Medicine Overview of Bendamax 25mg/vial Injection
Bendamax is used to treat cancer of the lymphatic system such as Non-Hodgkin’s Lymphoma (NHL). It may also be used to treat other types of cancer as determined by your doctor. It can be used alone, or together with certain other medicines as part of combination chemotherapy.
Bendamax is given as an injection into vein under the supervision of a doctor and should not be self-administered. This will depend on what you are being treated for and may change from time to time. You should take it exactly as your doctor has advised. Taking it in the wrong way or taking too much can cause very serious side effects. It may take several weeks or months for you to see or feel the benefits but do not stop taking it unless your doctor tells you to.
The most common side effects of this medicine include anemia (low number of red blood cells), decreased white blood cell count, infection, fatigue, nausea, and vomiting. If these bother you or appear serious, let your doctor know. There may be ways of reducing or preventing them.
Inform your doctor if you have a medical history, of bleeding disorders, heart or liver disease, radiation treatment or any infection. Many other medicines can affect, or be affected by, this medicine so let your doctor know all medications you are using. This medicine is known to reduce the number of blood cells in your blood thereby, increasing the susceptibility to infections. Regular blood tests are required to check your blood cells along with kidney, liver and heart function during treatment with this medicine. The use of effective contraception by both males and females during treatment is important to avoid pregnancy.
- Non-Hodgkin's lymphoma
- Blood cancer
- Multiple myeloma
- Anemia (low number of red blood cells)
- Decreased white blood cell count
- Infection
- Fatigue
- Nausea
- Fever
- Vomiting
- Low blood platelets
- Mucosal inflammation
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Bendamax is given as an injection into vein under the supervision of a doctor.
Intravenous
Chronic lymphocytic leukaemia
Adult: 100 mg/m2 infused over 30-60 min on days 1 and 2 of a 28-day cycle for up to 6 cycles.
For severe haematological or non-haematological toxicity: Reduce dose to 50 mg/m2 on days 1 and 2 of each cycle. If severe haematological toxicity recurs, further reduce dose to 25 mg/m2 on days 1 and 2 of each cycle. May consider dose re-escalation in subsequent cycles.
Multiple myeloma
Adult: 120-150 mg/m2 infused over 30-60 min on days 1 and 2 of a 28-day cycle. IV or oral prednisone may be given at a dose of 60 mg/m2 on days 1-4 of the cycle.
Non-Hodgkin’s lymphoma
Adult: 120 mg/m2 infused over 30-60 min on days 1 and 2 of a 21-day cycle for up to 8 cycles. For severe haematological or non-haematological toxicity: Reduced to 90 mg/m2 on days 1 and 2 of each cycle. If severe toxicity recurs, further reduce dose to 60 mg/m2 on days 1 and 2 of each cycle.
Hepatic Impairment
Mild: Use caution
Moderate: Reduce dose by 30%.
Severe hepatic impairment: Use not recommended
Renal Impairment
Mild-to-moderate: Use caution
CrCl <40 mL/min: Not recommended
Patient w/ history of hypersensitivity (e.g. anaphylaxis and anaphylactoid reactions); jaundice, severe bone marrow suppression, low leukocyte or platelet count. Severe hepatic impairment. Major surgery <30 days prior to treatment.
Interrupt if severe infusion reactions
Mild-mod renal impairment, mild hepatic impairment
Possibility of anaphylactic/infusion reactions: severe in rare cases
Myelosuppression may occur; delay or reduce dose; restart treatment based on ANC and platelet count recovery; complications of myelosuppression may lead to death
Monitor for fever and other signs of infection and treat promptly
Severe infusion and anaphylactic reactions reported; monitor clinically and discontinue therapy; premedicate in subsequent cycles for milder reactions
Tumor lysis syndrome reported; acute renal failure and death may occur; anticipate and use supportive measures
Discontinue for severe skin reactions; cases of SJS and TEN, some fatal, reported when bendamustine was administered concomitantly with allopurinol and other medications known to cause these syndromes
Premalignant and malignant diseases reported
Erythema and maked swelling can occur with extravasation; assure good venous access and monitor infusion site during and after administration
Fetal harm can occur when administered to a pregnant woman; women should be advised to avoid becoming pregnant when receiving bendamustine
Increased risk for reactivation of infections including (but not limited to) hepatitis B, cytomegalovirus, Mycobacterium tuberculosis, and herpes zoster; patients should undergo appropriate measures (including clinical and laboratory monitoring, prophylaxis, and treatment) for infection and infection reactivation prior to administration
Lactation: It is not known whether this drug is excreted in milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
>10%
Lymphopenia (68-99%),Leukopenia (61-94%; grade 3/4, 28-56%),Anemia (88-89%; grades 3/4 11-13%),Thrombocytopenia (77-86%; grade 3/4, 11-25%),,Neutropenia (75-86%; grade 3/4, 43-60%),Nausea (20-75%),Fatigue (9-57%),Vomiting (16-40%),Diarrhea (9-37%),Bilirubin increased (<34%; grade 3/4, 3%),Constipation (<29%),Fever (24-34%),Pyrexia (24%),Anorexia (<23%),Cough (4-22%)Headache (<21%),Weight loss (7-18%),Dehydration (<16%),Rash (8-16%),Stomatitis (<15%),Back pain (<14%),Dizziness (<14%),Chills (6-14%),Peripheral edema (13%),Abdominal pain (5-13%),Insomnia (<13%),Dyspepsia (<11%),Weakness (8-11%)
1-10%
Upper respiratory infection (10%),Gastroesophageal reflux disease (<10%),Urinary tract infection (<10%),Xerostomia (9%),Hypokalemia (<9%),Anxiety (8%),Hyperuricemia (<7%),Tachycardia (<7%),Taste alteration (<7%),Arthralgia (<6%),Chest pain (<6%),Depression (<6%),Hypotension (<6%),Injection site pain (<6%),Pain (<6%),Pruritus (5-6%),Febrile neutropenia (3-6%),Rash (5%)
Potentially Fatal: Myelosuppression, tumour lysis syndrome which may lead to acute renal failure, infections (e.g. sepsis, pneumonia, septic shock), Stevens-Johnson syndrome, toxic epidermal necrolysis. Rarely, severe anaphylatic and anaphylactoid reactions.
Pregnancy
There are no available data on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes; advise pregnant women of potential risk to fetus
Pregnancy testing recommended for females of reproductive potential prior to initiation of therapy
Contraception
Therapy can cause embryo-fetal harm when administered to pregnant women;
advise female patients of reproductive potential to use effective contraception during treatment and for 6 months after final dose
Based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment with drug and for at least 3 months after final dose
Infertility
Based on findings from clinical studies, therapy may impair male fertility; impaired spermatogenesis, azoospermia, and total germinal aplasia have been reported in male patients treated with alkylating agents, especially in combination with other drugs; in some instances spermatogenesis may return in patients in remission, but this may occur only several years after intensive chemotherapy has been discontinued; advise patients of potential risk to their reproductive capacities
Based on findings from animal studies, drug may impair male fertility due to an increase in morphologically abnormal
Spermatozoa; the long-term effects of therapy on male fertility, including the reversibility of adverse effects, have not been studied
Animal data
In animal reproduction studies, intraperitoneal administration to pregnant mice and rats during organogenesis at doses 0.6-1.8 times the maximum recommended human dose (MRHD) resulted in embryo-fetal and/or infant mortality, structural abnormalities, and alterations to growth
Lactation
There are no data on presence of drug or metabolites in either human or animal milk, effects on breastfed child, or on milk production; because of potential for serious adverse reactions in breastfed child, advise patients that breastfeeding is not recommended during treatment and for at least 1 week after the last dose
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