Actemra

The active ingredient in Actemra is tocilizumab, a monoclonal antibody that blocks the actions of interleukin-6 (IL-6), which is made by white blood cells and other cells in the body. Your immune system becomes overactive when this protein is activated, leading to inflammation and the symptoms of autoimmune diseases. Actrema is believed to prevent the immune system from becoming overactive by blocking the interleukin-6 receptor, which lowers inflammation and the symptoms of autoimmune disorders.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Actemra. However, the following is a synopsis of the general guidelines for the use of Actemra:

• Your doctor may test you for infections or tuberculosis before you start taking Actemra.
• Actemra is administered as an injection under your skin or in a vein. For the majority of illnesses, this medication is usually used every one to four weeks. Typically, only one dose is administered for CRS. This medication is administered gradually for approximately one hour after being injected into a vein.
• Don't prepare an injection until you're ready to administer it. If the medication appears hazy, has changed color, or contains particles, contact your doctor.
• You will be shown where to inject Actemra by your healthcare provider. Avoid injecting twice in the same location.
• Never reuse an autoinjector, syringe, or needle. Put them in a "sharps" container that can't be punctured, and dispose of it according to local or state regulations. Keep out of children's and pets' reach.
• Actemra may be used as monotherapy or along with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDs).
• You can be more susceptible to infections, even dangerous or lethal ones. You will require regular medical examinations and blood tests.
• You may also need liver function tests while using Actemra and for several months after you stop.

The most common side effects of Actemra seen in clinical trials include:

• Headaches.
• Upper respiratory tract infections.
• Increased liver enzymes.
• High blood pressure (hypertension).
• Dizziness.
• Injection site reaction.
• Skin rash.
• Mouth sores.
• Stomach pain.

Some individuals may experience serious side effects during Actemra treatment. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Increased risk of serious infections: fever, exhaustion, chills, coughing, and difficulty breathing.
• Liver problems: swelling of the stomach, yellowing of the skin or whites of the eyes, disorientation, and black or brown urine.
• Serious allergic reactions including anaphylaxis: hives, rash, blisters, reddening of the skin, swelling of the lips or tongue, and trouble breathing.
• Stomach blockages and tears: abdominal pain, change in your bowel habits, or blood in your stool or urine.
• Low neutrophil or platelet counts.

These are not all of the possible side effects of Actemra. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Actemra, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Signs or symptoms of a bacterial, viral, or fungal infection.
• A perforation (a hole or rip) in your stomach or intestines.
• Low neutrophil or platelet counts.
• Liver problems.
• High cholesterol.
• Diverticulitis, or intestinal or stomach ulcers.
• Multiple sclerosis.
• Diabetes.
• HIV or weakened immunity.
• Hepatitis B (or whether you have the virus).
• Cancer.
• Any live vaccinations scheduled.
• A condition being treated with other immunosuppressants.

Boxed Warning

• Actemra-treated patients are more likely to get serious infections, such as TB, bacterial, invasive fungal, viral, or other opportunistic infections, which can cause hospitalisation or even death. Actemra should be stopped until the infection is under control if a significant infection appears.

Actemra should not be taken if you are allergic to tocilizumab, or any of the inactive ingredients in the product.

Your reason for taking Actemra will determine how long it takes for it to start working. For instance, a trial of patients receiving intravenous infusions of Actemra for rheumatoid arthritis revealed that some patients experienced a reduction in RA symptoms as early as two weeks after starting the medicine. According to a different trial, patients with giant cell arteritis who got Actemra subcutaneously (together with a 6-month steroid taper) remained in remission after a year than those who only had the steroid taper.

When Actemra is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Methotrexate.
• Etanercept.
• Abatacept.
• Anakinra.
• Rituximab, infliximab, golimumab, certolizumab, or adalimumab.

Actemra (tocilizumab) and Tofidence (tocilizumab-bavi) can be given as an IV infusion (through a vein) over 1 hour or a subcutaneous injection (under the skin) depending on how well the medication works for you, your weight, age, and side effects.

Rheumatoid Arthritis

IV: 4 mg/kg for the first dose, then 4–8 mg/kg monthly (max 800 mg per infusion).

SC: Under 220 lbs: 162 mg every 1–2 weeks.

220 lbs or more: 162 mg weekly.

Giant Cell Arteritis

IV: 6 mg/kg monthly (max 600 mg per infusion).

SC: 162 mg every 1–2 weeks.

Systemic Sclerosis-Associated Interstitial Lung Disease (SSC-ILD)

SC: 162 mg weekly.

Polyarticular Juvenile Idiopathic Arthritis

IV: Under 66 lbs: 10 mg/kg monthly.

66 lbs or more: 8 mg/kg monthly.

SC: Under 66 lbs: 162 mg every 3 weeks.

66 lbs or more: 162 mg every 2 weeks.

Systemic Juvenile Idiopathic Arthritis

IV:

Under 66 lbs: 12 mg/kg every 2 weeks.

66 lbs or more: 8 mg/kg every 2 weeks.

SC:

Under 66 lbs: 162 mg every 2 weeks.

66 lbs or more: 162 mg weekly.

Cytokine Release Syndrome

IV:

Under 66 lbs: 12 mg/kg as a single dose (up to 3 more doses if needed, 8+ hours apart, max 800 mg per infusion).

66 lbs or more: 8 mg/kg as a single dose (up to 3 more doses if needed, 8+ hours apart, max 800 mg per infusion).

COVID-19

IV: 8 mg/kg as a single dose.

If no improvement, one additional dose may be given after 8+ hours (max 800 mg per infusion).

The prefilled syringe and autoinjector can be kept at or below 86 F (30 C) for up to two weeks after being taken out of the refrigerator. Even if there is medication left in the autoinjector or prefilled syringe, discard it after one usage.

Genentech and Roche are both known as the pharmaceutical companies that manufacture Actemra.

There are no generic versions available of Actemra.

Never stop using Actemra without first talking to your doctor. They will tell you how to taper off the drug gradually to reduce the chance that your condition will worsen when you stop taking it.

Actemra may harm your unborn baby. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

It is not known if Actemra passes into your breast milk. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.