Active Ingredient: Romiplostim
Romiplostim is indicated for the treatment of primary immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).
For this indication, competent medicine agencies globally authorize below treatments:
For:
Subcutaneous, 1 micrograms romiplostim, once weekly.
Romiplostim should be administered once weekly as a subcutaneous injection.
The initial dose of romiplostim is 1 mcg/kg based on actual body weight.
A subject’s actual body weight at initiation of therapy should be used to calculate dose. The once weekly dose of romiplostim should be increased by increments of 1 mcg/kg until the patient achieves a platelet count ≥50 × 109/L. Platelet counts should be assessed weekly until a stable platelet count (≥50 × 109/L for at least 4 weeks without dose adjustment) has been achieved. Platelet counts should be assessed monthly thereafter and appropriate dose adjustments made as per the dose adjustment table (table 2) in order to maintain platelet counts within the recommended range. See table below for dose adjustment and monitoring. A maximum once weekly dose of 10 mcg/kg should not be exceeded.
Dose adjustment guidance based on platelet count:
| Platelet count (x 109/L) | Action |
| < 50 | Increase once weekly dose by 1 mcg/kg |
| > 150 for two consecutive weeks | Decrease once weekly dose by 1 mcg/kg |
| > 250 | Do not administer, continue to assess the platelet count weekly After the platelet count has fallen to < 150 × 109/L, resume dosing with once weekly dose reduced by 1 mcg/kg |
Due to the interindividual variable platelet response, in some patients platelet count may abruptly fall below 50 × 109/L after dose reduction or treatment discontinuation. In these cases, if clinically appropriate, higher cut-off levels of platelet count for dose reduction (200 × 109/L) and treatment interruption (400 × 109/L) may be considered according to medical judgement.
A loss of response or failure to maintain a platelet response with romiplostim within the recommended dosing range should prompt a search for causative factors.
Treatment with romiplostim should be discontinued if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after four weeks of romiplostim therapy at the highest weekly dose of 10 mcg/kg.
Patients should be clinically evaluated periodically and continuation of treatment should be decided on an individual basis by the treating physician, and in non-splenectomised patients this should include evaluation relative to splenectomy. The reoccurrence of thrombocytopenia is likely upon discontinuation of treatment.
No overall differences in safety or efficacy have been observed in patients <65 and ≥65 years of age. Although based on these data no adjustment of the dosing regimen is required for older patients, care is advised considering the small number of elderly patients included in the clinical trials so far.
Liability Disclaimer : RxReasoner has utilized reasonable care in providing content and services that are accurate, complete and up to date. However, RxReasoner does not accept any responsibility or liability about it. The content and services of RxReasoner are for informational purposes only and they are not intended to be a substitute for the knowledge, expertise, skill, and judgment of physicians, pharmacists, nurses, or other healthcare professionals involved in patient care. RxReasoner offers no medical advice. Users are responsible for the use of the provided content. A shown indication or treatment should not be construed to indicate that the medication is safe, appropriate, or effective in any given patient or under any particular circumstances. The absence of an indication or treatment should not roule out the existence of other appropriate medications. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition or medicament. RxReasoner is not liable for any damages allegedly sustained arising out of the use of its content and services.