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romiplostim (Rx)Brand and Other Names:Nplate

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for injection

  • 250mcg/vial
  • 500mcg/vial
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Thrombocytopenia

Initial

  • 1 mcg/kg SC qWeek 

Maintenance

  • Plts <50x10³/mcL, increase dose by 1 mcg/kg qWeek
  • Plts >200 x 10³/mcL for 2 consecutive weeks, reduce dose by 1 mcg/kg qWeek
  • Plts >400 x 10³/mcL, do not dose; resume at dose reduced by 1 mcg/kg once Plt <200 x 10³/mcL
  • Monitor: CBC and platelets prior to, during, and for 2 weeks post-last dose
  • No more than 10 mcg/kg/week
  • Discontinue if no clinically significant improvement after 4 weeks at 10 mcg/kg dose

Administration

Not for self-administration

Reconstitute Single-use Vial Containing

  • 250 mcg deliverable drug (total content 375 mcg) in 0.72 mL sterile water for injection yields 250 mcg/0.5 mL deliverable amount
  • 500 mcg deliverable drug (total content 625 mcg) in 1.2 mL sterile water for injection yields 500 mcg/mL deliverable amount
  • Do NOT use bacteriostatic water for injection for reconstitution
  • Gently swirl and invert to dissolve
  • Reconstituted solution may be stored protected from light for 24 hr at room temperature or refridgerated

Renal Impairment

Not studied

Hepatic Impairment

Not studied

Other Indications & Uses

Thrombocytopenia

  • Chronic immune thrombocytopenic purpura after insufficient response to corticosteroids, IVIG or splenectomy
  • Nplate should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. Nplate should not be used in an attempt to normalize platelet counts

<18 years: Safety and efficacy not established

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Adverse Effects

>10%

Headache (35%)

Fatigue (33%)

Epistaxis (32%)

Confusion (25%)

Arthralgia (26%)

Upper respiratory infection (17%)

Dizziness (17%)

Diarrhea (17%)

Insomnia (16%)

Paresthesia (16%)

Myalgia (14%)

Nausea (13%)

Pain in extremity (13%)

Back pain (13%)

Bleeding (12%)

Abdominal pain (11%)

1-10%

Indigestion (7%)

Dyspepsia

Shoulder pain

Postmarketing Reports

Erythromelalgia

Hypersensitivity

Angioedema

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Warnings

Contraindications

Hypersensitivity

Within 24 hr of receiving myelosuppressive chemotherapy or radiation therapy

>10% leukemic myeloid blasts in bone marrow or peripheral blood

Cautions

Thrombotic/thromboembolic complications may result from increases in platelet counts with therapy; portal vein thrombosis reported in patients with chronic liver disease receiving therapy

Thrombocytopenia may worsen after discontinuation; if severe thrombocytopenia develops during therapy, assess patients for the formation of neutralizing antibodies

In some patients with myelodysplastic syndrome, therapy increases blast cell counts and increases risk of progression to acute myelogenous leukemia

Not indicated for non-ITP thrombocytopenia

Renal/hepatic impairment

Caution in pre-existing heart failure, history of fluid retention, hepatic or renal impairment

Dyspnea may occur

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Pregnancy & Lactation

Pregnancy Category: C

Lactation: Discontinue drug or do not nurse

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Fusion antibody-peptide that is a thrombopoietin receptor agonist; stimulates proliferation, differentiation, and activity of monocytes, neutrophils, eoxinophils, and macrophages

Pharmacokinetics

Peak plasma time: 1-3 hr (SC)

Onset: 7-14 days (increase in WBC)

Half-life elimination: 60 min (IV); 2.7 hr (SC)

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Images

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Formulary

FormularyPatient Discounts

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  • View the formulary and any restrictions for each plan.
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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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