Tocilizumab

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Generic Name: Tocilizumab Brand Name(s): Generics only. No brands available. Avability: Rx Pregnancy Category: N

Uses

What is Tocilizumab used for?

Tocilizumab is used alone or with other medications to treat moderate to severe rheumatoid arthritis in adults. It helps to reduce pain and swelling due to rheumatoid arthritis. Tocilizumab is also used to treat giant cell arteritis. It helps to reduce swelling in your blood vessels so blood can flow more easily. Tocilizumab belongs to a class of drugs known as Interleukin-6 (IL-6) blockers. It works by blocking IL-6, a substance made by the body that causes swelling (inflammation).

How should I take Tocilizumab?

If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package.

Remove one syringe from the refrigerator 30 minutes before using it to allow it to reach room temperature. Do not speed up the warming process in any way; for example, do not use the microwave or place the syringe in warm water. Check this product visually for particles or discoloration. If either is present, do not use the liquid.

If you are using this medication to treat rheumatoid arthritis, inject this medication under the skin as directed by your doctor, usually starting with once every 2 weeks, then increasing to once a week.

If you are using this medication to treat giant cell arteritis, inject this medication under the skin as directed by your doctor, usually once a week.

Recommended injection sites include the abdomen or the front of your thigh. The outer area of the upper arms may also be used if another person is giving you the injection. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard, or broken.

The dosage is based on your weight, laboratory tests, and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, mark the days you need to inject the medication on a calendar.

How do I store Tocilizumab?

Store the prefilled syringes in their original container in a refrigerator. Protect from moisture and light. Do not freeze. Throw away any prefilled syringes not used before the expiration date on the medicine label.

Each single-use prefilled syringe is for one use only. Throw it away after one use, even if there is still medicine left inside.

There may be different brands of Tocilizumab 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 Tocilizumab 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 Tocilizumab?

Before using tocilizumab, 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, infections (including past/current/returning), liver problems, low blood cell count, nervous system problems (such as multiple sclerosis), stomach/abdominal problems (such as ulcers, diverticulitis).

Tocilizumab can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, tuberculosis, flu). Tell your doctor if you live in, have lived in, or have traveled to certain areas where there is an increased chance of getting certain kinds of fungal infections (blastomycosis, coccidioidomycosis, histoplasmosis). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Drugs that affect the immune system (such as tocilizumab) may increase your risk of certain cancers. Tell your doctor if you have ever had any type of cancer.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

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

It is unknown if this drug passes into breast milk. 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 Tocilizumab during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Tocilizumab. Tocilizumab 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 Tocilizumab?

Headache or irritation/redness/pain at the injection site 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 serious side effects, including: severe stomach/abdominal pain.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 Tocilizumab?

Some products that may interact with this drug include: other drugs that can affect the immune system (such as certolizumab, corticosteroids including prednisone).

This medication can speed up the removal of other medications from your body, which may affect how they work. Examples of affected drugs include omeprazole, warfarin, and some cholesterol drugs such as atorvastatin/lovastatin/simvastatin, among others.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

Tocilizumab 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 Tocilizumab?

Tocilizumab 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 Tocilizumab?

Tocilizumab 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 Tocilizumab.

What is the dose of Tocilizumab for an adult?

Usual Adult Dose for Rheumatoid Arthritis

IV:

4 mg/kg IV as a 60-minute single drip infusion once every 4 weeks, followed by an increase to 8 mg/kg IV given once every 4 weeks as a 60-minute single drip infusion based on clinical response

Dose adjustment: Reduction from 8 mg/kg to 4 mg/kg is recommended for management of certain dose-related laboratory changes including elevated liver enzymes, neutropenia, and thrombocytopenia.

Maximum dose: 800 mg per infusion

Subcutaneous:

-Patients less than 100 kg: 162 mg subcutaneously every other week, followed by an increase to every week based on clinical response

-Patients 100 kg or greater: 162 mg subcutaneously every week

-Dose adjustment: Interruption of dose or reduction in frequency of administration from every week to every other week is recommended for management of certain dose-related laboratory changes including elevated liver enzymes, neutropenia, and thrombocytopenia.

Use: For adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs)

Usual Adult Dose for Giant Cell Arteritis

162 mg subcutaneously once a week in combination with a tapering course of glucocorticoids

Dose adjustment: 162 mg subcutaneously every other week in combination with a tapering course of glucocorticoids may be appropriate based on clinical considerations

Use: For giant cell arteritis (GCA)

Usual Adult Dose for Cytokine-Associated Toxicity

-Weight less than 30 kg: 12 mg/kg IV over 60 minutes

-Weight 30 kg or above: 8 mg/kg IV over 60 minutes

-If no clinical improvement in cytokine release syndrome (CRS) occurs after the first dose, up to 3 additional doses may be administered. The interval between consecutive doses should be at least 8 hours.

Maximum dose: 800 mg per infusion

Use: For cytokine chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS)

Renal Dose Adjustments

Mild or moderate renal impairment: No adjustment recommended.

Liver Dose Adjustments

The safety and efficacy of this drug has not been studied in patients with hepatic impairment, including patients with positive HBV and HCV serology.

Dose Adjustments

Hold therapy if a patient develops a serious infection until the infection is controlled.

What is the dose of Tocilizumab for a child?

Usual Pediatric Dose for Juvenile Idiopathic Arthritis

Polyarticular Juvenile Idiopathic Arthritis (PJIA):

2 years or older:

IV:

-Weight less than 30 kg: 10 mg/kg IV as a 60-minute single drip infusion

once every 4 weeks

-Weight 30 kg or more: 8 mg/kg IV as a 60-minute single drip infusion

once every 4 weeks

Subcutaneous:

2 years or older:

IV:

-Weight less than 30 kg: 162 mg subcutaneously once every 3 weeks

-Weight 30 kg or more: 162 mg subcutaneously once every 2 weeks

Systemic Juvenile Idiopathic Arthritis (SJIA):

2 years or older:

IV:

-Weight less than 30 kg: 12 mg/kg IV as a 60-minute single drip infusion

once every 2 weeks

-Weight 30 kg or more: 8 mg/kg IV as a 60-minute single drip infusion

once every 2 weeks

Uses:

-For patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis (PJIA)

-For patients 2 years of age and older with active systemic juvenile idiopathic arthritis (SJIA)

Usual Pediatric Dose for Cytokine-Associated Toxicity

2 years and older:

-Weight less than 30 kg: 12 mg/kg IV over 60 minutes

-Weight 30 kg or above: 8 mg/kg IV over 60 minutes

-If no clinical improvement in cytokine release syndrome (CRS) occurs after the first dose, up to 3 additional doses may be administered. The interval between consecutive doses should be at least 8 hours.

Maximum dose: 800 mg per infusion

Use: For cytokine chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in pediatric patients 2 years and older

Precautions

Safety and efficacy of the IV formulation of this drug have not been established in patients younger than 2 years.

Safety and efficacy of the subcutaneous formulation of this drug have not been established in patients younger than 18 years.

How is Tocilizumab available?

Tocilizumab is available in the following dosage forms and strengths:

  • Intravenous solution,
  • Subcutaneous solution.

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 Tocilizumab, 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: November 13, 2018 | Last Modified: November 13, 2018

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