Sunitinib Bluefish

Leaflet accompanying the packaging: patient information

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

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• 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, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Sunitinib Bluefish and what is it 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 packaging and other information

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

Sunitinib Bluefish contains the active substance sunitinib, which is a protein kinase inhibitor.
Sunitinib Bluefish is used to treat cancer. It inhibits the activity of a special group of proteins known to participate in the growth and spread of cancer cells.
Sunitinib Bluefish is used to treat the following types of cancer in adults:

• Gastrointestinal stromal tumors (GIST), a type of stomach and intestine cancer, when imatinib (another anticancer drug) 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 a progressive phase and cannot be surgically removed.

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

2. Important information before taking Sunitinib Bluefish

When not to take Sunitinib Bluefish

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

Warnings and precautions

Before starting Sunitinib Bluefish, you should discuss it 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 be treated with blood pressure-lowering medications.
• If you have or have had blood disorders, bleeding, or bruising.Treatment with Sunitinib Bluefish may increase the risk of bleeding or change 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 medications 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 disease.Sunitinib Bluefish may cause heart disease. You should tell your doctor if you experience fatigue, shortness of breath, or swelling of the feet or ankles.
• If you have heart rhythm disorders.Sunitinib Bluefish may cause abnormal heart rhythms. During treatment with Sunitinib Bluefish, your doctor may perform an electrocardiogram to assess these disorders. You should tell your doctor if you experience dizziness, fainting, or abnormal heart rhythms while taking Sunitinib Bluefish.
• If you have recently had blood clots in the veins and/or arteries (types of blood vessels), 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 damage to the smallest blood vessels called microangiopathic thrombocytopenic purpura. You should tell your doctor if you experience fever, fatigue, tiredness, bruising, bleeding, swelling, confusion, loss of vision, or seizures.
• If you have thyroid disease.Sunitinib Bluefish may cause thyroid disease. You should tell your doctor if you easily get tired, feel colder than others, or experience a deepened voice while taking Sunitinib Bluefish. Your doctor should check your thyroid function before starting Sunitinib Bluefish and regularly during treatment. If your thyroid does not produce enough thyroid hormone, you may need to be treated with replacement thyroid hormone.
• If you have or have had pancreatic 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 disease.You should inform your doctor if you experience any of the following symptoms of liver disorders 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 liver function before starting Sunitinib Bluefish, during treatment, and if there are clinical signs.
• If you have or have had kidney disease.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, and/or jaw pain, swelling, or mouth ulcers, numbness, or a feeling of heaviness in the jaw, or tooth mobility, you should immediately inform your oncologist and dentist.
• If you need invasive dental treatment or oral surgery, you should inform your dentist that you are taking Sunitinib Bluefish, especially if you are also taking or have taken intravenous bisphosphonates. Bisphosphonates are medicines used to prevent bone problems that may be taken for another condition.
• If you have or have had skin and subcutaneous tissue disorders.While taking this medicine, you may experience pyoderma gangrenosum (painful skin ulcers) or necrotizing fasciitis (a rapidly spreading infection of the skin and/or soft tissues that can be life-threatening). You should immediately contact your doctor if you experience symptoms of infection around a skin injury, including fever, pain, redness, swelling, or discharge of pus or blood. These disorders usually resolve after discontinuing sunitinib. While taking this medicine, severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been observed, which initially appear as reddened patches with a target-like shape or round patches, often with centrally located blisters. The rash can transform into widespread blisters or peeling of the skin and can be life-threatening. If you experience a rash or the above-mentioned skin symptoms, you should immediately consult 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 loss of vision.
• If you have diabetes.In patients with diabetes, blood sugar levels should be regularly checked to assess whether it is necessary to adjust the dose of the anti-diabetic medication to minimize the risk of hypoglycemia. You should inform your doctor as soon as possible if you experience symptoms related to low blood sugar (fatigue, palpitations, excessive sweating, hunger, and loss of consciousness).

Children and adolescents

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

Sunitinib Bluefish and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those that are available without a prescription, as well as any medicines 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 plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
Women who may 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 significant fatigue, you should be cautious when driving or operating machinery.

Sunitinib Bluefish contains sodium

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

3. How to take Sunitinib Bluefish

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, you should consult your doctor.
Your doctor will prescribe a dose suitable for you, depending on the type of cancer.
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 the medicine), in 6-week treatment cycles.
• pNET, the usual dose is 37.5 mg taken once a day continuously.

Your doctor will determine the appropriate dose for you and the end of treatment with Sunitinib Bluefish.
Sunitinib Bluefish can be taken with or without food.

Taking a higher dose of Sunitinib Bluefish than recommended

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

Missing a dose of Sunitinib Bluefish

You should not take a double dose to make up for a missed 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 disease.You should tell your doctor if you feel very tired, have shortness of breath, or swelling of the feet and ankles. These may be symptoms of heart problems, including heart failure and problems with the heart muscle (cardiomyopathy).
Lung disease 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 move to the lungs.
Kidney problems.You should tell your doctor if you experience changes in urination frequency or inability to urinate, 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 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 abdominal pain, fever, nausea, vomiting, blood in 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 fatigue, 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 ulcers, and/or inflammation and/or dryness of the mouth, taste disorders, stomach disorders, 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 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 disorders.

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 after a severe infection (sepsis) that can lead to tissue damage, organ failure, and death.
• Decreased blood sugar levels (see section 2).
• Protein loss in urine, sometimes causing swelling.
• Pseudo-flu 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 membrane 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.
• Disorders of skin sensation, itching, peeling, and inflammation of the skin, blisters, acne, nail discoloration, hair loss.
• Disorders of sensation 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 reduction of blood supply to the heart.
• Changes in heart rhythm or electrical activity.
• 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, and/or jaw pain, swelling, or mouth ulcers, numbness, or a feeling of heaviness in the jaw, or tooth mobility. These may be symptoms of jawbone damage (osteonecrosis), see section 2.
• Excessive production 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 reaction to allergens, including hay fever, skin rash, itching, hives, swelling of any part of the body, and breathing difficulties.
• Inflammation of the large intestine (colitis, ischemic colitis).

Rare: may affect up to 1 in 1000 people

• Severe skin reaction (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
• Tumor lysis syndrome, which is a group of metabolic complications that can occur during cancer treatment. These complications are caused by the breakdown products of dying cancer cells and can 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 changes and acute kidney failure.
• Abnormal muscle breakdown, which can cause kidney disease (rhabdomyolysis).
• Abnormal changes in the brain, which can cause a syndrome of symptoms including headache, disorientation, seizures, and loss of vision (reversible posterior leukoencephalopathy syndrome).
• Painful skin ulcers (pyoderma gangrenosum).
• Hepatitis.
• Thyroid inflammation.
• Damaged smallest blood vessels called microangiopathic thrombocytopenic purpura.

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

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

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sunitinib Bluefish

The medicine should be stored out of 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 stated.
Store in the original packaging 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. You should ask your 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 Sunitinib Bluefish contains

• The active substance of Sunitinib Bluefish is sunitinib. Each capsule contains 12.5 mg, 25 mg, or 50 mg of sunitinib.
• 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 ink printing "SB 12.5" and a white line on the body, containing

• yellow to orange granules, with a nominal length of approximately 14.3 mm.

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

• yellow to orange granules, with a nominal length of approximately 15.9 mm.

Sunitinib Bluefish, 50 mg, hard capsules:
Hard capsules, size "1", with a caramel cap and caramel body, with white ink printing "SB 50" and a white line on the body, containing yellow to orange granules, with a nominal length of approximately 19.4 mm.
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
Phone: +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