Tysabri

DRUG DESCRIPTION

TYSABRI (natalizumab) is a recombinant humanized IgG4? monoclonal antibody produced in murine myeloma cells. Natalizumab contains human framework regions and the complementarity-determining regions of a murine antibody that binds to ?4-integrin. The molecular weight of natalizumab is 149 kilodaltons. TYSABRI is supplied as a sterile, colorless, and clear to slightly opalescent concentrate for intravenous infusion.

Each 15 mL dose contains 300 mg natalizumab; 123 mg sodium chloride, USP; 17.0 mg sodium phosphate, monobasic, monohydrate, USP; 7.24 mg sodium phosphate, dibasic, heptahydrate, USP; 3.0 mg polysorbate 80, USP/NF, in water for injection, USP at pH 6.1.

What are the possible side effects of natalizumab (Tysabri)?

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash, hives, itching; dizziness, fever; nausea, vomiting; feeling flushed; chest pain, difficulty breathing; swelling of your face, lips, tongue, or throat; feeling light-headed or fainting.

Call your doctor at once if you have any of these serious side effects:

  • nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • signs of infection such as fever, chills,...

Read All Potential Side Effects and See Pictures of Tysabri

What are the precautions when taking natalizumab (Tysabri)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have ever had a certain medical condition. Before using this medicine, consult your doctor or pharmacist if you have ever had: a certain virus infection (progressive multifocal leukoencephalopathy-PML).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: weakened immune system (such as leukemia, lymphoma, HIV infection, organ transplant), current infections, history of certain virus infections that keep coming back (such as...

Read All Potential Precautions of Tysabri


Tysabri Consumer (continued)

SIDE EFFECTS: Headache, joint pain, redness/irritation at the injection site, swelling hands/feet/ankles, or changes in menstrual cycle may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if you have any side effects while this drug is being given or shortly after your treatment is finished. Examples of these side effects (infusion reaction) may include chills, fever, flushing, nausea, dizziness, tiredness, and chest pain.

Tell your doctor immediately if any of these unlikely but serious side effects occur: severe headache, fast/pounding heartbeat, signs of infection (such as fever, persistent sore throat, breathing problems, unusual vaginal discharge, painful/frequent urination), mood changes (such as depression, suicidal thoughts), severe stomach/abdominal pain.

This drug increases the risk of a possibly fatal brain infection (see Warning section for more details). In MS patients, the symptoms of PML can seem like an attack of worsening MS. Therefore, whether you are using this drug for MS or CD, tell your doctor immediately of any worsening symptoms that persist for several days such as: clumsiness, sudden change in your thinking (such as confusion, difficulty concentrating), difficulty moving muscles, seizure, problems with speech, vision changes.

This drug may rarely cause serious liver problems. If you notice any of the following rare but very serious side effects, tell your doctor immediately: persistent nausea/vomiting, dark urine, yellowing eyes/skin, feeling tired/weak.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have ever had a certain medical condition. Before using this medicine, consult your doctor or pharmacist if you have ever had: a certain virus infection (progressive multifocal leukoencephalopathy-PML).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: weakened immune system (such as leukemia, lymphoma, HIV infection, organ transplant), current infections, history of certain virus infections that keep coming back (such as herpes, shingles), mental/mood disorders (such as depression).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.


Tysabri Patient Information Including Side Effects

Brand Names: Tysabri

Generic Name: natalizumab (Pronunciation: nat ta LIZ yoo mab)

  • What is natalizumab (Tysabri)?
  • What are the possible side effects of natalizumab (Tysabri)?
  • What is the most important information I should know about natalizumab (Tysabri)?
  • What should I discuss with my healthcare provider before receiving natalizumab (Tysabri)?
  • How is natalizumab given (Tysabri)?
  • What happens if I miss a dose (Tysabri)?
  • What happens if I overdose (Tysabri)?
  • What should I avoid while receiving natalizumab (Tysabri)?
  • What other drugs will affect natalizumab (Tysabri)?
  • Where can I get more information?

What is natalizumab (Tysabri)?

Natalizumab is a monoclonal antibody that affects the actions of the body's immune system. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage.

Natalizumab is used in to treat relapsing forms of multiple sclerosis.

Natalizumab is also used to treat moderate to severe Crohn's disease in adults. It is usually given after other Crohn's disease medications have been tried without successful treatment of this condition.

Natalizumab may also be used for other purposes not listed in this medication guide.

What are the possible side effects of natalizumab (Tysabri)?

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash, hives, itching; dizziness, fever; nausea, vomiting; feeling flushed; chest pain, difficulty breathing; swelling of your face, lips, tongue, or throat; feeling light-headed or fainting.

Call your doctor at once if you have any of these serious side effects:

  • nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • signs of infection such as fever, chills, body aches, flu symptoms, sore throat, cough, redness, pain, swelling, or painful urination;
  • weakness on one side of the body, loss of balance or coordination;
  • change in your mental state, problems with speech or walking, decreased vision (these symptoms may start gradually and get worse quickly);
  • easy bruising or bleeding, unusual weakness;
  • white patches or sores inside your mouth or on your lips;
  • vaginal itching or discharge;
  • tooth pain, gum pain or swelling; or
  • flare of herpes infection (cold sores, blisters or lesions of the genital or anal area).

Less serious side effects may include:

  • headache;
  • joint or muscle pain;
  • stomach pain;
  • depression;
  • painful menstrual cramps; or
  • drowsiness, tiredness.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about natalizumab (Tysabri)?

Natalizumab increases the risk of a serious viral infection of the brain that can lead to disability or death. This risk is higher if you have a weak immune system or are receiving certain medicines. Call your doctor right away if you have symptoms such as change in your mental state, problems with speech or walking, or decreased vision. These symptoms may start gradually and get worse quickly.

Natalizumab is available only to select patients through a restricted-use program called the TOUCH Prescribing Program. To receive this medication, you must be enrolled in this program and meet all requirements. You will be interviewed before receiving each dose of this medicine to make sure you still meet these requirements.

During your natalizumab treatment, it is extremely important that your doctor check you every 3 to 6 months to make sure you are not developing any signs of serious infection. Do not miss any scheduled visits to your doctor.

Call your doctor at once if you develop any symptoms of liver damage, such as nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

You should also call your doctor right away if you develop any signs of infection such as fever, chills, sore throat, cough, stuffy nose, redness, pain, swelling, or painful urination.

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