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The following information outlines important safety considerations and warnings associated with the use of Nplate (romiplostim). It is crucial to be aware of these risks and discuss any concerns with your healthcare provider.

• Risk of Blood Cancer (Leukemia): Individuals with a pre-existing condition known as myelodysplastic syndrome (MDS) who use Nplate (romiplostim) may develop a more severe form of blood cancer, such as acute myeloid leukemia (AML). Nplate (romiplostim) is not approved for treating low platelet levels in patients with MDS. It is important to inform your healthcare provider if you have a history of blood cancer, as this medication may not be suitable for you.

• Risk of Blood Clots: Nplate (romiplostim) increases platelet levels, which can heighten the risk of developing blood clots. These clots have been observed particularly in the liver (known as portal vein thrombosis) in individuals with liver issues. If you experience symptoms such as stomach pain, nausea, vomiting, or diarrhea, contact your healthcare provider as these could indicate a clot in the liver. This is especially important if you have a history of liver problems or blood clots.

• Potential Ineffectiveness: Not all individuals respond effectively to Nplate (romiplostim). Some may develop antibodies that neutralize the medication, reducing its effectiveness. If you continue to experience symptoms such as easy bruising or persistent bleeding despite taking the medication, consult your provider. They may need to conduct tests to check for the presence of antibodies against Nplate (romiplostim).

Please ensure you discuss all potential risks and appropriate precautions with your healthcare provider to ensure the safe use of Nplate (romiplostim).

When taking this medication, you may experience some common side effects, which are generally mild. These include joint stiffness, dizziness, trouble sleeping, muscle pain, arm or leg pain, and stomach pain. In children, fever, mouth or throat pain, and diarrhea may also occur. Bruising, cough, runny nose, and other symptoms of an upper respiratory tract infection are also reported. While these effects are often manageable, if they persist or worsen, it’s advisable to consult your healthcare provider.

There are also rare and more serious side effects that require immediate medical attention. These include symptoms associated with blood clots, such as shortness of breath, rapid breathing, chest pain, sudden dizziness, pain or swelling in the groin or calf, trouble speaking, weakness on one side of the body, sudden vision changes, confusion, and severe headaches. Additionally, shoulder pain, heartburn, and a tingling sensation in the limbs should be promptly addressed.

A very serious allergic reaction to this drug is rare but demands urgent medical help if symptoms such as rash, itching, swelling (particularly of the face, tongue, or throat), severe dizziness, or trouble breathing occur. Always remain observant to any side effects not listed here and seek professional advice if needed.