Intacept-50mg

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

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Drug profile:

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

Intacept 50mg injection is used in rheumatoid arthritis condition. It should be used alone or by combination with other medicines which involved in the treatment of rheumatoid.

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

Intacept vial containing 50mg/1.0ml of Etanercept for solution for subcutaneous injection.


Brand name: Intacept

Key ingredients: Etanercept

Strength availability: 50mg/1.0ml

Mfg: Intas pharmaceuticals

Package: prefilled syringe containing 50mg of Etanercept for solution

Route of administration: Subcutaneous, single use

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


Intacept 50mg Prescribing Information:

Intacept is ideally used in the conditions like;

The uses of drug are


Ankylosing spondylitis:

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


Juvenile idiopathic arthritis:

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


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.


Intacept 50mg 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 the surface of the cells which is the 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 Intacept is absorbed very slowly after administered subcutaneously.

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

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

The onset of action occurs within 1 to 2 weeks.


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 50mg

Intacept is administered as weekly dose. Intacept 50mg/1.0ml

RA: rheumatoid arthritis; AS: Ankylosing spondylitis; PSA: psoriasis arthritis.


Dosage Regimens of Intacept 50mg

In adults:

Patients with RA, AS & PSA: The recommended dosage of Intacept is 50mg once a week

In patients with PsA:

Initial dose: The recommended dosage of Intacept is 50mg should be taken as two times a week for 3 months.

Continuation therapy:  The recommended dosage is 50mg given as once a week.

In these three conditions, methotrexate, salicylates, NSAIDs, or analgesics may be used with Intacept.


In pediatrics:

Juvenile idiopathic arthritis is one of the major condition that occur in the patients with age of 2years and older

Based on the body weight, Intacept dosage can be calculated;

63kg or more: The recommended dosage is 50mg given weekly as a single dose.

Less than 63kg: The prescribed dosage is 0.8mg/kg weekly.


Preparation of the Intacept 50mg:

Intacept is prefilled syringes, containing 50mg vial/1.0ml.

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

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.

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.


Intacept 50mg Called side effects:

The adverse reactions occur after the therapy is including;

Infections like viral, bacterial, fungal

Injection site reactions like itching, Erythema, swelling, bleeding, pain, bruising

Immunogenicity

Autoantibodies

Other adverse effects;

Upper respiratory infections

Diarrhea

Rash

Pruritus

Pyrexia

Urticaria

Hypersensitivity

Chest pain

Congestive heart failure

Inflammatory bowel syndrome

Angioedema, autoimmune hepatitis

Increase in transaminase

Systemic vasculitis, lupus-like syndrome

Non-melanoma skin cancer

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


Drug Interaction of Intacept 50mg

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 accumulating 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.


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 counts.

  

Food -Drug Interactions of Intacept 50mg:

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:

Intacept is contraindicated to the patients who are all having sepsis.

Serious infections may occur.

The anaphylactic reaction occurs, while patients are contraindicated in the component of the Intacept.

Concurrent of live vaccines or cyclophosphamide may be contraindicated.

Patients having Wegener granulomatosis getting immunosuppressant therapy. 

     

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

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

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


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 life 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 the concerned physician.

If the patient fails to take the dose of Intacept, must consult the physician and follow the instructions and as per the instruction is 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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