Product Details
ROMIDEPSIN PR 10MG W/DIL
Manufacturer: Fresenius Kabi
MFG#: 63323-0926-88
NDC: 63323-0926-88
PID: 639463
Additional Information
| Product Name | Romidepsin PR 10 mg with Diluent |
| Active Ingredient | Romidepsin |
| Mechanism of Action | Histone deacetylase (HDAC) inhibitor; induces apoptosis in malignant T-cells |
| Strength | 10 mg per vial |
| Container Type | Single-Dose Vial with Diluent |
| Route of Administration | Intravenous (IV) |
| Dosing Frequency | Once weekly for three weeks in a 28-day cycle |
| Common Side Effects | Nausea, fatigue, thrombocytopenia, neutropenia, infections |
| Serious Risks | QT prolongation, severe myelosuppression, hepatotoxicity, tumor lysis syndrome |
| Dilution Requirements | Must be reconstituted with provided diluent before IV administration |
| Precautions | Monitor ECG, blood counts, liver function, and electrolyte levels |
| Monitoring Parameters | CBC, liver function tests, ECG, electrolyte levels |
| Packaging | Single-use vial with diluent |
| Indications | Peripheral T-cell lymphoma (PTCL), cutaneous T-cell lymphoma (CTCL) |
Description
Romidepsin PR 10 mg with diluent is an injectable histone deacetylase (HDAC) inhibitor used in the treatment of peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) in patients who have received prior systemic therapy. It functions by inhibiting HDAC enzymes, leading to increased acetylation of histone proteins, which results in altered gene expression, cell cycle arrest, and apoptosis of malignant T-cells.
Romidepsin is administered as an intravenous infusion over a specified duration, typically once weekly for three weeks in a 28-day cycle. The dosing regimen may be adjusted based on patient tolerance and adverse reactions. Common side effects include nausea, fatigue, infections, thrombocytopenia, neutropenia, and QT prolongation. Due to its immunosuppressive effects, patients are at risk of opportunistic infections and require close monitoring during therapy.
Patients receiving romidepsin should undergo regular hematologic and biochemical assessments, including electrolyte levels and liver function tests, to prevent complications such as hepatotoxicity and electrolyte imbalances. Electrocardiogram (ECG) monitoring is recommended due to the potential for QT prolongation, particularly in patients with predisposing factors.
Frequently Asked Questions (FAQs)
The cost of ROMIDEPSIN PR 10MG W/DIL is $available for registerd members only
ROMIDEPSIN PR 10MG W/DIL is manufactured by Fresenius Kabi.
You can purchase ROMIDEPSIN PR 10MG W/DIL on our website at https://supplies.pipelinemedical.com/product/detail/romidepsin-10-mg-kit-639463