Tyruko (Intravenous)
Natalizumab is used in adults to treat relapsing forms of multiple sclerosis (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease).
Natalizumab is also used in adults to treat moderate to severe Crohn's disease. This medication is given after other treatments have failed or if cannot use other treatments.
Natalizumab may also be used for purposes not listed in this medication guide.
warnings
What is the most important information I should know about Tyruko (Intravenous)?
Natalizumab may cause a serious brain infection called progressive multifocal leukoencephalopathy (PML). This infection may be more likely if you use natalizumab for longer than 2 years, if you've used a medicine that weakens the immune system in the past, or if you've been infected with John Cunningham Virus (JCV).
You should not be treated with natalizumab if you are allergic to it or any of its ingredients, or if you have PML.
Natalizumab is available only under a special program. You must be registered in the program and understand the risks and benefits of this medicine.
Tell your doctor if you have or have ever had:
- fever, or an active infection (including shingles or any infection that does not go away);
- a weak immune system (caused by disease or by using certain medicine);
- hives, itching, or trouble breathing during or after a dose of natalizumab; or
- liver disease.
This medicine may cause new or worsening symptoms that last several days. Tell your doctor if you have problems with thinking, vision, balance, weakness on one side of the body, or using your arms or legs.
It is not known whether natalizumab can cause birth defects. Using this medicine during pregnancy may cause low platelet counts and low red blood cells (anemia) in the newborn. Tell your doctor if you are pregnant or plan to become pregnant.
Ask a doctor if it is safe to breastfeed while using this medicine.
Side Effects
What are the side effects of Tyruko (Intravenous)?
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Some side effects may occur during or after the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.
Natalizumab may cause a serious brain infection during treatment and for up to 6 months after stopping treatment. Tell your doctor right away if you have problems with speech, thought, balance, vision, or muscle movement. These symptoms can get worse quickly.
You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:
- fever, chills, sore throat;
- mouth sores, red or swollen gums;
- pale skin, easy bruising, unusual bleeding; or
- chest discomfort, wheezing, dry cough or hack, rapid weight loss.
Also call your doctor at once if you have:
- easy bruising, bleeding that is unusual or does not stop, or purple or red spots under your skin;
- symptoms of herpes virus--sudden fever, severe headache, confusion, vision changes, or eye pain or redness; or
- liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Common side effects may include:
- headache, feeling tired;
- depression;
- lung infection;
- skin rash;
- nausea, diarrhea, stomach pain;
- pain and burning when you urinate;
- cold symptoms such as stuffy nose, sneezing, sore throat;
- joint pain, pain in your arms and legs; or
- vaginal itching or discharge.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Pregnancy & Breastfeeding
Can I take Tyruko (Intravenous) if I’m pregnant or breastfeeding?
It is not known whether natalizumab can cause birth defects. Using this medicine during pregnancy may cause low platelet counts and low red blood cells (anemia) in the newborn. Tell your doctor if you are pregnant or plan to become pregnant.
Ask a doctor if it is safe to breastfeed while using this medicine.
Interactions
What drugs and food should I avoid while taking Tyruko (Intravenous)?
Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.
Dosage Guidelines & Tips
How to take Tyruko (Intravenous)?
Use Tyruko (Intravenous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Your doctor may recommend an MRI of your brain before and during your treatment with natalizumab.
Natalizumab is given as an infusion into a vein, usually once every 4 weeks. This medicine is usually given over 1 hour. A healthcare provider will give you this injection.
You will be watched closely during and after receiving natalizumab, to make sure you do not have an allergic reaction to the medicine.
You may get infections more easily, even serious or fatal infections. You will need frequent medical tests, including blood tests to check liver function. You may also need a brain scan or spinal tap (lumbar puncture) if you develop signs of a brain infection.
Your doctor will need to check your progress on a regular basis, even for 6 months after you stop receiving this medicine.
You may be given other medications to help treat allergic reactions. Keep taking these medicines for as long as your doctor has prescribed.
If you also use steroid medication for this condition, you should not stop using it suddenly. Follow your doctor's instructions about tapering your dose.
Call your doctor if your symptoms do not improve, or if they get worse.
This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using natalizumab.
Call your doctor for instructions if you miss an appointment for your natalizumab injection.
Overdose Signs
What happens if I overdose on Tyruko (Intravenous)?
In a medical setting an overdose would be treated quickly.