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Nplate
Overview
What is Nplate?
Romiplostim, a member of the TPO mimetic class, is an Fc-peptide fusion protein (peptibody) that activates intracellular transcriptional pathways leading to increased platelet production via the TPO receptor (also known as cMpl). The peptibody molecule contains two identical single-chain subunits, each consisting of human immunoglobulin IgG1 Fc domain, covalently linked at the C-terminus to a peptide containing two thrombopoietin receptor-binding domains. Romiplostim has no amino acid sequence homology to endogenous TPO. Romiplostim is produced by recombinant DNA technology in .
Nplate (romiplostim) for injection is supplied as a sterile, preservative-free, lyophilized, solid white powder for subcutaneous injection. Two vial presentations are available, which contain a sufficient amount of active ingredient to provide either 250 mcg or 500 mcg of deliverable romiplostim, respectively. Each single-dose 250 mcg vial of Nplate contains the following: 375 mcg romiplostim, 1.2 mg L-histidine, 30 mg mannitol, 0.03 mg polysorbate 20, 15 mg sucrose, and sufficient HCl to adjust the pH to a target of 5.0. Each single-dose 500 mcg vial of Nplate contains the following: 625 mcg romiplostim, 1.9 mg L-histidine, 50 mg mannitol, 0.05 mg polysorbate 20, 25 mg sucrose, and sufficient HCl to adjust the pH to a target of 5.0
What does Nplate look like?
What are the available doses of Nplate?
What should I talk to my health care provider before I take Nplate?
How should I use Nplate?
Nplate is indicated for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Limitations of Use:
Use the lowest dose of Nplate to achieve and maintain a platelet count ≥ 50 x 10/L as necessary to reduce the risk for bleeding. Administer Nplate as a weekly subcutaneous injection with dose adjustments based upon the platelet count response.
The prescribed Nplate dose may consist of a very small volume (eg, 0.15 mL). Administer Nplate only with a syringe that contains 0.01 mL graduations.
Initial Dose
The initial dose for Nplate is 1 mcg/kg based on actual body weight.
Dose Adjustments
Use the actual body weight at initiation of therapy, then adjust the weekly dose of Nplate by increments of 1 mcg/kg until the patient achieves a platelet count ≥ 50 x 10/L as necessary to reduce the risk for bleeding; do not exceed a maximum weekly dose of 10 mcg/kg. In clinical studies, most patients who responded to Nplate achieved and maintained platelet counts ≥ 50 x 10/L with a median dose of 2 mcg/kg.
During Nplate therapy, assess CBCs, including platelet counts, weekly until a stable platelet count (≥ 50 x 10/L for at least 4 weeks without dose adjustment) has been achieved. Obtain CBCs, including platelet counts, monthly thereafter.
Adjust the dose as follows:
Discontinuation
Discontinue Nplate if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks of Nplate therapy at the maximum weekly dose of 10 mcg/kg
. Obtain CBCs, including platelet counts, weekly for at least 2 weeks following discontinuation of Nplate
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What interacts with Nplate?
Sorry No Records found
What are the warnings of Nplate?
Sorry No Records found
What are the precautions of Nplate?
Sorry No Records found
What are the side effects of Nplate?
Sorry No records found
What should I look out for while using Nplate?
None.
What might happen if I take too much Nplate?
Overdoses due to medication errors have been reported in patients receiving Nplate. In the event of overdose, platelet counts may increase excessively and result in thrombotic/thromboembolic complications. In this case, discontinue Nplate and monitor platelet counts. Reinitiate treatment with Nplate in accordance with dosing and administration recommendations
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How should I store and handle Nplate?
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Nplate (romiplostim) for injection is supplied as a sterile, preservative-free, solid white lyophilized powder in single-dose vials that deliver 250 mcg (NDC 55513-221-01) and 500 mcg (NDC 55513-222-01) of romiplostim.Store Nplate vials in the refrigerator at 2º to 8º C (36º to 46º F) in the original carton to protect from light until time of use. Do not freeze.If needed, unopened Nplate vials may be stored in the original carton at room temperature up to a maximum of 25º C (77º F ) for a single period of up to 30 days. The new expiration date must be written in the space provided on the carton. Once stored at room temperature, do not place back in the refrigerator. If not used within the 30 days, discard Nplate.Nplate (romiplostim) for injection is supplied as a sterile, preservative-free, solid white lyophilized powder in single-dose vials that deliver 250 mcg (NDC 55513-221-01) and 500 mcg (NDC 55513-222-01) of romiplostim.Store Nplate vials in the refrigerator at 2º to 8º C (36º to 46º F) in the original carton to protect from light until time of use. Do not freeze.If needed, unopened Nplate vials may be stored in the original carton at room temperature up to a maximum of 25º C (77º F ) for a single period of up to 30 days. The new expiration date must be written in the space provided on the carton. Once stored at room temperature, do not place back in the refrigerator. If not used within the 30 days, discard Nplate.Nplate (romiplostim) for injection is supplied as a sterile, preservative-free, solid white lyophilized powder in single-dose vials that deliver 250 mcg (NDC 55513-221-01) and 500 mcg (NDC 55513-222-01) of romiplostim.Store Nplate vials in the refrigerator at 2º to 8º C (36º to 46º F) in the original carton to protect from light until time of use. Do not freeze.If needed, unopened Nplate vials may be stored in the original carton at room temperature up to a maximum of 25º C (77º F ) for a single period of up to 30 days. The new expiration date must be written in the space provided on the carton. Once stored at room temperature, do not place back in the refrigerator. If not used within the 30 days, discard Nplate.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Nplate increases platelet production through binding and activation of the TPO receptor, a mechanism analogous to endogenous TPO.
Non-Clinical Toxicology
None.Progression from myelodysplastic syndromes (MDS) to acute myelogenous leukemia (AML) has been observed in clinical trials with Nplate.
A randomized, double-blind, placebo-controlled trial enrolling patients with severe thrombocytopenia and International Prognostic Scoring System (IPSS) low or intermediate-1 risk MDS was terminated due to more cases of AML observed in the Nplate arm. This trial consisted of a 58-week study period with a 5-year long-term follow-up phase. The subjects were randomized 2:1 to treatment with Nplate or placebo (167 Nplate, 83 placebo). During the 58-week study period, progression to AML occurred in 10 (6.0%) subjects in the Nplate arm and 4 (4.8%) subjects in the placebo arm (hazard ratio [95%CI] = 1.20 [0.38, 3.84]). Of the 250 subjects, 210 (84.0%) entered the long-term follow-up phase of this study. With 5-years of follow-up, 29 (11.6%) subjects showed progression to AML, including 20/168 (11.9%) subjects in the Nplate arm versus 9/82 (11.0%) subjects in the placebo arm (HR [95% CI] = 1.06 [0.48, 2.33]). The incidence of death (overall survival) was 55.7% (93/167) in the Nplate arm versus 54.2% (45/83) in the placebo arm (HR [95% CI] = 1.03 [0.72, 1.47]). In the baseline low IPSS group, there was a higher incidence of death in the Nplate arm [41.3% (19/46)] compared to the placebo arm [30.4% (7/23)] [HR (95% CI) = 1.59 (0.67, 3.80)].
In a single-arm trial of Nplate given to 72 subjects with thrombocytopenia-related MDS, 8 (11.1%) subjects were reported as having possible disease progression, of which 3 (4.2%) had confirmation of AML during follow-up. In addition, in 3 (4.2%) subjects, increased peripheral blood blast cell counts decreased to baseline after discontinuation of Nplate.
Nplate is not indicated for the treatment of thrombocytopenia due to MDS or any cause of thrombocytopenia other than chronic ITP.
The following serious adverse reactions are discussed in greater detail in other sections:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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