ASTAGRAF XL
Details
- Status
- Prescription
- First Approved
- 2013-07-19
- Routes
- ORAL
- Dosage Forms
- CAPSULE, EXTENDED RELEASE
ASTAGRAF XL Approval History
What ASTAGRAF XL Treats
1 indicationsASTAGRAF XL is approved for 1 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Organ Rejection
ASTAGRAF XL Boxed Warning
MALIGNANCIES AND SERIOUS INFECTIONS IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS • Increased risk for developing serious infections and malignancies with ASTAGRAF XL ® or other immunosuppressants that may lead to hospitalization or death. [see Warnings and Precautions ( 5.1 , 5.2 )] • Increased mortality in female liver transplant patients with ASTAGRAF XL. ASTAGRAF XL is not approved for use in liver transplantation. [see Warnings and Precautions ( 5.3 )] ...
WARNING: MALIGNANCIES AND SERIOUS INFECTIONS IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS • Increased risk for developing serious infections and malignancies with ASTAGRAF XL ® or other immunosuppressants that may lead to hospitalization or death. [see Warnings and Precautions ( 5.1 , 5.2 )] • Increased mortality in female liver transplant patients with ASTAGRAF XL. ASTAGRAF XL is not approved for use in liver transplantation. [see Warnings and Precautions ( 5.3 )] WARNING: MALIGNANCIES AND SERIOUS INFECTIONS IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS See full prescribing information for complete boxed warning. • Increased risk for developing serious infections and malignancies with ASTAGRAF XL or other immunosuppressants that may lead to hospitalization or death. ( 5.1 , 5.2 ) • Increased mortality in female liver transplant patients with ASTAGRAF XL. Not approved for use in liver transplantation. ( 5.3 )
ASTAGRAF XL Target & Pathway
ProTarget
A cytokine that promotes Th2 immune responses and IgE production. IL-4 drives allergic inflammation in atopic dermatitis and asthma. Blocking IL-4 (often together with IL-13) reduces the type 2 inflammation underlying these conditions.
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Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ASTAGRAF XL FDA Label Details
ProIndications & Usage
FDA Label (PDF)ASTAGRAF XL ® is indicated for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants in adult and pediatric patients who can swallow capsules intact [see Use in Specific Populations and Clinical Studies , ]. ASTAGRAF XL is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants in adult and pediatric patients who can swallow capsules intact.
WARNING: MALIGNANCIES AND SERIOUS INFECTIONS IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS • Increased risk for developing serious infections and malignancies with ASTAGRAF XL ® or other immunosuppressants that may lead to hospitalization or death. [see Warnings...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.