Natalizumab

By Medically reviewed by hellodoktor

Generic Name: Natalizumab Brand Name(s): Natalizumab. Avability: Rx Pregnancy Category: N

Uses

What is Natalizumab used for?

Natalizumab is used to treat a certain type of multiple sclerosis (relapsing multiple sclerosis-MS). It is not a cure for MS, but it is thought to help by preventing your immune system from attacking the nerves in your brain and spinal cord. It helps decrease the number of episodes of worsening and may prevent or delay disability.

Natalizumab is also used to treat a bowel condition called Crohn’s disease (CD) when it is moderate to severe and/or keeps coming back. It is not a cure for CD, but it is thought to work by preventing your immune system from causing inflammation/swelling within your bowels.

Natalizumab is a protein called a monoclonal antibody.

How should I take Natalizumab?

This medication is given by a health care professional in an infusion center, usually every 4 weeks or as directed by your doctor. This medication is mixed in a solution and injected slowly into a vein, usually over 1 hour. It should not be given as a rapid injection. You will be monitored for 1 hour after your treatment is finished to make sure you do not have a serious reaction to the medication. It is important to use this medication regularly to get the most benefit from it. Do not miss any doses without your doctor’s approval.

Tell your doctor if your condition worsens. When using this medication for Crohn’s disease, if your condition does not improve after 12 weeks of treatment, your doctor will need to switch your treatment plan.

How do I store Natalizumab?

Store concentrated solution under refrigeration between 2°C to 8°C (36°F to 46°F); do not freeze. Protect from light. Do not shake. Following dilution, may be used immediately or refrigerated between 2°C to 8°C (36°F to 46°F) for use within 8 hours; allow diluted solution to warm to room temperature prior to infusion.

There may be different brands of Natalizumab that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Natalizumab down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Natalizumab?

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.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Natalizumab during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Natalizumab. Natalizumab is pregnancy risk category N according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Natalizumab?

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 right away 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 right away if any of these unlikely but serious side effects occur: severe/persistent headache, stiff/painful neck, 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 rare, possibly fatal, brain infection (see Warning section for more details). This condition may occur during treatment or, in some cases, after treatment has stopped. In MS patients, the symptoms of PML can seem like an attack of worsening MS. Therefore, whether you are using this drug or have stopped using it within the last 6 months, tell your doctor right away of any new or worsening symptoms that have lasted 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 right away: 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.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Natalizumab?

Some products that may interact with this drug include: past or current use of other drugs that weaken the immune system/increase the risk of infection (such as azathioprine, cyclosporine, 6-mercaptopurine, methotrexate, fingolimod, TNF blockers such as adalimumab, etanercept, infliximab), long-term use of corticosteroids (such as dexamethasone, prednisone).

Natalizumab may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Natalizumab?

Natalizumab may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Natalizumab?

Natalizumab may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Natalizumab.

What is the dose of Natalizumab for an adult?

Usual Adult Dose for Multiple Sclerosis

300 mg IV over 1 hour once every 4 weeks

Comments:

-Only prescribers registered in the MS TOUCH (R) Prescribing Program may prescribe this drug for multiple sclerosis.

-Patients should be observed during the infusion and for one hour after the infusion is complete.

Use: Multiple Sclerosis (MS): As monotherapy for the treatment of patients with relapsing forms of multiple sclerosis

Usual Adult Dose for Crohn’s Disease – Maintenance

300 mg IV over 1 hour once every 4 weeks

Comments:

-Only prescribers registered in the CD TOUCH (R) Prescribing Program may prescribe this drug for Crohn’s disease.

-This drug should not be used with concomitant immunosuppressants (e.g., 6-mercaptopurine, azathioprine, cyclosporine, methotrexate) or concomitant inhibitors of TNF-alpha.

-Aminosalicylates may be continued during treatment with this drug.

-If the patient has not experienced therapeutic benefit by 12 weeks of induction therapy, this drug should be discontinued.

-For patients who start this drug while on chronic oral corticosteroids, steroid tapering should commence as soon as a therapeutic benefit of this drug has occurred; if the patient cannot be tapered off of oral corticosteroids within 6 months of starting this drug, then this drug should be discontinued.

-Other than the initial 6 month taper, prescribers should consider discontinuing this drug for patients who require additional steroid use that exceeds 3 months in a calendar year to control their Crohn’s disease.

-Patients should be observed during the infusion and for one hour after the infusion is complete.

Use: Crohn’s Disease (CD): For inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate conventional CD therapies and inhibitors of TNF-alpha

Other Comments

Administration advice:

-Therapy with this drug should be initiated and supervised by neurologists, in centers with timely access to MRI.

-This drug should be administered within 8 hours of preparation.

Storage advice:

-Consult the manufacturer product information.

Reconstitution/preparation techniques:

-Consult the manufacturer product information.

General:

-This drug should not be administered as an IV push or bolus.

-In CD, discontinue in patients that have not experienced therapeutic benefit by 12 weeks of induction therapy, and in patients that cannot discontinue chronic concomitant steroids within six months of starting therapy.

Monitoring:

-Patients should be observed during the infusion and for one hour after the infusion is complete for adverse reactions.

What is the dose of Natalizumab for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Natalizumab available?

Natalizumab is available in the following dosage forms and strengths:

  • Intravenous concentrate.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Natalizumab, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: August 10, 2018 | Last Modified: September 12, 2019

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