Relapsed chronic lymphocytic leukemia cll in combination with rituximab in patients for whom rituximab alone would be considered appropriate therapy due to other comorbidities. From january 2014 to september 2015, the tower trial randomized adult patients with rr phnegative bcell all to either blinatumomab or standard of care chemotherapy. Impact of blinatumomab on patient outcomes in relapsed. Relapsed follicular lymphoma in patients who have received at least two prior systemic therapies. Steadystate achieved within a day of continuous iv infusion.
Do not throw away any of blinatumomab in the trash. Highlights of prescribing information these highlights do. Yescarta because the t reatment can cause sleepiness, confusion, weakness, temporary memory and coordination problems. Blincyto blinatumomab dosing, indications, interactions. Risk of serious infections see full prescribing information for complete boxed warning. The diluted solution of benlysta should be administered by intravenous infusion over a period of 1 hour.
Blinatumomab is also being studied in the treatment of other types of cancer. Blinatumomab is produced in chinese hamster ovary cells. Yescarta is a cd19directed genetically modified autologous t cell immunotherapy indicated for the treatment of. The approval of blincyto in these patients is based on a study that measured response rate and duration of response. Blincyto is produced in chinese hamster ovary cells. The nccn compendium is a derivative work of the nccn guidelines. Oct 02, 2018 from january 2014 to september 2015, the tower trial randomized adult patients with rr phnegative bcell all to either blinatumomab or standard of care chemotherapy. Each cycle of treatment is separated by a 2week treatmentfree interval. If the interruption after an adverse event is no longer than 7 days, continue the same cycle to a total of 28 days of infusion inclusive of days before and after the interruption in that cycle. Besponsa inotuzumab ozogamicin intravenous e document number.
With current available induction therapies, complete remission cr rates in adults are approximately 75% to 90% faderl et al. Benefitrisk assessment of blinatumomab in the treatment. The estimated mean sd systemic clearance with continuous intravenous infusion in patients receiving blinatumomab in clinical studies was 3. Blinatumomab blincyto blinatumomab blincyto is an immunotherapy regimen for acute lymphoid leukemia all how does blinatumomab work. Apr 02, 2020 the estimated mean sd systemic clearance with continuous intravenous infusion in patients receiving blinatumomab in clinical studies was 3. Each blincyto package contains 1 vial blincyto and 1 vial iv solution stabilizer. There are ongoing studies to confirm clinical benefit. Benlysta should be administered by healthcare providers prepared to manage anaphylaxis see warnings and precautions 5.
Dec 17, 20 a phase 3, randomized, open label study investigating the efficacy of the bite antibody blinatumomab versus standard of care chemotherapy in adult subjects with relapsedrefractory bprecursor acute lymphoblastic leukemia all tower study actual study start date. Mar 20, 2020 blinatumomab is a bispecific cd19directed cd3 tcell engager. A phase 3, randomized, open label study investigating the efficacy of the bite antibody blinatumomab versus standard of care chemotherapy in adult subjects with relapsedrefractory bprecursor acute lymphoblastic leukemia all tower study actual study start date. Cycle 1 is 3 weeks in duration, but may be extended to 4 weeks if the patient. Hospitalization is recommended for the first 3 days of cycle 1 and the first 2 days cycle 2 for patients with ball in first or second complete remission with minimal residual disease greater than or equal to 0. Highlights of prescribing information zinplavasafely and. Actemra subcutaneous formulation is not intended for. Blinatumumab may be prepared via 24hour, 48hour or 7day bag per package insert and institutional policy. Blincyto blinatumomab is a bispecific cd19directed cd3 tcell engager indicated for the treatment of philadelphia chromosomenegative relapsed or refractory bcell precursor acute lymphoblastic leukemia all, and minimal residual disease mrdpositive bcell precursor all. For the first cycle, the recommended total dose of besponsa for all patients is 1. Blinatumomab is a firstinclass immunotherapy agent called a bispecific tcellengager bite antibody. Highlights of prescribing information these highlights do not. In our scheme, the maximum refrigerated storage time for any bag is eight days.
Benlysta should not be infused concomitantly in the same intravenous line with other agents. Blinatumomab versus standard of care chemotherapy in. Actemra subcutaneous formulation is not intended for intravenous. Infuse via programmable, lockable, nonelastomeric infusion pump with an alarm. One part of the antibody will attach to a healthy tcell and the other part of the antibody will attach to a. Cytokine release syndrome crs, which may be lifethreatening or fatal, occurred in patients receiving blincyto. Medlineplus information on blinatumomab a lay language summary of important information about this drug that may include the following. The package containing blincyto will be opened by your healthcare provider and stored in the refrigerator at 36f to 46f 2c to 8c for up to 8 days. Highlights of prescribing information these highlights do not include all the information needed to use ferrlecit safely and effectively. All is a cancer of the blood and bone marrow in which a particular kind of. Ferrlecit sodium ferric gluconate complex in sucrose injection, for intravenous use initial u.
The two antigens targeted by the bispecific design include cd3, which is found on cytotoxic t cells, and cd19, which is found on b lymphocytes throughout their development. Blincyto blinatumomab for injection, for intravenous use initial u. Infusion reactions and cardiopulmonary arrest 1 indications and usage 1. Minimizing waste during preparation of blinatumomab infusions. Acute lymphoblastic leukemia all is a rare form of leukemia, with an estimated 6,250 new cases diagnosed in the united states in 2015 and approximately 1,450 deaths american cancer society, 2015. Minimizing waste during preparation of blinatumomab. The purpose of this study was to determine the effect of blinatumomab toxicities on drug therapy modifications in an intended 28day course of blinatumomab therapy.
Prepared iv solution containing blinatumomab is stable for 48 hours at room temperature or for 8 days refrigerated. Always consult your healthcare provider to ensure the information. Advancements in therapy for acute lymphoblastic leukemia. For treatment of relapsed or refractory bprecursor all, the dose depends on the patients bodyweight. Blincyto blinatumomab is a prescription medicine used to treat bcell precursor acute lymphoblastic leukemia all in patients who still have detectable traces of cancer after chemotherapy. Intravenous iv bags containing blincyto for infusion will arrive in a special package. Realworld experience managing blinatumomab toxicities in. Infuse 240 ml over 24 or 48 hr based on pharmacy label, at a rate of 10 mlhr for 24 hr or 5 mlhr for 48 hr.
Do not throw away dispose of any blincyto in your household trash. Blincyto is given by infusion drip into a vein using a pump device. Definition from the nci drug dictionary detailed scientific definition and other names for this drug. Most of the time, blinatumomab will be given in a hospital or doctors office. See package insert for volumes to add to iv bag for 15 mcgm 2 day dose. Blinatumomab is a bispecific cd19directed cd3 tcell engager. Blinatumomab relapsed or refractory pediatric acute lymphoblastic leukemia blinatumomab relapsed or refractory acute. Blinatumomab is a bite that binds to cd19 and cd3 that has clinical activity in patients with minimal residual disease mrd positive, bcell acute lymphoblastic leukemia all. Blinatumomab is known as a bispecific tcell engager or a bite antibody. No physical or biochemical compatibility studies have been conducted to evaluate the coadministration of benlysta with other agents. Cycle 1 is 3 weeks in duration, but may be extended to 4 weeks if the patient achieves a complete remission cr or complete remission with. Blincyto is infused continuously during a treatment cycle of 4 weeks.
Blincyto blinatumomab is a prescription medication used to treat a certain type of acute lymphoblastic leukemia all in adults and children. If stored at home, follow how to store as you were told by the doctor. Interrupt empliciti elotuzumab for grade 2 or higher and permanently discontinue for severe infusion reaction. If you get blinatumomab in a special package at home, do not open the package. Blinatumomab versus chemotherapy for advanced acute. Premedicate before each dose see dosage and administration 2. Phase ii trial of the anticd19 bispecific t cellengager blinatumomab shows hematologic and molecular remissions in patients with relapsed or refractory bprecursor acute lymphoblastic leukemia. Insert the syringe needle into the vial through the dosage in adult kidney transplant recipients nulojix should be administered in combination with basiliximab induction, mycophenolate mofetil mmf, and corticosteroids. Blinatumomab versus standard of care chemotherapy in patients. Besponsa inotuzumab ozogamicin dosage and administration. Acute lymphoblastic leukemia blincyto blinatumomab is a bispecific cd19directed cd3 tcell engager indicated for the treatment of philadelphia chromosomenegative relapsed or. Bcell precursor all immunotherapy blincyto blinatumomab. Monitor for fever and other signs of infection and treat promptly. Actemra tocilizumab injection, for intravenous or subcutaneous use initial u.
Known hypersensitivity to blinatumomab or to any component of the product formulation. Cytokine release syndrome and neurological toxicities see full prescribing information for complete boxed warning. Length of authorization coverage will be provided for 6 months for up to a maximum of 6 cycles and may not be renewed. Serious infections leading to hospitalization or death including. The effectiveness of arzerra is based on the demonstration of durable objective responses.
Blincyto blinatumomab for injection is supplied in a singledose vial as a sterile, preservativefree, white to offwhite lyophilized powder for intravenous use. Jan 15, 2016 the blinatumomab package insert indicates that blinatumomab prepared in infusion bags has a maximum storage time of eight days when refrigerated 28 c. Do not donate blood, organs, tissues and cells for transplantation. All is a cancer of the blood and bone marrow in which a. Persons with disabilities having problems accessing the pdf files below may call 301 7963634 for assistance. It consists of 504 amino acids and has a molecular weight of approximately 54 kilodaltons. Negligible amounts of blinatumomab were excreted in the urine at the tested clinical doses. The package containing blincyto will be opened by your healthcare provider and stored in the refrigerator at. Blincyto blinatumomab is a bispecific cd19directed cd3 tcell engager that binds to cd19 expressed on cells of blineage origin and cd3 expressed on t cells.
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