Only the preservative free formulation of methotrexate injection, usp may be administered by the intrathecal route. Dailymed bendeka bendamustine hydrochloride injection. 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 injection is a clear and colorless to yellow solution. 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. Gazyva dosing and administration guide indications gazyva is a cd20directed cytolytic antibody and is indicated. The admixture should be a clear and colorless to slightly yellow solution. Monitor patients and discontinue rituxan infusion for severe reactions 5. After transferring, thoroughly mix the contents of the infusion bag. 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. Tls is caused by the fast breakdown of cancer cells. The resulting fina l concentration of bendamustine hcl in the infusion bag should be within 0. Hepatotoxicity see full prescribing information for complete boxed warning.
Administer polivy, bendamustine, and rituximab product in any order on day 1 of each cycle. Highlights of prescribing information total car these. If particulate matter is observed, the reconstituted product should not be used. Methotrexate injection, usp is sterile and nonpyrogenic and may be given by the intramuscular, intravenous, intraarterial or intrathecal route. Treanda for injection singleuse vial containing 100 mg of bendamustine hcl as white to offwhite lyophilized powder. Bendamustine hydrochloride is an alkylating drug indicated for treatment of. May 01, 2019 bendamustine hydrochloride injection is a multipledose vial. Jul 05, 2018 this phase 12 study evaluated the combination of brentuximab vedotin bv plus bendamustine as a first salvage regimen in relapsedrefractory hl.
Bendeka is contraindicated in patients with a history of a hypersensitivity reaction to bendamustine, polyethylene glycol 400. If previously receiving 60 mg daily dose, resume treatment at 40 mg daily. Treanda 100 mg lyophilized powder in a singledose vial for reconstitution. The nccn compendium is a derivative work of the nccn guidelines. Fatal infusionrelated reactions within 24 hours of rituxan infusion.
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. A total of 55 patients 28 primary refractory and 27 relapsed were enrolled. 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. No other diluents have been shown to be compatible. Learn more about bendeka bendamustine hcl injection. 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. Bendeka bendamustine hcl injection information for patients. Stability of partially used vials needle punched vials. Highlights of prescribing information palmarplantar. Votrient pazopanib tablets, for oral use initial u. Highlights of prescribing information macular edema. Bendamustine clearance in humans is approximately 700 mlminute.
The recommended dose of bendamustine is 90 mgm day on day 1 and 2 when administered with polivy and a rituximab product. Ninlaro ixazomib capsules, for oral use hepatotoxicity. Your doctor should order a pregnancy test before you start this medication. See full prescribing information for complete boxed warning. Bendeka is not right for everyone, including patients with a known allergic response to bendamustine, polyethylene glycol 400, propylene glycol, or monothioglycerol. The onset of symptoms usually occurs within minutes to hours of receiving a new or a greater dose of a serotonergic medication. Highlights of prescribing information these highlights do not include all the information needed to use cancidas safely and effectively. Aseptically withdraw the volume needed for the required dose based on 5 mgml concentration and immediately transfer to a 500. 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. Highlights of prescribing information these highlights do not include all the information needed to use votrient safely and effectively.
Severe mucocutaneous reactions, some with fatal outcomes 5. No mean changes greater than 20 milliseconds were detected. Rituxan rituximab for ra, nhl, cll, gpa, mpa, and pv. 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. 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. Highlights of prescribing information these highlights do. Bendeka bendamustine hydrochloride injection is indicated for the treatment of patients with chronic lymphocytic leukemia. The recommended dose of rituximab product is 375 mgm. Patients treated is based on the pbrer report of patient exposure, which was calculated based on the global total milligram volume sales. Women should ask about reliable forms of birth control while using this medication.
Highlights of prescribing information skin reactions. The reconstituted solution must be transferred to the infusion bag within 30. Eagle pharmaceuticals, inc bendamustine hydrochloride. 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. 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. Highlights of prescribing information these highlights do not. Bendeka fda prescribing information, side effects and uses. After a single dose of 120 mgm2 bendamustine iv over 1hour the intermediate t12 of the parent compound is approximately 40 minutes. A burning sensation where the infusion needle is inserted may be a sign of. 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. Only the preservative free formulation of methotrexate injection.
Bendeka is not right for everyone, including patients with a known allergic response to. Bendamustine injection fda prescribing information, side. Gazyva, in combination with chemotherapy followed by gazyva monotherapy in patients. Infusion reactions and cardiopulmonary arrest 1 indications and usage 1. The admixture should be a clear, and colorless to yellow solution. Dailymed vinblastine sulfate vinblastine sulfate injection. 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. Bendeka is indicated for the treatment of patients with a chronic lymphocytic leukemia cll. Bendamustine for treatment of chronic lymphocytic leukemia. 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. Tls can cause you to have kidney failure and the need for dialysis treatment or may cause an abnormal heart rhythm.
Highlights of prescribing information central nervous. The resulting final concentration of bendamustine hydrochloride in the infusion bag should be within 1. Bendamustine hydrochloride injection is a cytotoxic drug. Bendamustine does not contain chromophores that absorb at wavelengths 290 nm2 and therefore is not expected to be susceptible to direct photolysis by sunlightsrc. Highlights of prescribing information infusionrelated. Product characteristics for bendeka and treanda bendamustine. 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. Bendamustine hydrochloride for injection prescribing information. The lyophilized powder should completely dissolve in 5 minutes. Treanda bendeka belrapzo bendamustine treanda bendeka belrapzo fep clinical rationale the safety and effectiveness of these medications in patients less than 18 years of.
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. The efficacy of bendamustine in patients with relapsed indolent bcell nhl is based on overall response. Dosing and administration bendeka bendamustine hcl injection. Ten has been reported for rituximab see rituximab package insert. Sections or subsections omitted from the full prescribing information are not listed. Bendamustine is a bifunctional mechlorethamine derivative containing a purine like. Monitor closely and restart treatment based on anc and platelet count recovery. Vinblastine sulfate is the salt of an alkaloid extracted from vinca rosea linn.
Bendeka bendamustine hydrochloride injection, for intravenous use initial u. In combination with chemotherapy followed by gazyva. Preclinical radiolabeled bendamustine studies showed that approximately 90% of drug administered was recovered in excreta primarily in the feces. Highlights of prescribing information these highlights do not include all the information needed to use angiomax safely and effectively. Bendamustine hcl extravasations have been reported in postmarketing resulting in hospitalizations from erythema, marked swelling, and pain. The indications below including fdaapproved indications and. 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. Store bendamustine hydrochloride injection at recommended refrigerated storage conditions 2 to 8c or 36 to 46f. Information for the user bendamustine hydrochloride 2. Follow applicable special handling and disposal procedures. Treanda bendamustine hydrochloride injection, for intravenous use. Rituxan can cause serious and lifethreatening side effects, including. Treanda bendamustine hydrochloride for injection fda.