NCT04498871

MAP to Provide Access to Nilotinib, for Patients With HES

Managed Access Program (MAP) to Provide Access to Nilotinib, for Patients With Hypereosinophilic Syndrome (HES)

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this program is to allow access to nilotinib for eligible patients diagnosed with Hypereosinophilic syndrome (HES). The patient's Treating Physician should follow the suggested treatment guidelines and comply with all local health authority regulations. The requesting Treating Physician submitted a request for access to drug (often referred to as Compassionate Use) to Novartis which was reviewed and approved by the medical team experienced with the drug and indication. Please refer to the latest Investigator's Brochure (IB) or approved label for overview of drug including: non-clinical and clinical experience, risk and benefits. Novartis will continue to provide any new safety information to the Treating Physician as they emerge.

Conditions

• Hypereosinophilic Syndrome (HES)

Interventions

Type	Name	Description
DRUG	Nilotinib	Nilotinib is recommended to be administered orally on a continuous schedule at a dose of 400 mg twice daily. The patient should be instructed to take each morning dose of nilotinib 2 hours after a light breakfast (e.g., toast and jam), with no oral intake other than water for 1 hour after dosing. It is recommended that the patient take nilotinib doses every 12 hours with a glass of water. The evening dose of nilotinib should be taken at least 2 hours after dinner with no oral intake other than water for 1 hour after dosing.

Timeline

• First posted: 2020-08-05
• Last updated: 2021-09-20