What are the precautions for taking Romiplostim?

The patient was taking romiplostim (Romiplostim) to treat immune thrombocytopenia (ITP) and acute exposure. In adult and pediatric patients (including term neonates) exposed to myelosuppressive doses of radiation, attention should be paid to the development of myelodysplastic syndrome to acute myeloid leukemia, thrombotic/thromboembolic complications, and loss of response to romiplostim.

1. Risk of myelodysplastic syndrome developing into acute myeloid leukemia:

A randomized, double-blind, placebo-controlled trial enrolling adult patients with severe thrombocytopenia and International Prognostic Scoring System (IPSS) low or intermediate 1 risk MDS was terminated because more cases of AML were observed in the romiplostim group. Romigrastim is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause other than ITP and should not be used to attempt to normalize platelet counts.

2. Thrombus formation/Thromboembolic complications: It may be caused by an increase in platelet count secondary to drug-induced thrombocytosis and is not related to the underlying disease. Portal vein thrombosis has been reported in patients with chronic liver disease receiving romiplostim. To minimize the risk of thrombotic/thromboembolic complications in patients withITP, do not use romigrastim in an attempt to normalize platelet counts. In the absence of myelosuppression induced by acute radiation exposure, romigrastim administration may result in excessive increases in platelet counts and may lead to thrombotic and thromboembolic complications.

3. Loss of response to romigrastim: Hyporesponsiveness to romigrastim or an inability to maintain a platelet response should prompt the search for causative factors, including neutralizing antibodies to romigrastim. Discontinue romiplostim if platelet counts do not increase enough to avoid clinically important bleeding after 4 weeks at the highest weekly dose of >10 mcg/kg.

4. Embryo-Fetal Toxicity: According to findings from animal reproduction studies, taking Romigrastim by pregnant women may cause harm to the fetus. The adverse effects of Romigrastim on the fetus as it crosses the placenta include thrombocytosis, post-implantation loss and increased pup mortality. Therefore, it is recommended that women not breastfeed during treatment with Romigrastim.

RomiplostimThe original drug has been approved by the State Food and Drug Administration for marketing. Due to its short time on the market, it is not included in the scope of medical insurance. It may be difficult to purchase it domestically. The price of the original version in Hong Kong may be RMB 10,000 per pill (the price may fluctuate due to exchange rates). European versionRomiplostim The price of the original drug may be 11,000 RMB per pill, the German version may be 9,850 RMB per pill, and the Hong Kong version may be 8,900 RMB per pill (the price may fluctuate due to the exchange rate). The ingredients of the drugs are basically the same. For specific prices and drug details, please consult Yaode’s medical consultant.