Uses

This medication is used with other medications to treat certain types of lupus. Belimumab belongs to a class of drugs known as monoclonal antibodies. It works by decreasing the effect of a certain protein that is increased in people with active lupus. This may help decrease some of the symptoms of lupus.

How To Use

Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using belimumab and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection under your skin as directed by your doctor, usually once a week. The injection is given in the thighs or abdomen (at least 2 inches from your belly button). The dosage is based on your medical condition and response to treatment. If you are switching from receiving this medication by injection into a vein, be sure you learn how and when to start using this form of belimumab.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package. Wash your hands before using this medication. Remove the medication from the refrigerator 30 minutes before you inject it to allow it to reach room temperature. Do not warm up this medication any other way such as by heating in the microwave, placing in hot water, or leaving it in direct sunlight. Do not shake the medication. The medication should be colorless to light yellow. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into skin that is tender, bruised, red, or hard. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely.

Use this medication regularly to get the most benefit from it. To help you remember, use it on the same day each week. It may help to mark your calendar with a reminder.

Tell your doctor if your condition does not get better or if it gets worse.

Side Effects

Bruising, redness, itching, or pain at the injection site may occur. Nausea, diarrhea, or trouble sleeping may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• mental/mood changes (such as new/worsening depression, thoughts of suicide)

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).

Very rarely, people using this medication have developed cancers (including skin cancer). Tell your doctor right away if you develop symptoms such as a new skin lesion or bump, change in size or color of a mole, night sweats, swollen glands, or unexplained weight loss.

This medication may increase your risk of getting a rare but very serious (possibly fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if you have any of these side effects:

• clumsiness
• loss of coordination/balance
• weakness
• sudden change in your thinking (such as confusion, difficulty concentrating, memory loss)
• difficulty talking/walking
• seizure
• vision changes

Get medical help right away if you have any very serious side effects, including:

• heart problems (such as chest/jaw/left arm pain, shortness of breath, unusual sweating)

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using belimumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• current/recent/returning infection
• mental/mood problems (such as depression, thoughts of suicide)
• cancer

Belimumab can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using belimumab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab)

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests may be done while you are using this medication. Keep all medical and lab appointments.

Missed Dose

If you miss a dose, use it as soon as you remember. Use your next dose at the regular time or continue using once a week based on the new day injected. If you are not sure when to inject your dose, ask your doctor or pharmacist. Do not use 2 doses on the same day to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store in the refrigerator. Do not freeze. Keep the product in the original carton to protect from light. Discard any unused portion after use. If this medication is left out of the refrigerator for more than 12 hours, do not use. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Medical Alert

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).