LOC US BEN Consumer IV Adherence Program-Week 3 D1€¦ · Talking to your doctor and starting a...

GETTING STARTED

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Before you begin your journey with BENLYSTA, it’s important that you understand the treatment process. This guide will take you through the infusion process and may help give you a clear idea of what BENLYSTA is all about.

BENLYSTA (belimumab) and you

“I was afraid, but I hoped that adding this drug would help me.”

SUSAN, CURRENTLY RECEIVING BENLYSTAActual patient; paid spokesperson.

Individual results may vary.

GSK sponsors BENLYSTA Ambassadors and pays them for their time and expense in sharing their experiences. Individual results may vary.

Please see accompanying Important Facts About BENLYSTA.

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BENLYSTA (belimumab) and you

Please see additional Important Safety Information on pages 16-17.

What is BENLYSTA?

BENLYSTA is a prescription medication used to treat patients with active systemic lupus erythematosus (SLE or lupus) who are receiving other lupus medicines. Intravenous dosing of BENLYSTA is approved for adults and children aged 5 years and older. Subcutaneous dosing of BENLYSTA is only approved for adult patients.

It is not known if BENLYSTA is safe and effective in people with severe active lupus nephritis or severe active central nervous system lupus, and it has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of BENLYSTA is not recommended in these situations.

Do not receive BENLYSTA if you are allergic to belimumab or to any of the ingredients in BENLYSTA.

Important Safety InformationBENLYSTA can cause serious side effects. Some of these side effects may cause death. It is not known if BENLYSTA causes these serious side effects. Tell your healthcare provider right away if you have any symptoms of infections (such as fever, chills, coughing up mucus, pain or burning with urination, urinating often, or warm, red, or painful skin or sores on your body), heart problems (such as chest discomfort or pain, or shortness of breath), allergic reactions (itching, dizziness or fainting, swelling of the face, lips, mouth, tongue, or throat, headache, trouble breathing, anxiousness, nausea, low blood pressure, or skin rash) or mental health problems (such as thoughts of suicide or dying, trouble sleeping (insomnia), new or worse anxiety or depression, acting on dangerous impulses). Serious allergic reactions can happen on the day of, or in the days after, receiving BENLYSTA and may cause death.

For more information, visit www.BENLYSTA.com or call 1-877-4-BENLYSTA (1-877-423-6597).

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Important Safety Information

Talking to your doctor and starting a treatment plan that adds BENLYSTA are important steps towards fighting back.


Tell your healthcare provider if you:

• think you have an infection or have infections that keep coming back. You should not receive BENLYSTA if you have an infection unless your healthcare provider tells you to.

• have or have had mental health problems such as depression or thoughts of suicide.

• have recently received a vaccination or if you think you may need a vaccination. If you are receiving BENLYSTA, you should not receive live vaccines.

• are taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

• are allergic to other medicines.

• are receiving other biologic medicines, monoclonal antibodies, or IV infusions of cyclophosphamide (CYTOXAN).

• have or have had any type of cancer.

• have any other medical conditions.

• are pregnant or plan to become pregnant. It is not known if BENLYSTA will harm your unborn baby. You should talk to your healthcare provider about whether to prevent pregnancy while on BENLYSTA. If you choose to prevent pregnancy, you should use an effective method of birth control while receiving BENLYSTA and for at least 4 months after the final dose of BENLYSTA. Tell your healthcare provider right away if you become pregnant during your treatment with BENLYSTA or if you think you may be pregnant.

• become pregnant while receiving BENLYSTA, talk to your healthcare provider about enrolling in the BENLYSTA Pregnancy Registry. You can enroll in this registry by calling 1-877-681-6296. The purpose of this registry is to monitor the health of you and your baby.

• are breastfeeding or plan to breastfeed. It is not known if BENLYSTA passes into your breast milk. You and your healthcare provider should talk about whether or not you should receive BENLYSTA and breastfeed.


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If it’s your first intravenous infusion, you may be a little nervous, and that’s okay. Here is some important information you should know before starting your journey with BENLYSTA.

Where do I go for an infusion?

The most common places are your healthcare provider’s office, a stand-alone infusion center, or a hospital. Your healthcare provider will help choose the best place for you.

How long does one infusion session take?

Your infusion with BENLYSTA (belimumab) for intravenous injection 120 mg/vial will take about an hour to complete, with additional preparation time before and observation time after the infusion.

What should I do if I’m sick on the day of my infusion?

Let your healthcare provider know right away. He or she will help you reschedule. You should not receive BENLYSTA if you have an infection, possibly even a cold, unless your healthcare provider tells you to.

How often do I need to receive an infusion?

The recommended schedule for the first three infusions of BENLYSTA is once every two weeks for three doses. After that, it’s given once every four weeks.

Understanding the infusion process

1st Infusion 2nd Infusion 3rd Infusion 4th Infusion

2 weeks 2 weeks 1 infusion every 4 weeks

Ongoing InfusionsInitial Infusions

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Possible side effects of BENLYSTA (belimumab)

Progressive multifocal leukoencephalopathy (PML) is a serious and life-threatening brain infection. PML can result in death or severe disability. Tell your healthcare provider right away if you notice any new or worsening medical problems: memory loss, trouble thinking, dizziness or loss of balance, difficulty talking or walking, or loss of vision.

Medicines that affect the immune system, including BENLYSTA, may increase your risk of certain cancers.

“ My infusion session with BENLYSTA is my time to sit and reflect on things that are happening in my life.”


MORGAN, CURRENTLY RECEIVING BENLYSTAActual patient; paid spokesperson.


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Preparing for my first infusion

Attending your first infusion appointment is a big step in the right direction. It’s important to go to bed early and get plenty of rest. Ask your healthcare provider if you might receive any medication prior to the infusion, such as an antihistamine, which may make you feel drowsy after the infusion. If so, you may want to arrange transportation to and from the infusion ahead of time. Try to get to the infusion appointment a few minutes early.

What to eat

Although there are no food restrictions with BENLYSTA, check with your healthcare provider about whether you should avoid any specific foods or beverages with your other medications.

How to dress

Dress comfortably. Wear loose clothing with sleeves that can be rolled up. Wear layers, as the temperature at the infusion site may be cool or warm. Keep in mind that the IV will be inserted into one of your arms or hands, so you may have limited use of that arm or hand during the infusion.

What to bring

Since the infusion of BENLYSTA takes an hour, here are some ideas that may help pass the time:

• Bring a friend or family member with you

• Use your ‘Communication Journal’ to write down your thoughts

• Use the time to get to know the staff members or use it as an opportunity to learn more about lupus and BENLYSTA

• Bring a book, newspaper, magazine, or laptop/tablet

• A pillow in case you’d like to catch up on some sleep

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What to expect on your first day

When you arrive, a healthcare provider will help you prepare for your infusion and:

• Take your temperature

• Measure your pulse rate and blood pressure

• Record your weight

• Discuss your medical history. It may help to have a list of all of the medicines that you are taking

• May give you medication before the infusion, such as an antihistamine, to help with possible allergic reactions. It is not known if these medications will help reduce the chance of an allergic reaction to BENLYSTA.

During the infusionAs soon as you’re seated comfortably in the infusion chair, the healthcare provider will:

• Explain the infusion process and answer any questions

• Begin monitoring you for signs of a potential reaction before, during, and after the infusion

• Ask you where you would like the IV to be placed; generally the IV is placed in an arm or a hand. If you are uncomfortable around needles, tell your healthcare provider

Be aware of how you feel during the infusion. Tell your healthcare provider right away if you feel any side effects.

TIP: Remember to share with your healthcare provider any thoughts, questions or concerns you’ve written in your ‘Communication Journal.’

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What to expect on your first day The most common side effects of BENLYSTA (belimumab) include:

The most common side effects of BENLYSTA are nausea, diarrhea, fever, stuffy or runny nose and sore throat, cough, trouble sleeping, leg or arm pain, depression, headache and pain, redness, itching, or swelling at the site of injection (when given subcutaneously). These are not all the possible side effects of BENLYSTA. Call your doctor for medical advice about side effects.



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After your infusion of BENLYSTA (belimumab)

After the infusion, you may feel some discomfort where the needle was inserted. That should go away within a few hours. If you were given an antihistamine, you may feel drowsy. If you do, it’s important that you have someone drive you home. If you don’t feel well or have any soreness that doesn’t go away, contact your healthcare provider.

Depending on how you feel, you may be able to return to your usual activities.

Make sure you:

• Schedule your next few infusion appointments. Ask about any activities you should avoid after your infusion

• Have your transportation ready to take you home, if needed

• Track your experiences in your ‘Communication Journal’

Important Safety Information BENLYSTA can cause serious side effects. Some of these side effects may cause death. It is not known if BENLYSTA causes these serious side effects. Tell your healthcare provider right away if you have any symptoms of infections (such as fever, chills, coughing up mucus, pain or burning with urination, urinating often, or warm, red, or painful skin or sores on your body), heart problems (such as chest discomfort or pain, or shortness of breath), allergic reactions (itching, dizziness or fainting, swelling of the face, lips, mouth, tongue, or throat, headache, trouble breathing, anxiousness, nausea, low blood pressure, or skin rash) or mental health problems (such as thoughts of suicide or dying, trouble sleeping (insomnia), new or worse anxiety or depression, acting on dangerous impulses). Serious allergic reactions can happen on the day of, or in the days after, receiving BENLYSTA and may cause death.

It is important to continue to receive BENLYSTA (belimumab) as prescribed, even if you are feeling better. Talk to your doctor for more information.


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After your infusion of BENLYSTA (belimumab)

“ I remember just looking up at that infusion bag and saying: well this is it – I really hope this helps.”

MICHELLE, CURRENTLY RECEIVING BENLYSTAActual patient; paid spokesperson.


TIP: Join a support group. Talking to others can help.

For more information, visit www.BENLYSTA.com or call 1-877-4-BENLYSTA (1-877-423-6597). 11

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Things to tell your healthcare provider at your next visit:

• How your last infusion went

• If your weight has changed (since the dose depends on your weight)

• If you’ve changed the medications you take

• If you’ve had an infection or you’ve been ill

• If you’ve had a reaction of any kind to the last infusion

• If you’ve had any vaccinations

• If you have noticed any change in your symptoms

When may BENLYSTA (belimumab) start working for me?Remember, every patient responds differently to BENLYSTA. It’s important that you communicate all your questions and concerns with your healthcare provider, and continue to receive BENLYSTA as prescribed. As you go along, you’ll become more familiar with the process. It is important to keep up with your treatment.

Important Safety Information Tell your healthcare provider if you:

• think you have an infection or have infections that keep coming back. You should not receive BENLYSTA if you have an infection unless your healthcare provider tells you to.

• have or have had mental health problems such as depression or thoughts of suicide.

• have recently received a vaccination or if you think you may need a vaccination. If you are receiving BENLYSTA, you should not receive live vaccines.


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“ Get educated – learn everything you can about lupus – and about BENLYSTA.”

SUSAN, CURRENTLY RECEIVING BENLYSTA Actual patient; paid spokesperson. Individual results may vary.

Patient experiences

The first day is usually the hardest. Learn from others who have experienced the infusion process with BENLYSTA.

Susan came to her first infusion fully informed and prepared. She was worried that they wouldn’t be able to find a vein and start the IV.

Her nurses explained everything that would happen, and monitored her blood pressure and temperature every fifteen to twenty minutes.

Based on Susan’s experience...

• What are some things you can do to prepare for an infusion?

• Are there any concerns you have about the infusion process?

Share your thoughts and questions with your healthcare provider. H

AVE THOUGHTS?

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For more information, visit www.BENLYSTA.com or call 1-877-4-BENLYSTA (1-877-423-6597). 13

MORGAN, CURRENTLY RECEIVING BENLYSTA (belimumab)Actual patient; paid spokesperson.


Even though she had done a lot of research on BENLYSTA and the infusion process, Morgan was a bit nervous knowing that a new drug was going into her, so on the day of her first infusion, her mom went with her.

Now, she uses the infuson session as ‘me time’. If she has work, she’ll bring it, but she also likes to spend that time catching up with the other infusion patients.

“ Remember, it’s a disease, not who you are.”

Based on Morgan’s experience...

• What kind of support system do you find most helpful?

• Is there anything about the infusion process that makes you nervous?

Share your thoughts and questions with your healthcare provider.

14 Please see accompanying Important Facts About BENLYSTA.

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Tell your healthcare provider if you (cont’d):

• are taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

• are allergic to other medicines.

• are receiving other biologic medicines, monoclonal antibodies, or IV infusions of cyclophosphamide (CYTOXAN).

• have or have had any type of cancer.

• have any other medical conditions.


• become pregnant while receiving BENLYSTA. Talk to your healthcare provider about enrolling in the BENLYSTA Pregnancy Registry. You can enroll in this registry by calling 1-877-681-6296. The purpose of this registry is to monitor the health of you and your baby.




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Do not receive BENLYSTA if you are allergic to belimumab or to any of the ingredients in BENLYSTA.

The most important information to know about BENLYSTA (belimumab)BENLYSTA can cause serious side effects. Some of these side effects may cause death. It is not known if BENLYSTA causes these serious side effects.

Tell your healthcare provider right away if you have any of the symptoms listed below while receiving BENLYSTA• Infections: fever, chills, pain or burning with urination, urinating often, coughing up

mucus, or warm, red, or painful skin or sores on your body. • Heart problems: chest discomfort or pain, shortness of breath, cold sweats, nausea,

dizziness, or discomfort in other areas of the upper body.• Allergic (hypersensitivity) reactions: itching, swelling of the face, lips, mouth,

tongue, or throat, trouble breathing, anxiousness, low blood pressure, dizziness or fainting, headache, nausea, or skin rash. Serious allergic reactions can happen on the day of, or in the days after, receiving BENLYSTA and may cause death.

• Mental health problems and suicide: thoughts of suicide or dying, attempt to commit suicide, trouble sleeping (insomnia), new or worse anxiety or depression, acting on dangerous impulses, other unusual changes in your behavior or mood, or thoughts of hurting yourself or others.

Before receiving BENLYSTA also discuss with your healthcare provider if you:• think you have an infection or have infections that keep coming back. You should

not receive BENLYSTA if you have an infection unless your healthcare provider tells you to.

• have or have had mental health problems such as depression or thoughts of suicide.• have recently received a vaccination or if you think you may need a vaccination. If

you are receiving BENLYSTA, you should not receive live vaccines.• are taking other medicines, including prescription and over-the-counter medicines,

vitamins, and herbal supplements.• are allergic to other medicines.• are receiving other biologic medicines, monoclonal antibodies, or IV infusions of

cyclophosphamide (CYTOXAN).• have or have had any type of cancer.• have any other medical conditions.


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• become pregnant while receiving BENLYSTA. Talk to your healthcare provider about enrolling in the BENLYSTA Pregnancy Registry. You can enroll in this registry by calling 1-877-681-6296. The purpose of this registry is to monitor the health of you and your baby.


Possible side effects of BENLYSTA• Progressive multifocal leukoencephalopathy (PML). PML is a serious and

life-threatening brain infection. PML can result in death or severe disability. Tell your healthcare provider right away if you notice any new or worsening medical problems: memory loss, trouble thinking, dizziness or loss of balance, difficulty talking or walking, or loss of vision.

• Cancer. Medicines that affect the immune system, including BENLYSTA, may increase your risk of certain cancers.

The most common side effects of BENLYSTA are nausea, diarrhea, fever, stuffy or runny nose and sore throat, cough, trouble sleeping, leg or arm pain, depression, headache, and pain, redness, itching, or swelling at the site of injection (when given subcutaneously). These are not all the possible side effects of BENLYSTA. Call your doctor for medical advice about side effects.

Other Important Information In clinical studies, there have been mixed results regarding how well BENLYSTA works in black/African American patients. Therefore, you should consult with your healthcare provider to determine if BENLYSTA is right for you.


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Have thoughts? Take notes.

We get it. The infusion process is a lot to take in, and a lot to remember. This is your safe place to record any specific information or questions you may have along the way.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.


©2019 GSK or licensor.BELBROC190087 September 2019Produced in USA. 0002-0003-41

Today is the day to ask your doctor if BENLYSTA is right for you.

For more information, visit BENLYSTA.com or call 1-877-4-BENLYSTA (1-877-423-6597).

Trademarks are owned by or licensed to the GSK group of companies.

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