Nilotinib Viatris

Leaflet accompanying the packaging: information for the user

Nilotinib Viatris, 50 mg, hard capsules

Nilotinib Viatris, 150 mg, hard capsules

Nilotinib Viatris, 200 mg, hard capsules

Nilotinib

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 or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• 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 Nilotinib Viatris and what is it used for
• 2. Important information before taking Nilotinib Viatris
• 3. How to take Nilotinib Viatris
• 4. Possible side effects
• 5. How to store Nilotinib Viatris
• 6. Contents of the packaging and other information

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

What is Nilotinib Viatris

Nilotinib Viatris is a medicine that contains the active substance nilotinib.

What is Nilotinib Viatris used for

Nilotinib Viatris is used to treat a type of leukemia called chronic myeloid leukemia (CML) with a positive Philadelphia chromosome (Ph+). CML is a blood cancer that causes the body to produce too many abnormal white blood cells.

Nilotinib Viatris is used to treat adult patients and children and adolescents with newly diagnosed CML or patients with CML who have not responded to previous treatment, including imatinib, or have experienced severe side effects that prevent them from continuing previous treatment.

How Nilotinib Viatris works

In patients with CML, a change in DNA (genetic material) leads to the production of a signal that causes the body to produce abnormal white blood cells. Nilotinib Viatris blocks this signal and thereby prevents the production of these abnormal cells.

Monitoring treatment with Nilotinib Viatris

During treatment, regular tests will be performed, including blood tests. These tests determine:

• the number of blood cells (white blood cells, red blood cells, and platelets) in the body to assess how well Nilotinib Viatris is tolerated.
• the function of the pancreas and liver in the body to assess how well Nilotinib Viatris is tolerated.
• the level of electrolytes in the body (potassium, magnesium), which are important for heart function.
• the level of sugar and fats in the blood. Heart rate will also be monitored using a device that measures the electrical activity of the heart (a test called EKG).

The doctor will regularly assess the treatment results and decide whether the patient should continue taking Nilotinib Viatris. If the patient is told to stop treatment with this medicine, the doctor will continue to monitor the patient's CML and may recommend that the patient resume treatment with Nilotinib Viatris if the patient's condition requires it.

2. Important information before taking Nilotinib Viatris

You should always follow the doctor's or pharmacist's instructions. They may differ from the general information contained in this leaflet.

When not to take Nilotinib Viatris

• if you are allergic to nilotinib or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, you should tell your doctor before taking Nilotinib Viatris.

Warnings and precautions

Before taking Nilotinib Viatris, you should discuss the following with your doctor or pharmacist:

• if you have previously experienced cardiovascular events such as heart attack, chest pain (angina), stroke, or poor circulation in the legs (claudication) or if you have risk factors for cardiovascular disease, such as high blood pressure, diabetes, or lipid disorders;
• if you have heart problems, such as abnormal electrical activity called "QT interval prolongation";
• if you are taking medicines that lower cholesterol levels in the blood (statins) or affect heart function (anti-arrhythmic drugs) or liver function (see "Other medicines and Nilotinib Viatris");
• if you have low levels of potassium or magnesium;
• if you have liver or pancreas problems;
• if you experience symptoms such as easy bruising, fatigue, or shortness of breath or if you have recurring infections;
• if you have had surgery to remove the entire stomach (total gastrectomy);
• if you have had or may have a hepatitis B virus infection; this is because Nilotinib Viatris may cause the hepatitis B virus to become active again, which can be life-threatening in some cases; patients will be closely monitored by their doctor for signs of this infection before and during treatment with Nilotinib Viatris.

During treatment with Nilotinib Viatris

• if you experience loss of consciousness (fainting) or irregular heartbeat, you should immediately tell your doctor, as this may be a sign of a serious heart condition. QT interval prolongation or irregular heartbeat can lead to sudden death. Sudden death has been reported in patients taking nilotinib.
• if you experience symptoms such as rapid heartbeat, severe weakness or paralysis, seizures, or sudden changes in thinking or concentration, you should immediately tell your doctor, as these may be symptoms of a condition called tumor lysis syndrome; tumor lysis syndrome has been rarely reported in patients treated with nilotinib.
• if you experience pain or discomfort in the chest, numbness or weakness, difficulty walking or speaking, pain, discoloration, or feeling of cold in a limb, you should immediately tell your doctor, as these may be symptoms of cardiovascular events. Serious cardiovascular events, including peripheral arterial disease, ischemic heart disease, and stroke, have been reported in patients taking nilotinib.

The doctor should check your lipid and blood sugar levels before and during treatment with Nilotinib Viatris.

• if you experience swelling of the feet or hands, generalized swelling, or rapid weight gain, you should tell your doctor, as these may be symptoms of fluid retention. Fluid retention has been reported in patients treated with nilotinib. Parents of children treated with Nilotinib Viatris should inform their doctor if any of the above situations apply to their child.

Children and adolescents

Nilotinib Viatris is used to treat children and adolescents with CML. There is limited experience with the use of this medicine in children under 2 years of age. There is limited experience with the use of Nilotinib Viatris in children under 10 years of age with newly diagnosed disease and in patients under 6 years of age who have not responded to previous CML treatment.

Some children and adolescents taking Nilotinib Viatris may grow more slowly than normal. The doctor will monitor growth during regular visits.

Nilotinib Viatris and other medicines

Nilotinib Viatris may affect the way other medicines work.

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. This is especially important for:

• anti-arrhythmic drugs used to treat irregular heartbeat;
• chloroquine, halofantrine, clarithromycin, haloperidol, methadone, moxifloxacin; these are medicines that may have a negative effect on the electrical activity of the heart;
• ketokonazole, itraconazole, voriconazole, clarithromycin, telithromycin; these are medicines used to treat infections;
• ritonavir; this is a medicine used to treat HIV infections;
• carbamazepine, phenobarbital, and phenytoin; these are medicines used to treat epilepsy;
• rifampicin; this is a medicine used to treat tuberculosis;
• St. John's Wort (also known as Hypericum perforatum); this is a herbal product used to treat depression and other conditions;
• midazolam; this is a medicine used as a sedative before surgery;
• alfentanil and fentanyl; these are medicines used to treat pain and as sedatives before and during surgery or medical procedures;
• cyclosporine, sirolimus, and tacrolimus; these are medicines used to suppress the body's immune system and fight infections, often used to prevent the rejection of transplanted organs such as the liver, heart, and kidney;
• dihydroergotamine and ergotamine; these are medicines used to treat dementia;
• lovastatin and simvastatin; these are medicines used to treat high levels of fats in the blood;
• warfarin; this is a medicine used to treat blood clotting disorders (such as thrombosis);
• astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, or ergot alkaloids (ergotamine, dihydroergotamine).

You should avoid taking the above medicines while taking Nilotinib Viatris. If you are taking any of these medicines, your doctor may prescribe alternative medicines.

If you are taking a statin (a type of medicine that lowers cholesterol levels in the blood), you should talk to your doctor or pharmacist. Nilotinib Viatris taken with certain statins may increase the risk of muscle problems caused by statins, which can rarely lead to serious muscle damage (rhabdomyolysis) that can cause kidney damage.

Additionally, before taking Nilotinib Viatris, you should tell your doctor or pharmacist if you are taking any medicines that neutralize stomach acid, such as antacids.

The following medicines should be taken separately from Nilotinib Viatris:

• histamine H2-receptor antagonists, which reduce stomach acid production. Histamine H2-receptor antagonists should be taken approximately 10 hours before and approximately 2 hours after taking Nilotinib Viatris.
• antacids containing aluminum hydroxide, magnesium hydroxide, and simethicone, which neutralize stomach acid. These medicines should be taken approximately 2 hours before or approximately 2 hours after taking Nilotinib Viatris.

You should also tell your doctor if you are already taking Nilotinib Viatris and have been prescribed a new medicine that has not been taken before with Nilotinib Viatris.

Taking Nilotinib Viatris with food and drink

Do not take Nilotinib Viatris with food.Food can increase the absorption of Nilotinib Viatris and increase the level of Nilotinib Viatris in the blood, even to a harmful level. Do not drink grapefruit juice or eat grapefruit. They can increase the level of Nilotinib Viatris in the blood, even to a harmful level.

Pregnancy and breastfeeding

• Nilotinib Viatris should not be taken during pregnancyunless it is absolutely necessary. If you are pregnant or think you may be pregnant, you should tell your doctor, who will discuss the possibility of taking this medicine with you.
• Women who may become pregnantshould be advised by their doctor to use highly effective contraception during treatment and for up to two weeks after treatment is stopped.
• Nilotinib Viatris should not be taken during breastfeedingand for two weeks after the last dose. If you are breastfeeding, you should tell your doctor. 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.

Driving and using machines

If you experience side effects such as dizziness or vision disturbances after taking this medicine, you should stop driving or operating machinery until these side effects have resolved.

Nilotinib Viatris contains lactose

This medicine contains lactose (also known as milk sugar). If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.

Nilotinib Viatris 50 mg and 150 mg contain sodium

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

3. How to take Nilotinib Viatris

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.

What dose of Nilotinib Viatris to take

Adult patients

• Patient with newly diagnosed CML: The recommended dose is 600 mg per day. This dose is achieved by taking two 150 mg hard capsules twice a day.
• Patient who have not responded to previous CML treatment: The recommended dose is 800 mg per day. This dose is achieved by taking two 200 mg hard capsules twice a day.

Children and adolescents

• The dose given to the child depends on the child's weight and growth. The doctor will calculate the correct dose to be taken and tell you which capsules and how many capsules of Nilotinib Viatris to give to the child. The total daily dose given to the child should not exceed 800 mg.

The doctor may prescribe a lower dose depending on how the patient responds to treatment.

Elderly patients (65 years and older)

Nilotinib Viatris can be given to patients 65 years and older at the same doses as other adults.

When to take Nilotinib Viatris

Hard capsules should be taken:

• twice a day (approximately every 12 hours);
• at least 2 hours after eating any food;
• you should wait 1 hour after taking the medicine before eating. If you are unsure about the timing of taking this medicine, you should consult your doctor or pharmacist. Nilotinib Viatris should be taken at the same time every day to help you remember to take the hard capsules.

How to take Nilotinib Viatris

• Hard capsules should be swallowed whole with water.
• Do not take hard capsules with food.
• Do not open hard capsules. For patients with swallowing difficulties, including children and adolescents who are unable to swallow hard capsules, other nilotinib-containing products should be used instead of Nilotinib Viatris.

How long to take Nilotinib Viatris

Nilotinib Viatris should be taken every day for as long as your doctor prescribes. The treatment is long-term. The doctor will regularly monitor the patient's condition to assess whether the treatment is having the desired effect.

The doctor may consider stopping treatment with Nilotinib Viatris based on specific criteria.

If you have any doubts about the duration of treatment with Nilotinib Viatris, you should consult your doctor.

Taking more Nilotinib Viatris than prescribed

If you take more Nilotinib Viatris than prescribed or take it by mistake, you should immediately consult your doctor or go to the hospital. You should show the doctor or hospital staff the packaging of the hard capsules and the leaflet. Medical attention may be necessary.

Missing a dose of Nilotinib Viatris

If you miss a dose, you should take the next dose according to the established schedule. Do not take a double dose to make up for the missed hard capsules.

Stopping treatment with Nilotinib Viatris

This medicine should be taken for as long as your doctor prescribes. Stopping treatment with Nilotinib Viatris without consulting your doctor may put you at risk of your condition getting worse, which can be life-threatening. If you are considering stopping treatment with Nilotinib Viatris, you should discuss this with your doctor, nurse, and/or pharmacist.

Doctor's recommendation to stop treatment with Nilotinib Viatris

The doctor will regularly assess the treatment results using specific diagnostic tests and decide whether you should continue taking this medicine. If you are told to stop treatment with Nilotinib Viatris, the doctor will continue to closely monitor your CML before, during, and after stopping treatment with Nilotinib Viatris and may recommend that you resume treatment with Nilotinib Viatris if necessary due to your condition.

If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Nilotinib Viatris can cause side effects, although not everybody gets them.

Most side effects are mild to moderate and go away after a few days or weeks of treatment.

Some side effects can be serious.

• musculoskeletal pain: joint pain and muscle pain
• cardiac disorders: chest pain or discomfort, high or low blood pressure, irregular heartbeat (fast or slow), palpitations, fainting, blue discoloration of the lips, tongue, or skin
• arterial occlusion: pain, discomfort, weakness, or cramping of the muscles in the legs, which may be caused by reduced blood flow, ulcers on the legs or hands that heal slowly or not at all, and noticeable changes in skin color (blue or pale) or temperature (cooling) of the legs or hands, fingers, or toes in the affected limbs
• hypothyroidism: weight gain, fatigue, hair loss, muscle weakness, feeling cold
• hyperthyroidism: rapid heartbeat, bulging eyes, weight loss, swelling of the front of the neck
• renal or urinary disorders: feeling thirsty, dry skin, irritability, dark urine, reduced urine output, difficult or painful urination, blood in the urine, abnormal urine color
• high blood sugar: excessive thirst, excessive urination, increased appetite with weight loss, feeling tired
• dizziness: dizziness or feeling of spinning
• pancreatitis: severe abdominal pain (in the middle or left side)
• skin disorders: painful, red lumps, skin pain, redness of the skin, scaling of the skin, or blistering
• fluid retention: rapid weight gain, swelling of the hands, ankles, feet, or face
• migraine: severe headache, often accompanied by nausea, vomiting, and sensitivity to light
• blood disorders: fever, easy bruising or bleeding for no apparent reason, severe or frequent infections, weakness for no apparent reason
• thrombophlebitis: swelling and pain in one part of the body
• neurological disorders: weakness or paralysis of limbs or face, difficulty speaking, severe headaches, seeing, feeling, or hearing things that do not exist, changes in vision, loss of consciousness, confusion, disorientation, trembling, feeling of tingling, pain, or numbness
• respiratory disorders: difficulty breathing or pain while breathing, cough, wheezing breath with or without fever, swelling of the feet or legs
• gastrointestinal disorders: abdominal pain, nausea, vomiting blood, black or bloody stools, constipation, heartburn, acid reflux, swelling of the abdomen
• liver disorders: yellowing of the skin and eyes, nausea, loss of appetite, dark urine
• hepatitis: recurrence (reactivation) of hepatitis B virus infection
• eye disorders: vision disturbances, including blurred vision, double vision, or flashes of light, reduced visual acuity, or loss of vision, blood in the eyes, increased sensitivity of the eyes to light, eye pain, redness, itching, or irritation, dry eyes, swelling, or itching of the eyelids
• electrolyte imbalance: nausea, shortness of breath, irregular heartbeat, cloudy urine, fatigue, and/or joint pain associated with abnormal blood test results (e.g., high levels of potassium, uric acid, and phosphorus, and low levels of calcium)

Some side effects are very common(may affect more than 1 in 10 people)

• diarrhea
• headache
• fatigue
• muscle pain
• itching, rash
• nausea
• constipation
• vomiting
• hair loss
• limb pain, bone pain, and back pain after stopping treatment with Nilotinib Viatris
• slowed growth rate in children and adolescents
• upper respiratory tract infection, including sore throat, runny nose, or stuffy nose, coughing
• low blood cell count (red blood cells, platelets) or low hemoglobin level
• high lipase activity in the blood (pancreatic function)
• high bilirubin level in the blood (liver function)
• high alanine aminotransferase activity in the blood (liver enzymes)

Some side effects are common(may affect up to 1 in 10 people)

• pneumonia
• abdominal pain, discomfort in the stomach after meals, bloating, swelling, or bloating of the abdomen
• bone pain, muscle cramps
• pain (including neck pain)
• dry skin, acne, decreased skin sensitivity
• weight gain or loss
• insomnia, depression, anxiety
• night sweats, excessive sweating
• general malaise
• nosebleeds
• gout: joint pain and swelling
• erectile dysfunction
• flu-like symptoms
• sore throat
• bronchitis
• ear pain, ringing in the ears (tinnitus), or other sounds in the ears that do not have an external source
• petechiae
• menstrual bleeding
• folliculitis
• vaginal thrush or oral thrush
• conjunctivitis: discharge from the eye, accompanied by itching, redness, and swelling
• eye irritation, redness of the eyes
• hypertension: high blood pressure, headache, dizziness
• flushing
• peripheral arterial disease: pain, discomfort, weakness, or cramping of the muscles in the legs, which may be caused by reduced blood flow, ulcers on the legs or hands that heal slowly or not at all, and noticeable changes in skin color (blue or pale) or temperature (cooling) of the legs or hands, fingers, or toes in the affected limbs (these symptoms may indicate arterial occlusion in the affected limb)
• shortness of breath
• mouth ulcers with gingivitis (also known as mucositis)
• high amylase activity in the blood (pancreatic function)
• high creatinine level in the blood (kidney function)
• high alkaline phosphatase or creatine phosphokinase activity in the blood
• high aspartate aminotransferase activity in the blood (liver enzymes)
• high gamma-glutamyltransferase activity in the blood (liver enzymes)
• leukopenia or neutropenia: low white blood cell count
• high platelet or white blood cell count in the blood
• low magnesium, potassium, sodium, calcium, or phosphorus level in the blood
• high lipid level in the blood (including cholesterol)
• high uric acid level in the blood

Some side effects are uncommon(may affect up to 1 in 100 people)

• allergic reaction (hypersensitivity to Nilotinib Viatris)
• dry mouth
• chest pain
• pain or discomfort in the side
• increased appetite
• breast enlargement in men
• herpes virus infection
• stiffness of the muscles and joints, swelling of the joints
• feeling of temperature changes (including feeling hot or cold)
• taste disturbances
• frequent urination
• gastritis: abdominal pain, nausea, vomiting, diarrhea, bloating of the abdomen
• memory loss
• skin cyst, thinning, or thickening of the skin, thickening of the outer layer of the skin, skin discoloration
• psoriasis: thickened, red, silvery patches of skin
• increased sensitivity of the skin to light
• hearing impairment
• arthritis
• urinary incontinence
• enteritis (also known as small intestine or colon inflammation)
• anal abscess
• breast swelling
• restless legs syndrome: uncontrollable urge to move a part of the body, usually the legs, which is accompanied by unpleasant sensations
• sepsis: fever, chest pain, rapid heartbeat, shortness of breath, or rapid breathing
• skin infection (subcutaneous abscess)
• skin warts
• high eosinophil count (a type of white blood cell)
• lymphopenia: low white blood cell count
• high parathyroid hormone level in the blood
• high lactate dehydrogenase level in the blood
• low blood sugar: nausea, sweating, weakness, dizziness, trembling, headache
• dehydration
• abnormal lipid level in the blood
• involuntary trembling
• difficulty concentrating
• unpleasant or abnormal sensations (also known as paresthesia)
• fatigue
• feeling of numbness or tingling in the fingers or toes (also known as peripheral neuropathy)
• facial paralysis
• red spots in the white of the eye due to blood vessel damage (also known as conjunctival hemorrhage)
• blood in the eyes
• eye irritation
• heart attack: sudden and crushing chest pain, fatigue, irregular heartbeat
• heart murmur: fatigue, discomfort in the chest, feeling of dizziness, pain, palpitations
• athlete's foot
• heart failure: shortness of breath, difficulty breathing when lying down, swelling of the feet or legs
• pericarditis: pain behind the breastbone (also known as pericarditis)
• hypertensive crisis: severe headache, dizziness, nausea
• intermittent claudication: pain and weakness in the legs when walking (also known as intermittent claudication)
• arterial stenosis: possible high blood pressure, pain, or cramping of the muscles in the hips, thighs, or legs when performing certain activities, such as walking or climbing stairs, numbness or weakness in the legs
• bruising (without any apparent reason such as bruising)
• fat deposits in the arteries, which can cause them to become blocked (also known as atherosclerosis)
• low blood pressure: feeling of dizziness, dizziness, or fainting
• pulmonary edema: shortness of breath
• pleural effusion: fluid accumulation between the layers of tissue lining the lungs and the chest cavity (which can reduce the heart's ability to pump blood in severe cases), chest pain, cough, hiccups, rapid breathing
• interstitial lung disease: cough, difficulty breathing, chest pain while breathing
• pleuritic pain: chest pain
• pleuritis: cough, chest pain while breathing
• hoarseness
• pulmonary hypertension: high blood pressure in the pulmonary arteries
• wheezing
• tooth sensitivity
• gingivitis: bleeding gums, tenderness, or swelling of the gums
• high urea level in the blood (kidney function)
• change in blood protein levels (low globulin or presence of paraprotein)
• high unconjugated bilirubin level in the blood
• high troponin level in the blood

Some side effects are rare(may affect up to 1 in 1,000 people)

• redness and swelling of the hands and feet (also known as palmar-plantar erythrodysesthesia syndrome)
• oral warts
• feeling of hardening or thickening of the breasts
• thyroiditis
• mood disorders or depression
• secondary hyperparathyroidism: bone and joint pain, frequent urination, abdominal pain, weakness, fatigue
• arterial stenosis in the brain: loss of vision affecting part or all of the field of vision in both eyes, double vision, dizziness (feeling of spinning), numbness or tingling, loss of coordination, dizziness, or confusion
• brain edema (possible headache and/or changes in mental status)
• optic neuritis: blurred vision, loss of vision
• heart problems (reduced ejection fraction): fatigue, discomfort in the chest, feeling of dizziness, pain, palpitations
• low insulin level in the blood (hormone that regulates blood sugar levels)
• low C-peptide level in the blood (pancreatic function)
• sudden death

The following side effects have been reported with an unknown frequency (cannot be estimated from the available data):

• heart problems (heart failure): shortness of breath, fatigue during rest, irregular heartbeat, discomfort in the chest, feeling of dizziness, pain, palpitations, frequent urination, swelling of the feet, ankles, and abdomen.

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 Drug Safety Monitoring of the 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 4921 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 Nilotinib Viatris

• 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 and blister after EXP. The expiry date refers to the last day of the month stated.
• Nilotinib Viatris, 50 mg, hard capsules: Do not store above 30°C. Nilotinib Viatris, 150 mg, hard capsules; Nilotinib Viatris, 200 mg, hard capsules: No special storage precautions are required.
• 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 Nilotinib Viatris contains

• The active substance is nilotinib.
• Each hard capsule contains 50 mg of nilotinib (as hydrochloride monohydrate). The other ingredients are:

Hard capsule contents: lactose monohydrate, crospovidone type A, colloidal anhydrous silica, magnesium stearate

Hard capsule shell: hypromellose, purified water, carrageenan, potassium chloride, erythrosine (E127), yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171)

Printing ink: shellac, propylene glycol, potassium hydroxide, black iron oxide (E172)

See section 2 "Nilotinib Viatris contains lactose and sodium".

• Each hard capsule contains 150 mg of nilotinib (as hydrochloride monohydrate). The other ingredients are: Hard capsule contents: lactose monohydrate, crospovidone type A, colloidal anhydrous silica, magnesium stearate Hard capsule shell: hypromellose, purified water, carrageenan, potassium chloride, erythrosine (E127), yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171) Printing ink: shellac, propylene glycol, potassium hydroxide, black iron oxide (E172) See section 2 "Nilotinib Viatris contains lactose and sodium".
• Each hard capsule contains 200 mg of nilotinib (as hydrochloride monohydrate). The other ingredients are: Hard capsule contents: lactose monohydrate, crospovidone type A, colloidal anhydrous silica, magnesium stearate Hard capsule shell: hypromellose, purified water, carrageenan, potassium chloride, yellow iron oxide (E172), titanium dioxide (E171) Printing ink: shellac, propylene glycol, potassium hydroxide, black iron oxide (E172) See section 2 "Nilotinib Viatris contains lactose and sodium".

How Nilotinib Viatris looks like and what the packaging contains

Nilotinib Viatris, 50 mg is in the form of hard capsules (capsules) size 4 (approximately 14.4 mm in length) with a light yellow opaque body and a red opaque cap, with black printing "50 mg" placed transversely on the body. The hard capsules are filled with a white to yellowish powder.
Nilotinib Viatris, 150 mg is in the form of red opaque hard capsules (capsules) size 1 (approximately 19.3 mm in length), with black printing "150 mg" placed transversely on the body. The hard capsules are filled with a white to yellowish powder.
Nilotinib Viatris, 200 mg is in the form of light yellow opaque hard capsules (capsules) size 0 (approximately 21.4 mm in length), with black printing "200 mg" placed transversely on the body. The hard capsules are filled with a white to yellowish powder.
Nilotinib Viatris, 50 mg, hard capsules are packaged:
In PVC/PE/PVdC/Aluminum or OPA/Aluminum/PVC/Aluminum foil blisters in:
A single unit package containing 112 or 120 hard capsules or a collective package containing 112 (4 boxes of 28 pieces) or 120 (3 boxes of 40 pieces) hard capsules.
In single-dose perforated blisters made of PVC/PE/PVdC/Aluminum or OPA/Aluminum/PVC/Aluminum foil in:
A single unit package containing 112 x 1 or 120 x 1 hard capsules or a collective package containing 112 x 1 (4 boxes of 28 x 1 pieces) or 120 x 1 (3 boxes of 40 x 1 pieces) hard capsules.
Nilotinib Viatris, 150 mg, hard capsules are packaged:
In PVC/PE/PVdC/Aluminum or OPA/Aluminum/PVC/Aluminum foil blisters in:
A single unit package containing 28, 112 or 120 hard capsules or a collective package containing 112 (4 boxes of 28 pieces) or 392 (14 boxes of 28 pieces) hard capsules.
In single-dose perforated blisters made of PVC/PE/PVdC/Aluminum or OPA/Aluminum/PVC/Aluminum foil in:
A single unit package containing 112 x 1 or 120 x 1 hard capsules or a collective package containing 112 x 1 (4 boxes of 28 x 1 pieces) or 392 x 1 (14 boxes of 28 x 1 pieces) hard capsules.
Nilotinib Viatris 200 mg hard capsules are packaged:
In PVC/PE/PVdC/Aluminum or OPA/Aluminum/PVC/Aluminum foil blisters in:
A single unit package containing 28, 112 or 120 hard capsules or a collective package containing 112 (4 boxes of 28 pieces), 120 (3 boxes of 40 pieces) or 392 (14 boxes of 28 pieces) hard capsules.
In single-dose perforated blisters made of PVC/PE/PVdC/Aluminum or OPA/Aluminum/PVC/Aluminum foil in:
A single unit package containing 112 x 1 or 120 x 1 hard capsules or a collective package containing 112 x 1 (4 boxes of 28 x 1 pieces) or 392 x 1 (14 boxes of 28 x 1 pieces) hard capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder

Viatris Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
DUBLIN
Ireland

Manufacturer

PharOS MT Limited
HF62X, Hal Far Industrial Estate
Birzebbugia, BBG 3000
Malta
To obtain more detailed information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
Viatris Healthcare Sp. z o.o.
Tel: +48 22 54 66 400

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

Countries:

Date of last revision of the leaflet:11.2024