Patient Leaflet Updated 11-Jul-2024 | Chiesi Limited
Lamzede 10 mg powder for solution for infusion
Lamzede® 10 mg
powder for solution for infusion
velmanase alfa
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
1. What Lamzede is and what it is used for
2. What you need to know before you use Lamzede
3. How to use Lamzede
4. Possible side effects
5. How to store Lamzede
6. Contents of the pack and other information
Lamzede contains the active substance velmanase alfa which belongs to a group of medicines known as enzyme replacement therapies. It is used to treat patients with mild to moderate alpha-mannosidosis disease. It is given for the treatment of non-neurological symptoms of the disease.
Alpha-mannosidosis disease is a rare genetic disorder caused by a lack of an enzyme named alpha-mannosidase, which is needed to break down certain sugar compounds (called ‘mannose‑rich oligosaccharides’) in the body. When this enzyme is missing or does not work properly, these sugar compounds build up inside cells and cause the signs and symptoms of the disease. The typical manifestations of the disease include distinctive facial features, mental retardation, difficulty in controlling movements, difficulties in hearing and speaking, frequent infections, skeletal problems, muscle pain and weakness.
Velmanase alfa is designed to replace the missing enzyme, in patients with alpha-mannosidosis disease.
Talk to your doctor before Lamzede is used.
Hypersensitivity reactions may occur with the administration of Lamzede. These reactions usually appear during or soon after the infusion and may manifest with several symptoms, such as localised or diffuse skin reactions, gastrointestinal symptoms or swelling of the throat, face, lips or tongue (see section 4 “Possible side effects”). If the hypersensitivity reaction is severe, immediate discontinuation of Lamzede is recommended and current medical standards for emergency treatment are to be followed. Less severe hypersensitivity reactions may be managed by temporary interruption of the infusion or by slowing down infusion rate; administration of medicines used to treat allergy may be considered by the physician.
If you are treated with Lamzede, you may experience a side effect during or immediately following the drip (infusion) used to give the medicine (see section 4 “Possible side effects”). This is known as an infusion-related reaction and can sometimes be severe.
Antibodies may play a role in hypersensitivity and infusion related reactions observed with the use of Lamzede.
Although 24% of patients developed antibodies against Lamzede during its clinical development, no clear correlation was found between antibody titres and reduction in efficacy or occurrence of hypersensitivity reactions.
Tell your doctor if you are taking, have recently taken or might take any other medicines.
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 this medicine is used.
You should not take this medicine during pregnancy unless your doctor states it is clearly necessary. Your doctor will discuss that with you.
It is not known whether velmanase alfa passes into breast milk. Lamzede can be used during breast-feeding since the velmanase alfa will not be absorbed by a breast-fed child.
Lamzede has no or negligible influence on the ability to drive and use machines.
This medicine contains less than 1 mmol sodium (23 mg) per dose unit, that is to say essentially ‘sodium-free’.
This medicine is only to be used under the supervision of a doctor experienced in the treatment of alpha-mannosidosis or other similar diseases and should only be given by a healthcare professional.
Lamzede is only used under the supervision of a doctor who is knowledgeable in the treatment of Alpha Mannosidosis disease. Your doctor may advise that you can be treated at home provided you meet certain criteria. Please contact your doctor if you would like to be treated at home.
The recommended dose of Lamzede is 1 mg/kg of body weight given once every week.
Lamzede may be given to children and adolescents at the same dose and frequency as in adults.
Lamzede is supplied in a vial as a powder for infusion which will be made up with water for injections before being given. Once it has been made up, the medicine will be given by infusion pump (drip) into a vein over a period of at least 50 minutes under your doctor’s supervision.
If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects occur during the infusion or shortly after (“infusion-related reaction”, see section 2 “Warnings and precautions”).
While under treatment with Lamzede, you may experience some of the following reactions:
Serious side effects
Common side effects (may affect up to 1 in 10 people)
If you experience any side effect like these, please tell your doctor immediately.
Other side effects
Very common side effects (may affect more than 1 in 10 people)
Common side effects (may affect up to 1 in 10 people)
Side effects – frequency not known (frequency cannot be estimated from the available data)
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:
or search for MHRA Yellow Card in the Google Play or Apple App Store
By reporting side effects you can help provide more information on the safety of this medicine.
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.
Store and transport refrigerated (2°C ‑ 8°C). Do not freeze.
Store in the original package in order to protect from light.
After reconstitution, the medicine should be used immediately. If not used immediately, the reconstituted solution may be stored up to 24 hours at 2°C to 8°C.
This medicine must not be used if the reconstituted solution contains opaque particles or is discoloured.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Lamzede is a white to off-white powder for solution for infusion, supplied in a glass vial.
Each carton contains 1, 5 or 10 vials.
Not all pack sizes may be marketed.
This leaflet was last revised in June 2024.
This medicine has been authorised under ‘exceptional circumstances’. This means that because of the rarity of this disease it has been impossible to get complete information on this medicine.
The Medicines and Healthcare products Regulatory Agency will review any new information on this medicine every year and this leaflet will be updated as necessary.
Is this leaflet hard to see or read? Phone 0161 488 5555 for help.
CP0064-7
0108014411/01
Chiesi Limited, 333 Styal Road, Manchester, M22 5LG
0800 009 2329
http://www.chiesi.uk.com
https://www.chiesimedical.co.uk
+44 (0) 161 488 5555
www.chiesi.uk.com/supply-of-chiesi-products
+44 (0)1748 827 271
