Summary of Prescribing Information

SPI_ LPDENB062021: Based on Enbrel LPD: LPDENB062021
 

Generic Name of the Product:
Etanercept is a recombinant dimeric fusion protein, consisting of the extracellular ligand-binding portion of the human tumor necrosis factor receptor, linked to the Fc portion of human IgG1.

Brand Name of the Product:
Enbrel® - Etanercept 25 mg prefilled syringe and 50 mg in MYCLIC® Pre-filled Pen.

INDICATIONS

• Reduction in signs and symptoms of moderately to severely active rheumatoid arthritis in patients who have had an inadequate response to one or more disease modifying anti-rheumatic drugs.
   
• Moderately to severely active early rheumatoid arthritis and juvenile rheumatoid arthritis.
   
• Treatment of ankylosing spondylitis in adults who have had inadequate therapy response to conventional therapy.
   
• For reduction in signs and symptoms of active arthritis in patients with psoriatic arthritis.
   
• Treatment of adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
   
• Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 8 years who are inadequately controlled by or are intolerant to other systemic therapies or photo therapies.

Pharmaceutical Form:
Etanercept is supplied as 25 mg / 50 mg solution for injection in a prefilled syringe or in a prefilled pen. Each 25 mg Pre-filled Syringe contains: Etanercept 25 mg. Each 50 mg MYCLIC^® Pre-filled Pen contains: Etanercept 50 mg.
 
POSOLOGY AND METHOD OF ADMINISTRATION:

• For adults with Rheumatoid Arthritis, Ankylosing Spondylitis, and Psoriatic Arthritis: Patients aged 18 years or older: The recommended dose is 25 mg etanercept twice weekly (72 to 96 hours apart) or 50 mg etanercept per week administered once weekly (as one subcutaneous injection using a 50 mg pen or as two 25 mg injections given at approximately the same time) as a subcutaneous injection.
   
• Adult Plaque Psoriasis Patients: The recommended dose of Etanercept is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly may be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly.
   
• Juvenile Idiopathic Arthritis Patients: The recommended dose is 0.4 mg/kg (up to a maximum of 25 mg per dose), given twice weekly as a subcutaneous injection with an interval of 3-4 days between doses or 0.8 mg/kg (up to a maximum of 50 mg per dose) given once weekly.
   
• Pediatric plaque psoriasis: Children (≥ 8 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. Retreatment, if indicated, should follow the same guidance.

 
Method of Administration:

• Administer etanercept 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.
   
• Solution for injection in pre-filled syringe - Before injection, 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 and colorless or pale yellow and practically free from visible particles.
   
• Solution for injection in pre-filled pen - Before injection, etanercept single-use pre-filled pens should be allowed to reach room temperature (approximately 15 to 30 minutes). The needle cover should not be removed while allowing the pre-filled pen to reach room temperature. By looking through the inspection window, the solution should be clear and colorless or pale yellow and practically free from visible particles.

 
CONTRAINDICATIONS
Etanercept is contraindicated in patients with known hypersensitivity to etanercept or any formulation component of Etanercept, patients with sepsis or at a risk for sepsis. Treatment with Etanercept should not be initiated in patients with serious active infections, including chronic or localized infections.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE:
Patients should be evaluated for infections before, during, and after treatment with etanercept,
taking into consideration that the mean elimination half-life of etanercept is approximately 70 hours (range 7 to 300 hours). Serious infections and sepsis have been reported in patients on Etanercept. Patients who develop a new infection while undergoing treatment with Etanercept should be monitored closely. Administration of Etanercept should be discontinued if a patient develops a serious infection. Allergic reactions have been reported. Malignancies (particularly Hodgkin's and non-Hodgkin's lymphomas), some fatal, have been rarely reported among children and adolescents who received treatment with TNF-antagonists, including etanercept. Live vaccines should not be given concurrently with etanercept. The safety and efficacy of etanercept in patients with immunosuppression have not been evaluated.

Precautions: Caution should be exercised when considering the use of etanercept in patients with a history of recurring or chronic infections or with underlying conditions which may predispose patients to infections. If an anaphylactic reaction occurs, administration of Etanercept should be discontinued immediately. Congestive heart failure: There have been post-marketing reports of worsening of congestive heart failure (CHF), with and without identifiable precipitating factors, in patients taking etanercept. There have also been rare (<0.1%) reports of new onset CHF, including CHF in patients without known pre-existing cardiovascular disease. Some of these patients have been under 50 years of age. Physicians should use caution when using etanercept in patients who also have CHF. Before initiation of therapy with etanercept, any patient at increased risk for TB should be evaluated for active or latent infection. If active tuberculosis is diagnosed, Etanercept therapy must not be initiated. Prophylaxis of latent TB infection should be initiated prior to therapy with etanercept. Some patients who tested negative for latent tuberculosis prior to receiving etanercept have developed active tuberculosis. Physicians should monitor patients receiving etanercept for signs and symptoms of active tuberculosis, including patients who tested negative for latent tuberculosis infection.
 
USE IN SPECIAL POPULATIONS:
Women of childbearing potential should consider the use of appropriate contraception to avoid becoming pregnant during Etanercept therapy and for three weeks after discontinuation of therapy. The effects of etanercept on pregnancy outcomes have been investigated in two observational cohort studies. Use etanercept during pregnancy only if clearly needed.
No dosage adjustment is needed in elderly or in patients with renal impairments or in patients with hepatic impairment.
The safety and efficacy of Etanercept in children aged less than 2 years has not been established.
 
UNDESIRABLE EFFECTS
The most frequent adverse event noted with Etanercept is injection site reaction. Apart from this the other adverse events noted are headache, allergy, infections, development of autoantibodies, itching, fever. Serious adverse events include fatal and life-threatening infections and sepsis, malignancies of the breast, lung, skin and lymph glands (lymphoma), worsening of cardiac failure, vasculitis, elevated liver enzymes, angioedema, autoimmune hepatitis, inflammatory bowel disease and rare reports of pancytopenia and very rare reports of aplastic anaemia. Cases of Kaposi’s sarcoma have been identified with available data limited to identify the frequency. The majority of adverse events in pediatric patients are mild in nature and similar in frequency and type to those seen in adults.
 
DRUG INTERACTIONS:
Patients treated with etanercept and anakinra were observed to have a higher rate of serious infection when compared with patients who were treated with etanercept alone. No interactions have been observed when etanercept was administered with glucocorticoids, salicylates (except sulfasalazine), non-steroidal anti-inflammatory drugs (NSAIDs), analgesics, or methotrexate in clinical trials with adult rheumatoid arthritis patients.

OVERDOSAGE: No dose-limiting toxicities were observed during clinical trials of rheumatoid arthritis patients. There is no known antidote to etanercept.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:
Etanercept has no or negligible influence on the ability to drive and use machines.

STORAGE CONDITION:
Enbrel pre-filled syringe and pre-filled pen must be stored refrigerated at 2°C to 8°C. Do not freeze. Keep the pre-filled syringes and pre-filled pens in the outer carton in order to protect from light. Keep out of reach of children.

LPD Version and Date: Based on Enbrel^® LPD: LPDENB062021 version 22 approved on 1st November 2021.

Last Updated: June 2021.

^® Trademark Proprietor: Wyeth LLC, USA Licensed User: Pfizer Limited, India

For the use only of registered medical practitioner or a hospital or a laboratory

Full Prescribing Information available on Request