Intacept 25mg (Etanercept)

Description of Intacept 25mg ( Etanercept 25mg)

Intacept 25mg ( Etanercept 25mg) has an active ingredient like Etanercept which is a protein medicine that binds to and involved in blockade of tumor necrosis activity. Intacept 25mg ( Etanercept 25mg) is manufactured in the form of injection for treating major inflammatory disease like rheumatoid arthritis. Intacept 25mg ( Etanercept 25mg) is available in the strength of 50mg and 25mg containing 1.0ml & 0.5ml respectively.

Medical use /Indication of Intacept 25mg ( Etanercept 25mg)

The primary indication of Intacept 25mg ( Etanercept 25mg) is involved in the treatment of rheumatoid arthritis. Some other indications like : Polyarticular

• juvenile idiopathic arthritis
• Psoriatic arthritis
• Ankylosing spondylitis
• Plaque psoriasis

In rheumatoid arthritis : Intacept 25mg ( Etanercept 25mg) is used to eradicating the manifestation of rheumatoid arthritis by combining with methotrexate or alone In JIA: Intacept 25mg ( Etanercept 25mg) is used for this condition occurs in the age of 2 years or older

In psoriatic arthritis : Intacept 25mg ( Etanercept 25mg) should be used by combining with methotrexate, for the patients who are not responding to methotrexate alone.

Mechanism of Action Intacept 25mg ( Etanercept 25mg)

Intacept works by inhibiting tumor necrosis factor, which is typically emerging cytokine necessary for inflammatory response, occurs in rheumatoid arthritis, juvenile idiopathic arthritis, AS etc. Rheumatoid arthritis causes accumulation of tumor necrosis factor in synovial fluid causes joint destruction in RA, JIA, AS, PA, and PsO. Intacept inhibiting the binding of tumor necrosis factor with cell surface receptors like p55 & p75 and prohibition of activity occurs causes TNF biologically inactive

ADME of Intacept 25mg ( Etanercept 25mg)

After administration of 25mg of Intacept subcutaneously, the peak plasma time occurs in 69 ± 34 hours. The absorption of Intacept occurs very slowly after administrating through subcutaneously. The outbreak of action occurs within 2 to 3 weeks, whereas in RA 1 to 2 weeks In RA the full effect of Intacept occurs in 3 months Clearance value of Intacept in both adults and pediatrics occurs as :

• 46ml/hr/m2 in pediatric patients
• 160 ± 80ml/hour in adults

The mean terminal half life period of Intacept is Children with age ≥4 years & adults in JIA: 70 to 94.8 hours with the range of 31.2 to 104.8 hours. Adults with RA: 102 ± 30 hours

Side effects of Intacept 25mg ( Etanercept 25mg)

Viral, bacterial or fungal infections may occur : Injection site

• Pain
• swelling
• redness
• Immunogenicity
• Auto antibodies
• Upper respiratory tract infections
• Rash
• Diarrhea
• Pruritus
• Pyrexia
• Urticaria
• Hypersensitivity reactions
• Varicella infections in pediatric patient
• Aseptic meningitis in pediatric patients with JIA

Post marketing experience:

Pancytopenia, Anemia, Leucopenia, Neutropenia, Thrombocytopenia, Lymphadenopathy, Aplastic anemia, Inflammatory bowel syndrome, Congestive heart failure, Elevation of transaminase, Angioedema, Chest pain, Autoimmune hepatitis, Lupus like syndrome, Interstitial lung disease.

Precautions of Intacept 25mg ( Etanercept 25mg)

• Intacept 25mg ( Etanercept 25mg) causes severe adverse effects; caution should be taken during the therapy Serious infections: In Intacept 25mg ( Etanercept 25mg) therapy, there is a chance of increase in exposure of severe infections caused by virus, bacteria and fungus.
• Concomitant use of Intacept 25mg ( Etanercept 25mg) with other Immuno suppressant agents like corticosteroids or methotrexate causes serious infection.
• Patients should be counsel about the risk and exposure of adverse effects before starting the therapy; Whether patient may suspected with tuberculosis or not Any fungal infections occur History of opportunistic infection Various effects; Neurological problems Malignancy like Lymphoma, leukemia, non-melanoma skin cancer In pediatric patients, chance to get lymphoma Severe congestive heart failure occur Hepatitis B viral reactivation occurs Anaphylactic reactions occur Immunization, live vaccines are not used Autoimmunity, lupus like symptoms occur for this condition discontinue the treatment immediately Immuno suppression.
• Use of Intacept 25mg ( Etanercept 25mg) is not recommended in the patients who receiving Immuno suppressive agents for Wegener’s granulomatosis patients.
• Concurrent use of Intacept 25mg ( Etanercept 25mg) with anakinra or abatacept should be avoided to reduce the adverse effects of these medicines.
• Intacept 25mg ( Etanercept 25mg) injection is used cautiously in the patients having severe alcoholic hepatitis.

Pregnancy & Lactation of Intacept 25mg ( Etanercept 25mg)

TGA pregnancy category: D

US FDA pregnancy category: B

Intacept 25mg ( Etanercept 25mg) is used cautiously in pregnancy condition, only under the guidance of medical practitioner

Lactation :

Breast feeding should not be recommended

Dosage of Intacept 25mg ( Etanercept 25mg)

In adults :

Patients suffering with rheumatoid arthritis, psoriatic arthritis & Ankylosing spondylitis :

The prescribed dosage of Intacept is 50mg administered once a week. Methotrexate, glucocorticoid, salicylates, NSAIDS or analgesics may combine with Intacept

Patients with plague psoriasis :

The recommended dosage of Intacept in this condition; Initial dose: 50mg of Intacept should be administered two times a week for 3 months, rather the initial dose of 25mg to 50mg should be given as a once a week. Continuance dose: 50mg of Intacept should be administered once a week

In pediatric :

In juvenile idiopathic arthritis: 2 years or older

Depending up on the weight of patients, dosage should be recommended;

63kg or more: 50mg of Intacept should be taken as once a week

Less than 63kg: 0.8mg/kg of Intacept should be taken as a once a week The maximum dosage of Intacept is 50mg should be taken as a once a week

In plaque psoriasis: 4 years or older

Less than 63kg: 0.8mg/kg of Intacept should be administered once a week
63kg or more: 50mg of Intacept should be taken as once a week The maximum dosage of Intacept is 50mg should be taken as a once a week

Storage of Intacept 25mg ( Etanercept 25mg)

Intacept 25mg ( Etanercept 25mg) injection 50mg & 25mg should be stored at 2℃ to 8℃

Protect from light

Kept in cool and dry place

Missed dose of Intacept 25mg ( Etanercept 25mg)

If patient fail to take the dose of Intacept 25mg ( Etanercept 25mg), must consult with medical practitioner and dministered the missed dose if possible. On the other way the missed dose should be avoid and follow the regular schedule