FLUDARA 50 mg injection 5 pcs

Product Description

FLUDARA 50 mg injection is a potent antineoplastic agent specifically formulated for intravenous administration.

It contains Fludarabine Phosphate, a purine analogue, which is a key component in the treatment of certain hematological malignancies.

This medication is primarily indicated for patients suffering from chronic lymphocytic leukemia (CLL) who have not responded to or have progressed during treatment with at least one prior standard alkylating agent-containing regimen.

Fludara works by interfering with DNA synthesis, thereby inhibiting the proliferation of malignant cells.

Each box contains 5 vials, with each vial providing 50 mg of Fludarabine Phosphate.

As a specialized chemotherapy drug, its use requires careful medical supervision and administration by qualified healthcare professionals.

Benefits of Use

FLUDARA 50 mg injection offers significant therapeutic benefits for specific cancer types.

It is an established treatment option for refractory or progressive B-cell chronic lymphocytic leukemia (CLL).

Fludarabine Phosphate can induce remissions and improve clinical outcomes in eligible patients.

Its targeted mechanism of action helps in controlling the spread of cancer cells.

It is a critical component of various chemotherapy regimens used worldwide.

How to Use

FLUDARA 50 mg injection must be administered by a physician experienced in antineoplastic therapy.

1. Reconstitution: The contents of the vial should be reconstituted with Sterile Water for Injection, USP.
2. The reconstituted solution should be clear and colorless.
3. Dilution: The appropriate dose of the reconstituted solution should be further diluted in 100 mL or 125 mL of 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP.
4. Administration: Administer as an intravenous infusion over approximately 30 minutes.
5. Dosage and duration of treatment will be determined by the treating oncologist based on the patient’s condition, response to therapy, and tolerability.
6. Follow strict aseptic techniques during preparation and administration.

Caution & Warnings

• FLUDARA should only be administered under the supervision of a qualified physician experienced in antineoplastic therapy.
• Close monitoring of hematologic and non-hematologic toxicity is essential.
• Severe bone marrow suppression (myelosuppression), including anemia, thrombocytopenia, and neutropenia, is common.
• Immunosuppression may lead to an increased risk of infections, including opportunistic infections.
• Neurotoxicity, including severe neurological events such as irreversible encephalopathy and seizure, has been reported.
• Tumor lysis syndrome may occur, particularly in patients with a large tumor burden.
• FLUDARA is embryotoxic and teratogenic in animals and should not be used during pregnancy.
• Effective contraception must be used by both male and female patients during and after treatment.
• Renal and hepatic impairment may require dose adjustments.
• Avoid live vaccines during and after FLUDARA treatment.
• Interactions with other medications, especially those affecting bone marrow, should be carefully managed.

Ingredients

• Active Ingredient: Fludarabine Phosphate 50 mg
• Excipients: Mannitol, Sodium Hydroxide (for pH adjustment).

Product Details

Product Name: FLUDARA 50 mg injection

Strength: 50 mg per vial

Pack Size: 5 vials per box

Dosage Form: Lyophilized powder for solution for injection

Manufacturer: Bayer HealthCare