Novartis is the Marketing Authorization Holder for Jakavi outside the United States The purpose of this Cohort Treatment Plan is to allow access to ruxolitinib for eligible patients diagnosed with severe/very severe COVID-19 illness. 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 ruxolitinib 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.
5 mg. Tablet
Other Name: Jakavi
Patients eligible for inclusion in this Treatment Plan have to meet all of the following
Written patient informed consent or assent must be obtained prior to start of treatment.
- Patients aged ≥ 6 years
- Patients clinically diagnosed with SARS-CoV-2 infection, either through positive serum antibodies (IgM or IgG); or by PCR; or by other approved diagnostic methodology. Patients with presumptive diagnosis of COVID-19 (other respiratory causes ruled out and SARS-CoV-2 test pending) may be included.
- Adult and adolescent patients (≥12years), who meet one of the below criteria - Respiratory frequency ≥ 30/min - Oxygen saturation ≤ 93% on room air (FiO2=0.21) - Arterial oxygen partial pressure (PaO2)/ fraction of inspired oxygen (FiO2)