Bendared Dosage/Direction for Use

For intravenous infusion over 30-60 minutes.
Infusion must be administered under the supervision of a physician qualified and experienced in the use of chemotherapeutic agents.
Poor bone marrow function is related to increased chemotherapy-induced haematological toxicity. Treatment should not be started if leukocyte and/or platelet values have dropped to <3,000/μl or <75,000/μl, respectively (see Contraindications).
Monotherapy for chronic lymphocytic leukaemia: 100 mg/m² body surface area bendamustine hydrochloride on days 1 and 2; every 4 weeks.
Monotherapy for indolent non-Hodgkin's lymphomas refractory to rituximab: 120 mg/m² body surface area bendamustine hydrochloride on days 1 and 2; every 3 weeks.
Treatment should be terminated or delayed if leukocyte and/or platelet values drop to <3000/μL or <75000/μL, respectively. Treatment can be continued after leukocyte values have increased to >4000/μL and platelet values to >100000/μL.
The leukocyte and platelet nadir is reached after 14-20 days with regeneration after 3-5 weeks. During therapy free intervals strict monitoring of the blood count is recommended (see Precautions).
In case of non-hematological toxicity, dose reductions have to be based on the worst common toxicity criteria (CTC) grades in the preceding cycle. A 50% dose reduction is recommended in case of CTC grade 3 toxicity. An interruption of treatment is recommended in case of CTC grade 4 toxicity.
If a patient requires a dose modification, the individually calculated reduced dose must be given on day 1 and 2 of the respective treatment cycle.
Hepatic impairment: On the basis of pharmacokinetic data, no dose adjustment is necessary in patients with mild hepatic impairment (serum bilirubin <1.2 mg/dL). A 30% dose reduction is recommended in patients with moderate hepatic impairment (serum bilirubin 1.2-3.0 mg/dL).
No data are available in patients with severe hepatic impairment (serum bilirubin values of >3.0 mg/dL) (see Contraindications).
Renal impairment: On the basis of pharmacokinetic data, no dose adjustment is necessary in patients with a creatinine clearance of >10 mL/min. Experience in patients with severe renal impairment is limited.
Pediatric patients: As there are limited data, the safety and efficacy of bendamustine in pediatric patients has not been established.
Elderly patients: There is no evidence that dose adjustments are necessary in elderly patients (see Pharmacology: Pharmacokinetics under Actions).
Method of administration: For intravenous infusion over 30-60 minutes.
Infusion must be administered under the supervision of a physician qualified and experienced in the use of chemotherapeutic agents.
Precautions to be taken before handling or administering the medicinal product.