Benlysta (Belimumab)

Benlysta increases the risk of serious infections, including progressive multifocal leukoencephalopathy (PML). It may also elevate the risk of malignancies. Patients should be monitored for signs of infection and any new or worsening neurological symptoms during treatment.

Your allergy to belimumab or any other allergies should be discussed with your doctor or pharmacist before you use this medication. Benlysta may contain inactive ingredients, which can cause allergic reactions or other problems. For more information, feel free to contact us and we will create a consultation with one of our licensed pharmacists.

Tell your doctor about your medical history, especially if you have a current/recent/recurring infection, mental/mood problems (such as depression, thoughts of suicide), or cancer.

Belimumab may increase your chances of getting an infection or may make your current infection worse. It would help if you avoided anyone with an infection that can quickly spread (such as chickenpox, COVID-19, measles, flu). For more information or if you have been exposed to an infection, consult your doctor.

It would help to inform your healthcare professional that you are using Belimumab before receiving any immunizations or vaccinations. It will help if you avoid contact with people who have recently received live vaccines).

The injection site may experience bruising, redness, itching, or pain. It is also possible to experience nausea, diarrhea, or trouble sleeping. Please let your doctor know immediately if these effects persist or worsen.

Your doctor prescribed this medication because they determined that its benefits outweighed any side effects it may cause. There are a few severe side effects associated with this medication.

In case of severe side effects, such as depression or thoughts of suicide, please tell your doctor as soon as possible.

You may be less able to fight infections if you take this medication. Infections (rarely fatal) may be more likely to occur or may be made worse if you already have one. Any signs of infection (such as a sore throat that doesn’t go away, fever, chills, or cough) should be reported immediately to your doctor.

There are very few cases of cancers (including skin cancers) developing in people taking this medication. In the event of a new skin lesion or bump, a change in the size or color of a mole, night sweats, swollen glands, or unexplained weight loss, call your doctor right away. If you are taking cancer medication, such as Xtandi or Ibrance, please inform your healthcare professional.

This medication may increase your risk of developing a rare but very serious (possibly fatal) brain infection (progressive multifocal leukoencephalopathy-PML). If you experience any of these side effects: clumsiness, loss of coordination/balance, weakness, sudden changes in your thinking (such as confusion, difficulty concentrating, memory loss), difficulty talking/walking, seizure, vision changes, contact your doctor immediately.

Any severe side effects, such as chest pain, jaw pain, shortness of breath, or unusual sweating, should be reported to your doctor immediately.

It is rare for this drug to cause a severe allergic reaction. You should seek medical attention immediately if you notice any signs of a severe allergic reaction, such as a rash, itching/swelling (especially of the face, tongue, or throat), severe dizziness, or trouble breathing.

There may be other side effects not listed here. Please contact your doctor or pharmacist if you notice other effects not listed above.

If you would like medical advice about side effects in the US, please contact your doctor. FDA can be reached at 1-800-FDA-1088 or www.fda.gov/medwatch if you are experiencing side effects.

Your doctor will usually prescribe Benlysta once weekly by injection under your skin. You will receive the injection in your thighs or abdomen (at least two inches from your belly button). Your medical condition and response to treatment determine dosage. You can learn how and when to begin using this form of belimumab if you are switching from receiving it by injection.

Learn how to prepare and use this medication from your health care professional and the product package if you use it at home. Use Benlysta only after washing your hands. Thirty minutes before injecting, remove the medication from the refrigerator so that it can reach room temperature. Benlysta should not be heated in any other way, including by microwave, hot water, or direct sunlight. The medication should not be shaken. Colorless to light yellow is the ideal color for the medication. Do not use the liquid if either of these conditions exists. Rub alcohol should be applied to the injection site before each dose. To prevent injury under the skin, change the injection site each time. If the skin is tender, bruised, red, or hard, do not inject. Avoid rubbing the injection site after a shot to reduce bruising.

Regular use of this medication will maximize its effectiveness. You can use it every week on the same day to make it easier for you to remember. I think a reminder on your calendar may be helpful.

You should tell your doctor if your condition does not improve or worsens.

There are two forms of Benlysta:

• A solution is formed by mixing powder with liquid. In this form, the drug is administered intravenously (IV) into an arm vein. Infusions are injections that are slowly dripped into your vein over time. A vial of Benlysta powder contains 120 milligrams (mg) or 400 milligrams (mg).
• Syringes and autoinjectors that are prefilled with a solution. In this form, the medication is administered subcutaneously (under the skin). Belimumab are contained in syringes or autoinjectors containing 200 mg.

Pregnant women are not advised to take Benlysta.

An exposed fetus may be affected by monoclonal antibodies, such as belimumab (the active ingredient in Benlysta).

Benlysta has not been found to increase the risk of harm to the fetus in animal studies.

These studies showed weakened immune systems of offspring born to mothers taking Benlysta, although there was no higher risk of harm to a fetus. It took 3 to 12 months for their immune systems to return to normal after birth, however. Human results may differ from those in animal studies.

Untreated lupus can also pose health risks to the mother. In pregnancy, Benlysta should only be used if the benefits outweigh the risks.

In the refrigerator, Benlysta vials, syringes, or autoinjectors should be stored between 36°F and 46°F (2°C and eight °C). To protect the medication from light, it should be stored in its original carton. It is not recommended to freeze or expose Benlysta to heat. Benlysta shouldn’t be shaken, either.

For up to 12 hours, Benlysta syringes or autoinjectors can be stored at room temperature (up to 86°F/30°C). Light should be kept away from them. Medications that have been out of the refrigerator for more than 12 hours should not be used once they are at room temperature. In addition, it should not be placed back in the refrigerator if left out for more than 12 hours. Throw it away instead.

As with all medications, the cost of Benlysta can vary. The actual price you’ll pay depends on your insurance plan and your location. 

Before approving coverage for Benlysta, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered. If you’re not sure if you’ll need to get prior authorization for Benlysta, contact your insurance company.

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