TYSABRI CONCENTRATE FOR SOLUTION FOR INFUSION 300MG/15ML [SIN14408P]

Product Info

TYSABRI CONCENTRATE FOR SOLUTION FOR INFUSION 300MG/15ML

[SIN14408P]

4.1 Therapeutic indications

Tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (RRMS) for the following patient groups:

• Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) (for exceptions and information about washout periods see sections 4.4 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

or

• Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain Magnetic Resonance Imaging (MRI) or a significant increase in T2 lesion load as compared to a previous recent MRI.

4.2 Posology and method of administration

Therapy is to be initiated and continuously supervised by specialised physicians experienced in the diagnosis and treatment of neurological conditions, in centres with timely access to MRI.

Patients treated with this medicinal product must be given the patient alert card and be informed about the risks of the medicinal product (see also Patient Information Leaflet). After 2 years of treatment, patients should be re-informed about the risks of the medicinal product, especially the increased risk of Progressive Multifocal Leukoencephalopathy (PML), and should be instructed together with their caregivers on early signs and symptoms of PML.

Resources for the management of hypersensitivity reactions and access to MRI should be available.

Some patients may have been exposed to immunosuppressive medicinal products (e.g. mitoxantrone, cyclophosphamide, azathioprine). These medicinal products have the potential to cause prolonged immunosuppression, even after dosing is discontinued. Therefore, the physician must confirm that such patients are not immunocompromised before starting treatment (see also section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Posology

Tysabri 300 mg is administered by intravenous infusion once every 4 weeks.

Continued therapy must be carefully reconsidered in patients who show no evidence of therapeutic benefit beyond 6 months.

Data on the safety and efficacy of natalizumab at 2 years were generated from controlled, double-blind studies. After 2 years continued therapy should be considered only following a reassessment of the potential for benefit and risk. Patients should be re-informed about the risk factors for PML, like duration of treatment, immunosuppressant use prior to receiving the medicinal product and the presence of anti-John Cunningham virus (JCV) antibodies (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Readministration

The efficacy of re-administration has not been established (for safety see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Special populations

Elderly

This medicinal product is not recommended for use in patients aged over 65 due to a lack of data in this population.

Renal and hepatic impairment

Studies have not been conducted to examine the effects of renal or hepatic impairment.

The mechanism for elimination and results from population pharmacokinetics suggest that dose adjustment would not be necessary in patients with renal or hepatic impairment.

Paediatric Population

The safety and efficacy of this medicinal product in children and adolescents up to 18 years have not been established. Currently available data are described in sections 4.8 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Method of Administration

This medicinal product is for intravenous use.

For instructions on dilution of the medicinal product before administration (see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

After dilution (see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information), the infusion is to be administered over approximately 1 hour and patients are to be observed during the infusion and for 1 hour after the completion of the infusion for signs and symptoms of hypersensitivity reactions.

After the first 12 intravenous Tysabri doses, patients should continue to be observed during infusion. If the patients have not experienced any infusion reactions, the post dose observation time may be reduced or removed according to clinical judgement.

Tysabri 300 mg concentrate for solution must not be administered as a bolus injection.

4.3 Contraindications

Hypersensitivity to natalizumab or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Progressive multifocal leukoencephalopathy (PML).

Patients with increased risk for opportunistic infections, including immunocompromised patients (including those currently receiving immunosuppressive therapies or those immunocompromised by prior therapies. (see sections 4.4 and 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)).

Combination with other DMTs.

Known active malignancies, except for patients with cutaneous basal cell carcinoma.