Humira

What is Humira?

Humira is a medicine called a Tumor Necrosis Factor (TNF) blocker.

• Humira is used to reduce the signs and symptoms of:
  • moderate to severe rheumatoid arthritis (RA) in adults. Humira can be used alone, with methotrexate, or with certain other medicines.
  • moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years and older. Humira can be used alone, with methotrexate, or with certain other medicines.
  • psoriatic arthritis (PsA) in adults. Humira can be used alone or with certain other medicines.
  • ankylosing spondylitis (AS) in adults.
  • moderate to severe Crohn’s disease (CD) in adults when other treatments have not worked well enough.
  • moderate to severe Crohn’s disease (CD) in children 6 years and older when other treatments have not worked well enough.
• In adults, to help get moderate to severe ulcerative colitis (UC) under control (induce remission) and keep it under control (sustain remission) when certain other medicines have not worked well enough. It is not known if Humira is 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 and children 2 years of age and older.

What is the most important information I should know about Humira?

1. Infections

Humira is a medicine that affects your immune system. Humira can lower the ability of your immune system to fight infections. Serious infections have happened in people taking Humira. 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 doctor should test you for TB before starting Humira.
• Your doctor should check you closely for signs and symptoms of TB during treatment with Humira.

You should not start taking Humira if you have any kind of infection unless your doctor says it is okay.

Before starting Humira, tell your doctor if you:

• Think you have an infection or have symptoms of infection such as:
  • fever, sweats, or chills
  • muscle aches
  • cough
  • shortness of breath
  • blood in phlegm
  • warm, red, or painful skin or sores on your body
  • diarrhea or stomach pain
  • burning when you urinate or urinate more often than normal
  • feel very tired
  • 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 doctor 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 Humira. Ask your doctor 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 Humira, call your doctor right away if you have an infection, or any sign of an infection.

Humira can make you more likely to get infections or make any infection that you may have worse.

2. Cancer

• For children and adults taking TNF-blockers, including Humira, 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 RA, especially more serious RA, may have a higher chance for getting a kind of cancer called lymphoma.
• If you use TNF blockers including Humira 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 doctor if you have a bump or open sore that does not heal.
• Some people receiving TNF blockers including Humira 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 should I tell my healthcare provider before taking Humira?

Humira may not be right for you. Before starting Humira, tell your doctor about all of your health conditions, including if you:

• Have an infection. See “What is the most important information I should know about Humira?”.
• 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.ave or had heart failure.
• Have recently received or are scheduled to receive a vaccine. You may receive vaccines, except for live vaccines while using Humira. Children should be brought up to date with all vaccines before starting Humira.
• Are allergic to rubber or latex. Tell your doctor if you have any allergies to rubber or latex.
  • The needle cover for the Humira Pen 40 mg/0.8 mL, Humira 40 mg/0.8 mL prefilled syringe, Humira 20 mg/0.4 mL prefilled syringe, and Humira 10 mg/0.2 mL prefilled syringe may contain natural rubber or latex.
  • The black needle cover for the Humira Pen 80 mg/0.8 mL, Humira 80 mg/0.8 mL prefilled syringe, Humira Pen 40 mg/0.4 mL, Humira 40 mg/0.4 mL prefilled syringe, Humira 20 mg/0.2 mL prefilled syringe, Humira 10 mg/0.1 mL prefilled syringe and the vial stopper on the Humira institutional use vial are not made with natural rubber or latex.
• Are allergic to Humira or to any of its ingredients. See the end of this Medication Guide for a list of ingredients in Humira.
• Are pregnant or plan to become pregnant, breastfeeding or plan to breastfeed. You and your doctor should decide if you should take Humira while you are pregnant or breastfeeding.
• Have a baby and you were using Humira during your pregnancy. Tell your baby’s doctor before your baby receives any vaccines.

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

Especially tell your doctor if you use:

• Orencia (abatacept), Kineret (anakinra), Remicade (infliximab), Enbrel (etanercept), Cimzia (certolizumab pegol) or Simponi (golimumab), because you should not use Humira while you are also using one of these medicines.
• Rituxan (rituximab). Your doctor may not want to give you Humira 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 doctor and pharmacist each time you get a new medicine.

How should I take Humira?

• Humira is given by an injection under the skin. Your doctor will tell you how often to take an injection of Humira. This is based on your condition to be treated. Do not inject Humira 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 Humira.
• Make sure you have been shown how to inject Humira before you do it yourself. You can call your doctor or 1-800-4Humira (1-800-448-6472) 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 Humira.
• Do not try to inject Humira yourself until you have been shown the right way to give the injections. If your doctor decides that you or a caregiver may be able to give your injections of Humira at home, you should receive training on the right way to prepare and inject Humira.
• Do not miss any doses of Humira unless your doctor says it is okay. If you forget to take Humira, 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 Humira, call your doctor or pharmacist.
• If you take more Humira than you were told to take, call your doctor.

What are the possible side effects of Humira?

Humira can cause serious side effects, including:

See “What is the most important information I should know about Humira?”

• Serious Infections. Your doctor will examine you for TB and perform a test to see if you have TB. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with Humira and during treatment with Humira. Even if your TB test is negative your doctor should carefully monitor you for TB infections while you are taking Humira. People who had a negative TB skin test before receiving Humira have developed active TB. Tell your doctor if you have any of the following symptoms while taking or after taking Humira:
  • cough that does not go away
  • low grade fever
  • weight loss
  • 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 Humira. Your doctor should do blood tests before you start treatment, while you are using Humira, and for several months after you stop treatment with Humira. Tell your doctor if you have any of the following symptoms of a possible hepatitis B infection:
  • muscle aches
  • feel very tired
  • dark urine
  • skin or eyes look yellow
  • little or no appetite
  • vomiting
  • clay-colored bowel movements
  • fever
  • chills
  • stomach discomfort
  • skin rash
• Allergic reactions. Allergic reactions can happen in people who use Humira. Call your doctor or get medical help right away if you have any of these symptoms of a serious allergic reaction:
  • hives
  • trouble breathing
  • 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 doctor right away if you get new worsening symptoms of heart failure while taking Humira, including:
  • shortness of breath
  • sudden weight gain
  • 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 Humira.
• Liver Problems. Liver problems can happen in people who use TNF-blocker medicines. These problems can lead to liver failure and death. Call your doctor right away if you have any of these symptoms:
  • feel very tired
  • poor appetite or vomiting
  • skin or eyes look yellow
  • pain on the right side of your stomach (abdomen)
• Psoriasis. Some people using Humira had new psoriasis or worsening of psoriasis they already had. Tell your doctor if you develop red scaly patches or raised bumps that are filled with pus. Your doctor may decide to stop your treatment with Humira.

Call your doctor or get medical care right away if you develop any of the above symptoms. Your treatment with Humira may be stopped.

Common side effects with Humira include:

• injection site reactions: redness, rash, swelling, itching, or bruising. These symptoms usually will go away within a few days. Call your doctor 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 the possible side effects with Humira. Tell your doctor if you have any side effect that bothers you or that does not go away. Ask your doctor 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.

General information about the safe and effective use of Humira

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

This Medication Guide summarizes the most important information about Humira. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Humira that is written for health professionals. For more information go to www.humira.com or you can enroll in a patient support program by calling 1-800-4Humira (1-800-448-6472).

How should I store Humira?

• Store Humira in the refrigerator at 36ºF to 46ºF (2ºC to 8ºC).
• Store Humira in the original carton until use to protect it from light.
• Do not freeze Humira. Do not use Humira if frozen, even if it has been thawed.
• Refrigerated Humira may be used until the expiration date printed on the Humira carton, dose tray, Pen or prefilled syringe. Do not use Humira after the expiration date.
• If needed, for example when you are traveling, you may also store Humira at room temperature up to 77°F (25°C) for up to 14 days. Store Humira in the original carton until use to protect it from light.
• Throw away Humira if it has been kept at room temperature and not been used within 14 days.
• Record the date you first remove Humira from the refrigerator in the spaces provided on the carton and dose tray.
• Do not store Humira in extreme heat or cold.
• 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 Humira. The prefilled syringe is glass.

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

What are the ingredients in Humira?

Active ingredient: adalimumab

Humira Pen 40 mg/0.8 mL, Humira 40 mg/0.8 mL prefilled syringe, Humira 20 mg/0.4 mL prefilled syringe, Humira 10 mg/0.2 mL prefilled syringe, and Humira 40 mg/0.8 mL institutional use vial:

• Inactive ingredients: citric acid monohydrate, dibasic sodium phosphate dihydrate, mannitol, monobasic sodium phosphate dihydrate, polysorbate 80, sodium chloride, sodium citrate and Water for Injection. Sodium hydroxide is added as necessary to adjust pH.

Humira Pen 80 mg/0.8 mL, Humira 80 mg/0.8 mL prefilled syringe, Humira Pen 40 mg/0.4 mL, Humira 40 mg/0.4 mL prefilled syringe, Humira 20 mg/0.2 mL prefilled syringe and Humira 10 mg/0.1 mL prefilled syringe:

• Inactive ingredients: mannitol, polysorbate 80, and Water for Injection.

Instructions for use

Included in this sections are the instructions for use for the:

• Humira single-dose pen 40mg/0.8ml
• Humira single-dose pen 40mg/0.4ml
• Humira single-dose pen 80mg/0.8ml
• Humira single-dose prefilled syringe 40mg/0.8ml, 20mg/0.4ml and 10mg/0.2ml
• Humira single-dose prefilled syringe 80mg/0.8ml, 40mg/0.4ml, 20mg/0.2ml and 10mg/0.1ml

Humira 40mg/0.8ml single-dose pen

Do not try to inject Humira yourself until you have been shown the right way to give the injections and have read and understand this Instructions for Use. If your doctor decides that you or a caregiver may be able to give your injections of Humira at home, you should receive training on the right way to prepare and inject Humira. It is important that you read, understand, and follow these instructions so that you inject Humira the right way. It is also important to talk to your doctor to be sure you understand your Humira dosing instructions. To help you remember when to inject Humira, 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 Humira.

Important:

• Do not use Humira if frozen, even if it has been thawed.
• The Humira Pen contains glass. Do not drop or crush the Pen because the glass inside may break.
• Each Humira Pen has 2 caps on it. Do not remove the gray cap (Cap #1) or the plum-colored cap (Cap #2) until right before your injection.
• When the plum-colored button on the Humira Pen is pressed to give your dose of Humira, you will hear a loud “click” sound.
  • You must practice injecting Humira with your doctor or nurse so that you are not startled by this click when you start giving yourself the injections at home.
  • The loud click sound means the start of the injection.
  • You will know that the injection has finished when the yellow marker appears fully in the window view and stops moving.

Gather the Supplies for Your Injection

• You will need the following supplies for each injection of Humira.
  Find a clean, flat surface to place the supplies on.
  • 1 alcohol swab
  • 1 cotton ball or gauze pad (not included in your Humira carton)
  • 1 Humira Pen (See Figure A)
  • Puncture-resistant sharps disposal container for Humira Pen disposal (not included in your Humira carton). See the “How should I dispose of the used Humira Pen?” section at the end of this Instructions for Use

If more comfortable, take your Humira Pen out of the refrigerator 15 to 30 minutes before injecting to allow the liquid to reach room temperature. Do not remove the gray cap (Cap #1) or the plum-colored cap (Cap #2) while allowing it to reach room temperature. Do not warm Humira in any other way (for example, do not warm it in a microwave or in hot water).

If you do not have all the supplies you need to give yourself an injection, go to a pharmacy or call your pharmacist. The figure below shows what the Humira Pen looks like. See Figure A.

Figure A

Check the carton, dose tray, and Humira Pen.

1. Make sure the name Humira appears on the carton, dose tray, and Humira Pen label.

2. Do not use and do call your doctor or pharmacist if:

• you drop or crush your Humira Pen.
• the seals on the top or bottom of the carton are broken or missing.
• the expiration date on the carton, dose tray, and Pen has passed.
• the Humira Pen has been frozen or left in direct sunlight.
• Humira has been kept at room temperature for longer than 14 days or Humira has been stored above 77°F (25°C).

See the “How should I store Humira?”

3. Hold the Pen with the gray cap (Cap # 1) pointed down.

4. Make sure the amount of liquid in the Pen is at the fill line or close to the fill line seen through the window. This is the full dose of Humira that you will inject. See Figure B.

5. If the Pen does not have the full amount of liquid, do not use that Pen. Call your pharmacist.

Figure B

6. Turn the Pen over and hold the Pen with the gray cap (Cap # 1) pointed up. See Figure C.

7. Check the solution through the windows on the side of the Pen to make sure the liquid is clear and colorless. Do not use your Humira Pen if the liquid is cloudy, discolored, or if it has flakes or particles in it. Call your pharmacist. It is normal to see one or more bubbles in the window.

Figure C

Choose the Injection Site

8. Wash and dry your hands well.

9. Choose an injection site on:

• the front of your thighs or
• your lower abdomen (belly). If you choose your abdomen, do not use the area 2 inches around your belly button (navel). See Figure D.

Figure D

• Choose a different site each time you give yourself an injection. Each new injection should be given at least one inch from a site you used before.
• Do not inject Humira into skin that is:
  • sore (tender)
  • bruised
  • red
  • hard
  • scarred or where you have stretch marks
• 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.

Prepare the Injection Site

10. Wipe the injection site with an alcohol prep (swab) using a circular motion.

• Do not touch this area again before giving the injection. Allow the skin to dry before injecting. Do not fan or blow on the clean area.

Preparing the Humira Pen

11. Do not remove the gray cap (Cap # 1) or the plum-colored cap (Cap # 2) until right before your injection.

12. Hold the middle of the Pen (gray body) with one hand so that you are not touching the gray cap (Cap # 1) or the plum-colored cap (Cap # 2). Turn the Pen so that the gray cap (Cap # 1) is pointing up. See Figure E.

Figure E

13. With your other hand, pull the gray cap (Cap # 1) straight off (do not twist the cap). Make sure the small needle cover of the syringe has come off with the gray cap (Cap # 1). See Figure F.

14. Throw away the gray cap (Cap # 1).

Figure F

• Do not put the gray cap (Cap # 1) back on the Pen. Putting the gray cap (Cap # 1) back on may damage the needle.
• The white needle sleeve, which covers the needle, can now be seen.
• Do not touch the needle with your fingers or let the needle touch anything.
• You may see a few drops of liquid come out of the needle. This is normal.

15. Remove the plum-colored cap (Cap # 2) from the bottom of the Pen by pulling it straight off (do not twist the cap). The Pen is now activated. Throw away the plum-colored cap (Cap # 2).

• Do not put the plum-colored cap (Cap # 2) back on the Pen because it could cause medicine to come out of the syringe.

The plum-colored activator button:

• Turn the Pen so the plum-colored activator button is pointed up. See Figure G.

Figure G

• Do not press the plum-colored activator button until you are ready to inject Humira. Pressing the plum-colored activator button will release the medicine from the Pen.
• Hold the Pen so that you can see the window. See Figure H. It is normal to see one or more bubbles in the window.

Figure H

Position the Pen and Inject Humira

16. Position the Pen:

• Gently squeeze the area of the cleaned skin and hold it firmly. See Figure I. You will inject into this raised area of skin.

Figure I

17. Place the white end of the Pen straight (at a 90º angle) and flat against the raised area of your skin that you are squeezing. Place the Pen so that it will not inject the needle into your fingers that are holding the raised skin. See Figure J.

Figure J

18. Inject Humira

• With your index finger or your thumb, press the plum-colored activator button to begin the injection. Try not to cover the window. See Figure K.

Figure K

• You will hear a loud ‘click’ when you press the plum-colored activator button. The loud click means the start of the injection.
• Keep pressing the plum-colored activator button and continue to hold the Pen against your squeezed, raised skin until all the medicine is injected. This can take up to 10 seconds, so count slowly to ten. Keep holding the Pen against the squeezed, raised skin of your injection site for the whole time so you get the full dose of medicine.
• You will know that the injection has finished when the yellow marker fully appears in the window view and stops moving. See Figure L.

Figure L

19. When the injection is finished, slowly pull the Pen from your skin. The white needle sleeve will move to cover the needle tip. See Figure M.

• Do not touch the needle. The white needle sleeve is there to prevent you from touching the needle.

Figure M

• Press a cotton ball or gauze pad over the injection site and hold it for 10 seconds. Do not rub the injection site. You may have slight bleeding. This is normal.

20. Throw away (dispose of) your used Humira Pen in a sharps disposal container right away after use. See the section “How should I dispose of the used Humira Pen?”

21. Keep a record of the dates and location of your injection sites. To help you remember when to take Humira, you can mark your calendar ahead of time.

How should I dispose of the used Humira Pen?

• Put your Pen in a FDA-cleared sharps disposal container right away after use. See Figure N. Do not throw away the Pen in your household trash.
• Do not try to touch the needle. The white needle sleeve is there to prevent you from touching the needle.

Figure N

• If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
  • made of a heavy-duty plastic,
  • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • upright and stable during use,
  • leak-resistant, and
  • 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.
• For the safety and health of you and others, never re-use your Humira Pens.
• The used alcohol pads, cotton balls, dose trays and packaging may be placed in your household trash.
• 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.
• Always keep the sharps container out of the reach of children.

Humira 40mg/0.4ml single-dose pen & 80mg/0.8ml single-dose pen

Before Injecting: Your healthcare provider should show you how to use Humira before you use it for the first time. Call your healthcare provider or 1-800-4HUMIRA (1-800-448-6472) if you need help.

Do not use the Pen and call your healthcare provider or pharmacist if:

• Liquid is cloudy, discolored, or has flakes or particles in it
• Expiration date has passed
• Liquid has been frozen (even if thawed) or left in direct sunlight
• The Pen has been dropped or crushed

Keep the caps on until right before injection. Keep Humira out of reach of children.

Read instructions on all pages before using the Humira Pen

Step by step instructions

Take Humira out of the refrigerator.
Leave Humira at room temperature for 15 to 30 minutes before injecting.

• Do not remove the Gray Cap (Cap #1) or Plum-colored Cap (Cap #2) while allowing Humira to reach room temperature
• Do not warm Humira in any other way. For example, do not warm it in a microwave or in hot water.
• Do not use the Pen if liquid has been frozen (even if thawed)

Check expiration date on the Pen label. Do not use the Pen if expiration date has passed.
Place the following on a clean, flat surface:

• 1 single-dose Pen and alcohol swab
• 1 cotton ball or gauze pad (not included)
• Puncture-resistant sharps disposal container (not included). See Step 9 at the end of this Instructions for Use for instructions on how to throw away (dispose of) your Humira Pen

Wash and dry your hands.

Choose an injection site:

• On the front of your thighs or
• Your abdomen (belly) at least 2 inches from your navel (belly button)
• Different from your last injection site

Wipe the injection site in a circular motion with the alcohol swab.

• Do not inject through clothes
• Do not inject into skin that is sore, bruised, red, hard, scarred, has stretch marks, or areas with psoriasis plaques

Hold the Pen with the Gray Cap #1 facing up. Check the window.

• It is normal to see 1 or more bubbles in the window
• Make sure the liquid is clear and colorless
• Do not use the Pen if the liquid is cloudy or has particles
• Do not use the Pen if it has been dropped or crushed

Pull the Gray Cap #1 straight off.
Throw the cap away.

• It is normal to see a few drops of liquid come out of the needle

Pull the Plum-colored Cap #2 straight off.
Throw the cap away.
Turn the Pen so that the white arrow points toward the injection site.

Squeeze the skin at your injection site to make a raised area and hold it firmly.
Point the white arrow toward the injection site.
Place the white needle sleeve straight (90° angle) against the injection site.
Hold the Pen so that you can see the inspection window.

Push and keep pushing the Pen down against the injection site.

Press the plum activator button and count slowly for 10 seconds.

• A loud “click” will signal the start of the injection
• Keep pushing the Pen down against the injection site
• Injection is complete when the yellow indicator has stopped moving

When the injection is completed, slowly pull the Pen from the skin. The white needle sleeve will cover the needle tip.

If there are more than a few drops of liquid on the injection site, call 1-800-4HUMIRA (1-800-448-6472) for help.

After completing the injection, place a cotton ball or gauze pad on the skin of the injection site.

• Do not rub
• Slight bleeding at the injection site is normal

How should I dispose the used Humira Pen?

• Put your used needles, Pens, and sharps in a FDA cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles, syringes, and the Pen in the household trash.
• If you do not have a FDA cleared sharps disposal container, you may use a household container that is:
  • made of a heavy-duty plastic,
  • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • upright and stable during use,
  • leak-resistant, and
  • 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.
• Always keep the Pen and the sharps disposal container out of reach of children

The Pen caps, alcohol swab, cotton ball or gauze pad, dose tray, and packaging may be placed in your household trash.

Keep a record of the dates and locations of your injections. To help remember when to take Humira, mark your calendar ahead of time.

Questions About Using the Humira Pen

What if I have not received in person training from a healthcare provider?

• Call your healthcare provider or 1-800-4HUMIRA (1-800-448-6472) or visit www.HUMIRA.com if you need help

How do I know when the injection is complete?

• The yellow indicator has stopped moving. This takes up to 10 seconds

What should I do if there are more than a few drops of liquid on the injection site?

• Call 1-800-4HUMIRA (1-800-448-6472) for help

What if I do not have an FDA-cleared sharps disposal container or proper household container?

• Call 1-800-4HUMIRA (1-800-448-6472) for a free FDA-cleared sharps disposal container

Humira (40mg/0.8ml, 20mg/0.4ml and 10mg/0.2ml) single-dose prefilled syringe

Do not try to inject Humira yourself until you have been shown the right way to give the injections and have read and understand this Instructions for Use. If your doctor decides that you or a caregiver may be able to give your injections of Humira at home, you should receive training on the right way to prepare and inject Humira. It is important that you read, understand, and follow these instructions so that you inject Humira the right way. It is also important to talk to your doctor to be sure you understand your Humira dosing instructions. To help you remember when to inject HUMIRA, 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 Humira.

Gather the Supplies for Your Injection

• You will need the following supplies for each injection of Humira.
  Find a clean, flat surface to place the supplies on.
  • 1 alcohol swab
  • 1 cotton ball or gauze pad (not included in your Humira carton)
  • 1 Humira prefilled syringe (See Figure A)
  • Puncture-resistant sharps disposal container for Humira prefilled syringe disposal (not included in your Humira carton). See the “How should I dispose of the used prefilled syringes and needles?” section at the end of this Instructions for Use

If more comfortable, take your Humira prefilled syringe out of the refrigerator 15 to 30 minutes before injecting to allow the liquid to reach room temperature. Do not remove the needle cover while allowing it to reach room temperature. Do not warm Humira in any other way (for example, do not warm it in a microwave or in hot water).

If you do not have all the supplies you need to give yourself an injection, go to a pharmacy or call your pharmacist.

The figure below shows what a prefilled syringe looks like. See Figure A.

Figure A

Check the carton, dose tray, and prefilled syringe

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

2. Do not use and do call your doctor or pharmacist if:

• the seals on top or bottom of the carton are broken or missing.
• the Humira labeling has an expired date. Check the expiration date on your Humira carton and do not use if the date has passed.
• the prefilled syringe that has been frozen or left in direct sunlight.
• Humira has been kept at room temperature for longer than 14 days or Humira has been stored above 77°F (25°C).
• the liquid in the prefilled syringe is cloudy, discolored or has flakes or particles in it. Make sure the liquid is clear and colorless.

See the “How should I store Humira?” section above.

Choose the Injection Site

3. Wash and dry your hands well.

4. Choose an injection site on:

• the front of your thighs or
• your lower abdomen (belly). If you choose your abdomen, do not use the area 2 inches around your belly button (navel). See Figure B.

Figure B

• Choose a different site each time you give yourself an injection. Each new injection should be given at least one inch from a site you used before.
• Do not inject into skin that is:
  • sore (tender)
  • bruised
  • red
  • hard
  • scarred or where you have stretch marks
• 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.

Prepare the Injection Site

5. Wipe the injection site with an alcohol prep (swab) using a circular motion.

6. Do not touch this area again before giving the injection. Allow the skin to dry before injecting. Do not fan or blow on the clean area.

Prepare the Syringe and Needle

7. Check the fluid level in the syringe:

• Always hold the prefilled syringe by the body of the syringe. Hold the syringe with the covered needle pointing down. See Figure C.

Figure C

• Hold the syringe at eye level. Look closely to make sure that the amount of liquid in the syringe is the same or close to the:
  • 0.8 mL line for the 40 mg prefilled syringe. See Figure D.
  • 0.4 mL line for the 20 mg prefilled syringe. See Figure D.
  • 0.2 mL line for the 10 mg prefilled syringe. See Figure D.

Figure D

8. The top of the liquid may be curved. If the syringe does not have the correct amount of liquid, do not use that syringe. Call your pharmacist.

9. Remove the needle cover:

• Hold the syringe in one hand. With the other hand gently remove the needle cover. See Figure E.
• Throw away the needle cover.

Figure E

• Do not touch the needle with your fingers or let the needle touch anything.

10. Turn the syringe so the needle is facing up and hold the syringe at eye level with one hand so you can see the air in the syringe. Using your other hand, slowly push the plunger in to push the air out through the needle. See Figure F.

Figure F

• You may see a drop of liquid at the end of the needle. This is normal.

Position the Prefilled Syringe and Inject Humira

Position the Syringe

11. Hold the body of the prefilled syringe in one hand between the thumb and index finger. Hold the syringe in your hand like a pencil. See Figure G.

Figure G

• Do not pull back on the plunger at any time.
• With your other hand, gently squeeze the area of the cleaned skin and hold it firmly. See Figure H.

Figure H

Inject Humira

12. Using a quick, dart-like motion, insert the needle into the squeezed skin at about a 45-degree angle. See Figure I.

Figure I

• After the needle is in, let go of the skin. Pull back gently on the plunger.

If blood appears in the syringe:

• It means that you have entered a blood vessel.
• Do not inject Humira.
• Pull the needle out of the skin while keeping the syringe at the same angle.
• Press a cotton ball or gauze pad over the injection site and hold it for 10 seconds. See Figure J.

Figure J

• Do not use the same syringe and needle again. Throw away the needle and syringe in your sharps container.
• Do not rub the injection site. You may have slight bleeding. This is normal.
• Repeat Steps 1 through 12 with a new prefilled syringe.

If no blood appears in the syringe:

• Slowly push the plunger all the way in until all the liquid is injected and the syringe is empty.
• Pull the needle out of the skin while keeping the syringe at the same angle.
• Press a cotton ball or gauze pad over the injection site and hold it for 10 seconds. Do not rub the injection site. You may have slight bleeding. This is normal.

13. Throw away the used prefilled syringe and needle in a sharps disposal container right away after use. See “How should I dispose of used prefilled syringes and needles?”

14. Keep a record of the dates and location of your injection sites. To help you remember when to take Humira, you can mark your calendar ahead of time.

How should I dispose of used prefilled syringes and needles?

• Put your used needles and syringes in a FDA-cleared sharps disposal container right away after use. See Figure K. Do not throw away (dispose of) loose needles and syringes in your household trash.
• Do not try to touch the needle.

Figure K

• If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
  • made of a heavy-duty plastic,
  • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • upright and stable during use,
  • leak-resistant, and
  • 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.
• For the safety and health of you and others, needles and used syringes must never be re-used.
• The used alcohol pads, cotton balls, dose trays and packaging may be placed in your household trash.
• 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.
• Always keep the sharps container out of the reach of children.

Humira (80mg/0.8ml, 40mg/0.4ml, 20mg/0.2ml and 10mg/0.1ml) single-dose prefilled syringe

Before Injecting: Your healthcare provider should show you how to use Humira before you use it for the first time. Call your healthcare provider or 1-800-4HUMIRA (1-800-448-6472) if you need help.

Do not use the Pen and call your healthcare provider or pharmacist if:

• Liquid is cloudy, discolored, or has flakes or particles in it
• Expiration date has passed
• Liquid has been frozen (even if thawed) or left in direct sunlight
• The Pen has been dropped or crushed

Keep the caps on until right before injection. Keep Humira out of reach of children.

Read instructions on all pages before using the Humira single-dose prefilled syringe.

Step by step instructions

Take Humira out of the refrigerator.
Leave Humira at room temperature for 15 to 30 minutes before injecting.

• Do not remove the Gray Cap (Cap #1) or Plum-colored Cap (Cap #2) while allowing Humira to reach room temperature
• Do not warm Humira in any other way. For example, do not warm it in a microwave or in hot water.
• Do not use the prefilled syringe if liquid has been frozen (even if thawed)

Check expiration date on the prefilled syringe. Do not use the prefilled syringe if expiration date has passed.
Place the following on a clean, flat surface:

• 1 single-dose prefilled syringe and alcohol swab
• 1 cotton ball or gauze pad (not included)
• Puncture-resistant sharps disposal container (not included). See Step 9 at the end of this Instructions for Use for instructions on how to throw away (dispose of) your prefilled syringe

Wash and dry your hands.

Choose an injection site:

• On the front of your thighs or
• Your abdomen (belly) at least 2 inches from your navel (belly button)
• Different from your last injection site

Wipe the injection site in a circular motion with the alcohol swab.

• Do not inject through clothes
• Do not inject into skin that is sore, bruised, red, hard, scarred, has stretch marks, or areas with psoriasis plaques

Hold the prefilled syringe in one hand.

Gently pull the needle cover straight off with the other hand.

• Throw the needle cover away
• Do not touch the needle with your fingers or let the needle touch anything

Hold the prefilled syringe with the needle facing up.

• Hold the prefilled syringe at eye level with one hand so you can see the air in the prefilled syringe
• Using your other hand, slowly push the plunger in to push the air out through the needle.
• You may see a drop of liquid at the end of the needle. This is normal.

Hold the body of the prefilled syringe in one hand between the thumb and index fingers. Hold the prefilled syringe in your hand like a pencil.
Do not pull back on the plunger at any time.

Gently squeeze the area of cleaned skin at your injection site with your other hand. Hold the skin firmly.

Insert the needle into the skin at about a 45-degree angle using a quick, dart-like motion.

• After the needle is in, let go of the skin.

Slowly push the plunger all the way in until all of the liquid is injected and the prefilled syringe is empty.

When the injection is completed, slowly pull the needle out of the skin while keeping the prefilled syringe at the same angle.

After completing the injection, place a cotton ball or gauze pad on the skin of the injection site.

• Do not rub
• Slight bleeding at the injection site is normal

How should I dispose the used Humira prefilled syringe?

• Put your used needles, syringes, and sharps in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in the household trash.
• If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
  • made of a heavy-duty plastic,
  • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • upright and stable during use,
  • leak-resistant, and
  • 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.
• Always keep the prefilled syringe and the sharps disposal container out of the reach of children.

The needle cover, alcohol swab, cotton ball or gauze pad, dose tray, and packaging may be placed in your household trash.

Keep a record of the dates and locations of your injections. To help remember when to take Humira, mark your calendar ahead of time.

Questions About Using the Humira Single-Dose Prefilled Syringe

What if I have not received in-person training from a healthcare provider?

• Call your healthcare provider or 1-800-4HUMIRA (1-800-448-6472) or visit www.HUMIRA.com if you need help

What if I do not have an FDA-cleared sharps disposal container or proper household container?

• Call 1-800-4HUMIRA (1-800-448-6472) for a free FDA-cleared sharps disposal container