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 British Society for Rheumatologists has already urged its members to tackle health authorities and NHS trusts which refuse to fund drugs such as Enbrel because of their high cost per patient.
For many years, her employers health insurance covered Enbrel at a cost to her that never exceeded $30 per month.
The FDA's approval of Erelzi is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Erelzi is biosimilar to Enbrel. The agency stresses that Erelzi has been approved as a biosimilar, not as an interchangeable product.
sales volume, followed by Enbrel in third place with $8.7 billion in 2015 U.S.
* Remicade (infliximab; MSD): Promoter numbers are evenly matched with Enbrel, but who stands to gain more from converting their detractors to promoters?
Those drugs include adalimumab (Humira) and infliximab (Remicade), but the authors also studied etanercept (Enbrel), a protein therapy medication, and other RA drugs for comparison.
After an initial 24-week blinded phase of the study, 169 patients received 25 mg of etanercept (Enbrel) twice weekly for an additional 48 weeks during the open-label extension phase.
The lawsuit alleges patent infringement by Immunex through its manufacture, importation and sale of Enbrel , Immunex's etanercept dimeric fusion protein for the treatment of rheumatoid arthritis and other related conditions.
Sandoz, a Novartis (NVS) division, announced that the United States District Court of New Jersey ruled against Sandoz in patent litigation concerning the Sandoz biosimilar, Erelzi for reference medicine Enbrel. The company will appeal the ruling to the U.S.
Bernard explained how she had successfully managed the symptoms of her RA with a prescription called Enbrel, until she retired at age 79 and moved from her employer-sponsored insurance coverage to Medicare.
Switzerland-based Novartis has received approval from the European Commission for its Erelzi, the biosimilar of Amgen and Pfizer's Enbrel (etanercept), intended for the treatment of multiple inflammatory diseases, it was reported yesterday.