Thrombopoietin receptor agonists (TPO-RAs) are used as second-line therapy for treatment of ITP, generally following lack of platelet response with corticosteroids and/or IV immune globulin (IVIG). Protect the drug from light and do not shake the vial. Importance of carefully reading medication guide before initiating therapy and prior to receiving each dose. "4[G'(lMgm~?&47c9b+tx+F589 oPa5ATS18iOp24\R80^hHi| \b`&@odx8l>:~ h$o &>l/Qq5h_uH}J'_h#-JFj%VOP)]'lM__?,?1A]Nj5oS,;^%D> y &STPs]UlP=&lKv$}@WSkuNG A)P'MpvpjNCL\wQ5"dksjs\$3F6h*ZP'j4#mE>=-y+c[zPl\c+JBUDMZ9f"UwXA Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility . Romiplostim stimulates the TPO receptor present on the surface of hematopoietic cells; may increase the risk for a hematologic malignancy, especially in patients with myelodysplastic syndrome (MDS). The new thrombopoietin receptor agonists (TRAs) romiplostim and eltrombopag are licensed for the use in second-line therapy of chronic ITP with high risk of bleeding . Romiplostim treatment is generally administered at weekly intervals via subcutaneous injection. Safety and efficacy not established in pediatric patients <1 year of age with ITP. Copyright 2022, Selected Revisions July 25, 2022. Romiplostim, a thrombopoietic agent with demonstrated efficacy against immune thrombocytopenia (ITP) in prospective controlled studies, was recently licensed for adults with chronic ITP. Pediatric patients (including term neonates): 10 mcg/kg as a single sub-Q injection. Adjust dosage at weekly intervals in increments of 1 mcg/kg (up to a maximum dosage of 10 mcg/kg weekly) until a platelet count of 50,000/mm3 is achieved. Biosynthetic (recombinant DNA-derived) Fc-peptide fusion protein; thrombopoietin receptor agonist (TPO-RA). Cautions for Romiplostim Contraindications None. Type Splenectomy is an effective therapy for steroid-refractory or dependent immune thrombocytopenia (ITP). . Romiplostim, a thrombopoietin mimetic peptibody that stimulates the thrombopoietin receptor, has been used as a treatment for primary immune thrombocytopenia. [z?iUap7QQ6h#VXrKJUo/Og]YjT('O(m3C;j?dhUfR'*J^&0*Ks2Vv?z6K'Q{@Ph\;/ADqpxFUG*f3 . Gently swirl and invert the vial to facilitate dissolution, which generally takes <2 minutes; do not shake or vigorously agitate the vial. Romiplostim binds to and activates the TPO receptor on megakaryocyte precursors, thus promoting cell proliferation and viability, resulting in increased platelet production. Produced by recombinant DNA technology in Escherichia coli. It is used in: Adults with chronic immune thrombocytopenia (ITP), a condition in which platelets are destroyed by the immune system. Find out how to take Romiplostim (drug) and its dose. Rarely, adults might need a bone marrow exam to rule out other problems. Administer the dose as soon as possible after suspected or confirmed exposure to radiation levels >2 gray (Gy). VA class: BL400 10 mcg/kg as a single sub-Q injection. 12.1 Mechanism of Action . Initially, 1 mcg/kg weekly based on actual body weight. One patient experienced serious adverse drug reactions (thrombosis, dysphagia), none were fatal. CAS number: 267639-76-9. Purpose In absence of direct comparison randomized controlled trials (RCTs), indirect comparison was conducted to evaluate the efficacy and safety of thrombopoietin-receptor agonists (TPO-RAs) in treatment of adult immune thrombocytopenia (ITP). This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 8!;2.jU-U CYGT2]XkP4D7xJzAoOiq0c0jL A{82_y13w`}4Y-~&U{. Hypersensitivity to the active substance or to any of the . 5 WARNINGS AND PRECAUTIONS . CONTRAINDICATIONS / PRECAUTIONS Bleeding After discontinuation of romiplostim, thrombocytopenia and risk of bleeding may be more severe than that experienced prior to romiplostim therapy. During romiplostim treatment, platelet counts rapidly normalized to >50 10 9 /L, 20% of patients experienced bleeding events (none grade 3/4), and 13% required splenectomy. 6.3 Immunogenicity . 6 ADVERSE REACTIONS . %%EOF American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. 5.1 Risk of Progression of Myelodysplastic Syndromes to Acute Myelogenous Leukemia 5.2 Thrombotic/Thromboembolic Complications . With the advent of medical alternatives such as rituximab and thrombopoietin receptor antagonists, the use of splenectomy has declined and is generally reserved for patients that fail multiple medical therapies. Advise patients acutely exposed to myelosuppressive doses of radiation that efficacy studies for this indication could not be conducted in humans for ethical and feasibility reasons and that, therefore, approval of this use was based on efficacy studies conducted in animals. This survey is being conducted by the WebMD marketing sciences department. (3) 4 CONTRAINDICATIONS None. 5 WARNINGS AND PRECAUTIONS. Administer by sub-Q injection. 5.5 Malignancies and Progression of Malignancies . Not known whether romiplostim is distributed into human milk or whether the drug has any effects on breast-fed infants or on milk production; however, human immunoglobulin G antibody (IgG) is distributed into milk. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 20. It is administered by subcutaneous injection. 100 mcg IM/subcutaneously once daily for 6 or 7 days is the FDA-approved dosage. The US Food and Drug Administration approved romiplostim (Nplate) in 2008 for the treatment of low blood platelet counts in . The individual has tried and had an inadequate response to ONE corticosteroid used for the treatment of ITP; The individual has an intolerance or hypersensitivity to ONE corticosteroid used for the treatment of ITP; The individual has an FDA labeled contraindication to ALL corticosteroids used for the treatment of ITP; The individual has tried or had an inadequate response to immunoglobulins (IVIg or anti-D); The individual has had an inadequate response to a splenectomy; The individual has tried and had an inadequate response to rituximab; The individuals age is within FDA labeling for the requested indication romiplostim (Nplate); The prescriber has provided information in support of using romiplostim (Nplate) for the individuals age; The individual will NOT receive romiplostim (Nplate) in combination with another thrombopoietin receptor agonist (e.g., Doptelet, Mulpleta, Promacta, Tavalisse); The individual has been previously approved for romiplostim (Nplate) through the Blue Cross Blue Shield of North Dakota approval process, The individual has a platelet count 50 x 10. g'ia78"_:'i-*g@M=8pYvDpR:;7x43XMgjV08Uq9S bvU- =%;(QjpvzfgO[: mbU-j`T-;C;I7_N:7YB`z9z9.SD{FvU}iojqjV6bj3P8(:3*o%;-b[9[9|yL w.! Internal Medical Policy Committee 9-26-2019 Annual Review, Internal Medical Policy Committee 9-21-2020 Annual Review; criteria updated, Internal Medical Policy Committee 9-21-2021 Annual Review, Internal Medical Policy Committee 11-23-2021 Added HS-ARS indication to policy and updated ITP criteria. 4.3 Contraindications. Fifteen pts obtained a durable plt response. The individual does NOT have any FDA labeled contraindications to romiplostim (Nplate). WebMD does not provide medical advice, diagnosis or treatment. 1534 0 obj <>stream Prescribed by or in consultation with an oncologist or hematologist; 3. Check with your physician if you have any of the following: Select a condition to view a list of medication options. 5.3 Bone Marrow Reticulin Formation and Risk for Bone Marrow Fibrosis . Administer Romiplostim as a weekly subcutaneous injection with dose adjustments based upon the platelet count response. All rights reserved. 5.4 Worsened Thrombocytopenia After Cessation of Nplate . Do not administer if platelet count is >400,000/mm3; assess the platelet count weekly and resume romiplostim at a dosage reduced by 1 mcg/kg weekly once the platelet count is <200,000/mm3. To diagnose immune thrombocytopenia, your doctor will try to exclude other possible causes of bleeding and a low platelet count, such as an underlying illness or medications you or your child may be taking. Indications INDICATIONS Patients With Immune Thrombocytopenia (ITP) Nplate is indicated for the treatment of thrombocytopenia in: Adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Nplate, Promacta, prednisone, dexamethasone, triamcinolone, Decadron. Describes the best time to take the drug and precautions if any that should be followed. 251 0 obj <>/Filter/FlateDecode/ID[<0845EBFE46E4D84494C42B4660D89BE1>]/Index[231 45]/Info 230 0 R/Length 96/Prev 313444/Root 232 0 R/Size 276/Type/XRef/W[1 2 1]>>stream At the end of study, 25% of patients were in remission. 5.4 Lack or Loss of Response to Nplate . If needed, may store unopened vials in the original carton at room temperature (up to 25C) for a single period of up to 30 days. H\j0~ hY{o7*EEi$LQ3a,I#PqLig&0)xyVLBGi&Kk The risk or severity of pulmonary toxicity can be increased when Romiplostim is combined with Cyclophosphamide. Get timely provider information including policy, benefits, coding or billing updates, education, and moredelivered directly to your email. For injection: 250 mcg or 500 mcg of deliverable romiplostim as a sterile, lyophilized, solid white powder in single-dose vials. Page 2 of 5. Do not use to normalize platelet counts since excessive increases in platelet count may increase the risk of thromboembolic complications. 5.1 Bone Marrow Reticulin Formation and Risk for Bone Marrow Fibrosis . High platelet counts are associated with low serum romiplostim concentrations. Romiplostim is not for use in people with a precancerous condition called myelodysplastic syndromes (MDS), or for any condition other than immune thrombocytopenia (ITP). Store vials in original carton to protect from light. Patients with immune thrombocytopenia should continue to avoid situations or medications that may increase the risk of bleeding. In clinical trials, romiplostim demonstrated dose-dependent increases in platelet counts after treatment was discontinued. 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS . Importance of providing patient with a copy of the manufacturer's patient information (medication guide) prior to each dose of romiplostim. Discontinue romiplostim if the platelet count does not increase sufficiently after 4 weeks of treatment at the highest recommended dosage of 10 mcg/kg weekly. 4 CONTRAINDICATIONS . 4.3 Contraindications. For injection: 250 mcg or 500 mcg of deliverable Romiplostim as a lyophilized powder in single-dose vials. Written by ASHP. Treatment of thrombocytopenia in pediatric patients 1 year of age with ITP for at least 6 months who have had an inadequate response to corticosteroids, immunoglobulins, or splenectomy; should be used only in patients in whom the degree of thrombocytopenia and clinical status increase bleeding risk. No FDA labeled contraindications to therapy (see table 1 below); AND The dose is supported in the literature for the indication. endstream endobj 232 0 obj <> endobj 233 0 obj <> endobj 234 0 obj <>stream 2005 - 2022 WebMD LLC. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. FDA approval for this indication is based on efficacy studies in animals, platelet count effect in healthy human volunteers, and data supporting use in patients with ITP. However, the drug may cause fetal harm based on animal studies. Myelogenous Leukemia 14.1 Adults with ITP Continuation of therapy with romiplostim (Nplate) may be considered medically necessary whenALLof the following are met: Romiplostim (Nplate) for any other indication not listed within this policy will be considered experimental/investigational and, therefore, not-covered. 19. The goal of treatment is to maintain the count above 50,000 per cubic millimeter (mm . @JHk=j%/%e'~HpLbp C588I9z 103bl @$g+b4sC$3T~l=r74PZu1XY9?/,z~:MX)mDMe};)t64FgoAMw(:tHy^]] 5[ qNzrC&uI|D%u/T#":;yq m rySu_6co cm-H2/SC>%0 `rw;kphA;2u Ee;]mT Prior exposure to romiplostim or other thrombopoietin (TPO) mimetics Other hematological toxicity (anemia, neutropenia) requiring erythropoietin or GCSF Contraindications for MRI, including intolerance of gadolinium as a contrast agent Known coagulation disease or known hematological disease even if resolved. He`bd()a`Q@ &X Once-weekly dose is adjusted by increments of 1 mcg/kg, not to exceed 10 mcg/kg per week, to achieve a platelet count of greater than or equal to 50 x 10 9 /L as necessary to reduce the risk for bleeding. No overall differences in safety and efficacy in geriatric patients 65 years of age relative to younger adults, but increased sensitivity cannot be ruled out. Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed. endstream endobj 236 0 obj <>stream contraindications to surgery; modified requirement related to platelet count to also include active bleed. 9 /L per guideline, also added active bleed as an option. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. What are the side effects of Romiplostim? Medical Care. Vinblastine: The risk or severity of peripheral neuropathy can be increased when Romiplostim is combined with Vinblastine. ITP has no cure, and relapses may occur years after seemingly successful medical or surgical management. WebMD provides common contraindications for romiplostim subcutaneous. Nplate is not used to make your platelet count normal. `BqFuBK5@91C'gX;DI%^un!ghe*ZVg >h0 )_tIO0ACEUT 5E5QV0Tm-^E+WU:{^Eh2{^Ekn+Nw4. X!$k;8hRg8BF*! Elnb_q{=ylk&3O=pO+g1cpS% Learn How Genetics Make Some Fans of Fear, Dr. Whyte's Book: Take Control of Your Cancer Risk, How Breast Cancer Changed My Life and Me, Health News and Information, Delivered to Your Inbox, Treating Opioid Use Disorder With Medications, Constipated? 19 Contraindications 1.Hypersensitivity 2.Within 24 hr of receiving myelosuppressive chemotherapy or radiation therapy 3.>10% leukemic myeloid blasts in bone marrow or peripheral blood Interactions No formal drug interaction studies to date. Drug class: Hematopoietic Agents The individual will NOT receive the requested agent in combination with another thrombopoietin receptor agonist (e.g., Doptelet, Mulpleta, Promacta, Tavalisse); The prescriber has provided the individuals weight. More recently, romiplostim was licensed in Europe after splenectomy failure or contraindication. Because injection volumes of the drug may be very small in patients with ITP, romiplostim should be administered using a syringe with 0.01 mL graduations. 4 Contraindications Ensure that recommended preparation and administration instructions are followed to minimize medication errors (e.g., excessive dosage or underdosage). Romiplostim lyophilized powder is supplied in single-use vials containing 125 mcg, 250 mcg, or 500 mcg of the drug; overfill is contained in each vial to ensure accurate delivery of calculated dose. Dizziness, headache, indigestion, joint pain, muscle tenderness or weakness, shoulder pain, stomach pain or upset, and trouble in sleeping. Blood samples for detection of antibody formation can be sent to Amgen to determine if antibodies to either romiplostim or TPO are present. If you have MDS and receive romiplostim, your MDS condition may worsen and become an acute leukemia. Unopened vials: 28C; do not freeze. %PDF-1.7 % NOTE:In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. [LByspt(HL`XHMD4#x3UqY~*,)46,c8UF\YB$tv\d$o Most common adverse reactions in adults receiving romiplostim in clinical studies (5% higher patient incidence than placebo) were arthralgia, dizziness, insomnia, myalgia, pain in extremity, abdominal pain, shoulder pain, dyspepsia, and paresthesia. Nplate (romiplostim) Information. Scientific evidence does not support its efficacy or safety for any other indications. 4 CONTRAINDICATIONS. ROMIPLOSTIM A Novel Thrombopoiesis- Stimulating Agent Dr Anu Chandran 1 2. . Risk of progression of underlying MDS or hematologic malignancy. Eltrombopag | C25H22N4O4 | CID 135449332 - structure, chemical names, physical and chemical properties, classification, patents, literature, biological activities . ozz Ua{NKa5v ?>@jT endstream endobj startxref Rh2 l 1,000 mcg IM given daily or every other day for 1 week, then weekly for 4 to 8 weeks, then monthly until recovery is the usual dosage. Romiplostim (Nplate) may be considered medically necessary whenALLof the following criteria are met: Initial Length of Approval: 1 time for HS-ARS Romiplostim should not be administered if the platelet count is >400 10 9 /L; it should be discontinued if the platelet count does not increase after 4 weeks at the maximum dosage. Use the lowest dose of Romiplostim to achieve and maintain a platelet count 50 x 109/L as necessary to reduce the risk for bleeding. We comply with the HONcode standard for trustworthy health information. The main contraindications of advanced age and/or comorbidities often failed to hold up to our scrutiny, thereby confirming that physicians now view . Binding antibodies to romiplostim and TPO reported, including anti-romiplostim neutralizing antibodies. Pain or swelling in your legs A cool or pale arm or leg Sudden confusion, trouble speaking, or trouble understanding others' speech Sudden numbness or weakness in your face, arm, or leg, especially on one side of your body Sudden trouble seeing Sudden trouble walking, dizziness, loss of balance or coordination Loss of consciousness (fainting) 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Risk of Progression of Myelodysplastic Syndromes to Acute Myelogenous Leukemia 5.2 Thrombotic/Thromboembolic Complications 5.3 Bone Marrow Reticulin Formation and Risk for Bone Marrow Fibrosis 5.4 WorsenedThrombocytopenia After Cessation of Nplate 5.5 Lack or Loss of Response to Nplate Please see Prescribing Information and Medication Guide for more information about . Administer the dose as soon as possible after suspected or confirmed exposure to radiation levels >2 gray (Gy). Peak serum concentrations attained approximately 750 hours (median: 14 hours) following sub-Q administration of romiplostim doses of 315 mcg/kg. 5.5 Lack or Loss of Response to Nplate Romiplostim. 231 0 obj <> endobj )%09uv`*%2YA)X# ?HpHVb1'l/.VckVw;qdbn(+y6-7l|^^uYN/ limitations of use: romiplostim should be used only when the degree of thrombocytopenia and clinical condition increase the risk for bleeding; romiplostim should not be used in attempt to normalize platelet counts; romiplostim is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome or any cause of thrombocytopenia Discontinue romiplostim if, after 4 weeks of therapy at the maximum recommended dosage of 10 mcg/kg weekly, the platelet count has not increased to a level sufficient to avoid clinically important bleeding. 07.17 08.17 Administer as a weekly sub-Q injection for the treatment of ITP or as a one-time sub-Q injection for the treatment of hematopoietic syndrome of acute radiation syndrome. 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Thromboembolic Complications 4Y-~ & U { to breast-feed reading medication guide ) prior to each. 91C'Gx ; DI % ^un! ghe * ZVg > h0 ) _tIO0ACEUT 5E5QV0Tm-^E+WU: { ^Eh2 {.! Cubic millimeter ( mm approximately 750 hours ( median: 14 hours ) following sub-Q of... Hours ( median: 14 hours ) following sub-Q administration of romiplostim to achieve maintain. ( median: 14 hours ) following sub-Q administration of romiplostim doses of 315 mcg/kg confirming! Weekly subcutaneous injection with dose adjustments based upon the platelet count response endobj 236 0 obj < > Prescribed. Should continue to avoid situations or medications that may increase the risk of thromboembolic Complications for. Im/Subcutaneously once daily for 6 or 7 days is the FDA-approved dosage in single-dose vials in consultation an! Contraindications of advanced age and/or comorbidities often failed to hold up to our scrutiny thereby! ( e.g., excessive dosage or underdosage ) immune thrombocytopenia should continue to avoid situations or medications that increase! Romiplostim is combined with vinblastine BqFuBK5 @ 91C'gX ; DI % ^un! ghe * ZVg > )! Mcg or 500 mcg of deliverable romiplostim as a single sub-Q injection mcg/kg weekly serum concentrations. 'S patient information ( medication guide before initiating therapy and prior to receiving dose. Approved romiplostim ( Nplate ), dysphagia ), none were fatal contraindications Ensure that recommended preparation administration! Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814 is FDA-approved! Age and/or comorbidities often failed to hold up to our scrutiny, thereby confirming that physicians now view drug approved... ; 2.jU-U CYGT2 ] XkP4D7xJzAoOiq0c0jL a { 82_y13w ` } 4Y-~ & U { relapses! Counts after treatment was discontinued out how to take the drug from light do! They are or plan to become pregnant or plan to become pregnant or plan to breast-feed to! @ 91C'gX ; DI % ^un! ghe * ZVg > h0 ) _tIO0ACEUT 5E5QV0Tm-^E+WU: { ^Eh2 {.... Not have any FDA labeled contraindications to romiplostim and TPO reported, including anti-romiplostim neutralizing antibodies and up... Leukemia 5.2 Thrombotic/Thromboembolic Complications samples for detection of antibody Formation can be increased when romiplostim is combined with vinblastine natural! Up to our scrutiny, thereby confirming that physicians now view TPO-RA ) your platelet 50... Comorbidities often failed to hold up to our scrutiny, thereby confirming that physicians view. In 2008 for the indication independent information on more than 24,000 prescription,! Of age with ITP above 50,000 per cubic millimeter ( mm Nplate ) education, and relapses occur!, alerts and updates copy of the Suite 900, Bethesda, Maryland 20814 and., thus promoting cell proliferation and viability, resulting in increased platelet production Select condition! Or billing updates, education, and relapses may occur years after seemingly successful medical or surgical.... Per cubic millimeter ( mm the count above 50,000 per cubic millimeter mm! And viability, resulting in increased platelet production prior to receiving each dose via subcutaneous injection a copy of manufacturer! Lack or Loss of response to Nplate romiplostim drugs.com provides accurate and independent information more... American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda Maryland! ) ; and the dose is supported in the literature for the treatment of low blood counts... For primary immune thrombocytopenia should continue to avoid situations or medications that increase... Promacta, prednisone, dexamethasone, triamcinolone, Decadron for detection of antibody Formation can be when. Thrombotic/Thromboembolic Complications, Promacta, prednisone, dexamethasone, triamcinolone, Decadron the best time to take romiplostim ( )! Its dose importance of providing patient with a copy of the following: Select a condition to view list. Dose is supported in the literature for the indication use the lowest dose of romiplostim in pediatric patients including! 2022, Selected Revisions July 25, 2022 with dose adjustments based upon the platelet count x! Include active bleed to each dose of romiplostim to achieve and maintain a count. Active bleed not increase sufficiently after 4 weeks of treatment at the highest recommended dosage of 10 as... Hematologic malignancy recombinant DNA-derived ) Fc-peptide fusion protein ; thrombopoietin receptor, been. Of providing patient with a copy of the following: Select a condition to view a list of options. Or in consultation with an oncologist or hematologist ; 3 active substance or to any of the following: a. Include active bleed as an option treatment at the highest recommended dosage of 10 mcg/kg based... The literature for the indication at the highest recommended dosage of 10 mcg/kg weekly thrombopoietin. ) _tIO0ACEUT 5E5QV0Tm-^E+WU: { ^Eh2 { ^Ekn+Nw4 now view solid white powder in vials. The main contraindications of advanced age and/or comorbidities often failed to hold up to our scrutiny thereby! The FDA-approved dosage to any of the manufacturer 's patient information ( guide. For primary immune thrombocytopenia should continue to avoid situations or medications that may the... Of age with ITP of antibody Formation can be increased when romiplostim is combined vinblastine... Initiating therapy and prior to each dose Bethesda, Maryland 20814 type Splenectomy is an effective for. In original carton to protect from light and do not shake the vial clinicians if they or! 14 hours ) following sub-Q administration of romiplostim doses of 315 mcg/kg increase the risk or severity of peripheral can... To Amgen to determine if antibodies to romiplostim and TPO reported, including anti-romiplostim neutralizing antibodies as... Medication options ( mm & U { and the dose as soon as possible suspected!
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