400 units powder for concentrate for infusion solution
Imiglucerase
1. What Cerezyme is and what it is used for
Cerezyme contains the active substance imiglucerase and is used to treat patients who have a confirmed diagnosis of Gaucher disease type 1 or type 3, and who show the following signs of the disease: anemia ( anemia ), a tendency to bleed easily (due to low numbers) platelets – a type of blood cell), enlargement of the spleen or liver, or skeletal disease.
People with Gaucher disease have low levels of an enzyme called acidic β-glucosidase. This enzyme helps the body control the levels of glucosylceramide. Glucosylceramide is a natural substance in the body and consists of sugar and fat. In Gaucher’s disease, glucosylceramide levels may be too high.
Cerezyme is an artificial enzyme called imiglucerase. It can replace the natural enzyme an acidic β-glucosidase that is missing or not sufficiently active in patients with Gaucher disease.
The information in this leaflet applies to all patient groups including children, adolescents, adults, and the elderly.
2. What you need to know before you use Cerezyme
Do not use Cerezyme
- if you are allergic to imiglucerase or any of the other ingredients of this medicine (see section 6).
Warnings and cautions
Talk to your doctor or pharmacist before using Cerezyme:
- if you are being treated with Cerezyme you may have an allergic reaction while receiving the medicine or shortly afterward. If you get such a reaction, you must tell your doctor immediately. Your doctor may test if you have an allergic reaction to imiglucerase.
- Some patients with Gaucher disease have high blood pressure in the lungs ( pulmonary hypertension ). The cause may be unknown, or it may be due to heart, lung or liver problems. It may occur whether the patient is being treated with Cerezyme or not. However, if you suffer from shortness of breath, you must tell your doctor.
Other medicines and Cerezyme
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Cerezyme must not be given mixed with other medicines in the same infusion (drip).
Pregnancy and breastfeeding
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. Careful use of Cerezyme during pregnancy and lactation is recommended.
Cerezyme contains sodium
The drug contains sodium and is administered in 0.9% sodium chloride intravenous solutions. This should be considered by patients on a low-salt diet. This medicine contains 280 mg of sodium (the main ingredient in common salt/table salt) per vial. This corresponds to 14% of the maximum recommended daily intake of sodium for adults.
3. How Cerezyme is given
Instructions for proper use
Cerezyme is given via a drip into a vein (by intravenous infusion ).
It is delivered as a powder which must be mixed with sterile water before it is given.
Cerezyme should only be used under the supervision of a doctor who is knowledgeable in the treatment of Gaucher’s disease . Your doctor may recommend that you receive treatment at home, provided you meet certain criteria. Contact your doctor if you want to receive treatment at home.
Your dose is specific to you. Your doctor will calculate dose one based on how severe your symptoms are and other factors. The recommended dose is 60 units/kg body weight once every two weeks.
The doctor carefully monitors how you react to the treatment, and can change someone (increase or decrease) until he / she finds the best dose to control your symptoms.
Once the doctor has found the right dose, he/she will still check your reactions to make sure you are using the right dose. This can be done every 6 to 12 months.
There is no information on the effect of Cerezyme on brain-based symptoms in patients with chronic neuronopathic Gaucher disease. Therefore, no specific dosing regimen can be recommended.
ICGG Gaucher Registry
You can ask your doctor to register your patient information in the “ICGG Gaucher Registry”. The purpose of this registry is to increase understanding of Gaucher’s disease and to check how well enzyme replacement therapy, such as Cerezyme, works. This should lead to an improvement in the safety and efficacy of Cerezyme. Your patient data is registered anonymously – no one gets to know that the information is about you.
If you use more Cerezyme than you should
No cases of overdose of Cerezyme have been reported.
If you forget to use Cerezyme
If you have missed an infusion, consult your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people):
- shortness of breath
- cough
- hives / local swelling of the skin or inside the mouth or throat
- itching
- rash
Uncommon (may affect up to 1 in 100 people):
- dizziness
- headache
- a feeling of skin tingling, stinging, stinging, or numbness
- increased heart rate
- bluish skin
- redness
- drop in blood pressure
- vomiting
- nausea
- stomach cramps
- diarrhea
- joint pain
- discomfort at the infusion site
- burning at the infusion site
- swelling at the infusion site
- abscess at the injection site
- chest discomfort
- fever
- stiffness
- fatigue
- back pain
Rare (may affect up to 1 in 1,000 people):
- severe hypersensitivity reaction
Some side effects were seen mainly while patients were receiving the drug or shortly after. These were itching, redness, hives / local swelling in the skin or inside the mouth or throat, chest discomfort, increased heart rate, bluish skin, shortness of breath, a feeling of skin tingling, stinging, stinging or numbness, drop in blood pressure and back pain. If you get any of these symptoms, tell your doctor immediately. You may need additional medicines to prevent an allergic reaction (eg antihistamines and/or corticosteroids ).
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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Cerezyme
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 carton after “EXP”. The expiration date is the last day of the specified month.
Unopened vials:
Store in a refrigerator (2 ° C – 8 ° C)
Diluted solution:
Cerezyme should be used immediately after mixing with sterile water. The reconstituted solution in the vial cannot be saved but should be immediately diluted in an infusion bag; an only diluted solution can be stored for up to 24 hours if stored cool (2 ° C – 8 ° C) and dark.
The medicine 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.
6. Contents of the packaging and other information
Content declaration
- The active substance is imiglucerase. Imiglucerase is a modified form of the human enzyme an acidic β-glucosidase and is produced by recombinant DNA technology. One vial contains 400 units of imiglucerase. After reconstitution , the solution contains 40 units of imiglucerase per ml.
- The other ingredients are mannitol, sodium citrate, citric acid monohydrate, polysorbate 80.
What the medicine looks like and the contents of the pack
Cerezyme, 400 units, is supplied as a powder for concentrate for solution for infusion(in a pack of 1, 5, or 25 vials). Not all pack sizes may be marketed.
Cerezyme is supplied as a white to off-white powder. After reconstitution, it is a clear, colorless liquid, free from particles. The reconstituted solution must be further diluted.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Genzyme Europe BV, Paasheuvelweg 25, 1105 BC Amsterdam, The Netherlands
Manufacturer
Genzyme Ireland Limited, IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Contact the representative of the marketing authorization holder to find out more about this medicine: