Reddy-Nilotinib: Uses, Side Effects and Dosage

What is Reddy-Nilotinib used for?

Reddy-Nilotinib is used to treat adults with:

• newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase,
• chronic phase and accelerated phase Ph+ CML who are no longer benefiting from other therapies for CML including imatinib.

Reddy-Nilotinib is used to treat children and adolescents 2 years of age and older with:

• newly diagnosed Ph+ CML in chronic phase,
• chronic phase Ph+ CML who are no longer benefiting from other therapies for CML including imatinib.

Serious Warnings and Precautions

Reddy-Nilotinib should be given under the supervision of a doctor experienced in the use of anti-cancer drugs. Serious side effects with Reddy-Nilotinib include:

• Sudden cardiac deaths,
• Prolongation of the QT interval (abnormal electrical signal of the heart),
• Ischemic heart disease (heart disorder), ischemic cerebrovascular events (stroke or other problems due to decreased blood flow to the brain) and peripheral arterial occlusive disease (PAOD) (problems with decreased blood flow to your leg), rare fatal cases have been reported,
• Liver failure or liver toxicity (increase of liver enzymes), fatal cases have been reported,
• Pancreatitis (inflammation of the pancreas),
• Myelosuppression (decrease of the production of blood cells).

Reddy-Nilotinib is not to be used in patients who have uncorrectable low levels of potassium or magnesium.

Reddy-Nilotinib should only be stopped under the supervision of a doctor experienced in the treatment of patients with chronic myeloid leukemia (CML).

How does Reddy-Nilotinib work?

CML is caused by a change in your DNA (genetic material) that triggers a signal in your body to produce abnormal white blood cells. Reddy-Nilotinib blocks this signal to stop making these abnormal cells.

What are the ingredients in Reddy-Nilotinib?

Medicinal ingredients: Nilotinib.

Non-medicinal ingredients: Capsules:

Colloidal silicon dioxide, crospovidone, ferric oxide red (50 mg, 150 mg), ferric oxide yellow, gelatin, poloxamer 188, lactose monohydrate, magnesium stearate, sodium lauryl sulphate and titanium dioxide.

Printing ink: Black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.

Reddy-Nilotinib comes in the following dosage forms:

Reddy-Nilotinib is supplied as a hard capsule, containing 50 mg, 150 mg or 200 mg nilotinib (as nilotinib hydrochloride monohydrate).

• The 50 mg capsules are with red opaque colored cap and light yellow opaque colored body imprinted with RDY on cap and 50 on body in black ink.
• The 150 mg capsules are with red opaque colored cap and body imprinted with RDY on cap and 150 on body in black ink.
• The 200 mg capsules are with light yellow opaque colored cap and body imprinted with RDY on cap and 200 on body in black ink.

Reddy-Nilotinib is available in monthly packs:

• The monthly pack for 50 mg capsules contains 120 capsules divided into 3 blister-cartons of 40 capsules/ carton.
• The monthly pack for 150 mg and 200 mg capsules contains 112 capsules divided into 4 individual weekly blister-packs.

Reddy-Nilotinib is also available in bottle packs as follows:

• 50 mg: Bottles of 120’s
• 150 mg: Bottles of 28’s and 120’s
• 200 mg: Bottles of 28’s

Do not use Reddy-Nilotinib if:

• You have a condition that causes an abnormal electrical signal in your heart (prolongation of QT interval).
• You have uncorrectable low levels of potassium or magnesium.
• You are allergic (hypersensitive) to nilotinib or any of the other ingredients of Reddy-Nilotinib.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Reddy-Nilotinib. Talk about any health conditions or problems you may have, including if you:

• have electrolyte problems (e.g., low blood potassium levels) or conditions that could lead to electrolyte disturbances (e.g., vomiting, diarrhea, dehydration),
• have an eating disorder or are following a strict diet,
• have diabetes, especially with associated nerve disorders,
• had a stroke or other problems due to decreased blood flow to the brain,
• have problems with decreased blood flow to your legs,
• have liver/kidney disease,
• have had pancreatitis (inflammation of the pancreas),
• have had a surgical procedure involving the removal of the entire stomach (total gastrectomy),
• have ever had or might now have a hepatitis B virus infection (a viral infection of the liver). This is because during treatment with Reddy-Nilotinib, hepatitis B may become active again, which can be fatal in some cases. This is called hepatitis B reactivation. Your doctor will check for signs of this infection before and during treatment with Reddy-Nilotinib.

Other warnings you should know about:

Lactose Intolerance:

Reddy-Nilotinib contains lactose. Tell your doctor if you have lactose intolerance or one of the following rare hereditary diseases:

• Galactose intolerance
• Lapp lactase deficiency
• Glucose-galactose malabsorption.

Heart Conditions:

Reddy-Nilotinib can cause sudden cardiac death or other serious heart conditions such as QTc prolongation. QTc prolongation causes an irregular heartbeat, which can be life threatening. These heart rhythm disturbances are more likely if;

• you have a heart condition,
• you have a family history of heart conditions, or
• you are taking medicines that affect your heartbeat (antiarrhythmics) or medicines that may have an unwanted effect on the function of the heart (QT prolongation) (see also other drugs that may interact with Reddy-Nilotinib under “INTERACTIONS WITH THIS MEDICATION”).

If you experience any symptoms of a possible heart rhythm disturbance, such as dizziness, palpitations (sensation of rapid, pounding, or irregular heartbeat), fainting, or seizures, you should seek immediate medical attention.

Growth and Development:

Children and adolescents may grow more slowly when taking Reddy-Nilotinib. Your child’s doctor will measure their growth at regular visits.

Medical Tests:

Before and during the treatment with Reddy-Nilotinib, certain blood tests will be done.

These will monitor how Reddy-Nilotinib is affecting your body. Electrocardiograms (ECG) may also be done regularly. An ECG is a test that measures how well your heart is working.

Driving and Heavy Machinery:

Reddy-Nilotinib may cause dizziness. DO NOT drive or use machines if you feel dizziness or are unable to see well while taking Reddy-Nilotinib.

Reproductive Health:

Men who take Reddy-Nilotinib must use highly effective birth control during treatment with Reddy-Nilotinib, and for at least 4 weeks after ending treatment. Tell your doctor right away if your female partner becomes pregnant.

Pregnancy and Breastfeeding:

Reddy-Nilotinib is not recommended during pregnancy as it may harm the fetus. Women who can get pregnant must use highly effective birth control during treatment with Reddy-Nilotinib and for at least 4 weeks after ending treatment.

You should not breast feed while taking Reddy-Nilotinib and for two weeks after the last dose.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following medicines may interact with Reddy-Nilotinib, used to treat/or:

• Anti-HIV medicine from the class “antiproteases”:

  Ritonavir;

• Asthma:

  Formoterol, salmeterol;

• Blood coagulation disorders (such as blood clots or thromboses):

  Warfarin;

• Cancers:

  Imatinib, lapatinib, sunitinib, vorinostat;

• Dementia:

  Dihydroergotamine and ergotamine;

• Epilepsy:

  Carbamazepine, phenobarbital, phenytoin;

• Gastrointestinal motility disorder:

  Domperidone;

• Herbal product (also known as Hypericum Perforatum):

  St. John’s Wort;

• High blood pressure and some types of irregular heartbeat:

  Verapamil;

• High level of fats in blood (class of drugs):

  Statins (such as simvastatin and lovastatin);

• Infections:

  Cefazolin, ciprofloxacin, clarithromycin, erythromycin, fluconazole, itraconazole, ketoconazole, levofloxacin, rifampicin, tacrolimus, telithromycin, voriconazole;

• Irregular Heartbeat:

  Antiarrhythmics such as amiodarone, digoxin, disopyramide, flecainide, ibutilide, procainamide, propafenone, quinidine, sotalol;

• Malaria:

  Chloroquine;

• Medicines that can disturb electrolyte levels:

  Amphotericin B, enemas, high dose corticosteroids, laxatives, water pills;

• Medicines that may have an unwanted effect on the function of the heart (QT prolongation):

  Bepridil, chloroquine, clarithromycin, halofantrine, haloperidol, methadone, moxifloxacin, pimozide;

• Mood disorder:

  Citalopram, fluoxetine, tricyclic/tetracyclic antidepressants (e.g.: amitriptyline, imipramine, maprotiline), venlafaxine;

• Nausea:

  Dolasetron, metoclopramide, ondansetron, prochlorperazine;

• Opioids dependence (substitute treatment):

  Buprenorphine;

• Pain (moderate to severe):

  Methadone, morphine;

• Pain and used as a sedative before or during surgery or medical procedure:

  Alfentanil and fentanyl;

• Pneumocystis carinii pneumonia:

  Pentamidine;

• Prevent organ transplantations rejections, and to treat autoimmune conditions:

  Cyclosporine A;

• Prevent the rejection of transplanted organs such as liver, heart and kidney:

  Cyclosporine, sirolimus and tacrolimus - medicines that suppress the “self-defense” ability of the body and fight infections;

• Relieve anxiety before surgery:

  Midazolam;

• Stabilize thinking and behaviour:

  Chlorpromazine, droperidol, ziprasidone; Thyroid deficiency: Levothyroxine;

• Tuberculosis:

  Rifampicin.

Taking Reddy-Nilotinib with Antacids:

While taking Reddy-Nilotinib, speak with your healthcare professional before taking antacids (medicines against heartburn). These medications need to be taken separately from Reddy-Nilotinib:

• antacids called H2 blockers which suppress the production of acid in the stomach – should be taken approximately 10 hours before or 2 hours after you take Reddy-Nilotinib;
• antacids such as those containing aluminum hydroxide, magnesium hydroxide and simethicone which neutralize the high acidity of the stomach – should be taken approximately 2 hours before or 2 hours after you take Reddy-Nilotinib.

Taking Reddy-Nilotinib with Food and Drink:

Do not take Reddy-Nilotinib with food. Taking Reddy-Nilotinib with food may increase the amount of Reddy-Nilotinib in the blood, possibly to a harmful level.

Do not take any products or juices containing grapefruit, star fruit, pomegranate, Seville oranges or similar fruits while taking Reddy-Nilotinib. This may increase the amount of Reddy-Nilotinib in blood, possibly to a harmful level.

How to take Reddy-Nilotinib:

• Always take Reddy-Nilotinib exactly as your healthcare professional has told you.
• Your healthcare professional may lower your dose or stop treatment. This may be based on a specific blood test result or if you feel unwell.
• If treatment with Reddy-Nilotinib is stopped, your healthcare professional will continue to carefully monitor your CML. Your doctor may tell you to re-start Reddy-Nilotinib if you require it.
• Swallow capsules whole with water on an empty stomach. Do not consume any food for at least 2 hours before the dose is taken and for at least 1 hour after the dose is taken.

If capsules cannot be swallowed:

• Open the capsules

• Mix the content of each capsule in one teaspoon of applesauce (pureed apple) Use only one single teaspoon of applesauce (not more).

  Use only applesauce (no other food).

  Swallow the mixture immediately.

Usual dose

Adults:

Newly diagnosed Ph+ CML in chronic phase:

• Usual daily dose 600 mg: take two 150 mg capsules two times a day, approximately every 12 hours.
• Reduced daily dose 400 mg: take two 200 mg capsules once a day.

Chronic phase and accelerated phase Ph+ CML in patients who are no longer benefitting from previous treatment for CML:

• Usual daily dose 800 mg: take two 200 mg capsules two times a day, approximately every 12 hours.
• Reduced daily dose 400 mg: take two 200 mg capsules once a day.

Children and adolescents:

• Your child’s dose will depend on their body weight and height. The doctor will calculate the correct dose to use and tell you how many capsules of Reddy-Nilotinib to give to your child.
• Your child’s dose of Reddy-Nilotinib may change as your child grows.

Pediatric dosing of Reddy-Nilotinib

Overdose:

Missed Dose:

If a dose is missed, take the next dose as scheduled. Do not take a double dose to make up for the forgotten capsules.

What are possible effects from using Reddy-Nilotinib?

As with all medicines, Reddy-Nilotinib can cause side effects. These are not all the possible side effects that may be experienced when taking Reddy-Nilotinib. If any side effects not listed here are experienced, or these affect you or your child severely, tell your doctor or pharmacist.

• fatigue;
• weakness;
• muscle pain;
• itching;
• hair loss;
• upper respiratory tract infections;
• dyspepsia (digestion problems), eating disorder (anorexia), disturbed sense of taste;
• skin reddening;
• insomnia, depression, anxiety.

Call your doctor as soon as possible if you faint (loss of consciousness) or have an irregular heartbeat while taking Reddy-Nilotinib as these may be due to a serious heart condition.

Serious side effects and what to do about them

Serious side effects and what to do about them

Serious side effects and what to do about them

Serious side effects and what to do about them

Serious side effects and what to do about them

This is not a complete list of side effects.

For any unexpected effects while taking Reddy-Nilotinib, contact your doctor or pharmacist.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

• Keep out of the reach and sight of children.
• Store at room temperature (15-30^oC).
• Store in the original package

If you want more information about Reddy-Nilotinib:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (www.drreddys.com), or by calling1-855-845-1739.

Last Revised: APR 01, 2025