Siltuximab Solution for injection

What is this medicine?

SILTUXIMAB is a monoclonal antibody. This medicine changes the way the body's immune system works. It is used commonly to treat multicentric Castleman's disease (MCD).

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• HIV or AIDS

• infection (especially a virus infection such as chickenpox, cold sores, or herpes)

• recently received or schedule to receive a vaccine

• stomach or intestine problems

• an unusual or allergic reaction to siltuximab, other medications, foods, dyes, or preservatives

• pregnant or trying to become pregnant

• breast-feeding

How should I use this medicine?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinical setting.

Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses as directed. It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• live virus vaccines

This medicine may also interact with the following medications:

• atorvastatin

• birth control pills

• cyclosporine

• lovastatin

• theophylline

• warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

You may need blood work done while you are taking this medicine. Your condition will be monitored carefully while you are receiving this medicine.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

Birth control pills may not work properly while you are taking this medicine. Talk to your doctor about using an extra method of birth control.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• signs of infection like fever or chills; cough; sore throat; pain or difficulty passing urine

• stomach pain

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• constipation

• headache

• loss of appetite

• signs of low blood pressure like dizziness; feeling faint or lightheaded, falls; unusually week or tired

• swelling of the ankles, feet, hands

• unusual bleeding or bruising

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.