Systemic lupus erythematosus (SLE, also known as lupus; an autoimmune disease where the immune system attacks healthy body parts like joints, skin, blood vessels, and organs) is a condition that affects adults and children over the age of five and is treated with belimumab in combination with other drugs. Adults with lupus nephritis, an autoimmune condition in which the immune system assaults the kidneys, can also be treated with belimumab in combination with other drugs. Belimumab belongs to the group of drugs known as monoclonal antibodies. In patients with SLE and lupus nephritis, it works by preventing the function of a certain protein.

In order to administer belimumab intravenously (into a vein), adults and children 5 years of age and older must mix the powder with a solution. Belimumab is also available as a liquid solution that people can inject subcutaneously (under the skin) using an autoinjector or prefilled syringe. A doctor or nurse typically administers intravenous medication over the course of at least an hour once every two weeks for the first three doses, and thereafter once every four weeks. Your doctor will base the frequency of your intravenous belimumab injections on how your body reacts to the drug. It is typically administered subcutaneously once each week, preferably on the same day each week.

Your doctor’s office will be where you get your first subcutaneous injection of belimumab. Your doctor will demonstrate how to inject the drug if you plan to administer belimumab injection subcutaneously on your own at home or have a friend or family member administer it on your behalf. The written directions for use that are provided with the drug should be read by both you and the person who will be injecting it.

30 minutes before injecting belimumab injection, take the autoinjector or prefilled syringe out of the fridge and let it come to room temperature. Avoid attempting to warm the medication in any way, including by microwaving, soaking, or submerging it in warm water. Clear to opalescent, colourless to light yellow, should describe the solution. Do not inject the drug if the syringe or container are defective; instead, contact your pharmacist.

Except for your navel and the two inches around it, you can inject belimumab anyplace on your stomach or the front of your thighs. A delicate, bruised, red, hard, or otherwise damaged area of skin should not receive the drug by injection. Every time you administer the drug, pick a different location.

Serious adverse effects are possible both during and after the administration of belimumab. Both during and after the infusion, a doctor or nurse will keep a close eye on you to make sure you are not having a severe reaction to the medication. To treat or avert responses to belimumab, other drugs might be administered to you. If you suffer any of the symptoms listed below during the intravenous infusion, subcutaneous injection, or for up to a week following medication administration, call your doctor or nurse right away. hives, difficulty breathing or swallowing, wheezing or shortness of breath, rash, itching, hives, swelling of the face, eyes, mouth, throat, tongue, or lips, anxiety, flushing, disorientation, fainting, headache, nausea, fever, chills, seizures, and muscular aches; and slow heartbeat.

Lupus is not cured by belimumab, but it does help control it. To determine how well belimumab works for you, your doctor will closely monitor you. Before you experience the full benefits of belimumab, it can take some time. It is critical to communicate your feelings to your doctor during your therapy.

Whenever you need a prescription refill for belimumab, your doctor or pharmacist will provide you the manufacturer’s patient information leaflet (Medication Guide). If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website at http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm.

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

Before using belimumab,

• If you have an allergy to belimumab, any other drugs, or any of the ingredients in belimumab injection, let your doctor and pharmacist know right away. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
• Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Incorporate any of the following: cyclophosphamide given intravenously, as well as monoclonal antibodies or other biologic drugs. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
• Inform your doctor if you have cancer, depression, thoughts of harming or killing yourself, an illness, or an infection that keeps coming back.
• If you are pregnant or plan to become pregnant, let your doctor know. It is unknown whether using belimumab while pregnant can affect the unborn child. Use reliable birth control if you decide to avoid getting pregnant throughout your belimumab therapy and for four months after your last dosage. Consult your physician about birth control options you can take while undergoing therapy. Call your doctor right away if you find out you’re pregnant while receiving belimumab medication.
• If you are breastfeeding, let your doctor know.
• Inform the surgeon or dentist that you are using belimumab if you are undergoing surgery, including dental surgery.
• Avoid getting any shots without first consulting your doctor. If you have had a vaccination within the last 30 days, let your doctor know.

Keep eating normally unless your doctor instructs you otherwise.

Call your doctor as soon as you can if you can’t make a belimumab infusion appointment.

If you forget to administer your belimumab subcutaneous injection, do so as soon as you remember. Next, administer your next dose at the specified time, or carry on with your weekly dosing according to the new injection day. To make up for a missing dose, do not provide a second injection. If you require assistance determining when to administer a belimumab injection, contact your doctor or pharmacist.

Belimumab could have negative effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

• Nausea
• Diarrhea
• Headache or migraine
• Having trouble falling or staying asleep
• At the injection site, redness, itching, swelling, discomfort, discoloration, or irritation may occur
• Ache in the legs or arms
• Clogged nose

Some adverse effects can be very harmful. Call your doctor right away if you suffer any of these symptoms or those detailed in the HOW section:

• Rash
• Hives
• Itching
• Breathing difficulty
• Face, throat, tongue, lips, and eye swelling
• Breathing or swallowing challenges
• Infection symptoms like a fever, sore throat, chills, cough, and others
• Bodily sores or skin that is heated, red, or painful
• Considering, planning, or attempting to injure or murder oneself or someone
• New or worsening anxiety or depression
• Uncharacteristic shifts in your behaviour or mood
• Acting on erroneous whims
• Frequent, uncomfortable, or challenging urinating
• Harsh or cloudy smelling urine
• Sneezing and coughing
• Vision alterations
• Loss of memory
• Having trouble being clear-headed
• Speaking or walking difficulties
• Unsteadiness or balance issues

Belimumab may make some cancers more likely to develop in you. According to studies, persons who took belimumab had a higher risk of dying from a variety of causes than those who did not. You should discuss the dangers of using this drug with your doctor.

There may be more negative effects with belimumab. If you experience any strange issues while taking this drug, call your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

Keep this medication tightly closed, out of the reach of children, and in the original container in which it was supplied. Belimumab-containing autoinjectors and prefilled syringes should not be shaken. Belimumab injection should only be kept chilled, never frozen. Avoid being in the heat. If shielded from sunlight, syringes can be kept outside the refrigerator (up to 30°C) for up to 12 hours. If the syringes have been out of the fridge for longer than 12 hours, neither use them nor put them back in the fridge. Throw away any medication that has expired or is no longer required. Consult your pharmacist for advice on how to properly dispose of your medications.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p for additional information.

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Keep all of your doctor’s appointments.

Ask your pharmacist any inquiries you may have regarding the injection of belimumab.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.