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This document outlines the risk evaluation and mitigation strategy for Nplate™ (romiplostim), a medication prescribed for thrombocytopenia. It includes details on patient enrollment, safety monitoring,

How to fill out nplate romiplostim nexus program

How to fill out Nplate™ (romiplostim) NEXUS Program REMS Submission

1. Gather necessary patient information including medical history and current medications.
2. Ensure the patient meets the eligibility criteria for Nplate™ (romiplostim) treatment.
3. Access the NEXUS Program REMS Submission portal online.
4. Complete the patient registration form with accurate details.
5. Provide the required prescriber information, including your NPI number.
6. Fill out the treatment plan and indication for Nplate™ (romiplostim).
7. Review all entered data for accuracy and completeness.
8. Submit the REMS application through the online portal.
9. Print or save the confirmation of submission for your records.

Who needs Nplate™ (romiplostim) NEXUS Program REMS Submission?

1. Patients diagnosed with chronic immune thrombocytopenia (ITP) who require treatment.
2. Healthcare providers administering treatment with Nplate™ (romiplostim).
3. Pharmacies that will dispense Nplate™ (romiplostim) to eligible patients.

People Also Ask about

How much does Nplate cost?

The cost for Nplate 125 mcg subcutaneous powder for injection is around $1,479 for a supply of 1 powder for injection, depending on the pharmacy you visit. Quoted prices are for cash-paying customers and are not valid with insurance plans.

What is the new code for Nplate?

Effective for dates of service on and after April 1, 2025, the HCPCS code J2796 for Nplate (romiplostim), which is presently on the Designated Medical Specialty Pharmacy Drug List, will be replaced with HCPCS code J2802.

What is the duration of treatment for Nplate?

About half of adults achieved treatment-free remission by about 6 months with Nplate®. However, the time it took to reach treatment-free remission varied from less than 2 months to more than 13 months.

What are the guidelines for Nplate?

Nplate® dosing can be individualized and allows for a maximum weekly dose of up to 10 mcg/kg. If platelet count is < 50 x 109 /L, increase by 1 mcg/kg. If platelet count is ≥ 50 x 109/L and ≤ 200 x 109/L, maintain dose. If platelet count is > 200 x 109/L and ≤ 400 x 109/L for 2 consecutive weeks, reduce by 1 mcg/kg.

What is the difference between Nplate and Promacta?

Nplate contains the active ingredient romiplostim, while Promacta contains the active ingredient eltrombopag. Both medications belong to a class of drugs called thrombopoietin receptor agonists.

Is promacta a rems drug?

REMS for Nplate and Promacta are still required. The revised REMS include a communication plan to inform healthcare professionals about the changes to the REMS programs, as well as the serious risks associated with treatment.

What is the criteria for Nplate?

Nplate® is indicated for the treatment of thrombocytopenia in pediatric patients 1 year of age and older with ITP for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

What are the precautions for romiplostim?

Avoid situations that can increase your risk of becoming hurt and increase your risk of bleeding. Talk with your healthcare provider about the use of medicines that may increase your risk of bleeding, such as aspirin. Nplate can affect your coordination.

For pdfFiller’s FAQs

What is Nplate™ (romiplostim) NEXUS Program REMS Submission?

The Nplate™ (romiplostim) NEXUS Program REMS Submission is a risk evaluation and mitigation strategy that ensures the safe use of Nplate™ in patients with immune thrombocytopenia by monitoring and managing potential risks associated with its use.

Who is required to file Nplate™ (romiplostim) NEXUS Program REMS Submission?

Healthcare providers, pharmacies, and other entities involved in prescribing or dispensing Nplate™ (romiplostim) are required to file the NEXUS Program REMS Submission to comply with regulatory requirements.

How to fill out Nplate™ (romiplostim) NEXUS Program REMS Submission?

To fill out the Nplate™ (romiplostim) NEXUS Program REMS Submission, entities must gather required patient information, complete the necessary forms accurately, and submit them through the designated platform or to the appropriate regulatory body.

What is the purpose of Nplate™ (romiplostim) NEXUS Program REMS Submission?

The purpose of the Nplate™ (romiplostim) NEXUS Program REMS Submission is to mitigate risks associated with treatment by ensuring that patients are monitored closely for adverse effects and that healthcare providers are educated on the proper use of the medication.

What information must be reported on Nplate™ (romiplostim) NEXUS Program REMS Submission?

The information that must be reported includes patient demographics, treatment details, monitoring results, any adverse events, and the healthcare provider's contact information as required by the REMS guidelines.