Belimumab (Intravenous route)
- Powder for Solution
Uses of This Medicine:
Belimumab injection is used to treat systemic lupus erythematosus (SLE or lupus) in patients who also receive other therapy. It is a monoclonal antibody that changes the immune system to help control lupus symptoms.
This medicine is to be given only by or under the immediate 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:
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.
Appropriate studies have not been performed on the relationship of age to the effects of belimumab injection in children. Safety and efficacy have not been established.
Appropriate studies on the relationship of age to the effects of belimumab have not been performed in the geriatric population. However, no geriatric-specific problems have been documented to date.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
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.
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.
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:
- Depression, history of or
- Mental illness, history of—Use with caution. May make these conditions worse.
- Infection or
- Weak immune system (eg, history of cancer or steroid use)—May decrease your body's ability to fight infection.
- Multiple drug allergy, history of—May increase the risk of having an allergic reaction to belimumab.
Proper Use of This Medicine:
A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.
You may also receive medicines to help prevent allergic reactions to the injection.
This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.
Precautions While Using This Medicine:
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to decide if you should continue to receive it.
You should not receive this medicine if you are also using other biologic therapies or cyclophosphamide (Cytoxan®).
Tell your doctor if you are pregnant or if you plan to become pregnant. Women who could potentially get pregnant must use an effective form of birth control during therapy and for at least 4 months after the last dose.
This medicine may increase your risk of developing infections, including a serious brain infection called progressive multifocal leukoencephalopathy (PML). Avoid being near people who are sick and wash your hands often. Check with your doctor right away if you have a fever, chills, a cough that won't go away, flu-like symptoms, a headache, night sweats, or weight loss. Tell your doctor if you have balance problems, confusion, difficulty talking or walking, dizziness, memory loss, or vision changes.
Using this medicine may increase your risk of getting cancer. Talk to your doctor if you have concerns about this risk.
Belimumab 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 a headache, itching, dizziness, fainting, lightheadedness, nausea, muscle or joint pain, or a rash.
This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have chest pain, hives, itching, a rash, swelling of the face, tongue, and throat, or trouble breathing after you receive the medicine.
This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become depressed. If you or your caregiver notice any of these unwanted effects, tell your doctor right away.
While you are being treated with belimumab, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Belimumab may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.
Side Effects of This Medicine:
- More common
- Bleeding, blistering, burning, coldness, skin discoloration, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- body aches or pain
- chest congestion
- difficulty with breathing or swallowing
- ear congestion
- itching, pain, redness, swelling, tenderness, or warmth of the skin
- joint pain
- loss of appetite
- lower back or side pain
- muscle aches and pains
- nausea or vomiting
- pain or tenderness around the eyes and cheekbones
- swelling of the eyes, face, or inside of the nose
- shortness of breath or trouble breathing
- sore throat
- stuffy or runny nose
- tightness in the chest
- unusual tiredness or weakness
- Less common
- Black, tarry stools
- bloody or cloudy urine
- difficult, burning, or painful urination
- fast heartbeat
- frequent urge to urinate
- sores, ulcers, or white spots on the lips or in the mouth
- swollen glands
- tender, swollen glands in the neck
- unusual bleeding or bruising
- voice changes
- More common
- Arm or leg pain
- headache, severe and throbbing
- unable to sleep
- Less common
- Abdominal or stomach pain
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:
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:
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.
Last Updated: 11/4/2014