Alternate Name(s):
TREANDA, CYTOSTASAN HYDROCHLORIDE, SDX-105
Classification:
Alkylating agent, Antineoplasic - CYTOTOXIC
Original Date:
September 2017
Indications:
- Relapsed indolent B-cell non-Hodgkin Lymphoma (NHL) patients who did not respond to or progressed during or shortly following treatment with a rituximab regimen.
- Symptomatic chronic lymphocytic leukemia (CLL) patients who have received no prior treatment.
THIS MEDICATION IS TO BE ADMINISTERED BY A CHEMO-TRAINED NURSE. IF THE NURSE IS NOT CHEMO-TRAINED, THEY ARE TO CONTACT THE UNIT NURSE EDUCATOR OR ADVANCED PRACTICE NURSE.
Reconstitution and Stability:
- Available as a Lyophilized powder, 25 mg/vial and 100 mg/vial. Store at 2-25C. Protect from light. Keep in original packaging.
- Reconstitute 25 mg vial with 5 mL sterile water for injection and 100 mg vial with 20 mL sterile water for injection to a final concentration of 5 mg/mL
- Shake well to yield a clear, colourless to a pale yellow solution.
- Lyophilized powder should dissolve within 5 minutes.
- Do not use if particulate matter is observed. - Further dilute to a final concentration of 0.2-0.6 mg/ml in 0.9%NaCl
- Reconstituted solution must be transferred to the infusion bag within 30 minutes of reconstitution
- After transferring, thoroughly mix the contents of the infusion bag.
- The admixture should be a clear and colorless to slightly yellow solution. - The prepared IV bag must be infused within 3 hours if stored at room temperature, or 24h if stored in fridge.
Compatibility:
-Solution Compatible: 0.9% NaCl
-Additives/Above Cassette Compatible: Do not mix with other drugs or IV solutions
-Y-site Compatible: Do not run with other drugs
Administration:
(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)
| SC | NO |
| IM | NO |
| IV Direct | NO |
| IV Intermittent Infusion | YES - over 60 minutes for NHL |
| IV Continuous Infusion | NO |
Dosage:
(For neonatal dosages, refer to Neonatal IV Drug Manual.)
Relapse/refractory NHL
- 60 – 120 mg/m2 IV on Day 1 and Day 2 of a 21-day cycle, up to 8 cycles
- Various dose regimen and dose modifications available, refer to protocol.
Potential hazards of parenteral administration:
- Emetogenic Potential: Moderate
- Extravasation Potential: Irritant
- Common (greater than 20%): nausea, vomiting, fatigue, myelosuppression, diarrhea, fever, chills, constipation, anorexia, weight loss, headache and mucositis.
- Occasional (less than or equal to 20%): arrhythmia, hypertension (may be severe), abdominal pain, dizziness, insomnia, mood changes, dyspepsia, fluid retention, infusion reaction, electrolyte abnormalities (hypoK, hypoMg), cough, dyspnea, rash & pruritus (may be severe).
- Rare, but serious (less than 3%): anaphylaxis and anaphylactoid reactions, cardiotoxicity, QT interval prolongation, sudden death, increase LFTs (grade 3-4), tumor lysis syndrome, secondary malignancy, renal failure, toxic skin reactions [Stevens - Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS)], bullous exanthema.
Notes:
- Bendamustine metabolite may possibly inhibit and/or induce CYP 1A2 leading to potential for drug interactions. Limited patient data available. Please consult oncology pharmacy for concerns with drug interactions.
- Premedication is generally not required unless patient has previously experienced an infusion-related reaction to bendamustine
- Subsequent infusions should be discontinued or given with premedication depending on the severity of the reaction
- Use with caution in patients with renal impairment (CrCL 40-80 ml/min). Do not use if CrCl is under 40 ml/min.
- Electrolytes abnormalities and hypertension should be corrected before start of treatment.
- Concomitant use with allopurinol may increase risk of severe toxic skin reactions.
- Skin reactions may be progressive and increase in severity during treatment. Patients with skin reactions should be monitored closely.
References:
- Drug Monograph: Treanda® (bendamustine). Lundbeck Canada Inc, February 2017.
- Cancer Care Ontario Monograph. Bendamustine. April 2017.