Benlysta
Benlysta (belimumab) is a monoclonal antibody, specifically known as a BLyS-specific inhibitor. It's used as an add-on to other medications to treat systemic lupus erythematosus (SLE) and lupus nephritis in adults and children. Benlysta (belimumab) can be given two different ways: either once per week as a self-injection under the skin (subcutaneous, SC) or as an injection into your vein (intravenous, IV) once per month (after the first few doses) by a healthcare professional. Common side effects include nausea, diarrhea, and fever.
What is Benlysta (belimumab)?
What is Benlysta (belimumab) used for?
- Add-on treatment for systemic lupus erythematosus (SLE) in people ages 5 years and older
- Add-on treatment for lupus nephritis (kidney damage related to SLE) in people ages 5 years and older
How Benlysta (belimumab) works
Benlysta (belimumab) is a type of biologic medication called a B-lymphocyte stimulator (BLyS)-specific inhibitor. It lowers the activity of B cells in the immune system by stopping a protein called BLyS from working. This can help lower inflammation.
Drug facts
Side effects of Benlysta (belimumab)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Nausea (15%)
- Diarrhea (12%)
- Fever (10%)
- Common cold (9%)
- Bronchitis (9%)
- Difficulty sleeping (7%)
- Pain in arms or legs (6%)
- Depression (5%)
- Migraine (5%)
- Sore throat (5%)
Note: Side effects listed were reported by people who received Benlysta IV injection for SLE. People who received SC injection experienced similar side effects.
Less Common Side Effects
- Reactions at the injection site (pain, redness, itching; for SC injection only)
- Bladder infection or urinary tract infection (UTI)
- Stomach flu
Benlysta (belimumab) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Severe infection: confusion, fever, difficulty breathing, weakness, cough, sweating, chills, stomach pain, diarrhea, burning sensation when you urinate
- Serious allergic reaction: difficulty breathing, hives, itching, fast heartbeat, tightness in the throat, nausea, stomach pain, dizziness, lightheadedness, swelling in the face or tongue
- Depression and thoughts or behaviors related to harming yourself
The following Benlysta (belimumab) side effects have also been reported
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 producing mucus
difficult, burning, or painful urination
difficulty with breathing or swallowing
dizziness
ear congestion
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
pain or tenderness around the eyes and cheekbones
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
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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Pros and cons of Benlysta (belimumab)
Pros
- Available as an SC and IV injection
- SC injection comes as a prefilled syringe or an autoinjector for easier use
- Only needs to be injected once per week when given SC
- If needed, SC injection can be stored at room temperature for up to 12 hours
Cons
- SC injection might be difficult for some people to administer correctly
- Only approved for use as an add-on to standard therapy
- Doesn't cure SLE or lupus nephritis
- Brand-name only, not available as a generic
Pharmacist tips for Benlysta (belimumab)
- Mark your calendar with your appointments to see your prescriber, especially if you're receiving Benlysta (belimumab) as an IV infusion. Also make sure to mark any appointments to get any blood work done. This will make sure you don't miss any doses, will help you and your healthcare provider (HCP) see how well Benlysta (belimumab) is working for you, and if you're having side effects.
- If you're receiving Benlysta (belimumab) as an IV infusion, it typically takes about 1 hour to receive the full dose.
- Benlysta (belimumab) can raise your risk of getting a serious or life-threatening infection. Get medical help right away if you develop symptoms of an infection (e.g., fever, cough, difficulty breathing, diarrhea, weakness, sweating, chills) while you're taking Benlysta (belimumab). You might have to stop taking Benlysta (belimumab) so your body can fight and fully recover from the infection.
- Tell your HCP or pharmacist that you're taking Benlysta (belimumab) before receiving any vaccines. This is because you shouldn't receive live vaccines, because it's not known if Benlysta (belimumab) affects your immune system and raises your risk of infection from the vaccine.
- Let your prescriber know if you're pregnant or nursing. There isn't enough information to know how safe Benlysta (belimumab) is for you and your baby during pregnancy and breastfeeding. Your healthcare team can talk with you about the risks and benefits of continuing treatment during this time.
- Your prescriber might recommend that you avoid getting pregnant after starting Benlysta (belimumab). If so, use effective birth control while taking Benlysta (belimumab) and for at least 4 months after your last dose.
How to give Benlysta (belimumab) SC injections at home
- The SC form of Benlysta (belimumab) comes as 200-mg prefilled syringes or autoinjectors. If your dose is 400 mg, you'll need to give yourself two 200-mg injections.
- Keep Benlysta (belimumab) in the original carton to protect it from light. Place the cartons in the refrigerator. Once out of the refrigerator, you can keep the medication at room temperature for up to 12 hours. Once it's been out at room temperature, don't place the medication back in the refrigerator.
- Before it's time for your dose of Benlysta (belimumab), take the medication out of the refrigerator, and lay it on a flat surface to warm up. This will take about 30 minutes. Don't try to warm up the medication any other way.
- Look at the medication liquid to make sure it's clear to opalescent and colorless to pale yellow. It also might have some air bubbles in it, which is normal. But it shouldn't have any particles (solid chunks) floating around in it. Don't use Benlysta (belimumab) if the liquid is cloudy, discolored, or has particles (solid. Instead, call your care team for a replacement.
- For the Benlysta (belimumab) prefilled syringe: Hold the syringe and insert the needle into a pinched area of the skin at a 45-degree angle using a dart-like motion.
- For the Benlysta (belimumab) autoinjector: Hold the autoinjector at a 90-degree angle and make sure the gold needle guard is flat on the skin. Make sure you can clearly see the inspection window. The purple indicator inside the inspection window should move while you're injecting, and will stop once the dose is complete.
- Inject Benlysta (belimumab) under the skin of your upper thighs or stomach into the fat tissue between your skin and muscle. If you're injecting it into your stomach, make sure it's at least 2 inches away from your belly button. Don't inject into your muscle or vein; it's not meant to be used this way.
- To lower the risk of bruising and irritation, don't inject Benlysta (belimumab) into the same area of skin twice in a row or in skin that's tender, bruised, red, or hard.
- After injecting Benlysta (belimumab), throw away the autoinjector or prefilled syringe in a sharps container or something made of heavy-duty plastic, such as an empty milk carton or laundry detergent bottle. This helps lower the risk of needle-stick injuries. Don't throw away needles or syringes in your trash can. For guidance on how to throw away your sharps container safely for your specific state, visit the FDA's website.
Common questions about Benlysta (belimumab)
No, Benlysta (belimumab) isn't chemotherapy. But rather, it's biologic medication known as a monoclonal antibody. Chemotherapies are medications typically used to treat cancer; they work by killing fast-growing cells, such as cancer cells.
Is Benlysta (belimumab) an immunosuppressant?
How long does it take for Benlysta (belimumab) to work?
How long do Benlysta (belimumab) side effects last?
Does Benlysta (belimumab) cause weight gain?
Why does Benlysta (belimumab) cause depression?
Does Benlysta (belimumab) cause fatigue?
Does Benlysta (belimumab) cause hair loss?
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Risks and warnings for Benlysta (belimumab)
Benlysta (belimumab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Serious infections
- Risk factors: Severe infection | Long-term or recurrent infection | Other conditions that raise your risk of infection | Taking medications that weaken your immune system
Benlysta (belimumab) can affect your body's ability to fight off infections. This can raise your risk of serious and sometimes life-threatening infections. The most common serious infections seen with using Benlysta (belimumab) were pneumonia, UTIs, and bronchitis. Tell your care team about your medical conditions and medications so they can make sure Benlysta (belimumab) is safe for you. If you develop symptoms of an infection (e.g., confusion, fever, cough, difficulty breathing, weakness, sweating, chills) while taking Benlysta (belimumab), get immediate medical care right away. You might have to stop taking Benlysta (belimumab) so your body can fight the infection.
Benlysta (belimumab) can also put you at risk of getting progressive multifocal leukoencephalopathy (PML). This is a brain infection caused by the John Cummingham virus (JCV). Though it's a common virus, people who get infected with JCV usually don't experience any symptoms. But in people who have a weakened immune system, JCV can cause PML, which can lead to death or severe disability. Seek medical attention right away and get tested for PML if you experience weakness on one side of the body, feel clumsy, or changes in personality, vision, or memory.
Serious allergic reactions
- Risk factors: Receiving Benlysta (belimumab) as an IV infusion
Serious allergic reactions to Benlysta (belimumab) are possible, including life-threatening reactions like anaphylaxis (closing of the throat). And when given IV, Benlysta (belimumab) can trigger symptoms of infusion-related reactions, including rash, hives, and trouble breathing. These reactions are more common within hours after the infusion. But some people have reported allergic reactions up to a week after their latest infusion.
To prevent these reactions, your healthcare professional (HCP) might give you pre-medications right before you receive your IV infusion. If you get any signs of infusion-related reactions or notice dizziness, a choking sensation, sweating, nausea, swelling around your eyes, swelling of the lips or tongue, or difficulty breathing after using Benlysta (belimumab), get medical attention right away.
Depression and thoughts of suicide
- Risk factors: History of depression or other mental health condition
People who received Benlysta (belimumab) in clinical studies reported depression and thoughts of harming yourself or others. This can happen to anyone taking Benlysta (belimumab). Let your prescriber know if you or your loved ones notice a change in your mood or behavior, or if you have thoughts of hurting yourself while taking Benlysta (belimumab). Depending on how severe your symptoms are, your prescriber might have you stop taking the medication.
Avoid live vaccines
Avoid live vaccines 30 days before and during treatment with Benlysta (belimumab) because it's not known if they're safe while using this medication. In addition, since Benlysta (belimumab) works on your immune system, the medication can affect how your body responds to these vaccines. Examples of live vaccines include the nasal spray version (FluMist) of the flu vaccine, the Varivax (varicella) vaccine for chickenpox, and the MMR (measles, mumps, rubella) vaccine. Before starting Benlysta (belimumab), you should be up-to-date with all of your vaccinations. Let your healthcare professional (HCP) or pharmacist know that you're taking Benlysta (belimumab) before you receive any vaccines.
Benlysta (belimumab) dosage
Autoinjector| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 200mg/ml | 4 autoinjectors | $4,938.15 | $1,234.54 |
Carton| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 4 autoinjectors of 200mg/ml | 1 carton | $4,938.15 | $4,938.15 |
| 4 prefilled syringes of 200mg/ml | 1 carton | $4,938.15 | $4,938.15 |
Syringe| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 200mg/ml | 4 syringes | $4,938.15 | $1,234.54 |
Typical dosage for Benlysta (belimumab)
Your healthcare team will determine your dose based on what condition you’re receiving Benlysta (belimumab) for, how you're injecting this medication (under the skin or through the veins), your age, and your body weight.
Subcutaneous (SC) injection:
-
Age 18 years and older:
- SLE:
- The typical dose is 200 mg injected under the skin once per week.
- Lupus nephritis:
- The typical dose is 400 mg injected under the skin once per week for 4 doses. After 4 doses, the dose will be 200 mg once per week.
- SLE:
-
Ages 5 to under 18 years:
- SLE:
- At least 40 kg (88 pounds): The typical dose is 200 mg injected under the skin once per week.
- 15 kg (33 lbs) to under 40 kg (88 lbs): The typical dose is 200 mg injected under the skin every 2 weeks.
- Lupus nephritis: Don't use. Under-the-skin injections of Benlysta (belimumab) haven't been studied in children under 18 years for lupus nephritis.
- SLE:
Intravenous (IV) injection:
- Ages 5 years and older:
- SLE and lupus nephritis:
- The typical dose is 10 mg/kg injected into your vein every 2 weeks for 3 doses. After 3 doses, the dose will be given every 4 weeks. The dose will be prepared and administered by a healthcare professional (HCP).
- SLE and lupus nephritis:
Interactions between Benlysta (belimumab) and other drugs
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.
- Tofacitinib
How much does Benlysta (belimumab) cost?
$4,938.15
What are alternatives to Benlysta (belimumab)?
