BENDAMUSTINE HCl
BENDAMUSTINE HCl · by ATCO
Composition
lnj 100 mg: Bendamustine HCl 100 mg as lyophilized powder
Indications & Dosage
Chronic Lymphocytic Leukemia (CLL): BY IV INF: Adult: 100 mg/m2 administered intravenously over 30 minutes on days 1 and 2 of a 28-day cycle, up to 6 cycles. Non-Hodgkins Lymphoma (NHL): BY IV INF: Adult: 120 mg/m2 administered intravenously over 60 minutes on Days 1 and 2 of a 21-day cycle, up to 8 cycles.
Administration
Reconstitute each 100 mg vial with 20 ml of only Sterile Water for Injection, USP. Shake well to yield a clear, colorless to a pale-yellow solution with a bendamustine HCl concentration of 5 mg/ml. If particulate matter is observed, the reconstituted product should not be used. Withdraw the volume needed for the required dose (based on 5 mg/mL concentration) and immediately transfer to a 500 ml infusion bag of 0.9% Sodium Chloride Injection, USP (normal saline). The resulting final concentration of bendamustine HCl in the infusion bag should be within 0.2 - 0.6 mg/ml. No other diluents have been shown to be compatible. Any unused solution should be discarded
Compatibility
Stable in NS, 0.9% Sodium Chloride Injection, USP (normal saline), 2.5% Dextrose/0.45% Sodium Chloride Injection,
Stability
Stored up to 25 C (77 F) with excursions permitted up to 30 C (86 F). Retain in original package until time of use to protect from light
Contraindications
Anaphylactic and anaphylactoid reactions to the drug
Precautions
Myelosuppression; monitor leukocytes, platelets, hemoglobin (Hgb), and neutrophils closely. Infection, including pneumonia and sepsis, infusion reactions and anaphylaxis; monitor clinically and discontinue drug for severe reactions. Tumor Lysis Syndrome may lead to acute renal failure; close monitoring of blood chemistry, particularly potassium and uric acid levels, and the use of allopurinol in patients at high risk. pre-malignant and other malignant diseases.
Pregnancy
Positive evidence of harm: Avoid
Lactation
Contraindicated. Discontinue breast-feeding
Side Effects
Abdominal pain and distension, nausea, vomiting, diarrhea, constipation, stomatitis, dyspepsia, GI reflux disease, fatigue, pyrexia, chills, edema peripheral, asthenia, chest pain, tachycardia, herpes zoster, upper respiratory tract infection, urinary tract infection, sinusitis, pneumonia, febrile neutropenia, oral Candidiasis, nasopharyngitis, anorexia, decreased appetite, hypokalemia, back pain, arthralgia, pain in extremity, headache, dizziness, dysgeusia, insomnia, anxiety, depression, cough, dyspnea, pharyngolaryngeal pain, wheezing, nasal congestion,skin rash, pruritus, hyperhidrosis, hypotension. Decreased hemoglobin, platelets, leukocytes, lymphocytes and neutrophils.