Enbrel


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etanercept

Enbrel

Pharmacologic class: Immunomodulator

Therapeutic class: Antiarthritic

Pregnancy risk category B

Action

Reacts with and deactivates free-floating tumor necrosis factor, responsible for inflammation

Availability

Powder for injection: 25 mg in multiple-use vial

Prefilled syringe (single-use): 50 mg/ml

Indications and dosages

Moderately to severely active rheumatoid arthritis; ankylosing spondylitis; psoriatric arthritis

Adults: 50 mg subcutaneously q week given as a single injection. Dosages above 50 mg/week are not recommended.

Chronic moderate to severe plaque psoriasis

Adults ages 18 and older: 50 mg subcutaneously twice weekly (given 3 or 4 days apart) for 3 months, followed by reduction to a maintenance dosage of 50 mg weekly

Polyarticular-course juvenile rheumatoid arthritis

Children ages 4 to 17: 0.8 mg/kg subcutaneously q week, to a maximum of 50 mg weekly

Contraindications

• Hypersensitivity to drug or its components
• Sepsis

Precautions

Use cautiously in:
• immunosuppression, chronic infection, heart failure
• latex allergy (needle cover of diluent syringe contains latex)
• elderly patients
• pregnant or breastfeeding patients
• children younger than age 4.

Administration

• Inject subcutaneously into thigh, abdomen, or upper arm.
• For adult, use single-use, 50 mg/ml prefilled syringe.
• For child weighing 63 kg (138 lb) or more, use single-use, 50 mg/ml pre-filled syringe for weekly dose; for child weighing 31 to 62 kg (68 to 137 lb), administer total weekly dose from multipleuse vial as two injections on same day or 3 or 4 days apart; for child weighing less than 31 kg (68 lb), give as a single weekly injection using multipleuse vial.
• Rotate injection sites.

Adverse reactions

CNS: asthenia, headache, depression, dizziness, paresthesia, fatigue, demyelinating disorders (such as multiple sclerosis and myelitis), cerebral hemorrhage, seizures, cerebrovascular accident (CVA)

CV: hypotension, hypertension, chest pain, deep-vein thrombosis, thrombophlebitis, myocardial ischemia, myocardial infarction (MI), heart failure

EENT: ocular inflammation, pharyngitis, rhinitis, sinusitis

GI: nausea, vomiting, diarrhea, abdominal pain, dyspepsia, anorexia, cholecystitis, abdominal abscess, GI hemorrhage, intestinal perforation, pancreatitis

GU: pyelonephritis, membranous glomerulonephropathy

Hematologic: anemia, aplastic anemia, leukopenia, pancytopenia, thrombocytopenia

Metabolic: hypomagnesemia

Musculoskeletal: bursitis, polymyositis, joint pain

Respiratory: cough, congestion, dyspnea, bronchitis, pneumonia, pulmonary embolism, interstitial lung disease

Skin: flushing, cellulitis, pruritus, rash, cutaneous vasculitis, urticaria, alopecia, angioedema

Other: altered taste, weight gain, adenopathy, fever, irritation at injection site, peripheral edema, flulike symptoms, autoantibody formation, lupus-like syndrome, serious infections, malignancies

Interactions

None significant

Patient monitoring

Watch for signs and symptoms of malignancies, pancytopenia and infection.

Monitor for evidence of GI bleeding, lupus-like syndrome, and serious hypersensitivity reactions. Stop therapy immediately if these occur.
• Monitor CBC and coagulation studies.

Check for signs and symptoms of cardiac compromise and cerebrovascular events.
• Monitor pulmonary function test results periodically to assess lung status.
• Assess patient's ability to self-administer drug.
• Check for irritation at injection site. As needed, apply cool compresses.
• Examine eyes for conjunctival dryness. As needed, apply artificial tears.

Patient teaching

Tell patient to withhold dose and contact prescriber if he develops signs or symptoms of infection or is exposed to anyone with chickenpox.

Tell patient to immediately report hypersensitivity reaction, neurologic or respiratory problems, sudden weight gain, chest pain, or easy bruising or bleeding.
• Teach patient or caregiver how to administer drug and handle and dispose of equipment.
• Caution patient not to get live-virus vaccines.
• Tell female to inform prescriber if she is pregnant or breastfeeding.
• Advise patient to expect redness, swelling, and pain at injection site. Assure him that these problems will diminish over time.
• As appropriate, review all other significant and life-threatening adverse reactions mentioned above.

Enbrel

(ĕn′brĕl′)
A trademark for the drug etanercept.

Enbrel®

Etanercept Rheumatology A TNF inhibitor that targets the immune system, ↓ M&M of moderately to severely active rheumatoid arthritis in Pts with an inadequate response to one or more disease-modifying antirheumatic drugs–DMARDs; can be used in combination with MTX for nonresponders to MTX alone

Enbrel

A brand name for ETANERCEPT.
References in periodicals archive ?
The CHMP provided its positive recommendation of a continuous dosing regimen for Enbrel based on data from the CRYSTEL and other trials.
Additionally, at one year, 80 percent of patients (n = 246) receiving ENBREL and methotrexate had no evidence of progression of joint damage as seen on x-ray, compared to 59 percent (n = 230) of those treated with methotrexate alone.
ENBREL is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in children ages 2 years and older.
The PRESTA study results demonstrated that Enbrel 50mg once-weekly or twice-weekly provides improvement of skin symptoms which continue to improve over time.
Enbrel has been used by more than 234,000 patients worldwide.
An expanded indication for ENBREL would address the unmet medical need for an approved and well-studied therapy in this small, under-served pediatric psoriasis patient population.
5,ACR20/50/70, and European League Against Rheumatism (EULAR) good response, the percentage of patients who achieved these secondary endpoints was significantly higher in the ENBREL treatment groups than the MTX-alone group (P<0.
This study was a randomized, double-blind clinical trial designed to compare the efficacy of ENBREL with sulphasalazine over 16 weeks in nearly 600 patients with active AS who had failed one or more non-steroidal anti-inflammatory drugs (NSAIDs) taken for at least three months.
Enbrel coupled with its blockbuster brethren Aranesp continue to produce for Amgen's bottom line.
Food and Drug Administration (FDA) for the expanded use of ENBREL in treating pediatric patients with chronic moderate to severe plaque psoriasis who are inadequately controlled with topical therapy or who have received systemic therapy or phototherapy.
Analysis of Ankylosing Spondylitis Trials Suggests Nocturnal Back Pain is Predictive of Fatigue, and ENBREL was Shown to Reduce These Symptoms
regulators said Thursday that they have approved Amgen's drug Enbrel to treat a type of spinal arthritis.