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. Cycle 1 is 3 weeks in duration, but may be extended to 4 weeks if the patient. The diluted solution of benlysta should be administered by intravenous infusion over a period of 1 hour. 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. With current available induction therapies, complete remission cr rates in adults are approximately 75% to 90% faderl et al. Highlights of prescribing information these highlights do not include all the information needed to use ferrlecit safely and effectively. Risk of serious infections see full prescribing information for complete boxed warning. Besponsa inotuzumab ozogamicin intravenous e document number. Blinatumomab is a firstinclass immunotherapy agent called a bispecific tcellengager bite antibody. Definition from the nci drug dictionary detailed scientific definition and other names for this drug. 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. Steadystate achieved within a day of continuous iv infusion.
Persons with disabilities having problems accessing the pdf files below may call 301 7963634 for assistance. The approval of blincyto in these patients is based on a study that measured response rate and duration of response. Highlights of prescribing information zinplavasafely and. Intravenous iv bags containing blincyto for infusion will arrive in a special package. For the first cycle, the recommended total dose of besponsa for all patients is 1. Blinatumomab is known as a bispecific tcell engager or a bite antibody. Apr 02, 2020 the estimated mean sd systemic clearance with continuous intravenous infusion in patients receiving blinatumomab in clinical studies was 3. Minimizing waste during preparation of blinatumomab infusions. 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.
The effectiveness of arzerra is based on the demonstration of durable objective responses. Blincyto blinatumomab dosing, indications, interactions. The nccn compendium is a derivative work of the nccn guidelines. Actemra subcutaneous formulation is not intended for. All is a cancer of the blood and bone marrow in which a particular kind of.
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. Relapsed follicular lymphoma in patients who have received at least two prior systemic therapies. Each blincyto package contains 1 vial blincyto and 1 vial iv solution stabilizer. 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. In our scheme, the maximum refrigerated storage time for any bag is eight days. 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. Highlights of prescribing information these highlights do. Benlysta should not be infused concomitantly in the same intravenous line with other agents. One part of the antibody will attach to a healthy tcell and the other part of the antibody will attach to a. Do not donate blood, organs, tissues and cells for transplantation. The package containing blincyto will be opened by your healthcare provider and stored in the refrigerator at. Blinatumomab is produced in chinese hamster ovary cells. Blinatumomab relapsed or refractory pediatric acute lymphoblastic leukemia blinatumomab relapsed or refractory acute. It consists of 504 amino acids and has a molecular weight of approximately 54 kilodaltons.
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. Blinatumomab blincyto blinatumomab blincyto is an immunotherapy regimen for acute lymphoid leukemia all how does blinatumomab work. Minimizing waste during preparation of blinatumomab. Blinatumomab is a bispecific cd19directed cd3 tcell engager.
Benlysta should be administered by healthcare providers prepared to manage anaphylaxis see warnings and precautions 5. Relapsed chronic lymphocytic leukemia cll in combination with rituximab in patients for whom rituximab alone would be considered appropriate therapy due to other comorbidities. Cytokine release syndrome crs, which may be lifethreatening or fatal, occurred in patients receiving blincyto. Blinatumomab versus standard of care chemotherapy in patients. Prepared iv solution containing blinatumomab is stable for 48 hours at room temperature or for 8 days refrigerated. Besponsa inotuzumab ozogamicin dosage and administration.
Blinatumumab may be prepared via 24hour, 48hour or 7day bag per package insert and institutional policy. Infuse via programmable, lockable, nonelastomeric infusion pump with an alarm. There are ongoing studies to confirm clinical benefit. 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. Negligible amounts of blinatumomab were excreted in the urine at the tested clinical doses. Mar 20, 2020 blinatumomab is a bispecific cd19directed cd3 tcell engager. Do not throw away dispose of any blincyto in your household trash. 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. Blinatumomab versus chemotherapy for advanced acute. Blincyto blinatumomab for injection is supplied in a singledose vial as a sterile, preservativefree, white to offwhite lyophilized powder for intravenous use. Blinatumomab versus standard of care chemotherapy in. The estimated mean sd systemic clearance with continuous intravenous infusion in patients receiving blinatumomab in clinical studies was 3.
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 also being studied in the treatment of other types of cancer. Medlineplus information on blinatumomab a lay language summary of important information about this drug that may include the following. Bcell precursor all immunotherapy blincyto blinatumomab. Highlights of prescribing information for intravenous. Most of the time, blinatumomab will be given in a hospital or doctors office. 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. No physical or biochemical compatibility studies have been conducted to evaluate the coadministration of benlysta with other agents.
Ferrlecit sodium ferric gluconate complex in sucrose injection, for intravenous use initial u. 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. Realworld experience managing blinatumomab toxicities in. Yescarta because the t reatment can cause sleepiness, confusion, weakness, temporary memory and coordination problems. If stored at home, follow how to store as you were told by the doctor. 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. Blincyto blinatumomab for injection, for intravenous use initial u. Cytokine release syndrome and neurological toxicities see full prescribing information for complete boxed warning. Benefitrisk assessment of blinatumomab in the treatment.
Each cycle of treatment is separated by a 2week treatmentfree interval. 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. Interrupt empliciti elotuzumab for grade 2 or higher and permanently discontinue for severe infusion reaction. Impact of blinatumomab on patient outcomes in relapsed. Acute lymphoblastic leukemia blincyto blinatumomab is a bispecific cd19directed cd3 tcell engager indicated for the treatment of philadelphia chromosomenegative relapsed or. Do not throw away any of blinatumomab in the trash. Always consult your healthcare provider to ensure the information. Known hypersensitivity to blinatumomab or to any component of the product formulation. 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. Advancements in therapy for acute lymphoblastic leukemia. Blincyto blinatumomab is a prescription medication used to treat a certain type of acute lymphoblastic leukemia all in adults and children. All is a cancer of the blood and bone marrow in which a.
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. Monitor for fever and other signs of infection and treat promptly. Length of authorization coverage will be provided for 6 months for up to a maximum of 6 cycles and may not be renewed. Yescarta is a cd19directed genetically modified autologous t cell immunotherapy indicated for the treatment of. Serious infections leading to hospitalization or death including. For treatment of relapsed or refractory bprecursor all, the dose depends on the patients bodyweight. Highlights of prescribing information these highlights do not. Blincyto is infused continuously during a treatment cycle of 4 weeks.
Blincyto is produced in chinese hamster ovary cells. Highlights of prescribing information these highlights do not include all the information needed to use blincyto safely and effectively. Actemra subcutaneous formulation is not intended for intravenous. 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. Actemra tocilizumab injection, for intravenous or subcutaneous use initial u. If you get blinatumomab in a special package at home, do not open the package.
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