romiplostim (Rx)

Brand and Other Names:Nplate
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 250mcg/vial
  • 500mcg/vial
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Thrombocytopenia

Initial

  • 1 mcg/kg SC qWeek 

Dose adjustment

  • Platelets <50x 10^9/L, increase dose by 1 mcg/kg qWeek
  • Platelets >200x 10^9/L for 2 consecutive weeks, reduce dose by 1 mcg/kg qWeek
  • Platelets >400x 10^9/L, do not dose; resume at dose reduced by 1 mcg/kg once platelets <200x 10^9/L
  • Monitor: CBC and platelets prior to, during, and for 2 weeks post-last dose
  • Not to exceed 10 mcg/kg/week
  • Discontinue if no clinically significant improvement after 4 weeks at 10 mcg/kg dose

Dose adjustment

  • Adjust weekly dose by increments of 1 mcg/kg until the patient achieves a platelet count ≥50x 10^9/L as necessary to reduce the risk for bleeding
  • Not to exceed maximum weekly dose of 10 mcg/kg
  • Most adults achieved and maintained platelets ≥50x 10^9/L with median dose of 2 mcg/kg
  • Determine dose adjustment by platelet count
    • Platelets <50x 10^9/L: Increase by 1 mcg/kg
    • Platelet >200 to ≤400x 10^9/L for 2 consecutive weeks: Reduce by 1 mcg/kg
    • Platelet >400x 10^9/L: Do not give dose; continue weekly platelet assessment, if platelets fall to <200x 10^9/L, resume at dose reduced by 1 mcg/kg

Renal Impairment

Not studied

Hepatic Impairment

Not studied

Dosing Considerations

Limitations of use

  • Not indicated for thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than chronic ITP
  • Only in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding
  • Do not use as an attempt to normalize platelet counts

Dosage recommendations for all patients

  • Use the lowest dose to achieve and maintain a platelet count ≥50x 10^9/L as necessary to reduce the risk for bleeding
  • Administer as a weekly SC injection with dose adjustments based upon platelet count response
  • Prescribed dose may be a very small volume (eg, 0.15 mL); administer only with syringe that contains 0.01 mL graduations
  • Discontinue if the platelet count does not increase to sufficient level in order to avoid clinically important bleeding after 4 weeks at the maximum weekly dose of 10 mcg/kg

Monitoring

  • Obtain CBC, including platelet counts, weekly during dose adjustment phase, and then monthly once stable dose established
  • Obtain CBC, including platelet counts, weekly for at least 2 weeks following discontinuation

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 250mcg/vial
  • 500mcg/vial
more...

Thrombocytopenia

Indicated for thrombocytopenia in children aged ≥1 year with immune thrombocytopenia (ITP) for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy

Initial

  • 1 mcg/kg SC qWeek
  • Actual body weight at initiation of treatment should always be used when calculating initial dose
  • In pediatric patients, future dose adjustments are based on changes in platelet counts and changes in body weight; reassess body weight q12Weeks

Dose adjustment

  • Adjust weekly dose by increments of 1 mcg/kg until the patient achieves a platelet count ≥50x 10^9/L as necessary to reduce the risk for bleeding
  • Not to exceed maximum weekly dose of 10 mcg/kg
  • Median dose was 5.5 mcg/kg in pediatric clinical trials
  • Determine dose adjustment by platelet count
    • Platelets <50x 10^9/L: Increase by 1 mcg/kg
    • Platelet >200 to ≤400x 10^9/L for 2 consecutive weeks: Reduce by 1 mcg/kg
    • Platelet >400x 10^9/L: Do not give dose; continue weekly platelet assessment, if platelets fall to <200x 10^9/L, resume at dose reduced by 1 mcg/kg

Dosing Considerations

Limitations of use

  • Not indicated for thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than chronic ITP
  • Only in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding
  • Do not use as an attempt to normalize platelet counts

Dosage recommendations for all patients

  • Use the lowest dose to achieve and maintain a platelet count ≥50x 10^9/L as necessary to reduce the risk for bleeding
  • Administer as a weekly SC injection with dose adjustments based upon platelet count response
  • Prescribed dose may be a very small volume (eg, 0.15 mL); administer only with syringe that contains 0.01 mL graduations
  • Discontinue if the platelet count does not increase to sufficient level in order to avoid clinically important bleeding after 4 weeks at the maximum weekly dose of 10 mcg/kg

Monitoring

  • Obtain CBC, including platelet counts, weekly during dose adjustment phase, and then monthly once stable dose established
  • Obtain CBC, including platelet counts, weekly for at least 2 weeks following discontinuation
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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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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
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  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

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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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.