Tysabri 300Mg Vial Of 15Ml Solution For Infusion

• Relapsing form of multiple sclerosis (MS) in adults.
• Patients aged 18 years and over with high disease activity despite treatment with a beta interferon or glatiramer acetate. These patients may be defined as those who have failed to respond to a full and adequate course, normally at least one year of treatment, of a beta interferon or glatiramer acetate.

• If you have, or have ever had, progressive multifocal leukoencephalopathy (PML).
• If you have had a hypersensitivity reaction to Tysabri 300 Injection. Reactions reported range from hives to anaphylaxis.

• Headache
• Tiredness
• Joint pain
• Urinary tract infection
• Lower respiratory tract infection
• Gastroenteritis
• Vaginal infection
• Depression
• Pain in an arm or leg
• Abdominal discomfort
• Diarrhoea
• Rash

Other General Warnings

• You have, or have ever had, progressive multifocal leukoencephalopathy.
• You develop any new or worsening neurological symptom, such as weakness, clumsiness, changes in vision, or changes in thinking, memory or personality.
• You have ever taken an immunosuppressant medicine, or you are taking one now.
• You have tested positive for anti-JC virus antibodies, or do not know your status.
• You have been on this treatment for a long period, as the risk of PML increases with the duration of therapy.
• You develop a severe headache with fever or a stiff neck, cold sores with confusion, or a sudden change in vision, as serious herpes infections have occurred.
• You notice yellowing of the skin or eyes, dark urine or unusual tiredness, as significant liver injury has occurred.
• You get hives, swelling, breathlessness or dizziness during or after an infusion.
• You have any infection now, or one that keeps coming back.
• You are pregnant, think you may be pregnant or are planning a baby, as this medicine can cause harm to an unborn baby.

• Tysabri 300 Injection is given by a healthcare professional as an infusion into a vein.
• The infusion is given over approximately one hour. It is never given as a rapid injection or bolus.
• You are observed during the whole infusion, and it is stopped promptly at the first sign of any reaction.
• Your doctor decides the schedule and reviews whether treatment should continue.
• It is available only through a restricted distribution programme, so it can only be prescribed and given through that route.
• Never try to change, delay or skip an infusion on your own.

• Tysabri 300 Injection is a hospital-administered medicine, so the pharmacy handles its storage, preparation and disposal.
• Do not freeze it.
• If the diluted solution is stored between 2 and 8 degrees Celsius, it must be used within 48 hours, and allowed to warm to room temperature before the infusion.
• Keep it out of the reach of children.
• Do not use it after the expiry date printed on the pack.
• Unused product and waste are disposed of by the hospital in line with local requirements. Do not dispose of it yourself.

• Report any new or worsening neurological symptom without waiting, such as weakness on one side, clumsiness, changes in vision, confusion, or changes in thinking, memory or personality. These can be the first signs of PML, and treatment is withheld immediately at the first suspicion.
• Tell your doctor if you have ever taken an immunosuppressant, as it raises the PML risk alongside anti-JCV antibody status and how long you have been on treatment.
• Report symptoms like yellowing of the skin or eyes, dark urine or unusual tiredness. Significant liver injury has occurred with this medicine.
• Get medical help immediately for hives, swelling, breathlessness or dizziness during or after an infusion.
• Report a severe headache with fever or a stiff neck, cold sores with confusion, or any sudden change in vision, as serious herpes infections may be seen.
• Keep every appointment and stay for the full infusion and observation.

Overdose

Missed a Dose

Interactions with other medicines

• Tell your doctor about all the medicines you take including herbal, over the counter or any prescription medicine you take.
• Tell your doctor if you have ever taken an immunosuppressant, as prior use is one of the factors that increases the risk of PML.
• This medicine should not be used together with immunosuppressants or with inhibitors of tumour necrosis factor alpha.
• Tell your doctor about any vaccination you are due.

Interactions with food items

• Tysabri 300 Injection is given into a vein by a healthcare professional, so interactions with food do not occur.