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intacept-50mg

PRODUCT DETAILS

Trade name : Intacept 50mg
Active ingredient : Etanercept
Strength availability : 50MG/1.0ML
Manufactured by : Intas pharmaceuticals
Package : prefilled syringe for single use
Category : Anti-inflammatory or Anti-rheumatoid arthritis
Route of administration : Subcutaneous route

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

INDICATION

The primary indication of Intacept 50mg 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 50mg is used to eradicating the manifestation of rheumatoid arthritis by combining with methotrexate or alone
In JIA: Intacept 50mg is used for this condition occurs in the age of 2 years or older
In psoriatic arthritis: Intacept 50mg should be used by combining with methotrexate, for the patients who are not responding to methotrexate alone.

AVAILABILITY OF STRENGTH

Intacept prefilled syringe, single use only Intacept injection is available in :
50mg containing 1.0ml solution of Etanercept

DOSAGE

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

ADME PROPERTIES

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

How Intacept 50mg works in a body

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

WARNING & SAFETY MEASURES

Intacept 50mg causes severe adverse effects; caution should be taken during the therapy Serious infections :
In Intacept 50mg therapy, there is a chance of increase in exposure of severe infections caused by virus, bacteria and fungus. Concomitant use of Intacept 50mg 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 50mg is not recommended in the patients who receiving Immuno suppressive agents for Wegener’s granulomatosis patients. Concurrent use of Intacept 50mg with anakinra or abatacept should be avoided to reduce the adverse effects of these drugs. Intacept 50mg injection is used cautiously in the patients having severe alcoholic hepatitis.

DRUG INTERACTION

Intacept 50mg should not be concomitant with live vaccines; patients who have risk of varicella virus should be discontinued with the therapy of Intacept 50mg for short period of time. While concomitant use of Intacept 50mg with immune modulating biologic products like Anakinra or abatacept causes serious adverse effects. Infections like bacterial pneumonia and cellulitis, pulmonary fibrosis and pneumonia causes respiratory failure occurs due to combination of Intacept 50mg with Anakinra. 2% of patients may have chance to get neutropenia while concurrent use of Intacept 50mg with Anakinra. Abatacept with Intacept 50mg combination, increase the risk of adverse effects. Intacept 50mg & cyclophosphamide combinational therapy should not be suggested. While combining sulfasalazine with Intacept 50mg, causes depletion of neutrophils counts

MISSED DOSE

If patient fail to take the dose of Intacept 50mg, 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.

SIDE EFFECTS

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.

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