romiPLOStim (Rx)
Generic: RomiPLOStim
Brand: Nplate
(roe-mi-ploe'stim)
Pharmacological Action
A thrombopoietin-like fusion protein produced by DNA recombinant technology
Therapeutic outcome: Increase in platelet counts, absence of bleeding
Uses
Chronic idiopathic thrombocytopenic purpura in patients who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy
Contraindications
Hypersensitivity to this product or mannitol
Precautions: Pregnancy C, breastfeeding, malignancies, bleeding, bone marrow suppression, children
Dosage & Routes
Thrombocytopenia in chronic idiopathic thrombocytopenic purpura (ITP) with insufficient response to corticosteroids, immunoglobulins, splenectomy
Adult: SUBCUT; initial dose is 1 mcg/kg SC qwk (based on actual body weight). Increase the weekly dose by 1 mcg/kg until the patient achieves a platelet count ≥50,000/mm3; do not exceed a maximum weekly dose of 10 mcg/kg; use the lowest dose needed to achieve and maintain a platelet count ≥50,000/mm3; monitor CBC, including platelet counts, qwk until a stable platelet count is achieved; platelets ≥50,000/mm3 ≥4 wk without dose adjustment; then, monitor the CBC, including platelet counts, monthly. Once a stable dose is achieved, if the platelet count falls to <50,000/mm3, increase the dose by 1 mcg/kg/wk. If the platelet count increases to >200,000/mm3 for 2 consecutive wk, reduce dose by 1 mcg/kg; if the platelet count is >400,000/mm3, temporarily stop romiplostim, and continue to monitor the platelet count weekly; once the platelets are <200,000/mm3, restart, but reduce the previous dose by 1 mcg/kg/wk. RomiPLOStim may be administered concomitantly with other medical ITP therapies. If platelet counts exceed 50,000/mm3, other medical ITP therapies may be reduced or discontinued. Discontinue romiPLOStim if the platelet count does not increase to avoid important bleeding after 4 wk of therapy at max dose of 10 mcg/kg
Available forms: Inj vials 250, 500 mcg
Implementation - Store vials in refrigerator, do not freeze; protect from light; diluted sol is stable refrigerated or at room temperature for 24 hrs SUBCUT route - Use 0.01 ml graduations syringe - Discard any unused portion in vial; do not pool unused portions from vials - Dilute 250 mcg/0.72 preservative-free sterile water for inj; 500 mcg/1.2 preservative-free sterile water for inj; final concentration 500 mcg/ml - Gently swirl until dissolved; do not shake - Do not use if discolored or if particulate matter is present - Inj into outer aspect of upper arm or abdomen except for 2 inches around navel or front aspect of middle thigh; do not use areas that are bruised, scratched, or scarred - Rotate inj sites
Adverse Effects
CNS: Dizziness, insomnia, headache, fatigue
GI: Abdominal pain, dyspepsia, diarrhea
HEMA: Thromboembolism, thrombosis, bleeding, myelofibrosis, erythromelalgia
MS: Myalgia
SYST: Secondary malignancy, antibody formation
Pharmacokinetics
Absorption: Unknown
Distribution: Unknown
Metabolism: Unknown
Excretion: Unknown
Half-life: Terminal 1-34 days
Pharmacodynamics
Onset: Unknown
Peak: 7-50 hr
Duration: Unknown
Interactions
Drug classifications Anticoagulants, NSAIDs, platelet inhibitors, thrombolytics, salicylates: possible risk of bleeding
Nursing Considerations
Assessment - Bone marrow suppression: If cytopenias occur, product should be discontinued; may use a bone marrow biopsy and straining for fibrosis - Thromboembolic disease: Do not use to normalize patients, use only in those with thrombocytopenia in ITP, maintain platelets ≥50,000/mm3 - Assess blood studies: CBC during treatment weekly and for 2 wks after discontinuing
Patient/family education - Instruct patient to report bleeding, to avoid hazardous activities that may cause bleeding - Inform the patient the reason for product and expected results - Advise patient to report a missed dose to prescriber due to increased risk of bleeding - Teach patient that lab tests will be done qwk and dose may be changed; if dose is not changed lab will be checked qmo; after drug is discontinued, labs will be checked qwk × 2 wk - Teach patient to advise prescriber if spleen has been removed: bleeding or clotting problems - Teach patient to notify prescriber if pregnancy is planned or suspected, pregnancy (C); if pregnancy occurs, call registry 1-877-675-2831
Evaluation
Positive therapeutic outcome: Increase in platelet counts, absence of bleeding
Reference
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