ENBREL Dosing and Administration
Dosing Guidelines for Adult Patients1
For adult patients with moderate to severe rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis, the recommended starting dose of ENBREL is 50 mg weekly.
MTX, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics may be continued during treatment with ENBREL.
Based on a study of 50 mg ENBREL twice weekly in patients with RA that suggested higher incidence of adverse reactions but similar ACR response rates, doses higher than 50 mg per week are not recommended.
Dosing Guidelines for Patients with Moderately to Severely Active Juvenile Idiopathic Arthritis
|63 kg (138 pounds) or more
||50 mg weekly
|Less than 63 kg (138 pounds)
||0.8 mg/kg weekly
In JIA patients, glucocorticoids, NSAIDs, or analgesics may be continued during treatment with ENBREL. Higher doses of ENBREL have not been studied in pediatric patients.
The Flexibility of Multiple Self-Administration Options
Help your patients find a method that works for them. Step-by-step demonstrations are available for all 4 options. A copy of the Instructions for Use can be downloaded here.
Patients should receive injection training from their health care professional prior to self-administration.
Enbrel® SureClick® 50 mg/mL Autoinjector
Patients can inject ENBREL using a 50-mg/mL prefilled autoinjector. The Enbrel® SureClick® autoinjector is for a single use only.
ENBREL Single-Use Prefilled Syringe
Patients can inject ENBREL using a prefilled syringe available in 50-mg/mL and 25-mg/0.5-mL dosage strengths. The prefilled syringe is for a single use only.
ENBREL 25-mg Multi-Use Vial Free-hand Method
For some children with JIA, one vial of ENBREL solution can be used for more than one dose. The free-hand method should be used for these children. The vial adapter method should not be used if the patient will be using the vial more than once.
ENBREL 25-mg Vial Adapter Method
Patients who use a single vial of ENBREL for each dose may use the vial adapter device to assist with mixing and withdrawing ENBREL.
ENBREL should not be administered to patients with sepsis.1
For convenience, the ENBREL syringe, autoinjector, and dose tray for the multi-use vial can be stored at room temperature between 68°-77°F (20°-25°C) for up to 14 days.
- Patients should store ENBREL in the refrigerator (36°-46°F or 2°-8°C) as a standard practice.
- ENBREL should not be returned to the refrigerator after it has reached room temperature.
- Mixed ENBREL powder should be used right away, or can be kept in the refrigerator for up to 14 days.
- ENBREL should be protected from light or physical damage. Do not shake.
- Do not store ENBREL in extreme heat or cold. Do not freeze.
Circumstances in Which You May Consider Discontinuation of ENBREL Therapy for Your Patients
Serious infections, including patients with pneumonia, sinusitis, abscess, and herpes zoster1,2
ENBREL should be discontinued if a patient develops a serious infection or sepsis. Consider the risks and benefits carefully prior to initiation of therapy in patients with chronic or recurrent infection. Monitor patients closely for infections during and after treatment, including the possible development of tuberculosis (TB) in patients who tested negative for latent TB prior to therapy initiation.
Pregnancy or intent to breast-feed1
ENBREL should be used in pregnancy only if clearly needed. For nursing mothers, a decision should be made whether to discontinue nursing or to discontinue the drug. ENBREL is Pregnancy Category B.
Vaccinations, including yellow fever, BCG, rubella, polio, cholera, typhoid, and varicella1-3
When taking ENBREL, patients may receive concurrent vaccination, except for live vaccines. Patients with significant exposure to varicella virus should temporarily discontinue ENBREL therapy and be considered for prophylactic treatment.
Most PsA patients receiving ENBREL were able to mount effective B-cell immune responses to pneumococcal polysaccharide vaccine, but titers in aggregate were moderately lower and fewer patients had 2-fold rises in titers compared to patients not receiving ENBREL. The clinical significance of this is unknown. Patients receiving ENBREL may receive concurrent vaccinations, except for live vaccines. No data are available on the secondary transmission of infection by live vaccines in patients receiving ENBREL.
Surgery, including dental surgery or hip replacement1,2
ENBREL therapy should be put on hold for patients who are scheduled for surgery. ENBREL can lower the ability of the immune system to fight infections. Patients should be closely monitored for the development of signs and symptoms of infection during and after surgery.
View ENBREL safety and tolerability data
In medical studies, ENBREL was shown to be clinically effective in about 2 out of 3 adults with moderate to severe RA at 3 months. ENBREL has been shown to begin working in as few as 2 weeks, and most patients who benefit will do so within 3 months. In another medical study, 55% of patients who were evaluated 5 years after beginning ENBREL therapy had no further progression of joint damage.
In a medical study, ENBREL was shown to be effective in about 50% of psoriatic arthritis patients at 6 months. Clinical responses were apparent at the time of the first visit (4 weeks) and were maintained through 6 months of therapy.