Chinese instructions for Roprestimin/Romigrastim for Injection

1. Name: Romiplostim,Romiplostim

Product name: Nplate, Winning, Romiplate

Other names: Romilastin, AMG531, Enpeiban

2. Indications:

1. Immune thrombocytopenia (ITP) patients: Romiplostim/Romiplostim is suitable for the treatment of thrombocytopenia in the following patients:

(1) Adult patients with ITP who have inadequate response to corticosteroids, immunoglobulins, or splenectomy

(2)Pediatric patients 1 year and older who have had ITP for at least 6 months have had an inadequate response to corticosteroids, immunoglobulins, or splenectomy.

2. Patients with acute radiation syndrome and hematopoietic syndrome: Ropremilast can improve the survival rate of adult and pediatric patients (including full-term newborns) who are acutely exposed to myelosuppressive doses of radiation.

3. Usage and dosage:

1. Recommended dose: The recommended dose of Roprostim is based on body weight, injected subcutaneously once a week, and the dose is adjusted according to the platelet count response.

(1) ITP patients: The initial dose of loplastin is 1mcg/kg. As needed, adjust the weekly dose of Roprostim in 1mcg/kg increments until the patient's platelet count is ≥50×10^9/L to reduce the risk of bleeding; do not exceed the maximum weekly dose of 10mcg/kg. In clinical studies, the majority of adult patients who responded to roprostim achieved and maintained platelet counts ≥50×10^9/L at a median dose of 2-3mcg/kg, and pediatric patients achieved a median dose of 5.5mcg/kg.

(2) Patients with acute radiation syndrome and hematopoietic syndrome: The recommended dose of loplastin is 10mcg/kg, injected once subcutaneously. Administer as soon as possible after suspected or confirmed exposure to radiation levels >2 Gray (Gy). Use ropremilast whether or not a complete blood count (CBC) is available. Estimate the patient's whole-body absorbed radiation dose (i.e., radiation exposure level) based on information provided by public health authorities, biological dosimetry (if available), or clinical findings (such as timing of emesis episodes or lymphocyte depletion kinetics).

2. Dose adjustment: If the patient's platelet count is <50×10^9/L, increase the dose of loprostim by 1mcg/kg. If the platelet count is >200×10^9/L and ≤400×10^9/L for 2 consecutive weeks, reduce the dose by 1mcg/kg. Do not administer if platelet count is >400×10^9/L. Continue to evaluate platelet counts weekly. After the platelet count drops to less than 200×10^9/L, resume roplastin at a reduced dose of 1 mcg/kg.

When necessary, use the lowest dose of roplastin to achieve and maintain a platelet count≥50×10^9/L to reduce the risk of bleeding. If platelet counts have not increased to a level sufficient to avoid clinically important bleeding after 4 weeks of treatment with ropruprimostat at a maximum dose of 10 mcg/kg per week, discontinue ropruprimostim injections.

4. Adverse reactions:

In clinical studies of Ropremilast, the most common adverse reactions in adults included headache, nose and throat infections, and allergic (hypersensitivity) reactions such as rash, itching, and rapid swelling under the skin; in children, the most common adverse reactions included nose and throat infections, runny nose, cough, fever, mouth and throat pain, abdominal pain, diarrhea, rash, and bruising. Adverse events such as erythromelalgia, angioedema, and allergic reactions also occurred after Roprostim was put on the market.

5. Supply and storage:

Roprestimin for injection is a sterile, preservative-free, white solid lyophilized powder available in single-dose vials of 125mcg (micrograms), 250mcg, and 500mcg. Store roprestimvials in the original carton in a refrigerator at 2°C to 8°C (36°F to 46°F) to protect from light. Do not freeze.

If desired, unopened vials of Ropremilast may be stored in the original carton at room temperature up to 25°C (77°F) for up to 30 days. Once stored at room temperature, do not return to the refrigerator. If not used within 30 days, throw away ropremilast.

6. Use restrictions:

1. Ropremilastis not suitable for the treatment of myelodysplastic syndrome (Thrombocytopenia due to MDS) or any cause of thrombocytopenia other than ITP;

2. Should only be used in patients with ITP whose degree of thrombocytopenia and clinical conditions increase the risk of bleeding

3. Roprostim should not be used to normalize platelet counts.

7. Mechanism of action:

Roplastin is a thrombopoietin receptor agonist that activates the intracellular transcription pathway throughc-Mpl to increase platelet production. It also acts similarly to thrombopoietin (TPO), an endogenous glycoprotein hormone that regulates platelet production in the bone marrow.

8. Overdose:

Overdose due to medication errors has been reported in patients receiving loproprimostat. If overdose occurs, platelet counts may increase excessively and lead to thrombotic/thromboembolic complications. In this case, stopthe drug and monitor the platelet count. Restart treatment with Ropremilast according to dosage and administration recommendations.