Patient leaflet - Krystexxa
B. PACKAGE LEAFLET
Package Leaflet: Information for the user
KRYSTEXXA 8 mg concentrate for solution for infusion pegloticase
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your doctor, pharmacist or nurse.
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– If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
What is in this leaflet
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1. What KRYSTEXXA is and what it is used for
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2. What you need to know before you receive KRYSTEXXA
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3. How to use KRYSTEXXA
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4. Possible side effects
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5. How to store KRYSTEXXA
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6. Contents of the pack and other information
1. What KRYSTEXXA is and what it is used for
KRYSTEXXA contains the active substance pegloticase. Pegloticase belongs to the class anti-gout medicines.
Pegloticase is used to treat severe long-term gout in adult patients who also have one or more painful deposits of uric acid crystals under the skin that cause difficulty in carrying out daily activities and who do not respond or cannot take other anti-gout medicines.
How KRYSTEXXA works
People with gout have too much uric acid in their body. Uric acid deposits as crystals in joints, kidneys, and other organs which may cause profound pain, redness and swelling (inflammation). KRYSTEXXA contains an enzyme called uricase that transforms the uric acid into a substance called allantoin, which can be removed easily in the urine.
2. What you need to know before you receive KRYSTEXXA
Do not use KRY STEXXA
- If you are allergic to pegloticase, or other uricases or any of the other ingredients of this medicine (listed in section 6).
- If you have a rare blood problem called glucose 6-phosphate dehydrogenase (G6PD) deficiency or favism. Your doctor may test you for G6PD before you start KRYSTEXXA.
Warnings and precautions
Talk to your doctor or nurse before using KRYSTEXXA:
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- if you are currently taking other medicines to lower your uric acid level
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- if you have been told you have heart failure
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- if you have ever been told you have an enzyme deficiency that causes anaemia
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- if you weigh over 100 kg
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- if you have been treated with KRYSTEXXA before
Monitoring during treatment
Your doctor will test your blood to measure uric acid levels before each dose to make sure that you should continue receiving KRYSTEXXA.
Children and adolescents
KRYSTEXXA has not been studied in children or adolescents under 18 years of age. Therefore, this medicine is not recommended in this age group.
Other medicines and KRYSTEXXA
Tell your doctor if you are taking, have recently taken or might take any other medicines. It is especially important to tell your doctor if you are currently taking other urate-lowering medicines (such as allopurinol or Febuxostat) or medicines containing polyethylene glycol (PEG) (such as pegylated interferon or Doxorubicin). These medicines may put you at higher risk of infusion reaction.
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 for advice before taking this medicine. Do not use KRYSTEXXA if you are pregnant or breast-feeding, since it is not known how it will affect you or your baby.
Driving and using machines
KRYSTEXXA has little or no effect on your ability to drive. If you do not feel well, experience symptoms such as dizziness or headache, or are tired after receiving KRYSTEXXA, you should not drive or operate any machines.
KRYSTEXXA contains sodium
KRYSTEXXA contains 4.2 mg sodium per dose which means it is essentially sodium free.
3. How to use KRYSTEXXA
KRYSTEXXA should be given to you by a doctor or nurse experienced in the treatment of severe chronic gout in a healthcare centre.
How much KRYSTEXXA is given
The recommended dose of KRYSTEXXA is 8 mg. This dose is not adjusted for weight, age or kidney disease.
Before you start treatment with KRYSTEXXA, your doctor may recommend that you take other medicines (such as an antihistamine, paracetamol and a corticosteroid) to help reduce the risk that you will get infusion-related reactions due to this treatment. Take these medicines as directed by your doctor.
How KRYSTEXXA is administered
KRYSTEXXA is injected slowly into a vein (i.v. infusion) and your treatment will take about 2 hours or sometimes longer. If you have a reaction during the infusion, your doctor may stop or adjust the treatment. Your doctor may also ask you to wait after your treatment to be sure that you do not have an infusion-related reaction.
You will receive KRYSTEXXA every 2 weeks.
If you stop taking KRYSTEXXA, and then are treated again, you may be at increased risk of infusion reactions, including severe acute allergic reactions (anaphylaxis) so your doctor will monitor you carefully when you restart treatment.
Your doctor will also test your blood to measure uric acid before your next dose to make sure that you should continue receiving KRYSTEXXA.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The most commonly reported serious side effects are: severe acute allergic reactions (common ), infusion reactions (very common ), and gout flares (very common ).
KRYSTEXXA will be administered by a doctor or nurse who will monitor you for side effects while you receive KRYSTEXXA and for some time afterwards.
Severe allergic reactions (common ) include fainting, sudden drop in blood pressure, and cardiac arrest. Allergic reactions usually happen within 2 hours of the infusion, but may also happen at a later time.
If you suddenly notice:
- a swelling of the throat, tongue or other part of your body
- tightness of the throat, hoarse voice or trouble swallowing
- a shortness of breath, wheezing or breathing problems
- a rash, itching or hives
tell your doctor or nurse IMMEDIATELY, since any of these may be signs of a serious allergic reaction.
The most common signs and symptoms of local infusion reactions were: redness at the injection site, itching, and rash. The most common signs and symptoms of generalised infusion reactions were: hives, shortness of breath, redness in the face, sweating, chest discomfort or pain, chills, and high blood pressure.
Allergic reactions may be more likely to occur in patients who weigh more than 100 kg.
An increase in gout flares is frequently observed when starting KRYSTEXXA. Your doctor may prescribe medicines to reduce the likelihood of gout flares after starting KRYSTEXXA.
KRYSTEXXA does not need to be discontinued because of a gout flare.
Very common side effects (may affect more than 1 in 10 people): hives, skin rash, itchy, dry or irritated skin, nausea
Common side effects (may affect up to 1 in 10 people): high blood sugar levels, vomiting, joint swelling, flu-like symptoms
Uncommon side effects: (may affect up to 1 in 100 people): worsening of a type of heart disease called congestive heart failure, skin infection, elevated potassium levels in the blood
Frequency not known (cannot be estimated from available data): destruction of red blood cells
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
5. How to store KRYSTEXXA
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 label and the carton after EXP.
The expiry date refers to the last day of that month.
This medicine will be stored in a healthcare facility where it is administered.
Store in a refrigerator (2°C to 8°C).
Keep the vial in the outer carton in order to protect from light.
From a bacteriological point of view, the product should be used immediately. If the diluted solution is not used immediately it can be stored refrigerated (2°C to 8°C). The solution should be used within 4 hours of dilution.
Do not use this medicine if you notice any particles or discolouration in the diluted solution.
6. Contents of the pack and other information
What KRYSTEXXA contains
- The active substance is pegloticase. Each vial contains 8 mg of pegloticase (8 mg/ml concentrate).
- The other ingredients are disodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride and water for injections.
What KRYSTEXXA looks like and contents of the pack
KRYSTEXXA 8 mg concentrate for solution for infusion is supplied in 2 ml glass vials containing 1 ml concentrate. KRYSTEXXA is a clear to slightly opalescent colourless solution.
Pack size of 1 vial.
Marketing Authorisation Holder
Crealta Pharmaceuticals Ireland Limited
Commercial House, Millbank Business Park, Lower Lucan Road, Lucan, Co. Dublin
Ireland
Manufacturer
United Drug, plc
United Drug House
Magna Business Park
Magna Drive, Citywest Road
Dublin 24
Ireland
This leaflet was last revised in {MM/YYYY}
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site:.
The following information is intended for healthcare professionals only:
KRYSTEXXA must be prepared as follows:
Instructions for preparation of the solution for infusion:
- KRYSTEXXA vial should be visually inspected for particles and discolouration prior to dilution and administration. Only solutions which are clear to slightly opalescent, colourless and free of visible particles should be used.
- Appropriate aseptic technique should be used when preparing the infusion. The vial should not be shaken.
- 1 ml of KRYSTEXXA should be withdrawn from the vial into a sterile syringe.
- 1 ml of KRYSTEXXA should be injected into a single 250 ml bag of sodium chloride
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4.5 mg/ml (0.45%) or 9 mg/ml (0.9%) solution for injection or infusion.
- The infusion bag containing the diluted KRYSTEXXA solution should be inverted a number of times gently to ensure thorough mixing. The infusion bag containing diluted KRYSTEXXA should not be shaken.
- Before administration, the diluted solution of KRYSTEXXA should be allowed to reach room temperature. KRYSTEXXA in a vial or in an intravenous infusion fluid must never be subjected to artificial heating (e.g., hot water, microwave).