Elaprase 2 mg/ml concentrate for solution for infusion
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Elaprase 2 mg/ml concentrate for solution for infusion
idursulfase
?This medicinal product is subject to additional monitoring, which will allow for rapid detection of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is included at the end of section 4.
Read the entire leaflet carefully before starting to use this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, since it may harm them.
- If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Elaprase is and what it is used for
- What you need to know before using Elaprase
- How to use Elaprase
- Possible side effects
- How to store Elaprase
- Contents of the pack and other information
1. What Elaprase is and what it is used for
Elaprase is used as enzyme replacement therapy to treat children and adults with Hunter syndrome (Mucopolysaccharidosis II) when levels of the enzyme iduronate-2-sulfatase in the body are lower than normal, helping to improve the symptoms of the disease. In Hunter syndrome, a carbohydrate called glycosaminoglycan, which is normally metabolized by the body, is not broken down and gradually accumulates in various cells of the body. This causes abnormal functioning of these cells, leading to problems in multiple organs that may result in tissue destruction and organ dysfunction and failure. Organs typically affected by glycosaminoglycan accumulation include the spleen, liver, lungs, heart, and connective tissue. In some patients, glycosaminoglycan also accumulates in the brain. Elaprase contains an active substance called idursulfase, which acts as a replacement for the deficient enzyme, thereby breaking down this carbohydrate in the affected cells.
Enzyme replacement therapy is generally administered as a long-term treatment.
2. What you need to know before using Elaprase
Do not use Elaprase
- if you have had severe or potentially life-threatening allergic-type reactions to idursulfase or to any of the other components of this medicine (listed in section 6), and these reactions cannot be controlled with appropriate medical treatment.
Warnings and precautions
Talk to your doctor or nurse before starting to use this medicine.
If you are being treated with Elaprase, you may experience adverse effects during or after the infusion (see section 4, Possible side effects). The most common symptoms are itching, rash, hives, fever, headache, increased blood pressure, and facial flushing. In most cases, you can continue receiving this medicine even if these symptoms occur. If you experience an allergic-type adverse reaction after receiving this medicine, you must contact your doctor immediately. You may be given other medicines, such as antihistamines and corticosteroids, to treat or help prevent allergic-type reactions.
Your doctor will stop the infusion immediately if severe allergic reactions occur and will start appropriate treatment. You may need to remain in the hospital.
The nature of your genotype (a genetic configuration of all active genes in human cells, which determines individual and specific characteristics of each person) may influence your therapeutic response to this medicine, as well as your risk of developing antibodies and experiencing infusion-related adverse effects. In individual cases, so-called "neutralizing antibodies" may develop, which could reduce the activity of Elaprase and your response to treatment. The long-term effects of antibody development on treatment response have not been established. Consult your doctor for further information.
Maintaining a record
To improve traceability of biological medicines, the name and batch number of the administered product should be clearly recorded. Speak with your healthcare professional if you have any questions.
Other medicines and Elaprase
No interactions between this medicine and other medicines are known.
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
The effect of this medicine on the ability to drive and use machines is none or negligible.
Elaprase contains sodium
This medicine contains 11.1 mg of sodium (main component of table/cooking salt) per vial. This corresponds to 0.6% of the maximum daily recommended sodium intake for an adult.
3. How to use Elaprase
Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor again.
This medicine will be administered under the supervision of a doctor or nurse experienced in the treatment of Hunter syndrome or other inherited metabolic disorders.
The recommended dose is an infusion of 0.5 mg (half a milligram) per kilogram of your body weight.
Elaprase must be diluted in a 9 mg/ml (0.9%) sodium chloride solution for infusion before use. After dilution, this medicine is administered through a vein (by drip). The infusion usually lasts between 1 and 3 hours and will be given once a week.
Use in children and adolescents
The recommended dose in children and adolescents is the same as that for adults.
If you use more Elaprase than you should
Consult your doctor in case of overdose with this medicine.
If you forget to use Elaprase
If you have missed an Elaprase infusion, contact your doctor.
If you have any further questions about the use of this medicine, ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most side effects are mild or moderate and related to the infusion; however, certain side effects can be serious. Over time, the number of these infusion-related reactions decreases.
If you have difficulty breathing, whether or not your skin appears bluish, inform your doctor immediately and seek immediate medical attention.
Very common side effects (may affect more than 1 in 10 people):
-
Headache
-
Facial flushing
-
Shortness of breath, wheezing
-
Abdominal pain, nausea, vomiting, frequent and/or loose stools
-
Chest pain
-
Hives, rash, itching, skin redness
-
Fever
-
Infusion-related reaction (see the section titled “Warnings and precautions”)
Common side effects (may affect up to 1 in 10 people):
- Dizziness, tremors
- Increased heart rate, irregular heartbeat, bluish skin
- Increased blood pressure, decreased blood pressure
- Difficulty breathing, cough, low oxygen levels in the blood
- Tongue swelling, indigestion
- Joint pain
- Swelling at the infusion site, swelling of the limbs, facial swelling
Uncommon side effects (may affect up to 1 in 100 people):
- Rapid breathing
Side effects of unknown frequency (cannot be estimated from available data):
- Severe allergic reactions
Reporting of side effects
If you experience any type of side effect, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Elaprase
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after EXP. The expiry date refers to the last day of the month indicated.
Store in a refrigerator (between 2°C and 8°C).
Do not freeze.
Do not use this medicine if you notice discoloration or the presence of foreign particles.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the container and other information
Composition of Elaprase
The active substance is idursulfase, which is a form of the human enzyme iduronate-2-sulfatase. Idursulfase is produced in a human cell line using genetic engineering techniques (involves introducing genetic information into human cells in the laboratory, leading to the production of the desired product).
Each vial of Elaprase contains 6 mg of idursulfase. Each ml contains 2 mg of idursulfase.
The other components are polysorbate 20, sodium chloride, dibasic sodium phosphate heptahydrate, monobasic sodium phosphate monohydrate, and water for injections.
Appearance of the product and contents of the container
This medicine is a concentrate for solution for infusion. It is supplied in a glass vial as a colourless solution, ranging from clear to slightly opalescent.
Each vial contains 3 ml of concentrate for solution for infusion.
Elaprase is supplied in pack sizes of 1, 4, and 10 vials. Only certain pack sizes may be marketed.
Marketing Authorisation Holder
Takeda Pharmaceuticals International AG Ireland Branch
Block 2 Miesian Plaza
50-58 Baggot Street Lower
Dublin 2
D02 HW68
Ireland
Manufacturer
Takeda Pharmaceuticals International AG Ireland Branch
Block 2 Miesian Plaza
50-58 Baggot Street Lower
Dublin 2
D02 HW68
Ireland
Date of latest revision of this leaflet: 11/2022
This medicinal product has been authorised under "exceptional circumstances". This means that, because the disease is rare, it has not been possible to obtain complete information about this medicine.
The European Medicines Agency will review any new information about this medicine each year, and this leaflet will be updated as necessary.
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu. Links to other websites on rare diseases and orphan medicinal products are also available.
This leaflet can be found on the European Medicines Agency website in all languages of the European Union/European Economic Area.
This information is intended for healthcare professionals only:
Instructions for use, handling and disposal
-
Calculate the total dose to be administered and the required number of Elaprase vials.
-
Dilute the total required volume of Elaprase concentrate for solution for infusion in 100 ml of 9 mg/ml (0.9%) sodium chloride solution for infusion. It is recommended to administer the total infusion volume using an in-line filter of 0.2 µm. Precautions should be taken to ensure sterility of the prepared solutions, as Elaprase does not contain preservatives or bacteriostatic agents; aseptic technique must be observed. After dilution, the solution should be gently mixed, but not shaken.
-
The solution should be inspected visually for particulate matter and discolouration prior to administration. Do not shake.
-
Administration should be initiated as soon as possible. The diluted solution has been shown to be chemically and physically stable for 8 hours at 25°C.
-
Elaprase must not be co-administered through the same intravenous line with other medicinal products.
For single use only. Any unused product and all materials that have been in contact with it should be disposed of in accordance with local regulations.