Etanercept

A to Z Drug Facts

 Action Binds specifically to tumor necrosis factor (TNF), blocks its interaction with cell surface TNF receptors, and can modulate biological responses that are induced or regulated by TNF.

 Indications Reducing signs and symptoms and inhibiting the progression of structural damage in moderately to severely active rheumatoid arthritis; reducing signs and symptoms of moderately to severely active polyarticular-course juvenile rheumatoid arthritis (JRA) in patients responding inadequately to one or more disease-modifying antirheumatic drugs; reducing signs and symptoms of psoriatic arthritis.

UNLABELED Psoriasis; ankylosing spondylitis; juvenile spondyloarthropathies.

 Contraindications Standard considerations.

 Route/Dosage

Adults: SC 25 mg twice weekly, separated by 72 to 96 hr.

Children (4 to 17 yr): SC 0.4 mg/kg (max 25 mg/dose) given twice weekly, separated by 72 to 96 hr.

 Interactions

None well documented.

 Lab Test Interferences None well documented.

 Adverse Reactions

CARDIOVASCULAR: Heart failure; MI; myocardial ischemia; cerebral ischemia; hypertension; hypotension; deep vein thrombosis; pulmonary embolism; thrombophlebitis; chest pain. CNS: Depression; headache; dizziness; stroke; paresthesias; seizures; fatigue; events suggestive of multiple sclerosis or isolated demyelinating conditions such as transverse myelitis or optic neuritis; personality disorder (JRA patients). DERMATOLOGIC: Rash; alopecia; cutaneous vasculitis; pruritus; subcutaneous nodules; urticaria; cutaneous ulcer (JRA patients). EENT: Rhinitis; pharyngitis; sinusitis; ocular inflammation; dry eyes; esophagitis (JRA patients). GI: GI hemorrhage; nausea; abdominal pain; dyspepsia; vomiting; altered taste; anorexia; dry mouth; intestinal perforation; diarrhea; gastroenteritis/gastritis (JRA patients). GU: Cholecystitis; pancreatitis; membranous glomerulonephropathy. HEMATOLOGIC: Adenopathy; anemia; leukopenia; thrombocytopenia; pancytopenia; aplastic anemia. METABOLIC: Weight gain; type 1 diabetes mellitus (JRA patients). RESPIRATORY: Dyspnea; non-upper respiratory tract infection; upper respiratory tract infection; cough; respiratory disorder; pneumonitis; interstitial lung disease; pulmonary disease. OTHER: Malignancies; infections; bursitis; polymyositis; asthenia; peripheral edema; mouth ulcer; fever; flu-like symptoms; angioedema; joint pain; generalized pain; varicella, soft tissue, and postoperative wound infection (JRA patients).

 Precautions

Pregnancy: Category B. Lactation: Undetermined. Children: Safety and efficacy not established in children less than 4 yr. Elderly: Because there is a higher incidence of infection in the elderly, use with caution. Benzyl Alcohol: The diluent preservative contains benzyl alcohol, which has been associated with fatal “gasping syndrome” in premature infants. Hematologic: Rare and sometimes fatal cases of pancytopenia, including aplastic anemia, have been reported. Infections: Serious infections and sepsis, including death, may occur. Injection Site Reactions: Mild to moderate injection site reactions (eg, erythema, itching, swelling) may occur. Latex Allergy: Diluent needle cover contains natural rubber (ie, latex), which should not be handled by latex-sensitive individuals. Neurologic Events: Agents that inhibit TNF have been associated with rare cases of new onset or exacerbation of CNS demyelinating disorders, some presenting with mental status changes and some associated with permanent disability; transverse myelitis, optic neuritis, and new onset or exacerbation of seizure disorders have been observed. Vaccinations: Do not give live virus vaccines concomitantly with etanercept.

 Administration/Storage

• Dose is usually administered twice weekly, 72 to 96 hr apart.
• Reconstitute powder using supplied diluent only. To prevent excessive foaming, inject diluent slowly into medication vial and swirl gently to dissolve. Do not shake or vigorously agitate medication vial.
• Reconstituted solution should be clear and colorless and administered within 6 hr of reconstitution.
• Do not administer if particulate matter, cloudiness, or discoloration is noted.
• Withdraw prescribed dose into syringe for injection. Do not filter reconstituted solution.
• Administer via SC route only.
• Rotate injection sites (eg, thigh, abdomen, upper arm). Give new injections 1 inch or more from old site and never into areas where the skin is tender, bruised, red, or hard.
• Do not add other medications to entanercept, nor reconstitute with other diluents.
• Methotrexate, glucocorticoids, salicylates, NSAIDs, and analgesics may be continued during treatment with entanercept.
• Use only 1 dose/vial. Do not reenter vial.
• Discard any unused solution. Do not save unused solution for later administration.
• Store entanercept dose tray in refrigerator (36° to 46°F). Do not freeze. Reconstituted solution should be used immediately or stored in refrigerator for up to 6 hr. Discard solution if not used within 6 hr.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies. Note any findings suggestive of active infection. Note history of recurrent infections, poorly controlled diabetes, or preexisting or recent onset of CNS demyelinating disorder.
• Document baseline disease state activity (eg, number of tender or swollen joints, pain, disability). Reassess periodically to document response to therapy.
• Ensure that patients with juvenile rheumatoid arthritis are brought up to date with all immunizations in agreement with current guidelines prior to initiating therapy if possible.
• Monitor patient for signs and symptoms of blood dyscrasias or infection (eg, persistent fever, sore throat, unusual bruising, bleeding, pallor). Immediately report to health care provider if noted.
• Monitor patient for signs and symptoms of anaphylactic or serious allergic reactions. Be prepared to treat appropriately.
• Monitor patient for CNS, GI, and general body side effects. Report to health care provider if noted and significant.
• Do not administer live virus vaccines concurrently with entanercept.

 Patient/Family Education

• Explain name, dose, action, and potential side effects of drug. If patient or caregiver will be administering at home, review How to Use Enbrel, Instructions for Preparing and Giving an Injection insert with the patient or caregiver. Ensure that the patient or caregiver understands how to store, prepare, and administer the dose, and dispose of used equipment and supplies. Perform the first injection under the supervision of a qualified health professional.
• Advise patient to continue other arthritis medications as recommended by health care provider.
• Advise patient to immediately report any of the following symptoms to health care provider: fever or other signs of infection, sore throat, unusual bruising or bleeding.
• Advise patient to report intolerable injection site reactions or unusual symptoms to health care provider.
• Instruct women to notify health care provider if becoming pregnant, planning on becoming pregnant, or are breastfeeding.
• Instruct patient to not take any prescription or otc medications or dietary supplements unless advised to do so by health care provider.
• Remind patient that office visits and laboratory tests will be required to monitor therapy and to be sure to keep appointments.

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Copyright © 2003 Facts and Comparisons
David S. Tatro
A to Z Drug Facts