Belimumab - Injection

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 provided by your pharmacist before you start using belimumab and each time you get a treatment. Discuss the risks and benefits of belimumab treatment. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection into a vein by a health care professional. It should be injected slowly over 1 hour. The first 3 doses are given every 2 weeks. After the third dose, it is usually given every 4 weeks, or as directed by your doctor. The dosage is based on your weight.

Your doctor may prescribe other medications for you to take before the start of your treatment to help prevent serious side effects.

This medication may cause very serious reactions during or after treatment. These reactions occur more often during the first and second treatments. Your doctor will monitor you closely. If you have a reaction, your treatment will be temporarily stopped. Tell your doctor or nurse right away if any of these effects occur: headache, slow heartbeat, muscle pain, dizziness/fainting, nausea, or rash/itching.

Use this medication regularly to get the most benefit from it. It may help to mark your calendar with a reminder.

Tell your doctor if your condition does not improve or if it worsens.

Side Effects

See also How to Use section.

Nausea, diarrhea, or trouble sleeping may 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)
• signs of cancer (such as fever, night sweats, unusual tiredness, unexplained weight loss, swollen glands, unusual lumps/growths)

This medication can lower your body's ability to fight an infection. You may be more likely to get serious infections such as pneumonia, urinary tract infection, and skin infections. It may also be harder to fight an infection you already have. Tell your doctor right away if you develop signs of a serious infection while using this drug, such as:

• fever
• chills
• sore throat
• cough
• pain or burning with urination
• urinating often
• bloody diarrhea
• coughing up mucus

Belimumab may increase your risk of getting a rare but very serious (sometimes fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if you develop any signs of PML, including:

• confusion
• memory loss
• loss of balance
• difficulty talking/walking
• vision changes

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

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

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:

• infections (current infections, infections that return)
• mental/mood problems (such as depression, thoughts of suicide)
• cancer

Belimumab can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Tell your doctor your vaccine history and ask if you need to get any vaccines before starting treatment with this medication. 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, and reliable forms of birth control with your doctor. The manufacturer recommends the use of reliable forms of birth control during treatment and for at least 4 months after your last treatment.

It is unknown if 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 include:

• 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 9-1-1. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Lab and/or medical tests may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Storage

Not applicable. This medication is given in a clinic and will not be stored at home.

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).