Intacept-25mg

This medication is a tumor-necrosis factor (TNF) blocker, prescribed for ankylosing spondylitis (type of joint pain that affects your back), juvenile arthritis (arthritis-related condition that... read more

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Drug profile:

Intacept 25mg injection is used in rheumatoid arthritis condition. It should be used alone or in combination with other medicines which involved in the treatment of rheumatoid

Intacept 25mg is an Intas pharmaceutical product, containing an active component called Etanercept. Intacept is an injection available in a prefilled syringe.

Intacept expels its action by inhibiting tumor necrosis factor which is produced by immune system

Intacept vial containing 25mg/0.5ml of Etanercept for a solution for subcutaneous injection.


Brand name: Intacept

Key ingredients: Etanercept

Strength availability: 25mg/0.5ml

Mfg: Intas pharmaceuticals

Package: prefilled syringe containing 25mg of Etanercept for solution

Route of administration: Subcutaneous, single use

Category: Disease-modifying Anti-rheumatoid arthritis, TNF prohibition, immunosuppressant


Intacept 25mg Prescribing Information:

Intacept is ideally used in the conditions like;

The uses of drug are


Rheumatoid arthritis:

In rheumatoid arthritis, Intacept injection is combined with methotrexate or used alone to reduce the progression


Psoriatic arthritis:

Intacept is used alone or combined with methotrexate which is involved in suppression of damage of arthritis. In combination with methotrexate in patients who are not respond for methotrexate alone


Ankylosing spondylitis:

In this condition, Intacept injection is used to decrease the signs and symptoms of Ankylosing spondylitis


Juvenile idiopathic arthritis:

This condition is mostly occurs at the age of 2 years & older, Intacept is used alone to reduce the symptoms


Intacept 25mg Mechanism of Action:

Tumor necrosis factor is developing a natural cytokine which is involved in typical inflammatory and immune responses.

Cytokine performed a vital role in inflammatory development in rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriasis arthritis, & Ankylosing spondylitis

In these conditions, TNF level are very high in range which is found in tissues and fluids of the infected patients

There are two specific receptors of TNF are;

  • 55 kilodalton protein p55
  • 75 kilodalton protein p75

These are present on a surface of the cells which is an insoluble form

Intacept exhibits its action by; Etanercept is a dimeric dispersible form of  p75 TNF receptor, can bind TNF fragment, thus results leads to prohibits merging of TNF-α & TNF-β to TNFRs cell surface and concludes as biologically passive


Absorption:

The bioavailability is occurred as 60% absolutely up to 76%

The onset of action occurs within 1 to 2 weeks

The Intacept is absorbed very slowly after administered subcutaneously

The peak plasma concentration reached only at 69 hours ± 34 hours after a single dose


Distribution:

The volume of distribution is 12L


Elimination:

The terminal half-life period of Intacept is 5 days with the clearance of 160 ± 80ml/min


When to take Intacept 25mg:

Intacept is administered as weekly dose. Intacept 25mg/0.5ml

Used in the conditions;

RA: rheumatoid arthritis; AS: Ankylosing spondylitis; PsA: psoriasis arthritis


Dosage Regimens of Intacept 25mg:

In adults:

Patients with RA, AS & PsA: The recommended dosage of Intacept is 25mg as a two times a week at interval of 3 to 4 weeks

Stop the therapy after 3 months, if no response occurs


In pediatric:

The recommended dosage is 0.4mg/kg up to 25mg per dose as given for twice-weekly maximum dose up to 0.8mg/kg in juvenile idiopathic arthritis


Preparation of the Intacept 25mg:

Intacept is prefilled syringes, containing 25mg/0.5ml

Intacept is a single-use prefilled syringe, before administration it should be allowed to kept in a room temperature

The content of the prefilled syringe should be checked before administration, if the content is between the two purple fill level indicator lines, then the syringe should not used for administration

Do not take out the needle cover hence permits the syringe to reach room temperature

To check the solution whether it is clear or not


Intacept 25mg Called side effects:

The adverse reactions occur after the therapy is including;

Injection site reactions like;

Itching

Erythema

Swelling

Bleeding, pain

Bruising

Immunogenicity

Autoantibodies

Infections like viral, bacterial, fungal


Other adverse effects:

Upper respiratory infections

Diarrhea

Rash

Pruritus

Pyrexia

Urticaria

Systemic vasculitis, lupus-like syndrome

Non-melanoma skin cancer

Convulsions, multiple sclerosis, demyelization, optic neuritis, uveitis, interstitial lung disease

Hypersensitivity

Chest pain

Congestive heart failure

Inflammatory bowel syndrome

Angioedema, autoimmune hepatitis

Increase in transaminase


Drug Interaction of Intacept 25mg

Immune modulating biologic products:

Inactive rheumatoid arthritis patients, Intacept & anakinra therapy should be followed for 24 weeks with concomitant use, as results patients may get serious effects compared to Etanercept used alone

Common effects like bacterial pneumonia, cellulitis, pulmonary fibrosis, pneumonia due to respiratory failure

Concomitant use of abatacept with Etanercept causes serious ill effects


Cyclophosphamide:

Concurrent use of cyclophosphamide with Intacept should be avoided


Sulfasalazine:

While concomitant sulfasalazine with Etanercept causes depletion in neutrophils count   


Vaccines:

In psoriasis arthritis patients who are receiving Intacept is efficient to raise effective B-cell immune responses to pneumococcal polysaccharide vaccine, but titers in accumulate moderately lower patients when compared to patients not getting vaccines

Patients acquired Intacept should concurrently received vaccines exception for live vaccines. Patients with serious hazard to varicella virus should discontinue Intacept therapy for that time


Food -Drug Interactions of Intacept 25mg:

While combining Intacept with methotrexate, avoid caffeine-containing foods and beverages because caffeine depletes the effectiveness of methotrexate in the therapy of arthritis

Avoid alcohol; the major side effect of methotrexate is liver toxic, if alcohol or alcohol containing food may increase the risk


Possible Contraindications:

Concurrent of live vaccines or cyclophosphamide may contraindicated

Patients having Wegener granulomatosis getting immunosuppressant therapy

Intacept is contraindicated to the patients who are all having sepsis

Serious infections may occurs

Anaphylactic reaction occurs, while patients are contraindicated to the component of the Intacept   

       

Safety Measures:

Patients receiving Etanercept having serious effects like

Severe infections:

During the therapy, patients may suspect with various infection because TNF range will be reduced. Some of infections like

Chronic infection

Tuberculosis

Endemic tuberculosis or endemic mycoses like histoplasmosis, coccidioidomycosis, and blastomycosis

Poorly controlled diabetics, invasive fungal infections

Some neurological events like disability, demyelinating disorders, optic neuritis, multiple sclerosis, other peripheral neuropathy

Avoid usage of Intacept in the patients having Wegener’s granulomatosis 

Malignancy: lymphoma, leukemia, non-melanoma skin cancer

Patient with concomitant use of Intacept with anakinra causes decreasing neutrophils counts

Hepatitis B reactivation occurs

Patients who are receiving Etanercept causes autoantibody production, in this condition Intacept should be discontinued

Intacept not concomitant with immunosuppressant agents


Pregnancy and Lactation:

The birth defects are higher in women who are receiving Etanercept while compared to unexposed women

In fetal and neonatal, the effect of Etanercept is not known, but worse and welfare of Etanercept is studied before administering live or live attenuated vaccines to infants

Breastfeeding should not be recommended because the low level of Etanercept is excreted in human milk


Storage and Handling:

Intacept prefilled single-use syringe should be stored at 2oC to 8oC (36oF to 46oF)

Do not freeze

Protect from light


Missed dose:

Intacept is used in very serious conditions, it is not self medicated by patients without knowledge of concerned physician

If patient fail to take the dose of Intacept, must consult the physician and follow the instructions and as per the instruction given by the physician the dose should be taken or the missed dose must be skipped and follow the regular dosing schedule

 Do not take an overdose.


Overdosage:

The outcome of overdosage of Intacept depends upon the amount of Etanercept taken subcutaneous or it may combine with any other medications, alcohol or other drugs.

The desirable treatment for the overdosage is administering or presuming fluids through an intravenous line 

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