Ribomustin Infusion
Bendamustine
25mg
ASTELLAS PHARMA GmbH
| Pack size | 5 Vials |
|---|---|
| Dispensing mode | POM |
| Source | GERMANY |
| Agent | PHARMATRADE |
| Retail Price | 2318.50 AED |
Available as:
Indications
Ribomustin Infusion is used for:
Chronic lymphocytic leukaemia, Non-hodgkin's lymphoma, Multiple myeloma
Adult Dose
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
Child Dose
Renal Dose
Renal Impairment
Mild-to-moderate: Use caution
CrCl <40 mL/min: Not recommended
Administration
Contra Indications
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.
Precautions
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.
Pregnancy-Lactation
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
Interactions
May increase plasma levels w/ CYP1A2 inhibitors (e.g. ciprofloxacin, fluvoxamine). May reduce plasma levels w/ CYP1A2 inducers (e.g. omeprazole and tobacco smoking).
Adverse Effects
Side effects of Bendamustine :
>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.
Mechanism of Action
Bendamustine is an antineoplastic alkylating agent. It interferes w/ DNA replication and RNA transcription that leads to disruption of nucleic acid function. It is also active against inert and dividing cells.
Note
Ribomustin 25mg Infusion manufactured by ASTELLAS PHARMA GmbH. Its generic name is Bendamustine. Ribomustin is availble in United Arab Emirates.
Farmaco UAE drug index information on Ribomustin Infusion is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.