Kevzara

Kevzara is an injectable prescription medicine known as an Interleukin- 6 (IL-6) receptor blocker. It treats adults with moderately to severely active rheumatoid arthritis (RA) after trying another disease-modifying antirheumatic drug (DMARD) without success.

Kevzara is also used to treat adult patients with polymyalgia rheumatica who have not responded well to corticosteroids or cannot tolerate them.

Warnings

Patients treated with Kevzara have an increased risk of serious infections that may require hospitalization or be fatal. Opportunistic infections have been reported in patients taking Kevzara, especially when combined with methotrexate or corticosteroids.

Avoid using Kevzara in patients with an active infection.

Reported infections include:

• Active tuberculosis, which can affect the lungs or other parts of the body. Test for latent tuberculosis before starting Kevzara and during treatment. Treat latent infection before using Kevzara.
• Invasive fungal infections like candidiasis and pneumocystis. These infections can be widespread.
• Bacterial, viral, and other infections from opportunistic pathogens.
• Closely monitor patients for signs of infection while on Kevzara. Discontinue Kevzara if a serious infection develops.
• Consider risks and benefits before starting Kevzara in patients with chronic or recurrent infection.

Side Effects of Kevzara

Kevzara can cause serious side effects, including:

• 1. Serious Infections. Kevzara lowers the immune system’s ability to fight infections. Some people using Kevzara have developed serious infections, such as tuberculosis (TB), bacterial, fungal, or viral infections that can spread throughout the body. Test for TB before starting Kevzara and monitor for signs of infection during treatment.
• 2. Changes in certain laboratory test results. Kevzara can cause low neutrophil and platelet counts, and increase liver function tests. Monitor blood counts and liver function regularly.
• 3. Tears (perforation) of the stomach or intestines. Inform your healthcare provider if you have a history of diverticulitis or ulcers. Taking Kevzara with nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate increases the risk of stomach or intestinal tears.
• 4. Cancer. Kevzara may increase the risk of certain cancers by affecting the immune system. Inform your healthcare provider if you have a history of cancer.
• Serious allergic reactions. Seek medical attention immediately if you experience signs of a serious allergic reaction, such as difficulty breathing, swelling, chest pain, or severe stomach pain or vomiting.

Common side effects of Kevzara include injection site redness, upper respiratory tract infection, urinary tract infection, nasal congestion, sore throat, and runny nose.

Call your doctor or report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Sanofi-Aventis at 1-800-633-1610.

Dosage

The recommended dosage of Kevzara is 200 mg subcutaneous injection once every two weeks, in combination with a corticosteroid taper. Kevzara can be used alone after discontinuing corticosteroids. Discontinue Kevzara if the patient develops neutropenia, thrombocytopenia, or liver enzyme abnormalities.

• Kevzara is administered as a subcutaneous injection.
• It is available in single-use pre-filled syringes or pens. Your healthcare provider will determine the best type and dose for you.
• If you are self-administering Kevzara, receive proper training from your healthcare provider before injecting it.
• Inject one dose of Kevzara every two weeks.

Pregnancy and Breastfeeding

The safety and efficacy of Kevzara in children have not been established.

Who Should Not Use Kevzara?

Do not use Kevzara if you are allergic to sarilumab or any of its ingredients.

Before using Kevzara, discuss all your medical conditions with your healthcare provider, including if you:

• Have an active infection.
• Have liver problems.
• Have a history of stomach pain, diverticulitis, or ulcers in the stomach or intestines.
• Have recently received or will receive a vaccine. Kevzara should not be used with live vaccines.
• Plan to undergo surgery or a medical procedure.
• Are pregnant or planning to become pregnant. Join the pregnancy registry if you are pregnant and using Kevzara.

Inform your healthcare provider about all medications, including over-the-counter drugs, vitamins, and herbal supplements.

Especially inform your healthcare provider if you use:

• Other medications for RA. Avoid using Kevzara with rituximab, etanercept, infliximab, anakinra, adalimumab, abatacept, certolizumab, golimumab, tocilizumab, or tofacitinib, as it may increase the risk of infection.
• Medications that affect liver enzymes. Consult your healthcare provider if you are unsure if your medication falls into this category.

Maintain a list of all your medications to show your healthcare provider and pharmacist when starting a new treatment.

Summary

Kevzara is an injectable prescription medicine known as an Interleukin-6 (IL-6) receptor blocker. It treats adults with moderately to severely active rheumatoid arthritis (RA) after trying another disease-modifying antirheumatic drug (DMARD) without success. Common side effects of Kevzara include injection site redness, upper respiratory tract infection, urinary tract infection, nasal congestion, sore throat, and runny nose. Serious side effects of Kevzara include serious infections, allergic reactions, and tears (perforation) of the stomach or intestines. Patients treated with Kevzara are at increased risk for developing serious infections that may lead to hospitalization or death.