Amgevita 40 Mg 2 Pre-Filled Syringe (Refrigerator)

Product Description:

• Amgevita 40 mg solution for injection in pre-filled pen.

Amgevita is used to treat:

• Rheumatoid arthritis


• Polyarticular juvenile idiopathic arthritis.


• Enthesitis-related arthritis.


• Ankylosing spondylitis ( ankylosing spondylitis ).


• Axial spondylitis without radiographic confirmation of ankylosing spondylitis.


• Psoriatic arthritis.


• Plaque psoriasis.


• Crohn's disease.


• Ulcerative colitis.


• Non-infectious uveitis.

The active substance in Amgevita, adalimumab, is a human monoclonal antibody:

• Monoclonal antibodies are proteins that attach to a specific target.


• The target of adalimumab is a protein called tumor necrosis factor (tnfα), which is involved in the immune system.


• In the inflammatory diseases above, it is present in increased levels. 


• By attaching to tnfα, Amgevita lowers the inflammatory process in these conditions.

Rheumatoid arthritis:

• Rheumatoid arthritis is an inflammatory disease of the joints.


• Amgevita is used to treat moderate to severe rheumatoid arthritis in adults. 


• You may first receive other disease-modifying drugs, such as methotrexate.


• If you do not respond well enough to these medicines, you will be given Amgevita.


• Amgevita can also be used to treat severe, active and progressive rheumatoid arthritis without previous treatment with methotrexate.


• Amgevita can slow the damage to the joints caused by the inflammatory disease and can help the joints move more freely.


• Your doctor will decide whether Amgevita should be taken with methotrexate or given alone.

Polyarticular juvenile idiopathic arthritis:

• Polyarticular juvenile idiopathic arthritis is an inflammatory disease of the joints.


• Amgevita is used to treat polyarticular juvenile idiopathic arthritis in patients over 2 years of age. You may first receive other disease-modifying drugs, such as methotrexate. 


• If you do not respond well enough to these medicines, you will be given Amgevita.


• Your doctor will decide whether Amgevita should be taken with methotrexate or given alone.

Enthesitis-related arthritis:

• Enthesitis-related arthritis is an inflammatory disease of the joints and the places where tendons are attached to the bone.


• Amgevita is used to treat enthesitis-related arthritis in patients over 6 years of age. 


• You may first receive other disease-modifying drugs, such as methotrexate. 


• If you do not respond well enough to these medicines, you will be given Amgevita.


• Ankylosing spondylitis and axial spondylitis without radiographic confirmation of ankylosing spondylitis


• Bekhterev's disease ( ankylosing spondylitis ) and axial spondyloarthritis without radiographic confirmation of ankylosing spondylitis are inflammatory diseases of the spine.


• Amgevita is used to treat severe ankylosing spondylitis and axial spondylitis without radiographic confirmation of ankylosing spondylitis in adults. 


• You may be given other medicines first. If you do not respond well enough to these medicines, you will be given Amgevita.

Psoriatic arthritis:

• Psoriatic arthritis is an inflammatory disease of the joints usually associated with psoriasis.


• Amgevita is used to treat psoriatic arthritis in adults. 


• Amgevita can slow the damage to the joints caused by the disease and can help the joints move more freely. 


• You may be given other medicines first. 


• If you do not respond well enough to these medicines, you will be given Amgevita.

Plaque psoriasis:

• Plaque psoriasis is a skin disease that causes red, scaly , dry patches of skin covered with silvery, scaly skin. 


• Plaque psoriasis can also affect the nails, causing crumbling, thickening and loosening from the nail bed which can be painful.

Amgevita is used to treat:

• Moderate to severe chronic plaque psoriasis in adults and severe chronic plaque psoriasis in children and adolescents from 4 to 17 years of age, where topical (local) treatment and light treatment have not worked well enough or are not suitable.

Hidrosadenite:

• Hidrosadenitis (also called sweat gland inflammation) is a chronic and often painful inflammatory disease of the skin. 


• Symptoms can be tender nodules (lumps) and boils (abscesses) that can leak pus. 


• Most often, specific areas of the skin are affected, such as e.g. under the breasts, in the armpits, inner thighs, groin and buttocks. Scarring may also occur in affected areas.

Amgevita is used to treat:

• Moderate to severe hidrosadenitis in adults and moderate to severe hidrosadenitis in adolescents from 12 to 17 years of age.


• Amgevita can reduce the number of nodules and boils caused by the disease, and the pain often associated with the disease. 


• You may be given other medicines first. If you do not respond well enough to these medicines, you will be given Amgevita.

Crohn's disease:

• Crohn's disease is an inflammatory disease of the digestive tract.

Amgevita is used to treat:

• Moderate to severe Crohn's disease in adults and moderate to severe Crohn's disease in children and adolescents aged 6 to 17 years.


• You may be given other medicines first. If you do not respond well enough to these medicines, you will be given Amgevita.

Ulcerative colitis:

• Ulcerative colitis is an inflammatory disease of the large intestine.

Amgevita is used to treat:

• moderate to severe ulcerative colitis in adults and moderate to severe ulcerative colitis in children and adolescents from 6 to 17 years of age


• You may be given other medicines first. 


• If you do not respond well enough to these medicines, you will be given Amgevita.

Non-infectious uveitis:

• Non-infectious uveitis is an inflammatory disease that affects certain parts of the eye.


• Amgevita is used to treat adults with non-infectious uveitis with inflammation affecting the back of the eye.


• children over 2 years of age with chronic non-infectious uveitis with inflammation affecting the front part of the eye (irisitis)


• This inflammation can lead to reduced vision and/or the presence of floating bodies in the eye (black dots or uneven lines that move across the field of vision).


• Amgevita works by reducing this inflammation.


• You may be given other medicines first.


• If you do not respond well enough to these medicines, you will be given Amgevita.

How To Use:

• Always use this medicine exactly as your doctor or pharmacist has told you. 


• Contact your doctor or pharmacist if you are unsure.


• Your doctor may prescribe a different strength of Amgevita if you need a different dose.

Ulcerative colitis:

Age or body weight:

Adults:

• First dose of 160 mg (four 40 mg injections in one day or two 40 mg injections daily for two consecutive days), followed by 80 mg (two 40 mg injections in one day) two weeks later.


• Thereafter, the usual dose is 40 mg every two weeks.

Children and young people from 6 years of age who weigh less than 40 kg:

• First dose of 80 mg (two 40 mg injections in one day), followed by 40 mg (one 40 mg injection) two weeks later.


• Thereafter, the usual dose is 40 mg every two weeks.

Children and young people aged 6 and over who weigh 40 kg or more:

• First dose of 160 mg (four 40 mg injections in one day or two 40 mg injections daily for two consecutive days), followed by 80 mg (two 40 mg injections in one day) two weeks later.

Thereafter, the usual dose is 80 mg every two weeks.    

Non-infectious uveitis:

Age or body weight:       

Adults:

• First dose of 80 mg (two 40 mg injections in one day), followed by 40 mg every other week starting one week after the first dose.

Children and young people over 2 years of age who weigh less than 30 kg:

• 20 mg every other week.

Children and young people over the age of 2 who weigh at least 30 kg:

• 40 mg every other week.

Method and mode of administration:

Amgevita is administered (given) by injection under the skin (by subcutaneous injection).

If you take too much Amgevita:

• If you accidentally inject Amgevita more often than your doctor has prescribed, see your doctor or pharmacist at the pharmacy and tell them that you have taken too much.


• Always take the outer packaging of the medicine with you, even if it is empty.

If you have forgotten to take Amgevita:

• If you have forgotten to take Amgevita, take the next dose as soon as you remember.


• You can then take the next dose on the day it was originally scheduled, as if you hadn't missed a dose.

If you stop treatment with Amgevita:

• The decision to stop treatment with Amgevita should be discussed with your doctor. 


• Your symptoms may return if you stop using Amgevita.


• Ask your doctor or pharmacist if you have any questions about the use of this medicine.

Warnings And Precautions:

Do not use Amgevita:

• If you are allergic to adalimumab or any of the other ingredients of this medicine.


• If you have active tuberculosis or other serious infections (see "Warnings and precautions").


• It is important that you inform your doctor if you have symptoms of infection , such as fever , sores, fatigue, problems with the teeth.


• If you have moderate to severe heart failure. 


• It is important that you tell your doctor if you have or have had serious heart disease.

Talk to your doctor or pharmacist before using Amgevita.

Allergic reactions:

• If you experience allergic reactions with symptoms such as tightness or wheezing in the chest, dizziness, swelling or rash, do not continue to inject Amgevita, but contact your doctor immediately as these reactions can rarely be life-threatening.

Infections:

• If you have an infection , including long-term infection or an infection in one part of the body (e.g. leg ulcer ), you must talk to your doctor before you start using Amgevita. 


• Contact your doctor if you are unsure.


• You may get infections more easily while being treated with Amgevita. 


• This risk may be greater if you have problems with your lung function. 

These infections can be serious and include:

Tuberculosis.

• infections caused by viruses, fungi, parasites or bacteria


• serious infections in the blood ( blood poisoning )
  In rare cases, these infections can be life-threatening. 


• It is important to tell your doctor about any symptoms such as fever , sores, fatigue or problems with the teeth. 


• Your doctor may recommend stopping treatment with Amgevita for a while.


• Tell your doctor if you live or travel in areas where fungal infections (eg histoplasmosis , coccidioidomycosis or blastomycosis ) are very common.


• Let your doctor know if you have had repeated infections or other conditions that increase the risk of infections .


• If you are over 65 years of age, you may be more susceptible to infections while being treated with Amgevita. 


• You and your doctor should pay particular attention to signs of infection while you are being treated with Amgevita.


• It is important that you tell your doctor if you get symptoms of infections , e.g. fever , sores, tiredness or dental problems.

Ingredients:

• Amgevita contains the active ingredient adalimumab.

Product Details: