romiplostim contraindications

Romiplostim, a thrombopoietic agent with demonstrated efficacy against immune thrombocytopenia (ITP) in prospective controlled studies, was recently licensed for adults with chronic ITP. 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 . Hypersensitivity to the active substance or to any of the . endstream endobj startxref Risk of thrombosis or a thromboembolic complication as a result of excessive increase in platelet count secondary to excessive dosages of romiplostim. Romiplostim is a man-made thrombopoietin receptor agonist (TPO mimetic) that increases platelet counts by increasing the number and maturation of bone marrow megakaryocytes. Available studies in humans are insufficient to inform a drug-associated risk if romiplostim is used during pregnancy. Reconstitute lyophilized romiplostim with sterile water for injection. 4 CONTRAINDICATIONS . The goal of treatment is to maintain the count above 50,000 per cubic millimeter (mm . 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. 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. FEP members can also obtain the list through thewww.fepblue.orgwebsite. Ensure that recommended preparation and administration instructions are followed to minimize medication errors (e.g., excessive dosage or underdosage). What are the side effects of Romiplostim? After clinical improvement and if a reticulocyte response is seen, give 100 mcg IM/subcutaneously on alternate days for 7 doses . Romiplostim injection may cause side effects. 12.1 Mechanism of Action . Biosynthetic (recombinant DNA-derived) Fc-peptide fusion protein; thrombopoietin receptor agonist (TPO-RA). %PDF-1.6 % HWYoF~GnKrIA A s|8(j=LhL[q=,O`D%"riVpjsTi5VbXbr? Fargo, N.D., 58121. Do not use to normalize platelet counts since excessive increases in platelet count may increase the risk of thromboembolic complications. 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. 5 WARNINGS AND PRECAUTIONS . 5.4 Worsened Thrombocytopenia After Cessation of Nplate . 8!;2.jU-U CYGT2]XkP4D7xJzAoOiq0c0jL A{82_y13w`}4Y-~&U{. 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. Gently swirl and invert the vial to facilitate dissolution, which generally takes <2 minutes; do not shake or vigorously agitate the vial. 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 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. 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 to provide a final concentration of 500 mcg/mL, Vial labeled as containing 250 mcg of romiplostim: reconstitute with 0.72 mL of sterile water for injection to provide a final concentration of 500 mcg/mL, Vial labeled as containing 500 mcg of romiplostim: reconstitute with 1.2 mL of sterile water for injection to provide a final concentration of 500 mcg/mL. If not used within the 30 days, discard. 9 /L per guideline, also added active bleed as an option. The US Food and Drug Administration approved romiplostim (Nplate) in 2008 for the treatment of low blood platelet counts in . 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. Romiplostim (Nplate) maybe renewed when the following are met: Fargo (Headquarters) It should not be used to treat thrombocytopenia caused by other conditions and may worsen pre . For injection: 250 mcg or 500 mcg of deliverable romiplostim as a sterile, lyophilized, solid white powder in single-dose vials. 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. Do not reconstitute or dilute the drug with bacteriostatic water for injection, or dilute with bacteriostatic sodium chloride injection. 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. Not known whether romiplostim is distributed into milk. 20. Type Brand name: Nplate AHFS DI Essentials. 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 . 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. 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. Advise patients that romiplostim may increase the risk of reticulin fiber formation in bone marrow which may improve upon discontinuance of therapy. 5.2 Thrombotic/Thromboembolic Complications . Approximately 134 days (median: 3.5 days). After reconstitution, a deliverable volume of 0.25 mL solution contains 125 mcg of romiplostim (500 mcg/mL). Elimination of the drug is partly dependent on the TPO receptor on platelets. 4 CONTRAINDICATIONS . Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Selected from data included with permission and copyrighted by First Databank, Inc. What are the . The individual has a diagnosis of hematopoietic syndrome of acute radiation syndrome (HS-ARS); The individual has a diagnosis of immune (idiopathic) thrombocytopenia (ITP), The individual is between the ages of 1 and 17 years old, The individual has a platelet count 30 X 10, The individual has a platelet count > 30 X 10. Adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. 12 Medicines That Could Help, List Romiplostim Subcutaneous side effects by likelihood and severity. 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. Half-life: 1-34 days. 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). Do not use romiplostim to treat thrombocytopenia related to MDS or any cause of thrombocytopenia other than ITP. 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. 4 months for ITP. 4 CONTRAINDICATIONS. Nplate, Promacta, prednisone, dexamethasone, triamcinolone, Decadron. After reconstitution, a deliverable volume of 0.5 mL solution contains 250 mcg of romiplostim (500 mcg/mL). The initial dose of romiplostim (Nplate) is 1 mcg/kg with future dose adjustments based on changes in platelet counts only. contraindications to surgery; modified requirement related to platelet count to also include active bleed. 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. 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. 5.2 Worsened Thrombocytopenia After Cessation of Nplate . The goal of medical care for immune thrombocytopenia (ITP) is to increase the platelet count to a safe level, permitting patients to live normal lives while awaiting spontaneous or treatment-induced remission. *Zp]T]6eu3XuU@NMjz4ro Written by ASHP. It is administered by subcutaneous injection. Through this mechanism, romiplostim reduces the need for other treatments and decreases bleeding events in patients with thrombocytopenia. 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). Binds to the thrombopoietin receptor (also known as cMp1) and activates intracellular transcriptional pathways leading to increased platelet production. In clinical trials, romiplostim demonstrated dose-dependent increases in platelet counts after treatment was discontinued. Protect the drug from light and do not shake the vial. $_ ib@+ Store vials in original carton to protect from light. What should I know regarding pregnancy, nursing and administering Romiplostim Subcutaneous to children or the elderly? Peak serum concentrations attained approximately 750 hours (median: 14 hours) following sub-Q administration of romiplostim doses of 315 mcg/kg. Importance of providing patient with a copy of the manufacturer's patient information (medication guide) prior to each dose of romiplostim. Data sources include IBM Watson Micromedex (updated 1 Nov 2022), Cerner Multum (updated 25 Oct 2022), ASHP (updated 12 Oct 2022) and others. Abstract. The prescribed Romiplostim dose may consist of a very small volume (eg, 0.15 mL). Romiplate may be used with other medical ITP therapies, such as corticosteroids, danazol, azathioprine, intravenous immunoglobulin (IVIG), and anti-D immunoglobulin. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. 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 . Vincristine Romiplostim is a man-made protein medicine used to treat low blood platelet counts (thrombocytopenia) in adults with chronic idiopathic thrombocytopenic purpura (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 50,000/mm3 is achieved. If the patient's platelet count is 50 x 10 9 /L, medical ITP therapies may be reduced or discontinued. 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS . This survey is being conducted by the WebMD marketing sciences department. 231 0 obj <> endobj 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. Children aged 1 year and older who have had ITP for at least 6 months. 6 ADVERSE REACTIONS . Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Adjust dosage based on platelet count monitoring and changes in body weight. Member has lower-risk MDS (IPSS-R (Very Low, Low, Intermediate), IPSS . No special population dosage recommendations at this time. 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. Describes the best time to take the drug and precautions if any that should be followed. Patients with immune thrombocytopenia should continue to avoid situations or medications that may increase the risk of bleeding. Risk of worsening thrombocytopenia with possible bleeding following discontinuance of romiplostim. Local prescribing information should be consulted for full details of contraindications, warnings and precautions that relate to the use of romiplostim. Produced by recombinant DNA technology in Escherichia coli. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. He`bd()a`Q@ &X Romiplostim is used in certain patients with ITP who have not gotten . Reduce dosage by 1 mcg/kg weekly if platelet count is >200,000/mm3 and 400,000/mm3 for 2 consecutive weeks. 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS . 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. Adjust dosage based on platelet count monitoring. 2005 - 2022 WebMD LLC. 5.1 Bone Marrow Reticulin Formation and Risk for Bone Marrow Fibrosis . Splenectomy is an effective therapy for steroid-refractory or dependent immune thrombocytopenia (ITP). 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. Most common adverse reactions in pediatric patients receiving romiplostim in clinical studies (25%) were contusion, upper respiratory tract infection, and oropharyngeal pain. ITP has no cure, and relapses may occur years after seemingly successful medical or surgical management. Romiplostim works by causing the cells in the bone marrow to produce more platelets. Myelogenous Leukemia 14.1 Adults with ITP )%09uv`*%2YA)X# ?HpHVb1'l/.VckVw;qdbn(+y6-7l|^^uYN/ 6.3 Immunogenicity . H\j0~ Contraindications 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 *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. 4.3 Contraindications. 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