Tocilizumab (Actemra)

Officially, Actemra is an interleukin-6 receptor antagonist. The drug reduces the impact that Interleukin-6  has on the inflammation process.   Interleukin-6 was discovered and cloned by Japanese immunologist, Tadamitsu Kishimoto who later helped develop the drug Actemra.  In 2010 the FDA approved Actemra for treatment of rheumatoid arthritis.

Actemra is given once every two weeks initially. Depending on the response, it may then be given weekly. The dose is 162mg and it is given  under the skin. Actemra comes in a prefilled syringe, and it also comes in an ACT pen which is an autoinjector. Actemra must be stored under refrigeration until 30 minutes before use.  Actemra may also be given as an infusion which is an IV given over several hours in a medical facility.

• Blackbox Warning    This warning for Actemra is given for serious, maybe deadly, infections. Infections may include tuberculosis, invasive fungal infections, bacterial, viral, and other infection due to opportunistic pathogens.  A person with a history of diverticulitis should pay attention to new abdominal symptoms, as gastrointestinal perforation has occurred while on Actemra during clinical trials.

Common Side effects   The most common side effects of Actemra are upper respiratory infections (common cold, sinus infection), headache, increased blood pressure and injection site reactions.

Additional serious side effects  

• Infections must be taken very seriously. A person on an RA biologic will have a compromised immune system.
• Tuberculosis, if present in the body, may be reactivated. A TB test will reveal the presence of TB. If positive, a person should be treated before starting Actemra.
• A person with a history of chicken pox should have the new shingles vaccine. Otherwise, there is a risk of shingles.
• Actemra causes cholesterol levels to rise.Levels should be monitored on a regular basis.

 Pregnancy and lactation            The effects of Actemra on the fetus during pregnancy or on the breast milk are unknown.          

Sarilumab (Kevzara)      

Sarilumab was FDA approved in 2017. It is a human monoclonal antibody produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell suspension culture.  It  is an IL-6 inhibitor.

It is given by subcutaneous injection either by a prefilled pen or prefilled syringe. The dosage is 200mg given under the skin every two weeks. It should be stored in the refrigerator. It may be stored at room temperature (77⁰F. max) for fourteen days. This is a unique characteristic of the biologics.

Clinical Studies At 52 weeks about 50% patients reached ACR20( 20% improvement); 40% reached ACR 50(50% improvement) ; 25% reached ACR70(70% improvement).

Common Side effects   The most common side effects of Kevzara are upper respiratory infection, urinary tract infection, redness at the injection site.

Precautions The most frequently observed serious infections with Kevzara include pneumonia and cellulitis. A person on Kevzara needs to be monitored for abnormal blood work, gastrointestinal perforation usually associated with diverticulitis, allergic reaction, increased cancer risk.

BLACK BOX WARNING 

The black box warning for Sarilumab states  “Serious infections leading to hospitalization or death including bacterial, viral, invasive fungi, and other opportunistic infections have occurred in patients receiving Kevzara.”       

Pregnancy and lactation   The effects of Kevzara on the fetus during pregnancy or in breast milk are unknown.