siltuximab

What is the most important information I should know about siltuximab?

What is siltuximab?

Siltuximab is used to treat Multicentric Castleman's Disease (MCD). MCD is a rare condition in which the body produces too much of a certain type of white blood cell. MCD can increase your risk of certain cancers by changing the way your immune system works.

Siltuximab is not for use in people who have human immunodeficiency virus (HIV) or human herpesvirus-8.

Siltuximab may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving siltuximab?

If you have a severe illness with fever or any type of infection, you may need to wait until you get better before receiving this medicine. Tell your doctor if you have recently had any signs of infection (fever, chills, body aches).

Tell your doctor if you have ever had:

• a chronic infection;
• a stomach or intestinal disorder, including ulcer or diverticulitis;
• stomach or intestinal bleeding;
• gout; or
• if you have recently received any vaccines, or if you are due to receive one.

How is siltuximab given?

Siltuximab is given as an infusion into a vein, usually once every 3 weeks. A healthcare provider will give you this injection.

This medicine must be given slowly, and the infusion can take at least 1 hour to complete.

Siltuximab can increase your risk of bleeding or infection. You will need frequent medical tests. Your siltuximab treatments may be delayed based on the results.

What happens if I miss a dose?

What happens if I overdose?

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving siltuximab?

Do not receive a "live" vaccine while using siltuximab. The vaccine may not work as well and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

What are the possible side effects of siltuximab?

Some side effects may occur during the injection. Tell your caregiver right away if you feel nauseated, or have back pain, warmth or redness under your skin, chest pain, pounding heartbeats, fluttering in your chest, or swelling in your face.

• bloody or tarry stools, cough with bloody mucus or vomit that looks like coffee grounds;
• signs of infection, such as fever, chills, painful mouth sores, pain when swallowing, cold or flu symptoms, cough, trouble breathing; or
• signs of a kidney problem --little or no urination; painful or difficult urination; swelling in your feet or ankles; severe pain in your side or lower back.

Common side effects may include:

• weight gain;
• itching or rash;
• cold symptoms such as stuffy nose, sneezing, sore throat; or
• high levels of uric acid in your blood (can lead to kidney problems or gout symptoms such as joint stiffness, pain, or swelling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect siltuximab?

Other drugs may affect siltuximab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your doctor or pharmacist can provide more information about siltuximab.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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