Active ingredient
- romiplostim
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: EU/1/08/497/008, EU/1/08/497/005, EU/1/08/497/006, EU/1/08/497/007.
Nplate with Reconstitution Pack
Package leaflet: Information for the user
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 because it contains important information for you.
What is in this leaflet
1. What Nplate is and what it is used for
2. What you need to know before you use Nplate
3. How to use Nplate
4. Possible side effects
5. How to store Nplate
6. Contents of the pack and other information
7. Instructions for preparing and giving an injection of Nplate
1. 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 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.
2. What you need to know before you use Nplate
Do not use Nplate:
Warnings and precautions
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.
Children and adolescents
Nplate is not recommended for use in children below age 18.
Other medicines and Nplate
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 anti-platelet 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
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.
Driving and using machines
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.
3. 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.
Always use Nplate exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure of how to use Nplate.
Instructions for preparing and giving an injection of Nplate
After suitable training, your doctor may also allow you to inject Nplate yourself. Please read the instructions at the end of this leaflet on how to inject Nplate, as discussed with your doctor. If your doctor has allowed you to self-inject, you should follow up with your doctor every month to have the doctor determine if Nplate is working for you or if another treatment needs to be considered.
After the first month of self-injecting Nplate, you will need to show that you can still prepare and inject Nplate correctly.
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 your doctor has allowed you to self-inject and you use more Nplate than you should, then inform your doctor immediately.
If you use less Nplate than you should
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 your doctor has allowed you to self-inject and you use less Nplate than you should, then inform your doctor 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 your doctor has allowed you to self-inject and you forget to give yourself an injection, you should inform your doctor immediately.
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.
Injecting Nplate yourself
Your doctor may decide that it is best for you to inject Nplate. Your doctor, nurse or pharmacist will show you how to inject yourself with Nplate. Do not try to inject yourself if you have not been trained. It is very important that you prepare Nplate properly and take the correct dose (see section 7. Instructions for preparing and giving an injection of Nplate, at the end of this leaflet).
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people (may show up in blood or urine tests)
Uncommon: may affect up to 1 in 100 people
Uncommon: may affect up to 1 in 100 people (may show up in blood or urine tests)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store
Ireland
Malta
5. How to store Nplate
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 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.
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.
6. Contents of the pack and other information
What Nplate contains
What Nplate looks like and contents of the pack
Nplate is a white powder for solution for injection supplied in a 5 mL single-dose 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.
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
Marketing Authorisation Holder
Manufacturer
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
This leaflet was last revised in January 2018.
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
7. Instructions for preparing and giving an injection of Nplate
This section contains information on how to give yourself an injection of Nplate. It is important that you do not try to give yourself the injection unless you have received training from your doctor, nurse or pharmacist. If you have questions about how to inject, please ask your doctor, nurse or pharmacist for assistance. It is very important the product is prepared correctly and the correct dose is taken.
This section is divided into the following subsections:
Before you begin
Step 1. Set up materials for an injection
Step 2. Prepare vial for use, attach vial adapter
Step 3. Prepare sterile water syringe
Step 4. Dissolving Nplate by injecting water into vial
Step 5. Prepare new syringe for injection
Step 6. Prepare injection needle
Step 7. Choose and prepare an injection site
Step 8. Injecting the Nplate liquid
Step 9. Disposing of supplies
Before you begin
Read all instructions for use thoroughly. These instructions are for patients who are already trained by their healthcare professional, such as your doctor, nurse, or pharmacist, in self injection. If you have not been trained, please contact your healthcare professional.
The Nplate self injection kit must be kept in the original package until use in order to protect the Nplate vial from light. Keep the Nplate self injection kit refrigerated at 2ºC to 8ºC.
Once Nplate has been dissolved, inject immediately.
You may have excess Nplate left over after administering your prescribed dose. Do not re-use Nplate! Any excess dissolved Nplate must be thrown away immediately after completing the injection process. Left over Nplate in vial must NEVER be re-used for another injection.
Step 1. Set up materials for an injection
Do the following:
Alcohol swab package x4
A vial of powder, either 250 micrograms OR 500 micrograms x1
13 mm vial adapter x1
Plunger rod for pre-filled sterile water syringe x1
Pre-filled sterile water syringe x1
1 mL Luer-lock tip syringe x1
Injection safety needle x1
Step 2. Prepare vial for use, attach vial adapter
Using: 2 alcohol swab packages, 1 vial, and 1 vial adapter package.
Do the following:
Step 3. Prepare sterile water syringe
Using: Pre-filled sterile water syringe and plunger rod.
Before you begin Step 3 please note the following:
Do the following:
Step 4. Dissolving Nplate by injecting water into vial
Using: Pre-filled sterile water syringe and vial with vial adapter attached.
Before you begin Step 4 please note the following:
Do the following:
Before continuing:
Before continuing:
Step 5. Prepare new syringe for injection
Using: A new 1 mL syringe package and the vial of dissolved, clear Nplate.
Before continuing:
Do the following:
A. Push air into vial.
B. Maintain pressure on plunger.
C. Turn vial assembly and syringe upside down, so the vial is directly above the syringe.
Before continuing:
Step 6. Prepare injection needle
Using: Filled syringe with measured Nplate dose and safety needle.
Do the following:
Step 7. Choose and prepare an injection site
Using: New alcohol swab.
Do the following:
Step 8. Injecting the Nplate liquid
Using: Filled syringe and needle assembly.
Do the following:
Step 9. Disposing of supplies
Do the following:
The injection device and Nplate vial must NEVER be reused.
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