Please see pages 1215 and accompanying full prescribing information, including boxed warnings and. Rituxan hycela rituximab and hyaluronidase human is covered under the medical benefit when used within the following guidelines. Serious allergic reactions, and reactions due to release of certain substances by your body that can lead to death, can happen with rituximab products, including rituxan hycela. Rituxan hycela rituximab and hyaluronidase human rituxan hycela fep clinical rationale rationale for inclusion in pa program background rituxan hycela is a monoclonal antibody that is manufactured through biotechnology methods rather than by the bodys own immune system. Most nhl patients received rituxan as an infusion of 375 mgm2 per infusion, given as a single agent weekly for up to 8 doses, in combination with chemotherapy for up to 8 doses, or following chemotherapy for up to 16 doses. How does subcutaneous rituximab hyaluronidase rituxan hycela work. Relapsed or refractory, follicular lymphoma fl as a single agent. Rituxan rituximab in combination with methotrexate is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tnf antagonist therapies. Vision impaired people having problems accessing certain pages of a pdf file may call 301 7963634 for assistance. See important safety including boxed warnings for more information.
Mozobil plerixafor injection, for subcutaneous use. Grade 3 arrs were reported during the first administration of rituxan hycela at cycle 2 by 2 patients. See full prescribing information for complete boxed warning. Persons with disabilities having problems accessing the pdf files below may call 301 7963634 for assistance. Rituximabhyaluronidase human rituxan hycela, genentech inc. Initiate treatment with rituxan hycela only after patients have received at least one full dose of a rituximab product by intravenous infusion see dosage and. Rituxan hycela rituximab and hyaluronidase human injection. The nccn compendium is a derivative work of the nccn guidelines. Rituxan hycela and for 12 months after the last dose of rituxan hycela.
The safety analysis population in part 2 of the study included 85 patients receiving rituxan hycela 1,600 mg rituximab26,800 units hyaluronidase human and 89 patients receiving 500 mgm. Rituxan hycela is not indicated for the treatment of nonmalignant conditions. Rituxan rituximab label food and drug administration. Rituxan hycela is indicated, in combination with fludarabine and cyclophosphamide fc, for the treatment of adult patients with previously untreated and previously treated cll. Nonprogressing, follicular lymphoma after first line cyclophosphamide, vincristine, and prednisone cvp chemotherapy. Follicular lymphoma fl as a singleagent therapy in patients whose disease recurred or did. Tls is caused by the fast breakdown of cancer cells. All patients must first receive at least one full dose of rituxan rituximab without.
The indications below including fdaapproved indications and compendial uses are considered covered. Initiate treatment with rituxan hycela only after patients have received at least. Learn about rituxan access solutions, a resource that provides reliable, effective access and reimbursement support to assist your patients and practice after rituxan rituximab has been prescribed. In both rituxan hycela and rituximab groups, patients had similar median duration of rituximab exposure 4. Initiate treatment with rituxan hycela only after patients have received at least one full. Rituximab and hyaluronidase human injection for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met. Rituximab is an fda approved antibody that is designed to target and bind to a protein on the surface of cancerous bcells. Administer 1,400 mg23,400 units 1,400 mg rituximab and 23,400 units hyaluronidase human subcutaneously according to recommended schedule.
Learn product information about rituxan hycela, including what to do prior to administration. Rituxan hycela prescription and dosage sizes information for physicians and healthcare professionals. Rituxan and rituxan hycela dosing and administration brochure please see pages 2427 and accompanying full prescribing information, including boxed warnings and medication guide, for rituxan hycela important safety information. Rituxan hycela rituximabhyaluronidase human is indicated for the treatment of adult patients with. You may report side effects to the fda at 800 fda1088. Receipt of sample product does not satisfy any criteria requirements for coverage. Rituxan hycela rituximab and hyaluronidase is a newly approved subcutaneous form of intravenous iv rituxan rituximab to treat adults with chronic lymphocytic leukemia, diffuse large bcell lymphoma, and follicular lymphoma. It is not known if rituxan hycela passes into your breast milk. During rituxan hycela monotherapy in the maintenance setting the incidence of arrs at each cyclewas. Leukemia diagnosed as chronic lymphocytic leukemia cll nonhodgkin lymphomas diagnosed as any one of the following. Rituxan hycela rituximab and hyaluronidase human notice this policy contains information which is clinical in nature. Rituxan hycela rituximab and hyaluronidase human is an approved treatment for follicular lymphoma fl, diffuse large bcell lymphoma dlbcl, and chronic lymphocytic leukemia cll. These highlights do not include all the information needed to use prolastin c. Do not breastfeed during treatment and for at least 6 months after your last dose of rituxan hycela.
Food and drug administration approval as an injected treatment for two lymphomas and a type of leukemia, genentech announced the approval covers rituxan hycelas use against relapsed or refractory follicular lymphoma and diffuse large bcell lymphoma dlbcl in patients who have yet to receive treatment. Rituxan hycela may cause a serious brain infection that can lead to disability or death. Monitor patients and discontinue rituxan infusion for severe reactions 5. Administer rituxan hycela as a singleagent every 8 weeks for 12 doses.
Important dosing information rituxan hycela is for subcutaneous use only. Fatal infusionrelated reactions within 24 hours of rituxan infusion. Fda approves rituxan hycela rituximab and hyaluronidase. Considerations rituxan hycela is administered by subcutaneous injection. Skin reactions at or near the injection site local, including injection site reactions can happen with rituxan hycela. Rituxan hycela is a combination of rituximab, a cd20directed cytolytic. The information in this policy is used by wellmark to make determinations whether medical treatment is covered under the terms of a wellmark members health benefit plan. Rituxan hycela 1,400 mg rituximab23,400 units hyaluronidase human singledose vial. Jun 22, 2017 rituxan hycela rituximabhyaluronidase human is a prescription medicine used to treat adults with. Rituxan hycela rituximab and hyaluronidase human fda. The drug works by reducing the number of specific immune cells in the.
It was developed by genentech, a member of the roche group. Follicular lymphoma fl, diffuse large bcell lymphoma dlbcl, and chronic lymphocytic leukemia. Talk to your healthcare provider about effective birth control. Find information about rituxan rituximab, a possible treatment for ra, nhl, cll, gpa, mpa, and pv. Learn about rituxan hycela for subcutaneous injection, a prescription antibody therapy used for fl, dlbcl and cll. We are dedicated to helping you understand your insurance coverage and assistance options. Rituxan hycela may be considered investigational in patients less than 18 years of and for all other indications. Please see pages 2427 and accompanying full prescribing information. Avoid getting pregnant for at least 12 months after you stop using this medicine. Please see the full prescribing information, including boxed warnings. Pharmacology, adverse reactions, warnings and side. Sample billing codes for rituxan hycela rituxan hycela cptcurrent procedural terminology.
Rituxan hycela should only be administered by a healthcare professional with appropriate medical support to manage severe. All patients must receive at least one full dose of a rituximab product by intravenous infusion before receiving rituxan hycela by subcutaneous injection. Rituxan hycela rituximab and hyaluronidase human last. Severe mucocutaneous reactions, some with fatal outcomes 5.
Previously untreated follicular lymphoma in combination with firstline chemotherapy and, in patients achieving a complete or partial response to rituximab in combination. If administration of rituxan hycela is interrupted, continue administering at the same site, or at a different site, but restricted to the abdomen. Genentech biooncology access solutions for rituxan hycela. Oct 02, 2018 rituxan prescribing information pdf download for more information, ask your doctor or pharmacist. When rituximab binds to this protein, it helps your. Mozobil, a hematopoietic stem cell mobilizer, is indicated in combination with granulocytecolony stimulating factor gcsf to mobilize hematopoietic stem cells hscs to the peripheral blood for collection and subsequent autologous transplantation in patients with nonhodgkins lymphoma and multiple myeloma. Rituxan rituximab administration and infusion information. Rituxan subcutaneous versus intravenous formulations. This can help you get the genentech medicine your doctor prescribed. Correct coding is the responsibility of the provider submitting the claim for the item or. Icd10cminternational classification of diseases, 10th revision, clinical modification.
You may report side effects to the fda at 800 fda1088 or. Rituxan rituximab for ra, nhl, cll, gpa, mpa, and pv. Acquired immune deficiency syndrome aidsrelated bcell lymphoma 2. Feb 04, 2020 rituxan hycela is usually given only after you have received at least 1 injection of rituximab alone. Read about rituxan rituximab administration and standard infusion information for nonhodgkins lymphoma and cll. Detailed dosage guidelines and administration information for rituxan hycela rituximab and hyaluronidase.
Initiate treatment with rituxan hycela only after patients have received at least one full dose of a rituximab product by intravenous infusion. Rituxan hycela maintenance treatment 8 weeks following completion of rituxan hycela in combination with chemotherapy. Learn about rituxan hycela for subcutaneous injection, a prescription. Rituxan hycela in not indicated for the treatment of nonmalignant conditions. Rituxan rituximab is indicated, in combination with fludarabine and cyclophosphamide fc, for the treatment of patients with previously untreated and previously treated cd20positive cll. Rituxan hycela rituximab and hyaluronidase human injection is a combination of a cd20directed cytolytic antibody and an endoglycosidase, indicated for the treatment of adult patients with. Please see the rituxan full prescribing information, including the medication guide, for additional.
Injected lymphoma therapy rituxin hycela receives fda approval. Provide medication guide to patient prior to rituxan hycela treatment. Use outside of these guidelines may result in nonpayment unless approved under an exception process. Rheumatoid arthritis ra rituxan rituximab in combination with methotrexate is indicated for the treatment of adult.
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