Trade name : Exemptia
Active ingredient : Adalimumab
Strength availability : 40MG/0.8ML
Manufactured by : Zydus Cadila
Package : one prefilled syringe/injection
Category : Anti-rheumatoid, Immuno suppressive agent
Route : Subcutaneous use
Exemptia is an anti-rheumatoid arthritis and Ankylosing spondylitis. Exemptia is used alone or combined with methotrexate. Exemptia is a prescription medicine, used by the patients who are all having a valid prescription only under the knowledge of medical practitioner. Exemptia containing Adalimumab has various activities like; Tumor necrosis factor inhibitory activity Anti-inflammatory activity Immuno suppressive activity Anti-rheumatoid activity (disease modifying) Monoclonal antibody
Exemptia injection is used in various conditions like; Rheumatoid arthritis used alone or combine with methotrexate Juvenile idiopathic arthritis in pediatric Psoriasis arthritis Adult crohn’s disease Ankylosing spondylitis Plaque psoriasis Ulcerative colitis All these conditions, Exemptia are used to reduce the symptoms and provide better heal.
Exemptia WORKS AS
Exemptia is used to inhibit the tumor necrosis factor which is commonly originating cytidine responsible for inflammatory and immunity response. Rheumatoid arthritis is a condition, in which TNF level gets elevated and accumulated in synovial fluid causes inflammation of joints. Exemptia containing Adalimumab expels its activity by certainly binds to TNF alpha and complicated in stoppage of association of TNH alpha with its receptors such as p55 & p75 cell surface TNF receptors. Exemptia is also experienced in lysis of surface TNF expose cells in vitro in the presence of complement.
The peak plasma concentration time of Exemptia is occurs at 131 ± 56 hours and maximum serum concentration reaches as 4.7 ± 1.6mcg/ml The mean bioavailability of Exemptia is reaches at 64%
The volume of distribution of Exemptia is 4.7 to 6.0L
Metabolism of Exemptia occur hepatically using microsomal enzymes, because of elevation of TNF levels in chronic inflammation which may diminish the production of CYP isoenzymes, the contrariety of TNF activity by Exemptia may distribute the formation of CYP isoenzymes
The systemic clearance of Adalimumab is relatively occurs as 12ml/hr The mean terminal half life period of Adalimumab is relatively occurs as 2 weeks ranging from 10 to 20 days
In rheumatoid arthritis, psoriasis arthritis & Ankylosing spondylitis (RA, PA, & AS) :
The usual prescribed dosage of Exemptia for these conditions, 40mg should be given for every other week through subcutaneously.
Methotrexate, NSAIDS, glucocorticoid, salicylates, analgesics, or DMARDs may be carrying out during the therapy with Exemptia if required.
In some conditional patients, methotrexate should not be used in combination. In this condition the frequency of dosage of Exemptia is increases to 40mg for every week.
In adult crohn’s : The usual recommended dosage of Exemptia is 160mg initiate at day 1 (administered as four 40mg in a day or two 40mg per day for two successive days) following with 80mg two weeks later (day 15). Later two weeks, day 29 initiates with maintenance dose of 40mg should be given for every other week. Aminosalicylates, corticosteroids, or Immuno modulatory agents may be used during the therapy with Exemptia
For pediatrics :
6 years & older : 17kg to less than 40kg: The initial dose is 80mg given subcutaneous on day 1 followed by 40mg two weeks later, then 20mg SC every other week 40kg or greater: The recommended dosage 160mg of Exemptia should be given subcutaneous on day 1, respectively 80mg SC for two weeks later, then 40mg SC every other week.
In juvenile idiopathic arthritis : The usual recommended dose of Exemptia is suitable for the age of 4 to 17 years with polyarticular JIA is calculated on the basis of body weight of the patients. 2 years and older pediatric patients Exemptia is suggested. Methotrexate, NSAIDS, glucocorticoid, salicylates or analgesics may be used in combination. • In 10kg to less than 15kg: 10mg dose should be recommended • In 15 kg to <30kg: 20mg of dose should be given for every other week • ≥30kg: 40mg of dose should be given for every other week In ulcerative colitis: The prescribed dosage of Exemptia is 160mg initially given at day 1 (administered as four 40mg in a day or two 40mg per day for two successive days) following with 80mg two weeks later (day 15). After two weeks, day 29 starts with continuance dose of 40mg every other week. Plaque psoriasis : The recommended dosage of Exemptia is starting with 80mg, which is followed by 40mg for every other week, initiate one week after the initial dose
WARNING & SAFETY MEASURES
While using Exemptia some adverse effects occur :
Active or latent tuberculosis,
Lymphoma and other malignancy,
Hepatosplenic T-cell lymphoma,
Various viral, fungal & bacterial infections occur,
Increased the risk of infections.
To reduce these conditions :
Avoid concurrent use of methotrexate with Exemptia Before initiate the treatment with Exemptia, patients must counsel about the adverse effects acquired by Exemptia
Risk factors :
Viral, fungal or bacterial infections, History of patient already having opportunistic infection, Exposure of tuberculosis, Serious or intermittent infections. Other adverse effects :
Neurological reactions, Hematological problems, HBV reoccurrence, Risk of non-melanoma skin carcinoma: Discontinuation of treatment with Exemptia
Hepatosplenic T-cell lymphoma in pediatric patients: Stop the therapy immediately Hypersensitivity reactions occurs, to prevent this reactions avoid concomitant use of Exemptia with other immunosuppressant agents.
Avoid the concomitant use of Exemptia with live vaccines. Anakinra, a interleukin 1 antagonist while combining with Exemptia causes serious infection associated to anakinra, to avoid this problem concomitant use of Exemptia with anakinra should not be recommended. Exemptia concurrently used with methotrexate, in rheumatoid arthritis may causes diminishing apparent clearance of Exemptia.
Exemptia has no contraindications Hypersensitivity reactions present, if patients are contraindicated to the ingredient of Exemptia
Exemptia is used by the patients having serious rheumatoid arthritis, no self medication occur. If patient fail to take the dose of Exemptia must consult with physician and follow the instruction given by medical adviser or skip the missed dose and follow the regular dosing schedule.
Once over dose occurs in the patients receiving Exemptia, must monitored the signs and manifestation due to overdose of Exemptia. Patient should be provided with safety measures.
Severe infections :
Malignancies, Erythema, Back pain, Hypertension, Thrombocytopenia, Anaphylaxis, Angioneurotic edema, Interstitial lung disease like pulmonary fibrosis, Cutaneous vasculitis, psoriasis, Erythema multiforme, Systemic vasculitis, Itching, Hemorrhage, Pain, swelling, Rash, Pneumonia, Tuberculosis, Lupus like syndrome, Sinusitis, Flu like syndrome, Respiratory tract infection, Abdominal pain, Nausea, Injection site pain, Headache, Lab values abnormalities : • Hematuria
• Elevation of alkaline phosphatase