When This Medicine Should Not Be Used:
This medicine is not right for everyone. You should not receive it if you had an allergic reaction to siltuximab.

How to Use This Medicine:
Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
• A nurse or other health provider will give you this medicine.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how siltuximab works. Tell your doctor if you are using atorvastatin, cyclosporine, lovastatin, theophylline, a blood thinner (such as warfarin), or birth control pills.
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant. It is not known if this medicine affects an unborn baby. You must use an effective form of birth control to keep from getting pregnant during treatment and for 3 months after the last dose of this medicine.
• Tell your doctor if you are breastfeeding, or if you have stomach or bowel problems (such as diverticulitis or ulcers) or any type of infection.
• This medicine may cause the following problems:
  
  • Higher risk of infection
  • Infusion reactions
  • Bowel perforation
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate
• Chest pain, trouble breathing, lightheadedness
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Rapid weight gain, swelling in your hands, ankles, or feet
• Severe stomach pain, red or black stools, vomiting blood or material that looks like coffee grounds
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Skin rash or itching

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088