DOCIVYX
Details
- Status
- Prescription
- First Approved
- 2022-11-22
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
DOCIVYX Approval History
What DOCIVYX Treats
5 indicationsDOCIVYX is approved for 5 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Breast Cancer
- Non-Small Cell Lung Cancer
- Prostate Cancer
- Gastric Adenocarcinoma
- Squamous Cell Carcinoma of the Head and Neck
DOCIVYX Boxed Warning
TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION Treatment-related mortality associated with DOCIVYX is increased in patients with abnormal liver function, in patients receiving higher doses, and in patients with non-small cell lung carcinoma and a history of prior treatment with platinum-based chemotherapy who receive DOCIVYX as a single agent at a dose of 100 mg/m 2 [see Warnings and Precautions (5.1) ] . Avoid the use of DOCIVYX in patients with bilir...
WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION Treatment-related mortality associated with DOCIVYX is increased in patients with abnormal liver function, in patients receiving higher doses, and in patients with non-small cell lung carcinoma and a history of prior treatment with platinum-based chemotherapy who receive DOCIVYX as a single agent at a dose of 100 mg/m 2 [see Warnings and Precautions (5.1) ] . Avoid the use of DOCIVYX in patients with bilirubin > upper limit of normal (ULN), or to patients with AST and/or ALT >1.5 × ULN concomitant with alkaline phosphatase >2.5 × ULN. Patients with elevations of bilirubin or abnormalities of transaminase concurrent with alkaline phosphatase are at increased risk for the development of severe neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death. Patients with isolated elevations of transaminase >1.5 × ULN also had a higher rate of febrile neutropenia. Measure bilirubin, AST or ALT, and alkaline phosphatase prior to each cycle of DOCIVYX [see Warnings and Precautions (5.2) ] . Do not administer DOCIVYX to patients with neutrophil counts of <1500 cells/mm 3 . Monitor blood counts frequently as neutropenia may be severe and result in infection. [see Warnings and Precautions (5.3) ] . Do not administer DOCIVYX to patients who have a history of severe hypersensitivity reactions to DOCIVYX [see Contraindications (4) ] . Severe hypersensitivity reactions have been reported in patients despite dexamethasone premedication. Hypersensitivity reactions require immediate discontinuation of the DOCIVYX infusion and administration of appropriate therapy [see Warnings and Precautions (5.5) ] . Severe fluid retention occurred in 6.5% (6/92) of patients despite use of dexamethasone premedication. It was characterized by one or more of the following events: poorly tolerated peripheral edema, generalized edema, ple
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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.
DOCIVYX FDA Label Details
ProIndications & Usage
FDA Label (PDF)DOCIVYX is a microtubule inhibitor indicated for: Breast Cancer (BC) : single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC Castration- Resistant Prostate Cancer (CRPC) : with prednisone in metastatic CRPC Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untr...
WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION Treatment-related mortality associated with DOCIVYX is increased in patients with abnormal liver function, in patients receiving higher doses, and in patients with non-small cell lung carcinoma and a ...
DOCIVYX Patents & Exclusivity
Patents (9 active)
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.