What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Black triangle. This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 08829/0188.


Lamzede 10 mg powder for solution for infusion

Package leaflet: Information for the patient

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.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Lamzede is and what it is used for
2. What you need to know before Lamzede is used
3. How Lamzede is used
4. Possible side effects
5. How Lamzede is stored
6. Contents of the pack and other information

1. What Lamzede is and what it is used for

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 aged 6 years and older with alpha-mannosidosis 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 may improve the symptoms of the disease.

2. What you need to know before Lamzede is used

Lamzede must not be used:

  • if you are allergic to velmanase alfa or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before Lamzede is used.

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). This is known as an infusion-related reaction and can sometimes be severe.

  • Infusion-related reactions include dizziness, headache, nausea, low or high blood pressure, tiredness and fever. If you experience an infusion-related reaction, you must tell your doctor immediately.
  • If you have an infusion-related reaction you may be given additional medicines to treat or help prevent future reactions. These medicines may include medicines used to treat allergies (antihistamines), medicines used to treat fever (antipyretics) and medicines to control inflammation (corticosteroids).
  • If the infusion-related reaction is severe, your doctor will stop the infusion immediately and start giving you appropriate medical treatment.
  • If the infusion-related reactions are severe and/or there is a loss of effect from this medicine, your doctor will perform a blood test to check for antibodies that might affect the outcome of your treatment.
  • Most of the time you can still be given Lamzede even if you experience an infusion-related reaction.

Children

Lamzede should not be used in children under the age of 6 years because no information on this age group is available.

Other medicines and Lamzede

Tell your doctor if you are taking, have recently taken or might take any other medicines.

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 this medicine is used.

Lamzede should be used during pregnancy only when medically necessary. It is not known whether velmanase alfa passes into breast milk; therefore it is recommended to use Lamzede only when medically necessary.

Driving and using machines

Lamzede has no or negligible influence on the ability to drive and use machines.

Lamzede contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free’.

3. How Lamzede is used

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.

Dosage

The recommended dose of Lamzede is 1 mg/kg of body weight given once every week infusion.

Use in children and adolescents

Lamzede may be given to children and adolescents (6 to 17 years of age) at the same dose and frequency as in adults.

Administration

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.

4. Possible side effects

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, gastrointestinal symptoms such as nausea, vomiting, diarrhea 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)
  • psychotic behaviour (mental illness with hallucinations, difficulty in thinking clearly and understanding reality, anxiety), 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

Reporting of side effects

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 ROI:

HPRA Pharmacovigilance
Earlsfort Terrace
IRL-Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie

UK: Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How Lamzede is stored

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).

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.

6. Contents of the pack and other information

What Lamzede contains

  • The active substance is velmanase alfa.
    One vial contains 10 mg of velmanase alfa.
    After reconstitution, one mL of the solution contains 2 mg of velmanase alfa (10 mg / 5 mL).
  • The other ingredients are: disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, mannitol and glycine.

What Lamzede looks like and contents of the pack

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.

Marketing Authorisation Holder

Chiesi Farmaceutici S.p.A.
Via Palermo 26/A
43122 Parma
Italy

Manufacturer

Chiesi Farmaceutici S.p.A.
Via San Leonardo, 96
43122 Parma
Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom
Chiesi Ltd
Tel: + 44 (0)161 488 5555

This leaflet was last revised in 11/2018

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 European Medicines Agency will review any new information on this medicine every 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 web site: http://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.

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