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Medications Lexicon

How does this medication work? What will it do for me?

Adalimumab belongs to the class of medications called biological response modifiers ("biologics") or TNF blockers (tumor necrosis factor blockers). It is used to treat:

  • moderate-to-severe rheumatoid arthritis
  • moderate-to-severely-active polyarticular juvenile idiopathic arthritis (JIA) for children and adolescents from 2 to 17 years of age who have not responded adequately to other treatments
  • active psoriatic arthritis that has not responded to treatment with methotrexate
  • ankylosing spondylitis in adults who have not responded to other treatments
  • moderate-to-severe Crohn's disease in adults who have not responded to other treatments
  • severely active Crohn's disease in adolescents 13 to 17 years of age, weighing more than 40 kg, who have not responded adequately to other treatments
  • moderate-to-severely active ulcerative colitis (UC) in adults who have not responded adequately to or cannot tolerate other treatments
  • moderate-to-severe plaque psoriasis in adults
  • moderate-to-severe hidradenitis suppurativa (HS), an inflammatory disease of the skin, in adults that has not responded to treatment with antibiotics
  • non-infectious uveitis (inflammation of the middle layer of the eye)

People with these immune conditions produce extra amounts of an inflammatory protein called tumour necrosis factor alpha (TNF-alpha), causing pain, inflammation, and cellular damage. Adalimumab works by blocking the production of TNF-alpha to reduce the inflammation in the joints and on the skin. Depending on what adalimumab is being used to treat, it can take 4 to 12 weeks for you to notice an improvement in your condition.

Your doctor may have suggested this medication for conditions other than the ones listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are using this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it.

How should I use this medication?

This medication is given by subcutaneous (under the skin) injection, usually in the front of the thigh or abdomen. The dose depends on the condition being treated.

For rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, the recommended dose for adults is 40 mg every other week.

For adults with Crohn's disease or ulcerative colitis, the recommended dose is a first dose of 160 mg, then 80 mg 2 weeks after the first dose, then 40 mg every second week starting 4 weeks after the first dose.

For psoriasis or uveitis, the recommended dose is a first dose of 80 mg, then 40 mg every other week starting one week after the first dose.

When treating polyarticular juvenile idiopathic arthritis, the dose is based on body size and calculated as 24 mg per square metre of body surface area, to a maximum of 40 mg every other week.

For Crohn's disease affecting children 13 to 17 years of age weighing more than 40 kg, the recommended starting dose is 160 mg the first week, 80 mg given at week 2 and then 20 mg every second week, starting on week 4. The dose may be increased to 40 mg every other week depending on your child's response. 

For hidradenitis suppurativa, the recommended dose is a first dose of 160 mg, then 80 mg 2 weeks after the first dose, then 40 mg every week starting 4 weeks after the first dose.

Adalimumab is used with the guidance and supervision of a doctor. Your doctor or nurse will assist you in the preparation and injection of your first dose (or first few doses). Do not attempt to inject this medication on your own until you completely understand how to inject a dose. If you are having difficulty giving yourself injections, ask a family member or other caregiver for help if they are willing to become involved with your treatment and are willing to learn how to give you your injections.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important to use this medication exactly as prescribed by your doctor. If you miss a dose, administer it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication in the refrigerator at 2°C to 8°C, protect it from light, and keep it out of the reach of children. Do not allow it to freeze. This medication may also be stored at room temperature (up to a maximum of 25°C) for a single period of 14 days. If it is stored at room temperature and is not used within 14 days, it must be discarded.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

Prefilled syringes

40 mg/0.8 mL
Each 0.8 mL of sterile solution for subcutaneous administration contains 40 mg of adalimumab. Nonmedicinal ingredients: citric acid monohydrate, dibasic sodium phosphate dihydrate, mannitol, monobasic sodium phosphate dihydrate, polysorbate 80, sodium citrate, sodium chloride, sodium hydroxide (added as necessary to adjust pH), and water for injection.

40 mg/0.4 mL
Each 0.4 mL of sterile solution for subcutaneous administration contains 40 mg of adalimumab. Nonmedicinal ingredients: citric acid monohydrate, dibasic sodium phosphate dihydrate, mannitol, monobasic sodium phosphate dihydrate, polysorbate 80, sodium citrate, sodium chloride, sodium hydroxide (added as necessary to adjust pH), and water for injection.

Prefilled pens

40 mg/0.8 mL
Each 0.8 mL of sterile solution for subcutaneous administration contains 40 mg of adalimumab. Nonmedicinal ingredients: citric acid monohydrate, dibasic sodium phosphate dihydrate, mannitol, monobasic sodium phosphate dihydrate, polysorbate 80, sodium citrate, sodium chloride, sodium hydroxide (added as necessary to adjust pH), and water for injection.

40 mg/0.4 mL
Each  0.4 mL of sterile solution for subcutaneous administration contains 40 mg of adalimumab. Nonmedicinal ingredients: citric acid monohydrate, dibasic sodium phosphate dihydrate, mannitol, monobasic sodium phosphate dihydrate, polysorbate 80, sodium citrate, sodium chloride, sodium hydroxide (added as necessary to adjust pH), and water for injection.

Vials (for pediatric use)
Each mL of sterile solution for subcutaneous administration contains 50 mg of adalimumab. Nonmedicinal ingredients: citric acid monohydrate, dibasic sodium phosphate dihydrate, mannitol, monobasic sodium phosphate dihydrate, polysorbate 80, sodium citrate, sodium chloride, sodium hydroxide (added as necessary to adjust pH), and water for injection.

Who should NOT take this medication?

Do not take adalimumab if you:

  • are allergic to adalimumab, latex, or any ingredients in the medication
  • have a severe infection such as sepsis, tuberculosis, and opportunistic infections (infections that strike people with weakened immune systems)
  • have moderate to severe heart failure

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • headache
  • injection site reactions (redness, itching, bleeding, pain, or swelling)
  • nausea
  • skin rash
  • upper respiratory infections (such as colds or sinus infections)
  • weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • abdominal pain
  • arm or leg weakness
  • cold sores
  • cough
  • double vision
  • flu-like symptoms
  • hair loss
  • joint pain
  • night sweats
  • numbness
  • scaly and red patches on the skin or skin bumps that are filled with pus
  • signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
  • signs of bleeding (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
  • signs of heart problems (e.g., fast, irregular heartbeat or pulse, sudden weight gain, chest pain, difficulty breathing, swelling of the hands or feet [if there is no shortness of breath])
  • signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
  • signs of a urinary tract infection (pain or burning sensation when urinating, frequent urination, blood in the urine)
  • skin colour changes
  • sores in the mouth
  • a sore that doesn't heal
  • tingling sensation
  • weight loss

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of a severe allergic reaction (such as difficulty breathing, hives, swelling of the face or throat)
  • symptoms of a severe infection (such as fever, shaking or chills, fast heartbeat, quick breathing, confusion, skin rash)
  • swelling of the hands or feet with shortness of breath

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Allergic reactions: In rare cases, some people may develop an allergic reaction to this medication. Signs of an allergic reaction include a severe rash, hives, swollen face or throat, or difficulty breathing. If these occur, contact your doctor immediately. The needle cover on the prefilled syringe contains dry natural rubber. Before you start injections, tell your doctor if you have an allergy to rubber or latex.

Blood disorders: Rarely, people taking this medication have become deficient in certain types of blood cells. If you notice signs of infection (such as fever, shaking or chills, fast heartbeat, or quick breathing) or bleeding (such as easy bruising, blood in the stools, black tarry stools, or vomiting blood or material that looks like coffee grounds), seek immediate medical attention.

Cancer: Compared to the general population, people taking adalimumab have a slightly greater risk of developing a cancer of the immune system known as lymphoma. This appears to be more likely if infliximab, azathioprine, or mercaptopurine have also been used. However, the risk is still small. In general, people with severe rheumatoid arthritis who take medications that suppress the immune system over long periods of time may also have a higher risk of developing lymphoma, even if they don't take adalimumab. If you experience any of the following or other unusual symptoms, contact your doctor immediately:

  • chills
  • decreased appetite
  • fever
  • night sweats
  • one or more enlarged lymph node
  • unusual fatigue
  • weight loss

Signs and symptoms of lymphoma can vary depending on the extent of the disease and the parts of the body involved (e.g., chest, abdomen, or bowel).

Dizziness: Adalimumab may cause dizziness and fatigue. Do not drive or operate machinery until you know that adalimumab does not affect your ability to perform these tasks safely.

Heart failure: Adalimumab may cause congestive heart failure (CHF) or worsen existing CHF. If you have CHF, you should be monitored closely by your doctors. Symptoms to watch for include swelling of the feet and ankles and shortness of breath. If you notice these symptoms, contact your doctor immediately.

Immune system disorders: Some people who take this medication have developed lupus-like syndrome, an autoimmune disease (a condition where the body is attacked by its own immune system). Symptoms of lupus-like syndrome include chest pain, joint pain, difficulty breathing, and a skin rash (usually on the cheeks and arms) that is sensitive to the sun. If you develop these symptoms, contact your doctor as soon as possible.

Infections: This medication or other TNF blockers can increase the risk of developing serious bacteria and fungi infections, such as tuberculosis and various types of pneumonia. If you notice signs of an infection such as fever, chills, pain, swelling, or pus, contact your doctor as soon as possible.

Tell your doctor if you have an infection or have a history of infections that keep coming back or other conditions that might increase your risk of infections, including fungal infections prior to initiating therapy. This medication should not be used in combination with anakinra, as this can increase the risk of severe infections.

People infected with hepatitis B virus (an infection that can damage the liver) may have a relapse of their condition while taking this medication. If you are at risk for hepatitis B, your doctor may test you for this infection before starting treatment with adalimumab and will follow your condition closely while you are taking the medication. If you notice symptoms of liver problems, such as abdominal pain, yellow eyes or skin, loss of appetite, fatigue, or dark urine, contact your doctor immediately.

Nervous system diseases: Rare cases of disorders that affect the nervous system have been reported by people taking adalimumab or other TNF blockers. If you are experiencing numbness and tingling, vision problems, weakness in your legs, and dizziness, contact your doctor immediately.

Surgery: There is little information regarding the safety of having surgical procedures if you are using adalimumab. You may be at an increased risk of developing infections after the surgery. Let all the medical professionals involved in your care know that you are taking adalimumab.

Vaccines: Live vaccines (e.g., yellow fever, BCG, cholera, typhoid, varicella) should not be given when you are taking adalimumab.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. Contact your doctor if you become pregnant while taking adalimumab.

Breast-feeding: It is not known if adalimumab passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children less than 2 years of age or weighing less than 10 kg, for the treatment of JIA. The use of adalimumab to treat Crohn's disease in adolescents should be limited to children weighing more than 40 kg and older than 13 years of age. When children and teenagers have been treated with adalimumab, some have developed lymphoma (cancer of the immune system) and other types of cancer.

Seniors: People over the age of 65 years may be more at risk of side effects from this medication.

What other drugs could interact with this medication?

There may be an interaction between adalimumab and any of the following:

  • abatacept
  • anakinra
  • bacillus Calmette-Guérin (BCG)
  • belimumab
  • corticosteroids (e.g., budesonide, dexamethasone, hydrocortisone, fluticasone, prednisone)
  • cyclosporine
  • echinacea
  • fingolimod
  • infliximab
  • leflunomide
  • medications to treat cancer (e.g., carboplatin, cyclophosphamide, doxorubicin, ifosfamide, vincristine)
  • natalizumab
  • pimecrolimus
  • rituximab
  • roflumilast
  • tacrolimus
  • theophyllines (e.g., aminophylline, oxtriphylline, theophylline)
  • tofactitinib
  • trastuzumab
  • vaccines
  • warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2018. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Humira

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