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References

1. CAVHANZA™ (nilotinib) Orally Disintegrating Tablets. Prescribing Information. Flex Pharma.

Tasigna® is a registered trademark of Novartis AG.

Indication and Important Safety Information

Indications

CAVHANZA (nilotinib) is a kinase inhibitor indicated for the treatment of:

  • Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).
  • Adults with CP Ph+ CML or accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy.

Contraindications

Do not take CAVHANZA if you have:

  • low levels of potassium or magnesium in your blood.
  • long QT syndrome.

Important Safety Information

Warning: QT Prolongation and Sudden Deaths

  • Nilotinib can cause changes in heart rhythm. Before starting and during treatment, your healthcare provider will check your potassium and magnesium levels and take steps to resolve any problems you may have. Your heart will be monitored with ECG tests at the start, after 7 days, regularly during treatment, and after any changes in dosage.
  • Sudden deaths have happened in people taking nilotinib. Do not take CAVHANZA if you have low potassium, low magnesium, or a heart rhythm disorder called long QT syndrome.
  • Avoid taking CAVHANZA with other medicines that can affect your heart rhythm or strong medicines that affect how nilotinib works.

Warnings and Precautions:

  • Different Nilotinib Products and Risk of Medication Errors: CAVHANZA is not the same as other nilotinib products. The amount of nilotinib in a dose of CAVHANZA may not be the same as the amount in other products containing nilotinib. Do not switch from CAVHANZA to other medicines that contain nilotinib without talking to your healthcare provider.
  • Low Blood Counts: CAVHANZA may cause your blood counts to drop, including low levels of white blood cells, red blood cells, or platelets. Your healthcare provider will check your blood counts regularly while you are taking CAVHANZA. If your blood counts change too much, your treatment may be temporarily stopped, or your dose may be lowered.
  • Heart and Blood Vessel problems: Heart and blood vessel problems, including blocked arteries, have been reported in patients newly diagnosed with Chronic Myeloid Leukemia (CML). Your healthcare provider will check your heart and blood vessel health before and during treatment. Risk factors will be monitored and treated as needed while you take CAVHANZA.
  • Pancreatitis Risk: CAVHANZA can cause an increase in a blood enzyme called lipase. If you have had pancreatitis before, you may be more susceptible to higher lipase levels. Your healthcare provider will monitor certain blood tests related to the pancreas while you are taking CAVHANZA. If you develop stomach pains alongside abnormal test results, your treatment may be paused, and further tests may be required to check for pancreatic inflammation.
  • Liver Problems: CAVHANZA may cause liver problems, shown by increases in certain tests (bilirubin, AST, ALT, and alkaline phosphatase). Your healthcare provider will check your liver function with blood tests regularly, usually once a month, or more often if needed, while you are taking CAVHANZA.
  • Electrolyte Abnormalities: CAVHANZA can affect the levels of some minerals (electrolytes) in your blood, such as phosphate, potassium, calcium, and sodium. These levels will be checked and corrected before you start treatment and monitored regularly while you are taking CAVHANZA.
  • Tumor Lysis Syndrome: Some patients treated with nilotinib for resistant or intolerant CML have developed tumor lysis syndrome (TLS). It is important to stay well hydrated. Your healthcare provider may do a blood test to check your uric acid levels are in normal range and offer treatment if required, to help reduce the risk of side effects when treatment begins.
  • Bleeding: Bleeding can happen while taking this medicine. Tell your healthcare provider right away if you notice any signs of bleeding. Your healthcare provider may check your blood, adjust your treatment and provide care to manage bleeding.
  • Fluid Retention: Tell your healthcare provider right away if you notice any sudden weight gain, swelling (such as in your legs or ankles), or shortness of breath while taking CAVHANZA. These symptoms will be checked and treated by your healthcare provider if necessary.
  • Effects on Growth and Development in Pediatric Patients: Nilotinib may slow growth and development in children. Growth changes, such as height and weight, may occur during treatment.
  • Pregnancy Risks: CAVHANZA can harm an unborn baby. If you can become pregnant, talk to your healthcare provider about this risk and use effective birth control during treatment with CAVHANZA.
  • Treatment Discontinuation: Before stopping treatment, patients must have a specific type of leukemia marker (BCR‐ABL) that can be accurately measured. A specially approved lab test that is very sensitive must be used to confirm eligibility. If your treatment is stopped, your healthcare provider will arrange regular blood tests with the same approved test to closely monitor you and make sure the disease does not return.

Adverse Reactions:

  • Heart rhythm problems have occurred with this medicine, including a condition called QT prolongation, which can be serious and may lead to sudden death. Your healthcare provider may check your heart function and electrolytes before and during treatment.
  • Serious side effects have been reported, including severe infections, bleeding in the brain, and significant drops in blood cell counts.
  • The most common side effects seen in studies were skin rash or itching, headache, nausea, feeling tired, hair thinning or hair loss, muscle pain, stomach pain, constipation, diarrhea, and vomiting.
  • Changes in blood counts can occur. CAVHANZA may lower the number of platelets, white blood cells, or red blood cells, which can increase the risk of bleeding, infections, or anemia. Your healthcare provider will monitor your blood counts during treatment.
  • Some patients stopped treatment because of side effects.
  • Additional side effects have been reported after the medicine became available, including damage to small blood vessels, facial weakness or paralysis, and bone damage (osteonecrosis).

Drug Interactions:

Medicines and foods that strongly affect liver enzymes (CYP3A inhibitors), such as grapefruit or grapefruit juice, should be avoided while taking CAVHANZA. If they cannot be avoided, your healthcare provider may lower your dose. Certain medicines and foods can increase the amount of nilotinib in your body and raise the risk of side effects.

Medicines that strongly increase liver enzyme activity (CYP3A inducers) should also be avoided while taking CAVHANZA. These medicines can lower the amount of nilotinib in your body and may reduce how well the treatment works.

Medicines that can affect heart rhythm (QT‐prolonging drugs), should not be taken with CAVHANZA, as using them together may increase the risk of abnormal heartbeats. Always tell your healthcare provider about all medicines you take.

Use in Specific Populations:

Pregnancy: There is limited information about the use of this medicine during pregnancy. Effects on an unborn baby are not fully known and taking this medicine may pose a risk to the fetus. If you are pregnant or think you may be pregnant, talk to your healthcare provider right away.

Lactation: It is not known whether nilotinib passes into human breast milk or if it could affect a breastfed baby. This medicine may cause serious side effects in a breastfed child, women should not breastfeed during treatment with CAVHANZA and for 14 days after the last dose. Talk to your healthcare provider about the best way to feed your baby during this time.

Pediatric use: CAVHANZA is not approved for use in children. Slowed growth has been reported in children taking nilotinib.

Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation’s TASIGNA (nilotinib) capsules. However, due to Novartis Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Geriatric use: No major differences for safety were observed in patients ≥65 years whilst taking CAVHANZA.

For more detailed information, please refer to the full Prescribing Information at cavhanza.com/pi/.

To report SUSPECTED ADVERSE REACTIONS, contact Cycle Pharmaceuticals at 1-855-831-5413, or the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch.

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US-NIL-2600004 | June 2026