Enbrel

Enbrel Dosage/Direction for Use

etanercept

Manufacturer:

Pfizer

Distributor:

Pfizer
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 (Enbrel) per week administered either 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 etanercept (Enbrel) twice weekly (72 to 96 hours apart) as a subcutaneous injection.
Methotrexate, glucocorticoids, salicylates, non-steroidal anti-inflammatory drugs (NSAIDs), or analgesics may be continued during treatment with etanercept (Enbrel) in adults.
Twenty-five mg administered once weekly gives a slower response and may be less effective.
Plaque psoriasis: The dose of etanercept (Enbrel) 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, if necessary, 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 (see Pharmacology: Pharmacodynamics under Actions). 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 (Enbrel) 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 etanercept (Enbrel) 25 mg/mL powder and solvent for solution for injection (see as follows for dosing for specific indications). Patients weighing 62.5 kg or more may be dosed using a fixed-dose pre-filled syringe.
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 (Enbrel) in children.
Etanercept (Enbrel) 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 (Enbrel) 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.
Method of administration: Administer etanercept (Enbrel) 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.
Patients or caregivers who are to administer etanercept (Enbrel) must be instructed in injection techniques. The first injection should be performed under the supervision of a qualified healthcare professional if etanercept (Enbrel) is to be administered by a patient or caregiver.
Before injection, etanercept (Enbrel) 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.
See also enclosed Instructions for Patients: Preparing and Injecting Etanercept (Enbrel) under Patient Counselling Information.
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.
Pediatric use: Etanercept (Enbrel) has not been studied in children <2 years of age (see Indications). For pediatric specific safety information concerning malignancies and vaccinations, see Precautions and Adverse Reactions.
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