Adult Dosing
Treatment of thrombocytopenia, chronic ITP-related
- Initial dose: 1 mcg/kg SC qwk based on actual body weight
- Dose adjustment:
- Increase the dose by 1 mcg/kg SC qwk until the patient achieves a platelet count
50 x 109/L [Max: 10 mcg/kg] - If platelet count is >200 x 109/L for 2 consecutive weeks: reduce the dose by 1 mcg/kg SC
- If platelet count is >400 x 109/L: Withhold treatment; resume the treatment after the platelet count has fallen to <200 x 109/L at a dose reduced by 1 mcg/kg SC
- If the platelet count does not increase to a level sufficient after 4 week at max 10 mcg/kg SC dose; discontinue the treatment
Note:
- For preparation and administration, refer package insert
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
See Supplemental Patient Information
- Stimulation of the TPO receptor on the surface of hematopoietic cells may increase the risk for hematologic malignancies
- Monitor complete blood counts (CBCs), including platelet counts and peripheral blood smears, prior and throughout the therapy
- Monitor CBCs, including platelet counts, for at least 2 weeks following discontinuation of therapy
- Use the lowest dose of romiplostim to achieve and maintain a platelet count = 50 x 109 /L as necessary to reduce the risk for bleeding
- Administer romiplostim as a weekly SC injection only with a syringe that contains 0.01 mL graduations and with dose adjustments based upon the platelet count response
- Romiplostim should not be used in an attempt to normalize platelet counts
- Romiplostim administration increases the risk for development or progression of reticulin fiber deposition within the bone marrow
- Hyporesponsiveness or failure to maintain a platelet response with romiplostim should prompt a search for causative factors including neutralizing antibodies to Nplate
- Discontinuation of romiplostim may result in worsened thrombocytopenia than was present prior to romiplostim therapy
Cautions: Use cautiously in
- Renal and hepatic impairment
- Myelodysplastic syndrome
- Hematologic malignancy
- Lactation
Supplemental Patient Information
- Patients should continue to avoid situations or medications that may increase the risk for bleeding
Pregnancy Category:C
Breastfeeding: Safety unknown; because of the potential for possible serious adverse reactions in nursing infants a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
