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Nplate 250 and 500 micrograms powder for solution for injection (Romiplostim)
Nplate 250 micrograms powder for solution for injection
Nplate 500 micrograms powder for solution for injection
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Nplate’s active ingredient is romiplostim, which is a protein used to treat low platelet counts in patients with immune (idiopathic) thrombocytopenic purpura (called ITP). ITP is a disease in which your body’s immune system destroys its own platelets. Platelets are the cells in your blood that help seal cuts and form blood clots. Very low platelet counts can cause bruising and serious bleeding.
Romiplostim is produced by recombinant DNA technology in Escherichia coli (E. coli).
Nplate is used to treat patients aged 1 year and over who may or may not have had their spleen removed for chronic ITP and who have been previously treated with corticosteroids or immunoglobulins, where these treatments don’t work.
Nplate works by stimulating the bone marrow (part of the bone which makes blood cells) to produce more platelets. This should help to prevent bruising and bleeding associated with ITP.
Talk to your doctor, pharmacist or nurse before using Nplate.
If you have very high blood platelet counts this may increase the risk of blood clotting. Your doctor will adjust your dose of Nplate to ensure that your platelet count does not become too high.
Bone marrow changes (increased reticulin and possible bone marrow fibrosis)
Long-term use of Nplate may cause changes in your bone marrow. These changes may lead to abnormal blood cells or your body making less blood cells. The mild form of these bone marrow changes is called “increased reticulin” and has been observed in Nplate clinical trials. It is not known if this may progress to a more severe form called “fibrosis.” Signs of bone marrow changes may show up as abnormalities in your blood tests. Your doctor will decide if abnormal blood tests mean that you should have bone marrow tests or if you should stop taking Nplate.
Worsening of blood cancers
Your doctor may decide to take a bone marrow biopsy if they decide it is necessary to ensure that you have ITP, and not another condition such as Myelodysplastic Syndrome (MDS). If you have MDS and receive Nplate you may have an increase in your blast cell counts and your MDS condition may worsen to become an acute myeloid leukaemia, which is a type of cancer of the blood.
Loss of response to romiplostim
If you experience a loss of response or failure to maintain a platelet response with romiplostim treatment, your doctor will investigate the reasons why including whether you are experiencing increased bone marrow fibres (reticulin) or have developed antibodies which neutralise romiplostim’s activity.
Nplate is not recommended for use in children aged under 1 year.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you are also taking medicines which prevent blood clots (anticoagulants or antiplatelet therapy) there is a greater risk of bleeding. Your doctor will discuss this with you.
If you are taking corticosteroids, danazol, and/or azathioprine, which you may be receiving to treat your ITP, these may be reduced or stopped when given together with Nplate.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Nplate is not recommended for use if you are pregnant unless indicated by your doctor.
It is not known whether romiplostim is present in human milk. Nplate is not recommended for use if you are breast-feeding. A decision on whether to discontinue breast-feeding or discontinue therapy with romiplostim should be made taking into account the benefit of breast-feeding to your child and the benefit of romiplostim therapy to you.
You should speak with your doctor before driving or using machines, as some side effects (e.g. temporary bouts of dizziness) may impair your ability to do so safely.
Adult and children (1 to 17 years):
Nplate will be given under the direct supervision of your doctor, who will closely control the amount of Nplate given to you.
Nplate is administered once a week as an injection under the skin (subcutaneous).
Your initial dose is 1 microgram of Nplate per kilogram of your body weight once a week. Your doctor will tell you how much you must take. Nplate should be injected once per week in order to keep your platelet counts up. Your doctor will take regular blood samples to measure how your platelets are responding and may adjust your dose as necessary.
Once your platelet count is under control, your doctor will continue to regularly check your blood. Your dose may be adjusted further in order to maintain long-term control of your platelet count.
Children (1 to 17 years old): in addition to adjusting your dose based on platelet counts, your doctor will also regularly reassess your body weight in order to adjust your dose.
Your doctor will ensure that you receive the right amount of Nplate. If you have been given more Nplate than you should, you may not experience any physical symptoms but your blood platelet counts may rise to very high levels and this may increase the risk of blood clotting. Therefore, if your doctor suspects that you have been given more Nplate than you should, it is recommended that you are monitored for any signs or symptoms of side effects and that you are given appropriate treatment immediately.
Your doctor will ensure that you receive the right amount of Nplate. If you have been given less Nplate than you should, you may not experience any physical symptoms but your blood platelet counts may become low and this may increase the risk of bleeding. Therefore, if your doctor suspects that you have been given less Nplate than you should, it is recommended that you are monitored for any signs or symptoms of side effects and that you are given appropriate treatment immediately.
If you have missed a dose of Nplate, your doctor will discuss with you when you should have your next dose.
If you stop using Nplate, your low blood platelet count (thrombocytopenia) is likely to reoccur. Your doctor will decide if you should stop using Nplate.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common: may affect more than 1 in 10 people
Very common: may affect more than 1 in 10 people
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP. The expiry date refers to the last day of that month.
Do not freeze.
Store in the original carton in order to protect from light.
This medicine may be removed from the refrigerator for a period of 30 days at room temperature (up to 25°C) when stored in the original carton.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Each vial of Nplate 250 micrograms powder for solution for injection contains a total of
375 micrograms of romiplostim. An additional overfill is included in each vial to ensure that 250 micrograms of romiplostim can be delivered. After dissolving, a deliverable amount of
0.5 mL solution contains 250 micrograms of romiplostim (500 micrograms/mL).
Each vial of Nplate 500 micrograms powder for solution for injection contains a total of
625 micrograms of romiplostim. An additional overfill is included in each vial to ensure that 500 micrograms of romiplostim can be delivered. After dissolving, a deliverable amount of 1 mL solution contains 500 micrograms of romiplostim (500 micrograms/mL).
Nplate is a white powder for solution for injection supplied in a single-dose glass vial.
Carton containing 1 or 4 vials of either 250 micrograms (red cap) or 500 micrograms of romiplostim (blue cap).
Not all pack sizes may be marketed.
Site of Manufacture of the Drug Product Amgen Technology (Ireland) Unlimited Company Pottery Road, Dun Laoghaire
Co. Dublin, Ireland
Amgen Europe B.V.
4817 ZK Breda The Netherlands
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
This leaflet was last approved in January 2018.