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Romiplostim Dosage

Applies to the following strength(s): 250 mcg ; 500 mcg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Idiopathic (Immune) Thrombocytopenic Purpura

Initial dose: 1 mcg/kg subcutaneous injection once a week based on actual body weight

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: 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.

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 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 18 years.

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:
-Once reconstituted, store at room temperature (25C/77F) or refrigerated (2 to 8C [36 to 46F]) for up to 24 hours before administration.
-Protect reconstituted product from light.

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.

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