Official Title
Managed Access Programs for INC424, Ruxolitinib
Brief Summary

The purpose of this registration is to list Managed Access Programs (MAPs) related to INC424, Ruxolitinib

Detailed Description

CINC424A2405 - Available - Managed Access Program (MAP) Cohort Treatment Plan CINC424A2405 to
provide access to Ruxolitinib for patients with Primary Myelofibrosis (PMF) or Post
Polycythemia Myelofibrosis (PPV MF) or Post-Essential Thrombocythemia Myelofibrosis (PET-MF)

CINC424A2001M - No longer available - Ruxolitinib Managed Access Program (MAP) for patients
diagnosed with severe/very severe COVID-19 illness

CINC424B2002I - Available - Managed Access Program (MAP) Cohort Treatment Plan CINC424B2002I
to provide access to Ruxolitinib for patients with Polycythemia Vera (PV)

CINC424C2001M - Available - Managed Access Program (MAP) Cohort Treatment Plan CINC424C2001M
to provide access to ruxolitinib for steroid refractory acute and chronic Graft versus Host
Disease (SR aGVHD and SR cGHVD).

Available
Intermediate-size Population
Primary Myelofibrosis (PMF)
Post Polycythemia Myelofibrosis (PPV MF)
Thrombocythemia Myelofibrosis (PET-MF)
Severe/Very Severe COVID-19 Illness
Polycythemia Vera (PV)
Steroid Refractory Acute Graft Versus Host Disease (SR aGVHD)
Steroid Refractory Chronic Graft Versus Host Disease (SR cGVHD)

Drug: Ruxolitinib

Patients receive Ruxolitinib
Other Name: INC424

Eligibility Criteria

Inclusion criteria

1. An independent request was received from a licensed physician.

2. The patient has a serious or life-threatening disease or condition and there is no
comparable or satisfactory alternative therapy available for diagnosis, monitoring, or
treatment.

3. The patient is not eligible or able to enroll in a clinical trial or continue
participation in such trial.

4. There is a potential patient benefit to justify the potential risk of the treatment
use, and the potential risk is not unreasonable in the context of the disease or
condition to be treated.

5. The patient must meet any other medical criteria established by the medical experts
responsible for the product or by the health authority in the country of request (as
applicable).

6. Provision of the product will not interfere with the initiation, conduct, or
completion of a Novartis clinical trial or overall development program.

7. Managed Access provision is allowed per local laws/regulations.

Eligibility Gender
All
Eligibility Age
Minimum: 2 Years ~ Maximum: N/A
Contacts

MAP requests are initiated by a licensed physician.https:// www.novart is.com/healthcare-professionals/managed-access-programs
1-88-669-6682
novartis.email@novartis.com

Novartis Pharmaceuticals
+41613241111

Novartis Pharmaceuticals
NCT Number
Keywords
MAP
Manage access program
Primary Myelofibrosis (PMF)
Post Polycythemia Myelofibrosis (PPV MF)
Thrombocythemia Myelofibrosis (PET-MF)
Severe/very severe COVID-19 illness
Polycythemia Vera (PV)
Steroid refractory acute Graft versus Host Disease (SR aGVHD)
Steroid refractory chronic Graft versus Host Disease (SR cGVHD)
INC424
ruxolitinib
MeSH Terms
Polycythemia Vera
Bronchiolitis Obliterans Syndrome
Primary Myelofibrosis
Polycythemia
Thrombocytosis
Graft vs Host Disease