| Common Brands | Benlysta |
|---|---|
|
Drug Class |
BLyS-specific inhibitor |
|
Controlled Substance Classification |
Not a controlled medication |
|
Generic Status |
No Lower-cost generic available |
|
Availability |
Prescription only |
Benlysta (generic name: belimumab) is a monoclonal antibody drug that is given to patients suffering from systemic lupus erythematosus (SLE). SLE is a chronic autoimmune disease in which the immune system attacks the tissues and organs of the body. Benlysta was the first drug approved by the FDA for the specific treatment of SLE over the past 50 years. Benlysta works by targeting and inhibiting a protein called B-lymphocyte stimulator, which is crucial in the survival of B cells. This action of the drug helps to interfere with this protein and reduce the activity of the immune system, thereby reducing inflammation and damage caused by lupus.
Approved in 2011, Benlysta is used in combination with other medications to manage moderate to severe SLE in adult patients. It has also been approved for use in children aged 5 years and older with lupus.
Benlysta is provided in two forms of administration: intravenous (IV) infusion and subcutaneous (SC) injection.
Intravenous Infusion: When given intravenously, Benlysta is administered by a healthcare professional in a clinic or hospital setting. The infusion is usually given over a period of an hour. The initial dosing schedule involves an infusion every two weeks for the first three doses, followed by once monthly thereafter. This schedule may be adjusted based on the patient’s response and clinical needs.
Benlysta is also available as a self-administered subcutaneous injection. Patients who are stable and have been trained by their health care provider can administer the medication at home. The usual dose is 200 mg administered once a week.
Both ways of administration are effective in the treatment of lupus symptoms, and the choice between them depends on the patient’s preference and how well he or she tolerates the infusion.
The mechanism of action of Benlysta is its binding to the B-lymphocyte stimulator, which is a protein critical for the survival and differentiation of B cells. In SLE, an increased level of BLyS contributes to the survival of autoreactive B cells, which in turn produce autoantibodies that attack the body’s tissues. Benlysta prevents BLyS from interacting with B cells because it binds to BLyS.
Therefore, the attack of B cells is restrained, and the production of autoantibodies is reduced with a decrease in the attack of the immune system to the body’s own tissues. This process reduces inflammation and prevents further damage of organs and tissues, usually affected by lupus such as the kidneys, skin, joints, and heart.
While Benlysta is usually well tolerated, it may cause side effects. The most common side effects include:
Infusion-related reactions (for IV administration): These may include fever, chills, nausea, and headaches. Reactions typically occur during the infusion and usually resolve once the infusion is completed.
Infections: Because Benlysta modulates the immune system, it may increase the risk of infections, including upper respiratory infections, sinusitis, and urinary tract infections.
Headache: Most common side effect, typically during the initial stages of therapy.
Diarrhea: Patients may experience gastrointestinal side effects such as diarrhea.
Nausea: Nausea is another common side effect, especially after infusion.
Fatigue: Patient may feel tired, but it is more common when the treatment is initiated.
Infections: As Benlysta can compromise the immune system, patients must be observed for signs of infection. Patients should seek medical attention if they notice new symptoms of infection such as fever, chills, or cough.
Mental Health: Benlysta was associated with a heightened tendency of mood changes such as depression and suicidal thoughts. Patients receiving Benlysta should be observed for changes in moods or behaviors, primarily at the beginning of their treatment.
Vaccinations: Patients starting treatment under Benlysta should first be vaccinated up to live vaccines. Live vaccines tend to be interfered by Benlysta.
Pregnancy and Breastfeeding: Benlysta is indicated as Category C for pregnancy. Thus, it should only be employed if the potential benefit to the patient justifies the potential risk to the fetus. It is unknown if Benlysta passes into the breast milk; hence, breastfeeding mothers should consult their healthcare provider before taking the drug.
Immunosuppressants: Combining Benlysta with other immunosuppressive drugs may increase the risk of infections due to a weakened immune system, requiring close monitoring.
Vaccines: Benlysta may reduce the effectiveness of live vaccines, so it’s important to avoid receiving live vaccines during treatment and consult your doctor before any vaccinations.
Biologic Drugs: Using Benlysta with other biologic therapies may increase the risk of serious infections or adverse effects, requiring careful supervision by a healthcare provider.
Anticoagulants: Benlysta may interact with blood thinners, increasing the risk of bleeding or bruising.
Adults with lupus: Recommended dosage:
IV Infusion: 10 mg/kg every two weeks for the first three doses, then once a month thereafter.
Subcutaneous Injection: The recommended dose is 200 mg once a week.
For pediatric patients (ages 5 and older), the dosage is based on body weight and will be determined by the prescribing doctor.
Benlysta is a prescription medication. Therefore, only after getting a prescription from a doctor is it possible to receive it. A confirmed diagnosis of systemic lupus erythematosus should occur prior to treatment.
Before administering the drug, all infections, mental conditions, and kidney functions in a patient’s medical history need to be evaluated carefully.
What is Benlysta?
Benlysta (belimumab) is a prescription medication used to treat systemic lupus erythematosus (SLE), a chronic autoimmune disease.
How does Benlysta work?
Benlysta works by inhibiting the function of a specific protein (BLyS) that is involved in the survival of B cells, which are responsible for producing antibodies that can attack healthy tissues in lupus.
What is the recommended dosage of Benlysta?
The typical starting dosage for adults is 10 mg/kg administered intravenously every two weeks for the first three doses, then once every four weeks thereafter. There is also a subcutaneous formulation available.
Can Benlysta be used in children?
Yes, Benlysta is FDA-approved for use in children aged 5 and older with lupus, but the safety and efficacy should be evaluated by a healthcare provider.
What are the common side effects of Benlysta?
Common side effects may include nausea, diarrhea, fever, and infusion-related reactions, such as headaches and rash.
Are there any serious side effects associated with Benlysta?
Serious side effects can include infections, allergic reactions, and mood changes, including depression and suicidal thoughts.
How is Benlysta administered?
Benlysta can be administered either as an intravenous infusion in a healthcare setting or as a subcutaneous injection that patients can self-administer.
Is Benlysta safe during pregnancy or breastfeeding?
Benlysta should be used during pregnancy only if the potential benefit justifies the potential risk. It is not known if it is excreted in breast milk, so caution is advised.
What should I do if I miss a dose of Benlysta?
If you miss a scheduled dose of Benlysta, contact your healthcare provider for guidance on rescheduling your treatment.
How long does it take for Benlysta to start working?
While some patients may notice an improvement within a few weeks, it can take up to several months to see the full therapeutic effects of Benlysta.
Can I take other medications while on Benlysta?
Yes, but it’s important to inform your healthcare provider about all other medications you are taking to avoid potential interactions.
What precautions should be taken while using Benlysta?
Patients should be monitored for signs of infections and should have regular check-ups to assess treatment efficacy and side effects.
Can Benlysta affect my immunization schedule?
Live vaccines should be avoided during treatment with Benlysta; consult your healthcare provider regarding your vaccination status and options.
Is Benlysta effective for all types of lupus?
Benlysta is specifically approved for systemic lupus erythematosus (SLE) and is not indicated for other forms of lupus or autoimmune diseases.
Does Benlysta require regular monitoring by a healthcare provider?
Yes, patients on Benlysta should have regular follow-ups with their healthcare provider to monitor for side effects and treatment response.
Can Benlysta impact fertility?
The effects of Benlysta on fertility are not fully understood; discuss concerns with your healthcare provider.
Are there any lifestyle changes recommended while on Benlysta?
Patients may be advised to maintain a healthy lifestyle, manage stress, and avoid infections, especially during the early stages of treatment.
Is there a risk of developing cancer while taking Benlysta?
There is a small risk of developing certain cancers associated with the long-term use of immunosuppressive therapies; discuss these risks with your healthcare provider.
What can I do to manage side effects while taking Benlysta?
Patients should report any new or worsening symptoms to their healthcare provider, maintain hydration, and follow dietary and lifestyle recommendations.
Where can I find more information about Benlysta?
For more information about Benlysta, consult your healthcare provider, pharmacist, or visit reputable medical websites and resources.
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