Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. 12.1 Mechanism of Action . Romiplostim (Nplate) may be considered medically necessary whenALLof the following criteria are met: Initial Length of Approval: 1 time for HS-ARS 5.1 Bone Marrow Reticulin Formation and Risk for Bone Marrow Fibrosis . Dizziness, headache, indigestion, joint pain, muscle tenderness or weakness, shoulder pain, stomach pain or upset, and trouble in sleeping. endstream endobj 232 0 obj <> endobj 233 0 obj <> endobj 234 0 obj <>stream Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal supplements, as well as any concomitant illnesses. 2.1 Romiplostim (Nplate, Amgen) is a protein that mimics the action of thrombopoietin by acting as an agonist at thrombopoietin receptors. It should not be used to treat thrombocytopenia caused by other conditions and may worsen pre . Use of romiplostim in pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation is based on efficacy studies conducted in animals; studies in humans could not be conducted because of ethical and feasibility reasons. endstream endobj startxref 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). May be used with other drugs to treat ITP such as corticosteroids, danazol, azathioprine, immune globulin IV (IGIV), and Rho(D) immune globulin. 1534 0 obj <>stream In patients with immune thrombocytopenia (ITP), monitor complete blood counts (CBCs), including platelet counts, weekly during the dose adjustment phase, and then monthly after establishment of a stable dosage; because of the potential for worsening thrombocytopenia following discontinuance of romiplostim, monitor CBCs, including platelet counts, weekly for at least 2 weeks following discontinuation of the drug. In this open-label, 52-week study, we randomly assigned 234 adult patients with immune thrombocytopenia, who had not undergone splenectomy, to receive the standard of care (77 patients) or weekly . Initial Length of Approval: 1 time for HS-ARS 4 months for ITP Reauthorization Criteria Continuation of therapy with romiplostim (Nplate) may be considered medically necessary when ALL of the following are met: 4 Contraindications 4.3 Contraindications. AHFS DI Essentials. Copyright 2022, Selected Revisions July 25, 2022. Has no amino acid sequence homology to endogenous thrombopoietin. Clinical Policy: Romiplostim (Nplate) Reference Number: CP.PHAR.179 Effective Date: 03.01.16 Last Review Date: 02.20 Line of Business: Commercial, HIM, Medicaid . What are the . Advise women not to breast-feed while receiving the drug. 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. Risk of adverse events associated with long-term administration not fully known. Romiplostim treatment is generally administered at weekly intervals via subcutaneous injection. All rights reserved. @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 4 CONTRAINDICATIONS . 4510 13th Ave. S. 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. Indications Romiplostim is approved by the FDA for the treatment of thrombocytopaenia in patients with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins or. The prescribed Romiplostim dose may consist of a very small volume (eg, 0.15 mL). CONTRAINDICATIONS / PRECAUTIONS Bleeding After discontinuation of romiplostim, thrombocytopenia and risk of bleeding may be more severe than that experienced prior to romiplostim therapy. Reconstitution of the lyophilized drug as directed provides a clear and colorless solution. 231 0 obj <> endobj Prior to injection, a complete blood count (CBC) is obtained, as the dosage is dependent on the individual's body weight and platelet count at the time of treatment. %PDF-1.7 % 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. 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 50,000/mm3 is achieved. Romiplostim (Nplate) is a thrombopoietin receptor agonist that increases platelet production through binding and activation of the thromobpoietin (TPO) receptor, similar in mechanism to endogonous TPO. Rh2 l 5.4 Lack or Loss of Response to Nplate . [z?iUap7QQ6h#VXrKJUo/Og]YjT('O(m3C;j?dhUfR'*J^&0*Ks2Vv?z6K'Q{@Ph\;/ADqpxFUG*f3 Time/action profile Contraindications/Precautions Contraindicated in: None noted. 5 WARNINGS AND PRECAUTIONS. In cases of hyporesponsiveness or failure to maintain a platelet response, consider performing an evaluation of possible causative factors (e.g., presence of neutralizing antibodies). 5 WARNINGS AND PRECAUTIONS . 6.3 Immunogenicity . Rarely, adults might need a bone marrow exam to rule out other problems. Used to increase survival in adults and pediatric patients (including term neonates) who are acutely exposed to myelosuppressive doses of radiation. Available studies in humans are insufficient to inform a drug-associated risk if romiplostim is used during pregnancy. Blood tests can check the levels of platelets. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Methods We searched PubMed, Embase and Cochrane Library, Clinical Trials.gov, China National Knowledge Infrastructure, and Chinese Biomedical . %PDF-1.6 % Binds to the thrombopoietin receptor (also known as cMp1) and activates intracellular transcriptional pathways leading to increased platelet production. Drug class: Hematopoietic Agents )%09uv`*%2YA)X# ?HpHVb1'l/.VckVw;qdbn(+y6-7l|^^uYN/ Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically. Adjust dosage based on platelet count monitoring and changes in body weight. Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). Reconstituted solutions that have been further diluted: Store in a syringe at room temperature (25C) or in the original vial refrigerated at 28C for up to 4 hours prior to administration. 5.2 Worsened Thrombocytopenia After Cessation of Nplate . 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. contraindications to surgery; modified requirement related to platelet count to also include active bleed. . Half-life: 1-34 days. 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 5.1 Risk of Progression of Myelodysplastic Syndromes to Acute Myelogenous Leukemia . Corticosteroids remain the standard initial therapy for newly diagnosed patients with ITP, but should be used for a limited duration only because of their adverse effects. Eltrombopag | C25H22N4O4 | CID 135449332 - structure, chemical names, physical and chemical properties, classification, patents, literature, biological activities . Romiplostim is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome ( MDS) or any cause of thrombocytopenia other than chronic ITP. All rights reserved. 12.2 Pharmacodynamics . The main contraindications of advanced age and/or comorbidities often failed to hold up to our scrutiny, thereby confirming that physicians now view . 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. Hypersensitivity to the active substance or to any of the . 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. ROMIPLOSTIM A Novel Thrombopoiesis- Stimulating Agent Dr Anu Chandran 1 2. . Warnings/Precautions Risk of Progression of Myelodysplastic Syndromes to Acute Myeloid Leukemia 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). This survey is being conducted by the WebMD marketing sciences department. Scientific evidence does not support its efficacy or safety for any other indications. Store vials in original carton to protect from light. Romiplostim should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding . Conclusion:A single injection of romiplostim administered 24 h after TBI is a promising radiation medical countermeasure that dramatically increased survival, with or without pegfilgrastim, and hastened PLT recovery in mice. 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. CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The median time to reach a plt count above 50 x 10 9 /L free of plt transfusion was 36 days (Figure 1), with required doses of 4 mg/Kg (IQR, 3-6). Medically reviewed by Drugs.com on Jul 25, 2022. Nplate (romiplostim) is used to treat low blood platelet counts in adults with chronic immune (idiopathic) thrombocytopenia (ITP), when certain other medicines . Contraindications 4 CONTRAINDICATIONS . 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. The individual does NOT have any FDA labeled contraindications to romiplostim (Nplate). Once stored at room temperature, do not place back in the refrigerator. Adjust dosage based on platelet count monitoring. He`bd()a`Q@ &X xc84(ZSktzP>}]Y+C_.}Yz|w6.n=))|tVS4{^}fNS=~C:?asb The elimination of romiplostim occurs according to the TPO receptor located on the platelet. An additional overfill is included in each vial to ensure that 250 mcg of romiplostim can be delivered. 12 Medicines That Could Help, List Romiplostim Subcutaneous side effects by likelihood and severity. Importance of informing patients of other important precautionary information. It is used in: Adults with chronic immune thrombocytopenia (ITP), a condition in which platelets are destroyed by the immune system. Ensure that recommended preparation and administration instructions are followed to minimize medication errors (e.g., excessive dosage or underdosage). 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. 7wN6|hp 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. The time to peak concentration (T max) with romiplostim is approximately 7 to 50 hours (median, 14 hours for the post- weekly dose). 8!;2.jU-U CYGT2]XkP4D7xJzAoOiq0c0jL A{82_y13w`}4Y-~&U{. Reassessment of body weight in pediatric patients is recommended every 12 weeks. Type 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. Administer the dose as soon as possible after suspected or confirmed exposure to radiation levels >2 gray (Gy). Romiplostim is a man-made thrombopoietin receptor agonist (TPO mimetic) that increases platelet counts by increasing the number and maturation of bone marrow megakaryocytes. 1-10% (Adults) Bronchitis Sinusitis Vomiting Arthralgia Myalgia Headache Dizziness Diarrhea Upper respiratory tract infection Cough Nausea Oropharyngeal pain Romiplostim injection may cause side effects. Cautions for Romiplostim Contraindications None. Find out what health conditions may be a health risk when taken with romiplostim subcutaneous 6 ADVERSE REACTIONS . Do not use to normalize platelet counts since excessive increases in platelet count may increase the risk of thromboembolic complications. Importance of avoiding situations or drug therapies that may increase risk of bleeding. Biosynthetic (recombinant DNA-derived) Fc-peptide fusion protein; thrombopoietin-receptor agonist (TPO-RA). Gently swirl and invert the vial to facilitate dissolution, which generally takes <2 minutes; do not shake or vigorously agitate the vial. Nplate is not used to make your platelet count normal. 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS . endstream endobj 236 0 obj <>stream ITP is a condition that may cause unusual bruising or bleeding due to an abnormally low number of platelets in the blood. *Zp]T]6eu3XuU@NMjz4ro *NOTE: The FDA approved prescribing information for romiplostim includes the following limitation of use: Romiplostim is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than chronic ITP. 5.1 Risk of Progression of Myelodysplastic Syndromes to Acute Myelogenous Leukemia 5.2 Thrombotic/Thromboembolic Complications . Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Although romiplostim has been available in the United States since January 2009, no data on its efficacy and safety in unselected patients have been reported to date. %(CT-^E+WU:{^EDv:Xbpz5; 9UkT^*+V^EWU4&WUfc8z[GK~goM*C4(}MX)d,SS|I!`[cDpEa]P&*qA)):O9+W&X+ZYhu {QEt Biosynthetic (recombinant DNA-derived) Fc-peptide fusion protein; thrombopoietin receptor agonist (TPO-RA). Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Efficacy studies not conducted for ethical and feasibility reasons. Treatment of thrombocytopenia in adults with immune thrombocytopenia (ITP; also known as idiopathic thrombocytopenic purpura) 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. If you have MDS and receive romiplostim, your MDS condition may worsen and become an acute leukemia. Administer by sub-Q injection. Unopened vials: 28C; do not freeze. The following reconstitution directions are for calculated romiplostim doses <23 mcg: Vial labeled as containing 125 mcg of romiplostim: reconstitute with 0.44 mL of sterile water for injection and dilute with 1.38 mL of 0.9% sodium chloride injection to provide a final concentration of 125 mcg/mL, Vial labeled as containing 250 mcg of romiplostim: reconstitute with 0.72 mL of sterile water for injection and dilute with 2.25 mL of 0.9% sodium chloride injection to provide a final concentration of 125 mcg/mL, Vial labeled as containing 500 mcg of romiplostim: reconstitute with 1.2 mL of sterile water for injection and dilute with 3.75 mL of 0.9% sodium chloride injection to provide a final concentration of 125 mcg/mL. After clinical improvement and if a reticulocyte response is seen, give 100 mcg IM/subcutaneously on alternate days for 7 doses . 5.4 Worsened Thrombocytopenia After Cessation of Nplate . However, the drug may cause fetal harm based on animal studies. Patients were excluded in the presence of bone marrow fibrosis, acute leukemia, myelodysplasia or other contraindications for surgery, bone marrow excess blasts or a history of . severe low platelet count in unresponsive chronic ITP, bone marrow failure from acute radiation toxicity, increase in the number of platelets in the blood, obstruction of a blood vessel by a blood clot, myelodysplastic syndrome, a bone marrow disorder, increased reticulin bone marrow deposition. . 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. Keywords: Thrombocytopenia; hematopoietic acute radiation syndrome; medical countermeasure; romiplostim. 5.1 Risk of Progression of Myelodysplastic Syndromes to Acute 12.3 Pharmacokinetics Myelogenous Leukemia . 2022 Blue Cross Blue Shield of North Dakota, Please wait while your form is being submitted, Directory Validation Instructions (No Surprises Act), Recredentialing & Credentialing Applications. - Colony-stimulating Factors 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. 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. 100 mcg IM/subcutaneously once daily for 6 or 7 days is the FDA-approved dosage. 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. Do not pool doses from multiple vials and do not use more than one dose from each single-use vial; discard any unused portions of the solution. Importance of understanding that the goal of therapy in ITP is to achieve and maintain a platelet count of 50,000/mm3 to reduce the risk of bleeding, not to normalize platelet counts. AcQEOY42XT^!J;BB8SQ tw~{qy/nz>t_^__q>?|_]|x{0on~s}}xw?k{Sw};|W?{otnot|wuys77^|t=~w}/NFeHaTR'58TYM:k*8qmhv6D?lC68mCL6CS. If the calculated dose is <23 mcg, further dilution with 0.9% sodium chloride injection is required to a reduced concentration that allows for low doses to be accurately calculated and consistently measured with a 0.01 mL graduated syringe.
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