In this article, we will discuss Romiplostim (Dosage Overview). So, let’s get started.
Indications
Romiplostim is indicated for the treatment of thrombocytopenia in:
• Adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
• 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.
Limitations 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.
• Romiplostim should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding.
• Romiplostim should not be used in an attempt to normalize platelet counts.
Dosage
Recommended Dosage Regimen
For All Patients
Use the lowest dose of Romiplostim to achieve and maintain a platelet count ≥ 50 × 109/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 Romiplostim dose may consist of a very small volume (e.g., 0.15 mL). Administer Romiplostim only with a syringe that contains 0.01 mL graduations.
Discontinue Romiplostim 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.
For Adult Patients with Chronic ITP
The initial dose of Romiplostim is 1 mcg/kg. Actual body weight at initiation of treatment should always be used when calculating the initial dose. In adults, future dose adjustments are based on changes in platelet counts only.
Adjust the weekly dose of Romiplostim by increments of 1 mcg/kg until the patient achieves a platelet count ≥ 50 × 109/L
as necessary to reduce the risk for bleeding; do not exceed a maximum weekly dose of 10 mcg/kg. In clinical studies, most adult patients who responded to Nplate achieved and maintained platelet counts ≥ 50 × 109/L with a
median dose of 2 mcg/kg.
Adjust the dose as follows for adult patients:
• If the platelet count is < 50 × 109/L, increase the dose by 1 mcg/kg.
• If platelet count is > 200 × 109/L and ≤ 400 × 109/L for 2 consecutive weeks, reduce the dose by 1 mcg/kg.
• If platelet count is > 400 × 109/L, do not dose. Continue to assess the platelet count weekly. After the platelet count has fallen to < 200 × 109/L, resume Nplate at a dose reduced by 1 mcg/kg.
For Pediatric Patients with ITP
The initial dose of Romiplostim is 1 mcg/kg. Actual body weight at initiation of treatment should always be used when calculating initial dose. In pediatric patients, future dose adjustments are based on changes in platelet counts and changes in body weight. Reassessment of body weight is recommended every 12 weeks. Adjust the weekly dose of Nplate by increments of 1 mcg/kg until the patient achieves a platelet count ≥ 50 × 109/L as necessary to reduce the risk for bleeding; do not exceed a maximum weekly dose of 10 mcg/kg. In a pediatric placebo-controlled clinical study, the median dose was 5.5 mcg/kg. Adjust the dose as follows for pediatric patients:
• If the platelet count is < 50 × 109/L, increase the dose by 1 mcg/kg.
• If platelet count is > 200 × 109/L and ≤ 400 × 109/L for 2 consecutive weeks, reduce the dose by 1 mcg/kg.
• If platelet count is > 400 × 109/L, do not dose. Continue to assess the platelet count weekly. After the platelet count has fallen to < 200 × 109/L, resume Nplate at a dose reduced by 1 mcg/kg.