Nplate 250 micrograms powder and solvent for solution for injection
Nplate 500 micrograms powder and solvent for solution for injection
Romiplostim
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
In this leaflet:
- 1. What Nplate is and what it is used for
- 2. Before you use Nplate
- 3. How to use Nplate
- 4. Possible side effects
- 5. How to store Nplate
- 6. Further information
What Nplate Is And What It Is Used For
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.
Before You Use Nplate
DO NOT use Nplate
- if you are allergic (hypersensitive) to romiplostim or to any of the other ingredients of Nplate.
- if you are allergic to other medicines that are produced by DNA technology using the micro-organism Escherichia coli (E. coli).
Take special care with Nplate
- If you stop taking Nplate a low blood platelet count (thrombocytopenia) is likely to reoccur. If you stop taking Nplate your platelet count will have to be monitored, and your doctor will discuss appropriate precautions with you.
- If you have very high blood platelet counts, as 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.” The mild form may cause no problems while the severe form may cause life-threatening blood problems. 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
Nplate is not for use in patients with blood cancer or a precancerous condition called myelodysplastic syndrome (MDS). If you have one of these conditions, there is a theoretical risk that Nplate may worsen your cancer or condition, however, this has not been observed in Nplate clinical trials.
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 To Use Nplate
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.
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):
- headache.
Common side effects (seen in more than 1 in 100 people taking Nplate):
- bone marrow disorder, including increased bone marrow fibres (reticulin);
- trouble sleeping (insomnia);
- dizziness;
- tingling or numbness of the hands or feet (paraesthesia);
- migraine;
- redness of the skin (flushing);
- blood clot in a lung artery (pulmonary embolism);
- nausea;
- diarrhoea;
- abdominal pain;
- indigestion (dyspepsia);
- constipation;
- itching of the skin (pruritis);
- bleeding under the skin (ecchymosis);
- bruising (contusion);
- rash;
- joint pain (arthralgia);
- muscles pain or weakness (myalgia);
- pain in your hands and feet;
- muscle spasm;
- back pain;
- bone pain;
- tiredness (fatigue);
- injection site bruising;
- injection site pain;
- injection site swelling;
- swelling in the hands and feet (oedema peripheral);
- flu like symptoms (influenza-like illness);
- pain;
- weakness (asthenia);
- fever (pyrexia);
- chills;
- contusion;
- low blood platelet count (thrombocytopenia) and low blood platelet count (thrombocytopenia) after stopping Nplate;
- higher than normal platelet counts (thrombocytosis).
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 To Store Nplate
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.
Further Information
What Nplate contains
- The active substance is romiplostim.
Each vial of Nplate 250 micrograms powder for solution for injection contains 250 micrograms of romiplostim. After reconstitution, a deliverable volume 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 500 micrograms of romiplostim. After reconstitution, a deliverable volume of 1 ml solution contains 500 micrograms of romiplostim (500 micrograms/ml). - The other ingredients are:
Powder: mannitol (E421), sucrose, L-histidine, hydrochloric acid (for pH adjustment) and polysorbate 20.
Solvent: water for injections.
What Nplate looks like and contents of the pack
Nplate is a white powder for solution for injection supplied in a 5 ml glass vial.
Nplate is supplied as a 1 pack or multipack comprising 4 packs. Each pack contains:
1 vial of 250 micrograms or 500 micrograms of romiplostim.
1 pre-filled syringe containing 0.72 or 1.2 ml of water for injections for reconstitution.
1 plunger rod for pre-filled syringe.
1 sterile vial adapter.
1 sterile 1 ml Luer lock syringe.
1 sterile safety needle.
4 alcohol swabs.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
United Kingdom
This leaflet was last approved in January 2010.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.
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