Medical Reimbursement Information | Tasigna (nilotinib) 200-mg capsules

IMPORTANT SAFETY INFORMATION

What is the most important information to know about TASIGNA?

TASIGNA can cause a possible life-threatening heart problem called QT prolongation.

QT prolongation causes an irregular heartbeat, which may lead to sudden death.

Your doctor should check your heart with a test called an "ECG":

Before taking TASIGNA
7 days after starting TASIGNA
Regularly during treatment
After any dose changes

Reimbursement Information

Novartis Oncology is dedicated to answering your questions and providing assistance with the reimbursement process for Novartis products. By calling 1-866-411-TASIGNA (1-866-411-8274), patients and healthcare providers can receive assistance in resolving reimbursement issues and concerns that they may have with TASIGNA(nilotinib) 200-mg capules.

Insurance Verification

The program verifies patients’ medical benefits, helps determine insurance coverage, and clarifies their copayment obligations.

Denials/Appeals

The program assists providers to obtain appropriate reimbursement.

Coding/Billing Questions

The program staff assist providers with questions regarding coding and billing.

Alternative Funding Searches

Program staff can search for possible assistance for patients with insufficient medical benefit coverage or no drug coverage and determine if there are other sources of funding that could help alleviate or reduce costs for the patient.

Patient Assistance Program

The program screens low-income patients who do not have any benefit coverage for patient assistance eligibility. If eligible, these patients will qualify for free drugs based on their residency status, insurance status, and household size and income.

Letter of Medical Necessity

The hotline provides copies of sample letters of medical necessity to doctors to support their claims.

Scheduled Counselor Appointments

Office practice managers can submit their questions and then schedule time to speak with a team of Novartis professionals who will seek to provide solutions to any problem.

DISCLAIMER
The Reimbursement Support Line and Novartis Pharmaceuticals Corporation do not guarantee success in obtaining reimbursement, nor do we submit appeals on behalf of providers or patients. Third-party payment for medical products and services is affected by numerous factors, not all of which can be anticipated or resolved by Reimbursement Support Line staff.

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Important Information about TASIGNA

TASIGNA (nilotinib) 200-mg capsules is indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in adult patients resistant or intolerant to prior therapy that included imatinib. The effectiveness of TASIGNA is based on hematologic and cytogenetic response rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.

What is the most important information to know about TASIGNA?

TASIGNA can cause a possible life-threatening heart problem called QT prolongation.

QT prolongation causes an irregular heartbeat, which may lead to sudden death.

Your doctor should check your heart with a test called an "ECG":

Before taking TASIGNA
7 days after starting TASIGNA
Regularly during treatment
After any dose changes

You may lower your chances for having QT prolongation with TASIGNA if you:

Take TASIGNA on an empty stomach.
DO NOT TAKE TASIGNA WITH FOOD

Food can affect the levels of TASIGNA in your body, which can lead to serious side effects. Taking TASIGNA on an empty stomach may lower your chances of having a possibly life-threatening heart problem called QT prolongation.

QT prolongation causes an irregular heartbeat, which may lead to sudden death.

Take TASIGNA:

At least 2 hours after eating any food, and
After taking TASIGNA, wait at least 1 hour before eating any food
Avoid grapefruit, grapefruit juice, and any supplement containing grapefruit extract while taking TASIGNA. Food and grapefruit products increase blood levels of TASIGNA in your body
Avoid taking other medicines, vitamins, or herbal supplements with TASIGNA that can also cause QT prolongation

TASIGNA is a prescription medication.

TASIGNA comes in 200 mg capsules. Your doctor will prescribe 400 mg of TASIGNA to be taken twice a day for a total daily dose of 800 mg. Each dose should be taken approximately 12 hours apart.

Swallow TASIGNA capsules whole with water.

Do not open TASIGNA capsules
Do not drink grapefruit juice, eat grapefruit, or take supplements containing grapefruit extract. It may affect the levels of TASIGNA in the blood
If you miss a dose, take your next dose as scheduled. Do not take a double dose to make up for a missed dose

Before taking TASIGNA

Talk to your doctor or pharmacist about all other medication(s) you may be taking, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements, since they may affect how TASIGNA works and increase your chance of serious and life-threatening side effects.

Tell your doctor if:

You have a heart disorder or are taking medication for the heart
You have an irregular heartbeat
You have QT prolongation or a family history of it
You know that you suffer from low blood levels of electrolytes, such as potassium or magnesium or you have a liver or pancreas disorder
Also tell your doctor if you are pregnant, breast feeding, or lactose-intolerant

Call your doctor right away if you faint or have an irregular heartbeat while taking TASIGNA.

These can be symptoms of QT prolongation.

Call your doctor immediately if you experience any of these symptoms.

Serious side effects

TASIGNA is sometimes associated with serious side effects, with symptoms that include:

Irregularity in heartbeat or fainting
Unexplained bleeding or bruising
Blood in urine or stool
Unexplained weakness
Yellow skin and eyes
Shortness of breath
Swelling of hands, ankles, feet, or face
Sudden stomach area pain with nausea and vomiting

Common side effects

Most patients experience side effects at some time. Some common side effects you may experience include:

Low blood count
Rash
Nausea
Headache
Itching
Tiredness
Diarrhea
Constipation

Be sure to tell your doctor or pharmacist if you have any side effects during treatment with TASIGNA.

Tell your doctor if you are pregnant or planning to become pregnant. TASIGNA can harm a fetus (unborn baby).

Women who can get pregnant must use effective birth control during treatment with TASIGNA

Tell your doctor if you are breast-feeding.

Women should not breast-feed while taking TASIGNA.

If you take too much TASIGNA, call your doctor or poison control center right away.

Your doctor will check your heart, do regular blood tests and take bone marrow samples during treatment with TASIGNA. These are done to check for side effects with TASIGNA and to see how well TASIGNA may be working for you. Your doctor should check your blood to monitor the amount of blood cells (white blood cells, red blood cells, and platelets) during treatment. These should be checked every two weeks for the first two months and then monthly thereafter, or as considered necessary by your doctor.

Your doctor may have you stop TASIGNA for some time or reduce your dose if you have side effects with it. Please see accompanying patient information, including Boxed WARNING, and the TASIGNA Medication Guide you received with your prescription.