The printed package leaflet of the medicinal product must state the name and address of the. The reconstituted concentration of bortezomib for subcutaneous administration 2. Highlights of prescribing information these highlights do not include all the information needed to use sivextro safely and effectively. Kyprolis carfilzomib prescribing information, onyx pharmaceuticals inc.
Kyprolis with dexamethasone and lenalidomide kyprolis with dexamethasone and cyclophosphamide for nontransplant candidates b. Kyprolis carfilzomib for relapsed multiple myeloma treatment. Kyprolis pharmacokinetics absorption bioavailability. 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. 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. Serious side effects associated with farydak include diarrhea, heart problems, and bleeding. Auc is doseproportional over the dose range of 2036 mgm 2. Kyprolis carfilzomib for relapsed or refractory multiple.
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. Kyprolis 60 mg powder in singledose vial for injection. Each ml of the sterile solution contains 20 mg of plerixafor. Daratumumab plus carfilzomib and dexamethasone in patients. Kyprolis, inncarfilzomib european medicines agency.
Kyprolis carfilzomib rationale for inclusion in pa. Sandostatin lar depot in the dosage regimen as described below patients currently receiving sandostatin injection. 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. Darzalex is a prescription medicine used to treat adults with multiple myeloma. Same as initial prior authorization policy criteria. October 30, 2019 page 3 of 3 kyprolis carfilzomib package insert applicable procedure codes j9047 injection, carfilzomib, 1 mg applicable diagnosis codes icd10. 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. 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. Dec 23, 2019 clinicians are encouraged to refer to the package inserts of each pi for details.
Dose calculation calculate the kyprolis dose see dosage. This approval was based on data from the phase iii arrow clinical trial, which demonstrated that kyprolis administered onceweekly at 70 mgm. Kyprolis is approved for use in combination with dexamethasone or with lenalidomide plus dexamethasone, which are other medicines used to treat multiple myeloma. Refer to the dexamethasone prescribing information for other information on that product. Kyprolis vials contain no antimicrobial preservatives and are intended for singledose only. 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. For detailed information on lupron depot, click on a link below. Injection, usp immediately before and after kyprolis administration. Men should avoid fathering a child during treatment with kyprolis and for 3 months following the final dose. 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. Sivextrotedizolid phosphate for injection,for intravenous use sivextro tedizolid phosphate tablet,for oral use initial u. In combination with the medicines lenalidomide and dexamethasone in people with newly diagnosed multiple myeloma.
If needed, give an additional 250 ml to 500 ml of intravenous fluids following kyprolis administration. 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. Your doctor will do regular tests before and during. Promacta eltrombopag tablets, for oral use promacta eltrombopag for oral suspension initial u. 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.
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. Women should avoid becoming pregnant during treatment with kyprolis and for 6 months following the final dose. The prevention of nausea andor vomiting associated with initial and repeat courses of emetogenic cancer. Nov 20, 2019 kyprolis will be given as an infusion into a vein. Learn more about revlimid, a treatment option for multiple myeloma. Ninlaro ixazomib capsules, for oral use hepatotoxicity. See full prescribing information for complete boxed warning. Twice weekly 2056 mgm2 regimen by 30minute infusion. Prior approval is required to ensure the safe, clinically appropriate and cost effective use of kyprolis while maintaining optimal therapeutic outcomes. Mozobil plerixafor injection, for subcutaneous use. Highlights of prescribing information for intravenous. Kyprolis in combination with lenalidomide and dexamethasone for the combination regimen with lenalidomide and dexamethasone, administer kyprolis intravenously as a 10minute infusion on two. Monitor patients and discontinue rituxan infusion for severe reactions 5.
Kyprolis is given 2 days in a row each week, for 3 weeks, followed by one week without treatment. Highlights of prescribing information qt prolongation has. Carefirst bluecross blueshield is the shared business name of carefirst of maryland, inc. For additional information please refer to the bortezomib and dexamethasone prescribing information. 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. Kyprolis 10 mg powder in singledose vial for injection. Carfilzomib was initially fdaapproved in 2012 as monotherapy in myeloma. 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. Kyprolis 30 mg powder in singledose vial for injection. Kyprolis sgm p2017 cvs caremark is an independent company that provides pharmacy benefit management services to carefirst bluecross blueshield and carefirst bluechoice, inc. Kyprolis prices, coupons and patient assistance programs. Fda approves new kyprolis carfilzomib combination therapy for.
Kyprolis is a proteasome inhibitor indicated for the treatment of patients with multiple myeloma who have received at least two prior therapies including. Highlights of prescribing information these highlights do not include all the information needed to use promacta safely and effectively. Vinp03 vinblastine sulfate for injection usp warning caution this preparation should be administered by individuals experienced in the administration of vinblastine sulfate. Kyprolis vials contain no antimicrobial preservatives and are intended for single dose only. Safety and effectiveness of teflaro for the treatment of absssi in pediatric patients less than 34. Highlightsof prescribing information kyprolis safely and. Mozobil plerixafor injection is a sterile, preservativefree, clear, colorless to paleyellow, isotonic solution for subcutaneous injection. Carfilzomib kyprolis drug monograph pharmacy benefits. 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. Kyprolis can cause harm to a fetus unborn baby when given to a pregnant woman.
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. Relapsed refractory multiple myeloma treatment pomalyst. Dose calculation calculate the kyprolis dose see dosage and administration 2. Authorization of 6 months may be granted for members prescribed kyprolis for the treatment of previously treated, relapsed, progressive, or refractory multiple myeloma in one of the following regimens. Fatal infusionrelated reactions within 24 hours of rituxan infusion. There are reports of serious infections caused by bacteria, fungi, or viruses that have spread throughout the body, including tuberculosis tb and histoplasmosis. 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. Lenalidomide and dexamethasone are other medicines used to treat multiple myeloma. Explore how pomalyst with dex works as an immunomodulatory treatment for relapsed refractory multiple myeloma. This means that kyprolis will be given to you on days 1, 2, 8, 9, 15, and 16 of each 28day cycle. Highlights of prescribing information initiate promacta at. Kyprolis carfilzomib rationale for inclusion in pa program.
Tilt the upright vial and insert a syringe with appropriately sized needle into the. See full prescribing information for kyprolis carfilzomib for injection, for intravenous use initial u. Insert needle and inject all the liquid subcutaneously. 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. Kyprolis carfilzomib is a treatment option for people who have already received 1 or more previous treatments for relapsed multiple myeloma. Do not mix kyprolis with or administer as an infusion with other medicinal products. The reconstituted solution contains carfilzomib at a concentration of 2 mgml. Simponi can lower your ability to fight infections. This will allow quick identification of new safety information. Cancidas is indicated for the treatment of esophageal candidiasisin adult and pediatric patients 3 months of age and older see clinical studies 14. Kyprolis carfilzomib for relapsed multiple myeloma. Kyprolis carfilzomib is an antineoplastic agent for the treatment of multiple myeloma in in combination with.
Farydak can cause serious side effects in some people. Teflaro should only be used if the potential benefit justifies the potential risk in these populations. Highlights of prescribing information these highlights do not include all the information needed to use revlimid safely and effectively. Kyprolis carfilzomib for injection, for intravenous use. Infuse over 10 or 30minutes depending on the kyprolis dose regimen see dosage and. Page 3 of 44 full prescribing information 1 indications and usage 1. Kyprolis in combination with either lenalidomide and dexamethasone or.
Highlights of prescribing information these highlights. In patients with a body surface area greater than 2. Kyprolis carfilzomib is a member of the proteasome inhibitors drug class and is commonly used for multiple myeloma. Infuse over 10 or 30minutes depending on the kyprolis dose regimen see dosage and administration 2. This kyprolis price guide is based on using the discount card which is accepted at most u. Severe mucocutaneous reactions, some with fatal outcomes 5. 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. Oct 04, 2019 kyprolis vials contain no antimicrobial preservatives and are intended for singledose only.
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. This medicinal product is subject to additional monitoring. Administration kyprolis can be administered in a 50ml or 100ml intravenous bag of 5% dextrose injection, usp. Jakafi is indicated for treatment of intermediate or highrisk myelofibrosis mf, including primary mf, postpolycythemia vera mf and postessential thrombocythemia mf in adults.
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