Names and pronunciation
(eh-tan′er-sept) Enbrel, Enbrel SureClick, Erelzi, Eticovo
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Drug reference
(eh-tan′er-sept) Enbrel, Enbrel SureClick, Erelzi, Eticovo
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Func. class.: Antirheumatic agent (disease modifying) (DMARD)
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Chem. class.: Anti-TNF agent
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ACTION: Binds tumor necrosis factor (TNF), which is involved in immune and inflammatory reactions
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USES: Acute, chronic rheumatoid arthritis that has not responded to other disease-modifying agents, poly- articular course of juvenile rheuma- toid arthritis (JRA), ankylosing spon- E dylitis, plaque psoriasis, psoriatic arthritis Unlabeled uses: Crohn’s disease; plaque psoriasis (child ≥4 yr) C O N T R A I N D I C AT I O N S : Sepsis Precautions: Pregnancy, breastfeeding, children <4 yr, geriatric patients, malig- nancies, HF, seizures, multiple sclerosis, latex hypersensitivity
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Black Box Warning: Infection, lympho- ma, neoplastic disease, TB Black Box Warning: Secondary malig- nancy: assess for lymphoma and other neoplastic diseases in children and ado- lescents; avoid use in those with a history of malignancy • For injection site pain, swelling; usu- ally occurs after 2 injections (4-5 days) Black Box Warning: Infection: patients using immunosuppressives, cortico steroids, methotrexate at greater risk; assess for fever, discontinue in serious infection; do not use in active infection; obtain TB testing prior to use; TB must be treated prior to use • Hypersensitivity: to this product, la- tex needle cap, benzyl alcohol; usual re- actions to product last 3-5 days • Pregnancy/breastfeeding: use only if clearly needed; use cautiously in breast- feeding; enroll in pregnancy surveillance program, Amgen (800-772-6436)
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SIDE EFFECTS CNS: Headache, asthenia, dizziness, seizures CV: Heart failure GI: Abdominal pain, dyspepsia, vomiting, hepatitis, diarrhea HEMA: Pancytopenia, anemia, thrombo- cytopenia, leukopenia, neutropenia INTEG: Rash, injection site reaction, keratoderma blenorrhagicum RESP: Pharyngitis, cough, URI, non- URI, sinusitis, rhinitis SYST: Serious infections, sepsis, death, malignancies, Stevens-Johnson syn- drome, reactivation of hepatitis B virus, lupus-like syndrome
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INTERACTIONS Increase: neutropenia—sulfaSALAzine • Do not give concurrently with live vi- rus vaccines; immunizations should be brought up to date before treatment • Avoid use with anakinra, cyclophos- phamide, rilonacept Drug/Lab Test Increase: LFTs
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DOSAGE AND ROUTES RA/ankylosing spondylitis • Adult: SUBCUT 50 mg/wk or 25 mg 2×/wk, 3-4 days apart • Child 2-17 yr: SUBCUT 0.8 mg/kg/wk, max 50 mg/wk Plaque psoriasis • Adult: SUBCUT 50 mg (Enbrel) 2×/wk × 3 mo, then 50 mg weekly maintenance or 50 mg (Erelzi) 2×/wk × 3 mo, then weekly • Adolescent/child 4-17 yr (unlabeled): SUBCUT 0.8 mg/kg/wk, max 50 mg/wk Juvenile rheumatoid arthritis (JRA) • Adolescent/child 2-17 yr: SUBCUT 0.8 mg/kg/wk, max 50 mg/wk Psoriatic arthritis (Enbrel only) • Adult: SUBCUT 50 mg weekly
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Available forms: Powder for injection 25 mg; injection 50 mg/mL; autoinjector, single use
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Administer: • May be administered by the patient or a caregiver • The needle caps on the prefilled syringe and on the SureClick autoinjector contain dry natural rubber (latex) and should not be handled by persons sensitive to this product Injectable route • Inspect for particulate matter and dis- coloration prior to use, solution should be clear and colorless, small white par- ticles may be seen in the autoinjector or prefilled syringe Subcut route • Injection sites include front of the thigh, abdomen except the 2 inches around the navel, or outer area of the upper arm; rotate injection sites; do not administer where skin is tender, bruised, red, or hard • Do not mix or transfer the contents of one vial into another vial; do not filter reconstituted product during preparation or administration; do not add other med- ications to solutions containing etaner- cept; ONLY use the supplied diluent • A vial adapter is supplied when recon- stituting the powder; the adapter should not be used if multiple doses are to be withdrawn • If the vial will be used for multiple doses, use a 25-gauge needle for recon- stituting and withdrawing • Use as soon as possible after reconsti- tution; place reconstituted vials for mul- tiple doses in the refrigerator at 36°F- 46°F (2°C-8°C) within 4 hr of reconstitution; may be stored up to 14 days; do not freeze Use of the SureClick autoinjector • Warm to room temperature, do not shake; immediately prior to use, remove the needle shield by pulling it straight off Use of the prefilled syringe • Single-use: warm to room temperature, do not shake; remove the needle shield
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Assess: • RA: pain, stiffness, ROM, swelling of joints prior to, during, after treatment
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Evaluate: • Therapeutic response: decreased in- flammation, pain in joints
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • That product must be continued for prescribed time to be effective • To use caution when driving; dizziness may occur • Not to receive live vaccinations during treatment • About self-administration if appropri- ate: injection should be made in thigh, abdomen, upper arm; rotate sites at least 1 inch from previous site, check for in- jection reactions that last 3-5 days • To notify prescriber of possible infec- tion (upper respiratory, other)
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PHARMACOKINETICS Elimination half-life 102 hr, 60% absorbed (SUBCUT)
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• Adolescent/child 4-17 yr (unlabeled): SUBCUT 0.8 mg/kg/wk, max 50 mg/wk Juvenile rheumatoid arthritis (JRA)
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• Adolescent/child 2-17 yr: SUBCUT 0.8 mg/kg/wk, max 50 mg/wk Psoriatic arthritis (Enbrel only)
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