Cavhanza (nilotinib) is a new FDA-approved orally disintegrating tablet (ODT) formulation of nilotinib, a prescription medicine used to treat a type of blood cancer called Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML).The FDA has approved Cavhanza for adults with newly diagnosed chronic-phase Ph+ CML as well as for those with chronic- or accelerated-stage disease who have not responded or are intolerant to prior treatments such as imatinib.Cavhanza is a second-generation tyrosine kinase inhibitor (TKI) that works by blocking the BCR‑ABL protein, keeping it in the “off” state to slow down the growth of leukemic cells.
Around 25% of patients with Ph+ CML use medicines such as proton pump inhibitors (PPIs) or H₂ blockers (H₂RAs) to treat common conditions including acid reflux or heartburn.
However, with older forms of nilotinib, these acid-suppressing medicines and even food can affect how well the nilotinib is absorbed, making dosing more complicated and less predictable.
According to the drugmaker, the ODT form of Cavhanza is designed for easy use and more reliable absorption, remaining effective even when taken with PPIs or H₂RAs, without requiring strict timing rules. This approval matters, as the ODT form of Cavhanza can be taken with or without food, offering more flexible dosing. Because the tablet dissolves in the mouth and can be taken with or without water, it may help patients who have a hard time swallowing pills, making it easier to continue their therapy.
Why Was It Approved?
The FDA’s approval of the ODT version of Cavhanza (with its twice-daily dosing schedule) was supported by proven safety and effectiveness data from well-controlled studies of the capsule form of nilotinib for treating adults with newly diagnosed chronic-phase Ph+ CML. The clinical responses supported Cavhanza’s use for adults with newly diagnosed chronic-phase Ph+ CML as well as for those who were resistant or intolerant to prior therapy, including imatinib. The studies showed no difference in the rate or extent of nilotinib absorption whether the ODT was swallowed whole or allowed to dissolve in the mouth before swallowing.
What Do I Need to Know?
The recommended Cavhanza dose is 120 mg twice daily for patients with newly diagnosed chronic-phase Ph+ CML and 160 mg twice daily for those with chronic- or accelerated-phase Ph+ CML who are resistant or intolerant to prior therapy; the dose can be taken with or without food. Take the two doses about 12 hours apart. Let the tablet dissolve on your tongue and then swallow it, or you may chew and swallow it or swallow the ODT whole with water. If you miss a dose, skip it and take the next dose at your usual time. Do not take two doses together. Do not eat or drink grapefruit products while taking Cavhanza. Your health care provider will check your heart rhythm with an electrocardiogram (EKG) before starting treatment, again about a week after the first dose, and from time to time afterward, including after any change in dose. They may also run tests to check your uric acid levels and blood counts before starting Cavhanza and monitor your fluid levels during treatment. Let your health care provider know if you have any liver or heart issues, or pancreas-related problems, as Cavhanza can increase the risk of liver or pancreatic injury. Also let them know if you have low potassium or magnesium levels or if you have long QT syndrome.
