Benlysta

Benlysta is an add-on therapy used to treat active systemic lupus erythematosus (SLE) or lupus nephritis (LN) in adults and children 5 years and older (weight ≥ 15 kg) already taking other lupus medicines. Benlysta (belimumab) is administered intravenously by a healthcare provider or self-administered subcutaneously.

• Not recommended for severe active central nervous system lupus because it has not been evaluated in this population.
• It is not known if Benlysta is safe or effective in children under 5 years of age or in children weighing less than 33 lbs when given under the skin.

Benlysta works by blocking the BLyS protein, which helps B cells survive and produce harmful autoantibodies in autoimmune diseases such as lupus and lupus nephritis.

Benlysta (belimumab) first gained FDA approval on March 9, 2011. There is no generic or biosimilar.

Benlysta is given intravenously by a healthcare provider or subcutaneously self-administered or administered by a caregiver or healthcare provider using a prefilled syringe or autoinjector.

When Given in a Vein (Intravenously)

• You will be given Benlysta by a healthcare provider through a needle placed in a vein (IV infusion).
• It takes about 1 hour to give you the full dose of Benlysta.
• Your healthcare provider will tell you how often you should receive Benlysta.
• Your healthcare provider may give you medicines before you receive Benlysta to help reduce your chance of having a reaction. A healthcare provider will watch you closely while you are receiving Benlysta and after your infusion for signs of a reaction. A healthcare provider will review the signs and symptoms of possible allergic reactions that could happen after your infusion.

When Given Under The Skin (Subcutaneously)

Your healthcare provider will tell you how often and how much of Benlysta you should use. Use Benlysta exactly as your healthcare provider tells you to.

• Read the Instructions for Use that come with your medicine about the right way to give Benlysta injections at home.

Benlysta may be prescribed as a single-dose autoinjector or as a single-dose prefilled syringe.

• The single-dose autoinjector is for use in adults and children 5 years of age and older.
• The single-dose prefilled syringe is for use in adults 18 years of age and older.
• Before you use Benlysta, your healthcare provider will show you or your caregiver how to give the injections and review the signs and symptoms of possible allergic reactions.
• For children under 10 years of age, Benlysta must be given by a healthcare provider or a trained caregiver.

Benlysta is injected under the skin (subcutaneously) of your stomach or thigh.

• Use Benlysta on the same day each week or the same day every 2 weeks, as your healthcare provider tells you.
• Rotate injection sites
• Avoid skin that is bruised, tender, red, or hard.

Immunosuppressive agents, including Benlysta, can cause serious side effects. Some of these side effects may cause death. The following are serious adverse reactions that have occurred in patients receiving Benlysta:

• Infections. Infections, some of which may be serious or severe and lead to hospitalization or death, may occur with Benlysta (belimumab). Tell your healthcare provider right away if you have any of the following symptoms of an infection: Fever Urinating often Chills Coughing up mucus Pain or burning with urination Warm, red, or painful skin or sores on your body.
• Allergic (Hypersensitivity) Reactions. Serious allergic reactions, including anaphylaxis and infusion-related reactions, can happen on the day of, or in the days after, receiving Benlysta and may cause death. Your healthcare provider will watch you closely while you are receiving Benlysta intravenously and after your infusion for signs of a reaction. Allergic reactions can sometimes be delayed. Tell your healthcare provider right away if you have any of the following symptoms of an allergic reaction following use of Benlysta: Itching Swelling of the face, lips, mouth, tongue, or throat Trouble breathing Anxiousness Low blood pressure Dizziness or fainting Headache Nausea Skin rash.
• Mental Health Problems and Suicide. Symptoms of mental health problems can occur with Benlysta. Tell your healthcare provider right away if you have any of the following symptoms: Thoughts of suicide or dying Attempt to commit suicide Trouble sleeping (insomnia) New or worse anxiety New or worse depression Acting on dangerous impulses Other unusual changes in your behavior or mood Thoughts of hurting yourself or others.
• Severe Skin Reactions. Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, can occur with Benlysta. Stop using Benlysta right away and tell your healthcare provider if you develop a painful rash, widespread skin peeling or blistering, or ulcers in the eyes, nose, mouth, throat, or genitals.

Do not receive Benlysta if you are allergic to belimumab, Benlysta, or any of the inactive ingredients in the formulation you are using, or if you have had Stevens-Johnson syndrome or toxic epidermal necrolysis with Benlysta.

Before you receive Benlysta, tell your healthcare provider about all of your medical conditions, including if you:

• Think you have an infection or have infections that keep coming back. You should not receive Benlysta if you have an infection unless your healthcare provider tells you to.
• Have or have had mental health problems such as depression or thoughts of suicide
• Have recently received a vaccination, or if you think you may need a vaccination. If you are receiving Benlysta, you should not receive live vaccines
• Are allergic to other medicines
• Are receiving other biologic medicines or monoclonal antibodies
• Have or have had any type of cancer
• Are pregnant or planning to become pregnant
• Are breastfeeding or plan to breastfeed.

Pregnancy

It is not known if Benlysta will harm an unborn baby. You should talk to your healthcare provider about whether to prevent pregnancy while on Benlysta.

If you choose to prevent pregnancy, you should use an effective method of birth control while receiving Benlysta and for at least 4 months after the final dose of Benlysta.

• Tell your healthcare provider right away if you become pregnant during your treatment with Benlysta or if you think you may be pregnant.
• If you become pregnant while receiving Benlysta, talk to your healthcare provider about enrolling in the Benlysta Pregnancy Registry.
• You can enroll in this registry by calling 1-877-311-8972 or going to https://mothertobaby.org/ongoing-study/benlysta-belimumab/
• The purpose of this registry is to collect information about the health of you and your baby.

Breastfeeding

It is not known if Benlysta passes into your breast milk. You and your healthcare provider should talk about whether or not you should receive Benlysta and breastfeed.

Common side effects

The most common side effects of Benlysta are:

• Nausea
• Diarrhea
• Fever
• Stuffy or runny nose and sore throat (nasopharyngitis)
• Persistent cough (bronchitis)
• Trouble sleeping (insomnia)
• Leg or arm pain
• Depression
• Headache (migraine)
• Pain, redness, itching, or swelling at the injection site (when given subcutaneously).

Serious side effects

In addition to the serious side effects listed in Important Information above, Benlysta may cause the following other serious side effects.

• Progressive multifocal leukoencephalopathy (PML). PML is a serious and life-threatening brain infection. Your chance of getting PML may be higher if you are treated with medicines that weaken your immune system, including Benlysta. PML can result in death or severe disability. If you notice any new or worsening medical problems such as those below, tell your healthcare provider right away: Memory loss Trouble thinking Dizziness or loss of balance Difficulty talking or walking Loss of vision.
• Cancer. Benlysta may reduce the activity of your immune system. Medicines that affect the immune system may increase your risk of certain cancers.

These are not all the possible side effects of Benlysta. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Benlysta (belimumab) works by targeting and blocking BLyS (B-Lymphocyte Stimulator), a protein that helps B cells survive and produce antibodies. By inhibiting BLyS, Benlysta reduces overactive B cells that create harmful autoantibodies in autoimmune diseases like lupus and lupus nephritis.

Benlysta belongs to the drug class called BLyS-specific inhibitors.

The cost of Benlysta depends on your insurance plan and eligibility.

The Benlysta Copay program helps eligible commercially insured patients with their eligible out-of-pocket costs for Benlysta (annual maximums apply), see GSKCopayPrograms.com

Also, see Benlysta Prices, Coupons, Copay Cards & Patient Assistance for more information.

Intravenous Dose of Benlysta for Active Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN)

• 10 mg/kg intravenously at 2-week intervals for the first 3 doses and then at 4-week intervals thereafter.
• Reconstitute, dilute, and administer as an intravenous infusion over 1 hour.
• Consider prophylactic premedications for infusion reactions and hypersensitivity reactions.

Subcutaneous Dose of Benlysta for Active SLE or Lupus Nephritis

Active SLE:

• Adults: 200 mg subcutaneously once weekly by autoinjector or prefilled syringe
• Pediatric patients 5+ (≥40 kg): 200 mg subcutaneously once weekly by autoinjector
• Pediatric patients 5+ (15 kg to <40 kg): 200 mg subcutaneously once every 2 weeks by autoinjector.

Active Lupus Nephritis:

• Adults: 400 mg subcutaneously once weekly for 4 doses, followed by 200 mg subcutaneously once weekly
• Pediatric patients 5+ (≥40 kg): 400 mg subcutaneously once weekly for 4 doses, followed by 200 mg subcutaneously once weekly using an autoinjector
• Pediatric patients 5+ (15 kg to <40 kg): 200 mg subcutaneously once weekly for 4 doses, then 200 mg subcutaneously once every 2 weeks using an autoinjector.

Note: The 400 mg dose requires two 200 mg injections. Prefilled syringes have not been studied in children under 18 years.

If you miss your subcutaneous dose of Benlysta on your planned day, inject a dose as soon as you remember.

• Then, inject your next dose at your regularly scheduled time or continue dosing based on the new day injected. In case you are not sure when to inject Benlysta, call your healthcare provider.

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

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

No formal drug interaction studies have been done for Benlysta. However, in clinical trials, it was administered concomitantly with other drugs such as corticosteroids, antimalarials, immunosuppressants (like azathioprine, methotrexate), blood pressure drugs, statins, and NSAIDs, without a clinically meaningful effect on Benlysta pharmacokinetics.

However, there may be additive clinical effects (such as immunosuppression).

Know the medicines you take. Keep a list of your medicines with you to show to your healthcare provider andpharmacist when you get a new medicine.

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

• Store autoinjectors and prefilled syringes in the refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze.
• Keep Benlysta autoinjectors and prefilled syringes in the original package until time of use to protect from light.
• Do not shake. Keep away from heat and sunlight.
• Do not use and do not return back to the refrigerator if left out at room temperature for more than 12 hours.
• Safely throw away medicine that is out of date or no longer needed.

Keep out of the reach of children.

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

Available as:

• Intravenous (IV): Single-dose vial: 120 mg or 400 mg lyophilized powder for reconstitution
• Subcutaneous (SC): Prefilled syringe: 200 mg/mL (adults 18+) and autoinjector: 200 mg/mL (ages 5+)

Benlysta is manufactured by GlaxoSmithKline LLC, Philadelphia, PA 19104.