250 micrograms powder and solvent for solution for injection; 500 micrograms powder and solvent for solution for injection.
romiplostim
What Nplate is and what it is used for
The active substance in Nplate is romiplostim which is a protein used to treat low platelet counts in patients with primary immunological thrombocytopenia (called ITP). ITP is a disease in which the body’s immune system destroys its platelets. Platelets ( platelets ) are the cells in the blood that help to close wounds and form blood clots. If you have very low platelet counts, you may get bruising and severe bleeding.
Nplate is used to treat adult patients (18 years of age and older) with ITP who may, but need not, have had their spleen removed and who have previously been treated with corticosteroids or immunoglobulins but who have not responded to these drugs.
Nplate works by stimulating the bone marrow (the part of the skeleton that produces blood cells) to produce more platelets. This will help prevent bruising and bleeding due to ITP.
What you need to know before using Nplate
Do not use Nplate:
- if you are allergic to romiplostim or any of the other ingredients of this medicine (listed in section 6).
- if you are allergic to other medicines produced by DNA technology using microorganism an Escherichia coli ( E. coli ) .
Warnings and cautions
- If you stop taking Nplate, it is likely that a low platelet count ( thrombocytopenia ) will return. If you stop taking Nplate, your platelet count must be monitored and your doctor will discuss appropriate precautions with you.
- If you are at risk of developing a blood clot or if a blood clot is common in your family. The risk of blood clots can also increase if you:- has liver problems,- is older (≥ 65 years),- is bedridden,- have cancer,- taking birth control pills or hormone replacement therapy,- has recently undergone surgery or suffered an injury,- is overweight,- smokes.
Talk to your doctor, pharmacist, or nurse before using Nplate.
If you have very high platelet counts in your blood, the risk of blood clots may increase. The doctor will set the Nplate dose so that the platelet count does not become too high.
Bone marrow changes (elevated reticulin and possible bone marrow fibrosis)
Prolonged use of Nplate can cause changes in the bone marrow. The changes can lead to the formation of abnormal blood cells or the body producing fewer blood cells. The mild form of these bone marrow changes is called “elevated reticulin” and has been observed in clinical trials with Nplate. It is not known if this condition can develop into a more severe form called “fibrosis”. Signs of bone marrow changes may show up as abnormal blood counts. Your doctor will decide if you need to have a bone marrow test due to abnormal blood counts or if you should stop using Nplate.
Exacerbation of blood cancer
Your doctor may decide to have a bone marrow biopsy, if he/she deems it necessary to check that you have ITP and not any other disease, e.g. myelodysplastic syndrome (MDS). If you have MDS and receive Nplate, the number of blast cells (immature white blood cells ) may increase. This can lead to MDS worsening and developing into acute myeloid leukemia, which is a type of blood cancer.
Failure to respond to romiplostim
If you are not responding to romiplostim treatment or are unable to maintain a platelet response, your doctor will investigate the reasons for this. Among other things, it is checked if you have elevated levels of bone marrow fibers (reticulin) or if you have developed antibodies that neutralize the effect of romiplostim.
Children and young people
Nplate is not recommended for children under 18 years of age.
Other drugs 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 that prevent blood clots (blood-thinning medicines such as anticoagulants or antiplatelet agents), the risk of bleeding increases. Your doctor will discuss this with you.
If you are taking corticosteroids, danazol, and/or azathioprine to treat your ITP, the dose of one of these may need to be reduced or discontinued when co-administered with Nplate.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, 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 during pregnancy unless your doctor prescribes it.
It is not known if romiplostim passes into breast milk. Nplate is not recommended during breastfeeding. A decision on whether to discontinue breastfeeding or to discontinue treatment with romiplostim should be made taking into account the benefit of breastfeeding to your baby and your benefit from romiplostim treatment.
Driving and using machines
You should talk to your doctor before driving or using machines as certain side effects (such as temporary dizziness) may affect your ability to do so safely.
How to use Nplate
Nplate is given under the direct supervision of your doctor, who will carefully monitor the amount of Nplate given to you.
Nplate is given once a week as an injection under the skin ( subcutaneously ).
The first dose is 1 microgram of Nplate per kilogram of body weight once a week. Your doctor will tell you how much you need to take. Nplate should be injected once a week to maintain platelet counts. The doctor will take regular blood tests to measure how the platelets react and may adjust the dose as needed.
When the platelet count is under control, the doctor continues to check the blood regularly. Dose one can be further adjusted to maintain long-term control of platelet counts.
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Instructions for preparation and injection of Nplate
After appropriate training, your doctor may allow you to inject Nplate yourself. Read the instructions at the end of this leaflet for how to inject Nplate, as discussed with your doctor. If you are allowed to inject yourself, you should follow this up with your doctor every month so that your doctor can determine if Nplate is working for you or if you need any other treatment.
After injecting Nplate yourself during the first month, you must demonstrate that you can still prepare and inject Nplate properly.
If you use more Nplate than you should:
Your doctor will make sure you get the right amount of Nplate. If you have been given too much Nplate, it is not certain that you will have any physical symptoms, but your platelets can rise to very high levels and this can increase the risk of clot formation. Therefore, if your doctor suspects that you have been given too much Nplate, it is recommended that you be monitored for signs or symptoms of side effects and that you receive appropriate treatment immediately.
If your doctor allows you to inject yourself and you have used too much Nplate, contact your doctor immediately.
If you use too little Nplate
Your doctor will make sure you get the right amount of Nplate. If you have received too little Nplate, it is not certain that you will have any physical symptoms, but your platelets may drop too low levels and this may increase the risk of bleeding. Therefore, if your doctor suspects that you have been given too little Nplate, it is recommended that you be monitored for signs or symptoms of side effects and that you receive appropriate treatment immediately.
If your doctor allows you to inject yourself and you have used too little Nplate, contact your doctor immediately.
If you forget to use Nplate:
If you have missed a dose of Nplate, your doctor will tell you when to take the next dose.
If your doctor allows you to inject yourself and you have forgotten an injection, contact your doctor immediately.
If you stop using Nplate:
If you stop using Nplate, your low platelet count ( thrombocytopenia ) is likely to return. Your doctor will decide if you should stop taking Nplate.
If you inject Nplate yourself
Your doctor may decide that you should inject Nplate yourself. A doctor, nurse, or pharmacist will show you how to inject Nplate yourself. Do not try to inject until you have received training. It is very important that you prepare Nplate correctly and that you take the correct dose (see section 7, Instructions for reconstitution and injection of Nplate, at the end of this leaflet).
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common: may affect more than 1 user in 10
- headache
- allergic reaction
- upper respiratory tract infection.
Common: may affect up to 1 in 10 users
- bone marrow disorders, including increase in bone marrow fibers (reticulin)
- sleep problems (insomnia)
- dizziness
- creeps or numbness in the hands or feet ( paresthesia )
- migraine
- flushing _ _
- pulmonary artery thrombosis ( pulmonary embolism )
- nausea
- diarrhea
- abdominal pain
- indigestion ( dyspepsia )
- constipation
- itching of the skin ( pruritus )
- bleeding under the skin ( ecchymosis )
- bruising (contusion)
- rash
- joint pain ( arthralgia )
- muscle pain or muscle weakness ( myalgia )
- pain in hands and feet
- muscle cramps
- back pain
- skeletal pain
- fatigue
- injection site reactions
- swollen hands and feet (peripheral edema )
- flu-like symptoms
- pain
- feeling of weakness ( asthenia )
- fever ( pyrexia )
- frostbite
- contusion
- swelling of the face, lips, mouth, tongue or throat that may make it difficult to swallow or breathe ( angioedema )
- gastrointestinal catarrh
- palpitation
- sinusitis ( sinusitis )
- inflammation in passages that transport air to the lungs ( bronchitis ).
Common: may affect up to 1 in 10 people (may show up in blood or urine samples)
- low platelet count ( thrombocytopenia ) and low platelet count ( thrombocytopenia ) after discontinuation of Nplate
- greater than normal platelet count ( thrombocytosis )
- anemia .
Uncommon: may affect up to 1 in 100 people
- bone marrow failure, bone marrow disorder that causes scarring (myelofibrosis), enlarged spleen ( splenomegaly ), vaginal bleeding, rectal bleeding, bleeding in the mouth, injection site bleeding
- heart attack ( myocardial infarction ), increased heart rate
- dizziness or vertigo
- eye problems including bleeding in the eye ( conjunctival haemorrhage), difficulty focusing or blurred vision (accommodation disorder, papillary edema or eye disorder), blindness, eye itching (eye pruritus), increased tearing, or visual disturbances
- problems with the digestive system including vomiting, bad breath, difficulty swallowing ( dysphagia ), indigestion or heartburn / acid reflux ( gastroesophageal reflux ), blood in the stool (hematochezi), stomach upset, cold sores or cold sores ( stomatitis ), discolored teeth
- weight loss, weight gain, alcohol intolerance, decreased appetite ( anorexia or decreased appetite), dehydration ( dehydration )
- general malaise, chest pain, irritability, swelling of the face (facial edema), feeling of heat, elevated body temperature, shaking
- influenza , local infection , inflammation of the nose and throat ( nasopharyngitis )
- nose and throat symptoms including cough, runny nose ( rhinorrhea ), dry throat, shortness of breath or difficulty breathing ( dyspnoea ), nasal congestion, painful breathing
- painful and swollen joints due to uric acid (breakdown product from food) ( gout )
- tense muscles, muscle weakness, shoulder pain, muscle cramps
- disorders of the nervous system including involuntary muscle contractions (cramps), changes in the sense of taste ( dysgeusia ), impaired sense of taste (hypogeusia), decreased sensations, especially in the skin ( hypoesthesia ), changes in nerve function in the arms and legs ( peripheral neuropathy ), blood clot in the transverse sinus ( thrombosis and transverse sinus)
- depression, abnormal dreams
- hair loss ( alopecia ), sensitivity to light (photosensitivity reaction), acne , allergic reaction in the skin on contact with allergen ( contact dermatitis ), skin symptoms with rash and blisters ( eczema ), dry skin, redness of the skin ( erythema ), severe scaly rash (exfoliative skin rash) , abnormal hair growth, thickened and itchy skin due to repeated itching (prurigo), bleeding under the skin surface or bruising under the skin (purpura), lumpy rash (papular rash), itchy rash (pruritic rash), generalized itchy rash ( urticaria ), lump on the skin, abnormal odor from the skin
- Problems with blood circulation including blood clot in the vein of the liver (portal vein thrombosis), deep vein thrombosis , low blood pressure ( hypotension ), increased blood pressure , clot in blood vessels ( peripheral embolism), decreased blood flow in hands, ankles or feet ( peripheral ischemia ), swelling and clot in a vein that can be very tender to the touch ( phlebitis or superficial thrombophlebitis ), blood clot ( thrombosis )
- a rare condition with periods of burning pain, redness and heat in the hands and feet (erythromelalgia).
Uncommon: may affect up to 1 in 100 people (may show up in blood or urine samples)
- a rare form of anemia with decreased number of red and white blood cells as well as platelets ( aplastic anemia )
- increased white blood cell count ( leukocytosis )
- excessive platelet production ( thrombocytemia ), increased platelet count , abnormal number of cells in the blood that prevent bleeding (abnormal platelet count)
- changes in certain blood tests (elevated liver transaminases, elevated lactate dehydrogenase in the blood)
- cancer output from white blood cells (multiple myeloma )
- protein in the urine.
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 expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C-8 ° C).
Do not freeze.
Store in the original package. Sensitive to light.
This medicine can be taken out of the refrigerator and stored for 30 days at room temperature (not above 25 ° C) if stored in the original package.
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.
Contents of the package and other information
Content declaration
- The active substance is romiplostim.
Each vial of Nplate 250 micrograms powder for solution for injection contains a total of 375 micrograms romiplostim. Each vial contains an excess to ensure that 250 micrograms of romiplostim can be administered. After reconstitution, a manageable amount of 0.5 ml solution contains 250 micrograms romiplostim (500 micrograms / ml).
Each vial of Nplate 500 micrograms powder for solution for injection contains a total of 625 micrograms romiplostim. Each vial contains an excess to ensure that 500 micrograms of romiplostim can be administered. After reconstitution, a manageable amount of 1 ml solution contains 500 micrograms romiplostim (500 micrograms / ml). - Other ingredients are:Powder: mannitol (E421), sucrose, L-histidine, hydrochloric acid (for pH adjustment) and polysorbate 20.Liquid: water for injections.
What the medicine looks like and contents of the pack
Nplate is a white powder for solution for injection, which is supplied in a 5 ml single-dose glass vial.
Nplate is delivered as unit packs or as multi-pack with 4 sets. Each set contains:
1 vial of 250 micrograms or 500 micrograms romiplostim.
1 pre-filled syringe with 0.72 or 1.2 ml water for reconstitution injections.
1 piston rod for the pre-filled syringe.
1 sterile vial adapter.
1 sterile Luer syringe of 1 ml.
1 sterile safety needle.
4 alcohol dryers.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Amgen Europe BV
Minervum 7061
4817 ZK Breda
Netherlands