Land: Den europeiske union
Språk: engelsk
Kilde: EMA (European Medicines Agency)
nusinersen sodium
Biogen Netherlands B.V.
M09
nusinersen
Other nervous system drugs
Muscular Atrophy, Spinal
Spinraza is indicated for the treatment of 5q Spinal Muscular Atrophy.
Revision: 14
Authorised
2017-05-30
26 B. PACKAGE LEAFLET 27 PACKAGE LEAFLET: INFORMATION FOR THE USER SPINRAZA 12 MG SOLUTION FOR INJECTION nusinersen READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD RECEIVES 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 or nurse. • If you or your child gets any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Spinraza is and what it is used for 2. What you need to know before you or your child are given Spinraza 3. How Spinraza is given 4. Possible side effects 5. How to store Spinraza 6. Contents of the pack and other information 1. WHAT SPINRAZA IS AND WHAT IT IS USED FOR Spinraza contains the active substance _nusinersen_ which belongs to a group of medicines known as _antisense oligonucleotides_ . Spinraza is used to treat a genetic disease called _spinal muscular atrophy_ (SMA). SPINAL MUSCULAR ATROPHY is caused by a shortage of a protein called _survival motor neuron_ (SMN) in the body. This results in the loss of nerve cells in the spine, leading to weakness of the muscles in the shoulders, hips, thighs and upper back. It may also weaken the muscles used for breathing and swallowing. Spinraza works by helping the body to produce more of the SMN protein that people with SMA are lacking. This reduces the loss of nerve cells and so may improve muscle strength. 2. WHAT YOU NEED TO KNOW BEFORE YOU OR YOUR CHILD ARE GIVEN SPINRAZA _ _ SPINRAZA MUST NOT BE GIVEN • If you or your child are ALLERGIC TO NUSINERSEN or any of the other ingredients of this medicine (listed in section 6). If you are not sure, talk to your doctor or nurse before you or your child are given Spinraza. WARNINGS AND PRECAUTIONS There is a risk of side effects occuring after Spinraza is given by a lumbar puncture procedure (see section 3). This can include headaches, vomiting and back pain. The Les hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Spinraza 12 mg solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml vial contains nusinersen sodium equivalent to 12 mg nusinersen. Each ml contains 2.4 mg of nusinersen. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear and colourless solution with pH of approximately 7.2. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Spinraza is indicated for the treatment of 5q Spinal Muscular Atrophy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Spinraza should only be initiated by a physician with experience in the management of spinal muscular atrophy (SMA). The decision to treat should be based on an individualised expert evaluation of the expected benefits of treatment for that individual, balanced against the potential risk of treatment with Spinraza. Patients with profound hypotonia and respiratory failure at birth, where Spinraza has not been studied, may not experience a clinically meaningful benefit due to severe survival motor neuron (SMN) protein deficiency. Posology The recommended dosage is 12 mg (5 ml) per administration. Spinraza treatment should be initiated as early as possible after diagnosis with 4 loading doses on Days 0, 14, 28 and 63. A maintenance dose should be administered once every 4 months thereafter. _ _ _Duration of treatment _ Information on long term efficacy of this medicinal product is not available. The need for continuation of therapy should be reviewed regularly and considered on an individual basis depending on the patient’s clinical presentation and response to the therapy. _Missed or delayed doses _ If a loading or a maintenance dose is delayed or missed, Spinraza should be administered according to the schedule in Table 1 below. 3 TABLE 1: RECOMMENDATIONS FOR DELAYED OR MISSED DOSE DELAYED OR MISSED DOSE TIMING OF DOSING ADMINISTRATION LOADING DOSE • Administer the delayed or missed loading dose as soon as pos Les hele dokumentet