Romiplostim
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From MedlinePlus, U.S. National Library of Medicine
Thrombopoietin Receptor Agonist
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
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Preparation and Administration To mitigate against medication errors (both overdose and underdose), ensure that these preparation and administration instructions are followed. Use aseptic technique. Only administer subcutaneously [see Overdosage] . Nplate is supplied in single-dose 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.
Calculation of Patient Dose Multiply the patient’s weight (kg) by the prescribed dose to obtain the Calculated Patient Dose. Calculated Patient Dose (mcg) = Weight (kg) × Prescribed dose (mcg/kg) Reconstitution and Dilution of Nplate Single - Dose Vials Reconstitute Nplate with Sterile Water for Injection, USP. Do not reconstitute or dilute with Bacteriostatic Water for Injection, USP or dilute with Bacteriostatic Sodium Chloride Injection, USP.
If the Calculated Patient Dose is less than 23 mcg, dilution with 0.9% Sodium Chloride Injection, USP is required to reduce the concentration of Nplate (see Table 1 ). This reduced concentration allows for low-doses to be accurately calculated, and consistently measured with a 0.01 mL graduated syringe. [See table below.] 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 colorless. Visually inspect the reconstituted solution for particulate matter and/or discoloration. Do not administer Nplate if particulate matter and/or discoloration is observed.
Calculate Volume to Administer by dividing the Calculated Patient Dose (mcg) by the final concentration of prepared solution. See Table 2 for final concentrations. [See table below.] Administration of Prepared Nplate Solution Administer Nplate only using a syringe with 0.01 mL graduations for accurate dosage. Round volume to the nearest hundredth mL.
Verify that the syringe contains the correct dosage. Discard any unused portion. Do not pool unused portions from the vials. Do not administer more than one dose from a vial. Storage of Reconstituted Solution Reconstituted product with Sterile Water for Injection, USP that has not been further diluted can remain in the original vial at room temperature 25°C (77°F) or be refrigerated at 2°C to 8°C (36°F to 46°F) for up to 24 hours following reconstitution.
Reconstituted product with Sterile Water for Injection, USP may be held in a syringe at room temperature 25°C (77°F) for a maximum of 4 hours following reconstitution. Protect product from light. Do not shake. Storage of Diluted solution (after initial reconstitution) Reconstituted and further diluted product with 0.9% Sodium Chloride Injection, USP can be held in a syringe at room temperature 25°C (77°F) or in the original vial refrigerated at 2°C to 8°C (36°F to 46°F) for no longer than 4 hours prior to administration.
Protect product from light. Do not shake.
| Calculated Patient Dose | StrengthVial contains overfill to ensure delivery of labeled vial strength. | Reconstitute with Sterile WaterAdd Sterile Water for Injection, USP directly to the vial. | Dilute with Normal SalineAdd 0.9% Sodium Chloride Injection, USP directly to the vial. | Final Concentration |
|---|---|---|---|---|
| Calculated Dose greater than or equal to 23 mcg | 125 mcg | 0.44 mL | Not Required | 500 mcg/mL |
| 250 mcg | 0.72 mL | Not Required | ||
| 500 mcg | 1.2 mL | Not Required | ||
| Calculated Dose less than 23 mcg | 125 mcg | 0.44 mL | 1.38 mL | 125 mcg/mL |
| 250 mcg | 0.72 mL | 2.25 mL | ||
| 500 mcg | 1.2 mL | 3.75 mL |
| Calculated Patient Dose | Final Concentration | Volume to Administer (mL) |
| Calculated Dose greater than or equal to 23 mcg | 500 mcg/mL | = Calculated Patient Dose / 500 mcg/mL |
| Calculated Dose less than 23 mcg | 125 mcg/mL | = Calculated Patient Dose / 125 mcg/mL |
Drug interactions
Check romiplostim against a medication listLabel text (1 paragraph)
Nplate may be used with other medical ITP therapies, such as corticosteroids, danazol, azathioprine, intravenous immunoglobulin (IVIG), and anti-D immunoglobulin [see Clinical Studies ( 14.1 )] .
Contraindications
None. None ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Based on findings from animal reproduction studies, Nplate may cause fetal harm when administered to a pregnant woman. Available data with Nplate use in pregnant women are insufficient to draw conclusions about any drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction and developmental toxicity studies, romiplostim crossed the placenta, and adverse fetal effects included thrombocytosis, postimplantation loss, and an increase in pup mortality (see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In rat and rabbit embryo-fetal development toxicity studies, no evidence of fetal harm was observed at romiplostim doses up to 11 times (rats) and 82 times (rabbits) the maximum human dose (MHD) based on systemic exposure (AUC). In mice at doses 5 times the MHD, reductions in maternal body weight and increased postimplantation loss occurred.
In a prenatal and postnatal development study in rats, at doses 11 times the MHD, there was an increase in perinatal pup mortality. Romiplostim crossed the placental barrier in rats and increased fetal platelet counts at clinically equivalent and higher doses.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.