ABRILADA™ Full Patient Information

MEDICATION GUIDE ABRILADA™ (AH brill-ah-dah) (adalimumab-afzb) injection, for subcutaneous use
Read the Medication Guide that comes with ABRILADA before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or treatment.
What is the most important information I should know about ABRILADA? ABRILADA is a medicine that affects your immune system. ABRILADA can lower the ability of your immune system to fight infections. Serious infections have happened in people taking adalimumab products. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi or bacteria that have spread throughout the body. Some people have died from these infections. • Your healthcare provider should test you for TB before starting ABRILADA. • Your healthcare provider should check you closely for signs and symptoms of TB during treatment with ABRILADA. You should not start taking ABRILADA if you have any kind of infection unless your healthcare provider says it is okay. Before starting ABRILADA, tell your healthcare provider if you: • think you have an infection or have symptoms of infection such as:
	o fever, sweats, or chills o muscle aches o cough o shortness of breath o blood in phlegm	o warm, red, or painful skin or sores on your body o diarrhea or stomach pain o burning when you urinate or urinate more often than normal o feel very tired o weight loss
• are being treated for an infection. • get a lot of infections or have infections that keep coming back. • have diabetes. • have TB, or have been in close contact with someone with TB. • were born in, lived in, or traveled to countries where there is more risk for getting TB. Ask your healthcare provider if you are not sure. • live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may happen or become more severe if you use ABRILADA. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common. • have or have had hepatitis B. • use the medicine ORENCIA (abatacept), KINERET (anakinra), RITUXAN (rituximab), IMURAN (azathioprine), or PURINETHOL (6–mercaptopurine, 6-MP). • are scheduled to have major surgery After starting ABRILADA, call your healthcare provider right away if you have an infection, or any sign of an infection. ABRILADA can make you more likely to get infections or make any infection that you may have worse. Cancer • For children and adults taking tumor necrosis factor (TNF) blockers, including ABRILADA, the chances of getting cancer may increase. • There have been cases of unusual cancers in children, teenagers, and young adults using TNF blockers. • People with rheumatoid arthritis (RA), especially more serious RA, may have a higher chance for getting a kind of cancer called lymphoma. • If you use TNF blockers including ABRILADA your chance of getting two types of skin cancer may increase (basal cell cancer and squamous cell cancer of the skin). These types of cancer are generally not life-threatening if treated. Tell your healthcare provider if you have a bump or open sore that does not heal. • Some people receiving TNF blockers including ABRILADA developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. Most of these people were male teenagers or young men. Also, most people were being treated for Crohn's disease or ulcerative colitis with another medicine called IMURAN (azathioprine) or PURINETHOL (6-mercaptopurine, 6-MP).
What is ABRILADA? ABRILADA is a medicine called a tumor necrosis factor (TNF) blocker. ABRILADA is used: • To reduce the signs and symptoms of: o moderate to severe RA in adults. ABRILADA can be used alone, with methotrexate, or with certain other medicines. o moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years and older. ABRILADA can be used alone or with methotrexate. o psoriatic arthritis (PsA) in adults. ABRILADA can be used alone or with certain other medicines. o ankylosing spondylitis (AS) in adults. o moderate to severe hidradenitis suppurativa (HS) in adults. • To treat moderate to severe Crohn's disease (CD) in adults and children 6 years of age and older. • To treat moderate to severe ulcerative colitis (UC) in adults. It is not known if adalimumab products are effective in people who stopped responding to or could not tolerate TNF-blocker medicines. • To treat moderate to severe chronic (lasting a long time) plaque psoriasis (Ps) in adults who have the condition in many areas of their body and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills). • To treat non-infectious intermediate, posterior, and panuveitis in adults.
What should I tell my healthcare provider before taking ABRILADA? ABRILADA may not be right for you. Before starting ABRILADA, tell your healthcare provider about all of your medical conditions, including if you: • have an infection. See "What is the most important information I should know about ABRILADA?" • have or have had cancer. • have any numbness or tingling or have a disease that affects your nervous system such as multiple sclerosis or Guillain-Barré syndrome. • have or had heart failure. • have recently received or are scheduled to receive a vaccine. You may receive vaccines, except for live vaccines while using ABRILADA. Children should be brought up to date with all vaccines before starting ABRILADA. • are allergic to ABRILADA or to any of its ingredients. See the end of this Medication Guide for a list of ingredients in ABRILADA. • are pregnant or plan to become pregnant, breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you should take ABRILADA while you are pregnant or breastfeeding. • have a baby and you were using ABRILADA during your pregnancy. Tell your baby's healthcare provider before your baby receives any vaccines. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you use: • ORENCIA (abatacept), KINERET (anakinra), REMICADE (infliximab), ENBREL (etanercept), CIMZIA (certolizumab pegol) or SIMPONI (golimumab), because you should not use ABRILADA while you are also using one of these medicines. • RITUXAN (rituximab). Your healthcare provider may not want to give you ABRILADA if you have received RITUXAN (rituximab) recently. • IMURAN (azathioprine) or PURINETHOL (6–mercaptopurine, 6-MP). Keep a list of your medicines with you to show your healthcare provider and pharmacist each time you get a new medicine.
How should I take ABRILADA? • ABRILADA is given by an injection under the skin. Your healthcare provider will tell you how often to take an injection of ABRILADA. This is based on your condition to be treated. Do not inject ABRILADA more often than you were prescribed. • See the Instructions for Use inside the carton for complete instructions for the right way to prepare and inject ABRILADA. • Make sure you have been shown how to inject ABRILADA before you do it yourself. You can call your healthcare provider or 1-800-438-1985 if you have any questions about giving yourself an injection. Someone you know can also help you with your injection after they have been shown how to prepare and inject ABRILADA. • Do not try to inject ABRILADA yourself until you are shown the right way to give the injections and read and understand the Instructions for Use. If your healthcare provider decides that you or a caregiver may be able to give your injections of ABRILADA at home, you should receive training on the right way to prepare and inject ABRILADA. • Do not miss any doses of ABRILADA unless your healthcare provider says it is okay. If you forget to take ABRILADA, inject a dose as soon as you remember. Then, take your next dose at your regular scheduled time. This will put you back on schedule. In case you are not sure when to inject ABRILADA, call your healthcare provider or pharmacist. • If you take more ABRILADA than you were told to take, call your healthcare provider.
What are the possible side effects of ABRILADA? ABRILADA can cause serious side effects, including: See "What is the most important information I should know about ABRILADA?" • Serious Infections. Your healthcare provider will examine you for TB and perform a test to see if you have TB. If your healthcare provider feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with ABRILADA and during treatment with ABRILADA. Even if your TB test is negative your healthcare provider should carefully monitor you for TB infections while you are taking ABRILADA. People who had a negative TB skin test before receiving adalimumab products have developed active TB. Tell your healthcare provider if you have any of the following symptoms while taking or after taking ABRILADA:
	o cough that does not go away o low grade fever	o weight loss o loss of body fat and muscle (wasting)
• Hepatitis B infection in people who carry the virus in their blood. If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus can become active while you use ABRILADA. Your healthcare provider should do blood tests before you start treatment, while you are using ABRILADA, and for several months after you stop treatment with ABRILADA. Tell your healthcare provider if you have any of the following symptoms of a possible hepatitis B infection:
	o muscle aches o feel very tired o dark urine o skin or eyes look yellow o little or no appetite o vomiting	o clay-colored bowel movements o fever o chills o stomach discomfort o skin rash
• Allergic reactions. Allergic reactions can happen in people who use ABRILADA. Call your healthcare provider or get medical help right away if you have any of these symptoms of a serious allergic reaction:
	o hives o trouble breathing	o swelling of your face, eyes, lips or mouth
• Nervous system problems. Signs and symptoms of a nervous system problem include: numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness. • Blood problems. Your body may not make enough of the blood cells that help fight infections or help to stop bleeding. Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale. • New heart failure or worsening of heart failure you already have. Call your healthcare provider right away if you get new worsening symptoms of heart failure while taking ABRILADA, including:
	o shortness of breath o sudden weight gain	o swelling of your ankles or feet
• Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or a rash on your cheeks or arms that gets worse in the sun. Symptoms may improve when you stop ABRILADA. • Liver problems. Liver problems can happen in people who use TNF-blocker medicines. These problems can lead to liver failure and death. Call your healthcare provider right away if you have any of these symptoms:
	o feel very tired o poor appetite or vomiting	o skin or eyes look yellow o pain on the right side of your stomach (abdomen)
• Psoriasis. Some people using adalimumab products had new psoriasis or worsening of psoriasis they already had. Tell your healthcare provider if you develop red scaly patches or raised bumps that are filled with pus. Your healthcare provider may decide to stop your treatment with ABRILADA. Call your healthcare provider or get medical care right away if you develop any of the above symptoms. Your treatment with ABRILADA may be stopped. The most common side effects of ABRILADA include: • injection site reactions: redness, rash, swelling, itching, or bruising. These symptoms usually will go away within a few days. Call your healthcare provider right away if you have pain, redness or swelling around the injection site that does not go away within a few days or gets worse. • upper respiratory infections (including sinus infections). • headaches. • rash. These are not all of the possible side effects with ABRILADA. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Ask your healthcare provider or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store ABRILADA? • Store ABRILADA in the refrigerator at 36°F to 46°F (2°C to 8°C). Store ABRILADA in the original carton until use to protect it from light. • Do not freeze ABRILADA. Do not use ABRILADA if frozen, even if it has been thawed. • Refrigerated ABRILADA may be used until the expiration date printed on the ABRILADA carton, pen or prefilled syringe. Do not use ABRILADA after the expiration date. • If needed, for example when you are traveling, you may also store ABRILADA at room temperature up to 86°F (30°C) for up to 30 days. Store ABRILADA in the original carton until use to protect it from light. • Throw away ABRILADA if it has been kept at room temperature and not been used within 30 days. • Record the date you first remove ABRILADA from the refrigerator in the spaces provided on the ABRILADA pen carton or the prefilled syringe carton. • Do not store ABRILADA in extreme heat or cold. • The medicine in ABRILADA should be clear and colorless to very light brown. Do not use a pen or prefilled syringe if the liquid is cloudy, discolored, or has flakes or particles in it. • Do not drop or crush ABRILADA. The prefilled syringe is glass. Keep ABRILADA, injection supplies, and all other medicines out of the reach of children.
General information about the safe and effective use of ABRILADA Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ABRILADA for a condition for which it was not prescribed. Do not give ABRILADA to other people, even if they have the same condition. It may harm them. This Medication Guide summarizes the most important information about ABRILADA. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about ABRILADA that is written for health professionals.
What are the ingredients in ABRILADA? Active ingredient: adalimumab-afzb ABRILADA pen 40 mg/0.8 mL, ABRILADA 40 mg/0.8 mL prefilled syringe, ABRILADA 20 mg/0.4 mL prefilled syringe, ABRILADA 10 mg/0.2 mL prefilled syringe, and ABRILADA 40 mg/0.8 mL institutional use vial: Inactive ingredients: edetate disodium dihydrate, L-histidine, L-histidine hydrochloride monohydrate, L-methionine, polysorbate 80, sucrose, and Water for Injection. Manufactured by Pfizer Inc. New York, NY 10001 Distributed by Pfizer Labs Division of Pfizer Inc. New York, NY 10001 US License No. 2001 LAB-1351-5.0 For more information go to www.Pfizer.com.

This Medication Guide has been approved by the U.S. Food and Drug Administration.     Revised: 08/2023

17 PATIENT COUNSELING INFORMATION

Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

INSTRUCTIONS FOR USE

ABRILADA (AH brill-ah-dah)
(adalimumab-afzb)
40 mg/0.8 mL
Single-dose Prefilled Pen
Injection, for subcutaneous (under the skin) use

Keep this leaflet. These instructions show step by step directions on how to prepare and give an injection.

Storage Information:

•

Store your ABRILADA pen in the refrigerator at 36°F to 46°F (2°C to 8°C).

•

Store ABRILADA pen in the original carton until use to protect from light.

•

Do not freeze ABRILADA. Do not use ABRILADA if frozen, even if it has been thawed.

•

Refrigerated ABRILADA may be used until the expiration date printed on the ABRILADA carton or pen. Do not use ABRILADA after the expiration date.

•

If needed, for example when you are traveling, you may also store ABRILADA at room temperature up to 86°F (30°C) for up to 30 days. Store ABRILADA in the original carton until use to protect it from light.

•

Throw away ABRILADA if it has been kept at room temperature and not been used within 30 days.

•

Record the date you first remove ABRILADA from the refrigerator in the spaces provided on the ABRILADA pen carton.

•

Do not store ABRILADA in extreme heat or cold.

•

Do not use the pen if the liquid is cloudy, discolored, or has flakes or particles in it.

Keep ABRILADA, injection supplies, and all other medicines out of the reach of children.

ABRILADA for injection comes in a disposable (throw away) single-use pen that contains a single dose of medicine.

ABRILADA for injection can be given by a patient, caregiver or healthcare provider. Do not try to inject ABRILADA yourself until you are shown the right way to give the injections and read and understand the Instructions for Use. If your healthcare provider decides that you or a caregiver may be able to give your injections of ABRILADA at home, you should receive training on the right way to prepare and inject ABRILADA. It is important that you read, understand, and follow these instructions so that you inject ABRILADA the right way.

It is important to talk to your healthcare provider to be sure you understand your ABRILADA dosing instructions. To help you remember when to inject ABRILADA, you can mark your calendar ahead of time. Call your healthcare provider if you or your caregiver have any questions about the right way to inject ABRILADA.

Step 1. Supplies you need

•

You will need the following supplies for each injection of ABRILADA. Find a clean, flat surface to place the supplies on.

o

1 ABRILADA pen (included inside the carton)

o

1 alcohol swab (included inside the carton)

o

1 cotton ball or gauze pad (not included in your ABRILADA carton)

o

1 puncture resistant sharps disposal container for pen disposal (not included in your ABRILADA carton). See Step 10 "Dispose of used pen" at the end of this Instructions for Use.

Step 2. Getting ready

•

Remove the ABRILADA carton from the refrigerator.

•

Make sure the name ABRILADA appears on the carton and prefilled pen label.

•

Take out 1 ABRILADA pen and the alcohol swab. Keep your pen out of direct sunlight. Put the original carton with any unused pens back in the refrigerator.

•

Do not use your pen if:

o

your pen or the carton containing the pen has been dropped

o

it has been frozen or thawed

o

it has been kept in direct sunlight

o

it appears to be damaged

o

the seals on a new carton are broken

o

it has been out of the refrigerator for more than 30 days

o

the expiration date has passed

o

the liquid is cloudy, discolored or has flakes or particles

•

For a more comfortable injection, you may leave your pen at room temperature for 15 to 30 minutes before your injection.

•

Do not warm ABRILADA in any other way (for example, do not warm it in a microwave or in hot water).

•

Do not shake your pen. Shaking can damage your medicine.

•

Wash your hands with soap and water, and dry completely.

•

Do not remove the cap until you are ready to inject.

•

Look carefully at your medicine in the window.

•

Make sure the medicine in the pen is clear and colorless to very light brown and free from flakes or particles.

•

It is normal to see one or more air bubbles in the window.

•

Check the expiration date on the pen label. The location of the expiration date on the pen label is shown below. Do not use the pen if the expiration date has passed.
If you have any questions about your medicine, please contact your healthcare provider or pharmacist.

•

Choose a different injection site each time you give an injection:

o

Only use the front of your thighs or your lower abdomen (belly) as shown. If you choose your abdomen, do not use the area 2 inches around your belly button (navel).

o

Each new injection should be given at least one inch from a site you used before.

•

Do not inject into bony areas or areas on your skin that are bruised, red, sore (tender) or hard. Avoid injecting into areas with scars or stretch marks.

o

If you have psoriasis, do not inject directly into any raised, thick, red, or scaly skin patches or lesions on your skin.

•

Do not inject through your clothes.

•

Wipe the injection site with the alcohol swab.

•

Allow the injection site to dry. Do not fan or blow on the clean area.

•

Do not touch this area again before giving the injection.

•

Twist and pull off the cap.

•

Throw the cap away into a sharps disposal container. You will not need it again.
Important: Handle your pen with care to avoid an accidental needle stick injury.
Note: A needle cover stays inside the cap after cap removal.

•

Push your pen firmly against the skin at 90 degrees, as shown in the diagram.
Note: The needle goes into the skin as you push your pen down. You will only be able to press down the injection button in Step 7 when you are pushing down firmly enough.

•

Keep your pen pushed against the skin until Step 9.

•

Press the injection button all the way down and you will hear a click. The click means the start of the injection.

•

Keep holding your pen firmly against the skin while the orange bar moves across the window. You will hear a 2nd click.

•

Wait for at least 5 more seconds after the 2nd click to make sure you get the full dose of medicine.
Note: If you cannot press down the injection button, it is because you are not pushing the pen down firmly enough at the injection site. See the Question and Answer section on the right side of this Instructions for Use for more information on what to do if the injection button does not press down.

•

You should see an orange bar in the window.

•

Do not remove your pen until you have waited at least 5 seconds after the 2nd click and until the orange bar completely fills the window.

•

Remove your pen from the skin.
Note: After you remove your pen from the skin, the needle will be automatically covered.

•

If the window has not turned orange, this means you have not received a full dose. Call your healthcare provider or pharmacist right away.

•

Do not inject another dose.

•

Put your used pen in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) pens in your household trash.

•

If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:

o

made of heavy duty plastic,

o

can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,

o

upright and stable during use,

o

leak-resistant, and

o

is 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 the FDA's website at http://www.fda.gov/safesharpsdisposal.

•

Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

•

Look closely at your injection site. If there is blood, use a clean cotton ball or gauze pad to press lightly on the injection area for a few seconds.

•

Do not rub the injection site.
Note: Store any unused pens in the refrigerator in the original carton.

Questions and Answers

What should I do with my pen if it has been dropped?

Do not use it, even if it looks undamaged. Dispose of your pen in the same way as a used pen. You will need to use a new pen to give your injection.

Can I use my pen straight from the refrigerator?

Yes, however you may find that using the pen at room temperature reduces stinging or discomfort. If you allow your pen to reach room temperature before use, you must keep it away from direct sunlight as this can damage your medicine.

What should I do if I need to travel?

When you are traveling, you may store your pen in its carton at room temperature up to 86°F (30°C) for up to 30 days.

Is it okay to shake my pen before I use it?

No, do not shake your pen. Shaking can damage your medicine. When you check your medicine, gently tilt your pen back and forth while looking carefully into the window. It is normal to see one or more air bubbles.

Do I need to remove any air bubbles before using my pen?

No, do not attempt to remove air bubbles.

Drops of medicine have appeared at the needle tip. Is this okay?

Yes, it is normal to see a few drops of medicine at the needle tip when you remove the cap.

Can I re-insert the needle if I change my mind where I want to inject?

No, you should not re-insert the needle into your skin. If you change your mind, you will need a replacement pen if the needle has already been inserted into the skin. After the injection button has been pressed, you must not lift your pen from the skin until the injection has finished.

I pushed my pen against the skin but could not press the button down. What should I do?

Take your finger off the injection button and push your pen down more firmly against the skin. Then try pushing the button again. If this does not work, stretching the skin may make the injection site firmer, making pressing the injection button easier.

Can I pinch or stretch the skin at the injection area?

Yes, pinching or stretching the skin before injection may make the injection site firmer, making it easier to press the injection button.

Do I need to keep my finger pressed on the injection button for the whole injection?

No, you can stop pressing the button when the injection has started. However, make sure you keep holding the pen firmly against the skin. The pen will continue to deliver your medicine.

How long will the injection take?

From the time the dose begins until you hear the 2nd click, it usually takes 3 to 10 seconds. After the 2nd click, you should continue to hold your pen in place for at least 5 more seconds to make sure you give the full dose.

What should I do if I see more than a small drop of medicine on the skin after giving my injection?

Nothing this time, but for your next injection wait a little longer before removing the pen from the skin to make sure all of the medicine went into your skin.

What should I do if I have any questions about my ABRILADA pen or medicine?

Contact your healthcare provider or pharmacist.

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

Manufactured by Pfizer Inc.
New York, NY 10001

Distributed by Pfizer Labs
Division of Pfizer Inc.
New York, NY 10001

US License No. 2001

LAB-1352-3.0

Revised: 06/2023

INSTRUCTIONS FOR USE

ABRILADA (AH brill-ah-dah)
(adalimumab-afzb)
10 mg/0.2 mL, 20 mg/0.4 mL, 40 mg/0.8 mL
Single-dose Prefilled Syringe

Injection, for subcutaneous (under the skin) use only

Keep this leaflet. These instructions show step by step directions on how to prepare and give an injection.

Storage Information:

•

Store your ABRILADA prefilled syringe in the refrigerator at 36°F to 46°F (2°C to 8°C).

•

Store ABRILADA prefilled syringe in the original carton until use to protect from light.

•

Do not freeze ABRILADA. Do not use ABRILADA if frozen, even if it has been thawed.

•

Refrigerated ABRILADA may be used until the expiration date printed on the ABRILADA carton or prefilled syringe. Do not use ABRILADA after the expiration date.

•

If needed, for example when you are traveling, you may also store ABRILADA at room temperature up to 86°F (30°C) for up to 30 days. Store ABRILADA in the original carton until use to protect it from light.

•

Throw away ABRILADA if it has been kept at room temperature and not been used within 30 days.

•

Record the date you first remove ABRILADA from the refrigerator in the spaces provided on the ABRILADA prefilled syringe carton.

•

Do not store ABRILADA in extreme heat or cold.

•

Do not use a prefilled syringe if the liquid is cloudy, discolored, or has flakes or particles in it.

•

Do not drop or crush ABRILADA. The prefilled syringe is glass.

Keep ABRILADA, injection supplies, and all other medicines out of the reach of children.

ABRILADA for injection comes in a disposable (throw away) single use prefilled syringe that contains a single dose of medicine.

ABRILADA for injection can be given by a patient, caregiver or healthcare provider. Do not try to inject ABRILADA yourself until you are shown the right way to give the injections and read and understand the Instructions for Use. If your healthcare provider decides that you or a caregiver may be able to give your injections of ABRILADA at home, you should receive training on the right way to prepare and inject ABRILADA. It is important that you read, understand, and follow these instructions so that you inject ABRILADA the right way.

It is important to talk to your healthcare provider to be sure you understand your ABRILADA dosing instructions. To help you remember when to inject ABRILADA, you can mark your calendar ahead of time. Call your healthcare provider if you or your caregiver have any questions about the right way to inject ABRILADA.

Step 1. Supplies you need

•

You will need the following supplies for each injection of ABRILADA. Find a clean, flat surface to place the supplies on.

o

1 ABRILADA prefilled syringe in a tray inside the carton

o

1 alcohol swab inside the carton

o

1 cotton ball or gauze pad (not included in your ABRILADA carton)

o

1 puncture resistant sharps disposal container for prefilled syringe disposal (not included in your ABRILADA carton). See Step 10 "Dispose of used syringe" at the end of this Instructions for Use.

Step 2. Getting ready

•

Remove ABRILADA carton from the refrigerator.

•

Open the carton and take out the tray containing your prefilled syringe.

•

Make sure the name ABRILADA appears on the dose tray and prefilled syringe label.

•

Check your carton and tray. Do not use if:

o

it has been dropped

o

it has been frozen or thawed

o

it appears to be damaged

o

the seals on a new carton are broken

o

it has been out of the refrigerator for more than 30 days

o

the expiration date has passed

Wash your hands with soap and water, and dry completely.
If you have any questions about your medicine, please contact your healthcare provider or pharmacist.

•

Peel back the paper seal on the tray.

•

Remove 1 prefilled syringe from the tray and put the original carton with any unused prefilled syringes back in the refrigerator.

•

Do not use your syringe if:

o

it appears to be damaged

o

It has been kept in direct sunlight

o

liquid is cloudy, discolored, or has flakes or particles

•

Do not shake your syringe. Shaking can damage your medicine.

•

For a more comfortable injection, leave the prefilled syringe at room temperature for 15 to 30 minutes before your injection.

•

Do not warm ABRILADA in any other way (for example, do not warm it in a microwave or in hot water).

•

Do not remove the needle cover from your prefilled syringe until you are ready to inject.
Always hold the prefilled syringe by the barrel to prevent damage.

•

Look carefully at your medicine in the window.

•

Make sure the medicine in the prefilled syringe is clear and colorless to very light brown and free from flakes or particles.

•

It is normal to see one or more air bubbles in the window.

•

Check the expiration date on the prefilled syringe label as shown in the figure in Step 1. Do not use the prefilled syringe if the expiration date has passed.
If you have any questions about your medicine, please contact your healthcare provider or pharmacist.

•

Choose a different injection site each time you give an injection.

o

Only use the front of your thighs or your lower abdomen (belly) as shown. If you choose your abdomen, do not use the area 2 inches around your belly button (navel).

o

Each new injection should be given at least one inch from a site you used before.

•

Do not inject into bony areas or areas on your skin that are bruised, red, sore (tender) or hard. Avoid injecting into areas with scars or stretch marks.

o

If you have psoriasis, do not inject directly into any raised, thick, red, or scaly skin patches or lesions on your skin.

•

Do not inject through your clothes.

•

Wipe the injection site with the alcohol swab.

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Allow the injection site to dry. Do not fan or blow on the clean area.

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Do not touch this area again before giving the injection.

•

Hold the prefilled syringe by the barrel. Carefully pull the needle cover straight off and away from your body when you are ready to inject.

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It is normal to see a drop of liquid at the end of the needle.

•

Throw the needle cover away into a sharps disposal container.
Note: Be careful when you handle your prefilled syringe to avoid an accidental needle stick injury.

•

Gently pinch up a fold of skin in the cleaned injection site area.

•

Insert the needle to its full depth into the skin, at a 45 degree angle, as shown.

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After the needle is inserted, release the pinched skin.

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Using slow and constant pressure, push the plunger rod all the way down until the barrel is empty.
Note: It is recommended to hold your prefilled syringe in the skin for an additional 5 seconds after the plunger has been pressed down completely to make sure you get the full dose of medicine.

•

Pull the needle out of the skin at the same angle at which it entered.

•

Check that your medicine has completely emptied from your prefilled syringe. If the gray stopper is not in the position shown, you may not have injected all of your medicine. Contact your healthcare provider right away.

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Never re-insert the needle.

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Never put the cap back on the needle.

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Put your used syringe in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) syringes in your household trash.

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If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:

o

made of heavy duty plastic,

o

can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,

o

upright and stable during use,

o

leak-resistant, and

o

is 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 the FDA's website at http://www.fda.gov/safesharpsdisposal.

•

Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

•

Look closely at your injection site. If there is blood, use a clean cotton ball or gauze pad to press lightly on the injection area for a few seconds.

•

Do not rub the site.
Note: Store any unused syringes in the refrigerator in the original carton.

Questions and Answers

What should I do with my prefilled syringe if it has been dropped?

Do not use it if it has been dropped or the carton containing your prefilled syringe has been dropped even if it looks undamaged. Dispose of your prefilled syringe in the same way as a used prefilled syringe. You will need to use a new prefilled syringe to give your injection.

Can I use my prefilled syringe straight from the refrigerator?

Yes, however you may find that using the prefilled syringe at room temperature reduces stinging or discomfort. If you allow your prefilled syringe to reach room temperature before use, you must keep it away from direct sunlight as this can damage your medicine.

What should I do if I need to travel?

When you are traveling, you may store your prefilled syringe in its carton at room temperature up to 86°F (30°C) for up to 30 days.

Is it okay to shake my prefilled syringe before I use it?

No, do not shake your prefilled syringe. Shaking can damage your medicine. When you check your medicine, gently tilt your syringe back and forth while looking carefully into the window. It is normal to see one or more bubbles.

Do I need to remove any air bubbles before using my prefilled syringe?

No, do not attempt to remove air bubbles.

Drops of medicine have appeared at the needle tip. Is this okay?

Yes, it is normal to see a few drops of medicine at the needle tip when you remove the needle cover.

Can I re-insert the needle into my skin?

No, you should not re-insert the needle into the skin. You will need a replacement prefilled syringe if the needle has already been inserted into the skin.

How long will the injection take?

Dose delivery will take approximately 2 to 5 seconds. Remember to hold your prefilled syringe in place for at least 5 seconds after the plunger has been pushed down all the way.

What should I do if I have any questions about my prefilled syringe or medicine?

Contact your healthcare provider or pharmacist.

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

Manufactured by Pfizer Inc.
New York, NY 10001

Distributed by Pfizer Labs
Division of Pfizer Inc.
New York, NY 10001

US License No. 2001

LAB-1353-3.0

Revised: 06/2023