Enbrel 50 mg/ml SC Injection

Uses

Adults with Rheumatoid Arthritis (RA): Enbrel 50 mg/ml SC Injection used for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA). Enbrel 50 mg/ml SC Injection can be initiated in combination with methotrexate (MTX) or used alone for the treatment of active rheumatoid arthritis (RA) in adults when one or more disease modifying antirheumatic drugs (DMARDs), including methotrexate (unless contraused), has proved inadequate.

Pediatric patients with Juvenile Idiopathic Arthritis(JIA): Enbrel 50 mg/ml SC Injection used for the treatment of polyarticular-course juvenile idiopathic arthritis (JIA) in children and adolescents from the age of 2 years when the response to one or more DMARDs has proven inadequate.

Adults with Psoriatic Arthritis (PsA): Enbrel 50 mg/ml SC Injection is used for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis (PsA). Enbrel 50 mg/ml SC Injection can be used in combination with methotrexate (MTX) in patients who do not respond adequately to MTX alone.

Adults with Ankylosing Spondylitis (AS): Enbrel 50 mg/ml SC Injectionis used for reducing signs and symptoms in patients with active ankylosing spondylitis (AS).

Adults with Plaque Psoriasis (PsO): Enbrel 50 mg/ml SC Injection is used for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.

Pediatric patients with Plaque Psoriasis (PsO): Enbrel 50 mg/ml SC Injection is used for the treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years, who are inadequately controlled by or are intolerant to systemic therapies or phototherapies.

Enbrel 50 mg/ml SC Injection is also used to associated treatment for these conditions: Ankylosing Spondylitis (AS), Graft Versus Host Disease (GVHD), Polyarticular Juvenile Idiopathic Arthritis, Psoriasis Vulgaris (Plaque Psoriasis), Psoriatic Arthritis, Pyoderma Gangrenosum, Rheumatoid Arthritis, Stevens-Johnson Syndrome

How Enbrel 50 mg/ml SC Injection works

There are two distinct receptors for TNF (TNFRs), a 55 kilodalton protein (p55) and a 75 kilodalton protein (p75). The biological activity of TNF is dependent upon binding to either cell surface receptor (p75 or p55). Enbrel 50 mg/ml SC Injection is a dimeric soluble form of the p75 TNF receptor that can bind to two TNF molecules, thereby effectively removing them from circulation. Notably, etancerpt is only capable of binding to the active trimeric form of TNF as its binding site is located in the cleft between subunits.TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Increased levels of TNF are found in tissues and fluids of those with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.

Dosage

Enbrel 50 mg/ml SC Injection dosage

Rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis: Patients aged 18 years or older- 50 mg Enbrel 50 mg/ml SC Injection per week administered either once weekly (as one subcutaneous injection using a 50 mg syringe or as two 25 mg injections given at the same time) or 25 mg Enbrel 50 mg/ml SC Injection twice weekly (72 to 96 hours apart) as a subcutaneous injection. Methotrexate, glucocorticoids, salicylates, nonsteroidal anti- inflammatory drugs (NSAIDs), or analgesics may be continued during treatment with Enbrel 50 mg/ml SC Injection in adults. 25 mg once weekly gives a slower response and may be less effective.

Plaque psoriasis: The dose of etanercept is 50 mg syringe 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 intermittent 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. No dose adjustment is required for elderly and or patient with renal and hepatic impairment. Patient weighs less than 62.5kg should be accurately dosed on an mg/kg basis. Patients weighing 62.5 kg or more may be fixed-dose prefilled syringe.

Juvenile idiopathic arthritis: Children (⩾2 to <18 years): 0.4mg/kg (up to maximum of 25 mg per dose) twice weekly (72 to 96 hours apart). Glucocoticoids, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics may be continued during treatment with etanercept in children. Enbrel 50 mg/ml SC Injection has not been studied in children <2 years of age.

Pediatric plaque psoriasis: Children (⩾6 to <18 years): 0.8mg/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 retreatment of etanercept is indicated, the above guidance on treatment duration should be followed. The dose should be 0.8 mg/kg (up to maximum of 50 mg per dose) once weekly.

Administer etanercept as subcutaneous injections in the thigh, abdomen or upper arm. Given each new injection at least 3 cm from a previous site. Do not use in the area where the skin is tender, bruised, red or hard. The injection should be performed under supervision of qualified healthcare professional. Before injection, single-use prefilled syringe should be allowed to reach room temperature (approximately 15-30 minutes). The needle cover should not be removed while allowing the pre-filled syringe to reach at room temperature. Before disposal of blank PFS, please activate the needle guard to avoid any chance of needle-stick injury.

Side Effects

Very common: Infections (including colds, sinusitis, bronchitis, urinary tract infections and skin infections); injection site reactions (including bleeding, bruising, redness, itching, pain, and swelling). Reactions at the injection site (these do not occur as often after the first month of treatment. Some patients have developed a reaction at an injection site that was used before.

Common: Allergic reactions; fever; itching; antibodies directed against normal tissue (autoantibody formation).

Uncommon: 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); hives (elevated patches of red or pale skin that often itch); eye inflammation; psoriasis (new or worsening); rash; inflammation or scarring of the lungs; inflammation of the blood vessels affecting multiple organs.

Precaution

Special warning and special precautions for use-

• 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

Enbrel 50 mg/ml SC Injection Drug Interaction

Major: adalimumab, adalimumabModerate: atorvastatin, atorvastatinUnknown: calcium / vitamin d, calcium / vitamin d, celecoxib, celecoxib, duloxetine, duloxetine, furosemide, furosemide, pregabalin, pregabalin, acetaminophen, acetaminophen, levothyroxine, levothyroxine, cholecalciferol, cholecalciferol

Enbrel 50 mg/ml SC Injection Disease Interaction

Major: hepatitis B, infections, tuberculosisModerate: alcoholic hepatitis, heart failure, hematologic abnormalities, hypoglycemia, nervous system disorders, varicella, Wegener's granulomatosis

Volume of Distribution

Population pharmacokinetic modeling predicts a total Vd of 5.49 L with a peripheral compartment of 1.24 L in adults with RA and an apparent Vd with subcutaneous administration in pediatric JIA patients of 7.88 L.

Elimination Route

Population pharmacokinetic modeling in adults with RA, AS, or who were healthy showed a subcutaneous bioavailability of 56.9% with a Ka of 0.0223/h. Another model in pediatric JIA patients showed an increased Ka of 0.05/h with a high mean interindividual variability of 215%. Cmax after a single 25 mg subcutaneous dose of Enbrel is reported as 1.1 mcg/L with a Tmax of 69 h. Cmax after repeated dosing is reported as 2.4 mcg/L in adult RA patients with a dosage of 25 mg twice weekly and 2.1 mcg in pediatric JIA patients with a dosage of 0.4 mg/kg twice weekly.

Half Life

Enbrel 50 mg/ml SC Injection has a mean half-life of elimination of 102 hours in RA patients. Population models have shown a mean half-life of 68 hours in healthy adults and 70.7-94.8 hours in pediatric JIA patients.

Clearance

Enbrel 50 mg/ml SC Injection has a mean apparent clearance of 160 mL/h in RA patients. Population models predict a mean apparent clearance of 132 mL/h in healthy adults and 0.0576 L/h in pediatric JIA patients.

Pregnancy & Breastfeeding use

The safe use of etanercept during pregnancy has not been established. Use etanercept during pregnancy only if clearly needed. The safe use of etanercept during lactation has not been established. It is not known whether etanercept is excreted in human milk. Following subcutaneous administration to lactating rats, etanercept was excreted in the milk and detected in the serum of the pups. Because immunoglobulins and many medicinal products can be excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue etanercept while nursing.

Contraindication

If any hypersensitivity to etanercept or to any component of the formulation. Incase of sepsis or risk of sepsis. Treatment with etanercept should not be initiated in patients with serious active infections, including chronic or localized infection.

Acute Overdose

The maximum tolerated dose of etanercept has not been established in humans. Single intravenous doses up to 60 mg/m² have been administered to healthy volunteers in an endotoxemia study without evidence of dose-limiting toxicities. The highest dose level evaluated in rheumatoid arthritis patients has been an intravenous loading dose of 32 mg/m² followed by subcutaneous doses of 16 mg/m² (25 mg) administered twice weekly. No dose-limiting toxicities were observed during clinical trials of rheumatoid arthritis patients. There is no known antidote to etanercept.

Storage Condition

Enbrel 50 mg/ml SC Injection should be stored in refrigerator at 2-8°C. Do not freeze. Do not shake. Keep away from light. Keep out of reach of children.

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