Description
Belimumab injection is used to treat active, autoantibody-positive, systemic lupus erythematosus (SLE) and active lupus nephritis in patients who are also receiving other lupus treatments. It is a monoclonal antibody that changes the immune system to help control lupus symptoms.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Solution
- 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 belimumab injection to treat systemic lupus erythematosus and lupus nephritis, given as a needle placed into one of the veins in children younger than 5 years of age and to treat lupus nephritis in children and systemic lupus erythematosus in children younger than 5 years of age, given as a shot under the skin. 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 belimumab injection in the elderly. However, elderly patients may require caution when receiving this medicine.
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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Rituximab
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:
- Cancer, history of or
- 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
A nurse or other trained health professional will give you this medicine in a medical facility. It is given through an IV catheter that is placed into one of your veins or as a shot under your skin, usually in the stomach or thighs. You or your caregiver may be trained to prepare and inject this medicine at home. Be sure that you understand how to use the medicine.
If this medicine is given through a vein in your arm, it must be injected by your doctor slowly and your IV will need to stay in place for 1 hour.
If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections. Do not inject into skin areas that are tender, red, bruised, or hard.
This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
This medicine is available in three forms: a vial (glass container), a prefilled syringe, or an autoinjector. The prefilled syringe and autoinjector are the dosage forms you can use at home.
Check the liquid in the prefilled syringe or autoinjector. It should be colorless or slightly yellow. Do not use the medicine if the liquid is cloudy, discolored, or has particles in it. Do not shake.
Allow the medicine to warm to room temperature for 30 minutes before you use it. Do not warm it in any other way.
Do not remove the needle cap from the prefilled syringe or the ring cap from the autoinjector until you are ready to use it.
You might not use all of the medicine in each prefilled syringe or autoinjector. Use each prefilled syringe and autoinjector only one time. Do not save an open syringe or autoinjector.
You may also receive other medicines to help prevent allergic reactions from the injection.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For injection dosage form (solution):
- For systemic lupus erythematosus:
- Adults and children 5 to less than 18 years of age weighing 40 kilograms (kg) or more—200 milligrams (mg) injected under your skin once a week, preferably on the same day each week.
- Children 5 to less than 18 years of age weighing 15 kg to less than 40 kg—200 mg injected under the skin once every 2 weeks, preferably on the same day every 2 weeks.
- Children younger than 5 years of age and weighing less than 15 kg—Should not be used in this age group.
- For lupus nephritis:
- Adults—At first, 400 milligrams (mg) (two 200-mg injections) injected under your skin once a week for 4 doses, then 200 milligrams once a week, preferably on the same day each week.
- Children—Should not be used in this age group.
- For systemic lupus erythematosus:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store in the refrigerator. Do not freeze.
Store this medicine in its original container until you are ready to use it. Keep it refrigerated until 30 minutes before use. Do not use and do not place this medicine back in the refrigerator if it has been left out for more than 12 hours.
Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
Precautions
It is very important that your doctor check your or your child's progress closely and at regular visits to make sure this medicine is working properly and to decide if you should continue to receive it. Blood and urine tests may be needed to check for unwanted effects.
You should not receive this medicine if you are also using other biologic treatments or cyclophosphamide (Cytoxan®). Using these medicines together may increase your chance for more serious side effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control during treatment and for at least 4 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.
This medicine may cause serious infections (eg, pneumonia, urinary tract infections, cellulitis, and bronchitis). Check with your doctor right away if you have bladder pain, bloody or cloudy urine, chest pain, cough, cough producing mucus, difficult, burning, or painful urination, fever or chills, frequent urge to urinate, itching, pain, redness, swelling, tenderness, or warmth of the skin, lower back or side pain, sneezing, sore throat, trouble breathing, or tightness in the chest.
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 infusion reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness or fainting, after receiving this medicine.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this 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. Also tell your doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these unwanted effects, tell your doctor right away.
While you are being treated with belimumab, and 30 days before starting 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 are receiving 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.
Tell your doctor if you are African-American or have African ancestry. This medicine may not work the same way and may require caution in African-American patients receiving belimumab. Talk to your doctor if you have concerns.
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 immediately if any of the following side effects occur:
More common
- Bladder pain
- 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
- bloody or cloudy urine
- body aches or pain
- chest pain or tightness
- chills
- cough
- cough producing mucus
- diarrhea
- difficult, burning, or painful urination
- difficulty with breathing or swallowing
- dizziness
- ear congestion
- fever
- frequent urge to urinate
- headache, severe and throbbing
- hives, skin rash
- 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
- pain or tenderness around the eyes and cheekbones
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- sneezing
- sore throat
- stuffy or runny nose
- sweating
- swelling of the eyes, face, or inside of the nose
- trouble breathing
- unusual tiredness or weakness
- vomiting
Less common
- Black, tarry stools
- blood in the urine or stools
- discouragement
- fast heartbeat
- feeling sad or empty
- hoarseness
- irritability
- loss of interest or pleasure
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- sores, ulcers, or white spots on the lips or in the mouth
- tender, swollen glands in the neck
- trouble concentrating
- trouble sleeping
- unusual bleeding or bruising
- voice changes
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
- Arm or leg pain
Less common
- Stomach pain
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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