Pronunciation: ben-LIST-ah
Generic name: belimumab
Dosage form: single-dose vial for intravenous infusion (120 mg/vial, 400 mg/vial), prefilled syringe for subcutaneous use (200 mg/mL), prefilled autoinjector for subcutaneous use (200 mg/mL)
Drug class: Selective immunosuppressants

Medically reviewed by Carmen Pope, BPharm. Last updated on Nov 9, 2025.

What is Benlysta Used For?

Benlysta is FDA-approved to treat:

• Active systemic lupus erythematosus (SLE) in adults and children 5 years and older receiving standard therapy
• Active lupus nephritis (lupus-related kidney inflammation) in adults and children 5 years and older receiving standard therapy

Important limitation: Benlysta is not recommended for severe active central nervous system lupus because its effectiveness has not been evaluated in this population.

Who Can Take Benlysta?

• Adults with active lupus or lupus nephritis
• Children aged 5 years and older weighing at least 15 kg (33 lb)
• Patients currently receiving other lupus medications (Benlysta is used as add-on therapy).

What Makes Benlysta Different? First FDA-Approved Lupus Treatment in Over 50 years

Benlysta represents a breakthrough in lupus treatment. Approved by the FDA on March 9, 2011, Benlysta is:

• The first new lupus treatment approved in over 50 years
• The first medication specifically designed to target the underlying autoimmune process in lupus
• The only FDA-approved biologic for both systemic lupus erythematosus (SLE) and lupus nephritis

Unlike older treatments borrowed from other diseases, Benlysta was developed specifically for lupus patients, offering a targeted approach that blocks the B-lymphocyte stimulator (BLyS) protein responsible for overactive immune responses.

How Does Benlysta Work?

Targeting the Root Cause of Lupus

In lupus, your immune system mistakenly attacks healthy tissue. Benlysta works by:

1. Blocking the BLyS protein that keeps harmful B-cells alive and active
2. Reducing B-cell survival and decreasing autoantibody production
3. Controlling the overactive immune response that causes lupus symptoms.

The result: Improved symptoms like fatigue and joint pain, reduced lupus flares, and better disease control.

Unlike broad immunosuppressants that affect your entire immune system, Benlysta specifically targets the cells and proteins involved in lupus, offering a more precise treatment approach.

How Is Benlysta Given?

Benlysta offers flexible administration options to fit your lifestyle:

Intravenous (IV) Infusion

Best for: Patients who prefer healthcare facility administration with medical supervision.

• Given by a healthcare provider over 1 hour
• Dosing schedule:
  • Initial: Every 2 weeks for the first 3 doses (loading doses)
  • Maintenance: Every 4 weeks thereafter
• Dose: 10 mg/kg based on your body weight
• May require premedication to prevent infusion reactions.

Subcutaneous (Under-the-Skin) Injection

Best for: Patients who want the convenience of self-administration at home.

For Adults:

• Lupus (SLE): 200 mg once weekly
• Lupus nephritis: 400 mg weekly for 4 weeks, then 200 mg weekly

For Children (5+ years):

• Weight ≥ 40 kg: Same as adult dosing
• Weight 15-40 kg: 200 mg every 2 weeks (or weekly during loading phase for lupus nephritis).

Available as:

• Single-dose autoinjector (for ages 5+)
• Single-dose prefilled syringe (for ages 18+).

How to Give Yourself Benlysta Injections

1. Remove from refrigerator and let reach room temperature for 30 minutes
2. Inject into your stomach (abdomen) or thigh
3. Rotate injection sites
4. Avoid skin that is bruised, tender, red, or hard

Important: Do not use if left at room temperature longer than 12 hours. Each prefilled syringe or autoinjector is for one-time use only.

How Long Does Benlysta Take to Work?

Most patients see improvement within 2-6 months, although individual responses vary:

• As early as 8 weeks: Some patients notice reduced fatigue and joint pain
• 2-6 months: Most patients begin seeing improvements in lupus symptoms
• Up to 12 months: Full benefits may take this long to develop

Important: Continue treatment as prescribed even if you don't see immediate results. Benlysta works gradually to suppress your overactive immune response.

Common Benlysta Side Effects

The most common side effects of Benlysta include:

• Nausea and diarrhea
• Fever 
• Sore throat, runny or stuffy nose (nasopharyngitis)
• Persistent cough (bronchitis)
• Headache (migraine)
• Trouble sleeping (insomnia)
• Pain in arms or legs
• Depression
• Injection site reactions (pain, itching, redness, or swelling).

Note: Hair loss and weight gain are not common side effects of Benlysta.

Related/similar drugs

Serious Side Effects and Warnings

When to Call Your Doctor Immediately

Serious Infections

Benlysta can lower your ability to fight infections. Contact your healthcare provider right away if you have:

• Fever or chills
• Frequent urination or burning with urination
• Coughing up mucus
• Warm, red, or painful skin or sores on your body.

Allergic Reactions

Serious allergic reactions can occur during or after Benlysta treatment. Warning signs include:

• Trouble breathing or wheezing
• Swelling of the face, lips, tongue, or throat
• Widespread skin rash or hives
• Severe dizziness or fainting
• Low blood pressure.

Mental Health Changes

Tell your healthcare provider if you experience:

• New or worsening depression
• Thoughts of suicide or self-harm
• Unusual changes in behavior or mood
• New or worse anxiety
• Trouble sleeping

Progressive Multifocal Leukoencephalopathy (PML)

This rare but serious brain infection can occur. Contact your doctor immediately if you have:

• Memory loss or confusion
• Difficulty talking or walking
• Dizziness or loss of balance
• Vision problems

Cancer Risk

Benlysta may reduce immune system activity, potentially increasing your risk of certain cancers. Discuss your individual risk with your doctor.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before You Start Benlysta

Tell Your Healthcare Provider If You:

• Have an active infection or infections that keep coming back
• Have or have had mental health problems, including depression or suicidal thoughts
• Recently received a vaccination or plan to receive one
• Are receiving other biologic medicines or immunosuppressants
• Have or have had any type of cancer
• Are pregnant, planning to become pregnant, or breastfeeding
• Are allergic to belimumab or any ingredients in Benlysta.

Pregnancy and Breastfeeding

Pregnancy: It is not known if Benlysta will harm your unborn baby. If you:

• If you are planning to become pregnant, discuss risks and benefits with your healthcare provider
• Use effective birth control during treatment and for at least 4 months after your final dose
• Become pregnant while taking Benlysta, enroll in the Benlysta Pregnancy Registry by calling 1-877-311-8972

Breastfeeding: It may not be safe to breastfeed while using Benlysta. Discuss the risks and benefits with your doctor.

What to Avoid While Taking Benlysta

Live Vaccines

Do not receive live vaccines while taking Benlysta. They may not work properly and could cause infection.

Live vaccines to avoid:

• Measles, mumps, rubella (MMR)
• Rotavirus
• Typhoid
• Yellow fever
• Varicella (chickenpox)
• Zoster (shingles)
• Nasal flu vaccine.

Safe vaccines: Inactivated vaccines, such as the flu injection, are generally safe and recommended. Always discuss vaccination plans with your healthcare provider.

Sick Contacts

Avoid close contact with people who are sick or have infections. Your immune system may be weakened while taking Benlysta.

Drug Interactions

Other medications may interact with Benlysta. Tell your doctor about all medicines you take, including:

• Prescription medications
• Over-the-counter medicines
• Vitamins and supplements
• Herbal products
• Vaccinations.

Important: Research does not support using Benlysta with other biologic treatments like rituximab due to increased risk of serious infections and reactions.

What If I Miss a Dose?

Subcutaneous injection: Inject a dose as soon as you remember, then continue your regular schedule or dose based on the new day.

IV infusion: Call your doctor for instructions if you miss an appointment.

Benlysta J Code

Benlysta J code is J0490 (Injection, belimumab, 10 mg).

Storage Instructions

Refrigeration: Store autoinjectors and prefilled syringes at 36°F to 46°F (2°C to 8°C)

Protection: Keep in original carton to protect from light until use

Important:

• Do not freeze
• Do not shake
• Avoid exposure to heat
• Do not use if left at room temperature longer than 12 hours.

Frequently Asked Questions About Benlysta

Is Benlysta a chemotherapy drug?

No. Benlysta is a targeted biologic therapy that specifically blocks the BLyS protein involved in lupus. Unlike chemotherapy drugs that kill rapidly dividing cells throughout the body, Benlysta selectively reduces overactive B-cells without the widespread cellular damage associated with chemotherapy.

What's the difference between IV and subcutaneous Benlysta?

Both forms contain the same active ingredient and are equally effective. The main differences:

IV Infusions:

• Given at a healthcare facility
• Every 2-4 weeks
• Takes about 1 hour
• Medical supervision for reactions.

Subcutaneous Injections:

• Self-administered at home
• Weekly or every 2 weeks
• More flexibility and independence
• Requires comfort with self-injection.

Your doctor will help determine which method is best for your lifestyle and medical needs.

Can I travel while taking Benlysta?

Yes, with proper planning:

For subcutaneous injections:

• Bring enough medication plus extra for delays
• Pack in carry-on luggage with a cooling pack (not frozen)
• Bring a prescription and a doctor's letter
• Research medication import requirements for international destinations.

For IV infusions:

• Coordinate with a healthcare provider to find infusion centers at your destination
• Consider adjusting the dosing schedule around travel dates.

Is financial assistance available?

Yes, several options exist:

• Benlysta Co-pay Program: For eligible patients with commercial insurance (may significantly reduce out-of-pocket costs)
• Patient Assistance Programs: GSK offers programs based on income qualifications for uninsured/underinsured patients
• Lupus Organizations: Many provide grant programs and financial assistance.

Contact GSK patient support: 1-844-4BENLYSTA (1-844-423-6597).

Will Benlysta cure my lupus?

No. Lupus currently has no cure. However, Benlysta can significantly help manage lupus by:

• Reducing disease activity
• Decreasing frequency and severity of flares
• Improving symptoms like fatigue and joint pain
• Potentially slowing organ damage
• Improving quality of life.

Treatment goals focus on achieving remission or low disease activity while minimizing side effects.

Can I drink alcohol while taking Benlysta?

There are no specific restrictions on alcohol with Benlysta. However:

• Other lupus medications (like methotrexate or NSAIDs) may interact with alcohol
• Alcohol can worsen lupus symptoms like fatigue and depression
• Alcohol may impair immune function, increasing infection risk.

Recommendation: Drink in moderation and discuss your alcohol consumption with your healthcare provider.

Product Information

Available Formulations

Intravenous (IV):

• Single-dose vial: 120 mg or 400 mg lyophilized powder for reconstitution

Subcutaneous (SC):

• Prefilled syringe: 200 mg/mL (adults 18+)
• Autoinjector: 200 mg/mL (ages 5+)

Ingredients

Active ingredient: belimumab

Inactive ingredients (IV): citric acid, polysorbate 80, sodium citrate, sucrose

Inactive ingredients (SC): L-arginine hydrochloride, L-histidine, L-histidine monohydrochloride, polysorbate 80, sodium chloride

Manufacturer

GlaxoSmithKline LLC
Philadelphia, PA 19104

Coding Information

Benlysta J Code: J0490 (Injection, belimumab, 10 mg).

Getting Support

BENLYSTA Cares Support Team

The support team can answer general questions about your treatment and provide additional resources.

Phone: 1-877-4-BENLYSTA (1-877-423-6597)
Hours: Monday-Friday, 8 AM to 8 PM ET

The Support Team does not provide medical advice and will direct you to your healthcare provider for disease-, treatment-, or referral-related questions.

Pregnancy Registry

If you become pregnant while taking Benlysta:

Phone: 1-877-311-8972
Website: https://mothertobaby.org/ongoing-study/benlysta-belimumab/

Benlysta Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Benlysta.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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