s. Visually inspect the reconstituted solution for particulate matter and/or discoloration. Do not administer Nplate if particulate matter and/or discoloration is observed.
Reconstituted Nplate can be kept at room temperature (25°C/77°F) or refrigerated at 2° to 8°C (36° to 46°F) for up to 24 hours prior to administration. Protect the reconstituted product from light.
To determine the injection volume to be administered, first identify the patient’s total dose in micrograms (mcg) using the dosing information in section 2.1. For example, a 75 kg patient initiating therapy at 1 mcg/kg will begin with a dose of 75 mcg. Next, calculate the volume of Nplate solution that is given to the patient by dividing the microgram dose by the concentration of the reconstituted Nplate solution (500 mcg/mL). For this patient example, the 75 mcg dose is divided by 500 mcg/mL, resulting in an injection volume of 0.15 mL.
As the injection volume may be very small, use a syringe with graduations to 0.01 mL.
Discard any unused portion. Do not pool unused portions from the vials. Do not administer more than one dose from a vial.
2.3 Use of Nplate With Concomitant Medical ITP Therapies
Nplate may be used with other medical ITP therapies, such as corticosteroids, danazol, azathioprine, intravenous immunoglobulin (IVIG), and anti-D immunoglobulin. If the patient’s platelet count is ≥ 50 x 109/L, medical ITP therapies may be reduced or discontinued [see Clinical Studies (14.1)].
3 DOSAGE FORMS AND STRENGTHS
Single-use vials contain 250 or 500 mcg of deliverable romiplostim as a sterile, lyophilized, solid white powder.
4 CONTRAINDICATIONS
None
5 WARNINGS AND PRECAUTIONS
5.1 Bone Marrow Reticulin Formation and Risk for Bone Marrow Fibrosis
Nplate administration increases the risk for development or progression of reticulin fiber deposition within the bone marrow. In clinical studies, Nplate was discontinued in four of the 271 patients because of bone marrow reticulin deposition. Six additional patients had reticulin observed upon bone marrow biopsy. All 10 patients with bone marrow reticulin deposition had received Nplate doses ≥ 5 mcg/kg and six received doses ≥ 10 mcg/kg. Progression to marrow fibrosis with cytopenias was not reported in the controlled clinical studies. In the extension study, one patient with ITP and hemolytic anemia developed marrow fibrosis with collagen during Nplate therapy. Clinical studies have not excluded a risk of bone marrow fibrosis with cytopenias.
Prior to initiation of Nplate, examine the peripheral blood smear closely to establish a baseline level of cellular morphologic abnormalities. Following identification of a stable Nplate dose, examine peripheral blood smears and CBCs monthly for new or worsening morphological abnormalities (eg, teardrop and nucleated red blood cells, immature white blood cells) or cytopenia(s). If the patient develops new or worsening morphological abnormalities or cytopenia(s), discontinue treatment with Nplate and consider a bone marrow biopsy, including staining for fibrosis [see Adverse Reactions (6.1)].
5.2 Worsened Thrombocytopenia After Cessation of Nplate
Discontinuation of Nplate may result in thrombocytopenia of greater severity than was present prior to Nplate therapy. This worsened thrombocytopenia may increase the patient’s risk of bleeding, particularly if Nplate is discont |
