FDA Issues Updated Tasigna (Nilotinib) Label for Leukemia Patients


Patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) usually face lifelong treatments to keep the disease in check. This diagnosis may seem devastating, since it likely includes regular chemotherapy treatment — and side effects. But the U.S. Food and Drug Association recently updated the nilotinib (Tasigna) packaging insert and drug warning label. Perhaps even more shocking is that this update offers some positive news for CML patients currently in the chronic phase.

Which Leukemia Patients Take Tasigna (Nilotinib)?

The FDA first approved Tasigna (generic name: nilotinib) in 2007 to treat chronic myeloid leukemia as well as Ph+ CML. Tasigna’s active ingredient, nilotinib, belongs to the tyrosine kinase inhibitor (TKI) drug class. Like other TKI medications, nilotinib blocks the specific BCR-ABL protein, which is responsible for leukemia cells rapidly growing and reproducing. But doctors usually only prescribe nilotinib to leukemia patients who fit within certain treatment guidelines, including:

  • Imatinib-resistant leukemia patients — or those who took Gleevec before, but didn’t see their symptoms improve several weeks after starting treatment. Just like antibiotics can stop effectively killing bacterial infections within your body, leukemia cells can develop a drug resistance, too. Gleevec is another TKI drug doctors usually prescribe first to treat CML patients. But if Gleevec doesn’t work, doctors often switch CML and Ph+ CML patients over to Tasigna’s active ingredient, nilotinib, instead.
  • Only leukemia patients in the chronic and accelerated phase typically receive Tasigna (nilotinib) over Gleevec. Although survival rates are high with Tasigna, the drug’s side effects can diminish quality of life for some patients. Nilotinib studies show some serious adverse reactions in patients, including rapid-onset atherosclerosis (coronary artery disease). This can lead to heart attack, stroke, and death, even in patients with no cardiovascular disease risk factors or history.

FDA Issues Updated Nilotinib (Tasigna) Treatment Guidelines

The FDA’s December 2017 Tasigna update, however, has some encouraging news for CML patients. The label now stipulates that Ph+ CML patients in the chronic phase may qualify to stop treatment with Tasigna altogether. However, you must take Tasigna for at least three years and achieve specific predetermined remission criteria before stopping treatment. More specifically, the updated FDA guidelines say patients must achieve a sustained deep molecular response of MR4.5 before stopping Tasigna. The FDA also recently authorized a test that can detect this response in nilotinib therapy patients that achieve treatment-free remission.

“Today’s approval shows that some patients may be able to stop treatment with Tasigna altogether if they are showing a strong response to therapy,” asserts Dr. Richard Pazdur, director at the FDA’s Oncology Center of Excellence. “While we welcome this progress in patient care, it’s important to note that any discontinuation of treatment still means patients must be regularly monitored for disease recurrence,” adds Dr. Pazdur.

Patients In Sustained Remission May Avoid Dangerous Nilotinib Side Effects

This update on how and when to safely stop nilotinib therapy may drastically improve CML patients’ lives and survival rates. Prior to this, even if doctors could find no detectable BCR-ABL traces in the patient’s blood, treatment continued indefinitely. Why? Since it’s not clear when a leukemia patient’s “cured,” doctors might lower the drug’s dosage, or switch from nilotinib back to imatinib. However, most oncologists felt that stopping treatment altogether was too risky for leukemia patients. Since Tasigna’s linked to rapid-onset atherosclerosis and sudden deaths in patients just starting nilotinib therapy, doctors may change their minds. For some leukemia patients, nilotinib therapy’s severe heart damage risks may prove even more dangerous than the cancer itself.

This Tasigna change enables those who meet certain criteria to discontinue nilotinib therapy after achieving sustained remission, limiting complication risks.

How Certain Leukemia Patients Can Safely Stop Taking Tasigna

Before safely stopping nilotinib therapy for CML and Ph+ CML, eligible patients must first meet the following requirements:

  1. You must take Tasigna for three years or more before safely stopping treatment.
  2. Your specific leukemia diagnosis must show a positive treatment response, according to specific criteria in the FDA-approved testing guidelines. The FDA-approved test monitors genetic information (RNA data) — specifically, the BCR-ABL protein levels found in your blood samples.
  3. You must agree to regular blood monitoring to detect any disease recurrences early. This means for the first year after stopping nilotinib therapy, you must get blood tests every month. With no changes in BCR-ABL levels after a year, you can cut back to one blood test every six weeks. If you’re still showing good results two years after achieving sustained treatment-free remission, you’ll need just four blood tests annually.

Commonly Reported Nilotinib Therapy Side Effects

Still, many patients would prefer regular blood test monitoring over indefinite Tasigna treatment for Ph+ CML or chronic phase CML. Why? Because nilotinib is associated with many different unpleasant side effects, including:

  • Body aches
  • Bone pain
  • Pain in extremities
  • Nausea
  • Rash
  • Headache
  • Fatigue
  • Itching
  • Vomiting
  • Diarrhea
  • Cough
  • Constipation
  • Joint pain
  • Upper respiratory inflammation
  • Fever
  • Night sweats
  • Low levels of blood platelets

While these are the most common side effects, Tasigna patients also risk developing more serious complications.

Drug’s Label Highlights Life-Threatening Tasigna Risks

In addition to common side effects,Tasigna’s label includes a black box warning for life-threatening complications, including:

  • Pancreas inflammation (pancreatitis). Pancreatitis is associated with sudden pain around your stomach area, nausea and vomiting. Severe cases are often life-threatening and may require surgery.
  • Liver problems. Your liver is essential for digesting food and removing toxic substances from your body. Yellow skin and eyes can indicate that Tasigna is affecting your liver’s ability to function, and you may develop jaundice.
  • Tumor Lysis Syndrome (TLS). When cancer cells break down too quickly, it can cause TLS. This condition causes kidney failure, making you dependent on dialysis treatment to handle those specific bodily functions. It also can lead to an abnormal heartbeat, which may cause strokes, heart attacks or sudden death.
  • Bleeding problems. Some Tasigna patients report serious bleeding problems, and some bleeds result in sudden death shortly after starting nilotinib therapy.
  • Fluid retention. Some patients retain too much fluid while taking Tasigna, which makes them look or feel bloated. Fluid retention symptoms include shortness of breath, rapid weight gain, and visible swelling in various body parts.

Tasigna is now linked to several serious and life-threatening conditions which many patients claim they weren’t warned about before treatment. As a result, injured leukemia patients are now filing Tasigna lawsuits against the drug’s manufacturer, Novartis.

Check Your Eligibility for Tasigna Compensation Now

If you or someone you love suffered serious complications after starting Tasigna (nilotinib), you may qualify for a cash settlement. Dangerous side effects include coronary artery disease, heart attacks and sudden death. To check your eligibility for compensation online, complete your free Tasigna injury claim evaluation today. Once you’ve submitted your information, an experienced lawyer will call to discuss your case and possible compensation options

Related: What Tasigna’s QT Prolongation Warning Means In Plain English

Mandy Voisin

Mandy Voisin is a freelance writer, blogger, and author of Girls of the Ocean and Star of Deliverance. As an accomplished content marketing consultant, mom of four and doctor's wife, Mandy has written hundreds of articles about dangerous drugs and medical devices, medical issues that impact disabled Americans, veterans' healthcare and workers' compensation issues since 2016.