romiplostim contraindications

However, the drug may cause fetal harm based on animal studies. Selected from data included with permission and copyrighted by First Databank, Inc. 12 Medicines That Could Help, List Romiplostim Subcutaneous side effects by likelihood and severity. 5.4 Worsened Thrombocytopenia After Cessation of Nplate . Adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. 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 . Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal supplements, as well as any concomitant illnesses. After reconstitution, a deliverable volume of 0.5 mL solution contains 250 mcg of romiplostim (500 mcg/mL). What conditions does Romiplostim Subcutaneous treat? 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 Loss of Response to Nplate 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Postmarketing Experience 6.3 Immunogenicity 7 DRUG INTERACTIONS Adjust dosage based on platelet count monitoring. 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) 5.2 Thrombotic/Thromboembolic Complications . Vinblastine: The risk or severity of peripheral neuropathy can be increased when Romiplostim is combined with Vinblastine. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. The initial dose of romiplostim (Nplate) is 1 mcg/kg with future dose adjustments based on changes in platelet counts only. The following side effects are common (occurring in greater than 30%) for patients taking romiplostim: Headache fatigue Coughing up blood These side effects are less common side effects (occurring in about 10-29%) of patients receiving romiplostim: Joint pain (arthralgia) Dizziness Insomnia Muscle pain (myalgia) Pain in extremity Abdominal pain Diagnosis. 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 . Reconstitute lyophilized romiplostim with sterile water for injection. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Children aged 1 year and older who have had ITP for at least 6 months. ROMIPLOSTIM A Novel Thrombopoiesis- Stimulating Agent Dr Anu Chandran 1 2. . Romiplate may be used with other medical ITP therapies, such as corticosteroids, danazol, azathioprine, intravenous immunoglobulin (IVIG), and anti-D immunoglobulin. Blood tests can check the levels of platelets. Each vial contains 250 mcg of romiplostim. Fifteen pts obtained a durable plt response. Find out how to take Romiplostim (drug) and its dose. 9 /L per guideline, also added active bleed as an option. Member has lower-risk MDS (IPSS-R (Very Low, Low, Intermediate), IPSS . High platelet counts are associated with low serum romiplostim concentrations. Importance of carefully reading medication guide before initiating therapy and prior to receiving each dose. Rh2 l Cqv1Xpl%3,QC~:?[>27C 8Bc u6{Wn7:gZk"W8'4 xdtN=$cM0.zuFTu%@"($O~p_7MeLq'{(0KdkJ1PQ? Half-life: 1-34 days. 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. Romiplostim is a man-made protein medicine used to treat low blood platelet counts (thrombocytopenia) in adults with chronic idiopathic thrombocytopenic purpura (ITP). Pediatric patients 1 year of age and older with ITP for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. It is used in: Adults with chronic immune thrombocytopenia (ITP), a condition in which platelets are destroyed by the immune system. 7 DRUG INTERACTIONS 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: 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). endstream endobj 232 0 obj <> endobj 233 0 obj <> endobj 234 0 obj <>stream The US Food and Drug Administration approved romiplostim (Nplate) in 2008 for the treatment of low blood platelet counts in . An additional overfill is included in each vial to ensure that 125 mcg of romiplostim can be delivered. Brand name: Nplate Available for Android and iOS devices. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically. 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. 6 ADVERSE REACTIONS . The individual does NOT have any FDA labeled contraindications to romiplostim (Nplate). 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. Nplate (romiplostim) is used to treat low blood platelet counts in adults with chronic immune (idiopathic) thrombocytopenia (ITP), when certain other medicines . 2 The technology. 5.2 Thrombotic/Thromboembolic Complications 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility [z?iUap7QQ6h#VXrKJUo/Og]YjT('O(m3C;j?dhUfR'*J^&0*Ks2Vv?z6K'Q{@Ph\;/ADqpxFUG*f3 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. Administer the dose as soon as possible after suspected or confirmed exposure to radiation levels >2 gray (Gy). 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. What are the . Smart Grocery Shopping When You Have Diabetes, Surprising Things You Didn't Know About Dogs and Cats, Latest Facts on COVID-19 Vaccine Boosters, History Does Repeat: Vaccine Resistance Is Not New, Synthetic Chemical in Many Products Linked to Early Death, New Drug for Early Breast Cancer: First Advance in 20 Years, Love Horror? Tell your doctor if any of these symptoms are severe or do not go away: headache joint or muscle pain pain in the arms, legs, or shoulders numbness, burning, or tingling in the arms or legs stomach pain heartburn vomiting diarrhea difficulty falling asleep or staying asleep 10 mcg/kg as a single sub-Q injection. 8!;2.jU-U CYGT2]XkP4D7xJzAoOiq0c0jL A{82_y13w`}4Y-~&U{. 5 WARNINGS AND PRECAUTIONS . Nplate is not used to make your platelet count normal. V2S&38MJ9L`&k57-:-ba'mNl 8s5nz;zl]Gib'-q[+:En_lwmYh`4tA1_q xD]FP1,"Y!= /]uj.uG"6U%T|6&I Romiplostim may encourage the progression of myelodysplasia to acute myeloid leukemia.. An 85-year-old woman with thrombocytopenia, thought to be immune but actually secondary to myelodysplasia, was given romiplostim, initially 1 microgram/kg/week, increasing weekly to 10 micrograms/kg/week [27].After 6 weeks she developed leukemic skin lesions with an extensive diffuse dermal infiltrate of . 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. 0 Dizziness, headache, indigestion, joint pain, muscle tenderness or weakness, shoulder pain, stomach pain or upset, and trouble in sleeping. 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS . To minimize the risk, do not use romiplostim to normalize platelet counts and follow recommended dosage adjustment guidelines. - Colony-stimulating Factors Protect the drug from light and do not shake the vial. 5.3 Bone Marrow Reticulin Formation and Risk for Bone Marrow Fibrosis . Used to increase survival in adults and pediatric patients (including term neonates) who are acutely exposed to myelosuppressive doses of radiation. Romiplostim injection may cause side effects. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. 2.1 Romiplostim (Nplate, Amgen) is a protein that mimics the action of thrombopoietin by acting as an agonist at thrombopoietin receptors. Scientific evidence does not support its efficacy or safety for any other indications. Medical Care. No special population dosage recommendations at this time. Romiplostim, a thrombopoietic agent with demonstrated efficacy against immune thrombocytopenia (ITP) in prospective controlled studies, was recently licensed for adults with chronic ITP. Contains 2 identical single-chain subunits, each consisting of human IgG1 Fc domain covalently linked at the C-terminus to a peptide containing 2 thrombopoietin receptor-binding domains. Administer the dose as soon as possible after suspected or confirmed exposure to radiation levels >2 gray (Gy). 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 If you have MDS and receive romiplostim, your MDS condition may worsen and become an acute leukemia. Type Find out what health conditions may be a health risk when taken with romiplostim subcutaneous At the end of study, 25% of patients were in remission. Administer the drug regardless of whether a CBC can be obtained. 5.1 Risk of Progression of Myelodysplastic Syndromes to Acute . In clinical trials, romiplostim demonstrated dose-dependent increases in platelet counts after treatment was discontinued. Not known whether romiplostim is distributed into milk. 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). Romiplostim. 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. This survey is being conducted by the WebMD marketing sciences department. Nplate is used to try to keep your platelet count about 50,000 per microliter in order to lower the risk for bleeding. The following conditions are contraindicated with this drug. The individual has been previously approved for romiplostim (Nplate) through the Blue Cross Blue Shield of North Dakota approval process; The individual has a diagnosis of immune (idiopathic) thrombocytopenia (ITP) AND ONE of the following: The individuals platelet count is 50 x 10. Contraindications Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Ensure that recommended preparation and administration instructions are followed to minimize medication errors (e.g., excessive dosage or underdosage). Reassessment of body weight in pediatric patients is recommended every 12 weeks. . Binds to the thrombopoietin receptor (also known as cMp1) and activates intracellular transcriptional pathways leading to increased platelet production. Romiplostim treatment is generally administered at weekly intervals via subcutaneous injection. Common side effects of Romiplostim include: bruising, headache, dizziness, joint pain, muscle weakness or tenderness, pain in the arms, legs, or shoulder, numbness or tingling in the hands or feet, trouble sleeping, stomach pain, indigestion, nausea, vomiting, diarrhea, 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. Approximately 134 days (median: 3.5 days). One patient experienced serious adverse drug reactions (thrombosis, dysphagia), none were fatal. `BqFuBK5@91C'gX;DI%^un!ghe*ZVg >h0 )_tIO0ACEUT 5E5QV0Tm-^E+WU:{^Eh2{^Ekn+Nw4. X!$k;8hRg8BF*! Eltrombopag | C25H22N4O4 | CID 135449332 - structure, chemical names, physical and chemical properties, classification, patents, literature, biological activities . Romiplostim is used in certain patients with ITP who have not gotten . All rights reserved. h]sdq\&W7U.U9%rJH*JY>h!YsC41nZI5w]K-]]-]mWB-v9~ZNHF$_|BRR$+Tr{EUO^E76'd;> UygBjJ8zG]T6&C{RQk:\TQDDBnD[U! Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Local prescribing information should be consulted for full details of contraindications, warnings and precautions that relate to the use of romiplostim. . Efficacy studies not conducted for ethical and feasibility reasons. AHFS DI Essentials. 4.3 Contraindications. 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). Done by : Ahmed Fahad Basilim clinical pharmacist intern Supervised by: Dr. Muna Filfilan 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. 07.17 08.17 After reconstitution, a deliverable volume of 0.25 mL solution contains 125 mcg of romiplostim (500 mcg/mL). 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. 100 mcg IM/subcutaneously once daily for 6 or 7 days is the FDA-approved dosage. Cautions for Romiplostim Contraindications None. 231 0 obj <> endobj Rarely, adults might need a bone marrow exam to rule out other problems. 14 CLINICAL STUDIES. Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. *Zp]T]6eu3XuU@NMjz4ro 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. 5.3 Loss of Response to Nplate . Prescribed by or in consultation with an oncologist or hematologist; 3. 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. Binding antibodies to romiplostim and TPO reported, including anti-romiplostim neutralizing antibodies. endstream endobj 235 0 obj <>stream 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). Patients with immune thrombocytopenia should continue to avoid situations or medications that may increase the risk of bleeding. 5.1 Risk of Progression of Myelodysplastic Syndromes to Acute 12.3 Pharmacokinetics Myelogenous Leukemia . 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility . Use Cautiously in: Hepatic or renal impairment; Geriatric: Elderly patients may be more sensitive to effects, escalate dose cautiously, consider concurrent disease states, age-related in organ function and drug therapy. 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 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. contraindications to surgery; Changed platelet criterion from < 50 to < 30 x 10. 1-10% (Adults) Bronchitis Sinusitis Vomiting Arthralgia Myalgia Headache Dizziness Diarrhea Upper respiratory tract infection Cough Nausea Oropharyngeal pain 7wN6|hp Methods We searched PubMed, Embase and Cochrane Library, Clinical Trials.gov, China National Knowledge Infrastructure, and Chinese Biomedical . Things to remember when you fill your prescription. The time to peak concentration (T max) with romiplostim is approximately 7 to 50 hours (median, 14 hours for the post- weekly dose). Do not use romiplostim to treat thrombocytopenia related to MDS or any cause of thrombocytopenia other than ITP. Importance of avoiding situations or drug therapies that may increase risk of bleeding. Individualize treatment decisions and consider comparative risks and benefits, and adverse effects of therapy. 5 WARNINGS AND PRECAUTIONS. Eltrombopag has also been recently approved (late 2012) for the treatment of thrombocytopenia (low blood platelet counts) in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy. CONTRAINDICATIONS / PRECAUTIONS Bleeding After discontinuation of romiplostim, thrombocytopenia and risk of bleeding may be more severe than that experienced prior to romiplostim therapy. Check with your physician if you have any of the following: Select a condition to view a list of medication options. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 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. Safety and efficacy not established in pediatric patients <1 year of age with ITP. 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. - CSFs 12.1 Mechanism of Action . 5 WARNINGS AND PRECAUTIONS . A total of 17 and 12 pts experienced aGVHD and cGVHD, respectively, with 100 days CumI of . VA class: BL400 $_ ib@+ Elnb_q{=ylk&3O=pO+g1cpS% Corticosteroids remain the standard initial therapy for newly diagnosed patients with ITP, but should be used for a limited duration only because of their adverse effects. Romiplostim is approved to treat: Thrombocytopenia (low platelet levels). Warnings/Precautions Risk of Progression of Myelodysplastic Syndromes to Acute Myeloid Leukemia Romiplostim stimulates the TPO receptor present on the surface of hematopoietic cells; may increase the risk for a hematologic malignancy, especially in patients with myelodysplastic syndrome (MDS). 5.2 Worsened Thrombocytopenia After Cessation of Nplate . g'ia78"_:'i-*g@M=8pYvDpR:;7x43XMgjV08Uq9S bvU- =%;(QjpvzfgO[: mbU-j`T-;C;I7_N:7YB`z9z9.SD{FvU}iojqjV6bj3P8(:3*o%;-b[9[9|yL w.! Store vials in original carton to protect from light. Drug class: Hematopoietic Agents Romiplostim, a thrombopoietin mimetic peptibody that stimulates the thrombopoietin receptor, has been used as a treatment for primary immune thrombocytopenia. Internal Medical Policy Committee 9-26-2019 Annual Review, Internal Medical Policy Committee 9-21-2020 Annual Review; criteria updated, Internal Medical Policy Committee 9-21-2021 Annual Review, Internal Medical Policy Committee 11-23-2021 Added HS-ARS indication to policy and updated ITP criteria. JzRj!gdR83h 'qm!bI%S*k^Pk^Rj^Qb(?cB%l\?\ex Pediatric patients (including term neonates): 10 mcg/kg as a single sub-Q injection. Nplate, Promacta, prednisone, dexamethasone, triamcinolone, Decadron. hY{o7*EEi$LQ3a,I#PqLig&0)xyVLBGi&Kk CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. Fargo, N.D., 58121. %(CT-^E+WU:{^EDv:Xbpz5; 9UkT^*+V^EWU4&WUfc8z[GK~goM*C4(}MX)d,SS|I!`[cDpEa]P&*qA)):O9+W&X+ZYhu {QEt 5.1 Risk of Progression of Myelodysplastic Syndromes to Acute Myelogenous Leukemia 5.2 Thrombotic/Thromboembolic Complications . 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. (See Cautions.). endstream endobj startxref Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. 1534 0 obj <>stream Biosynthetic (recombinant DNA-derived) Fc-peptide fusion protein; thrombopoietin-receptor agonist (TPO-RA). 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 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. Peak serum concentrations attained approximately 750 hours (median: 14 hours) following sub-Q administration of romiplostim doses of 315 mcg/kg. . The individuals platelet count has increased sufficiently to avoid clinically important bleeding; The individual has a diagnosis of immune (idiopathic) thrombocytopenia (ITP); The individual is between the ages of 1 and 17 years old AND the diagnosis has lasted for at least 6 months; The individual has had an insufficient response to a splenectomy; The individual has tried and had an inadequate response to corticosteroids or immunoglobulins (IVIg or anti-D); The individual has a documented intolerance, FDA labeled contraindication, or hypersensitivity to corticosteroids; The individual is NOT being treated with another thrombopoietin receptor agonist (e.g., Doptelet, Mulpleta, Promacta, Tavalisse); The individual is currently being treated with another thrombopoietin receptor agonist AND will discontinue prior to initiating romiplostim (Nplate); The prescriber has provided the individual's weight. Do not reconstitute or dilute the drug with bacteriostatic water for injection, or dilute with bacteriostatic sodium chloride injection. %PDF-1.7 % Do not use to normalize platelet counts since excessive increases in platelet count may increase the risk of thromboembolic complications. The prescribed Romiplostim dose may consist of a very small volume (eg, 0.15 mL). This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Myelogenous Leukemia 14.1 Adults with ITP Each vial contains 125 mcg of romiplostim. Time/action profile Contraindications/Precautions Contraindicated in: None noted. It should not be used to treat thrombocytopenia caused by other conditions and may worsen pre . 4 CONTRAINDICATIONS . 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. 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). hbbd``b`.@;tA,y $m7{D@#h And if a reticulocyte response is seen, give 100 mcg IM/subcutaneously on alternate for Reduces the need for other treatments and decreases bleeding events in patients with ITP ITP for at 6 The count above 50,000 per cubic millimeter ( mm to produce more.! 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