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All about: Etanercept

Big Image Pronouncation: (EE-tan-err-sept)
Class: Immunomodulator

Trade Names:
Enbrel
- Injection 50 mg/mL
- Powder for injection, lyophilized 25 mg

Mechanism of Action

Pharmacology

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

Pharmacokinetics

Absorption

C max is approximately 1.1 mcg/mL. T max is approximately 69 h (single dose). C max increases 2- to 7-fold, while AUC increases approximately 4-fold with repeated dosing.

Elimination

The t ½ is approximately 102 h. Cl is approximately 160 mL/h.

Special Populations

Renal Function Impairment

No studies conducted.

Hepatic Function Impairment

No studies conducted.

Elderly

Pharmacokinetics do not vary with age in adults.

Children

Cl is slightly reduced in patients 4 to 8 yr of age.

Gender

Pharmacokinetics are not different between men and women.

Indications and Usage

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 1 or more disease-modifying antirheumatic drugs; reducing signs and symptoms of psoriatic arthritis; reducing signs and symptoms in patients with active ankylosing spondylitis; treatment of adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Unlabeled Uses

Crohn disease.

Contraindications

Sepsis; hypersensitivity to etanercept or to any of its components.

Dosage and Administration

Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis
Adults

Subcutaneous 50 mg/wk, given as 1 injection.

JRA
Children 4 to 17 yr of age

Subcutaneous 0.8 mg/kg per wk (max, 50 mg/wk). For children weighing 63 kg (138 lb) or more, give 50 mg/wk. For children weighing 31 to 62 kg (68 to 136 lb), give total weekly dose as 2 injections, either on the same day or 3 or 4 days apart. For children weighing less than 31 kg (68 lb), give a single injection once weekly.

Plaque Psoriasis
Adults

Subcutaneous 50 mg 2 times/wk for 3 mo followed by reduction to a maintenance dose of 50 mg/wk.

General Advice

  • For subcutaneous administration only. Not for intradermal, IM, IV, or intra-arterial administration.
  • Administer prescribed dose once or twice a week as ordered. For twice weekly dose, separate doses by 72 to 96 h.
  • For a 50 mg dose as 1 subcutaneous injection, use a 50 mg/mL prefilled syringe. For a 50 mg dose administered as two 25 mg subcutaneous injections, use the multiple-use vial. Give the two 25 mg injections either on the same day or as single injections 3 or 4 days apart.
  • Rotate injection sites (thigh, abdomen, upper arm). Give new injections at least 1 inch or more from old site and never into areas where the skin is tender, bruised, red, or hard. In psoriasis patients, try not to inject directly into any raised, thick, red, or scaly patches (psoriasis skin lesions).
  • Methotrexate, glucocorticoids, salicylates, NSAIDs, and analgesics may be continued during treatment with etanercept.
Single-use prefilled syringe
  • Allow syringe to reach room temperature (approximately 15 to 30 min) before administering. Do not remove the needle shield while allowing the prefilled syringe to reach room temperature.
  • Do not shake prefilled syringe.
Multiple-use vial
  • Reconstitute powder using only supplied diluent (sterile bacteriostatic water for injection) and following manufacturer's instructions.
  • Use vial adapter if reconstituted solution will be administered as a single dose. If the vial will be used for multiple doses, use a 25-gauge needle for reconstituting and withdrawing etanercept.
  • To prevent excessive foaming, inject diluent very slowly into medication vial and swirl gently to dissolve. Do not shake or vigorously agitate medication vial. Complete dissolution may take up to 10 min.
  • Reconstituted solution should be clear and colorless and administered within 14 days of reconstitution.
  • Do not administer if particulate matter, cloudiness, or discoloration noted.
  • Withdraw prescribed dose into syringe for injection. Do not filter reconstituted solution. Do not mix contents with or transfer to another vial of etanercept.
  • Do not add other medications to etanercept or reconstitute with other diluents.

Storage/Stability

Refrigerate multiple-use vial dose tray at 36° to 46°F. Do not freeze. Use reconstituted solution immediately or refrigerate for up to 14 days. Discard solution if not used within 14 days. Refrigerate single-use prefilled syringe at 36° to 46°F. Do not freeze. Keep prefilled syringes in the original carton to protect from light until time of use. Do not use multiple-use vial or prefilled syringe beyond expiration date.

Drug Interactions

Anakinra

A 7% rate of serious infections was observed in a 24-wk study with patients receiving etanercept and anakinra therapy.

Sulfasalazine

The incidence of decreased neutrophil counts may be greater than with either drug alone.

Vaccinations

Do not give live virus vaccines concomitantly with etanercept.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Deep vein thrombosis; heart failure; hypertension; hypotension; MI; myocardial ischemia; thrombophlebitis; chest pain, new-onset CHF, vasodilation (postmarketing).

CNS

Headache (24%); dizziness (8%); aseptic meningitis; cerebral ischemia; depression; hydrocephalus; multiple sclerosis; personality disorder; seizure; stroke; isolated demyelinating conditions (eg, optic neuritis, transverse myelitis), paresthesias (postmarketing).

Dermatologic

Rash (14%); alopecia (6%); cutaneous ulcer; worsening psoriasis; cutaneous vasculitis, pruritus, subcutaneous nodules, urticaria (postmarketing).

EENT

Rhinitis (16%); pharyngitis (7%); sinusitis (5%); dry eyes, ocular inflammation, optic neuritis (postmarketing).

GI

Nausea (15%); dyspepsia (11%); abdominal pain (10%); mouth ulcer (6%); vomiting (5%); appendicitis; cholecystitis; esophagitis/gastritis; gastroenteritis; GI bleeding; GI hemorrhage; pancreatitis; altered sense of taste, anorexia, diarrhea, dry mouth, intestinal perforation (postmarketing).

Genitourinary

Kidney calculus; membranous glomerulonephropathy; UTI. (postmarketing).

Hematologic-Lymphatic

Lymphadenopathy; adenopathy, anemia, aplastic anemia, coagulopathy, leukopenia, neutropenia, pancytopenia, thrombocytopenia (postmarketing).

Lab Tests

Transaminase elevations (postmarketing).

Local

Injection site reactions (37%).

Metabolic-Nutritional

Type 1 diabetes mellitus; weight gain (postmarketing).

Musculoskeletal

Bursitis; polymyositis; joint pain, lupus-like syndrome (postmarketing).

Respiratory

Upper respiratory tract infections (31%); cough (6%); respiratory disorder (5%); dyspnea; pulmonary embolism; sarcoidosis; interstitial lung disease, pulmonary disease, worsening of prior lung disorder (postmarketing).

Miscellaneous

Non-upper respiratory tract infections (51%); asthenia (11%); peripheral edema (8%); group A streptococcal septic shock; soft tissue and postoperative wound infection; varicella infection; abscess with bacteremia, angioedema, death, fatigue, fever, flu-like symptoms, generalized pain, sepsis, tuberculous arthritis (postmarketing).

Precautions

Monitor

Document baseline disease-state activity. Reassess periodically to document response to therapy. Monitor patient for signs and symptoms of blood dyscrasias. Monitor patient for signs and symptoms of infection while on or after treatment with etanercept. Closely monitor new infections and be prepared to discontinue etanercept if patient develops a serious infection during therapy.


Pregnancy

Category B .

Lactation

Undetermined.

Children

Safety and efficacy not established in children younger than 4 yr of age. Safety and efficacy in children with plaque psoriasis have not been established.

Elderly

Because there is a higher incidence of infection in the elderly, use with caution.

Autoimmunity

Formation of autoantibodies and, rarely, development of lupus-like syndrome may occur.

Benzyl alcohol

The diluent preservative contains benzyl alcohol, which has been associated with fatal gasping syndrome in premature infants.

Heart failure

Worsening of CHF, with and without identifiable precipitating factors, has been reported during postmarketing.

Hematologic

Rare and sometimes fatal cases of pancytopenia, including aplastic anemia, reported.

Immunizations

If possible, bring JRA patients up-to-date with all immunizations in agreement with current guidelines prior to initiating therapy. Temporarily discontinue therapy in patients with significant exposure to varicella virus and consider prophylactic treatment with varicella zoster immune globulin.

Immunosuppression

Anti-TNF therapy affects host defenses against infections and malignancies. Safety and efficacy in patients with immunosuppression or chronic infections have not been evaluated.

Infections

Serious infections and sepsis, including death, may occur. Do not initiate treatment in patients with active infections, including chronic or localized infections. Rare cases of tuberculosis have been observed.

Injection site reactions

Mild to moderate injection site reactions (eg, erythema, itching, swelling) may occur.

Latex allergy

Needle cover of the prefilled syringe contains natural rubber (latex).

Malignancies

Lymphoma has been reported in patients receiving TNF-blocking agents.

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, multiple sclerosis, and new onset or exacerbation of seizure disorders have been observed.

Overdosage

Symptoms

Maximum tolerated dosage has not been established.

Patient Information

  • Advise patient, family, or caregiver to read patient information leaflet before starting therapy and with each refill.
  • 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 the patient or caregiver understands how to store, prepare, and administer the dose, and dispose of used equipment and supplies. The first injection should be performed under the supervision of a qualified health professional.
  • Caution patient not to change the dose or discontinue therapy unless advised by health care provider.
  • Advise patient that if a dose is missed to contact health care provider for instructions on when to take the next dose.
  • Advise patient to continue other arthritis medications as recommended by health care provider.
  • Advise patient to immediately report any of the following to health care provider: fever or other signs of infection, sore throat, bleeding or unusual bruising, paleness.
  • Advise patient to report intolerable injection site reactions or unusual symptoms to health care provider.
  • Advise patient with heart failure to notify health care provider immediately if new or worsening symptoms of heart failure (eg, shortness of breath, swelling of ankles or feet) develop.
  • Warn patient not to receive live vaccines while undergoing etanercept therapy.
  • Advise latex-sensitive patient that the needle cover on the prefilled syringe contains dry natural rubber (latex).

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