness on one side of the body, difficulty speaking, headache, or dizziness while taking Sunitinib Bluefish.
• If you have or have had an aneurysm (enlargement and weakening of the wall of a blood vessel) or a tear in the wall of a blood vessel.
• If you have or have had a condition called thrombotic microangiopathy (a condition characterized by the formation of blood clots in small blood vessels).You should tell your doctor if you experience fever, fatigue, weakness, bruising, bleeding, swelling, confusion, loss of vision, or seizures.
• If you have thyroid problems.Sunitinib Bluefish may cause thyroid problems. You should tell your doctor if you experience fatigue, feeling cold, or a deepening of your voice while taking Sunitinib Bluefish. Your doctor should check your thyroid function before starting treatment with Sunitinib Bluefish and regularly during treatment. If your thyroid is not producing enough thyroid hormone, you may need to take replacement thyroid hormone.
• If you have or have had pancreas or gallbladder problems.You should tell your doctor if you experience any of the following symptoms: stomach pain (upper abdomen), nausea, vomiting, and fever. These may be symptoms of pancreatitis or gallbladder inflammation.
• If you have or have had liver problems.You should inform your doctor if you experience any of the following symptoms of liver problems while taking Sunitinib Bluefish: itching, yellowing of the eyes or skin, dark urine, and pain or discomfort in the right upper abdomen. Your doctor should perform blood tests to check your liver function before starting treatment with Sunitinib Bluefish, during treatment, and if you show signs of liver problems.
• If you have or have had kidney problems.Your doctor will monitor your kidney function.
• If you are going to have surgery or have recently had surgery.Sunitinib Bluefish may affect wound healing. The medicine is usually stopped before surgery, and your doctor will decide when to restart Sunitinib Bluefish.

It is recommended that you have a dental check-up before starting treatment with Sunitinib Bluefish.

• If you experience mouth pain, toothache, jaw pain or swelling, mouth sores, numbness or a feeling of heaviness in the jaw, or tooth mobility, you should immediately inform your oncologist and dentist.
• If you need to have invasive dental treatment or surgery, you should inform your dentist that you are taking Sunitinib Bluefish, especially if you are also taking or have taken bisphosphonates intravenously. Bisphosphonates are medicines used to prevent bone problems, which may be taken for another condition.
• If you have or have had skin and subcutaneous tissue disorders.While taking this medicine, you may experience a painful skin rash (pyoderma gangrenosum) or a life-threatening infection of the skin and soft tissues (necrotizing fasciitis). You should immediately contact your doctor if you experience signs of infection around a skin injury, including fever, pain, redness, swelling, or discharge of pus or blood. These disorders usually resolve after stopping treatment with sunitinib. While taking this medicine, severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme) have been observed, which initially appear as red patches, often with a target-like appearance, or circular patches, often with central blisters. The rash may progress to widespread blisters or peeling of the skin and may be life-threatening. If you experience a rash or the above-mentioned skin symptoms, you should immediately contact your doctor.
• If you have or have had seizures.You should inform your doctor as soon as possible if you experience high blood pressure, headache, or vision loss.
• If you have diabetes.In patients with diabetes, blood sugar levels should be regularly checked to assess whether the dose of anti-diabetic medicine needs to be adjusted to minimize the risk of low blood sugar. You should inform your doctor as soon as possible if you experience symptoms of low blood sugar (fatigue, palpitations, sweating, hunger, and loss of consciousness).

Children and adolescents

Sunitinib Bluefish is not recommended for use in children and adolescents under 18 years of age.

Sunitinib Bluefish and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, including those obtained without a prescription and those you plan to take.
Some medicines may affect the levels of Sunitinib Bluefish in your body. You should inform your doctor if you are taking medicines containing the following active substances:

• ketokonazole, itraconazole - used to treat fungal infections;
• erythromycin, clarithromycin, rifampicin - used to treat infections;
• ritonavir - used to treat HIV infections;
• dexamethasone - a corticosteroid used in various diseases (such as allergic disorders and/or respiratory disorders or skin diseases);
• phenytoin, carbamazepine, phenobarbital - used to treat epilepsy and other neurological conditions;
• herbal products containing St. John's Wort (Hypericum perforatum) - used to treat depression and anxiety disorders.

Sunitinib Bluefish with food and drink

While taking Sunitinib Bluefish, you should not drink grapefruit juice.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Women who can become pregnant should use effective contraception during treatment with Sunitinib Bluefish.
Women who are breastfeeding should inform their doctor. You should not breastfeed while taking Sunitinib Bluefish.

Driving and using machines

If you experience dizziness or extreme tiredness, you should be careful when driving or operating machinery.

Sunitinib Bluefish contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which is essentially sodium-free.

3. How to take Sunitinib Bluefish

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.
Your doctor will prescribe the dose that is right for you, depending on the type of cancer you have.
For patients being treated for:

• GIST or MRCC, the usual dose is 50 mg taken once a day for 28 days (4 weeks), followed by a 14-day (2-week) break (without treatment), in 6-week treatment cycles.
• pNET, the usual dose is 37.5 mg taken once a day continuously.

Your doctor will determine the right dose for you and when to stop treatment with Sunitinib Bluefish.
Sunitinib Bluefish can be taken with or without food.

If you take more Sunitinib Bluefish than you should

If you have taken too many capsules, contact your doctor immediately.
Medical attention may be necessary.

If you forget to take Sunitinib Bluefish

Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should contact your doctor immediately if you experience any of the following side effects (see also Important information before taking Sunitinib Bluefish):
Heart problems.You should tell your doctor if you feel very tired, have shortness of breath, or swelling of your feet and ankles. These may be symptoms of heart problems, including heart failure and problems with the heart muscle (cardiomyopathy).
Lung problems or breathing difficulties.You should tell your doctor if you experience coughing, chest pain, sudden shortness of breath, or coughing up blood. These may be symptoms of a condition called pulmonary embolism, which occurs when blood clots travel to the lungs.
Kidney problems.You should tell your doctor if you experience changes in the frequency or absence of urination, which may be a sign of kidney failure.
Bleeding.You should tell your doctor if you experience any of the following symptoms or severe bleeding while taking Sunitinib Bluefish: stomach pain and swelling (abdomen); vomiting blood; black and tarry stools; blood in the urine; headache or changes in consciousness; coughing up blood or bloody sputum from the lungs or airways.
Tumor lysis syndrome leading to intestinal perforation. You should tell your doctor if you experience severe stomach pain, fever, nausea, vomiting, blood in the stool, or changes in bowel movements.
Other side effects of Sunitinib Bluefish may include:

• Very common: may affect more than 1 in 10 people
• Decreased number of platelets, red blood cells, and/or white blood cells (e.g., neutrophils).
• Shortness of breath.
• High blood pressure.
• Extreme tiredness, loss of strength.
• Swelling caused by fluid accumulation under the skin and around the eyes, allergic rash, deep.
• Pain and/or irritation in the mouth, painful sores and/or inflammation and/or dryness of the mouth, changes in taste, stomach upset, nausea, vomiting, diarrhea, constipation, abdominal pain and/or swelling, loss of and/or decreased appetite.
• Decreased thyroid activity (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleeds.
• Back pain, joint pain.
• Pain in the arms and legs.
• Yellowing of the skin and/or discoloration, excessive skin pigmentation, hair color changes, palmar-plantar erythrodysesthesia, rash, dry skin.
• Cough.
• Fever.
• Sleep disturbances.

Common: may affect up to 1 in 10 people

• Blood clots in blood vessels.
• Insufficient blood supply to the heart due to a blockage or narrowing of the coronary arteries.
• Chest pain.
• Decreased amount of blood pumped by the heart.
• Fluid accumulation, including in the lungs.
• Infections.
• A complication of severe infection (sepsis), which can lead to tissue damage, organ failure, and death.
• Decreased blood sugar levels (see section 2).
• Protein loss in the urine, sometimes causing swelling.
• Flu-like syndrome.
• Abnormal blood test results, including pancreatic and liver enzymes.
• High levels of uric acid in the blood.
• Hemorrhoids, anal pain, gum bleeding, difficulty swallowing or loss of swallowing ability.
• Burning sensation or pain in the tongue, inflammation of the mucous membranes of the digestive tract, excessive gas in the stomach or intestines.
• Weight loss.
• Musculoskeletal pain (muscle and bone pain), muscle weakness, muscle fatigue, muscle cramps.
• Dryness of the nasal mucosa, feeling of nasal congestion, excessive tearing.
• Skin sensitivity disorders, itching, peeling, and inflammation of the skin, blisters, acne, nail discoloration, hair loss.
• Sensitivity disorders in the limbs.
• Disorders related to increased or decreased sensitivity, especially to touch.
• Heartburn.
• Dehydration.
• Hot flashes.
• Abnormal urine color.
• Depression.
• Chills.

Uncommon: may affect up to 1 in 100 people

• Life-threatening infection of soft tissues, including the perineal area (see section 2).
• Stroke.
• Heart attack caused by interruption or narrowing of blood flow to the heart.
• Changes in the electrical or rhythmic activity of the heart.
• Fluid accumulation around the heart (pericardial effusion).
• Liver failure.
• Stomach pain (abdomen) caused by pancreatitis.
• Tumor lysis syndrome leading to intestinal perforation.
• Inflammation (swelling or redness) of the gallbladder with or without gallstones.
• Formation of abnormal connections between one body cavity and another or with the skin.
• Mouth pain, toothache, jaw pain or swelling, mouth sores, numbness or a feeling of heaviness in the jaw, or tooth mobility. These may be symptoms of jawbone damage (osteonecrosis), see section 2.
• Overproduction of thyroid hormones leading to increased resting metabolism.
• Impaired wound healing after surgery.
• Increased activity of the muscle enzyme (creatine phosphokinase) in the blood.
• Excessive allergic reaction, including fever, skin rash, itching, hives, swelling of any part of the body, and difficulty breathing.
• Inflammation of the large intestine (colitis, ischemic colitis).

Rare: may affect up to 1 in 1000 people

• Severe skin and mucous membrane reaction (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
• Tumor lysis syndrome, a group of metabolic complications that can occur during cancer treatment. These complications are caused by the breakdown products of dying cancer cells and may include nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, lack of urine clarity, and fatigue associated with abnormal laboratory test results (high levels of potassium, uric acid, and phosphorus, and low levels of calcium in the blood), which can lead to kidney damage and acute kidney failure.
• Abnormal muscle breakdown, which can cause kidney disease (rhabdomyolysis).
• Abnormal brain changes, which can cause a syndrome of symptoms including headache, disorientation, seizures, and vision loss (reversible posterior leukoencephalopathy syndrome).
• Painful skin ulcers (pyoderma gangrenosum).
• Hepatitis.
• Thyroid inflammation.
• Damaged small blood vessels called thrombotic microangiopathy.

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

• Enlargement and weakening of the wall of a blood vessel or rupture of a blood vessel (aneurysm and arterial dissection).
• Lack of energy, confusion, drowsiness, loss of consciousness, or coma - these symptoms may be signs of a toxic effect of high blood ammonia levels on the brain (hyperammonemic encephalopathy).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Pharmacovigilance Department, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sunitinib Bluefish

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, and bottle after: Expiry date (EXP). The expiry date refers to the last day of the month shown.
Store in the original package to protect from light.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Sunitinib Bluefish contains

• The active substance is sunitinib. Each capsule contains 12.5 mg, 25 mg, or 50 mg of sunitinib.
• The other ingredients are:
• Capsule content: microcrystalline cellulose (type 200), mannitol (E 421), croscarmellose sodium, povidone K-30, magnesium stearate
• Capsule shell:12.5 mg: gelatin, iron oxide red (E 172), and titanium dioxide (E 171). 25 mg and 50 mg: gelatin, iron oxide red (E 172), iron oxide yellow (E 172), iron oxide black (E 172), and titanium dioxide (E 171)
• Printing ink:shellac, titanium dioxide (E 171), and propylene glycol

What Sunitinib Bluefish looks like and contents of the pack

Sunitinib Bluefish, 12.5 mg, hard capsules:
Hard capsules, size 4, with an orange cap and orange body, with white printing "SB 12.5" and a white line on the body, containing yellow to orange granules

• approximately 14.3 mm in length.

Sunitinib Bluefish, 25 mg, hard capsules:
Hard capsules, size 3, with a caramel cap and orange body, with white printing "SB 25" and a white line on the body, containing yellow to orange granules

• approximately 15.9 mm in length.

Sunitinib Bluefish, 50 mg, hard capsules:
Hard capsules, size 1, with a caramel cap and caramel body, with white printing "SB 50" and a white line on the body, containing yellow to orange granules

approximately 19.4 mm in length.
Sunitinib Bluefish 12.5 mg, 25 mg, and 50 mg hard capsules are available in blisters and bottles with a container containing silicon dioxide as a desiccant, in a cardboard box.
Pack size: 28 capsules

Marketing authorization holder and manufacturer

Marketing authorization holder

Bluefish Pharmaceuticals AB
P.O. Box 49013
100 28 Stockholm
Sweden
tel. +46 8 51 91 16 00

Manufacturer

Pharmacare Premium Ltd
HHF003 Hal Far Industrial Estate
Birzebbugia, BBG3000
Malta
Genepharm S.A.
18 km Marathonos Avenue
153 51 Pallini Attiki
Greece

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

Date of last revision of the leaflet:07/2024