Nplate is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic immune idiopathic thrombocytopenic purpura itp who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Keep nplate vials refrigerated at 2 to 8c 36 to 46f. Amgen safety net foundation is a nonprofit prior to. Verify that the syringe contains the correct dosage. Nplate with reconstitution pack patient information leaflet. Has the patient experienced an inadequate response or intolerance to corticosteroids, immunoglobulins, or splenectomy. Nplates active ingredient is romiplostim, which is a protein used to treat low platelet counts in patients with immune idiopathic thrombocytopenic purpura called. Nplate mimics the bodys natural thrombopoietin and is designed to increase platelet counts in patients with chronic itp. Nplate will be given under the direct supervision of your doctor, who will closely control the amount of nplate given to you. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information multum provides. Keep the nplate self injection kit refrigerated at 2.
Romiplostim nplate medical clinical policy bulletins aetna. Romiplostim, a member of the tpo mimetic class, is an fcpeptide fusion protein peptibody that activates intracellular transcriptional pathways leading to increased platelet production via the tpo receptor also known as cmpl. Risk for hepatic decompensationin patients with chronic hepatitis candrisk of hepatotoxicity in patients with chronic hepatitis c, promacta in combination with interferon and ribavirin may increase the risk of hepatic decompensationsee warnings and precautions 5. Learn about nplate romiplostim dosing practices and find an nplate dosing guide, info on dosing and administration for your patients, and access to the dosing calculator. The amgen first step program is here to help eligible commercially insured patients pay for their outofpocket prescription costs, including deductible, coinsurance, and copayment. Information for the user nplate 125 micrograms powder for solution. Nplate is the first fdaapproved treatment specifically for adult. Once nplate has been dissolved, inject immediately. The nplate self injection kit must be kept in the original package until use in order to protect the nplate vial from light. Nplate is used to prevent bleeding episodes in people with chronic immune thrombocytopenic purpura itp, a bleeding condition caused by a lack of platelets in the blood nplate is for use in adults and children who are at least 1 year old. Amgen is committed to keeping our patients, customers, staff and their families safe. Dailymed nplate romiplostim injection, powder, lyophilized. I wanted to share this information with the public in the hopes it can help save lives.
Nplate should be used only in patients with itp whose degree of thrombocytopenia. Nplate patient information including if i miss a dose. Promacta is a prescription medicine used to treat low blood platelet counts in people with chronic hepatitis c virus hcv infection before and during treatment with interferon. Nplate 125 micrograms powder for solution for injection. Nplate romiplostim for injection is supplied as a sterile, preservativefree, lyophilized, solid white powder for subcutaneous injection. Nplate patient support and resources nplate romiplostim. Nplate fda prescribing information, side effects and uses. Guidelines for calculating individual patient dose and volume of romiplostim to administer. An increased risk of hypocalcemia has been observed in clinical trials of patients with increasing renal dysfunction, most commonly with severe dysfunction creatinine clearance less than 30 mlmin andor on. Seek emergency medical attention or call the poison help line at 1. Your initial dose is 1 microgram of nplate per kilogram of your body weight once a week.
In a clinical trial, one patient with itp and hemolytic anemia developed. Amgen australia takes no responsibility for, and exercises no control over the organisation, views, or information contained on the server or site which you will be accessing. Compare prices, print coupons and get savings tips for nplate romiplostim and other chronic itp drugs at cvs, walgreens, and other pharmacies. Find clinical trials for romiplostim check for trials from ncis list of cancer clinical trials now accepting patients. This patients benefit plan requires prior authorization for certain medications in order for the drug to be covered. For practical information about using nplate, patients should read the package leaflet or. Nplate romiplostim study in the lancet shows significant. Promacta eltrombopag the official patient site from novartis. Oct 19, 2019 adjust the weekly dose of nplate by increments of 1 mcgkg until the patient achieves a platelet count.
Nplate 250 micrograms powder and solvent for solution for injection reconstitution pack patient information leaflet pil by amgen ltd. Adult patients with immune thrombocytopenia itp who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. The peptibody molecule contains two identical singlechain subunits. Xyntha is available as lyophilized powder in singleuse vials containing fdaapproved patient labeling nominally250, 500, or 2000 iu. If, after velcade has been withheld, the toxicity does not resolve, discontinue velcade. For example, a 75 kg patient initiating therapy at 1 mcgkg will begin with a dose of 75 mcg.
See 17 for patient counseling information and medication guide revised. Also, within weeks, the majority of patients on nplate reached at least 50,000 platelets. They are written in accordance with plain language principles and answer the four or five most important questions a person might have about a medical problem. Aug, 2018 each vial of nplate 125 micrograms powder for solution for injection contains a total of 230 micrograms of romiplostim.
Has the patient been on nplate therapy continuously for the last 6 months, excluding samples. A randomized, doubleblind study of romiplostim to determine. Onceweekly nplate has been proven to boost and sustain platelets to lower the risk of bleeding, so there may be one less thing to keep you from doing what you love. Nplate 250 micrograms powder and solvent for solution for. Three vial presentations are available, which contain a sufficient amount of active ingredient to provide either 125 mcg, 250 mcg or 500 mcg of deliverable romiplostim. Fda label information for this drug is available at dailymed. Adults with chronic immune thrombocytopenia itp, a condition in which platelets are destroyed by the immune system children aged 1 year and older who have had itp for at least 6 months. In a pediatric placebocontrolled clinical study, the median of the most frequent dose of nplate received by patients during. Reconstitution and dilution of nplate singledosevials calculated patient dose labeled vial content of nplate actual vial content of nplate reconstitute with sterile water dilute with normal saline final concentration calculated dosegreater than or equalto 23 mcg 125 mcg 230 mcg 0. If this is your first visit to our site, just click below to get started. Highlights of prescribing information initiate promacta at. Treatment with nplate romiplostim for immune thrombocytopenia itp this guide for adult patients prescribed nplate cover topics such as, what is itp.
Anytown hospital 100 main street 7 anytown, anystate 01010 nplate. Please read the patient information leaflet pil that comes. Nplate is indicated for the treatment of thrombocytopenia in patients with. Nplate should be used only in patients with itp whose degree of. This patient information sheet applies only to approved uses of the drug. See 17 for patient counseling information and medication.
See full prescribing information for complete boxed warning. Nplate should be used only in patients with itp whose degree of contusion, upper. Each vial of nplate 125 micrograms powder for solution for injection contains a total of 230 micrograms of romiplostim. This formation may improve upon discontinuation of nplate. Three vial presentations are available, which contain a sufficient amount of active ingredient to provide either 125 mcg, 250 mcg or. The efficacy and safety of romiplostim in adult patients with chronic. An additional overfill is included in each vial to ensure that 125 micrograms of romiplostim can be delivered.
To register for amgen assist 360 online, click here already registered. Store nplate vials in their carton to protect from light until time of use. Find patient medical information for nplate subcutaneous on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Nplate is indicated for the treatment of thrombocytopenia in. Nplate 125 micrograms powder for solution for injection vial. No this is initiation of therapy, please answer the following questions. These patients will be provided with a home administration training hat pack by their healthcare professional. Thromboticthromboembolic complications nplate physician. The nplate treated patient died following an intracranial haemorrhage that occurred after nplate was discontinued in the presence of antiplatelet therapy.
The fatal adverse events in the placebotreated patients were n %. In a clinical trial, one patient with itp and hemolytic anemia developed marrow fibrosis with collagen during nplate therapy. 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. For routine prophylaxis in c hildren less than 6 years of age. Cvs caremark administers the prescription benefit plan for the patient identified. Anytown hospital 100 main street 7 anytown, anystate 01010. For adults with chronic immune thrombocytopenia itp. Promacta should only be used in people with chronic hcv whose low blood platelet counts keep them from starting or continuing interferonbased therapy.
Nplate restores platelet stability for 8 out of 10 patients with chronic itp. Nichola cooper, department of haematology, hammersmith hospital, london, uk. Nplate administration may increase the risk for development or progression of reticulin fiber formation within the bone marrow. P oct 25, 2019 the absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Vraylar is not approved for the treatment of patients with dementiarelated psychosis. The total infusion dose of nulojix should be based on the actual body weight of the patient at the time of transplantation, and should not be modified during the course of therapy, unless there is a change in body weight of greater than 10%. Patients with itp have low platelet counts and are at risk of bleeding. Nplate is administered once a week as an injection under the skin subcutaneous. Patient must have private insurance and is not participating in any federal, state or governmentfunded healthcare program, such as medicare, medicare advantage, medicare part d, medicaid, etc. However, much of the information may also apply to unapproved uses that are being studied. Nplate romiplostim side effects, images, uses, dosage.
Find support and resources, including nplate navigator which may help patients navigate the challenges of itp. The patient missed his week 8 dose, and 1 week later, his platelet count decreased to. If toxicity resolves such that the patient has an anc at or above 0. Amgen safety net foundation the foundation is a nonprofit patient assistance program that helps qualifying patients access amgen medicines at no cost. She was in her mid30s, perfectly healthy save her itp and hashimotos, and had been wrestling with itp since she was 18. Next, calculate the volume of nplate solution that is given to the patient by dividing the microgram dose by the concentration of the reconstituted nplate solution 500 mcgml. Amgen safety net foundation is a nonprofit prior to applying. Please see important safety information on next page. Highlights of prescribing information discontinuation of. In the randomization phase, 14 of 15 romiplostimtreated patients 93% experienced correction of their platelet count within 3 weeks, compared with one of eight control patients 12. Learn more about medicare prescription drug plans and savings with goodrx. Nplate romiplostim is a manmade protein medicine used to treat low blood platelet counts in adults with chronic immune thrombocytopenia itp, when certain other medicines, or surgery to remove your spleen, have not worked well enough. Romiplostim nplate for injection is available as 250 mcg or 500 mcg of deliverable romiplostim as a lyophilized powder in singledose vials.
Oct 25, 2019 nplate is supplied in singledose vials that deliver 250 mcg ndc 55522101 and 500 mcg ndc 55522201 of romiplostim. You may have excess nplate left over after administering your prescribed dose. Nplate romiplostim is a manmade form of a protein that increases production of platelets bloodclotting cells in your body. For this patient example, the 75 mcg dose is divided by 500 mcgml, resulting in an injection volume of 0. The longterm risk for progression to myelofibrosis is unknown. Oct 01, 2019 adjust the weekly dose of nplate by increments of 1 mcgkg until the patient achieves a platelet count. Oct 19, 2019 nplate romiplostim for injection is supplied as a sterile, preservativefree, lyophilized, solid white powder for subcutaneous injection. Nplate, innromiplostim european medicines agency europa eu. Call your doctor for instructions if you miss an appointment for your romiplostim injection. Uptodate offers two levels of content for patients. Download leaflet view the patient leaflet in pdf format below is a text only representation of the patient information. After initial dose, the dose is adjusted based on platelet response, using the lowest dose to achieve and maintain a platelet count greater than or equal to 50 x 10 9 l as necessary to reduce the risk.
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