Pronunciation:

sil-TUX-i-mab

Brand Names:

• Sylvant

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

Siltuximab injection is used to treat a rare blood disorder called multicentric Castleman's disease (MCD). This medicine is used in patients who do not have human immunodeficiency virus (HIV) and human herpes virus-8 (HHV-8) infection.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of siltuximab injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of siltuximab injection in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Infection, severe—May decrease your body's ability to fight infection. It must be treated first before receiving this medicine.

• Stomach or bowel problems (eg, diverticulitis, ulcers)—Use with caution. May increase risk for stomach or bowel perforation (tear or hole).

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed into one of your veins. It must be injected slowly, so the needle will need to stay in place for at least 1 hour every 3 weeks.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Tell your doctor if you are pregnant or planning to become pregnant. You must use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for 3 months after the last dose.

Your body's ability to fight infections may be reduced while you are receiving siltuximab. It is very important that you call your doctor at the first sign of any infection. Check with your doctor right away if you have any of the following symptoms while receiving this medicine: a fever, chills, cough, flu-like symptoms, or unusual tiredness or weakness.

While you are being treated with siltuximab, do not have any immunizations (vaccines) without your doctor's approval. Live virus vaccines should not be given with this medicine or soon after you receive it.

This medicine may cause a serious allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, trouble breathing or swallowing, or any swelling of your hands, face, or mouth while you are receiving this medicine.

Siltuximab may cause an infusion reaction while you are receiving it or right after the infusion ends. Check with your doctor or nurse right away if you have back pain, chest pain or discomfort, fast or uneven heartbeat, nausea or vomiting, trouble breathing, or redness of the face, neck, arms, and upper chest.

This medicine may increase your risk for stomach or bowel perforation. Tell your doctor right away if you have any of the following symptoms: severe abdominal or stomach pain or cramps, bloody, black, or tarry stools, or vomiting of material that looks like coffee grounds.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Black, tarry stools

bleeding gums

bloating or swelling of the face, arms, hands, lower legs, or feet

bloody urine

blurred vision

body aches or pain

chills

confusion

cough

decreased frequency or amount of urine

difficulty with breathing

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

ear congestion

fever

full or bloated feeling

headache

increased thirst

loss of appetite

loss of voice

lower back or side pain

nasal congestion

nausea

pinpoint red spots on the skin

pressure in the stomach

rapid weight gain

runny nose

sneezing

sore throat

stomach pain

sweating

swelling of the abdominal or stomach area

tingling of the hands or feet

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain or loss

vomiting

Less common

Back pain

chest pain or discomfort

dizziness

dry mouth

fainting

fast, irregular, pounding, or racing heartbeat or pulse

feeling of warmth

flushing or redness of the skin

lightheadedness

rapid breathing

redness of the face, neck, arms, and occasionally, upper chest

sunken eyes

unusually warm skin

wrinkled skin

Rare

Difficulty with swallowing

hives, itching, or skin rash

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

tightness in the chest

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Difficulty having a bowel movement

difficulty with moving

joint pain, stiffness, or swelling

muscle pain or stiffness

rash with flat lesions or small raised lesions on the skin

Less common

Darkening of the skin

decreased appetite

dry skin

skin rash, encrusted, scaly, and oozing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.