Humira - Consumer Medicine Information
|Condition:||Ankylosing Spondylitis, Crohn's Disease, Maintenance, Crohn's Disease, Acute, Crohn's Disease, Hidradenitis Suppurativa, Plaque Psoriasis, Psoriatic Arthritis, Psoriasis, Rheumatoid Arthritis, Spondyloarthritis, Ulcerative Colitis|
|Class:||Antirheumatics, TNF alfa inhibitors|
|Form:||Liquid solution, Subcutaneous (SC)|
|Ingredients:||adalimumab, citric acid monohydrate, dibasic sodium phosphate dihydrate, mannitol, monobasic sodium phosphate dihydrate, polysorbate 80, sodium citrate, sodium chloride|
About this medication
HUMIRA treatment should be started and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), adult and pediatric Crohn’s disease (CD), ulcerative colitis (UC), hidradenitis suppurativa (HS) or psoriasis (Ps), and familiar with the HUMIRA efficacy and safety profile.
What the medication is used for:
HUMIRA is a medicine that is used in:
- adults with rheumatoid arthritis, which is an inflammatory disease of the joints.
- adults with psoriatic arthritis, which is an inflammatory disease of the joints and skin.
- adults with ankylosing spondylitis, which is a form of arthritis.
- adults with Crohn’s disease, which is an inflammatory disease of the digestive tract.
- children 13 to 17 years weighing ≥ 40 kg who have severe Crohn’s disease or who have Crohn’s disease which has not responded to other usual treatments.
- adults with ulcerative colitis, which is an inflammatory disease of the bowel (colon).
- adults with moderate to severe hidradenitis suppurativa (HS) who have not responded to antibiotics. HS is a painful, progressive, chronic inflammatory skin disease that causes nodules, abscesses, sinus tracts and fistulas under the breasts, underarms, buttocks and groin.
- adults with psoriasis, which is an inflammatory disease of the skin. Your doctor prescribed HUMIRA to reduce the signs and symptoms of your plaque psoriasis.
People with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, hidradenitis suppurativa or psoriasis may be given other medicines for their disease before they are given HUMIRA. If you have ulcerative colitis or you/your child have Crohn’s disease, you /your child will first be given other medicines. If you do not respond well enough to these medicines, you/your child will be given HUMIRA to reduce the signs and symptoms of your/your child’s disease.
What it does:
HUMIRA is a fully human monoclonal antibody produced by cultured cells. Monoclonal antibodies are proteins that recognize and bind to other unique proteins. HUMIRA binds to a specific protein called TNF-alpha (also known as tumor necrosis factor). People with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, hidradenitis suppurativa or psoriasis have too much of TNF-alpha in their bodies. The extra TNF-alpha in your/your child’s body can attack normal healthy body tissues and cause inflammation, especially in the tissues of your bones, cartilage, joints, digestive tract and skin. By binding to TNF-alpha, HUMIRA decreases the inflammation process of these diseases.
HUMIRA helps reduce the signs and symptoms of rheumatoid arthritis and psoriatic arthritis (such as pain and swollen joints), may help improve your ability to perform daily activities (such as getting dressed, walking and climbing stairs), and may help prevent further damage to your bones and joints. In addition, HUMIRA helps reduce the signs and symptoms of ankylosing spondylitis (back pain and morning stiffness), and adult and pediatric Crohn’s disease or ulcerative colitis (abdominal pain and diarrhea). HUMIRA may also help normalize childhood growth and pubertal development, and improve the quality of life in children who have Crohn’s disease (such as body image, functional and social skills, and emotional health). HUMIRA may help improve the work productivity and activity impairment in caregivers of children with Crohn’s disease.
HUMIRA is also used to treat inflammatory lesions (nodules and abscesses) in adult patients with Hidradenitis Suppurativa.
HUMIRA also helps reduce the signs and symptoms of psoriasis (such as pain, itching and scaly patches on skin). HUMIRA, however, can also lower your/your child’s body’s ability to fight infections. Taking HUMIRA can make you/your child more prone to getting infections or make any infection you/your child have worse.
When it should not be used:
You/your child should not take HUMIRA if you/your child have:
- an allergy to any of the ingredients in HUMIRA (see What the important non-medicinal ingredients are section).
- a serious infection such as tuberculosis, infections caused by bacteria or fungi, and bacterial infections that have spread throughout the body (sepsis).
- moderate to severe heart failure (NYHA class III/IV).
What the medicinal ingredient is:
What the important non-medicinal ingredients are:
citric acid monohydrate, dibasic sodium phosphate dihydrate, mannitol, monobasic sodium phosphate dihydrate, polysorbate 80, sodium citrate, sodium chloride
For a full listing of non-medicinal ingredients see PART I of the Product Monograph.
What dosage forms it comes in:
HUMIRA is available in the following forms:
- Single-use, 1 mL pre-filled Pen containing 40 mg adalimumab dissolved in 0.8 mL sterile solution (50 mg/mL)
- Single-use, 1 mL pre-filled glass syringe containing 40 mg adalimumab dissolved in 0.8 mL sterile solution (50 mg/mL)
All packaging components are latex-free.
HUMIRA is also available in a single-use, 1 mL vial containing 40 mg adalimumab dissolved in 0.8 mL sterile solution (50 mg/mL) for pediatric use.
Warnings and precautions
Before starting, during and after treatment with HUMIRA, you or your child should be checked for active or inactive tuberculosis infection with a tuberculin skin test.
Any medicine can have side effects. Like all medicines that affect your immune system, HUMIRA can cause serious side effects. The possible serious side effects include:
Serious Warnings and Precautions
If you/your child received HUMIRA while pregnant, your/her baby may be at higher risk for getting an infection for up to approximately five months after the last dose of HUMIRA received during pregnancy. It is important that you tell your/her baby's doctors and other healthcare professionals about your/her HUMIRA use during pregnancy so they can decide when your/her baby should receive any vaccine.
BEFORE you use HUMIRA, talk to the doctor or pharmacist if:
- you/your child have or have had any kind of infection including an infection that is in only one place in your body (such as an open cut or sore), or an infection that is in your whole body (such as the flu). Having an infection could put you at risk for serious side effects from HUMIRA. If you are unsure, ask your doctor.
- you/your child have a history of infections that keep coming back or other conditions that might increase your risk of infections, including fungal infections.
- you/your child have ever had tuberculosis, or if you/your child have been in close contact with someone who has had tuberculosis. If you/your child develop any of the symptoms of tuberculosis (a dry cough that doesn't go away, weight loss, fever, night sweats) call your doctor right away. Your doctor will need to examine you for tuberculosis and perform a skin test.
- you/your child resided or traveled to areas where there is a greater risk for certain kinds of infections such as tuberculosis, histoplasmosis, coccidioidomycosis, blastomycosis, or parasitic infections. These infections are caused by a bacteria or a fungus that can affect the lungs or other parts of your body. If you/your child take HUMIRA these may become active or more severe. If you don’t know if you have lived in or travelled to an area where these infections are common, ask your doctor.
- you/your child have ever had liver injury or hepatitis B virus infection or are at risk of developing this infection. Signs and symptoms include the following: yellowing of the skin or eyes (jaundice), feeling of sickness, tiredness, loss of appetite, joint pain, fever, dark brown-colored urine, vomiting, and abdominal pain. If you experience any of these signs and symptoms, contact your doctor immediately. These symptoms may occur several months after starting therapy with HUMIRA.
- you/your child experience any numbness or tingling or have ever had a disease that affects your nervous system like multiple sclerosis or Guillain-Barré syndrome.
- you/your child have or have had heart failure.
- you/your child are scheduled to have major surgery.
- you/your child are scheduled to be vaccinated for anything. It is recommended that pediatric Crohn’s disease patients, if possible, be brought up to date with all immunizations according to current guidelines before starting HUMIRA.
- you are taking other medicines for your rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis, or other conditions. You can take other medicines provided your doctor has prescribed them or has told you it is acceptable to take them while you are taking HUMIRA. It is important that you tell your doctor about any other medicines you are taking for other conditions (for example, high blood pressure medicine) before you start taking HUMIRA.
- your child is taking other medicines for his/her Crohn’s disease or other conditions. Your child can take other medicines provided the doctor has prescribed them or has told you it is acceptable that your child takes them while he/she is taking HUMIRA. It is important that you tell the doctor about any other medicines your child is taking for other conditions before he/she starts taking HUMIRA.
- you/your child are taking any over-the-counter drugs, herbal medicines and vitamin and mineral supplements.
- you/your child are pregnant, could becomepregnant, or are breast-feeding. HUMIRA has not been studied in pregnant women or nursing mothers, so the effects on pregnant women or nursing babies are unknown. HUMIRA may cross the placenta into the serum of infants born to women treated with HUMIRA during pregnancy. Breast-feeding is not recommended for at least five months after the last HUMIRA treatment.
If you are not sure or have any questions about any of this information, ask your doctor.
Interactions with this medication
You should not take HUMIRA with:
- other TNF-blockers such as Enbrel, Remicade, Cimzia, or Simponi
- abatacept (Orencia)
- anakinra (Kineret)
If you have questions, ask your doctor.
Proper use of this medication
HUMIRA is administered by injection under the skin (by subcutaneous injection).
Adults with Rheumatoid Arthritis, Psoriatic Arthritis or Ankylosing Spondylitis:
- The recommended dose is 40 mg administered every other week as a subcutaneous injection.
Adults with Crohn’s Disease or Ulcerative Colitis:
- The recommended induction dose is 160 mg at Week 0 (dose can be administered as four injections in one day or as two injections per day for two consecutive days), followed by 80 mg at Week 2.
- The recommended maintenance dose regimen is 40 mg every other week beginning at Week 4.
Adults with Hidradenitis Suppurativa:
- The recommended initial dose is 160 mg, followed by 80 mg two weeks later. The first dose of 160 mg can be administered as four injections in one day or as two injections per day for two consecutive days. The second dose of 80 mg is given as two 40 mg injections in one day.
- The recommended maintenance dose regimen is 40 mg every week beginning four weeks after the initial dose.
Adults with Psoriasis:
- The recommended dose is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose.
Children, 13 to 17 years of age weighing ≥ 40 kg, with Crohn’s disease:
- The recommended dose is 160 mg initially at Week 0 (given as four 40 mg injections in one day, or as two 40 mg injections per day for two consecutive days), followed by 80 mg at Week 2 (given as two 40 mg injections). At Week 4, your child will begin a maintenance dose of 20 mg every other week. Depending on your child’s response, the doctor may increase the dose to 40 mg every other week (given as one 40 mg injection).
For children who do not require a full 40 mg dose of HUMIRA, a 40 mg vial is also available.
If you accidentally inject HUMIRA more frequently than instructed, contact your doctor or local poison control centre right away.
If you forget to give yourself or your child an injection, you should inject the missed dose of HUMIRA as soon as you remember. Then administer the next dose as you would have on the originally scheduled date.
The following instructions explain how to inject HUMIRA. Please read the instructions carefully and follow them step-by-step. You will be instructed by your doctor or his/her assistant on the technique of self-injection. Do not attempt to self-inject until you are sure that you understand how to prepare and give the injection. After proper training, the injection can be self- administered or given by another person; for example, a healthcare professional, a family member or friend. The PROGRESS patient assistance program is also available to you if you require assistance with injections should you prefer nurse- administered injections for you or your child.
This injection should not be mixed in the same syringe with any other medicine.
Step 1. Setting Up
- You will need two alcohol pads/swabs (not included in the HUMIRA kit)
- Remove one dose tray containing a HUMIRA Pen or pre- filled syringe from the box in the refrigerator.
- Do not shake or drop the Pen or pre-filled syringe.
- Do not use the Pen or pre-filled syringe if it is frozen or if it has been left in direct sunlight.
- If you are using the Pen, only remove the caps immediately before injection.
- Set up the following on a clean, flat working surface:
- One HUMIRA Pen
- One alcohol pad (swab)
- One pre-filled syringe of HUMIRA for injection
- One alcohol pad (swab)
- If you do not have all of the pieces you need to give yourself an injection, call your pharmacist. Use only the items provided in the box your HUMIRA prescription comes in (except for the alcohol pad/swab, which is not included in the HUMIRA kit).
- Make sure that the name HUMIRA appears on the dose tray and Pen or pre-filled syringe label.
- Check the expiry date on the Pen or pre-filled syringe. Do not use the product if the date has passed the month and year shown.
- Make sure the liquid in the Pen or pre-filled syringe is clear and colourless. Do not use the Pen or pre-filled syringe if the liquid is cloudy or discoloured or if flakes or particles can be seen.
- Have a puncture-proof container nearby for disposing of the used Pen, needles and syringe.
FOR YOUR PROTECTION, IT IS IMPORTANT THAT YOU FOLLOW THESE INSTRUCTIONS.
Step 2. Choosing and Preparing the Injection Site
- Wash your hands thoroughly.
- Choose a site on the front of your thighs or your abdomen. If you choose your abdomen, you should avoid the area two inches around your navel.
- 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 areas where the skin is tender, bruised, red or hard or where you have scars or stretch marks.
- You may find it helpful to keep notes on the location of previous injections.
- Wipe the injection site where HUMIRA is to be injected with an alcohol pad (swab), using a circular motion. Do NOT touch this area again before giving the injection.
Step 3. Preparing the Dose for Injection
- Hold the Pen with the gray cap pointing up. Check the appearance of the solution through the windows on the sides of the Pen to make sure the liquid is clear and colourless. Do not use the Pen if the liquid is cloudy or discoloured or has flakes or particles in it. Do not use if frozen or if it has been left in direct sunlight.
HUMIRA Pre-Filled Syringe
- Remove the needle cover from the syringe, taking care not to touch the needle with your fingers or allowing it to touch any surface.
- Turn the syringe so the needle is facing up and slowly push the plunger in to push the air in the syringe out through the needle. If a small drop of liquid comes out of the needle, this is acceptable.
Step 4. Injecting HUMIRA
- Only remove the caps immediately before injection.
- Hold the gray body of the Pen with one hand.
- Place your hand on the middle of the Pen so that neither the gray cap (Cap 1) nor the plum cap (Cap 2) is covered.
- Hold the Pen with the gray cap (Cap 1) pointing up.
- With your other hand, pull the gray cap (Cap 1) straight off (without twisting) and discard the cap.
- Check that the small needle cover of the syringe has been removed with the cap.
- If a few small drops of liquid come out of the needle, this is acceptable.
- The white needle sleeve, which covers the needle, will now be exposed. Do not try to touch the needle housed in the barrel.
- DO NOT RECAP as you may damage the needle.
- Care should be taken to avoid dropping or crushing the product as it contains a glass syringe.
- Pull the plum safety cap (Cap 2) straight off (without twisting) to expose the plum-coloured activation button. The Pen is now ready to use.
- Please note that the Pen is activated after removing Cap 2 and that pressing the button under Cap 2 will immediately result in discharge of medication.
- Do not press the plum-coloured activation button until properly positioned.
- DO NOT RECAP as this could cause the unit to discharge.
- Hold the Pen so that the window is in view. The presence of one or more bubbles in the window is normal.
- With your free hand, gently squeeze a sizable area of the cleaned skin at the injection site and hold firmly. You will inject into this raised area of skin.
- Place the white end of the Pen straight (a 90° angle) and flat against the raised area of skin. Position the Pen so that it will not inject the needle into your fingers.
- With your index finger or thumb, press the plum-coloured button to begin the injection.
- Try not to cover the window.
- Note that you will hear a loud ‘click’ when you press the button, which indicates the start of the injection. You will feel a small prick as the needle advances.
- Keep pressing and continue to hold the Pen with steady pressure in place for about 10 seconds to ensure complete injection. (A way to remember is simply ‘click and count to 10’.) Do not remove the Pen while the injection is being given.
- It is important to maintain steady pressure at the injection site for the entire period of time.
- You will see a yellow indicator move into the windows during the injection. The injection is complete when the yellow indicator stops moving.
- Lift the Pen straight up from the injection site. The white needle sleeve will move down over the needle and lock into place over the needle tip. Do not try to touch the needle. The white needle sleeve is there to protect you from touching the needle.
- Press a cotton ball or gauze pad over the injection site and hold it for 10 seconds. Do NOT rub the injection site. If you have slight bleeding, this is normal.
- Dispose of the Pen immediately into your special sharps container.
HUMIRA Pre-Filled Syringe
- With one hand, gently pinch the cleaned area of skin and hold it firmly. With the other hand, hold the syringe like a pencil at about a 90° angle to the skin.
- With a quick, short, “dart-like” motion, push the needle into the skin.
- After the needle is in, let go of the skin. If blood appears in the syringe, it means that you have entered a blood vessel. Do not inject HUMIRA. Withdraw the needle and repeat the steps to choose and clean a new injection site. However do NOT use the same syringe (discard the syringe in your puncture-proof container). If no blood appears, slowly push the plunger all the way in until all of the HUMIRA is injected.
- When the syringe is empty, remove the needle from the skin, being careful to keep it at the same angle as it was when it was inserted.
- Immediately press a cotton ball or gauze pad over the injection site and hold for 10 seconds. Slight bleeding may occur. Do NOT rub the injection site. A bandage is optional.
- Dispose of the syringe immediately into your special sharps container.
Step 5. Disposing of Supplies
- You should always check with your healthcare provider (e.g., doctor, nurse, or pharmacist) for instructions on how to properly dispose of used needles and syringes (including the Pen). Do NOT use the same needle and syringe more than once. You should follow any special provincial or local laws regarding the proper disposal of needles and syringes. Do NOT throw used needles or syringes (including the Pen) in the household trash or recycling bin.
- Dispose of used needles and syringes (including the Pen) in a container made specially for this purpose (sharps container), or a hard plastic container with a screw-on cap or metal container with a plastic lid labelled “Used Syringes”. Do not use glass or clear plastic containers.
- Always keep the container out of the reach of children.
- When the container is about two-thirds full, tape the cap or lid down so it does not come off and dispose of it as instructed by your doctor, nurse or pharmacist. DO NOT THROW THE CONTAINER IN THE HOUSEHOLD TRASH OR RECYCLING BIN.
- The used alcohol pads may be placed in the trash, unless otherwise instructed by your doctor, nurse or pharmacist. The dose tray and cover may be recycled.
Side effects and what to do about them
Like all medicines, HUMIRA can cause side effects. Most side effects are mild to moderate. However, some may be serious and require treatment.
Tell your doctor immediately if you experience any of the following:
- severe rash, hives or other signs of allergic reaction
- swollen face, hands, feet
- trouble breathing, swallowing
- sudden weight gain (this is possibly indicative of new or worsening heart failure)
- bruising or bleeding very easily, looking very pale; this could mean a blood problem such as low red blood cells (anemia).
Tell the doctor as soon as possible if you notice any of the following:
- signs of infection such as fever, malaise, wounds, dental problems, burning on urination
- feeling weak or tired
- double vision
- arm or leg weakness
- arm or leg pain, swelling or redness
- bump or open sore that does not heal
- red scaly patches or raised bumps that are filled with pus (this could be new or worsening hidradenitis suppurativa, new or worsening psoriasis or a skin infection)
- alopecia (loss of hair)
- changes in the colour of the skin
- changes in the colour of your urine (dark or red)
- worsening of the appearance of a scar
- night sweats
- weight loss
- pain in the abdomen or chest
Serious side effects, how often they happen and what to do about them
Symptom/effect Talk with your doctor or pharmacist Stop taking
Injection site reaction √ Common Cough and cold symptoms, including sore throat √ Headache √ Rash √ Nausea √ Pneumonia √ √ Fever √ Abdominal pain √ Uncommon Tuberculosis √ √ Other serious infections √ √ Nerve disorder √ √ Appendicitis √ √ Blood clots:abdominal pain, chest pain, leg or arm pain with redness and swelling √ √ Bladder infection (painful urination) √ √ Hepatitis [jaundice (yellow skin, dark urine), abdominal pain, tiredness] √ √
This is not a complete list of side effects. For any unexpected effects while taking HUMIRA, contact your doctor or pharmacist.
How to store it
Keep HUMIRA and all other medicines out of the reach of children.
Store between 2 and 8oC (in a refrigerator) in the original carton until ready to use. DO NOT FREEZE HUMIRA. Protect from light. Refrigerated HUMIRA remains stable until the expiration date printed on the Pen or pre-filled syringe. Do not use beyond the expiration date.
When needed, for example when you are traveling, a HUMIRA Pen or pre-filled syringe can be stored at room temperature (up to 25oC/77oF) for a single maximum period of 14 days.
Once taken out of the refrigerator for room temperature storage, a HUMIRA Pen or pre-filled syringe must be used within 14 days, even if it is put back in the refrigerator. If not used within 14 days, the HUMIRA Pen or pre-filled syringe must be discarded. You should record the date when the HUMIRA Pen or pre-filled syringe is first removed from the refrigerator.
Care should be taken to avoid dropping or crushing the product as it contains a glass syringe.
General Advice About Prescription Medicines
Talk to your doctor or other healthcare provider if you have any questions about this medicine or your condition. Medicines are sometimes prescribed for purposes other than those listed in a CONSUMER INFORMATION leaflet. If you have any concerns about this medicine, ask your doctor. Your doctor or pharmacist can give you information about this medicine that was written for health care professionals. Do not use this medicine for a condition for which it was not prescribed. Do not share this medicine with other people. A toll-free information service is also available at 1-866-8HUMIRA (1-866-848-6472).
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Postal Locator 0701D
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
The most recent version of this document plus the full Product Monograph, prepared for health professionals can be found at:
or by contacting the sponsor, AbbVie Corporation, Saint-Laurent, Qc H4S 1Z1 at 1-866-8HUMIRA (1-866-848-6472).