Enbrel Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage Patient Counseling Information MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Etanercept

Indications/Uses

Signs & symptoms & inhibiting structural damage progression in moderately to severely active RA in combination w/ MTX in patients w/ inadequate response to MTX alone. Active polyarticular juvenile idiopathic arthritis in childn & adolescent from 2 yr w/ inadequate response to or who have proved intolerant of MTX. Reduction of signs & symptoms of active psoriatic arthritis in combination w/ MTX in patients w/ inadequate response to MTX alone. Active ankylosing spondylitis in adult. Active non-radiographic axial spondyloarthritis w/ objective signs of inflammation as indicated by elevated C-reactive protein &/or MRI evidence in adults w/ inadequate response to NSAID. Moderate to severe plaque psoriasis in adults who failed to respond to, have contraindication to or are intolerant to other systemic therapy including cyclosporine, MTX or PUVA. Chronic severe plaque psoriasis in childn & adolescents from 6 yr who are inadequately controlled by, or are intolerant to other systemic therapies or phototherapies.

Click to view Enbrel detailed prescribing information

Dosage/Direction for Use

SC Adult 18-64 yr & elderly ≥65 yr RA, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis 25 mg twice wkly or 50 mg once wkly. Plaque psoriasis 25 mg twice wkly or 50 mg once wkly. Alternatively, 50 mg twice wkly for up to 12 wk followed by 25 mg twice wkly or 50 mg once wkly, if necessary, for up to 24 wk. Polyarticular juvenile idiopathic arthritis 0.4 mg/kg twice wkly w/ 3-4 days interval between doses, up to max: 25 mg/dose. Paed plaque psoriasis ≥6 yr 0.8 mg/kg once wkly for up to 24 wk, up to max: 50 mg/dose.

Click to view Enbrel detailed prescribing information

Overdosage

View Enbrel overdosage for action to be taken in the event of an overdose.

Contraindications

Hypersensitivity. Sepsis or risk of sepsis. Not to be initiated in serious active infections including chronic or localised infections.

Click to view Enbrel detailed prescribing information

Special Precautions

Not to be inj into tender, bruised, red or hard skin areas. Not recommended in Wegener's granulomatosis & moderate to severe alcoholic hepatitis. Allergic reactions; immunosuppression. History of recurring or chronic infections, underlying conditions which may predispose patients to infections; opportunistic infections including invasive fungal infections; worsening of hepatitis C. Risk for development of lymphomas, other hematopoietic or solid malignancies. Previous history of blood dyscrasias; formation of autoimmune Ab, pre-existing or recent onset of CNS demyelinating disease or patients at increased risk of developing demyelinating disease. Psoriasis; CHF; hypoglycemia; inflammatory bowel disease. Hypersensitivity to latex. Monitor for signs & symptoms of active TB & HBV reactivation. Perform periodic skin exam for patients at risk of skin cancer. Not to be given concurrently w/ live vaccines. Concurrent treatment w/ anakinra & abatacept. Pregnancy & lactation. Not to be used in childn <2 yr.

Click to view Enbrel detailed prescribing information

Use In Pregnancy & Lactation

Click to view Enbrel detailed prescribing information

Adverse Reactions

Infections eg, URTI, bronchitis, cystitis, skin infections; headache; inj site reactions eg, bleeding, bruising, erythema, itching, pain & swelling. Allergic reactions, autoAb formation; pruritus; rash; pyrexia.

Click to view Enbrel detailed prescribing information

Drug Interactions

Higher rate of serious infections & neutropenia w/ anakinra. Increased serious adverse event incidence w/ abatacept. Decreased WBC counts w/ sulfasalazine.

Click to view Enbrel detailed prescribing information

Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Enbrel detailed prescribing information

Storage

View Enbrel storage conditions for details to ensure optimal shelf-life.

Description

View Enbrel description for details of the chemical structure and excipients (inactive components).

Action

View Enbrel mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

ATC Classification

L04AB01 - etanercept ; Belongs to the class of tumor necrosis factor alpha (TNF-alpha) inhibitors. Used as immunosuppressants.

Regulatory Classification

Patient Counseling Information

View Enbrel patient counselling information

Presentation/Packing

Form

Enbrel soln for inj 25 mg

Packing/Price

4 × 1's

Form

Enbrel soln for inj 50 mg

Packing/Price

4 × 1's

Enbrel

etanercept

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma