Highlights of prescribing information skin reactions. Pulmonary toxicity in a clinical investigation using fludarabine phosphate injection in combination with pentostatin deoxycoformycin for the treatment of refractory chronic lymphocytic leukemia cll in adults, there was an unacceptably high incidence of fatal pulmonary. Bendamustine was approved by the united states fda in march 2008 for the treatment of cll, based on a phase iii study comparing bendamustine and chlorambucil as firstline therapy for. Treanda bendamustine hydrochloride for injection, for intravenous infusion. The onset of symptoms usually occurs within minutes to hours of receiving a new or a greater. Full prescribing information 1 indications and usage mayzent is indicated for the treatment of relapsing forms of multiple sclerosis ms, to include clinically isolated syndrome. Learn more about bendeka bendamustine hcl injection. Bendeka bendamustine hydrochloride injection is indicated for the treatment of patients with indolent bcell nonhodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximabcontaining regimen. Patients treated is based on the pbrer report of patient exposure, which was calculated based on the global total milligram volume sales. No other diluents have been shown to be compatible. The recommended dose of bendamustine is 90 mgm day on day 1 and 2 when administered with polivy and a rituximab product.
Severe mucocutaneous reactions, some with fatal outcomes 5. Bendeka bendamustine hydrochloride injection, for intravenous use initial u. After transferring, thoroughly mix the contents of the infusion bag. Patients treated is based on the pbrer report of patient exposure, which was calculated based on the global total milligram volume sales divided by the average dose per patient per year, based on us approved indications. Women should ask about reliable forms of birth control while using this medication. Monitor closely and restart treatment based on anc and platelet count recovery. Retain the partially used vial in original package to protect from light and store refrigerated 2 to 8c or 36 to 46f if additional dose withdrawal from the same vial is intended. Bendeka is indicated for the treatment of patients with a chronic lymphocytic leukemia cll. The lyophilized powder should completely dissolve in 5 minutes. Monitor patients and discontinue rituxan infusion for severe reactions 5.
Only the preservative free formulation of methotrexate injection, usp may be administered by the intrathecal route. The efficacy of bendamustine in patients with relapsed indolent bcell nhl is based on overall response. Highlights of prescribing information these highlights do not. Fatal infusionrelated reactions within 24 hours of rituxan infusion. A burning sensation where the infusion needle is inserted may be a sign of. The resulting fina l concentration of bendamustine hcl in the infusion bag should be within 0.
Highlights of prescribing information central nervous. The resulting final concentration of bendamustine hydrochloride in the infusion bag should be within 1. Bendeka bendamustine hydrochloride injection is indicated for the treatment of patients with indolent bcell nonhodgkin lymphoma that has progressed during or within six months of. Bendeka is not right for everyone, including patients with a known allergic response to bendamustine, polyethylene glycol 400, propylene glycol, or monothioglycerol. Dailymed vinblastine sulfate vinblastine sulfate injection. The recommended dose of rituximab product is 375 mgm. Preclinical radiolabeled bendamustine studies showed that approximately 90% of drug administered was recovered in excreta primarily in the feces. Bendamustine does not contain chromophores that absorb at wavelengths 290 nm2 and therefore is not expected to be susceptible to direct photolysis by sunlightsrc. Hepatotoxicity see full prescribing information for complete boxed warning. The nccn compendium is a derivative work of the nccn guidelines. Administer polivy, bendamustine, and rituximab product in any order on day 1 of each cycle. Bendamustine hydrochloride injection is a clear and colorless to yellow solution.
Bendeka is contraindicated in patients with a history of a hypersensitivity reaction to bendamustine, polyethylene glycol 400. No mean changes greater than 20 milliseconds were detected. Bendeka bendamustine hcl injection information for patients. Dosing and administration bendeka bendamustine hcl injection. In combination with chemotherapy followed by gazyva monotherapy in patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage ii bulky, iii or iv follicular lymphoma fl. Aseptically withdraw the volume needed for the required dose based on 5 mgml concentration and immediately transfer to a 500.
Gazyva obinutuzumab is a prescription medicine used with the chemotherapy drug, bendamustine, followed by gazyva alone for follicular lymphoma fl in adults who did not respond to a rituximabcontaining regimen, or whose fl returned after such treatment. Ninlaro ixazomib capsules, for oral use hepatotoxicity. Bendeka bendamustine hydrochloride injection is indicated for the treatment of patients with chronic lymphocytic leukemia. Treanda for injection singleuse vial containing 100 mg of bendamustine hcl as white to offwhite lyophilized powder. Highlights of prescribing information these highlights do not include all the information needed to use votrient safely and effectively. Infusion reactions and cardiopulmonary arrest 1 indications and usage 1. Rituxan rituximab for ra, nhl, cll, gpa, mpa, and pv.
Efficacy relative to first line therapies other than chlorambucil has not been established. Dailymed bendeka bendamustine hydrochloride injection. Highlights of prescribing information palmarplantar. The admixture should be a clear, and colorless to yellow solution. Product characteristics for bendeka and treanda bendamustine. Bendeka fda prescribing information, side effects and uses. Gazyva, in combination with chemotherapy followed by gazyva monotherapy in patients. Highlights of prescribing information these highlights do not include all the information needed to use angiomax safely and effectively. After a single dose of 120 mgm2 bendamustine iv over 1hour the intermediate t12 of the parent compound is approximately 40 minutes. Jul 05, 2018 this phase 12 study evaluated the combination of brentuximab vedotin bv plus bendamustine as a first salvage regimen in relapsedrefractory hl.
In combination with chemotherapy followed by gazyva. If previously receiving 60 mg daily dose, resume treatment at 40 mg daily. Highlights of prescribing information these highlights do not include all the information needed to use cancidas safely and effectively. Your doctor should order a pregnancy test before you start this medication. Treanda bendeka belrapzo bendamustine treanda bendeka belrapzo fep clinical rationale the safety and effectiveness of these medications in patients less than 18 years of. Jan 01, 2020 the effect of bendamustine on the qtc interval was evaluated in 53 patients with indolent nhl and mantle cell lymphoma on day 1 of cycle 1 after administration of rituximab at 375 mgm 2 intravenous infusion followed by a 30minute intravenous infusion of bendamustine at 90 mgm 2 day. Full prescribing information 1 indications and usage mayzent is indicated for the treatment of relapsing forms of multiple sclerosis ms, to include clinically isolated syndrome, relapsingremitting disease, and active secondary progressive disease, in adults. Bendamustine hydrochloride for injection prescribing information. Highlights of prescribing information macular edema. Methotrexate injection, usp is sterile and nonpyrogenic and may be given by the intramuscular, intravenous, intraarterial or intrathecal route. The reconstituted solution must be transferred to the infusion bag within 30. Assure good venous access prior to starting bendeka infusion and monitor the intravenous infusion site for redness, swelling, pain, infection, and necrosis during and after. Bendamustine hydrochloride is an alkylating drug indicated for treatment of.
Bendeka is not right for everyone, including patients with a known allergic response to. Gazyva dosing and administration guide indications gazyva is a cd20directed cytolytic antibody and is indicated. Cases of stevensjohnson syndrome sjs and ten, some fatal, have been reported when treanda was administered concomitantly with allopurinol and other medications known to cause these syndromes. If particulate matter is observed, the reconstituted product should not be used. Bendamustine is a bifunctional mechlorethamine derivative containing a purine like. Ten has been reported for rituximab see rituximab package insert. Efficacy relative to firstline therapies other than chlorambucil has not been established or a indolent bcell nonhodgkin lymphoma nhl that has progressed during or within six months of treatment with rituximab or a rituximabcontaining regimen. Treanda bendamustine hydrochloride injection, for intravenous use. May 01, 2019 bendamustine hydrochloride injection is a multipledose vial. Bendamustine for treatment of chronic lymphocytic leukemia.
Highlights of prescribing information total car these. A total of 55 patients 28 primary refractory and 27 relapsed were enrolled. Information for the user bendamustine hydrochloride 2. Eagle pharmaceuticals, inc bendamustine hydrochloride. The indications below including fdaapproved indications and. Stability of partially used vials needle punched vials. Tls is caused by the fast breakdown of cancer cells. Vinblastine sulfate is the salt of an alkaloid extracted from vinca rosea linn. Bendeka is indicated for the treatment of patients with chronic lymphocytic leukemia cll or indolent bcell nonhodgkin lymphoma nhl that has progressed during or within six months of treatment with rituximab or a rituximabcontaining regimen. The admixture should be a clear and colorless to slightly yellow solution. Bendamustine injection fda prescribing information, side. Bendamustine hcl extravasations have been reported in postmarketing resulting in hospitalizations from erythema, marked swelling, and pain.
It is not commonly given with the goal of cure, but to put the lymphoma in remission and keep it in remission for months to even years. Bendamustine was approved by the united states fda in march 2008 for the treatment of cll, based on a phase iii study comparing bendamustine and chlorambucil as firstline therapy for cll. Highlights of prescribing information infusionrelated. Bendamustine clearance in humans is approximately 700 mlminute. Follow applicable special handling and disposal procedures. Store bendamustine hydrochloride injection at recommended refrigerated storage conditions 2 to 8c or 36 to 46f. Only the preservative free formulation of methotrexate injection.
The onset of symptoms usually occurs within minutes to hours of receiving a new or a greater dose of a serotonergic medication. Rituxan can cause serious and lifethreatening side effects, including. Sections or subsections omitted from the full prescribing information are not listed. Bendamustine hydrochloride injection is a cytotoxic drug. Jan 14, 2020 120 mgm 2 infused intravenously over 10 minutes on days 1 and 2 of a 21day cycle, up to 8 cycles. Treanda bendamustine hydrochloride for injection fda. Treanda 100 mg lyophilized powder in a singledose vial for reconstitution. See full prescribing information for complete boxed warning. Gazyva, in combination with bendamustine followed by gazyva monotherapy, is indicated for the treatment of patients with follicular lymphoma who relapsed after, or are refractory to, a rituximab containing regimen see clinical studies 14. Tls can cause you to have kidney failure and the need for dialysis treatment or may cause an abnormal heart rhythm.
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