viders under their direction.
2.1 Recommended Dosage Regimen
Monitor complete blood counts (CBCs), including platelet counts and peripheral blood smears, prior to initiation of Nplate and throughout Nplate therapy. Monitor CBCs, including platelet counts, for at least 2 weeks following discontinuation of Nplate [see Warnings and Precautions (5.6)].
Use the lowest dose of Nplate to achieve and maintain a platelet count ≥ 50 x 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. Nplate should not be used in an attempt to normalize platelet counts [see Warnings and Precautions (5.3)].
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 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 patients who responded to Nplate achieved and maintained platelet counts ≥ 50 x 109/L with a median dose of 2 mcg/kg.
During Nplate therapy, assess CBCs, including platelet count and peripheral blood smears, weekly until a stable platelet count (≥ 50 x 109/L for at least 4 weeks without dose adjustment) has been achieved. Obtain CBCs, including platelet counts and peripheral blood smears, monthly thereafter.
Adjust the dose as follows:
If the platelet count is < 50 x 109/L, increase the dose by 1 mcg/kg.
If platelet count is > 200 x 109/L for 2 consecutive weeks, reduce the dose by 1 mcg/kg.
If platelet count is > 400 x 109/L, do not dose. Continue to assess the platelet count weekly. After the platelet count has fallen to < 200 x 109/L, resume Nplate at a dose reduced by 1 mcg/kg.
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 [see Warnings and Precautions (5.4)]. Obtain CBCs, including platelet counts, weekly for at least 2 weeks following discontinuation of Nplate [see Warnings and Precautions (5.6)].
2.2 Preparation and Administration
Nplate is supplied in single-use vials as a sterile, preservative-free, white lyophilized powder that must be reconstituted as outlined in Table 1 and administered using a syringe with 0.01 mL graduations. Using aseptic technique, reconstitute Nplate with preservative-free Sterile Water for Injection, USP as described in Table 1. Do not use bacteriostatic water for injection.
Table 1. Reconstitution of Nplate Single-Use Vials *
Use preservative-free Sterile Water for Injection.
Nplate Single-Use Vials Total Vial Content
of Romiplostim Sterile Water for Injection* Deliverable Product and Volume Final Concentration
250 mcg 375 mcg add 0.72 mL = 250 mcg/0.5 in mL 500 mcg/mL
500 mcg 625 mcg add 1.2 mL = 500 mcg/1 m in 500 mcg/mL
Gently swirl and invert the vial to reconstitute. Avoid excess or vigorous agitation: DO NOT SHAKE. Generally, dissolution of Nplate takes less than 2 minutes. The reconstituted Nplate solution should be clear and colorles |
