Tasigna (nilotinib) is a medication used to treat Philadelphia chromosome positive chronic myelogenous leukemia (Ph+CML), an aggressive type of cancer. It may be effective in some cases where the leukemia cancer was not treatable with imatinib/Gleevic or other medications which are tyrosine-kinase inhbitors.
Tasigna works by inhibition of the BCR-ABL kinase enzyme needed for division of rapidly dividing cancer cells. Blocking the enzyme may help to limit cancer growth.
Tasigna is approved to treat:
- New diagnosis of Philadelphia chromosome positive chronic myeloid leukemia (PH+CML) in chronic phase in adults and children over the age of 1 with
- PH+CML in chronic and accelerated phase, which is resistant or intolerant to prior treatment with imatinib (Gleevic) in adult patients
- PH+CML in chronic phase which is resistant or intolerant to prior treatment with tyrosine-kinase inhibitor (TKI) in pediatric patients over the age of 1
Tasigna Side Effects
All chemotherapy treatments cause side effects which can be bothersome or even severe. Tasigna however, may also cause side effects which can be serious or life-threatening and are not usually expected with many chemo drugs.
Common side effects of Tasigna which may be similar to other chemo treatments include:
- Nausea and vomiting
- Decreased appetite
- Abdominal pain
- Constipation or diarrhea
- Hair loss
- Rash and itching
- Dry skin
- Fever
- Fatigue
- Headache
- Muscle or joint pain
- Insomnia
- High blood pressure
- Laboratory abnormalities
More serious side effects may include:
- Pneumonia
- Myelosuppression (neutropenia, leukopenia, thrombocytopenia)
- Intracranial hemorrhage
- QT prolongation
- Sudden death
Severe or sudden side effects should be reported to a medical professional immediately.
Tasigna Cardiac Complications
Tasigna may increase the risk for cardiac complications, including heart attack, stroke and amputation due to arterial occlusion. Increased cardiac risk may be a result of developing atherosclerosis due to Tasigna’s effects.
Novartis failed to warn U.S. physicians and consumers about the risk of atherosclerosis, even though doctors in Canada had been warned. The company did not issue safety alerts in the U.S. about the increased risk until they were forced to address the problem by the U.S. Food and Drug Administration (FDA).
In part, due to an increased risk of atherosclerosis which may clog arteries, Tasigna use may result in a higher than normal rate of arterial blockage in arteries in the heart and other areas of the body. Blockage of arterial blood flow around the heart may cause ischemic heart disease and may increase the risk of heart attack. In the brain, similar blockage can result in cerebrovascular accident (CVA) or stroke.
When arterial blockage occurs in the extremities, it is known as peripheral arterial occlusion which may cut off blood flow and oxygen supply to the arms or legs and may result in tissue death and a need for amputation.
In addition to increasing the chance for atherosclerosis, Tasigna may increase serum lipase levels and may lead to acute pancreatitis. People with prior history of pancreatitis may be at increased risk. Routine EKG/ECG monitoring and laboratory testing should be a part of a Tasigna treatment plan.
Symptoms of heart attack, stroke, arterial occlusion or pancreatitis such as sudden pain in chest, head, arms or legs, head or abdomen should be treated as an emergency.
Tasigna FDA Black Box Warnings
The FDA has required that all Tasigna prescribing information include “black box” or “boxed statement” warnings regarding the risk of serious cardiac effects.
Tasigna’s black box states that use of the medication may cause a change in heart rhythm known as “QT prolongation” which may lead to sudden death. Patients who have low magnesium (hypomagnesemia) or low potassium (hypokalemia) levels and those who have preexisting QT prolongation may be at increased risk of sudden death.
Use of other medications which prolong the QT interval and certain antacids, antibiotics or other medications known to be strong CYP3A4 inhibitors should be avoided as they may increase the risk of dangerous side effects.
Tasigna Lawsuits and Settlements
Novartis was previously accused of paying kickbacks to specialty pharmacies for promoting Tasigna and other company products. In 2015, Novartis agreed to pay $390 million to a number of federal and state governmental agencies to settle those claims of illegal marketing but the company is now likely facing lawsuits for injuries caused by Tasigna.
People are filing lawsuits against Novartis for injuries caused by Tasigna such as:
- Heart attack
- Stroke
- Amputation
- Sudden death
The complications cited in the lawsuits are separate and different from any events that may be caused by cancer and are a result of Tasigna use.
No settlements have been announced but, in the past, medical injury lawsuits have provided compensation for damages such as medical costs, lost wages, wrongful death, and pain and suffering. Each case is unique but people who have been harmed or family members of those who died due to Tasigna complications should seek advice from an attorney.Sources:
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.