What is it and how is it used?
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.
Nplate is used to treat adult patients (aged 18 years and over) who 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 may also be used in previously treated adult patients (aged 18 years and over) with chronic ITP in whom surgery is not an option.
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.
What do you have to consider before using it?
DO NOT use Nplate
Take special care with 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 MDS.
Loss of response to romiplostim
If you experience a loss of response or failure to maintain a platelet response with romiplostim treatment, you 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 below age 18.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
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.
Pregnancy and breast-feeding
It is important to tell your doctor if you are pregnant; think you may be pregnant; or plan to get pregnant. 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.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed. 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.
How is it used?
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.
If you use more Nplate than you should
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.
If you forget to use Nplate
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
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.
What are possible side effects?
Like all medicines, Nplate can cause side effects, although not everybody gets them.
Very common side effects (seen in more than 1 in 10 people taking Nplate):
Common side effects (seen in more than 1 in 100 people taking Nplate):
Uncommon side effects (seen in more than 1 in 1000 people taking Nplate):
Uncommon side effects that may show up in blood or urine tests (seen in more than 1 in 1000 people taking Nplate):
Other side effects:
A rare disorder characterised by periods of burning pain, redness and warmth in the feet and hands (erythromelalgia).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How should it be stored?
Keep out of the reach and sight of children.
Do not use Nplate 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.
Store in a refrigerator (2° C – 8° C).
Do not freeze.
Store in the original carton in order to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
