• are being treated for an infection.
• get a lot of infections or have infections that keep coming back.
• have diabetes, HIV, or a weak immune system. People with these conditions have a higher chance of getting infections.
• have TB, or have been in close contact with someone with TB.
• live or have lived, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance of getting certain fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may happen more often or become more severe if you use KEVZARA. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common.
• have or have had hepatitis.

After starting KEVZARA, call your healthcare provider right away if you have any symptoms of an infection.

2.

Changes in certain laboratory test results.
Your or your child's healthcare provider should do blood tests before you start KEVZARA, 4 to 8 weeks after starting KEVZARA, and then every 3 months during treatment to check for:

• low neutrophil count. Neutrophils are white blood cells that help the body fight off bacterial infections. A low neutrophil count is common with KEVZARA, and can be severe.
• low platelet count. Platelets are blood cells that help with blood clotting and stop bleeding.
• increase in certain liver function tests. An increase in certain liver function tests is common with KEVZARA, and can be severe.

Your healthcare provider may not prescribe KEVZARA if your neutrophil or platelet counts are too low, or your liver function tests are too high. Your healthcare provider may stop your KEVZARA treatment for a period of time or change your dose if needed because of changes in these blood test results.
Your or your child's healthcare provider should do blood tests 4 to 8 weeks after starting KEVZARA and then every 6 months during treatment to check for an:

• increase in blood cholesterol levels.

3.

Tears (perforation) of the stomach or intestines. Tell your healthcare provider if you have had a condition known as diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people using KEVZARA get tears in their stomach or intestine. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Call your healthcare provider right away if you have fever and stomach (abdominal) pain that does not go away.

4.

Cancer. KEVZARA may increase your risk of certain cancers by changing the way your immune system works. Tell your healthcare provider if you have ever had any type of cancer.

See "What are the possible side effects of KEVZARA?" for more information about side effects.

• To treat adults with moderately to severely active rheumatoid arthritis (RA) after at least one other medicine called a disease modifying antirheumatic drug (DMARD) has been used and did not work well or could not be tolerated.
• To treat adults with polymyalgia rheumatica (PMR) after corticosteroids have been used and did not work well or when a slow decrease in the dose of corticosteroids (taper) cannot be tolerated.
• To treat people with active polyarticular juvenile idiopathic arthritis (pJIA) who weigh 63 kg or more.

It is not known if KEVZARA is safe and effective in children with pJIA under 2 years of age.

• have an infection. See "What is the most important information I should know about KEVZARA?"
• have liver problems.
• have had stomach (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestines.
• have recently received or are scheduled to receive a vaccine. People who take KEVZARA should not receive live vaccines.
  • All vaccines should be brought up-to-date before starting KEVZARA, unless urgent treatment initiation is required.
• plan to have surgery or a medical procedure.
• are pregnant or plan to become pregnant. It is not known if KEVZARA will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if KEVZARA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use KEVZARA.

Tell your healthcare provider about all the medicines you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Especially tell your healthcare provider if you or your child use:

• any other medicines to treat your RA, PMR or pJIA. You should not take rituximab (Rituxan®), etanercept (Enbrel®), infliximab (Remicade®), anakinra (Kineret®), adalimumab (Humira®), abatacept (Orencia®), certolizumab (Cimzia®), golimumab (Simponi®), tocilizumab (Actemra®), or tofacitinib (Xeljanz®) while you are using KEVZARA. Using KEVZARA with these medicines may increase your risk of infection.
• medicines that affect the way certain liver enzymes work. Ask your healthcare provider if you are not sure if your medicine is one of these.

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

• See the detailed Instructions for Use that comes with this Medication Guide for instructions about the right way to prepare and give your KEVZARA injections at home.
• KEVZARA is given as an injection under the skin (subcutaneous injection).
• KEVZARA is available as a single-use pre-filled syringe and a single-use pre-filled pen. Your healthcare provider will prescribe the dose and type of KEVZARA that is best for you or your child.
• If your healthcare provider decides that you or a caregiver can give the injections of KEVZARA at home using the pre-filled pen or pre-filled syringe, you or your caregiver should receive training on the right way to prepare and inject KEVZARA. Do not try to inject KEVZARA until you have been shown the right way to give the injections by your healthcare provider.
• Inject 1 dose of KEVZARA every 2 weeks.

• injection site redness
• injection site itching
• upper respiratory tract infection
• urinary tract infection
• nasal congestion, sore throat, and runny nose

These are not all of the possible side effects of KEVZARA.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to sanofi-aventis at 1-800-633-1610.

• Store KEVZARA in the refrigerator between 36°F to 46°F (2°C to 8°C). Store KEVZARA in the original carton until use to protect it from light.
• Do not freeze KEVZARA.
• Do not shake KEVZARA.
• KEVZARA may be stored at room temperature up to 77°F (25°C) for up to 14 days in the original outer carton.
• Throw away KEVZARA if it has been kept at room temperature and not been used within 14 days.