Description
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.
This product is available in the following dosage forms:
- Powder for Solution
Before Using
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.
Pediatric
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.
Geriatric
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.
Breastfeeding
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.
Drug Interactions
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
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
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
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.
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