Hadlima

Brand Name

Hadlima

Common Name

adalimumab

In this drug factsheet:

• How does this medication work? What will it do for me?
• How should I use this medication?
• What form(s) does this medication come in?
• Who should NOT take this medication?
• What side effects are possible with this medication?
• Are there any other precautions or warnings for this medication?
• What other drugs could interact with this medication?

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 (pJIA) 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 for adults who have not responded to other treatments
• moderate-to-severe Crohn's disease for adults who have not responded to other treatments
• severely active Crohn's disease for adolescents 13 to 17 years of age, who weigh more than 40 kg and  have not responded adequately to other treatments
• moderate-to-severely active ulcerative colitis (UC) for adults who have not responded adequately to or cannot tolerate other treatments
• moderate-to-severely active ulcerative colitis (UC) for children 5 years of age and older who have not responded adequately to or cannot tolerate other treatments
• moderate-to-severe plaque psoriasis for adults
• moderate-to-severe hidradenitis suppurativa (HS), an inflammatory disease of the skin, for adults and adolescents 12 years of age and older who weigh more than 30 kg and have not responded to treatment with antibiotics
• non-infectious uveitis (an inflammatory disease of the eye) for adults who have not responded to corticosteroids, or to reduce the amount of corticosteroid needed
• chronic non-infectious uveitis affecting the front of the eye for children over 2 years old who have not responded 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. Adalimumab works by blocking the production of TNF-alpha to reduce the inflammation in the joints and on the skin. Depending on what condition adalimumab is being used to treat, it can take 4 to 12 weeks for you to notice an improvement in your condition.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

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 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 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. Your doctor may suggest a higher starting dose for children 6 years of age or older.

When treating polyarticular juvenile idiopathic arthritis for children over 2 years old, the dose of 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 who weigh 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 ulcerative colitis affecting children aged 5 years and older the dose is based on body weight. Children who weigh less than 40 kg should receive a first dose of 80 mg, followed by 40 mg two weeks later, then at week 4 either 40 mg every second week or 20 mg every week. Children who weigh 40 kg or more receive a first dose of 160 mg, followed by 80 mg two weeks later, then starting week 4, either 80 mg every other week or 40 mg every week.

For adults with 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. For adolescents 12 years of age and older who weigh more than 30 kg, the recommended dose is a first dose of 80 mg, then 40 mg every other week starting 1 week later.

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. 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.

What form(s) does this medication come in?

Prefilled Syringe

40 mg/0.4 mL
Each 0.4 mL of preservative-free, sterile solution contains 40 mg of adalimumab. Nonmedicinal ingredients: sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, succinic acid, sodium succinate dibasic, L-histidine, L-histidine hydrochloride monohydrate, mannitol, polysorbate 20 and water for injection.

40 mg/0.8 mL
Each 0.8 mL of preservative-free, sterile solution contains 40 mg of adalimumab. Nonmedicinal ingredients: citric acid monohydrate, sodium citrate dihydrate, L-histidine, L-histidine hydrochloride monohydrate, sorbitol, polysorbate 20, and water for injection.

PushTouch Autoinjector

40 mg/0.4 mL
Each 0.4 mL of preservative-free, sterile solution contains 40 mg of adalimumab. Nonmedicinal ingredients: sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, succinic acid, sodium succinate dibasic, L-histidine, L-histidine hydrochloride monohydrate, mannitol, polysorbate 20 and water for injection.

40 mg/0.8 mL
Each 0.8 mL of preservative-free, sterile solution contains 40 mg of adalimumab. Nonmedicinal ingredients: citric acid monohydrate, sodium citrate dihydrate, L-histidine, L-histidine hydrochloride monohydrate, sorbitol, polysorbate 20, 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, or an opportunistic infection (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
• tiredness
• upper respiratory infections (such as colds or sinus infections)
• weakness
• worsening appearance of a scar

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 or pain
• breathing difficulty
• chest pain
• cold sores
• cough
• double vision
• fever
• 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 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 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
• symptoms of pneumonia (e.g., fever or chills, shortness of breath, fatigue, chest pain, cough)
• tingling sensation
• trouble swallowing
• 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)
• 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 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 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 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 nodes
• 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. Before starting treatment with this medication, check with your doctor to ensure your immunizations are up to date.

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: This medication may pass into breast milk. If you are breast-feeding and taking adalimumab, 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 who weigh less than 10 kg, for the treatment of JIA, or for the treatment of uveitis. The use of adalimumab to treat adolescents with Crohn's disease should be limited to children who weigh more than 40 kg and are over 13 years old. Adalimumab should not be used to treat ulcerative colitis for children who are younger than 5 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?

For a full list of interactions, use the Drug Interaction Checker available on the Drugs.com website.

• 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.

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 – 2024. 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/Hadlima