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Enbrel

Enbrel Dosage/Direction for Use

etanercept

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
Use in Adults: Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis: Patients aged 18 years or older: 50 mg etanercept per week administered once weekly as one subcutaneous injection.
Methotrexate, glucocorticoids, salicylates, non-steroidal anti-inflammatory drugs (NSAIDs), or analgesics may be continued during treatment with etanercept in adults.
Plaque psoriasis: The dose of etanercept is 50 mg once weekly (as one subcutaneous injection using a 50 mg syringe or as two 25 mg injections given at approximately the same time) or 25 mg twice weekly (72 to 96 hours apart) as a subcutaneous injection. Higher responses may be achieved from initial treatment with a dose of 50 mg twice weekly for up to 12 weeks, followed, by a dose of 50 mg once weekly or 25 mg twice weekly.
Adult patients may be treated intermittently or continuously, based on physician judgment and individual patient needs. Treatment should be discontinued in patients who show no response after 12 weeks. With intermittent use, treatment cycles subsequent to the initial cycle should use a dose of 50 mg once weekly or 25 mg twice weekly.
Pediatric Population: The dosage of etanercept is based on body weight for pediatric patients. Patients weighing less than 62.5 kg should be accurately dosed on a mg/kg basis using ENBREL 25 mg/mL powder and solvent for solution for injection (see following text for dosing for specific indications). Patients weighing 62.5 kg or more may be dosed using a fixed-dose pre-filled syringe or pre-filled pen.
Juvenile idiopathic arthritis (age 2 years and above): Children (≥2 to <18 years): 0.4 mg/kg (up to a maximum of 25 mg per dose) twice weekly (72 to 96 hours apart), or 0.8 mg/kg (up to a maximum of 50 mg per dose) given once weekly.
Glucocorticoids, non-steroidal anti-inflammatory drugs (NSAIDs), or analgesics may be continued during treatment with etanercept in children.
Etanercept has not been studied in children <2 years of age.
Pediatric plaque psoriasis (age 6 years and above): Children (≥6 to <18 years): 0.8 mg/kg (up to a maximum of 50 mg per dose) once weekly for up to 24 weeks. Treatment should be discontinued in patients who show no response after 12 weeks.
If re-treatment with etanercept is indicated, the previously mentioned guidance on treatment duration should be followed. The dose should be 0.8 mg/kg (up to a maximum of 50 mg per dose) once weekly.
Elderly (≥65 years): No dosage adjustment is required.
Renal Impairment: No dosage adjustment is required.
Hepatic Impairment: No dosage adjustment is required.
Preparation of ENBREL: ENBREL is intended for use under the guidance and supervision of a physician. Patients may self-inject when deemed appropriate and if they receive medical follow-up, as necessary. Patients should not self-administer until they receive proper training in how to prepare and administer the correct dose.
Solution for injection in pre-filled syringe: Before injection, etanercept single-use pre-filled syringe should be allowed to reach room temperature (approximately 15 to 30 minutes). The needle cover should not be removed while allowing the pre-filled syringe to reach room temperature. The solution should be clear to opalescent, colorless to yellow or pale brown and liquid may contain trace levels of translucent to white amorphous particles.
Solution for injection in pre-filled pen: Before injection, ENBREL single-use pre-filled pens should be allowed to reach room temperature (approximately 15 to 30 minutes). The needle cover should not be removed while allowing the pre-filled pen to reach room temperature. By looking through the inspection window, the solution should be clear to opalescent, colorless to yellow or pale brown, and liquid may contain trace levels of translucent to white amorphous particles.
Prior to administration, visually inspect the solution for particulate matter and discoloration. The solution should not be used if discolored or cloudy, or if particulate matter is present. Check to see if the amount of liquid in the pre-filled syringe falls between the two purple fill level indicator lines on the syringe. If the syringe does not have the right amount of liquid, DO NOT USE THAT SYRINGE.
If a patient or caregiver is to self-administer ENBREL, he/she should be instructed in injection techniques and how to measure the correct dose to help ensure the proper administration of ENBREL. The first injection should be performed under the supervision of a qualified health care professional. The patient's or caregiver's ability to self-inject subcutaneously should be assessed.
A puncture-resistant container for disposal of needles and syringes should be used. Patients and caregivers should be instructed in the technique as well as proper syringe and needle disposal, and be cautioned against reuse of these items.
Method of Administration: Administer etanercept as subcutaneous injections in the thigh, abdomen, or upper arm. Give each new injection at least 3 cm from a previous site. Do NOT inject into areas where the skin is tender, bruised, red, or hard.
Pediatric Use: Etanercept has not been studied in children <2 years of age (see INDICATIONS/USES). For pediatric specific safety information concerning malignancies and vaccinations, see PRECAUTIONS and ADVERSE REACTIONS.
Missed doses: If a dose is missed, patients should be advised to administer the dose as soon as they remember, unless the next scheduled dose is the next day, in which case the missed dose should be skipped. Patients should continue to inject the medicine on their usual day(s). If a patient does not remember until the day that the next injection is due, instruct the patient not to take a double dose.
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