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Bendamustine (Bendamustine) instructions
Common name: Bendamustine
Trade name: Treanda
Full names: Bendamustine, Treakisym, Belrapzo, Bendeka, Bendamustine, Treanda, BENDIT, Leuben
Indications:
Chronic lymphocytic leukemia (CLL)
Non-Hodgkin lymphoma (NHL)
Multiple myeloma
Usage and dosage:
Bendamustine can be used alone (monotherapy) or in combination with other drugs, and is injected into the vein at different doses for 30-60 minutes.
Treatment of CLL: 100mg/㎡ intravenous infusion, infusion time over 30 minutes, medication on the 1st and 2nd days, one course of treatment every 28 days, 6 courses of treatment.
Treatment of NHL: 120mg/㎡ intravenous infusion, the infusion time should be more than 60 minutes, medication is used on the 1st and 2nd days, 21 days is a course of treatment, and a total of 8 courses of treatment are carried out.
Multiple myeloma: 1. Bendamustine is infused intravenously at 120-150 mg/㎡ on days 1 and 2 (based on height and weight) 2. Prednisone is infused intravenously at 60 mg/㎡ on days 1-4 (based on height and weight) 3. Repeat the cycle at least 6 times after 3 weeks.
Adverse reactions:
>10%:
Cardiovascular diseases: peripheral edema (13%)
Central nervous system: fatigue (9%-57%), headache (21%), dizziness (14%), chills (6%-14%), insomnia (13%)
Skin diseases: rash (8%-16%)
Internal division Secretion and metabolism: weight loss (7%-18%), dehydration (14%)
Gastrointestinal tract: nausea (20%-75%), vomiting (16%-40%), diarrhea (9%-37%) ), constipation (29%), anorexia (23%), stomatitis (15%; grade 3/4: <1%), abdominal pain (13%), decreased appetite (13%), indigestion (11%)
Hematology and Oncology: Lymphopenia (68%-99%; grade 3/4: 47%-94%), myelosuppression (grade 3/4: 98%), leukopenia (61%-94%; 3/ Grade 4: 28%-56%), hemoglobin decrease (88%-89%; Grade 3/4: 11%-13%), neutropenia (75%-86%; Grade 3/4: 43%-6 0%), thrombocytopenia (77%-86%; grade 3/4: 11%-25%)
Liver: elevated serum bilirubin (34%)
Neuromuscular and skeletal: back pain (14%), fatigue (8%-11%)
Respiratory: cough (4%-22%), dyspnea (16%)
Others: fever (24%-34%)
1% -10%:
Cardiovascular diseases: fast heartbeat (7%), chest pain (6%), low blood pressure (6%), exacerbation of high blood pressure (3%)
Central nervous system: anxiety (8%), depression (6%), pain (6%)
Skin diseases: itching (5%-6%), hyperhidrosis (5%), night sweats (5%), xeroderma (5%)
Endocrinology and metabolism: hypokalemia (9%), hyperuricemia (7%), hyperglycemia (grade 3/4: 3%), hypocalcemia (grade 3/4: 2%), hyponatremia (grade 3/4: 2%)
Gastrointestinal tract: gastroesophageal reflux disease (10%), xerostomia (9%) , loss of appetite (7%), oral candidiasis (6%), abdominal distension (5%), epigastric pain (5%)
Genitourinary system: urinary tract infection (10%)
Hematology and tumors: febrile neutropenia (grade 3/4: 6%)
Liver: elevated serum alanine aminotransferase (grade 3/4: 3%), elevated serum aspartate aminotransferase (Grade 3/4: 1%)
Hypersensitivity: Anaphylaxis (5%)
Infections: Herpes zoster infection (10%), infection (6%), herpes simplex infection (3%)
Local reactions: Infusion site pain (6%), catheter pain (5%)
Neuromuscular and skeletal: Arthralgia (6%), limb pain (5%), bone pain (5%)
Kidneys: Elevated serum creatinine (Grade 3/4: 2%)
Respiratory system: Upper respiratory tract infection (10%), sinusitis (9%), sore throat (8%), pneumonia (8%), nasopharyngitis (6%-7%), nasal congestion (5%), wheezing (5%)
Undefined frequency:< br>Central nervous system: drowsiness, malaise
Skin disorders: dermatitis, skin necrosis
Gastrointestinal tract: mucositis
Hematology and neoplasms: hemolysis
<1%:
Post-marketing or case reports:
Acute renal failure, anaphylactic shock, anaphylaxis, atrial fibrillation, bronchial carcinoma, bullous rash, heart failure, dermatological reactions (toxicity), DRESS Syndrome, erythema, extravasation injury, hepatitis, hepatotoxicity, injection site reaction, myelodysplastic syndrome, myeloid leukemia (acute), myocardial infarction, neutropenic sepsis
Contraindications:
Allergic to bendamustine or any ingredient in the preparation.
Precautions:
Myelosuppression: Myelosuppression (neutropenia, thrombocytopenia, and anemia) is a common toxicity; treatment delay or dose reduction may be necessary; frequent monitoring of blood counts (nadir usually occurs during the third week of treatment). Complications from febrile neutropenia and severe thrombocytopenia, some of which are fatal, have been reported. Before cycling begins, ANC should return to ≥1000/mm³ and platelets should return to ≥75000/mm³.
Skin Toxicity: Serious and fatal skin toxicities have been reported, including Stevens-Johnson syndrome and toxic epidermal necrosis, drug reactions with eosinophilia and systemic symptoms, bullous rash, and rash. Persistent skin reactions or exacerbations may occur following monotherapy and combination therapy with other antineoplastic agents. Concomitant use of allopurinol with other drugs known to cause skin toxicity may increase the risk of serious skin toxicity. Monitor closely for skin toxicity. For severe or progressive skin reactions, discontinue treatment.
Extravasation: Bendamustine is an irritant; ensure proper needle or catheter placement before and during infusion; avoid extravasation. After extravasation, erythema, obvious swelling or pain will appear.
Gastrointestinal Toxicity: Bendamustine is associated with moderate vomiting; antiemetics are recommended to prevent nausea and vomiting.
Hepatotoxicity: Cases of serious and fatal liver injury have been reported, usually within the first 3 months of starting treatment. Confounding factors in some patients included combination therapy, progressive disease, or hepatitis B reactivation. Monitor liver function.
Allergic or infusion reactions: Common infusion reactions include chills, fever, itching, and rash.
Hypokalemia: Hypokalemia has been reported; monitor potassium closely in patients with cardiac disease.
Secondary Malignancies: Cases of malignancies (including myelodysplastic syndrome, myelodysplasia, acute myeloid leukemia, and bronchial carcinoma) and precancerous lesions have been reported in patients receiving bendamustine.
Oncolytic syndrome: It can cause acute renal failure and even death. It is necessary to predict the symptoms and provide symptomatic and supportive treatment.
Fetal Toxicity: Based on data from mechanism of action and animal reproduction studies, in utero exposure to bendamustine may cause harm to the fetus.
Storage:
Storage temperature should not exceed 30℃, and should be protected from light.
Mechanism of action:
Bendamustine is a bifunctional alkylating agent with anti-tumor and cytocidal effects. The main mechanism of the anti-tumor and cell-killing effect of this product is the cross-linking of DNA single and double strands through alkylation, which disrupts the function of DNA and DNA synthesis, and also causes cross-linking between DNA and proteins, and between proteins and proteins, thereby exerting anti-tumor effects.