Usual Adult Dose for Idiopathic (Immune) Thrombocytopenic Purpura

Initial dose: 1 mcg/kg subcutaneous injection once a week based on actual body weight; adjust the weekly dose by increments of 1 mcg/kg until the patients achieves a platelet count of 50 x 10(9)/L or greater

Maintenance dose: Use the lowest dose to achieve and maintain a platelet count of 50 x 10(9)/L or greater as needed to reduce bleeding risk.

Maximum dose: 10 mcg/kg/week

Duration of therapy: Discontinue this drug if platelets remain insufficient to avoid clinically important bleeding after 4 weeks at the maximum dose.

Comments: In clinical studies, most patients who responded to this drug achieved and maintained platelet counts of 50 x 10(9)/L or greater with a median dose of 2 mcg/kg.

Use: Treatment of thrombocytopenia in patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy; use only in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding.

Usual Pediatric Dose for Idiopathic (Immune) Thrombocytopenic Purpura

1 Year or Older:
Initial dose: 1 mcg/kg subcutaneous injection once a week based on actual body weight; adjust the weekly dose by increments of 1 mcg/kg until the patients achieves a platelet count of 50 x 10(9)/L or greater

Maintenance dose: Use the lowest dose to achieve and maintain a platelet count of 50 x 10(9)/L or greater as needed to reduce bleeding risk.

Maximum dose: 10 mcg/kg/week

Comments:

• Dose adjustments are based on changes in platelet counts and changes in body weight. Reassessment of body weight is recommended every 12 weeks.
• In a pediatric placebo-controlled clinical study, the median dose was 5.5 mcg/kg.

Use: Treatment of thrombocytopenia in patients with immune thrombocytopenia (ITP) for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy; use only in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

This drug should be used at the lowest dose in order to achieve and maintain a platelet count of 50 x 10(9)/L or greater as needed to reduce bleeding risk.

Dose adjustments based on platelet counts:

• Platelet count less than 50 x 10(9)/L: Increase dose by 1 mcg/kg
• Platelet count greater than 200 x 10(9)/L and less than or equal to 400 x 10(9)/L for 2 consecutive weeks: Reduce dose by 1 mcg/kg
• Platelet count greater than 400 x 10(9)/L: Interrupt treatment and assess platelet count weekly; may resume treatment at a dose reduced by 1 mcg/kg after the platelet count is less than 200 x 10(9)/L.

Precautions

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for romiplostim. It includes a communication plan. For additional information: www.fda.gov/REMS

Safety and efficacy have not been established in patients younger than 1 year with immune thrombocytopenia (ITP).

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Only administer subcutaneously with a syringe that contains 0.01 mL graduations.
• Do not administer more than one dose from a vial.

Storage requirements:

• Reconstituted product with Sterile Water for Injection, USP that has not been further diluted can remain in the original vial at room temperature (25C [77F]) or refrigerated (2 to 8C [36 to 46F]) for up to 24 hours following reconstitution. Reconstituted product with Sterile Water for Injection, USP may be held in a syringe at room temperature (25C [77F]) for a maximum of 4 hours following reconstitution.
• Reconstituted and further diluted product with 0.9% Sodium Chloride Injection, USP can be held in a syringe at room temperature (25C [77F]) or in the original vial refrigerated at 2C to 8C (36F to 46F) for no longer than 4 hours prior to administration.
• Protect reconstituted product from light. Do not shake.

Reconstitution/preparation techniques: The manufacturer product information should be consulted.

General:

• This drug is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than chronic immune thrombocytopenia (ITP).
• This drug should not be used in an attempt to normalize platelet counts.

Monitoring:

• Hematologic: Complete blood counts (CBCs), including platelet counts, weekly until a stable platelet count (50 x 10(9)/L or greater for at least 4 weeks without dose adjustment) has been achieved, monthly thereafter, and weekly for at least 2 weeks following discontinuation of this drug.

Patient Advice:

• Inform patients that the risks associated with long-term use of this drug are unknown.
• Advise patients to avoid situations that may increase the risk of bleeding.
• Advise females of reproductive potential to inform their prescriber of a known or suspected pregnancy.
• Advise women not to breastfeed during treatment with this drug.

Frequently asked questions

• Is Nplate a chemotherapy drug?
• How is Nplate administered?