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 COMET study's secondary endpoints included proportions of patients achieving ACR 20, ACR 50 and ACR 70 scores at week 52 following treatment with ENBREL plus methotrexate, compared to methotrexate alone.
The study, which was designed to assess the long-term safety of ENBREL in people with JRA, found that the overall rate of serious adverse events did not increase with long-term use of ENBREL.
Enbrel has shown PASI-75 scores of up to 47%, while Humira and Remicade have shown PASI-75 scores in the 65-80% range, said Meacham.
I took my Enbrel with me and injected myself while I was out there.
When his condition started to deteriorate, doctors decided to offer Andrew ground-breaking injections of Enbrel, being trialled at the hospital's rheumatology department last year.
A study confirming the established safety profile of Enbrel (etanercept) for up to 2.
The partnership between Wyeth and Takeda to co-promote Enbrel should help make Japan one of the strongest markets for this important biotech product," says Bernard Poussot, President, Wyeth Pharmaceuticals.
Enbrel sales increased 35 percent during the third quarter to $668 million, versus $496 million in the year-ago period.
The company also revised the drug's label, advising doctors not to prescribe Enbrel for patients with infections and to closely monitor all patients taking the drug.
Several products including Enbrel (Genentech), Remicade (J&J) and Humira (Abbott Laboratories) act to mop up the TNFa released and we are developing drug molecules to prevent the release of TNFa.
Special Considerations: The safety profile in trials was similar to that seen in trials of Enbrel for other indications, including a greater rate of upper respiratory infections in treated patients.