Information for the patient kyprolis 10 mg powder for solution for infusion kyprolis 30 mg powder for solution for infusion kyprolis 60 mg powder for solution for infusion carfilzomib this medicine is subject to additional monitoring. Dose calculation calculate the kyprolis dose see dosage and administration 2. Injection, usp immediately before and after kyprolis administration. Highlights of prescribing information these highlights do not include all the information needed to use promacta safely and effectively. Kyprolis is a proteasome inhibitor indicated for the treatment of patients with multiple myeloma who have received at least two prior therapies including. Lenalidomide and dexamethasone are other medicines used to treat multiple myeloma. Safety and effectiveness of teflaro for the treatment of absssi in pediatric patients less than 34.
Infuse over 10 or 30minutes depending on the kyprolis dose regimen see dosage and administration 2. Oct 04, 2019 kyprolis vials contain no antimicrobial preservatives and are intended for singledose only. Kyprolis carfilzomib for relapsed or refractory multiple. Tilt the upright vial and insert a syringe with appropriately sized needle into the.
Infuse over 10 or 30minutes depending on the kyprolis dose regimen see dosage and. Kyprolis carfilzomib is a member of the proteasome inhibitors drug class and is commonly used for multiple myeloma. Twice weekly 2056 mgm2 regimen by 30minute infusion. Kyprolis 30 mg powder in singledose vial for injection. Same as initial prior authorization policy criteria. Twice weekly 2056mgm2 regimen by 30minute infusion kyprolis is administered intravenously as a 30minute infusion on two consecutive days, each week for threeweeks followed by a 12day rest period as shown in table2. Highlights of prescribing information qt prolongation has. Your doctor will do regular tests before and during. Highlights of prescribing information these highlights. The prevention of nausea andor vomiting associated with initial and repeat courses of emetogenic cancer. This will allow quick identification of new safety information. See full prescribing information for kyprolis carfilzomib for injection, for intravenous use initial u. Highlights of prescribing information these highlights do not include all the information needed to use revlimid safely and effectively. Kyprolis is a proteasome inhibitor indicated for the treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent and have demonstrated disease progression on or within 60 days of completion of the last therapy.
Teflaro should only be used if the potential benefit justifies the potential risk in these populations. Cancidas is indicated for the treatment of esophageal candidiasisin adult and pediatric patients 3 months of age and older see clinical studies 14. Monitor patients and discontinue rituxan infusion for severe reactions 5. Prior approval is required to ensure the safe, clinically appropriate and cost effective use of kyprolis while maintaining optimal therapeutic outcomes. Kyprolis carfilzomib for relapsed multiple myeloma treatment. October 30, 2019 page 3 of 3 kyprolis carfilzomib package insert applicable procedure codes j9047 injection, carfilzomib, 1 mg applicable diagnosis codes icd10 icd10 description c90. Women should avoid becoming pregnant during treatment with kyprolis and for 6 months following the final dose. In combination with the medicines lenalidomide and dexamethasone in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells autologous stem cell transplant and in people who have received at least one prior medicine to treat multiple myeloma. Kyprolis carfilzomib is a treatment option for people who have already received 1 or more previous treatments for relapsed multiple myeloma. Vinp03 vinblastine sulfate for injection usp warning caution this preparation should be administered by individuals experienced in the administration of vinblastine sulfate.
Farydak can cause serious side effects in some people. Kyprolis sgm p2017 cvs caremark is an independent company that provides pharmacy benefit management services to carefirst bluecross blueshield and carefirst bluechoice, inc. Serious side effects associated with farydak include diarrhea, heart problems, and bleeding. Your doctor will do regular tests before and during treatment to check the levels of fluid and electrolytes in your blood, platelet counts, and an electrocardiogram ecg. Kyprolis is given 2 days in a row each week, for 3 weeks, followed by one week without treatment. October 30, 2019 page 3 of 3 kyprolis carfilzomib package insert applicable procedure codes j9047 injection, carfilzomib, 1 mg applicable diagnosis codes icd10. Sandostatin lar depot is available in singleuse kits for injectable suspension containing a 6ml vial of 10 mg, 20 mg, or 30 mg strength, a syringe containing 2 ml of diluent, one vial adapter, and one. Carefirst bluecross blueshield is the shared business name of carefirst of maryland, inc. Explore how pomalyst with dex works as an immunomodulatory treatment for relapsed refractory multiple myeloma. Kyprolis is approved for use in combination with dexamethasone or with lenalidomide plus dexamethasone, which are other medicines used to treat multiple myeloma.
Relapsed refractory multiple myeloma treatment pomalyst. Mozobil plerixafor injection, for subcutaneous use. Ninlaro ixazomib capsules, for oral use hepatotoxicity. This approval was based on data from the phase iii arrow clinical trial, which demonstrated that kyprolis administered onceweekly at 70 mgm. Kyprolis carfilzomib is a prescription medication used to treat patients with relapsed or refractory multiple myeloma who have received one to three previous treatments for multiple myeloma. Simponi can lower your ability to fight infections. Men should avoid fathering a child during treatment with kyprolis and for 3 months following the final dose. Highlights of prescribing information these highlights do not include all the information needed to use sivextro safely and effectively. The reconstituted solution contains carfilzomib at a concentration of 2 mgml. Each ml of the sterile solution contains 20 mg of plerixafor. Fda approves new kyprolis carfilzomib combination therapy for the treatment of patients with relapsed or refractory multiple myeloma pivotal headtohead endeavor study shows kyprolis and dexamethasone doubled progressionfree survival versus velcade bortezomib and dexamethasone. Carfilzomib was administered weekly on days 1, 8, and 15 of each 28day cycle as a 30minute infusion prior to daratumumab on days when both were administered. This medicinal product is subject to additional monitoring. Sandostatin lar depot in the dosage regimen as described below patients currently receiving sandostatin injection.
Fatal infusionrelated reactions within 24 hours of rituxan infusion. Kyprolis can cause harm to a fetus unborn baby when given to a pregnant woman. Kyprolis 10 mg powder in singledose vial for injection. Kyprolis 60 mg powder in singledose vial for injection. Nov 20, 2019 kyprolis will be given as an infusion into a vein. Highlightsof prescribing information kyprolis safely and.
Revlimid lenalidomide is a prescription medicine, used to treat adults with multiple myeloma mm in combination with the medicine dexamethasone, or as maintenance treatment after autologous hematopoietic stem cell transplantation a type of stem cell transplant that uses your own stem cells. In combination with the medicines lenalidomide and dexamethasone in people with newly diagnosed multiple myeloma. There are reports of serious infections caused by bacteria, fungi, or viruses that have spread throughout the body, including tuberculosis tb and histoplasmosis. Highlights of prescribing information for intravenous. For detailed information on lupron depot, click on a link below. Carfilzomib kyprolis drug monograph pharmacy benefits. Kyprolis, inncarfilzomib european medicines agency. Kyprolis pharmacokinetics absorption bioavailability. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after revlimid treatment see warnings and precautions. Patients currently receiving sandostatin injection patients currently receiving sandostatin injection can be switched to sandostatin lar depot in a dosage of 20 mg given im intragluteally at 4week intervals for 2 months.
Mozobil plerixafor injection is a sterile, preservativefree, clear, colorless to paleyellow, isotonic solution for subcutaneous injection. This means that kyprolis will be given to you on days 1, 2, 8, 9, 15, and 16 of each 28day cycle. Page 3 of 44 full prescribing information 1 indications and usage 1. Carfilzomib was initially fdaapproved in 2012 as monotherapy in myeloma. The recommended hydration includes both oral fluids 30 ml per kg at least 48 hours before cycle 1, day 1 and intravenous fluids 250 ml to 500 ml of appropriate intravenous fluid prior to each dose in cycle 1. Severe mucocutaneous reactions, some with fatal outcomes 5. 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. Insert needle and inject all the liquid subcutaneously.
Kyprolis prices, coupons and patient assistance programs. Kyprolis in combination with lenalidomide and dexamethasone for the combination regimen with lenalidomide and dexamethasone, administer kyprolis intravenously as a 10minute infusion on two. Thrombocytopenia has been reported with ninlaro with platelet nadirs typically occurring between days 1421 of each 28day cycle and recovery to baseline by the start of the next cycle. Sivextrotedizolid phosphate for injection,for intravenous use sivextro tedizolid phosphate tablet,for oral use initial u. Kyprolis with dexamethasone and lenalidomide kyprolis with dexamethasone and cyclophosphamide for nontransplant candidates b. Jakafi is indicated for treatment of intermediate or highrisk myelofibrosis mf, including primary mf, postpolycythemia vera mf and postessential thrombocythemia mf in adults. See full prescribing information for complete boxed warning.
Kyprolis vials contain no antimicrobial preservatives and are intended for singledose only. Fda approves new kyprolis carfilzomib combination therapy for. In patients with a body surface area greater than 2. Kyprolis carfilzomib rationale for inclusion in pa. The printed package leaflet of the medicinal product must state the name and address of the.
Dec 23, 2019 clinicians are encouraged to refer to the package inserts of each pi for details. Kyprolis carfilzomib rationale for inclusion in pa program. Kyprolis in combination with either lenalidomide and dexamethasone or. Refer to the dexamethasone prescribing information for other information on that product. Kyprolis carfilzomib is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy kyprolis is indicated as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of. This kyprolis price guide is based on using the discount card which is accepted at most u. Dose calculation calculate the kyprolis dose see dosage. Unopened vials of kyprolis are stable until the date indicated on the package when stored in the original package at 2c to 8c 36f to 46f.
Darzalex is a prescription medicine used to treat adults with multiple myeloma. Promacta eltrombopag tablets, for oral use promacta eltrombopag for oral suspension initial u. Kyprolis vials contain no antimicrobial preservatives and are intended for single dose only. Kyprolis carfilzomib for injection, for intravenous use. For additional information please refer to the bortezomib and dexamethasone prescribing information. Do not mix kyprolis with or administer as an infusion with other medicinal products. Daratumumab plus carfilzomib and dexamethasone in patients. Kyprolis carfilzomib is an antineoplastic agent for the treatment of multiple myeloma in in combination with. Learn more about revlimid, a treatment option for multiple myeloma. Administration kyprolis can be administered in a 50ml or 100ml intravenous bag of 5% dextrose injection, usp. Highlights of prescribing information initiate promacta at.
1191 1135 918 561 336 320 703 886 444 141 539 1627 1549 585 538 1280 1494 1296 443 130 997 758 63 311 1259 768 1030 1009 1639 183 495 474 1113 195 1393 353 1401 708 644 22 432 1233 1044 166 224 1095 148 887 718