Lamzede 10 mg powder for solution for infusion
1. NAME OF THE MEDICINAL PRODUCT
Lamzede 10 mg powder for solution for infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
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).
For the full list of excipients, see section 6.1.
*Velmanase alfa is produced in mammalian Chinese Hamster Ovary (CHO) cells using recombinant
DNA technology.
3. PHARMACEUTICAL FORM
Powder for solution for infusion.
White to off-white powder.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Enzyme replacement therapy for the treatment of non-neurological manifestations in patients withmild to moderate alpha-mannosidosis. See sections 4.4 and 5.1.
4.2 Posology and method of administration
The treatment should be supervised by a physician experienced in the management of patients withalpha-mannosidosis or in the administration of other enzyme replacement therapies (ERT) forlysosomal storage disorder. Administration of Lamzede should be carried out by a healthcareprofessional with the ability to manage ERT and medical emergencies.
PosologyThe recommended dose regimen is 1 mg/kg of body weight administered once every week byintravenous infusion at a controlled speed. For infusion rate see section “Method of administration”.
Special populations
Renal or hepatic impairment
No dose adjustment is necessary for patients with renal or hepatic impairment.
ElderlyNo data are available and no relevant use in elderly patients is described.
Paediatric populationNo dose adjustment is necessary for the paediatric population.
Method of administrationFor intravenous infusion use only.
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
The reconstituted solution of Lamzede should be administered using an infusion set equipped with apump and an in-line low protein-binding 0.22 µm filter. The infusion duration should be calculatedindividually considering a maximum infusion rate of 25 mL/hour to control the protein load. Theinfusion duration should be a minimum of 50 minutes. A slower infusion rate may be prescribed whenclinically appropriate according to the physician’s judgment, for example at the beginning of thetreatment or in case of previous infusion-related reactions (IRRs).
For the calculation of the infusion rate and the infusion time based on body weight see the table insection 6.6.
The patient should be observed for IRRs for at least one hour after the infusion according to clinical
conditions and the physician’s judgment. For further instructions, see section 4.4.
4.3 Contraindications
Severe allergic reaction to the active substance or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
The effects of treatment with velmanase alfa should be periodically eva luated and discontinuation oftreatment considered in cases where no clear benefits could be observed.
As the accumulation of end organ damage progresses over time, it is more difficult for the treatment toreverse the damage or to show improvements. As with other enzyme replacement therapies, velmanasealfa does not cross the blood-brain-barrier. It should be considered by the treating physician that the
administration of velmanase alfa does not affect the irreversible complications (i.e. skeletaldef |
