is unknown whether velmanase alfa or its metabolites are excreted in human milk. Nevertheless, theabsorption of any ingested milk-containing velmanase alfa in the breastfed child is considered to beminimal and no untoward effects are therefore anticipated. Lamzede can be used during breastfeeding.
Fertility
There are no clinical data on the effects of velmanase alfa on fertility. Animal studies do not showevidence of impaired fertility.
4.7 Effects on ability to drive and use machines
Lamzede has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
Summary of the safety profile
The most common adverse reactions observed were weight increase (18%), IRRs (9%), diarrhoea
(12%), headache (9%), arthralgia (9%), increased appetite (6%) and pain in extremity (6%).
All of these adverse reactions were non-serious. IRRs include hypersensitivity in 3 patients andanaphylactoid reaction in 1 patient. These reactions were non-serious and mild to moderate inintensity.
A total of 2 serious adverse reactions (loss of consciousness in 1 patient and acute renal failure in1 patient) were observed. In both cases the patients recovered without sequelae.
Tabulated list of adverse reactions
The adverse reactions reflecting exposure of 33 patients treated with velmanase alfa in clinical studiesare listed in the table 1 below. Adverse reactions are classified by system organ class and preferredterm according to the MedDRA frequency convention. Frequency is defined as very common (≥1/10),common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare(<1/10,000) or not known (cannot be estimated from the available data).
Table 1: Adverse reactions reported in clinical studies in patients with alpha-mannosidosis
treated with velmanase alfa
System organ class Adverse reaction Frequency
Immune system disorders Hypersensitivity(1) Common
Anaphylactoid reaction(1) Common
Metabolism and nutrition disorders Increased appetite Common
Psychiatric disorders Psychotic behaviour Common
Initial insomnia Common
Nervous system disorders Confusional state Common
Loss of consciousness(2) Common
Syncope Common
Tremor Common
Dizziness Common
Headache Common
Eye disorders Eye irritation Common
Eyelid oedema Common
Ocular hyperaemia Common
Cardiac disorders Bradycardia Common
Respiratory, thoracic and
mediastinal disorders
Epistaxis Common
Gastrointestinal disorders Diarrhoea Very common
Abdominal pain Common
Abdominal pain upper Common
Nausea(1) Common
Vomiting(1) Common
Reflux gastritis Common
Skin and subcutaneous tissue
disorders
Urticaria(1) Common
Hyperhidrosis(1) Common
Musculoskeletal and connective
tissue disorders
Arthralgia Common
Back pain Common
Joint stiffness Common
Myalgia Common
Pain in extremity Common
System organ class Adverse reaction Frequency
Renal and urinary disorders Renal failure acute(2) Common
General disorder and
administration site conditions
Pyrexia(1) Very common
Catheter site pain Common
Chills(1) Common
Feeling hot(1) Common
Fatigue Common
Malaise(1) Common
Investigations Weight increase Very common
Injury, poisoning and procedural
complications
Procedural headache Common
(1) Preferred terms considered as IRR as described in the section below
(2) Selected adverse reaction |
