Efficacy relative to firstline therapies other than chlorambucil has. Xenazine increases the risk for suicidality in patients with hd. Bendamustine for treatment of chronic lymphocytic leukemia. Toxic deaths, hepatotoxicity, neutropenia, hypersensitivity reactions, and fluid. Treanda bendamustine hydrochloride 05feb2010 1 of highlights of prescribing information these highlights do not include all the information needed to use treanda safely and effectively. Severe mucocutaneous reactions, some with fatal outcomes 5. In patients with untreated cll, the product monograph recommends an. Sections or subsections omitted from the full prescribing information are not listed. Treanda, bendeka, and belrapzo are bifunctional mechlorethamine. Dailymed treanda bendamustine hydrochloride injection. Diphtheria and tetanus toxoids and acellular pertussis.
Thus, canadian recommendations on the administration of bendamustine and. The use of tricor should be avoided in patients with. Docetaxel injection this product information is intended only for residents of the united states. Highlights of prescribing information these highlights do not include all the information needed to use docetaxel safely and effectively. Dailymed vinblastine sulfate vinblastine sulfate injection. Monitor patients and discontinue rituxan infusion for severe reactions 5. Bendamustine hydrochloride is an alkylating drug indicated for treatment of. Patients with combined abnormalities of transaminase and alkaline phosphatase should, in general, not be treated with taxotere. Tigan medication page for healthcare professionals to search for scientific information on pfizer medications. A canadian perspective on the safe administration of bendamustine. Treanda fda prescribing information, side effects and uses. Bendamustine is a bifunctional mechlorethamine derivative containing a purinelike.
Treanda bendamustine hydrochloride for injection fda. Learn about sabril vigabatrin for refractory complex partial seizures and infantile spasms, including important safety information and full prescribing information, including boxed warning. The indications below including fdaapproved indications and compendial uses are considered a covered. Treanda bendamustine hydrochloride for injection, for intravenous infusion. Please confirm you are a healthcare professional to continue. The recommended dose of rituximab product is 375 mgm. The indications below including fdaapproved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy. Highlights of prescribing information these highlights do not include all the information needed to use tecentriq safely and effectively. Treanda bendeka belrapzo bendamustine treanda bendeka belrapzo fep clinical rationale rationale for inclusion in pa program background treanda, bendeka, and belrapzo are bifunctional mechlorethamine derivatives used to treat chronic lymphocytic leukemia and bcell nonhodgkin lymphoma.
Page 2 of 21 full prescribing information 1 indications and usage 1. Fda approves bendeka bendamustine hydrochloride injection. Since grapefruit juice is known to inhibit cyp3amediated metabolism of oral amiodarone in the intestinal mucosa, resulting in increased plasma levels of amiodarone, do not drink grapefruit juice during treatment. Also find the package insert, announcements, resources, and ways to connect with pfizer medical through a variety of channels. Vinblastine sulfate is the salt of an alkaloid extracted from vinca rosea linn. Jevtana is a prescription medicine used with the steroid medicine prednisone to treat men with prostate cancer that is resistant to medical or surgical treatments that lower testosterone and has worsened after treatment with other medicines, including docetaxel. Administer polivy, bendamustine, and rituximab product in any order on day 1 of each cycle. I am a healthcare professional in the us i am a patient or caregiver in the us, 18 years of age or older i am a patient or caregiver in the us, 18 years of age or older. See full prescribing information for complete boxed warning. Highlights of prescribing information infusionrelated. Chronic lymphocytic leukemia cll has an extended disease course in many patients.
Package insert fluorouracil injection, usp for intravenous use only description fluorouracil injection, an antineoplastic antimetabolite, is a sterile, nonpyrogenic injectable solution for intravenous administration. Treatment with tricor should be initiated at a dose of 48 mg per day in patients having mild to moderately impaired renal function, and increased only after evaluation of the effects on renal function and lipid levels at this dose. Highlights of prescribing information skin reactions. A burning sensation where the infusion needle is inserted may be a sign of. Treanda for injection singleuse vial containing either 25 mg or 100 mg of bendamustine hcl as white to offwhite lyophilized powder. Treanda for injection singleuse vial containing 100 mg of bendamustine hcl as white to offwhite lyophilized powder. This leaflet is part iii of a threepart product monograph published when. Sections or subsections omitted from the full prescribing information are not. Treanda and bendeka may be considered medically necessary in patients 18 years of age and older with chronic lymphocytic leukemia cll, bcell nonhodgkin lymphoma nhl, and refractory or relapsed hodgkin lymphoma. Information for the user bendamustine hydrochloride 2. Previously, the generic name was vincaleukoblastine, abbreviated vlb. The name of your medicine is bendamustine hydrochloride 2. Treanda is contraindicated in patients with a known hypersensitivity e. Treanda for injection is an alkylating drug indicated for treatment of patients.
Docetaxel injection, for intravenous use initial u. Treanda and bendeka are considered investigational in patients less than 18 years of age and for all other indications. Information for the user paclitaxel 6 mgml concentrate for solution for infusion paclitaxel read all of this leaflet carefully before you start using this medicine because it contains important information for you. Arterial occlusion has occurred in at least 35% of iclusigtreated patients including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain. When possible, interrupt therapy with brilinta for fivedays prior to. Treanda bendamustine hydrochloride injection, solution, concentrate treanda bendamustine hydrochloride injection, powder, lyophilized, for solution if this spl contains inactivated ndcs listed by the fda initiated compliance action, they will be specified as such. With a chemotherapy drug called chlorambucil to treat chronic lymphocytic leukemia cll in adults who have not had previous cll treatment and whose doctor has decided not to treat them with a chemotherapy drug called fludarabine.
Bendamustine is a bifunctional mechlorethamine derivative containing a purine like. Treanda 25 mg lyophilized powder in a singledose vial for reconstitution. 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. The recommended dose of bendamustine is 90 mgm day on day 1 and 2 when administered with polivy and a rituximab product.
Bendeka bendamustine hcl injection information for patients. Fatal infusionrelated reactions within 24 hours of rituxan infusion. Phlebitis is inflammation of a vein, commonly occurring at the site of an inserted catheter. Treanda bendamustine hydrochloride for injection, for. In a 12week, doubleblind, placebocontrolled study in patients with chorea associated with huntingtons disease, 10 of 54 patients 19% treated with xenazine were reported to have an adverse event of depression or worsening depression. Treanda bendamustine hydrochloride injection, for intravenous use. This information is intended for us healthcare professionals. See full prescribing information, including boxed warning. Bendeka is indicated for the treatment of patients with a chronic lymphocytic leukemia cll.
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