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.

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.

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.

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)

• loss of consciousness (fainting, which may be preceded by feeling dizzy, lightheaded or confused)
• acute renal insufficiency (kidney problems which can be recognised from fluid retention, swelling in legs, ankles or feet, drowsiness, shortness of breath or fatigue)
• hypersensitivity and serious allergic reaction (symptoms including localised or diffuse skin itching, dizziness, difficulty breathing, chest pain, chills, fever, gastrointestinal symptoms such as nausea, vomiting, diarrhoea or intestinal pain, swelling of the throat, face, lips or tongue)

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)

• diarrhoea
• weight increase
• fever/increased body temperature

Common side effects (may affect up to 1 in 10 people)

• low heart beat (bradycardia)
• blue skin and lips (cyanosis)
• psychotic behaviour (mental illness with hallucinations, difficulty in thinking clearly and understanding reality, anxiety), initial difficulty in sleeping
• confused state, fainting, tremor, dizziness, headache
• intestinal (abdominal) pain, irritation of the stomach caused by digestive acids (reflux gastritis), nausea, vomiting
• pain at the site the infusion is given, chills, feeling hot, malaise, tiredness (fatigue)
• skin rashes (urticaria), increased sweating (hyperhidrosis)
• nosebleed
• joint pain, back pain, joint stiffness, muscle pain, pain in extremity (hands, feet)
• eye irritation, eye swelling (eyelid oedema), eye redness
• increased appetite

Side effects – frequency not known (frequency cannot be estimated from the available data)

• infection of the inner wall of the sac around the heart (endocarditis)
• furuncle
• infection caused by a bacteria called Staphylococcus
• decreased appetite
• agitation, stool soiling, nervousness
• inability to coordinate muscle movements
• somnolence
• increased lacrimation
• deafness
• aortic valve incompetence (a condition in which the aortic valve does not close tightly)
• fast and/or rapid heart beat
• low blood pressure
• vascular fragility
• oropharyngeal pain
• wheezing
• painful swallowing
• reddening of the skin
• joint swelling, joint warmth
• weakness

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.