Product 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 this entire product information carefully before starting to use this medicine, as it contains important information for you.
The active ingredient of Nplate is romiplostim, which is a protein used to treat low platelet counts in patients with primary immune thrombocytopenia (PTI). PTI is a disease in which the immune system of your body destroys your own platelets. Platelets are the blood cells that help heal wounds and form blood clots. Very low platelet counts can cause severe bruises and bleeding.
Nplate is used in adult patients (18 years or older) with PTI who may or may not have had their spleen removed and who have previously been treated with corticosteroids or immunoglobulins that did not work for them.
Nplate works by stimulating the bone marrow (part of the bone that generates blood cells) to produce more platelets. This should help prevent the bruises and bleeding related to PTI.
Do not use Nplate
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to use Nplate.
If you have a very high platelet count, you may increase the risk of blood clots. Your doctor will adjust your Nplate dose to ensure that your platelet count is not too high.
Bone marrow changes(increase in reticulin and possible fibrosis in the bone marrow)
The long-term use of Nplate may cause changes in your bone marrow. These changes may lead to abnormal blood cells or a decrease in the production of blood cells. The mild form of these changes in the bone marrow is called “increase in reticulin” and has been observed in Nplate clinical trials. It is unknown if this could progress to a more severe form called “fibrosis.” Your blood tests may show signs of bone marrow changes as anomalies. Your doctor will decide if an abnormal blood test means that a bone marrow test should be done or if treatment with Nplate should be interrupted.
Worsening of blood cancer
Your doctor may decide to perform a bone marrow biopsy if they consider it necessary to ensure that you have PTI and not another disease such as Myelodysplastic Syndrome (MDS). If you have MDS and receive Nplate, you may experience an increase in blast cells and a worsening of MDS to acute myeloid leukemia, which is a type of blood cancer.
Loss of response to romiplostim
If you experience a loss of response to romiplostim or inability to maintain a platelet response during treatment with romiplostim, your doctor will investigate the reasons, including if you are experiencing an increase in bone marrow fibers (reticulin) or if you have developed antibodies that neutralize the activity of romiplostim.
Children and adolescents
Nplate is not recommended for use in children under 18 years of age.
Other medications and Nplate
Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.
If you are also taking other medications that prevent blood clot formation (anticoagulant or antiplatelet therapy), there is a higher risk of bleeding. Your doctor will discuss this aspect with you.
If you are taking corticosteroids, danazol, and/or azathioprine, which you may be receiving to treat your PTI, you may need to reduce or discontinue their administration when combined with Nplate.
If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication. Nplate is not recommended during pregnancy unless your doctor advises it.
The excretion of romiplostim in human milk is unknown. Nplate is not recommended during breastfeeding. The decision to interrupt breastfeeding or interrupt romiplostim treatment should be made considering the benefits of breastfeeding for the baby and the benefits of romiplostim treatment for the patient.
Driving and operating machinery
Consult your doctor before driving or operating machinery, as some side effects (e.g., temporary episodes of dizziness) may impair your ability to perform these activities safely.
Nplate should be administered under the direct supervision of a doctor who will accurately control the amount of Nplate administered.
Nplate is administered once a week through subcutaneous injection.
The initial dose is 1 microgram of Nplate per kilogram of body weight once a week. Your doctor will indicate the amount of Nplate you should use. Nplate should be injected once a week for platelet count maintenance. Your doctor will regularly draw blood samples to evaluate how your platelets are responding and adjust the dose if necessary.
Once your platelet count is controlled, your doctor will continue to perform blood tests for monitoring. Your dose may be adjusted later to maintain long-term control of your platelet count.
Always follow exactly the Nplate administration instructions indicated by your doctor. In case of doubt, consult your doctor again on how to use Nplate.
Instructions for preparing and administering a Nplate injection
After adequate training, your doctor may also allow you to self-inject Nplate. Please read the instructions at the end of this prospectus on how to inject Nplate, as discussed with your doctor. If your doctor has allowed you to self-inject, you must follow up with him every month to determine if Nplate is working or if you should consider another treatment.
After the first month of self-injecting Nplate, you will need to demonstrate 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 correct amount of Nplate. If you have received more Nplate than you should, you may not present any physical symptoms, but your blood platelet levels may increase to very high levels and this may increase the risk of blood clotting. Therefore, if your doctor suspects that you have received more Nplate than you should, it is recommended that you be monitored for any signs or symptoms of side effects and that you be administered the appropriate treatment immediately.
If your doctor has allowed you to self-inject and you use more Nplate than you should, inform your doctor immediately.
If you use less Nplate than you should
Your doctor will ensure that you receive the correct amount of Nplate. If you have received less Nplate than you should, you may not present any physical symptoms, but your blood platelet levels may decrease to low levels and this may produce a risk of bleeding. Therefore, if your doctor suspects that you have received less Nplate than you should, it is recommended that you be monitored for any signs or symptoms of side effects and that you be administered the appropriate treatment immediately.
If your doctor has allowed you to self-inject and you use less Nplate than you should, inform your doctor immediately.
If you forget to use Nplate
If you forget a dose of Nplate, your doctor will indicate when you should receive the next dose.
If your doctor has allowed you to self-inject and you forgot to administer your injection, inform your doctor immediately.
If you interrupt treatment with Nplate
If you stop using Nplate, it is likely that you will experience a low platelet count (thrombocytopenia) again. Your doctor will decide if you should stop taking Nplate.
Self-injecting Nplate
Your doctor may decide that it is better for you to inject Nplate. Your doctor, nurse, or pharmacist will show you how to inject Nplate. Do not attempt to inject yourself if you have not been trained. It is very important that you prepare Nplate correctly and take the correct dose (see section 7. Instructions for preparing and administering a Nplate injection, at the end of this prospectus).
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people (may be observed in blood or urine tests)
Rare: may affect up to 1 in 100 people
Rare: may affect up to 1 in 100 people (may be observed in blood or urine tests)
Reporting of adverse reactions
If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V.By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the packaging and on the vial label after CAD. The expiration date is the last day of the month indicated.
Store in refrigerator (between 2°C and 8°C).
Do not freeze.
Store in the original packaging to protect it from light.
When stored in the original packaging, this medication may be kept at room temperature (up to 25°C) for a maximum period of 30 days.
Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.
Composition of Nplate
Each vial of Nplate 250 micrograms powder for injectable solution contains a total of 375 micrograms of romiplostim. An additional volume has been added to each vial to ensure that 250 micrograms of romiplostim can be administered. After dissolution, a volume of 0.5 ml of the final product solution contains 250 micrograms of romiplostim (500 micrograms/ml).
Each vial of Nplate 500 micrograms powder for injectable solution contains a total of 625 micrograms of romiplostim. An additional volume has been added to each vial to ensure that 500 micrograms of romiplostim can be administered. After dissolution, a volume of 1 ml of the final product solution contains 500 micrograms of romiplostim (500 micrograms/ml).
Powder: mannitol (E421), sucrose, L-histidine, hydrochloric acid (for pH adjustment), and polisorbate 20.
Solvent: water for injectable preparations.
Appearance of the product and contents of the package
Nplate is a white powder for injectable solution that is supplied in a single-dose glass vial of 5 ml.
Nplate is supplied in a single-use or multi-use package with 4 packages. Each package contains:
1 vial of 250 micrograms or 500 micrograms of romiplostim.
1 pre-loaded syringe containing 0.72 ml or 1.2 ml of water for injectable preparations for reconstitution.
1 plunger for the pre-loaded syringe.
1 sterile vial adapter.
1 sterile 1 ml syringe with Luer lock.
1 safety needle.
4 alcohol wipes.
Only some package sizes may be marketed.
Marketing authorization holder and responsible manufacturer
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
Netherlands
Marketing authorization holder
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
Netherlands
Responsible manufacturer
Amgen Technology (Ireland) Unlimited Company
Pottery Road
Dun Laoghaire
Co Dublin
Ireland
Responsible manufacturer
Amgen NV
Telecomlaan 5-7
1831 Diegem
Belgium
You can request more information about this medicine by contacting the local representative of the marketing authorization holder.
België/Belgique/BelgienLietuva
s.a. Amgen n.v.Amgen Switzerland AG Vilniaus filialas
Tel/Tél: +32 (0)2 7752711Tel: +370 5 219 7474
????????Luxembourg/Luxemburg
?????? ???????? ????s.a. Amgen
???.: +359 (0)2 424 7440Belgique/Belgien
Tel/Tél: +32 (0)2 7752711
Ceská republikaMagyarország
Amgen s.r.o.Amgen Kft.
Tel: +420 221 773 500Tel.: +36 1 35 44 700
DanmarkMalta
Amgen filial af Amgen AB, SverigeAmgen B.V.
Tlf: +45 39617500The Netherlands
Tel: +31 (0)76 5732500
DeutschlandNederland
AMGEN GmbHAmgen B.V.
Tel.: +49 89 1490960Tel: +31 (0)76 5732500
EestiNorge
Amgen Switzerland AG Vilniaus filialasAmgen AB
Tel: +372 586 09553Tel: +47 23308000
Amgen Ελλ?ς Φαρμακευτικ? Ε.Π.Ε.Amgen GmbH
Τηλ.: +30 210 3447000Tel: +43 (0)1 50 217
EspañaPolska
Amgen S.A.Amgen Biotechnologia Sp. z o.o.
Tel: +34 93 600 18 60Tel.: +48 22 581 3000
FrancePortugal
Amgen S.A.S.Amgen Biofarmacêutica, Lda.
Tél: +33 (0)9 69 363 363Tel: +351 21 4220606
HrvatskaRomânia
Amgen d.o.o.Amgen România SRL
Tel: +385 (0)1 562 57 20Tel: +4021 527 3000
IrelandSlovenija
Amgen Ireland LimitedAMGEN zdravila d.o.o.
Tel: +353 1 8527400Tel: +386 (0)1 585 1767
ÍslandSlovenská republika
Vistor hf.Amgen Slovakia s.r.o.
Sími: +354 535 7000Tel: +421 2 321 114 49
ItaliaSuomi/Finland
Amgen S.r.l.Amgen AB, sivuliike Suomessa/Amgen AB, filial
Tel: +39 02 6241121i Finland
Puh/Tel: +358 (0)9 54900500
K?προςSverige
C.A. Papaellinas LtdAmgen AB
Τηλ.: +357 22741 741Tel: +46 (0)8 6951100
LatvijaUnited Kingdom
Amgen Switzerland AG Rigas filialeAmgen Limited
Tel: +371 257 25888Tel: +44 (0)1223 420305
Last review date of this leaflet in
Other sources of information
The detailed information on this medicine is available on the European Medicines Agency websitehttp://www.ema.europa.eu
This section contains information on how to self-inject Nplate. It is essential that you do not attempt to self-administer the injection if you have not received training from your doctor, nurse, or pharmacist. If you have questions about how to administer the injection, consult your doctor, nurse, or pharmacist. It is crucial that the product is prepared correctly and that the correct dose is administered.
This section is divided into the following sub-sections:
Before starting
Step 1. Place the injection materials
Step 2. Prepare the vial for use, place the vial adapter
Step 3. Prepare the sterile water syringe
Step 4. Dissolve Nplate by injecting water into the vial
Step 5. Prepare a new syringe for the injection
Step 6. Prepare the safety needle for the injection
Step 7. Choose and prepare the injection site
Step 8. Inject the Nplate liquid
Step 9. Disposal of supplies
Before starting
Read all the usage instructions carefully.These instructions are for patients who have alreadybeen trained by their healthcare professional, such as their doctor, nurse, or pharmacist, in self-injection. If you have not been trained, please contact your healthcare professional.
The Nplate auto-injection kit should be kept in the original packaging until use to protect the Nplate vial from light. Store the Nplate auto-injection kit in the refrigerator between 2°C and 8°C.
Once Nplate has been dissolved, inject immediately.
You may be left with excess Nplate after administering the prescribed dose. Do not reuse Nplate! Any excess dissolved Nplate must be disposed of immediately after completing the injection process. The excess Nplate from the vial MUST NOT be reused for another injection.
Step 1. Place the injection materials
Do the following:
Check the expiration date included in the auto-injection kit. If the expiration date has passed, do not use it.Do not continue and inform your healthcare professional.
Alcohol wipe packagex4
Adapter for vial of 13 mmx1 | |
500 microgramsx1 | |
Plunger for sterile water syringex1Sterile water syringex1
Syringe of 1 ml with Luer lockx1Safety needle for injectionx1
Step 2. Prepare the vial for use, place the vial adapter
Use:2 alcohol wipes, 1 vial, and 1 vial adapter package.
Do the following:
(500 micrograms) from the vial. | |
| |
| |
| |
| |
|
Step 3. Prepare the sterile water syringe
Use:The pre-loaded sterile water syringe and plunger.
Before starting Step 3, please note the following:
Do the following:
| |
| |
|
Step 4. Dissolve Nplate, inject water into the vial
Use:The pre-loaded sterile water syringe and vial with vial adapter attached.
Before starting Step 4, please note the following:
Do the following:
| |
| Press slowly and carefully |
Before continuing:
| Correct |
| Incorrect |
Before continuing:
|
Step 5. Prepare a new syringe for the injection
Use:A new 1 ml syringe from the package and the vial with dissolved and transparent Nplate.
Before continuing:
Do the following:
| Take air into the syringe until the 1 ml mark |
| |
| A.B.C. Turn downwards |
| |
| Correct |
| Air bubbles: Correct Incorrect |
| Adjust the amount to your prescribed dose |
Before continuing:
| |
|
Step 6. Prepare the safety needle for the injection
Use:The full syringe and safety needle.
Do the following:
| |
|
Step 7. Choose and prepare the injection site
Use:New alcohol wipes.
Do the following:
| |
|
Step 8. Inject the Nplate liquid
Use:The full syringe and safety needle.
Do the following:
| |
Страна регистрации Активное вещество Требуется рецепт Да Производитель Состав Manitol (e-421) (0 - mg),
Sacarosa (0 - mg) Информация носит справочный характер и не является медицинской рекомендацией. Перед приёмом любых препаратов проконсультируйтесь с врачом. Oladoctor не несёт ответственности за медицинские решения, принятые на основе этого контента. Общайтесь с врачом онлайнЕсть вопросы по этому лекарству или вашим симптомам? Свяжитесь с лицензированным врачом для получения помощи и персонализированного ухода. Смотреть всех врачей |