Tasigna

The U.S. Food and Drug Administration approved Novartis’ Tasigna in 2007 to treat Philadelphia chromosome-positive chronic myeloid leukemia, or Ph+ CML, in chronic phase. While it is more effective than Novartis’ other drug Gleevec, Tasigna has more side effects, including atherosclerosis and sudden death.

Tasigna
Tasigna Facts
  1. Use Treats Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase
  2. Side Effects Low blood cell counts, decreased blood flow, pancreatitis, hardening of the arteries, QT prolongation, liver problems, nausea, rash, headache, vomiting, night sweats
  3. Manufacturer Novartis

Tasigna (nilotinib) is an oral chemotherapy drug manufactured by Novartis. The U.S. Food and Drug Administration approved it in 2007.

Doctors prescribe the drug to treat a specific type of blood cancer called Philadelphia chromosome-positive chronic myeloid leukemia. They may also recommend the medication to patients who did not respond well to other cancer treatments, such as Gleevec (imatinib).

Did You Know?
Tasigna remains one of Novartis’ top moneymaking drugs. It earned about $1.8 million in 2018.
Source: Novartis’ 2018 annual report

The drug can cause several common side effects, such as nausea and headaches. It may increase the risk of blocked arteries, potentially fatal heart rhythms called QT prolongation, and sudden death.

From 2007 to March 31, 2019, the FDA received 10,779 reports of serious side effects, including 2,853 deaths, involving Tasigna, according to the FDA Adverse Events Reporting System (FAERS) Public Dahsboard.

People who took the drug and suffered heart or vascular problems, such as clogged arteries, are filing Tasigna lawsuits.

Nilotinib’s Effects on the Body

Tasigna’s active ingredient, nilotinib, works by blocking cancer-growing proteins called tyrosine kinases. It belongs to a class of drugs called tyrosine kinase inhibitors, or TKIs.

Specifically, nilotinib works by blocking signals from the abnormal blood proteins that create leukemia cancer cells. Blocking cancer cell signals may stop cancer from spreading and may allow more healthy blood cells to grow, according to Novartis’ Tasigna website.

An infographic that illustrates how tasigna works.
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The goals of treatment with drugs like Tasigna are to achieve normal blood counts, to reduce and eliminate the Philadelphia chromosome, and to reduce and eliminate BCR-ABL1 gene expression, according to a 2011 study published in Cancer. Researchers call achieving these goals a major molecular response, or MMR, to the medication.

Philadelphia chromosomes are abnormal chromosomes found in bone marrow cells, according to Cancer Treatment Centers of America. They form when a piece of chromosome 9 and a piece of chromosome 22 detach and swap places. BCR-ABL1 refers to the gene sequence that forms on chromosome 22 where the piece of chromosome 9 affixes.

If a patient achieves an MMR after taking Tasigna for at least three years, their doctor may allow them to discontinue the drug.

Capsule Strengths and Twice-Daily Doses

Tasigna comes in 50 mg, 150 mg and 200 mg capsules to be taken by mouth.

For adults newly diagnosed with Philadelphia chromosome-positive chronic myeloid leukemia, the starting dose is 300 mg twice daily. For treatment-resistant adults, the recommended dose is 400 mg twice daily.

Tasigna Dosing Tip
People who cannot swallow Tasigna capsules may open each capsule and put the contents in a teaspoon of applesauce.
Source: 2018 Tasigna Drug Label Information

For children, the recommended dose is 230 mg/m2 twice daily, rounded to the nearest 50 mg dose, depending on the child’s body surface area. The maximum single dose for children is 400 mg.

Patients should take the drug twice daily at approximately 12-hour intervals on an empty stomach. They should not eat for at least two hours before and one hour after taking each dose.

Antacids and Other Substances that May Interact with Tasigna

Several drugs may interact with Tasigna. These include certain antacids, antibiotics, opioids and antidepressants.

The drugs may increase or decrease in effectiveness when combined with nilotinib. They may also decrease or increase blood concentrations of nilotinib.

The most dangerous interactions can cause prolonged QT intervals that may be deadly. Fruit juices and herbs can also affect how the drug works in the body.

Potential Interactions with Tasigna

Potential Interactions with Tasigna
  • Atazanavir increased atazanavir exposure
  • Clopidrogel increased clopidrogel exposure
  • Darunavir increased nilotinib exposure
  • Digoxin increased QT interval
  • Fluoroquinolones increased QT interval
  • Fluoxetine increased QT interval
  • Grapefruit juice increased nilotinib exposure
  • Haloperidol increased QT interval
  • Ketoconazole increased QT interval
  • Licorice increased nilotinib exposure
  • Losartan increased losartan exposure
  • Metoclopramide increased QT interval
  • Metoprolol increased metoprolol exposure
  • Pioglitazone increased pioglitazone exposure
  • Risperidone increased QT interval
  • St. John’s Wort decreased nilotinib exposure
  • Venlafaxine increased QT interval
  • Warfarin increased anticoagulation

This is not a complete list. Patients should inform their doctors of all medications and supplements they take.

Precautions: Lactose Intolerance, Pregnancy, Heart Disorder and Mineral Deficiencies

Tasigna’s prescribing information lists several precautions and warnings. People with hypokalemia (low potassium), hypomagnesemia (low magnesium) or long QT syndrome should not take this drug.

Nilotinib is toxic to fetuses. Women who may become pregnant should use contraception while taking Tasigna. Women should not breastfeed during treatment and for at least 14 days after their final dose.

The drug’s capsules contain lactose, so patients who are lactose intolerant or have milk allergies should tell their doctors.

Tasigna vs Gleevec

Like Tasigna, Gleevec treats Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase, but it’s approved for other uses as well. Novartis manufactures both drugs. The FDA approved Gleevec in 2001.

In clinical trials, twice as many adults who took Tasigna achieved MMR at one year compared to those who took Gleevec, according to Novartis’ Tasigna website. About 93.7 percent of adults survived at least five years with Tasigna. This is just slightly higher than the 91.7 percent who survived with Gleevec.

An infographic that compares the survival rates between Tasigna and Gleevec.

In 2017, the FDA approved an addition to Tasigna’s label that says patients with early phase chronic myeloid leukemia who have been taking the medication for at least three years may be eligible to stop taking the drug if their leukemia has responded to treatment according to specific criteria. Patients who take Gleevec don’t have the same option.

“Patients diagnosed with CML generally face a lifetime of treatment to keep their leukemia from growing or recurring,” Dr. Richard Pazdur, director of the FDA’s Oncology Center of Excellence, said in a press release. “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.”

But Tasigna may come with more serious side effects than Gleevec. For example, Gleevec’s labeling does not include a black box warning while Tasigna’s labeling must feature the FDA’s most serious warning for QT prolongation and sudden deaths.

Please seek the advice of a medical professional before making health care decisions.

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Michelle Llamas, Senior Content Writer
Written By Michelle Llamas Senior Writer

Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for seven years. She specializes in fluoroquinolone antibiotics and products that affect women’s health such as Essure birth control, transvaginal mesh and talcum powder. Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. Some of her qualifications include:

  • American Medical Writers Association (AMWA) Engage Committee and Membership Committee member
  • Centers for Disease Control and Prevention (CDC) Health Literacy certificates
  • Original works published or cited in The Lancet, British Journal of Clinical Pharmacology and the Journal for Palliative Medicine
Edited By

12 Cited Research Articles

  1. Cancer Treatment Centers of America. (n.d.). Tasigna. Retrieved from https://www.cancercenter.com/terms/tasigna/
  2. Cortes, J., Quintas-Cardama, A. & Kantarjian, H.M. (2011). Monitoring Molecular Response in Chronic Myeloid Leukemia. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4969001/
  3. Evidence-Based Medicine Consult. (n.d.) Common Medications Classified as Weak, Moderate and Strong Inhibitors of CYP3A4. Retrieved from https://www.ebmconsult.com/articles/medications-inhibitors-cyp3a4-enzyme
  4. Haouala, A. et al. (2011). Drug interactions with the tyrosine kinase inhibitors imatinib, dasatinib, and nilotinib. Retrieved from http://www.bloodjournal.org/content/bloodjournal/117/8/e75.full.pdf?sso-checked=true
  5. National Cancer Institute. (n.d.). NCI Dictionary of Cancer Terms: Philadelphia Chromosome. Retrieved from https://www.cancer.gov/publications/dictionaries/cancer-terms/def/philadelphia-chromosome
  6. National Institutes of Health. (2018, December 13). Gleevec – imatinib mesylate tablet. Retrieved from https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=211ef2da-2868-4a77-8055-1cb2cd78e24b&audience=consumer
  7. National Institutes of Health. (2018, November 18). Tasigna – nilotinib capsule. Retrieved from https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6093952a-5248-45cb-ad17-33716a411146&audience=consumer#section-7
  8. Novartis. (2018). Annual Report 2018. Retrieved from https://www.novartis.com/sites/www.novartis.com/files/novartis-annual-report-2018-en.pdf
  9. Novartis. (n.d.). How Treatment May Help. Retrieved from https://www.us.tasigna.com/about-treatment/clinical-trials/
  10. Novartis. (n.d.). Understanding Treatment. Retrieved from https://www.us.tasigna.com/about-treatment/understanding-treatment/
  11. U.S. Food and Drug Administration. (2017, December 22). FDA updates the label of Tasigna to reflect that certain patients with a type of leukemia may be eligible to stop treatment after sustained response. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-updates-label-tasigna-reflect-certain-patients-type-leukemia-may-be-eligible-stop-treatment
  12. U.S. Food and Drug Administration. (n.d.). FDA Adverse Events Reporting System (FAERS) Public Dashboard. Retrieved from https://fis.fda.gov/.
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