TM Owner Amgen
Nplate 250mcg Injection
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Indications & Clinical Uses
- Nplate 250 mcg (romiplostim) is a thrombopoietin-receptor agonist, a type of protein that stimulates the bone marrow to produce more platelets.
- It is used to treat low platelet counts (thrombocytopenia) in adults and children aged 1 year and older with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.
- Nplate is also approved to increase survival in adults and children, including newborn babies, who have been exposed to a dose of radiation that suppresses bone marrow function (haematopoietic subsyndrome of acute radiation syndrome).
- Nplate is not indicated for low platelet counts caused by myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than ITP, and is not intended to normalise platelet counts completely, only to reduce bleeding risk.
- It is given as a weekly subcutaneous injection under medical supervision, usually in a hospital or specialist clinic.
Side Effects
- The most common side effects of Nplate in adults include headache, affecting around one in three people, along with joint pain, dizziness, insomnia, muscle pain and abdominal pain; in children, bruising, upper respiratory tract infections and pain in the mouth or throat are most frequent.
- There is no boxed warning for Nplate, but three serious risks are highlighted prominently: progression of myelodysplastic syndrome to acute myeloid leukaemia in patients who have MDS (which is why Nplate must not be used for MDS-related low platelets); blood clots such as deep vein thrombosis, pulmonary embolism or heart attack, which can occur even in people with normal platelet counts; and increased bone marrow reticulin fibres, which usually reverses after stopping treatment.
- Loss of platelet response can occur if the body forms antibodies against the medicine.
- Report leg swelling, chest pain, breathlessness, unusual bruising or bleeding promptly.
Precautions & Warnings
- Nplate has no listed contraindications, but it must be used with particular caution in anyone with myelodysplastic syndrome because of the risk of progression to leukaemia, and in patients with liver disease, where thrombosis risk from rising platelet counts is higher even at normal platelet levels.
- Platelet counts are checked weekly while the dose is being adjusted, and blood counts, including a peripheral blood smear, are monitored regularly during treatment to detect early bone marrow changes.
- Nplate is stopped if the platelet count does not increase to a level that reduces bleeding risk after four weeks at the maximum dose.
- It is given only by subcutaneous injection, never intravenously or intramuscularly, and dosing is based on actual body weight.
- Vials are refrigerated at 2°C to 8°C, protected from light and not frozen; unopened vials may be kept at room temperature, up to 25°C, for a single 30-day period if needed.
- Safety in pregnancy has not been established, so use is considered only if the expected benefit outweighs potential risk.
Avoid Interactions
- No formal drug-interaction studies have been carried out with Nplate, and no specific medicines are listed as contraindicated alongside it.
- It has been used together with other standard ITP therapies, including corticosteroids, danazol, azathioprine, intravenous immunoglobulin (IVIG) and anti-D immunoglobulin, without a documented interaction, and your healthcare provider may combine Nplate with these treatments as part of your overall management plan.
- Because Nplate raises platelet counts, any other medicine that also affects blood clotting, including anticoagulants such as warfarin or heparin, and antiplatelet medicines such as aspirin or clopidogrel, should be used with care and monitored closely, since the combination could increase the chance of thrombosis.
- Tell your healthcare provider and pharmacist about every prescription medicine, over-the-counter product and herbal supplement you take, particularly anything that affects bleeding or clotting, before starting or continuing Nplate.
References
Frequently Asked Questions
Nplate (romiplostim) raises low platelet counts in adults and children aged 1 and over with immune thrombocytopenia (ITP) who haven't responded well enough to steroids, immunoglobulins or spleen removal. It's also used after high-dose radiation exposure. It is not used for MDS-related low platelets.
Nplate is given as a weekly injection under the skin (subcutaneous), usually by a healthcare provider in a clinic, with the dose based on your body weight. Your platelet count is checked weekly at first so the dose can be adjusted to keep it in a safe range.
Headache is the most common side effect, affecting around one in three adults, along with joint pain and dizziness. Serious risks include blood clots, worsening of myelodysplastic syndrome toward leukaemia, and bone marrow changes. Report leg swelling, chest pain or unusual bruising right away.
Nplate should not be used to treat low platelets caused by myelodysplastic syndrome (MDS), as it can raise the risk of leukaemia progression. Because it raises platelet counts, combining it with blood thinners or antiplatelet medicines needs closer monitoring. Tell your provider about all your medicines.
Your platelet count is checked weekly while your dose is being adjusted, then regularly afterward. Your healthcare provider also monitors blood counts and, periodically, a blood smear to check for bone marrow changes. If platelets don't rise enough after 4 weeks at the top dose, Nplate is stopped.
Nplate can be used long-term for chronic ITP as long as it continues to help, with regular monitoring. It is approved for children aged 1 year and older with ITP, dosed by body weight in the same way as for adults, under specialist supervision.
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