Product Description
TYSABRI contains the active substance Natalizumab. It is used for the treatment of multiple sclerosis (a condition in which the immune system attacks the protective covering of the nerves called myelin, causing disrupted communication between the brain and body) and moderately to severe Crohn’s disease (a chronic bowel disease that affects any part of the gastrointestinal tract, mainly small and large intestine) in patients who are unable to tolerate conventional Crohn’s disease therapy and inhibitors of TNF-α.
It belongs to the group of medicines called integrin receptor antagonists. It works by binding to the chemical substance called α4β7 integrin (present on the surface of the leukocytes that enters the gut), which is responsible for inflammation. This slows progression of disease and reduces the number of attacks in multiple sclerosis.
Inform the doctor if you have or have ever had Tuberculosis or any active infection, bleeding disorders, injury, GI perforation, fistula formation, proteinuria, thromboembolic disorders, diabetes, hypertension or heart problems, dental problems, kidney problems and liver problems (such as hepatic injury).
Inform the doctor about all your medical conditions, prescription and non-prescription drugs, vitamin supplements, herbal medications, since TYSABRI can interact with them. TYSABRI can cause an allergic reaction in some patients therefore it is necessary to read the complete composition list and consult the doctor in case of any ingredient that induces allergies. This medicine may make your skin more sensitive to sun, so it is better to use good sunscreen and protective clothing when outdoors.
Consult the doctor if you are planning, on a pregnancy or breastfeeding. It is advisable to avoid driving and operating heavy machinery during the course of TYSABRI.
Indications of TYSABRI Injection
TYSABRI indicated for the treatment of multiple sclerosis (a condition in which the immune system attacks the protective covering of the nerves called myelin, causing disrupted communication between the brain and body) and moderately to severe Crohn’s disease (a chronic bowel disease that affects any part of the gastrointestinal tract, mainly small and large intestine) in patients who are unable to tolerate conventional Crohn’s disease therapy and inhibitors of TNF-α.
Therapeutic Effects of TYSABRI Injection
TYSABRI Injection belongs to the group of medicines called monoclonal antibody that works by binding to the chemical substance called α4β7 integrin (present on the surface of the leukocytes that enters the gut), which is responsible for inflammation. This slows progression of disease and reduces the number of attacks in multiple sclerosis.
Directions for Use
TYSABRI is given as an injection under the skin or as an intravenous infusion. The dosage and duration of treatment will depend on the individual’s condition and response to the medication and should be determined by the doctor.
Your doctor will decide the dose and frequency of administration based on your health condition.
A trained healthcare doctor/Nurse will administer TYSABRI. So, do not self-administer.
Storage
TYSABRI Injection should be stored in refrigerator at 2°C to 8°C. Do not freeze. Do not shake.
If you are traveling, carefully follow all patient instructions for storing your medicine during travel. Avoid extreme heat or cold. Keep the injection in the original container to protect from light and moisture.
Keep TYSABRI Injection out of sight and reach of children.
Common:
- Fatigue
- Nausea
- Throat infection
- Diarrhea
- Headache
- Joint pain
- Rash
- Stomach pain
- Urinary tract infection
- Vaginal inflammation
Serious:
- Progressive multifocal leukoencephalopathy (PML)
- Infusion reactions
- Liver damage
- Infections
- Hypersensitivity
Tell a doctor or nurse straight away, if you notice any of the side effects above.
Contraindications
TYSABRI Injection is contraindicated in patients with a known hypersensitivity to TYSABRI or any of the excipients.
Drug Interactions
TYSABRI might interact with other medicines. Therefore, it is recommended to inform your doctor about all the prescriptions you have.
Safety Advices for TYSABRI Injection
Consult Your Doctor
It is unknown whether TYSABRI Injection interacts with alcohol. However, it is best to avoid alcohol or limit your alcohol consumption while taking any medication. Consult your doctor.
Consult Your Doctor
There is limited information on the use of TYSABRI during pregnancy. However, if you are pregnant or planning to get pregnant during the treatment, please consult your doctor. Your doctor will prescribe if the benefits are found to outweigh the risks.
Consult Your Doctor
It is recommended that you do not breast-feed to avoid passing the virus to the baby through breast milk. Consult your doctor if you are breastfeeding before taking this medication.
UNSAFE
TYSABRI may cause dizziness, lightheadedness, or sleepy in some patients. Therefore, avoid driving or operating machines that require mental concentration until you are not alert.
Consult Your Doctor
If you have pre-existing or a history of lung problems, consult your doctor before taking TYSABRI. Your doctor may adjust the dose of this medicine or prescribe a suitable alternative based on your condition.
Consult Your Doctor
If you have a pre-existing or a history of liver problems, consult your doctor before taking TYSABRI. It should be used cautiously in liver disease patients as it could further enhance liver damage. Your doctor may adjust the dose of this medicine or prescribe a suitable alternative based on your condition.
Consult Your Doctor
If you have a pre-existing or a history of kidney disease, consult your doctor before taking TYSABRI. Your doctor may adjust the dose of this medicine or prescribe a suitable alternative based on your condition.
UNSAFE
TYSABRI is not recommended for use in children below 18 years old as the safety and efficacy are not established.
- 1. Briggs GG, Freeman RK, editors. A Reference Guide to Fetal and Neonatal Risk: Drugs in Pregnancy and Lactation. 10th ed. Philadelphia, PA: Wolters Kluwer Health; 2015. pp. 959-61.
- 2. MS Society. Natalizumab. [Accessed 21 Jan. 2019] (online) Available from: https://www.mssociety.org.uk/about-ms/treatments-and-therapies/disease-modifying-therapies/natalizumab
- 3. Tysabri. Natalizumab. [Accessed 26 Mar. 2019] (online) Available from: https://www.tysabri.com/
- 4. Natalizumab. Cambridge, Massachusetts: Biogen Idec Inc.; 2004 [revised Jan. 2012]. [Accessed 26 Mar. 2019] (online) Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125104s0576lbl.pdf
- 5. Rachel Branstadter, Ilana Katz Sand; The use of Tysabri 300mg injection for multiple sclerosis; Neuropsychiatrist Disease and Treatment; Published on June 2017; Accessed on 30th July 2023; http://www.ncbi.nlm.nih.gov/pmc/articles/pmc5499927/

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multiple sclerosis | multiple sclerosis (MS) |
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