Tasigna is touted as an effective treatment for chronic myelogenous leukemia, but there are some concerns surrounding its prolonged use. Tasigna may be related to complications, including heart attack, stroke, blood clots and more.
Chronic myelogenous leukemia
Heart attack, stroke, blood clots
Tasigna, also known as Nilotinib, is an oral form of chemotherapy used to treat chronic myelogenous leukemia (CML).
The National Cancer Institute estimates that approximately 8,950 patients will be diagnosed with CML this year. About 60 percent of people with CML are male, and most cases occur in individuals over 65.
Tasigna is a tyrosine kinase inhibitor (TKI), which treats the first chronic phase of CML. Tasigna has become a popular drug for treating CML because it can help to control the disease in its early stages.
However, patients may be unfamiliar with the possible risks of taking the chemotherapy medication. Tasigna risks may include heart attacks, strokes, blood clots, amputations and more.
Studies + Science
How Tasigna Works
Tyrosine kinases are enzymes that facilitate chemical reactions within the body. In particular, tyrosine kinases help trigger reactions that stimulate the growth of cancer cells.
Tasinga blocks a tyrosine kinase protein called Bcr-Abl, which is produced by chronic myeloid leukemia cells. These cells have an abnormal chromosome, known as the Philadelphia (Ph+) chromosome.
About Chronic Myelogenous Leukemia
According to the FDA, almost all patients with CML have the Philadelphia chromosome. Ph+ is discovered during routine blood work, and it vastly increases the likelihood of developing CML. Once detected, treatment for CML can begin in accordance with the phase the patient is currently in.
Chronic myelogenous leukemia has three clinical phases. There’s an initial chronic phase, which can last for years. It can be easily managed with the correct medication.
The second phase is a transitional period, known as the accelerated phase. The final phase is the blast crisis phase, the aggressive stage which is usually fatal. Treatments for later stages include bone marrow or stem cell transplantation, but Tasigna is used to manage or even cure a patient’s chronic phase CML.
Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, commented on the longevity and difficulty of treating CML.
“Patients diagnosed with CML generally face a lifetime of treatment to keep their leukemia from growing or recurring," Pazdur said.
Studies on Tasigna Side Effects
The American Society of Hematology conducted a study in 2012 and found that in a median period of 2 years, almost 15 percent of patients taking Tasigna developed some form of the severe peripheral arterial occlusive disease (PAOD).
Additionally, a 2016 study by the American Journal of Hematology has linked Tasigna to peripheral artery disease and other devastating side effects, including death.
A peripheral arterial occlusive disease may take the form of, or cause, various illnesses, including:
Peripheral arterial disease
The most alarming part of these side effects is that their occurrence is highly unpredictable.
Another 2011 study states that “[None] of the patients had a history of cardiovascular disease, tobacco use, or diabetes mellitus,” and in the American Society of Hematology study, half of the affected population had no history of tobacco use, diabetes, or hypertension.
The FDA requires Nilotinib and Tasigna to print warnings of heart complications, but that hasn’t stopped efforts to expand the medication for other uses. In 2017, Tasigna was authorized to treat Ph+ CML in children, and although the box labels are clear, Tasigna’s website doesn’t mention peripheral arterial disease or cardiac failure.
In Dec. 2017, the FDA announced that “patients with early (chronic) phase CML who have been taking Tasigna for three years or more, and whose leukemia has responded to treatment according to specific criteria . . . may be eligible to stop taking Tasigna.” However, three years of taking Tasigna is not without risk. A 2019 study published in Oncology confirmed the FDA’s decision to discontinue Tasigna could be safe but echoed the agency’s safety warnings.
In July 2018, an FDA announcement associated Tasigna with thrombotic microangiopathy, a condition which leads to blood clotting. It can pose a serious health risk to patients.
In the U.S., however, the labeling wasn't updated. In the United Kingdom, Cancer Research UK also is aware of the risk of cardiac problems arising from Tasigna. The agency has not included the risk of a cardiac event. The agency views the issues as“very rare" occurring in “fewer than 1 in 100 people."
Though Tasigna may be safe for patients, it’s not the only leukemia treatment option. Imatinib may be a safer, reliable alternative, according to the American Society of Hematology. Imatinib has a stronger likelihood of treatment without complications in the same period as Tasigna and is recommended as the “front-line medication” in CML treatment.
If you're taking Tasigna, ask your doctor about the possibility of side effects.
Contact an advocate to learn more about available resources for Tasigna complications.