RIBOMUSTIN 100 mg Powder for Solution for Infusion

RIBOMUSTIN 100 mg is a specialized chemotherapy medication used in the treatment of various types of cancer. This potent drug, containing Bendamustine Hydrochloride, is prepared as a powder for concentrate, which is then reconstituted into a solution for intravenous infusion. It plays a crucial role in oncology by targeting and inhibiting the growth of cancer cells.

Benefits of Use

RIBOMUSTIN 100 mg is prescribed for the treatment of specific cancers, offering targeted therapeutic action:

• Effective in treating chronic lymphocytic leukemia (CLL).
• Used for the treatment of indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or after rituximab-containing therapy.
• May be utilized in certain cases of multiple myeloma, as directed by an oncologist.

How to Use

RIBOMUSTIN 100 mg is a cytotoxic drug and must be administered strictly under the supervision of a qualified healthcare professional experienced in the use of antineoplastic agents. It is not for self-administration.

1. Preparation: The powder for concentrate is reconstituted with sterile water for injection by a healthcare professional in a controlled environment.
2. Dilution: The reconstituted solution is then further diluted with appropriate intravenous fluids (e.g., 0.9% Sodium Chloride Injection, USP) to the desired concentration for infusion.
3. Administration: The diluted solution is administered as an intravenous infusion over a specified period, typically 30 to 60 minutes, depending on the dosage and treatment protocol.
4. Dosage: The exact dosage, frequency, and duration of treatment are determined by the treating physician based on the patient's specific cancer type, stage, body surface area, and overall health.

Caution & Warnings

• Professional Supervision: RIBOMUSTIN must only be administered by qualified healthcare professionals in a hospital or clinic setting.
• Myelosuppression: May cause severe bone marrow suppression, leading to anemia, leukopenia (including neutropenia), and thrombocytopenia. Regular blood counts are essential.
• Infections: Increased risk of serious and opportunistic infections due to immunosuppression.
• Hypersensitivity Reactions: Acute anaphylactic and anaphylactoid reactions have been reported, particularly during subsequent cycles.
• Skin Reactions: Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have occurred.
• Tumor Lysis Syndrome: Can occur, especially in patients with a high tumor burden.
• Hepatotoxicity: Liver enzyme elevation has been observed.
• Pregnancy and Lactation: Contraindicated in pregnant or breastfeeding women due to potential fetal harm and passage into breast milk. Effective contraception should be used by both male and female patients during and after treatment.
• Extravasation: Avoid extravasation as it can lead to tissue damage.
• Drug Interactions: Caution should be exercised when co-administering with other myelosuppressive agents or drugs that affect liver enzymes.

Ingredients

Each vial of RIBOMUSTIN contains:

• Active Ingredient: Bendamustine Hydrochloride 100 mg
• Excipients: Mannitol and others as required for formulation stability (e.g., hydrochloric acid for pH adjustment).

Product Details

• Product Name: RIBOMUSTIN 100 mg Powder for Concentrate for Solution for Infusion
• Strength: 100 mg
• Dosage Form: Powder for concentrate for solution for infusion
• Packaging: 1 Vial
• Manufacturer: Teva Pharmaceutical Industries
• Primary Use: Chemotherapy for specific cancers (e.g., CLL, NHL)