Version May 2024
Hematopoietic syndrome of acute radiation syndrome: SubQ: 10 mcg/kg once; begin as soon as possible after suspected or confirmed exposure to radiation levels >2 (gray) Gy; do not delay romiplostim if CBC is not readily available.
Immune thrombocytopenia: Note: Use the lowest dose sufficient to maintain platelet count ≥50,000/mm3 as necessary to reduce the risk of bleeding. Do not use to normalize platelet counts.
SubQ: Initial: 1 mcg/kg once weekly (based on actual body weight); adjust dose by 1 mcg/kg/week increments to achieve platelet count ≥50,000/mm3 and to reduce the risk of bleeding; Maximum dose: 10 mcg/kg/week (median dose needed to achieve response in clinical trials: 2 to 3 mcg/kg).
Dosage adjustment recommendations:
Adjust dose based on platelet count response:
Platelet count <50,000/mm3: Increase weekly dose by 1 mcg/kg.
Platelet count >200,000/mm3 to ≤400,000/mm3 for 2 consecutive weeks: Reduce weekly dose by 1 mcg/kg.
Platelet count >400,000/mm3: Withhold dose; assess platelet count weekly; when platelet count <200,000/mm3, resume with the weekly dose reduced by 1 mcg/kg.
Discontinue if platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks at the maximum recommended dose of 10 mcg/kg/week.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
(For additional information see "Romiplostim: Pediatric drug information")
Hematopoietic syndrome of acute radiation syndrome: Infants, Children, and Adolescents: SubQ: 10 mcg/kg once; administer dose as soon as possible after suspected or confirmed exposure to radiation levels >2 (gray) Gy; do not delay romiplostim if CBC is not readily available.
Immune thrombocytopenia (ITP): Note: Use the lowest dose sufficient to maintain platelet count ≥50,000/mm3 as necessary to reduce the risk of bleeding. Do not use to normalize platelet counts. Reassess body weight every 12 weeks. Calculate dose using actual body weight.
Children and Adolescents: SubQ: Initial: 1 mcg/kg/dose once weekly; adjust dose by 1 mcg/kg/week increments to achieve platelet count ≥50,000/mm3 and to reduce the risk of bleeding; maximum dose: 10 mcg/kg/week.
Dosage adjustment recommendations:
Adjust dose based on platelet count response:
Platelet count <50,000/mm3: Increase weekly dose by 1 mcg/kg.
Platelet count >200,000/mm3 to ≤400,000/mm3 for 2 consecutive weeks: Reduce weekly dose by 1 mcg/kg.
Platelet count >400,000/mm3: Withhold dose; assess platelet count weekly; when platelet count <200,000/mm3, resume with the weekly dose reduced by 1 mcg/kg.
Discontinue if platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks at the maximum recommended dose of 10 mcg/kg/week.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Incidences reported are for adult population unless otherwise noted.
>10%:
Dermatologic: Skin rash (children and adolescents: 15%)
Gastrointestinal: Abdominal pain (11%), diarrhea (children and adolescents: 20%; adults: ≥5%), upper abdominal pain (children and adolescents: 14%)
Hematologic & oncologic: Acute myelocytic leukemia (4% to 12%), bruise (children and adolescents: 41%)
Nervous system: Dizziness (17%), headache (35%), insomnia (16%)
Neuromuscular & skeletal: Arthralgia (26%), limb pain (13%), myalgia (14%)
Respiratory: Oropharyngeal pain (children and adolescents: 25%; adults: ≥5%), upper respiratory tract infection (children and adolescents: 31%; adults: ≥5%)
Miscellaneous: Fever (children and adolescents: 24%)
1% to 10%:
Cardiovascular: Peripheral edema (children and adolescents: 7%)
Dermatologic: Urticaria (children and adolescents: 5%)
Gastrointestinal: Dyspepsia (7%), gastroenteritis (children and adolescents: 5%), nausea (≥5%), vomiting (≥5%)
Hematologic & oncologic: Purpuric disease (children and adolescents: 7%), thrombocythemia (2%)
Immunologic: Antibody development (children, adolescents, and adults: 6% to 9%; neutralizing: 3% to 7%)
Nervous system: Paresthesia (6%)
Neuromuscular & skeletal: Shoulder pain (8%)
Otic: Otic infection (children and adolescents: 5%)
Respiratory: Bronchitis (≥5%), cough (≥5%), sinusitis (children, adolescents, and adults: ≥5%)
<1%: Hematologic & oncologic: Myelofibrosis (bone marrow reticulin formation/deposition)
Postmarketing:
Cardiovascular: Erythromelalgia, portal vein thrombosis (in patients with chronic liver disease)
Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity reaction
There are no contraindications listed in the manufacturer's US labeling.
Canadian labeling: Hypersensitivity to romiplostim or any component of the formulation; known history of sensitivity or allergy to any E. coli-derived product.
Concerns related to adverse effects:
• Bone marrow reticulin: May increase the risk for bone marrow reticulin fiber formation; this formation may improve upon discontinuation of therapy.
• Concomitant ITP medications: May be used in combination with other therapies for ITP, including corticosteroids, danazol, azathioprine, immune globulin, or Rho(D) immune globulin. Reduce dose of or discontinue ITP medications when platelet count ≥50,000/mm3.
• Error prevention: To prevent overdose or underdose, use caution when calculating dose and appropriate volume for administration (volume may be very small; administer with syringe that allows for 0.01 mL graduations).
• Hyporesponsiveness: Lack of response or failure to maintain platelet response should trigger investigation into causative factors, including neutralizing antibodies to romiplostim.
• Malignancy: Progression from existing myelodysplastic syndrome (MDS) to acute myeloid leukemia (AML) has been observed in clinical trials studying romiplostim for severe thrombocytopenia associated with MDS (not an approved indication); a higher percentage of patients receiving romiplostim experienced transformation to AML (compared to placebo). An increase in the percentage of circulating myeloblasts in peripheral blood counts was also noted (both in patients who progressed to AML and in those who did not); blast cells decreased to baseline after discontinuation in some patients.
• Thromboembolism: Thromboembolism or thrombotic complications with romiplostim therapy may occur from increased platelet counts secondary to drug-induced thrombocytosis, regardless of the underlying disease. Follow dosage adjustment recommendations to minimize the risk for thrombotic or thromboembolic complications. Portal vein thrombosis has been observed in patients with chronic liver disease receiving romiplostim.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Subcutaneous [preservative free]:
Nplate: 125 mcg (1 ea); 250 mcg (1 ea); 500 mcg (1 ea)
No
Solution (reconstituted) (Nplate Subcutaneous)
125 mcg (per each): $1,502.56
250 mcg (per each): $3,005.06
500 mcg (per each): $6,010.12
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Subcutaneous:
Nplate: 250 mcg (1 ea); 500 mcg (1 ea)
SubQ: Administer subcutaneously only. Administration volume may be small; use appropriate syringe (with graduations to 0.01 mL) for administration. Verify calculations, final concentration, and volume drawn up for administration. Do not pool unused portions from vials; do not administer more than one dose from a vial.
Parenteral: SubQ: Administer subcutaneously only. Reconstitute and dilute (if needed [ie, dose < 23 mcg]) prior to administration. Verify calculations, final concentration, and volume drawn up for administration. Concentrations for administration are different based on dose (if dose <23 mcg: Concentration is 125 mcg/mL; if dose ≥23 mcg: Concentration is 500 mcg/mL). Administration volume may be small; only administer using a syringe with 0.01 mL graduations; round dose to the nearest 0.01 mL. Do not pool unused portions from vials; do not administer more than 1 dose from a vial.
An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125268s167lbl.pdf#page=18, must be dispensed with this medication.
Hematopoietic syndrome of acute radiation syndrome: Treatment to increase survival due to acute exposure to myelosuppressive radiation doses in adult and pediatric patients (including term neonates).
Immune thrombocytopenia: Treatment of thrombocytopenia in adult patients with immune thrombocytopenia (ITP) who have had insufficient response to corticosteroids, immune globulin, or splenectomy; treatment of thrombocytopenia in pediatric patients ≥1 year of age with ITP for ≥6 months who have had insufficient response to corticosteroids, immune globulin, or splenectomy.
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 other than ITP.
RomiPLOStim may be confused with romiDEPsin
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Based on data from animal reproduction studies, romiplostim may cause fetal harm if administered to a pregnant patient.
Outcome data following maternal use of romiplostim during pregnancy are available (Bussel 2023; Chua 2020; Howaidi 2022; Michel 2020; Rosa María 2020).
Thrombopoietin (TPO) receptor agonists are not currently a preferred treatment of immune thrombocytopenia during pregnancy; use may be considered in very serious cases when other therapies have failed. If a TPO receptor agonist is needed, use of romiplostim may be considered in the third trimester near delivery (Provan 2019).
It is not known if romiplostim is present in breast milk.
Infant outcome data following maternal use of romiplostim while breastfeeding are limited (Patras 2020). Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during romiplostim treatment.
Some products may contain sucrose.
Immune thrombocytopenia: CBC with differential and platelets at baseline, weekly during dosage adjustment phase of treatment, then monthly, and weekly for at least 2 weeks following discontinuation or completion of treatment.
Evaluate for neutralizing antibodies in patients with inadequate response (blood samples may be submitted to the manufacturer for assay [1-800-772-6436]).
Immune thrombocytopenia: Target platelet count of 50,000 to 200,000/mm3; platelet life span: 8 to 11 days.
Romiplostim is a thrombopoietin (TPO) peptide mimetic that increases platelet counts in ITP by binding to and activating the human TPO receptor.
Onset of action: Platelet count increase: SubQ: 4 to 9 days (Wang 2004); Peak platelet count increase: Days 12 to 16 (Wang 2004)
Duration: Platelet counts return to baseline by day 28 (Wang 2004)
Absorption: SubQ: Slow (Wang 2004)
Half-life elimination: Median: 3.5 days (range: 1 to 34 days)
Time to peak, plasma: SubQ: Median: 14 hours (range: 7 to 50 hours)
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