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Tasigna – Black Box Warning & Side Effects

Cancer drug Tasigna, an expensive medication used for an aggressive type of leukemia may be causing complications which result in a need for amputation. Tasigna (nilotinib) is a chemotherapy drug used to treat an aggressive type of cancer known as “Philadelphia chromosome positive chronic myelogenous leukemia” or Ph+CML.

Tasigna (nilotinib)

Tasigna (nilotinib) is a chemotherapy drug used to treat an aggressive type of cancer known as  “Philadelphia chromosome positive chronic myelogenous leukemia” or Ph+CML. Though it may be useful, even for those whose cancer was not with Gleevic (imatinib) or other medications, it may be increasing the risk for atherosclerosis and peripheral vascular complications that can result in a need for amputation.

Manufacturing information

Brand Name Tasigna
Generic Name nilotinib
Classification kinase inhibitor chemotherapeutic
Manufacturer Novartis
Dosage form(s) 50mg capsule 150mg capsule 200mg capsule
Normal dosage 300 to 400mg twice daily for adults, pediatric dosing by weight

How Does Tasigna Work?

Tasigna works to treat chronic myelogenous leukemia by inhibiting the BCR-ABL Kinase enzymes) needed for cell division. Inhibiting this e and is approved to treat:

  • Adults and children over 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (PH+CML) in chronic phase
  • Adult patients with chronic phase and accelerated phase PH+CML that is resistant or intolerant to prior treatment with imatinib
  • Pediatric patients over 1 year of age with chronic phase PH+CML that is resistant or intolerant to prior treatment with tyrosine-kinase inhibitor (TKI)

Tasigna Side Effects

Most chemotherapy medications cause a number of bothersome side effects. Many chemotherapy side effects can be treated with other medications or will become less bothersome over time. Some Tasigna side effects, however, may be more serious or even life-threatening.

Common Tasigna side effects:

  • Dry skin
  • Rash and itching
  • Hair loss
  • Headache
  • Nausea and vomiting
  • Decreased appetite
  • Constipation or diarrhea
  • Fatigue
  • Fever
  • Abdominal pain
  • Muscle or joint pain
  • Insomnia
  • Laboratory abnormalities
  • High blood pressure

Severe or more serious Tasigna side effects:

  • Blood vessel blockage
  • Pneumonia
  • Bone marrow suppression (thrombocytopenia, neutropenia, leukopenia, anemia)
  • QT prolongation
  • Intracranial hemorrhage
  • Sudden death

All side effects of Tasigna should be reported to a physician. Sudden or severe Tasigna side effects should be reported immediately.

Tasigna FDA Warnings

In December of 2017, the U.S. Food and Drug Administration (FDA) added a “black box warning” to Tasigna. A black box or boxed statement warning is the most severe safety alert which can be issued by the FDA and is required to be printed at the top of all drug labeling. The black box statement on Tasigna’s prescribing information warns of the risk of serious cardiac side effects from a condition called “QT prolongation”. QT prolongation is a change in the heart rhythm that may cause sudden death.

The risk of sudden death caused by QT prolongation is worsened in patients with low magnesium or low potassium levels. It may also be more likely in patients who already have or are at high risk for long QT syndrome or who are taking medications such as antiarrhythmics which increase the QT interval.

Medications known to affect certain liver enzymes such as some anti-infectives and ulcer medications which are CYP3A4 inhibitors may increase the effects of Tasigna, increasing the possibility of serious side effects.

Tasigna Complications

Tasigna has been shown to increase the chance for developing atherosclerosis. In some cases, atherosclerosis may contribute to cardiac side effects and may increase the chance for developing an arterial vascular occlusion, otherwise known as a blockage. Blockage of arteries that surround the heart may increase the risk of cardiac events such as ischemic heart disease. When blockages occur in the extremities, it may lead to peripheral artery disease. Acute peripheral arterial occlusion may block blood supply to an extremity which may result in tissue death and a need for amputation.

Novartis has been accused of withholding information about Tasigna’s risk of atherosclerosis and corresponding complications from U.S. health care providers and consumers. Novartis issued warnings to Canadian health professionals but did not provide the same information to U.S. providers until the FDA intervened. In some cases, the failure to issue warnings may have increased the potential for cardiac complications in certain patients and may have led to an increased occurrence of heart attack, stroke and amputation.

In addition to atherosclerosis, Tasigna may increase blood levels of the enzyme lipase which may mask the identification of pancreatitis as high serum lipase levels are dismissed due to drug side effects. Routine laboratory testing and EKG/ECG monitoring should be a part of Tasigna cancer treatment.

Abdominal symptoms should be reported to a healthcare professional immediately. Sudden pain in arms or legs or any occurrence of chest pain, or heart attack or stroke symptoms should be treated as an emergency.

Tasigna Lawsuits

Tasigna is a costly medication used to treat an aggressive, potentially fatal type of cancer, however people who used the medication have suffered complications or death that were not caused by cancer. Some of these patients or their loved ones have filed Tasigna lawsuits against Novartis seeking compensation for their injuries.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.

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