SILTUXIMAB - INJECTION

PHONETIC PRONUNCIATION: (sil-TUX-i-mab)

COMMON BRAND NAME(S): Sylvant

GENERIC NAME(S): siltuximab

Uses

USES: Siltuximab is used to treat a certain rare illness (multicentric Castleman's disease - MCD) if you do not have HIV or herpes infections. Siltuximab blocks a certain natural substance that affects the immune system. Siltuximab can improve the symptoms of MCD including lumps under the skin, fever, weakness or tiredness, or night sweats.

How to use SILTUXIMAB - INJECTION

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using siltuximab and each time you get a refill. If you have any questions, ask your doctor or pharmacist. This medication is given by a health care professional. It is given slowly into a vein as directed by your doctor, usually over 1 hour every 3 weeks. The dosage is based on your weight, medical condition, and response to treatment. Siltuximab may cause side effects (such as trouble breathing, chest pain/discomfort, pounding heartbeat, wheezing, dizziness, flushing, nausea, vomiting, swelling of the lips, or rash) while it is being given. Your doctor may decide to temporarily stop or slow down the medication infusion if this happens during your treatment. Tell your healthcare professional right away if you have any of these symptoms. Your doctor may direct you to take other medications (such as antihistamines, drugs for fever, or corticosteroids such as prednisone) to treat your reaction and before your next treatment(s) to prevent these reactions from happening again. If the reaction is severe, your doctor may stop any further treatment with siltuximab. Use this medication regularly to get the most benefit from it. To help you remember, use it on the same day every 3 weeks. Tell your doctor if your condition gets worse.

Side Effects

SIDE EFFECTS: Dry skin, darkening skin, diarrhea, headache, weight gain, fatigue, constipation, pain in the arms/legs, or joint pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: easy bleeding/bruising, signs of infection (such as sore throat that doesn't go away, fever, chills), stomach/abdominal pain, signs of kidney problems (such as change in the amount of urine). A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: Before taking siltuximab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: active infection, HIV infection, a certain herpes infection (human herpes virus-8), stomach/intestinal problems (such as ulcers). Siltuximab can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details. This product may cause live bacterial vaccines (such as typhoid vaccine) to not work as well. Do not have any immunizations/vaccinations while using this medication unless your doctor tells you to do so. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Tell your doctor if you are pregnant or plan to become pregnant. Siltuximab may harm an unborn baby. Ask about reliable forms of birth control while using this medication and for 3 months after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication. It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

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Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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