Bendamustine
Cytostatic · Alkylating agent
Indications
First-line treatment of chronic lymphocytic leukaemia (CLL; Binet stage B or C) when fludarabine is not appropriate. As monotherapy for indolent non-Hodgkin's lymphoma (NHL) that has progressed during or within 6 months of rituximab treatment. With prednisone for multiple myeloma (Durie-Salmon stage II with progress or stage III) in patients>65 years age who are not eligible for autologous stem cell transplantation, thalidomide or bortezomib.
Dosage
All by IV inf over 30-60 min. Adults: CLL: 100 mg/m² on days 1 and 2 of 4-wk cycle. NHL: 120 mg/m² on days 1 and 2 of 3-wk cycle. Multiple myeloma: 120-150 mg/m² on day 1 and 2 of 4 wk cycle, with prednisone. Children: Not recommended.
Administration
Once diluted, the final admixture is stable for 24 hours under refrigeration, or 3 hours at room temperature and room light. Administration of bendamustine must be completed within this period. Administer Bendamustine via IV infusion over 60 min for NHL or over 30 min for CLL. Reconstitution: Aseptically reconstitute each Bendamustine vial as follows: For the 25 mg add 5 mL and for the 100 mg add 20 mL SWFI respectively to get the concentration of 5 mg/mL. Aseptically withdraw the volume needed for the required dose and immediately transfer to a 500 mL infusion bag of NaCl 0.9%. As an alternative to NaCl 0.9%, a 500 mL infusion bag of dextrose 2.5% and NaCl 0.45% may be considered. The resulting final concentration of bendamustine in the infusion bag should be within 0.2 to 0.6 mg/mL. The reconstituted solution must be transferred to the infusion bag within 30 min of reconstitution.
Adverse Effects
Severe skin reactions. Infections, tumour lysis syndrome, blood dyscrasias, haemorrhage, insomnia, cardiac disorders, skin reactions, amenorrhoea, hypotension, hypertension, pulmonary dysfunction, GI upset, fever, chills, fatigue, pain, dehydration, anorexia, mucosal inflammation, increased LFTs, hypokalaemia, decreased haemoglobin, increased creatinine, increased urea.
Risk Factor (Pregnancy/Lactation)
Pregnancy: Risk cannot be ruled out. Lactation: Contraindicated or not recommended. Contraindications: Infections. Severe hepatic impairment, jaundice, severe bone marrow suppression, severe blood count alterations (leukocytes <3000 per microlitre and/or platelets <75000 per microlitre), major surgery within previous 30 days. Precautions: Ensure contraceptive measures by both male and female patients during and for up to 6 months after treatment. Risk of irreversible infertility in men. Moderate hepatic impairment, severe renal impairment (CrCl<10 mL/min), cardiac disorders. Monitor blood counts, K+ levels. If myelosuppression occurs, monitor at least weekly and advise patients to report any signs of infection; ensure leukocytes >4000 per microlitre and/or platelets >100000 per microlitre before next treatment cycle.
Interactions
Myelosuppressive agents, cyclosporin, tacrolimus, CYP1A2 inhibitors, live vaccines.
Advice to Patient
If medication accidentally comes in contact with skin, wash it off right away with soap and water. If a dose is missed, inform prescriber immediately. Contact prescriber if there is high fever, severe nausea, vomiting and diarrhoea, black or dark coloured stools, blood in urine, difficulty and pain on urination, severe skin rash or itching, yellowing of the skin or eyes, dry mouth, tiredness, loss of appetite, dizziness, decreased amount of urine, severe thirst. Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials.
Pharmacokinetics
Metabolism: Hepatic. Half-life elimination: Bendamustine: Approx. 40 mins. M3: Approx. 3 hrs. M4: Approx. 30 mins. Excretion: Urine (approx. 50%). Faeces (approx. 25%).
Brands with this active ingredient
Compiled by Healify Pharmacy from published drug references. How we compile it →
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