Etanercept Dosage

Usual Adult Dose for Ankylosing Spondylitis

25 mg subcutaneously twice weekly, 3 to 4 days apart. Alternatively, 50 mg subcutaneous doses may be given once a week on the same day.

Usual Adult Dose for Rheumatoid Arthritis

25 mg subcutaneously twice weekly, 3 to 4 days apart. Alternatively, 50 mg subcutaneous doses may be given once a week on the same day.

Usual Adult Dose for Wegener's Granulomatosus

25 mg subcutaneously twice weekly, 3 to 4 days apart. Alternatively, 50 mg subcutaneous doses may be given once a week on the same day.

Usual Adult Dose for Psoriatic Arthritis

25 mg subcutaneously twice weekly, 3 to 4 days apart. Alternatively, 50 mg subcutaneous doses may be given once a week on the same day.

Usual Adult Dose for Still's Disease

Study (n=12)
25 mg subcutaneously, twice to three times per week.

Usual Adult Dose for SAPHO Syndrome

Case (n=1)
25 mg subcutaneously twice weekly, along with corticosteroid therapy.

Usual Adult Dose for Psoriasis

Plaque Psoriasis:
Initial: 50 mg subcutaneously twice weekly (administered 3 to 4 days apart) for 3 months. Alternatively, starting doses of 25 mg to 50 mg per week have been shown to be effective.
Maintenance: 50 mg subcutaneously once weekly.

Usual Pediatric Dose for Uveitis

3 years or older: 0.4 mg/kg/dose (to a maximum of 25 mg) subcutaneously, twice weekly.

Usual Pediatric Dose for Histiocytosis

Case (n=1)
5 months or older: 0.4 mg/kg subcutaneously three times weekly.

Usual Pediatric Dose for Macrophage Activation Syndrome

Case (n=1)
7 years or older: 0.4 mg/kg/dose subcutaneously twice weekly, for 11 weeks.

Usual Pediatric Dose for Juvenile Rheumatoid Arthritis

4 years or older: 0.8 mg/kg/week (to a maximum of 50 mg per week) subcutaneously.

Child weight 31 to 62 kg (68 to 136 pounds): the total weekly dose should be administered as two (subcutaneous) injections, either on the same day or 3 to 4 days apart.

Child weight less than 31 kg (68 pounds): the dose should be administered as a single subcutaneous injection once weekly.

The maximum dose injected per site should not exceed 25 mg (1 mL).

Usual Pediatric Dose for Juvenile Idiopathic Arthritis

Age 2 to 17 years with active polyarticular-course JIA:

Twice weekly dosing: 0.4 mg/kg/dose twice weekly given 72 to 96 hours apart
Maximum dose: 25 mg

Alternative once weekly dosing: 0.8 mg/kg/dose once weekly
Maximum: 50 mg per week

The 25 mg prefilled syringe is not recommended for pediatric patients weighing less than 31 kg (68 pounds). The 50 mg prefilled syringe or SureClick (TM) auto-injector may be used for pediatric patients weighing 63 kg (138 pounds) or more.

Renal Dose Adjustments

Reduced renal function may affect clearance (increased half-life), although the manufacturer does not recommend dosage adjustment for renal insufficiency.

Liver Dose Adjustments

No adjustment recommended

Dose Adjustments

In plaque psoriasis, starting doses of 25 mg or 50 mg per week were also shown to be efficacious.

Precautions

The needle cap on the prefilled syringe and on the SureClick auto-injector contains dry natural rubber (a derivative of latex) which may cause allergic reactions in patients sensitive to latex.

Before injection, etanercept may be allowed to reach room temperature (approximately 15 to 30 minutes). DO NOT remove the needle cover or shield while allowing the product to reach room temperature.

Prior to administration, the container should be visually inspected for particulate matter and discoloration. There may be small white particles of protein in the solution. This is not unusual for proteinaceous solutions. The solution should not be used if discolored or cloudy, or if foreign particulate matter is present.

Etanercept is intended for use under the guidance and supervision of a trained health care provider. 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.

Dialysis

Data not available

Other Comments

Patients may continue their therapies with methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics during treatment with etanercept

Patients should be instructed to call their doctor immediately if they develop symptoms such as persistent fever, bruising, bleeding, or paleness.

Healthcare professionals are encouraged to report any serious adverse events possibly associated with the use of etanercept to Amgen at 1-800-772-6436. Information may also be reported to the FDA MedWatch reporting system by phone (1-800-FDA-1088), fax (1-800-FDA-0178), the MedWatch website at www.fda.gov/medwatch, or by mail (using postage-paid form) to MedWatch, HF-2, 5600 Fishers Lane, Rockville, MD 20852-9787.

A pregnancy registry has been established to monitor outcomes of pregnant women. Physicians are encouraged to register patients by calling: 1-877-311-8972.

See also...