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Humira

Humira

(adalimumab)

Humira (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-activepolyarticular juvenile idiopathic arthritis (JIA) for children andadolescents from 2 to 17 years of age who have not responded adequately toother treatments active Psoriatic Arthritis thathas not responded to treatment with Methotrexate ankylosing spondylitis inadults 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 diseasein adolescents 13 to 17 years of age, weighing more than40 kg, who have not responded adequately to other treatments moderate-to-severely activeulcerative colitis (UC) in adults who have not responded adequately to orcannot tolerate other treatments moderate-to-severe plaquepsoriasis in adults moderate-to-severe hidradenitissuppurativa (HS), an inflammatory disease of the skin, in adults andadolescents 12 years of age and older who weigh more than 30 kg who havenot responded to treatment with antibiotics non-infectious uveitis (aninflammatory disease of the eye) in adults who have not responded tocorticosteroids chronic non-infectious uveitisaffecting the front of the eye in children over 2 years old who have notresponded adequately to or cannot tolerate other treatments 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.

Available form

Dosage

Injectable

40MG/0.8ML

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Humira information

Dosage

Side Effects

Available Form

Contraindications

Precautions

Warnings

Humira (Adalimumab) 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 adults with 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.

For children over 2 years old with uveitis, the dose of Humira (Adalimumab) is 20 mg every other week for children who weigh less than 30 kg and 40 mg every other week for children who weigh 30 kg or more.

When treating polyarticular juvenile idiopathic arthritis in children over 2 years old, the dose of Humira (Adalimumab) is 20 mg every other week for children who weigh 10 kg to less than 30 kg. For children who weigh 30 kg or more, the dose is 40 mg given 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 in adults, 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. For adolescents 12 years of age and older and weighing more than 30 kg, the recommended dose is a first dose of 80 mg, then 40 mg every other week starting 1 week later. Humira (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 Humira (Adalimumab) 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 Humira (Adalimumab) 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 Humira (Adalimumab) 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. The pen or pre-filled syringe 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.

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 Humira (Adalimumab). If you are concerned about side effects, discuss the risks and benefits of Humira (Adalimumab) with your doctor.

The following side effects have been reported by at least 1% of people taking Humira (Adalimumab). 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 theskin or skin bumps that are filled with pus
signs of Anemia (low red bloodcells; 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 noshortness of breath])
signs of infection (symptoms mayinclude Fever or chills, severe Diarrhea, shortness of breath, prolongeddizziness, headache, stiff neck, weight loss, or listlessness)
signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
signs of a urinary tractinfection (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 Anaphylaxis (severe allergic reaction) (such as difficulty breathing, Hives, swelling of the face orthroat)

signs of a blood clot in the arm or leg (tenderness, pain, swelling, warmth, or redness in the arm or leg) or lungs (difficulty breathing, sharp chest pain that is worse when breathing in, coughing, coughing up blood, sweating, or passing out)

symptoms of a severe infection(such as fever, shaking or chills, fast heartbeat, quick breathing,confusion, skin rash)
swelling of the hands or feetwith 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 Humira (Adalimumab).

Prefilled syringes

10 mg/0.1 mL
Each 0.1 mL of sterile solution for subcutaneous administration contains 10 mg of Humira (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.

20 mg/0.2 mL
Each 0.2 mL of sterile solution for subcutaneous administration contains 20 mg of Humira (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/0.8 mL
Each 0.8 mL of sterile solution for subcutaneous administration contains 40 mg of Humira (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 Humira (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.

80 mg/0.8 mL
Each 0.8 mL of sterile solution for subcutaneous administration contains 80 mg of Humira (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

Vials (for pediatric use)
Each mL of sterile solution for subcutaneous administration contains 50 mg of Humira (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.

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 Humira (Adalimumab).

Allergic reactions: In rare cases, some people may develop an allergic reaction to Humira (Adalimumab). 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 Humira (Adalimumab) have become deficient in certain types of blood cells. If you notice signs of anemia (dizziness, pale skin, unusual tiredness or weakness, shortness of breath), 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 Humira (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 Humira (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: Humira (Adalimumab) may cause dizziness and fatigue. Do not drive or operate machinery until you know that Humira (Adalimumab) does not affect your ability to perform these tasks safely.

Heart failure: Humira (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 Humira (Adalimumab) 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: Humira (Adalimumab) 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. Humira (Adalimumab) 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 Humira (Adalimumab). If you are at risk for hepatitis B, your doctor may test you for this infection before starting treatment with Humira (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 Humira (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 Humira (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 Humira (Adalimumab).

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

Pregnancy: Humira (Adalimumab) should not be used during pregnancy unless the benefits outweigh the risks. Contact your doctor if you become pregnant while taking Humira (Adalimumab).

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

Children: The safety and effectiveness of using Humira (Adalimumab) have not been established for children less than 2 years of age or who weigh less than 10 kg, for the treatment of JIA or for the treatment of uveitis. The use of Humira (Adalimumab) to treat Crohn's disease in adolescents should be limited to children who weigh more than 40 kg and are over 13 years old. When children and teenagers have been treated with Humira (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 Humira (Adalimumab).

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