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BENLYSTA- belimumab injection, powder, lyophilized, for solutionBENLYSTA- belimumab solution


  1. Patient Information
  2. What Is Benlysta?
  3. Do Not Use Benlysta If You:
  4. How Will I Receive Benlysta?
  5. Benlysta Can Cause Serious Side Effects, Including:
  6. Active Ingredient:
  7. Inactive Ingredients (intravenous):
  8. Inactive Ingredients (subcutaneous):
  9. Find A Comfortable, Well-lit, And Clean Surface And Place The Following Supplies Within Reach:
  10. If You Do Not Have A Fda-cleared Sharps Disposal Container, You May Use A Household Container That:
  11. Reconstitution:
  12. Contents:
  13. Revised: 9/2019document Id:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). It is important that the patient s overall health be assessed at each visit and any questions resulting from the patient s reading of the Medication Guide and Instructions for Use be discussed.

For patients receiving BENLYSTA, give patients the Medication Guide for BENLYSTA.

Mortality

Advise patients that more patients receiving BENLYSTA in the main clinical trials died than did patients receiving placebo treatment[

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

1.
Infections.Symptoms of an infection can include:
fever urinating often
chills coughing up mucus
pain or burning with urination warm, red, or painful skin or sores on your body
2.
Heart Problems.Symptoms of heart problems can include:
chest discomfort or pain nausea
shortness of breath dizziness
cold sweats discomfort in other areas of the upper body
3.
Allergic (hypersensitivity) reactions.Serious allergic reactions can happen on the day of, or in the days after, receiving BENLYSTA and may cause death. Your healthcare provider will watch you closely while you are receiving BENLYSTA given intravenously (infusion) and after your infusion for signs of a reaction. Allergic reactions can sometimes be delayed. Tell your healthcare provider right away if you have any of the following symptoms of an allergic reaction following use of BENLYSTA:
itching low blood pressure
swelling of the face, lips, mouth, dizziness or fainting
tongue, or throat headache
trouble breathing nausea
anxiousness skin rash
4.
Mental health problems and suicide.Symptoms of mental health problems can include:

thoughts of suicide or dying new or worse depression

attempt to commit suicide acting on dangerous impulses

trouble sleeping (insomnia) other unusual changes in your behavior or mood

new or worse anxiety thoughts of hurting yourself or others

What Is Benlysta? 

BENLYSTA is a prescription medicine 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.

BENLYSTA contains belimumab which is in a group of medicines called monoclonal antibodies. Lupus is a disease of the immune system (the body system that fights infection). When given together with other medicines for lupus, BENLYSTA decreases lupus disease activity more than other lupus medicines alone.

It is not known if BENLYSTA is safe and effective in people with severe active lupus nephritis or severe active central nervous system lupus.

Do Not Use Benlysta If You: 

are allergic to belimumab or any of the ingredients in BENLYSTA.
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 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.
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.
o
Tell your healthcare provider right away if you become pregnant during your treatment with BENLYSTA or if you think you may be pregnant.
If you 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.

Tell your healthcare provider about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of your medicines with you to show to your healthcare provider and pharmacist when you get a new medicine.

How Will I Receive Benlysta? 

When administered intravenously (by vein)

You will be given BENLYSTA by a healthcare provider through a needle placed in a vein (IV infusion). It takes about 1 hour to give you the full dose of BENLYSTA.
Your healthcare provider will tell you how often you should receive BENLYSTA.
Your healthcare provider may give you medicines before you receive BENLYSTA to help reduce your chance of having a reaction. A healthcare provider will watch you closely while you are receiving BENLYSTA and after your infusion for signs of a reaction. A healthcare provider will review the signs and symptoms of possible allergic reactions that could happen after your infusion.

When administered subcutaneously (under your skin)

Use BENLYSTA exactly as your healthcare provider tells you to.
Read theInstructions for Usethat comes with BENLYSTA for instructions about the right way to give your injections at home.
BENLYSTA may be prescribed as a single-dose autoinjector or as a single-dose prefilled syringe.
Before you use BENLYSTA, your healthcare provider will show you or your caregiver how to give the injections and review the signs and symptoms of possible allergic reactions.
BENLYSTA is injected under your skin (subcutaneously) of your stomach (abdomen) or thigh.
Use BENLYSTA 1 time a week on the same day each week.
If you miss your dose of BENLYSTA on your planned day, inject a dose as soon as you remember. Then, inject your next dose at your regularly scheduled time or continue weekly dosing based on the new day injected. In case you are not sure when to inject BENLYSTA, call your healthcare provider. Do not use 2 doses on the same day to make up for a missed dose.

Benlysta Can Cause Serious Side Effects, Including: 

Store autoinjectors and prefilled syringes in the refrigerator at 36 F to 46 F (2 C to 8 C). Do not freeze.
Keep BENLYSTA autoinjectors and prefilled syringes in the original package until time of use to protect from light.
Do not shake. Keep away from heat and sunlight.
Do not use and do not place back in the refrigerator if left out at room temperature for more than 12 hours.
Safely throw away medicine that is out of date or no longer needed.

Keep BENLYSTA and all medicines out of the reach of children.

General information about the safe and effective use of BENLYSTA.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use BENLYSTA for a condition for which it was not prescribed. Do not give BENLYSTA to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about BENLYSTA. You can ask your healthcare provider or pharmacist for information about BENLYSTA that is written for healthcare professionals.

Active Ingredient: 

belimumab.

Inactive Ingredients (intravenous): 

citric acid, polysorbate 80, sodium citrate, sucrose.

Inactive Ingredients (subcutaneous): 

L-arginine hydrochloride, L-histidine, L-histidine monohydrochloride, polysorbate 80, sodium chloride.

For more information, go towww.BENLYSTA.comor call 1-877-423-6597

BENLYSTA is a registered trademark owned by or licensed to the GSK group of companies. The other brand listed is a trademark owned by or licensed to its respective owner and is not owned by or licensed to the GSK group of companies. The maker of this brand is not affiliated with and does not endorse the GSK group of companies or its products.

Manufactured by:Human Genome Sciences, Inc.(a subsidiary of GlaxoSmithKline), Rockville, Maryland 20850

U.S. License No. 1820

Marketed by:GlaxoSmithKline, Research Triangle Park, NC 27709

2019 GSK group of companies or its licensor.

BNL:9MG

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 04/2019

Instructions for Use

BENLYSTA (ben-LIST-ah)

(belimumab)

injection, for subcutaneous use

Prefilled Syringe

Read this Instructions for Use before you start to use BENLYSTA and each time you refill your prescription. There may be new information. You should also receive training from your healthcare provider on how to use the prefilled syringe the right way. If you do not follow these instructions the prefilled syringe may not work properly. BENLYSTA is for useunder the skin only(subcutaneous).

Important Storage Information

Keep refrigerated until 30 minutes before use.
Keep in the original package until time of use to protect from light.
Do notfreeze BENLYSTA.
Keep away from heat and sunlight.
Do notuse anddo notplace back in the refrigerator if BENLYSTA is left out for more than 12 hours.
Keep out of the reach of children.

Important Warnings

The prefilled syringe should be used only 1 time and then thrown away. See below, Dispose of used prefilled syringe and inspect.
Do notshare your BENLYSTA prefilled syringe with other people. You may give other people a serious infection, or get a serious infection from them.
Do notshake the prefilled syringe.
Do notuse if dropped onto a hard surface.
Do notremove the Needle Cap until right before the injection.

BENLYSTA Prefilled Syringe Parts

Before use

BENLYSTA prefilled syringe parts

After Use Needle is covered by Needle Guard

Needle Guard

Supplies needed for the injection

BENLYSTA prefilled syringe

BENLYSTA Prefilled Syringe

Gauze Pad or Cotton Ball

Alcohol Swab(not included)

Gauze Pad or Cotton Ball(not included)

Supplies_Sharps_Container_PFS

Sharps Container(not included)

1 Gather and check supplies

Gather supplies

Remove 1 sealed tray containing a prefilled syringe from the refrigerator.

Find A Comfortable, Well-lit, And Clean Surface And Place The Following Supplies Within Reach: 

BENLYSTA Prefilled Syringe
Alcohol Swab (not included)
Gauze Pad or Cotton Ball (not included)
Sharps Container (not included)
Do notperform the injection if you do not have all the supplies listed.

Check expiration date

Peel back the film of the tray and remove the prefilled syringe by holding the middle of the syringe body.
Check the expiration date on the prefilled syringe. See Figure A.
Figure_A_PFS
Do notuse if the expiration date has passed.

2 Prepare and inspect the BENLYSTA Prefilled Syringe

Allow to come to room temperature

Allow the prefilled syringe to sit at room temperature for 30 minutes. See Figure B.
Figure_B_PFS
o
Do notwarm the prefilled syringe in any other way. For example, do not warm in a microwave oven, hot water, or in direct sunlight.
o
Do notremove the Needle Cap during this step.

Inspect BENLYSTA solution

Look in the Inspection Window to check that the BENLYSTA solution is colorless to slightly yellow in color. See Figure C.
Figure_C_PFS
It is normal to see 1 or more air bubbles in the solution.
Do notuse if the solution looks cloudy, discolored, or has particles.

3 Choose and clean the injection site

Choose the injection site

Choose where to inject (abdomen or thigh). See Figure D.
Avoid injecting into the same site each time or in areas where the skin is tender, bruised, red, or hard.
Figure_D_PFS
Do notinject within 2 inches of the belly button.

Clean the injection site

Wash your hands.
Clean the injection site by wiping it with an Alcohol Swab. Allow the skin to air dry. See Figure E.
Figure_E_PFS
Do nottouch this area again before giving the injection.

4 Prepare for the injection

Remove the Needle Cap

Do notremove the Needle Cap until right before you give the injection.
Hold the prefilled syringe by the body and with the Needle facing away from you. Remove the Needle Cap by pulling it straight off. See Figure F.
Figure_F_PFS
You may see a drop of liquid at the end of the Needle. This is normal.
Do notlet the Needle touch any surface.
Do notpush any air bubbles out of the prefilled syringe.
Do notput the Needle Cap back onto the prefilled syringe.
Keep your hands awayfrom the Plunger to avoid pushing it before injecting.

5 Inject BENLYSTA

Insert the Needle

Hold the prefilled syringe in one hand and use your free hand to gently pinch the skin around the injection site. See Figure G.
Insert the entire Needle into the pinched area of the skin at a slight 45-degree angle using a dart-like motion.
Figure_G_PFS
After the Needle is completely inserted, release the pinched skin.

Complete the injection

Push the Plunger all the way down until all of the solution is injected. See Figure H.
Figure_H_PFS
While keeping your hold on the syringe, slowly move your thumb back, allowing the Plunger to rise up. The Needle will automatically rise up into the Needle Guard. See Figure I.
Figure_I_PFS

6 Dispose of used prefilled syringe and inspect

Dispose of the used prefilled syringe

Throw away(dispose of) the used syringe and Needle Cap in a Sharps Container. See Figure J.

Put your used syringe and sharps in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash.
If you do not have a FDA-cleared sharps disposal container, you may use a household container that:
o
is made of a heavy-duty plastic,
o
can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
o
is upright and stable during use,
o
is leak-resistant, and
o
properly labeled to warn of hazardous waste inside the container.
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to:http://www.fda.gov/safesharpsdisposal.
Do notdispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
Figure_J_PFS

Inspect the injection site

There may be a small amount of blood at the injection site. If needed, press a Cotton Ball or Gauze Pad on the injection site.
Do notrub the injection site.

Additional information

For more information about BENLYSTA, go towww.BENLYSTA.comor call 1-877-423-6597.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Trademark is owned by or licensed to the GSK group of companies.

Manufactured by Human Genome Sciences, Inc., (a subsidiary of GlaxoSmithKline), Rockville, MD 20850

U.S. License No. 1820

2018 GSK group of companies or its licensor.

BNL:2IFU-S

Revised June 2018

Instructions for Use

BENLYSTA (ben-LIST-ah)

(belimumab)

injection, for subcutaneous use

Prefilled Autoinjector

Read this Instructions for Use before you start to use BENLYSTA and each time you refill your prescription. There may be new information. You should also receive training from your healthcare provider on how to use the autoinjector the right way. If you do not follow these instructions the autoinjector may not work properly. BENLYSTA is for useunder the skin only(subcutaneous).

Important Storage Information

Keep refrigerated until 30 minutes before use.
Keep in the original package until time of use to protect from light.
Do notfreeze BENLYSTA.
Keep away from heat and sunlight.
Do notuse anddo notplace back in the refrigerator if BENLYSTA is left out for more than 12 hours.
Keep out of the reach of children.

Important Warnings

The autoinjector should be used only 1 time and then thrown away. See below, Dispose of used autoinjector and inspect.
o
Do notshare your BENLYSTA Autoinjector with other people. You may give other people a serious infection, or get a serious infection from them.
o
Do notshake the autoinjector.
o
Do notuse if dropped onto a hard surface.
o
Do notremove the Ring Cap until right before the injection.

BENLYSTA Autoinjector Parts

Autoinjector_parts_open-view_AI

Supplies needed for the injection

BENLYSTA autoinjector

BENLYSTA Autoinjector

Gauze Pad or Cotton Ball

Alcohol Swab(not included)

Gauze Pad or Cotton Ball(not included)

Supplies_Sharps_Container_AI

Sharps Container(not included)

1 Gather and check supplies

Gather supplies

Remove 1 sealed tray containing an autoinjector from the refrigerator.

If You Do Not Have A Fda-cleared Sharps Disposal Container, You May Use A Household Container That: 

o
is made of a heavy-duty plastic,
o
can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
o
is upright and stable during use,
o
is leak-resistant, and
o
properly labeled to warn of hazardous waste inside the container.
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to:http://www.fda.gov/safesharpsdisposal.
Do notdispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
Figure_K_AI

Inspect the injection site

There may be a small amount of blood at the injection site. If needed, press a Cotton Ball or Gauze Pad on the injection site.
Do notrub the injection site.

Additional information

For more information about BENLYSTA, go towww.BENLYSTA.comor call 1-877-423-6597.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Trademark is owned by or licensed to the GSK group of companies.

Manufactured by Human Genome Sciences, Inc., (a subsidiary of GlaxoSmithKline), Rockville, MD 20850

U.S. License No. 1820

2018 GSK group of companies or its licensor.

BNL:2IFU-A

Revised June 2018

PRINCIPAL DISPLAY PANEL

NDC 49401-101-01

Benlysta

(belimumab)

for Injection

120 mg/vial

For Intravenous Infusion after dilution only. Single-dose vial.

Discard unused portion

Reconstitution: 

Reconstitute with 4.8 mL of Sterile Water for Injection, USP. After reconstitution, the concentration of BENLYSTA is 80 mg/mL.

Dilute:Further dilute in 250 mL of one of the following solutions before use:

0.9% Sodium Chloride Injection, USP
0.45% Sodium Chloride Injection, USP
Lactated Ringer s Injection, USP

Federal Law requires dispensing of BENLYSTAwith the Medication Guide provided with this carton.

Rx only

2016 the GSK group of companies

Rev. 7/16

10000000141890

benlysta 400 mg per vial carton

PRINCIPAL DISPLAY PANEL

NDC 49401-088-35

Benlysta

(belimumab)

Injection

200 mg/mL

Once-weekly

For Subcutaneous Use

Rx only

Contents: 

4 Single-Dose 1-mL Prefilled Autoinjectors
Instructions for Use (Read carefully)
Medication Guide
Prescribing Information

Federal Law requires dispensing of BENLYSTA with the Medication Guide provided with this package.

2019 GSK group of companies or is licensor.

Rev. 1/19

62000000034180

Benlysta 200mg-mL 4 count carton
BENLYSTA
belimumab injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:49401-102
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BELIMUMAB(UNII: 73B0K5S26A) (BELIMUMAB - UNII:73B0K5S26A)BELIMUMAB400 mg in 5 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CITRATE, UNSPECIFIED FORM(UNII: 1Q73Q2JULR)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
SUCROSE(UNII: C151H8M554)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49401-102-011 in 1 CARTON03/10/2011
15 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA12537003/10/2011
BENLYSTA
belimumab injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:49401-101
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BELIMUMAB(UNII: 73B0K5S26A) (BELIMUMAB - UNII:73B0K5S26A)BELIMUMAB120 mg in 1.5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
SODIUM CITRATE, UNSPECIFIED FORM(UNII: 1Q73Q2JULR)
SUCROSE(UNII: C151H8M554)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49401-101-011 in 1 CARTON03/10/2011
11.5 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA12537003/10/2011
BENLYSTA
belimumab solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:49401-088
Route of AdministrationSUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BELIMUMAB(UNII: 73B0K5S26A) (BELIMUMAB - UNII:73B0K5S26A)BELIMUMAB200 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
ARGININE HYDROCHLORIDE(UNII: F7LTH1E20Y)
HISTIDINE(UNII: 4QD397987E)
HISTIDINE MONOHYDROCHLORIDE(UNII: 1D5Q932XM6)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49401-088-474 in 1 CARTON07/20/2017
1NDC:49401-088-421 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:49401-088-501 in 1 CARTON07/20/2017
2NDC:49401-088-421 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3NDC:49401-088-354 in 1 CARTON07/20/2017
3NDC:49401-088-011 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
4NDC:49401-088-021 in 1 CARTON07/20/2017
4NDC:49401-088-011 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA76104307/20/2017
Labeler -Human Genome Sciences, Inc. (034062104)

Revised: 9/2019document Id: 

31a57420-ef52-4314-ac5b-127065823036Set id: 2fa3c528-1777-4628-8a55-a69dae2381a3Version: 22Effective Time: 20190913Human Genome Sciences, Inc.



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