Ibritumomab tiuxetan an overview sciencedirect topics. Coordination of activities and personnel is essential to the success of this protocol and includes the following steps. Zevalin is a radiolabeled monoclonal antibody therapy that is used to treat some types of nonhodgkins bcell lymphoma. The median age was 63 yrs range 4677, all patients were relapsed with histologically confirmed cd20. Pregnant women nursing women men or women of childbearing potential who are unwilling to employ adequate contraception for. Initiate the zevalin therapeutic regimen following recovery of platelet counts to. Mary beth farrell, ms, cnmt, nct, fsnmmits, editor. Zevalin first line in follicular lymphoma full text view. Zevalin is a cd20directed radiotherapeutic antibody administered as part of the zevalin therapeutic regimen indicated for the treatment of patients with. Update on the rational use of 90yibritumomab tiuxetan in the. The zevalin regimen is indicated for the treatment of patients with relapsed or. In the cancer center treatment room, the patient was infused with rituxin 250mgm2 or 470 mg over a four hour period. This treatment is for patients with relapsed or refractory lowgrade, follicular or transformed bcell nonhodgkins lymphoma.
The chmp decided that zevalins benefits are greater than its risks as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma and for the treatment of adult patients with rituximab relapsed or refractory cd20positive follicular bcell nonhodgkins lymphoma. After infusion into a patient, the monoclonal antibody targets the cd20 antigen, which is found on the surface of mature b cells and bcell tumors. This treatment is for patients with relapsed or refractory lowgrade, follicular or. Zevalin kit side effects by likelihood and severity webmd. Ibritumomab tiuxetan is also being studied in the treatment of other types of cancer. Resistance to ibritumomab in lymphoma ebook, 2018 worldcat. Rituximab is used to reduce the number of bcells in your blood and y90 zevalin is given to treat your nonhodgkins lymphoma nhl. Zevalin therapy to treat nonhodgkins follicular lymphoma. Phase i studies have determined the optimal dose of pretreatment rituximab to be 250 mgm2 seven days prior and immediately. Get emergency medical help if you have signs of an allergic reaction hives, difficult breathing, swelling in your face or throat or a severe skin reaction fever, sore throat, burning eyes, skin pain, red. Rituximab with or without yttrium y90 ibritumomab tiuxetan. Ibritumomab tiuxetan injection zevalin side effects.
Ibritumomab tiuxetan zevalin medical clinical policy. Zevalin radioimmunotherapy is not associated with significant. Similarly, shipley et al 29 observed an improvement of cr rates from 28% after a short course of rchop to 67% following rit consolidation. Zevalin is a two step protocol administered by iv over 7 to 9 days. Pregnant women nursing women men or women of childbearing potential who are unwilling to employ adequate contraception for at least three months after completing study treatment. Rituxan infusion of 250 mgm2 starting at a slow rate. The zevalin therapeutic regimen is used to treat patients with. Radioimmunotherapy is a form of targeted radionuclide therapy that uses a monoclonal antibody to deliver localized radiation. Induction therapy with a single course of 90yttriumibritumomab tiuxetan according to the standard procedure that includes rituximab 250 mgm2 plus 111indiumibritumomab tiuxetan for dosimetry on day one followed by rituximab 250 mgm2 and 90yibritumomab tiuxetan 15 mbqkg on day 8 or 9 up to a maximal dose of 12. Zevalin ibritumomab tiuxetan injection for intravenous use is a prescription medication that has three parts. Its advantages are singledose, outpatient, preservation of quality of life and excellent patient tolerance. Zevalin builds on the combined effect of a targeted biologic. The chmp decided that zevalins benefits are greater than its risks as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma and for the treatment of adult patients with rituximab relapsed or refractory cd20positive follicular b.
Phase 2 study of zevalin versus zevalin and motexafin. Zevalin ibritumomab tiuxetan is a radioactive drug product, which is the combination of a. The main purpose of the in111 zevalin study is to determine based on its biodistribution, if you may proceed to treatment with y90 zevalin. Y90 ibritumomab tiuxetan administration results in severe and prolonged cytopenias in most patients. Administer the zevalin therapeutic regimen as outlined below. Yttrium90 helps kill the cancer cells, and indium111 helps to show how the medication is spread throughout the body imaging studies. Murray concluded, zevalin therapy appears to be well tolerated and clinically active in the treatment of relapsed or refractory, low grade, follicular or transformed bcell nhl and, unlike typical courses of chemotherapy, has the ability to clear circulating bcl2 positive cells. The murine immunoglobulin igg1 kappa monoclonal cd20 antibody uses the chelator molecule tiuxetan to form a stable link to either in111 or y90. The study compared patients who received zevalin and patients who received no additional treatment. On an intenttotreat basis, the pfs and os at 24 months were 73% and 94. Table 3a details the protocol for administration of zevalin therapy 19. The antibody moiety of zevalin is ibritumomab, a murine igg 1 kappa monoclonal antibody directed against the cd20 antigen.
Zevalin ibritumomab tiuxetan chemotherapy, side effects. Zevalin can be reacted with 111indium 111 in to form 111 inzevalin which is used for imaging and dosimetry, or with 90yttrium 90 y to form 90 yzevalin which is used for therapy of patients with relapsed bcell nonhodgkins lymphoma. Ibritumomab tiuxetan and rituximab are known as monoclonal antibodies. Listing a study does not mean it has been evaluated by the u. Final results of the two zevalin pivotal trials in. The number of european nuclear medicine departments using zevalin is continuously increasing, since the therapy is often. Lowgrade or follicular bcell nhl that has relapsed during or after treatment with other. In111 zevalin, y90 zevalin ibritumomab uses, side effects. Rituxan infusion is given a second time as described above. The median age was 63 yrs range 4677, all patients were relapsed with histologically confirmed cd20positive. Clinical trial results with zevalin zevalin therapy to.
Update on the rational use of 90yibritumomab tiuxetan in. Y90 zevalin was administered at least 6 weeks but no more than 12 weeks following the last dose of chemotherapy. Dec 31, 2018 the approximate molecular weight of ibritumomab tiuxetan is 148 kd. Chemotherapy followed by zevalin for relapsed mantle cell. Do not exceed absolute maximum allowable dose of 32. Austin radiological association nuclear medicine procedure. The bioscan step is no longer required with zevalin therapy.
Quickreference protocol manual for nuclear medicine technologists. Dramatic results showing that radioimmunotherapy with zevalin prolongs progressionfree survival by 2 years come just days after cuts in reimbursement for this therapy. Side effects of zevalin ibritumomab tiuxetan, warnings, uses. Zevalin improves progressionfree survival in follicular lymphoma. Ignacio azinovic gamo md, phd, in leibel and phillips textbook of radiation. It is most appropriate for treatment of multiple tumor sites that cannot be readily excised surgically or irradiated using external beam radiation or brachytherapy. Find information about common, infrequent and rare side effects of zevalin y90 intravenous. The radiolabeled monoclonal antibody was withdrawn from the market more than a year ago, but a few have not forgotten its value in advanced lymphoma, and theres hope for. Do not administer to patients with greater than or equal to 25% lymphoma marrow involvement andor impaired bone marrow reserve. They work by killing certain blood and cancer cells from your immune system b cells. Ibritumomab tiuxetan zevalin ibritumomab tiuxetan zevalin spectrum pharmaceuticals, irvine, ca consists of a monoclonal antibody linked to the radioactive isotope yttrium90.
For patients with relapsed or refractory, lowgrade of follicular nhl, zevalin may be used. Find patient medical information for zevalin y90 intravenous on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Dramatic results showing that radioimmunotherapy with zevalin prolongs progressionfree survival by 2 years come just days after cuts in reimbursement for this therapy were announced in the united. A simple radioincorporation process allows stable chelation of the pure betaemitting radioisotope 90 y to zevalin. Zevalin consists of a murine igg1 kappa monoclonal antibody against cd20 ibritumomab conjugated to the linkerchelator tiuxetan mxdtpa. How zevalin ibritumomab tiuxetan chemotherapy works, side effects, interactions and precautions. Has insurance coverage or is willing to pay for protocol therapy rituximab x 4 or zevalin x 1 exclusion criteria any of the following.
Ibritumomab tiuxetan is a clear, colorless, sterile, pyrogenfree, preservativefree solution that may contain translucent particles. These highlights do not include all the information needed to. Fulldose 90y ibritumomab tiuxetan therapy is safe in patients with prior myeloablative chemotherapy. The objectives of this study are to evaluate the efficacy and safety of the zevalin regimen compared to zevalin and motexafin gadolinium in patients with. A randomized study comparing yttrium90 ibritumomab tiuxetan zevalin and highdose beam chemotherapy versus beam alone as the conditioning regimen before autologous stem cell transplantation in patients with aggressive lymphoma. Dec 24, 2018 the safety data reflect exposure to zevalin in 270 patients with relapsed or refractory nhl with platelet counts. Ibritumomab tiuxetan zevalin is a cd20directed radiotherapeutic antibody administered as part of the ibritumomab tiuxetan therapeutic regimen indicated for the treatment of relapsed or refractory, lowgrade or follicular bcell nonhodgkins lymphoma nhl and for previously. Sep 01, 2019 patients were randomized to receive zevalin n208 or no further therapy n206. The zevalin therapeutic regimen is a novel form of radioimmunotherapy.
For consolidation therapy, zevalin has been studied in one main study involving 414 patients who had achieved a partial or complete remission during induction treatment for nonhodgkins lymphoma. The safety data reflect exposure to zevalin in 270 patients with relapsed or refractory nhl with platelet counts. Facts about the zevalin ibritumomab tiuxetan therapeutic. Exploiting simple devices this unique system provides reducing the irradiation of the. Rituximab, 111indium zevalin and 90yzevalin administration. It has demonstrated therapeutic efficacy with durable responses and allows delivery of ionizing radiation directly to the tumor site, while minimizing toxicity. Fcr fludarabine, cyclophosphamide, rituximab regimen. Get emergency medical help if you have signs of an allergic reaction hives, difficult breathing, swelling in your face or throat or a severe skin reaction fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling. What are the possible side effects of ibritumomab in111 zevalin, y90 zevalin. This retrospective analysis is focused on the efficacy and safety of radioimmunotherapy rit with zevalin in nine patients with recurrent follicular lymphoma fl who were treated in a consolidation setting after having achieved complete remission or partial remission with fcr. The main efficacy outcome measure was progressionfree survival pfs assessed by study investigators using the international workshop to standardize. Oct 15, 2008 induction therapy with a single course of 90yttriumibritumomab tiuxetan according to the standard procedure that includes rituximab 250 mgm2 plus 111indiumibritumomab tiuxetan for dosimetry on day one followed by rituximab 250 mgm2 and 90yibritumomab tiuxetan 15 mbqkg on day 8 or 9 up to a maximal dose of 12.
Feb 18, 2009 on an intenttotreat basis, the pfs and os at 24 months were 73% and 94. The radioisotope 90yttrium 90 y is linked to the monoclonal anticd20 antibody ibritumomab by the chelator tiuxetan. The ibritumomab tiuxetan protocol is performed by a multidisciplinary team of healthcare professionals over 79 d. The approximate molecular weight of ibritumomab tiuxetan is 148 kd. Zevalin fda prescribing information, side effects and uses. Ibritumomab tiuxetan zevalin was the first fdaapproved radiolabeled antibody therapy agent fig. More than 90% of the emitted radiation is absorbed within 5 mm. Chemotherapy followed by zevalin for relapsed mantle cell lymphoma the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The zevalin ibritumomab tiuxetan therapeutic regimen radioimmunotherapy is an innovative form of cancer therapy, combining a monoclonal antibody against a specific target antigen with a source of radiation such as a radioisotope. A treatment course for zevalin includes a rituxan infusion 250 mgm.
Administration guidelines for radioimmunotherapy of non. A randomized study comparing yttrium90 ibritumomab tiuxetan. The zevalin therapeutic regimen consists of two components. The first was a singlearm study of 54 patients with rituximabrefractory nhl. This volume, in discussing resistance to ibritumomab, will focus on the mechanism, hematological aspects, radiological and nuclear medicine aspects, and medical physics that deal with radiation. Who are having a complete or partial response to firstline chemotherapy.
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