Actemra is an immunosuppressive biologic drug used for treating autoimmune conditions like rheumatoid arthritis (RA). The FDA also approved the medication for giant cell arteritis treatment and for patients who developed cytokine release syndrome after CAR T cell therapy. It is available in an infusion or injection. Its dosing varies. Many patients and doctors believed Actemra was a safer alternative to rheumatoid arthritis medications like Humira and Enbrel. This is because Actemra’s label does not warn of certain serious side effects. But the drug has led to patient injuries and deaths.
Actemra is a biologic drug that changes the way the immune system works. The active ingredient in Actemra is tocilizumab.
Acemtra is used to treat rheumatoid arthritis (RA). It can also treat other autoimmune conditions caused by inflammation. It comes in an injection or infusion.
The U.S. Food and Drug Administration first approved Actemra in 2010. Genentech makes Actemra. The company is a subsidiary of Roche.
What Is Actemra Used For?
Actemra is mostly used to treat rheumatoid arthritis. RA is an autoimmune disease. It causes the body’s immune system to attack the joints.
But the U.S. Food and Drug Administration also approved Actemra for other uses. This includes giant cell arteritis treatment. The FDA also approved Actemra to treat cytokine release syndrome associated with CAR T cell therapy in patients 2 years of age and older.
Rheumatoid Arthritis – autoimmune disease in which the body’s immune system attacks the joints
Systemic Juvenile Idiopathic Arthritis – chronic inflammatory joint disease that affects children under age 16
Polyarticular Juvenile Idiopathic Arthritis – affects five or more joints in children under age 16
Giant Cell Arteritis Treatment – an inflammatory disease of blood vessels
CAR T Cell Induced Cytokine Release Syndrome – immunotherapy designed for the treatment of certain cancers causes a large, rapid release of cytokines into the blood
How Does Actemra Work?
Actemra works by blocking the action of a certain protein in the body called interleukin 6 (IL-6).
IL-6 acts as both a pro-inflammatory and anti-inflammatory. It’s said to have a role in rheumatoid arthritis and its effects.
IL-6 connects to the body’s cells. It communicates a message to the cells, triggering them to activate. This activation may cause various signs and symptoms of RA.
Actemra is the first RA drug to block IL-6 from connecting to cells.
How Is Actemra Administered?
Patients can receive Actemra via two different methods. The first method is by subcutaneous (SC) injection. The second method is by intravenous (IV) infusion.
Actemra comes in a syringe or a shot for injection under the skin. You can administer it yourself at home, or a caregiver or health care professional can administer it for you.
Patients receive Actemra in IV form at a health care provider’s office or other medical center. A medical professional administers the liquid solution into the vein with a needle. This type of infusion lasts about one hour.
Dosing for Actemra depends on a person’s weight, how the drug is given and the condition it’s treating.
Other factors can also influence the recommended dosage. These include any pre-existing health conditions and whether the patient takes other medications.
- Rheumatoid Arthritis (RA)
- IV infusion: 4 mg per kg given once every four weeks; the dose may be gradually increased to 8 mg per kg once every four weeks, depending on the patient’s tolerance; dosing should not exceed 800 mg per IV infusion
Subcutaneous injection: 162 mg once every other week in patients who weigh less than 220 pounds and 162 mg once every week in patients who weigh over 220 pounds
- Giant Cell Arteritis
- IV infusion: Not approved for GCA
Subcutaneous injection: 162 mg every week
- Polyarticular Juvenile Idiopathic Arthritis
- IV infusion: 8 mg per kg (patients at or above 30 kg) to 10 mg per kg (patients less than 30 kg) every four weeks as a 60-minute single intravenous (IV) drip infusion
Subcutaneous injection: 162 mg every three weeks in patients less than 30 kg and 162 mg every two weeks in patients at or above 30 kg
- Systemic Juvenile Idiopathic Arthritis
- IV Infusion: 8 mg per kg (patients at or above 30 kg) to 12 mg per kg (patients less than 30 kg) every two weeks as a 60-minute single intravenous (IV) drip infusion
Subcutaneous injection: Not approved for SJIA
- Cytokine Release Syndrome (CRS)
- IV Infusion: 8 mg per kg (patients at or above 30 kg) to 12 mg per kg (patients less than 30 kg) as a 60-minute single intravenous (IV) drip infusion; up to 3 additional doses can be given with an interval of at least eight hours between consecutive doses
Subcutaneous injection: Not approved for CRS
Actemra Side Effects
Actemra side effects can be mild or severe.
Common side effects include upper respiratory tract infections, headache, increased blood pressure and reactions at the injection site.
Serious or deadly side effects can include heart failure, heart attack, stroke and pancreatitis.
Patients injured by Actemra have filed Actemra lawsuits against Genentech and Roche. Families of patients who died after using Actemra are also suing for compensation.
Competing Rheumatoid Arthritis Medications
Other FDA-approved rheumatoid arthritis medications include Humira, Enbrel and Remicade.
Unlike with Actemra, these medications’ labels warn of many serious side effects. This led many patients and doctors to believe that Actemra was safer than the other drugs.
But studies and reports to the FDA reveal similar risks with Actemra. In fact, a 2017 STAT investigation showed the risk of certain side effects is as high or higher with Actemra compared with other rheumatoid arthritis medications.
All the drugs are similarly effective in treating rheumatoid arthritis. They are all used to treat other conditions as well.
|FDA Approval Date||2010||2006||2002||1999|
|Average Cost||$1,300 to $6,300 per three vials of 4ml, 10ml or 30ml of 20mg||$5,500 per two 40mg syringes or pens||$5,000 per carton of four 50 mg cartridges, sureclicks or syringes||$5,000 to $16,000 per infusion/ $1,100 to $1,300 per vial|
|Dose for RA||IV: 4 mg per kg of weight every four weeks; subcutaneous injection: 162 mg weekly or every other week depending on weight||40 mg every other week||50 mg weekly; pediatric doses range from 0.8 mg to 50 mg weekly||3 mg given at 0, 2 and six weeks followed by 3 mg every eight weeks|
|Common Side Effects||Runny or stuffy nose, sinus pain, sore throat, headache, dizziness, itching, stomach cramps, or UTI – urinary tract infection||Injection site reactions, headache, stuffy nose, sinus pain, stomach pain||Nausea, vomiting, diarrhea, stomach pain, headache, injection site reactions, heartburn, weight changes, cold symptoms, weakness||Headache, stomach pain, nausea, stuffy nose, sinus pain, skin rash, flushing|
Using Actemra with other drugs or substances can change the way Actemra works. Drug interactions can increase or decrease Actemra’s effectiveness. They can also result in the increase or decrease of the effects of the other drugs or substances.
Before starting Actemra, patients should speak with their doctor about all other substances they are using. This includes medications, supplements and alcohol.
Patients taking Actemra with CYP450 substrates may have an increased metabolism of the CYP450 enzyme medications. The effect of Actemra on the activity of the CYP450 enzyme can last for several weeks after stopping Actemra.
Also, patients taking CYP3A4 substrates with Actemra should use caution. Actemra may decrease the effectiveness of these drugs.
You should limit the amount of alcohol you drink while taking Actemra. This can help prevent further injury to the liver.
Tocilizumab is the active ingredient in Actemra. It is linked to elevated liver enzymes and liver toxicity. Doctors should assess patients for liver injury before starting them on Actemra.
Patients taking Actemra should avoid live vaccines. Researchers haven’t evaluated how safe and effective live vaccines are in Actemra users.
You should make sure you are up-to-date on vaccines before starting Actemra.
Who Should Not Take Actemra?
Actemra may not be the right treatment for everyone.
Patients who have signs of an infection or have ever had tuberculosis should speak with their doctor before using Actemra.
This is also true for anyone scheduled to receive live vaccines. These include the shingles vaccine, the chickenpox vaccine and the MMR vaccine. Others live vaccines protect against polio, rotavirus, typhoid or yellow fever.
Tell your doctor if you are pregnant or breastfeeding before starting Actemra.
- Active or chronic infection
- Liver disease
- Stomach ulcer
- Stomach or intestinal bleeding
- HIV or a weak immune system
- Hepatitis B
- Nerve muscle disorders like multiple sclerosis
Please seek the advice of a medical professional before making health care decisions.