Nilotinib (Oral)

Overview

Nilotinib is a drug given to patients suffering from various forms of leukemia. Leukemia itself is a cancer that occurs where the patient's body creates too many white blood cells that are abnormal.

Nilotinib is also known as an antineoplastic, or cancer medicine. It works by interfering with the way in which the cancer cells grow. Eventually, it helps destroy those cancer cells. Be aware that Nilotinib also affects the way that normal healthy cells grow, as such, patients will experience other unwanted side effects. If these side effects are serious then they must be reported to doctor immediately. There may also be other less serious side effects which should not cause as much concern.

Before being prescribed this drug, you will have an in-depth consultation with your doctor about the risks it poses and the benefits it can bring you. You can only obtain Nilotinib through a doctor's prescription.

Condition(s) treated

  • Leukemia

Type of medicine

  • Capsule

Side effects

Along with the intended effects of this medication, it can produce some unwanted side effects. Whilst not all of these side effects may occur, you should seek medical attention if any do appear.

Check with your doctor right away if you suffer from any of the following side effects listed below whilst taking Nilotinib:

More common

  • No blood pressure
  • Sweating

Less common

  • Muscle cramps in the arms, hands, feet, legs or face

Less common or rare

  • Depressed mood

Incidence not known

  • Rapid, shallow breathing

Some of the side effects that can occur with this drug typically don't require medical attention. Most people find that these side effects go away during your treatment as your body starts adjusting to the medication. If however, you are finding these side effects bothersome, you can contact your local pharmacist for advice on ways to reduce or prevent these side effects. Check with your doctor right away if any of the following side effects continue to linger or become bothersome.

More common

  • Swollen joints

You may suffer from other side effects that are not listed above. Contact your doctor or healthcare professional if you notice anything unusual. Remember to report all side effects to the FDA on 1-800-FDA-1088.

Dosage

The final dose of this medication will depend upon a number of different factors. This will include individual factors such as your weight, age, and height, any other medical conditions you suffer from including medication you take for treatment. The amount of medication that you take will also depend on the strength of the medication, the number of doses you take each day, the length of time you are required to take the medication and of course, your reaction to the first dose.

Do not change your dose without consultation with your doctor. Changing your dose could increase your risk of side effects or reduce the effectiveness of the drug.

For oral dosage form for the treatment of CML-AP and Ph+ CML-after other treatments have not worked.

Adults. 400 milligrams twice daily, with about twelve hours between the two doses. Your doctor can adjust your dose as necessary.
Children. The final dose and use will be determined by a doctor.

For the treatment of newly diagnosed Ph+ CML-CP:

Adults. Should be given 300 milligrams twice daily with about twelve hours between the two doses. Your doctor can adjust the dose as necessary.
Children. The final dose and use will be determined by a doctor.

If you miss a dose of Nilotinib, you should skip the dose you have missed and return to your regular dosing schedule. Don't double doses in order to make up for a missed dose.

This medication will come alongside a Medication Guide. You should read this carefully and follow the instruction. If you have any questions you should contact your doctor or a local pharmacist. If you do not have a medication guide, request one from your local pharmacist.

It's best to take this medication on an empty stomach (at least one or two hours after a meal.)

Swallow this tablet whole with water. If you experience difficulty with swallowing the capsule, you can open them and sprinkle the content inside onto a teaspoon of applesauce. Don't sprinkle Tasigna® on other foods. This mixture needs to be taken right away within fifteen minutes and cannot be stored for later use.

If you're taking a stomach medication (eg, famotidine), take it at least ten hours before or two hours after taking nilotinib.

If you're taking an antacid that contains magnesium, aluminium, or simethicone, you should take it at least two hours before or two hours after taking this drug.

Don't eat or drink grapefruit or grapefruit juice when you are using this medication. The consumption of these products could alter the amount of medication that is absorbed by the body.

Interactions

It is possible that Nilotinib will interact with other drugs you are currently taking. In many cases, your doctor will want to remove such interactions as they can interfere with the course of your treatment. However, in other cases, your doctor may realize that taking both medicines is beneficial for your health despite the interactions. Depending on the circumstances, your doctor may then wish to alter one or both medicines altogether or change the doses you receive of each one. Either way, you should be careful in informing your doctor of any drugs you currently take, both prescription and nonprescription. Below is a list of drugs with which it is not recommended you take at the same time as Nilotinib. This may, therefore, mean your doctor will change one or both of the interaction medicines.

  • Saquinavir

It is usually not recommended that you take any of the following medicines at the same time as Nilotinib. However, taking both may still be best for your treatment. If this is the case, then your doctor may need to alter one or both of the doses in order to minimize the extent of the interaction.

  • Bedaquiline

Below is a list of drugs which, if taken at the same time as Nilotinib, can cause an increased chance of experiencing certain side effects. However, you may find that taking both is again best for your treatment. This means your doctor may simply have to alter both doses or find other means to limit the interaction.

  • Pioglitazone

As well as interacting with other drugs, it is possible that Nilotinib will interact with other parts of your dietary intake. This includes things you eat, smoke, or drink. You should inform your doctor of your dietary intake and then follow any guidance they give you on adjusting your diet. Such guidelines are in the best interest of your treatment and will help avoid interactions occurring with this medicine. Below is a list of things that your doctor will need to give you further instructions about consuming.

  • Grapefruit Juice

Finally, other medical problems you are currently suffering from may also interfere with Nilotinib. You will be required to give your doctor a full overview of all medical problems you suffer from now or have had a history of suffering from. Be especially careful about pointing out any of the following.

  • Liver disease. You should use Nilotinib with caution as its effects may be heightened due to slower removal of the medicine from your body

Warnings

Before prescribing you with this drug, your doctor will first want to ensure that it is indeed the most suitable drug for helping to treat your condition.As a part of this process, they will need to know about any and all allergies you suffer from. This includes any allergies to dyes, preservatives, animals, or foods.

As of writing, no appropriate studies have been conducted into the relationship between age and the effects of this drug in the child populations. As such, no efficacy and safety have yet been established.

The suitable studies that have taken place in older patients using this medicine have not highlighted any geriatric-specific problems that would make this drug any less suitable for older patients.

It appears that studies taken place on pregnant women using this medicine have highlighted an increased risk to the unborn fetus. However, it is possible that the benefits of taking this drug will outweigh the risks, due to the life-threatening nature of Leukemia.

As of writing, no suitable studies have taken place on the effects of Nilotinib on breastfeeding patients. Instead, your doctor is best placed to advise you of any increased risks. Together, you can then weigh these risks against the benefits of using Nilotinib.

If you are going to be taking Nilotinib for a long period of time, then it is important that you maintain regular appointments with your doctor. This is so they can check how your condition is progressing and what effect this medicine is having. It will also then be possible to check for any unwanted effects and make necessary adjustments to the medicines you are taking.

Taking this medicine whilst being pregnant does pose a risk to the fetus. As such, it is advisable that you sue suitable birth control whilst taking Nilotinib. If you do become pregnant whilst taking this drug, you should inform your doctor immediately.

Nilotinib does have the potential to cause changes in your heart rhythm. This includes conditions such as QT prolongation. These conditions can alter the way in which your heart beats and eventually cause serious side effects and fainting. If you experience pounding, irregular, or fast heartbeats whilst taking Nilotinib, you should inform your doctor right away. They can then use an ECG test to check your heartbeat. They will likely do this before, during, and up to seven days after you have started taking Nilotinib.

Taking Nilotinib may cause you to experience blood vessel or heart problems This includes things like decreased blood flow to your brain, legs or heart. If you suffer from any of the following symptoms at any time, then inform your doctor:

  • Leg pain

It is possible that this medicine will cause the number of white blood cells in your blood to become lower. This then increases the chances you have of getting an infection. It can also cause the number of patents you have to drop, which reduces the ability of your blood to clot properly. If this does occur then you can follow these precautions in order to reduce your risk of bleeding or of getting an infection:

  • If you do need to use any sharp objects, such as toenail cutters or a safety razor, be careful in not cutting yourself.
  • If you notice any blood in your stools or urine, red pinpoint spots on your skin, tarry, black stools, or unusual bruising or bleeding, you should inform your doctor immediately.

Seek advice from your doctor immediately if you suffer any of the following symptoms of a serious liver problem.

  • Unusual weakness or tiredness

This medication can cause a serious type of reaction known as tumor lysis syndrome. Your healthcare professional can provide you with a medication to help prevent this. Contact your doctor immediately if you have a change or decrease in urine amount, stiffness, joint pain, or swelling, side, lower back or stomach pain, swelling of the lower legs or feet, a rapid weight gain, or unusual weakness or tiredness.

This medication can cause edema (fluid retention). You should let your doctor know immediately if you suffer from swelling or bloating in the face, hands, arm, feet, or lower legs, experience trouble breathing or rapid weight gain.

Don't take other medicines unless they have been previously discussed with your healthcare team or doctor. This includes both prescription and nonprescription medications, vitamin supplements and herbal (eg, St. John's wort).

Storage

You should store this medication in a closed container and ensure it is kept at room temperature. Keep it away from moisture, heat, and light and prevent it from freezing. Keep this drug out of the reach of children. Do not keep any medication that has passed its expiry date or you no longer require. You should seek advice from your local pharmacist for the best method of disposal for the medication you no longer need.

Summary

When used correctly, Nilotinib is successful in the treatment of different types of leukemia. However, due to a large number of interactions possible with this drug, it is imperative that you give your doctor a full list of all medications you are taking. You should not use this drug whilst pregnant and let your doctor know right away if you fall pregnant whilst taking this medication. It's important to take preventative measures to avoid falling pregnant. It's best to avoid breastfeeding whilst taking Nilotinib. The safety and efficacy of this drug have not yet been established in children so therefore use is not recommended. When taking this medication it's important to attend regular checkups to monitor progress and potential side effects. It's important that you do not change the dose of your medication without discussing it with your doctor or healthcare team first. If you increase your dose you could increase your risk of severe side effects and if you reduce your dose you could decrease the drug's ability is successfully treating you. If you require any further information about the practical uses of Nilotinib or you require further information, you should contact your local healthcare professional or doctor for advice.