More from Etacept
Other strengths and forms by Healthcare Pharmaceuticals Ltd.
Indications & Uses
Etacept is indicated for:
Pharmacology
Etanercept is a tumor necrosis factor (TNF) blocker. It is a dimeric fusion protein, made by linking the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) to the Fc portion of human IgG1. The Fc part of etanercept has the CH2 domain, the CH3 domain and the hinge region, but not the CH1 domain of IgG1. It is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons.
Etanercept is a TNF alpha inhibitor. It binds specifically to tumor necrosis factor (TNF) and stops it from interacting with the TNF receptors on the cell surface. TNF is a cytokine that occurs naturally in the body and takes part in normal inflammatory and immune responses. Raised levels of TNF are found in the synovial fluid of RA patients. TNF also plays an important role in the inflammatory processes of rheumatoid arthritis (RA), polyarticular-course juvenile rheumatoid arthritis (JRA) and the joint damage that follows.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Dosage
Rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis
For patients aged 18 years or older, the dose of Etanercept is 50 mg per week, given as a subcutaneous injection. This can be one 50 mg injection once weekly (using a 50 mg syringe, or as two 25 mg injections given at the same time). The other option is 25 mg twice weekly, with the injections 72 to 96 hours apart. In adults, methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs) or analgesics may be continued during treatment with Etanercept. A dose of 25 mg once weekly gives a slower response and may be less effective.
Plaque psoriasis
The dose of etanercept is 50 mg once weekly, given as a subcutaneous injection (one injection using a 50 mg syringe, or two 25 mg injections given at approximately the same time). Another option is 25 mg twice weekly, 72 to 96 hours apart, also by subcutaneous injection. A higher response may be reached by starting with 50 mg twice weekly for up to 12 weeks. After that, if necessary, the dose is 50 mg once weekly or 25 mg twice weekly.
Adults may be treated intermittently or continuously, depending on the physician's judgment and what the individual patient needs. Treatment should be stopped in patients who show no response after 12 weeks. With intermittent use, later treatment cycles after the first one should use 50 mg once weekly. No dose adjustment is required for elderly patients or for patients with renal and hepatic impairment. A patient who weighs less than 62.5 kg should be dosed accurately on an mg/kg basis. Patients weighing 62.5 kg or more may use the fixed-dose prefilled syringe.
Juvenile idiopathic arthritis
For children aged 2 to under 18 years, the dose is 0.4 mg/kg (up to a maximum of 25 mg per dose) twice weekly, 72 to 96 hours apart. Glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs) or analgesics may be continued during treatment with etanercept in children. Etanercept has not been studied in children under 2 years of age.
Pediatric plaque psoriasis
For children aged 6 to under 18 years, the dose is 0.8 mg/kg (up to a maximum of 50 mg per dose) once weekly for up to 24 weeks. Treatment should be stopped in patients who show no response after 12 weeks. If etanercept needs to be given again, the same guidance on treatment duration applies, and the dose should be 0.8 mg/kg (up to a maximum of 50 mg per dose) once weekly.
Side Effects
Very common side effects of Etanercept are infections, including colds, sinusitis, bronchitis, urinary tract infections and skin infections. Injection site reactions are also very common, and they can include bleeding, bruising, redness, itching, pain and swelling. These reactions don't occur as often after the first month of treatment. Some patients have developed a reaction at an injection site that was used before. Common side effects are allergic reactions, fever, itching, and antibodies directed against normal tissue (autoantibody formation). Uncommon side effects are serious infections, including pneumonia, deep skin infections, joint infections, blood infection and infections at various sites. Low blood platelet count, skin cancer (excluding melanoma), localized swelling of the skin (angio edema) and hives (elevated patches of red or pale skin that often itch) are also uncommon. So are eye inflammation, psoriasis (new or worsening), rash, inflammation or scarring of the lungs, and inflammation of the blood vessels affecting multiple organs.
Cautions & Contraindications
Warnings & Precautions
Allergic reactions, infections/surgery, infections/diabetes, infections/monitoring, tuberculosis, hepatitis-B, hepatitis-C, blood disorders, nervous system and eye disorders, congestive heart failure, cancer, chickenpox, latex, alcohol abuse, Wegener's granulomatosis, anti-diabetic medicine.
Contraindications
Etanercept should not be used if the patient is allergic to etanercept or to any other component of the formulation. It should also not be used in sepsis or when there is a risk of sepsis. Don't start etanercept in patients who have a serious active infection, and that includes chronic infections and infections that are limited to one area of the body.
Pregnancy & Breastfeeding
Nobody has established that etanercept is safe to use in pregnancy, so it should be used during pregnancy only if it is clearly needed. The same is true for breastfeeding, where its safety has also not been established.
We don't know whether etanercept passes into human milk. In lactating rats given etanercept under the skin, it did appear in the milk and was found in the blood serum of the pups. Immunoglobulins and many other medicines can pass into human milk, so a decision has to be made: either stop nursing, or stop etanercept while nursing.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Overdose
The maximum tolerated dose of Etanercept hasn't been established in humans. Healthy volunteers in an endotoxemia study were given single intravenous doses of up to 60 mg/m2, and no dose-limiting toxicities were seen. In rheumatoid arthritis patients, the highest dose level studied was an intravenous loading dose of 32 mg/m2, followed by subcutaneous doses of 16 mg/m2 (25 mg) given twice weekly. No dose-limiting toxicities were observed in the clinical trials of these patients. There is no known antidote to Etanercept.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Keep Etanercept in the refrigerator at 2-8°C. Don't freeze it and don't shake it. Keep it away from light, and keep it out of reach of children.
Common questions about Etacept 50 mg/ml
What is Etacept 50 mg/ml SC Injection?
Etacept 50 mg/ml SC Injection is a medicine that contains Etanercept. It is made by Healthcare Pharmaceuticals Ltd. It belongs to the Immunosuppressant group of medicines.
What is Etacept used for?
Etacept is used for: Rheumatoid Arthritis, Psoriasis.
What are the side effects of Etacept?
Very common side effects of Etanercept are infections, including colds, sinusitis, bronchitis, urinary tract infections and skin infections. Injection site reactions are also very common, and they can include bleeding, bruising, redness, itching, pain and swelling.
Can I take Etacept during pregnancy or while breastfeeding?
Nobody has established that etanercept is safe to use in pregnancy, so it should be used during pregnancy only if it is clearly needed. The same is true for breastfeeding, where its safety has also not been established. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Etacept?
The maximum tolerated dose of Etanercept hasn't been established in humans. Healthy volunteers in an endotoxemia study were given single intravenous doses of up to 60 mg/m2, and no dose-limiting toxicities were seen. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Etacept?
Keep Etanercept in the refrigerator at 2-8°C. Don't freeze it and don't shake it.
Do I need a prescription for Etacept?
Etacept is a prescription (Rx) medicine. Take it as your doctor advises.