Once-weekly Nplate®—individualized for stable platelet response11

Use the lowest dose of Nplate® to achieve and maintain a platelet count ≥ 50 x 109/L as necessary to reduce the risk for bleeding. Administer Nplate® as a once-weekly subcutaneous injection with dose adjustments based upon the platelet count response. Do not exceed maximum weekly dose of 10 mcg/kg.11

Dosing Algorithm

Initial Dose

Nplate® 1 mcg/kg, based on actual body weight11

Monitoring and dose adjustment

Weekly

Obtain weekly complete blood counts (CBCs), including platelet counts, during dose adjustment until stable platelet count ≥ 50 x 109/L is achieved for ≥ 4 weeks without further changes in dose11

INCREASE

If platelet count is
< 50 x 109/L,
INCREASE dose by 1 mcg/kg. 11

MAINTAIN

If platelet count is 50-200 x 109/L,
MAINTAIN same dose. 11

REDUCE

If platelet count is > 200 x 109/L for 2 consecutive weeks, REDUCE dose by 1 mcg/kg.11

HOLD

If platelet count is > 400 x 109/L, DO NOT DOSE. Assess platelet count weekly. After platelet count is < 200 x 109/L, resume at dose decreased by 1 mcg/kg.11

Monthly

After achieving stable platelet count and stable Nplate® dose, obtain monthly complete blood counts (CBCs), including platelet counts.11

Titrate Nplate® according to individual patient response; adjust the weekly dose of Nplate® by increments of 1 mcg/kg until the patient achieves a platelet count of ≥ 50 x 109/L, as necessary, to reduce the risk of bleeding.1

Do not exceed maximum weekly dose of 10 mcg/kg.11

Discontinuation
Discontinue Nplate® if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks of Nplate® therapy at the maximum weekly dose of 10 mcg/kg. Obtain CBCs, including platelet counts, weekly for at least 2 weeks following discontinuation of Nplate®.11

CBCs, complete blood count.

Nplate® dosing and administration
See what Nplate® dosing* and administration might look like for you and your practice

Always reference the complete dosing and administration information in the full prescribing information for Nplate®. Download now >

Watch the Nplate (romiplostim) dosing and administration video
Watch Nplate (romiplostim) Dosing Perspectives from two leading hematologists, Dr. Michael Tarantino from the Bleeding and Clotting Disorders Institute, IL, and Dr. Terry Gernsheimer from the Seattle Cancer Care Alliance, WA, as they discuss Nplate dosing and titration

Dosing and Reconstituting Nplate® (video at left)(video at top) provides an overview of the preparation and administration process.

Nplate® Dosing Perspectives (video at right)(video at bottom) follows two leading hematologists, Dr. Michael Tarantino from the Bleeding and Clotting Disorders Institute, IL, and Dr. Terry Gernsheimer from the Seattle Cancer Care Alliance, WA, as they discuss Nplate® dosing and titration to address their patients' needs.

*The recommended starting dose for Nplate® is 1 mcg/kg.11 Please see the Nplate® full Prescribing Information for complete dosing instructions, including guidelines for dose adjustments.

Individualize dosing based on patient's platelet response11
Meet 3 patients representing potential titration scenarios. Not all patients will respond to Nplate®, and results may vary during therapy. These examples are intended to provide an overview only.

Important points for preparation and administration11:

  • To mitigate against medication errors (both overdose and underdose), ensure that the preparation and administration instructions in the full Prescribing Information are followed.
  • As the injection volume may be very small, use a syringe with graduations to 0.01 mL and verify that the syringe contains the correct dosage.
  • Only administer subcutaneously.
Angela:
3 mcg/kg example dose

Meet Angela:

Achieved stable platelet response at 3 mcg/kg

INITIATE
Week 1 / Platelet count: 15 x 109/L
  • Patient dose: 59 kg x 1 mcg/kg = 59 mcg/500 mcg/mL vial of Nplate® = 0.118 mL injection volume of the reconstituted vial of Nplate®.

    Please refer to the full Prescribing Information for Nplate® for instructions on appropriately reconstituting Nplate® single-dose vials.
Initial actual body weight is used to calculate dose
ADJUST
Week 2–3 / Platelet count: 45 x 109/L
Increased weekly dose by 1 mcg/kg each week to 3 mcg/kg
Week 4 / Platelet count: 52 x 109/L
Dose maintained at 3 mcg/kg
Week 5–6 / Platelet count: 204 x 109/L–216 x 109/L
> 200 x 109/L for 2 consecutive weeks. Reduced weekly dose by 1 mcg/kg to 2 mcg/kg
Week 7 / Platelet count: 37 x 109/L
Increased weekly dose by 1 mcg/kg to 3 mcg/kg
Week 8–11 / Platelet count: 65 x 109/L–125 x 109/L
Dose maintained at 3 mcg/kg
MAINTAIN
Angela's Nplate® dose is maintained weekly at 3 mcg/kg
MONITORING REQUIREMENTS
  • Obtain weekly CBCs, including platelet counts during dose adjustment period, until a stable platelet count (≥ 50 x 109/L) is maintained for 4 consecutive weeks without further changes in dose
  • After achieving stable platelet count and stable Nplate® dose, obtain monthly CBCs including platelet counts
Meet Angela, who achieved a stable platelet response at 3 mcg/kg. Sample patient, individual results may vary.
Based on her platelet response, Angela's maintenance dose is 3 mcg/kg per week of Nplate®
Peter: 4 mcg/kg example dose
Peter:
4 mcg/kg example dose

Meet Peter:

Achieved stable platelet response at 4 mcg/kg

INITIATE
Week 1 / Platelet count: 11 x 109/L
  • Patient dose: 97 kg x 1 mcg/kg = 97 mcg/500 mcg/mL vial of Nplate® = 0.194 mL injection volume of the reconstituted vial of Nplate®.

    Please refer to the full Prescribing Information for Nplate® for instructions on appropriately reconstituting Nplate® single-dose vials.
Initial actual body weight is used to calculate dose
ADJUST
Week 2–6 / Platelet count: 15 x 109/L–26 x 109/L
Increased weekly dose by 1 mcg/kg each week to 6 mcg/kg
Week 7 / Platelet count: 92 x 109/L
Dose maintained at 6 mcg/kg
Week 8–9 / Platelet count: 212 x 109/L–335 x 109/L
> 200 x 109/L for 2 consecutive weeks. Reduced weekly dose by 1 mcg/kg to 5 mcg/kg
Week 10 / Platelet count: 293 x 109/L
Reduced weekly dose by 1 mcg/kg to 4 mcg/kg
Week 11–14 / Platelet count: 96 x 109/L–107 x 109/L
Dose maintained at 4 mcg/kg
MAINTAIN
Peter’s Nplate® dose is maintained weekly at 4 mcg/kg
MONITORING REQUIREMENTS
  • Obtain weekly CBCs, including platelet counts during dose adjustment period, until a stable platelet count (≥ 50 x 109/L) is maintained for 4 consecutive weeks without further changes in dose
  • After achieving stable platelet count and stable Nplate® dose, obtain monthly CBCs including platelet counts
Meet Peter, who achieved a stable platelet response at 4 mcg/kg. Sample patient, individual results may vary.
Based on his platelet response, Peter's maintenance dose is 4 mcg/kg per week of Nplate®
Alan: 10 mcg/kg example dose
Alan:
10 mcg/kg example dose

Meet Alan:

Achieved stable platelet response at 10 mcg/kg

INITIATE
Week 1 / Platelet count: 41 x 109/L
  • Patient dose: 100 kg x 1 mcg/kg = 100 mcg/500 mcg/mL vial of Nplate® = 0.2 mL injection volume of the reconstituted vial of Nplate®.

    Please refer to the full Prescribing Information for Nplate® for instructions on appropriately reconstituting Nplate® single-dose vials.
Initial actual body weight is used to calculate dose
ADJUST
Week 2–6 / Platelet count: 24 x 109/L–38 x 109/L
Increased weekly dose by 1 mcg/kg each week to 6 mcg/kg
Week 7 / Platelet count: 12 x 109/L
Increased weekly dose by 1 mcg/kg to 7 mcg/kg
Week 8-10 / Platelet count: 15 x 109/L–49 x 109/L
Increased dose each week to a maximum dose of 10 mcg/kg
Week 11 / Platelet count: 65 x 109/L
Dose maintained at 10 mcg/kg
Week 12-15 / Platelet count: 96 x 109/L–107 x 109/L
Dose maintained at 10 mcg/kg
  • Do not exceed a maximum weekly dose of 10 mcg/kg
MAINTAIN
Alan's Nplate® dose is maintained weekly at 10 mcg/kg
MONITORING REQUIREMENTS
  • Obtain weekly CBCs, including platelet counts during dose adjustment period, until a stable platelet count (≥ 50 x 109/L) is maintained for 4 consecutive weeks without further changes in dose
  • After achieving stable platelet count and stable Nplate® dose, obtain monthly CBCs including platelet counts
Meet Alan, who achieved a stable platelet response at 10 mcg/kg. Sample patient, individual results may vary.
Based on his platelet response, Alan's maintenance dose is 10 mcg/kg per week of Nplate®
Angela: 3 mcg/kg example dose

Important Safety Information

Risk of Progression of Myelodysplastic Syndromes to Acute Myelogenous Leukemia

  • In Nplate® (romiplostim) clinical trials of patients with myelodysplastic syndromes (MDS) and severe thrombocytopenia, progression from MDS to acute myelogenous leukemia (AML) has been observed.
  • Nplate® is not indicated for the treatment of thrombocytopenia due to MDS or any cause of thrombocytopenia other than chronic ITP.

Thrombotic/Thromboembolic Complications

  • Thrombotic/thromboembolic complications may result from increases in platelet counts with Nplate® use. Portal vein thrombosis has been reported in patients with chronic liver disease receiving Nplate®.
  • To minimize the risk for thrombotic/thromboembolic complications, do not use Nplate® in an attempt to normalize platelet counts. Follow the dose adjustment guidelines to achieve and maintain a platelet count of ≥ 50 x 109/L.

Loss of Response to Nplate®

  • Hyporesponsiveness or failure to maintain a platelet response with Nplate® should prompt a search for causative factors, including neutralizing antibodies to Nplate®.
  • To detect antibody formation, submit blood samples to Amgen (1‑800‑772‑64361‑800‑772‑6436). Amgen will assay these samples for antibodies to Nplate® and thrombopoietin (TPO).
  • Discontinue Nplate® if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks at the highest weekly dose of 10 mcg/kg.

Laboratory Monitoring

  • Obtain CBCs, including platelet counts, weekly during the dose adjustment phase of Nplate® therapy and then monthly following establishment of a stable Nplate® dose.
  • Obtain CBCs, including platelet counts, weekly for at least two weeks following discontinuation of Nplate®.

Adverse Reactions

  • In the placebo-controlled trials, headache was the most commonly reported adverse drug reaction, occurring in 35% of patients receiving Nplate® and 32% of patients receiving placebo. Headaches were usually of mild or moderate severity.
  • Most common adverse reactions (≥ 5% higher patient incidence in Nplate® versus placebo) were Arthralgia (26%, 20%), Dizziness (17%, 0%), Insomnia (16%, 7%), Myalgia (14%, 2%), Pain in Extremity (13%, 5%), Abdominal Pain (11%, 0%), Shoulder Pain (8%, 0%), Dyspepsia (7%, 0%), and Paresthesia (6%, 0%).
  • Nplate® administration may increase the risk for development or progression of reticulin fiber formation within the bone marrow. This formation may improve upon discontinuation of Nplate®. In a clinical trial, one patient with ITP and hemolytic anemia developed marrow fibrosis with collagen during Nplate® therapy.


Women who become pregnant during Nplate® treatment are encouraged to enroll in Amgen's Pregnancy Surveillance Program. Patients or their physicians should call 1‑800‑77‑AMGEN1‑800‑77‑AMGEN (1‑800‑772‑64361‑800‑772‑6436) to enroll.

Indication

Nplate® is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

Nplate® is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than chronic ITP. 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.

Please see full Prescribing Information and Medication Guide.

See More Close

Important Safety Information

Risk of Progression of Myelodysplastic Syndromes to Acute Myelogenous Leukemia

  • In Nplate® (romiplostim) clinical trials of patients with myelodysplastic syndromes (MDS) and severe thrombocytopenia, progression from MDS to acute myelogenous leukemia (AML) has been observed.
  • Nplate® is not indicated for the treatment of thrombocytopenia due to MDS or any cause of thrombocytopenia other than chronic ITP.

Thrombotic/Thromboembolic Complications

  • Thrombotic/thromboembolic complications may result from increases in platelet counts with Nplate® use. Portal vein thrombosis has been reported in patients with chronic liver disease receiving Nplate®.
  • To minimize the risk for thrombotic/thromboembolic complications, do not use Nplate® in an attempt to normalize platelet counts. Follow the dose adjustment guidelines to achieve and maintain a platelet count of ≥ 50 x 109/L.

Loss of Response to Nplate®

  • Hyporesponsiveness or failure to maintain a platelet response with Nplate® should prompt a search for causative factors, including neutralizing antibodies to Nplate®.
  • To detect antibody formation, submit blood samples to Amgen (1‑800‑772‑64361‑800‑772‑6436). Amgen will assay these samples for antibodies to Nplate® and thrombopoietin (TPO).
  • Discontinue Nplate® if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks at the highest weekly dose of 10 mcg/kg.

Laboratory Monitoring

  • Obtain CBCs, including platelet counts, weekly during the dose adjustment phase of Nplate® therapy and then monthly following establishment of a stable Nplate® dose.
  • Obtain CBCs, including platelet counts, weekly for at least two weeks following discontinuation of Nplate®.

Adverse Reactions

  • In the placebo-controlled trials, headache was the most commonly reported adverse drug reaction, occurring in 35% of patients receiving Nplate® and 32% of patients receiving placebo. Headaches were usually of mild or moderate severity.
  • Most common adverse reactions (≥ 5% higher patient incidence in Nplate® versus placebo) were Arthralgia (26%, 20%), Dizziness (17%, 0%), Insomnia (16%, 7%), Myalgia (14%, 2%), Pain in Extremity (13%, 5%), Abdominal Pain (11%, 0%), Shoulder Pain (8%, 0%), Dyspepsia (7%, 0%), and Paresthesia (6%, 0%).
  • Nplate® administration may increase the risk for development or progression of reticulin fiber formation within the bone marrow. This formation may improve upon discontinuation of Nplate®. In a clinical trial, one patient with ITP and hemolytic anemia developed marrow fibrosis with collagen during Nplate® therapy.

Women who become pregnant during Nplate® treatment are encouraged to enroll in Amgen's Pregnancy Surveillance Program. Patients or their physicians should call 1‑800‑77‑AMGEN1‑800‑77‑AMGEN (1‑800‑772‑64361‑800‑772‑6436) to enroll.

Indication

Nplate® is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

Nplate® is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than chronic ITP. 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.

Please see full Prescribing Information and Medication Guide.

References: 1. Nplate® (romiplostim) prescribing information, Amgen.

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