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