Revlimid package insert pdf

It promotes immune responses to help slow tumor growth revlimid is used to treat multiple myeloma bone marrow cancer, either in combination with another medicine or after stem cell transplant revlimid is also used to treat anemia a lack of red blood cells in patients with myelodysplastic syndrome. This leaflet is part iii of a threepart product monograph published when. Minimum ppe required ppe requirements hazardous drug handling. Luxturna voretigene neparvovecrzyl full prescribing information 1 indications and usage. Revlimid is indicated for the treatment of patients with transfusiondependent anemia due to low or intermediate1risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or. Prior approval is required to ensure the safe, clinically appropriate and cost effective use of revlimid while maintaining optimal therapeutic outcomes. Rationale for inclusion in pa program background revlimid is classed as an immunomodulator and is a chemical derivative of thalidomide. Empliciti elotuzumab for injection, for intravenous use initial u. Minimum ppe required ppe requirements hazardous drug.

Minimum ppe required handling only no alteration contained crushsplit crushsplit minimum ppe required abacavir susp 2 ziagenepzicomtrizivir low abacavir tablet 2 ziagenepzicomtrizivir universal low moderate. Revlimid is indicated as maintenance therapy in adult patients with mm following autologous hematopoietic stem cell transplantation autohsct. Kyprolis carfilzomib for relapsed multiple myeloma treatment. Reactions may include hypotension, dyspnea, upper airway edema, lip swelling, rash, pruritus, and urticaria. Highlights of prescribing information these highlights do not include all the information needed to use gleevec safely and effectively. Afinitor is a prescription medicine used to treat adults with a type of cancer known as neuroendocrine tumor net of the stomach and intestine gastrointestinal or lung that has progressed and cannot be treated with surgery. Revlimid is used on its own as a maintenance therapy after patients have. Xgeva includes the same active ingredient denosumab found in prolia.

Highlightsof prescribing information kyprolis safely and. Minimum ppe required handling only no alteration contained crushsplit crushsplit minimum ppe required abacavir susp 2 ziagenepzicomtrizivir low abacavir tablet 2 ziagenepzicomtrizivir universal low moderate acitretin capsule 3 soriatane universal moderate anastrazole tablet 1 arimidex low moderate high android capsule 3. Initially, 25 mg once daily given on days 121 of each 28day cycle. Revlimid maintenance therapy versus 2 years for patients who had not. Darzalex is a prescription medicine used to treat adults with multiple myeloma. Medication guide revlimid rev li mid lenalidomide capsules. If you are eligible, our copay program lowers your copay responsibility. Highlights of prescribing information these highlights do not. Revlimid should not be used to treat people who have chronic lymphocytic. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for revlimid lenalidomide. Revlimid lenalidomide in combination with dexamethasone dex is indicated for the treatment of adult patients with multiple myeloma mm.

The recommended starting dose of revlimid is 25 mg orally once da ily on days 121 of repeated 28day cycles in combination with dexamethasone. Tagrisso osimertinib tablets, for oral use initial u. How can ninlaro ixazomib treat my multiple myeloma. Refer to the dexamethasone prescribing information for other information on that product. Dailymed darzalex daratumumab injection, solution, concentrate. Before you begin taking revlimid, you must read and agree. Revlimid should not be used to treat people who have chronic lymphocytic leukemia cll unless. Apr 01, 2020 revlimid can cause severe, lifethreatening birth defects or death of a baby if the mother or the father is taking this medicine at the time of conception or during pregnancy.

Revlimid is a thalidomide analogue indicated for the treatment of adult patients with. Patient information empliciti elotuzumab for injection. Empliciti is indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to. Revlimid is a prescription medicine used to treat people. Patients experiencing new or worsening peripheral neuropathy during velcade therapy may require a decrease in the dose andor a less doseintense schedule. Even one dose of lenalidomide can cause major birth defects of the babys arms and legs, bones, ears, eyes, face, and heart. 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 these highlights do not include all the information needed to use tagrisso. Download leaflet view the patient leaflet in pdf format. Relapsed refractory multiple myeloma treatment pomalyst. A treatment option for multiple myeloma revlimid lenalidomide. Revlimid in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated marginal zone lymphoma mzl. The infusion time must not be less than 15 minutes given over a constant infusion rate. Initiate treatment with letairis in females of reproductive potential only after a negative pregnancy test.

Pomalyst pomalidomide is a thalidomide analogue indicated, in combination with dexamethasone, for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor 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. The recommended starting dose of revlimid is 25 mg once daily on days 121 of repeated 28day cycles. Please see indication and important safety information. Afinitor is not for use in people with carcinoid tumors that actively produce hormones. Page 3 of 44 full prescribing information 1 indications and usage 1. Ninlaro is a prescription medicine used to treat multiple myeloma in combination with the medicines revlimid. Gleevec imatinib mesylate tablets, for oral use initial u. Ninlaro is taken along with 2 other medications, lenalidomide and dexamethasone, in 4week cycles. Mm, as maintenance following autologous hematopoietic stem cell transplantation autohsct. Ninlaro ixazomib is the first and only oral medication of its kind, a proteasome inhibitor, that you can take at home. The capsules should not be opened, broken, or chewed.

Revlimid is indicated for the treatment of adult patients with transfusiondependent anemia due to low or intermediate1risk myelodysplastic syndromes mds associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Empliciti is used with other prescription medicines called revlimid lenalidomide and dexamethasone or pomalyst pomalidomide and dexamethasone. 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. This medicinal product is subject to additional monitoring.

Revlimid capsules should be swallowed whole with water. Revlimid is for the type of mds with a chromosome problem where part of chromosome 5 is missing. Revlimid lenalidomide a treatment option for multiple. Revlimid should be taken orally at about the same time each day, either with or without food. To avoid embryofetal exposure to lenalidomide, revlimid is only available through a restricted distribution program, the revlimid remstm program formerly known as the revassist program 5. Revlimid, innlenalidomide european medicines agency. Nov 07, 2019 revlimid is a thalidomide analogue indicated for the treatment of adult patients with. This dosing calendar is a snapshot of the ninlaro regimen for a 28day cycle. Sections or subsections omitted from the full prescribing information are not listed. You should not receive velcade if you are allergic to bortezomib, boron, or mannitol. Patient information empliciti elotuzumab for injection read. Darzalex is a cd38directed cytolytic antibody indicated for the treatment of adult patients with multiple myeloma. Patients should not break, chew or open the capsules.

Rebetol monotherapy is not effective for the treatment of chronic hepatitis c virus infection and should not be used alone for this indication see warnings and precautions 5. Revlimid lenalidomide is indicated for the treatment of patients with transfusion dependent anemia due to low or intermediate1risk. After initiation of revlimid therapy, subsequent revlimid dose modification should be based on individual patient treatment tolerance, as described elsewhere in this section. Retreatment of pagets disease after a single treatment with reclast in pagets disease an extended remission period is observed.

Another significant finding supporting revlimids role as postasct maintenance therapy was presented at the december 2016 meeting. Revlimid is contraindicated in pregnant women andwomen at risk of becoming pregnant. Highlights of prescribing information these highlights do not include all the information needed to use empliciti safely and effectively. Please see accompanying full prescribing information.

Highlights of prescribing information hypocalcemia may worsen. Revlimid lenalidomide is a prescription medicine used to treat adults with a condition called myelodysplastic syndromes mds. Revlimid is a registered trademark of celgene corporation. You can ask your healthcare provider or pharmacist for information about dexamethasone.

Ninlaro ixazomib capsules, for oral use hepatotoxicity. For a complete listing, see dosage forms, composition and packaging. Revlimid is not indicated and is not recommended for the treatme nt of patients with cll outside of controlled clinical trials see warnings and precautions 5. Velcade can cause damage to the nerves, a condition called peripheral neuropathy. Revlimid lenalidomideis contraindicatedin patients who are hypersensitive to itor to thalidomide, pomalidomideor to any ingredient in the formulation or component of the container. Highlights of prescribing information these highlights do not include all the information needed to use reclast safely and effectively. 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. What is the most important information i should know about revlimid. Revlimid is indicated as maintenance therapy in adult patients with mm following autologous hematopoietic stem. Explore how pomalyst with dex works as an immunomodulatory treatment for relapsed refractory multiple myeloma. Kyprolis carfilzomib for relapsed 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.

Highlights of prescribing information hypocalcemia. Multiple myeloma mm, in combination with dexamethasone. Read the medication guide that comes with revlimid if used with revlimid and pomalyst if used with pomalyst. Highlights of prescribing information these highlights do not include all the information needed to use tecentriq safely and effectively. A study showed that adding ninlaro to revlimid lenalidomide and dexamethasone improved median progressionfree survival pfs by nearly 6 months 20. Learn more about revlimid, a treatment option for multiple myeloma. Jan 01, 2020 darzalex is a cd38directed cytolytic antibody indicated for the treatment of adult patients with multiple myeloma. The recommended dose of dexamethasone is 40 mg once daily on days 14, 912, and 1720 of each 28day cycle for the first 4 cycles of therapy and then 40 mg once daily orally on days 14 every 28 days. 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. Transfusiondependent anemia due to low or intermediate1risk myelodysplastic syndromes mds. Highlights of prescribing information these highlights do not include all the information needed to use pomalyst safely and effectively. Empliciti elotuzumab, when used with pd or rd, is a prescription treatment for certain adults with relapsed or refractory multiple myeloma. For dose or schedule modification guidelines for patients who experience velcaderelated neuropathic pain andor peripheral neuropathy see table 5. Although the exact mechanism of action is unknown, lenalidomide also has antiinflammatory and anticancer.

368 1225 635 581 393 1453 71 1041 1434 747 785 210 723 1229 1423 1181 9 525 976 1370 1516 259 1510 100 955 1573 485 375 1043 510 1569 948 1355 1385 255 1391 1228 1497 241 215 621 255 691