Parenteral Manual

Romiplostim (NON-FORMULARY)

Disclaimer: Official controlled document is the CHEO online copy. It is the responsibility of user to ensure that any paper copy version is the same as the online version before use.

Alternate Name(s): 
Colony stimulating factor, thrombopoetic factor
Original Date: 
March 2010
  • Treatment of thrombocytopenia in patients (adults) with chronic immune (idiopathic) thrombocytopenia purpura (ITP) who have had insufficient response to corticosteroids, immune globulin or splenectomy
Reconstitution and Stability: 
  • Available as a sterile, preservative free, lyophilized solid white powder for reconstitution
  • store intact vials refrigerated; do not freeze
  • protect from light
  • 250 mcg vial (contains 375 mcg); reconstitute with 0.72 mL of sterile water for a final concentration of 500 mcg/mL (total extractable dose per vial is 250 mcg per 0.5 mL)
  • 500 mcg vial (contains 625 mcg); reconstitute with 1.2 mL of sterile water for a final concentration of 500 mcg/mL (total extractable dose per vial is 500 mcg per 1 mL)
  • gently invert vial and swirl; DO NOT SHAKE
  • Reconstituted solution may be stored at room temperature or refrigerated for up to 24 hours.  Protect reconstituted solution from light

Do not mix with other medication


(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)

IV Direct NO
IV Intermittent Infusion NO
IV Continuous Infusion NO

(For neonatal dosages, refer to Neonatal IV Drug Manual.)






  • Investigational use (see adult dosing)


  • Initial: 1 mcg/kg SC once weekly; adjust dose by 1 mcg/kg/week to achieve platelet count > 50,000/mm3  and to reduce the risk of bleeding; maximum 10 mcg/kg (median dose needed to achieve response in clinical trials; 2 mcg/kg)


    Dosage adjustment recommendations:

    Platelet count < 50,000/ mm3  : Increase dose by 1 mcg/kg

    Platelet count > 200,000/ mm3  for 2 consecutive weeks: Reduce dose by 1 mcg/kg

    Platelet count > 400,000/ mm3  : Withhold dose; assess platelet count weekly; when platelet count < 200,000/ mm3  , resume with the dose reduced by 1 mcg/kg

Potential hazards of parenteral administration: 
  • CNS: Headache, fatigue, dizziness, insomnia
  • GI: Diarrhea, nausea, abdominal pain, dyspepsia
  • Neuromuscular & skeletal; arthralgia, myalgia, back pain, limb pain, shoulder pain, paresthesia
  • Respiratory: Epistaxis, upper respiratory tract infection
  • Hematologic: rebound thrombocytopenia, bone marrow reticulin formation/deposition
  • Miscellaneous: antibody formation (romiplostim 10%; TPO 5%)
  • Postmarketing and/or case reports: thromboembolism
  • Discontinue if platelet count does not respond to a level that avoids clinically important bleeding after 4 weeks at the maximum recommended dose
  • Concomitant ITP medications; may be used in combination with other therapies for ITP, including corticosteroids, danazol, azathioprine, immune globulin, or RHo(D) immune globulin. Reduce dose of or discontinue ITP medications when platelet count > 50,000/mm3
  • Monitoring: CBC with differential and platelets (baseline, during treatment [weekly until platelet response stable for 4 weeks then monthly] and weekly for at least 2 weeks following completion of treatment]
  • Evaluate for neutralizing antibodies in patients with inadequate response (blood samples may be submitted to Amgen for assay [1-888-772-6436])

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