Bimode (Bendamustine )

DESCRIPTION

Bimode100mg belongs antineoplastic medication by alkylation process.

Bimode100mg consist of nitrogen-mustard compound necessary in the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

Bimode100mg is a prescription drug which is used under the guidance of medical supervision.

INDICATION

Bimode100mg is indicated for following condition :

The treatment of Chronic lymphocytic Leukaemia

The treatment of Indolent B-cell non-Hodgkin’s lymphoma

The treatment of Myeloma

MECHANISM OF ACTION

Bendamustine consist of bifunctional mechlorethamine derivative capable of forming electrophilic alkyl groups which covalently attach to other molecules. Due to this function as an alkylating agent, bendamustine occurs intra- and inter-strand cross links between DNA bases resulting in cell death. It is active against both active and quiescent cells, even though the proper mechanism of action is unknown

ADME

Time to peak plasma: At end of infusion
Protein bound: 94-96%
Volume of distribution: 25L
Metabolized by CYP1A2
Excretion: feces 90%; Urine 1-10%
Half-life: 40min

DOSAGE MANAGEMENT

The prescribed dose for chronic lymphocytic Leukaemia is 100mg/m2 IV infusion on days 1 and 2 of 28-day cycle, repeated for up to 6 cycles
The recommended dose for Non-Hodgkin Lymphoma is 120mg/m2 IV infusion on days 1 and 2 of 21-day cycle repeated for up to 8 cycles

PRECAUTIONS

• While on treatment will causes tumor lysis syndrome occurs; acute renal failure and death may report; anticipate and use supportive measures.
  • Control the fever and other signs of infection and treat promptly.
  • Lethal and severe cases of liver injury resulted with bendamustine hydrochloride injection.
  • Check for liver chemistry tests prior to and during treatment.
  • Serious infusion and anaphylactic reactions resulted; check clinically and stops treatment; premeditate in consecutive cycles for milder reactions.
  • Myelosuppression may report; decrease dose; restart treatment based on ANC and platelet count recovery; difficult situation of myelosuppression may lead to death.
  • While on treatment, Premalignant and malignant diseases reported.

SIDE EFFECTS

Side effects caused due to Bimode100mg :
• Bleeding gums
• Sore throat
• Breathing trouble
• Fast heartbeat
• Blistering and peeling of skin
• Decreased blood counts
• Infusion reaction
• Dizziness
• Fever
• Nausea
• Vomiting
• Fatigue
• Diarrhae
• Rash
• Infertility

DRUG INTERACTION

When concomitant use of Bimode100mg with CYP1A2 inhibitors will have possible to have high plasma concentration of bendamustine and lowers plasma concentration of active metabolites.

When concomitant use of Bimode100mg with CYP1A2 inducers will have possible to reduces the plasma concentration of bendamustine and increase plasma concentration of active metabolites.

CONTRAINDICATIONS

Hypersensitivity to bendamustine and its metabolites

PREGNANCY 

Pregnancy category is D

Based on adverse reaction, Bimode100mg will cause fetal harm when given to a pregnant woman. Bimode100mg reported malformations in animals.

Avoid using Bimode100mg during pregnancy.

LACTATION

The drug excreted into human milk is unknown and effects in the new born baby are unknown

Hence use is contraindicated

STORAGE 

store in refrigerator at 2°C to 8°C
keep in original containers until time of use.

OVER DOSAGE

In case of over dosage of Bimode100mg tablets, patients must provided with some supportive measures and discontinue the therapy. The half life of Bimode100mg is occurs for 5.8 days. Seizure is the major adverse effect occurred due to over dosage of Bimode100mg. Seizure is not described at ≤240mg daily; since three seizures occurs at 360mg, 480mg and 600mg daily.

MISSED DOSE

If dose is missed, then have immediately before the reaching of next dose time or swap the missed dose and continue regular schedule. Consult the doctors for more information