Eterapext 25 mg Solution

ETERAPEXT contains the active etanercept which is a medicine that is made from two human proteins. It blocks the activity of another protein in the body that causes inflammation. ETERAPEXT works by reducing the inflammation associated with certain diseases.

In adults, ETERAPEXT can be used for:

• moderate or severe rheumatoid arthritis (long term autoimmune disorders that mainly affects joints);
• psoriatic arthritis (a type of inflammatory arthritis which can affect any joint in the body);
• severe axial spondyloarthritis (a type of chronic inflammatory arthritis involving the spine and/or sacroiliac joints) including ankylosing spondylitis (a type of arthritis that affects the spine);
• moderate or severe psoriasis (raised, red, scaly patches on the skin).

In each case usually when other widely used treatments have not worked well enough or are not suitable for you. For rheumatoid arthritis, ETERAPEXT is usually used in combination with methotrexate, although it may also be used alone if treatment with methotrexate is unsuitable for you. Whether used alone or in combination with methotrexate, ETERAPEXT can slow down the damage to your joints caused by the rheumatoid arthritis and improve your ability to do normal daily activities. For psoriatic arthritis patients with multiple joint involvement, ETERAPEXT can improve your ability to do normal daily activities. For patients with multiple symmetrical painful or swollen joints (e.g., hands, wrists and feet), ETERAPEXT can slow down the structural damage to those joints caused by the disease.

ETERAPEXT is also prescribed for the treatment of the following diseases in children and adolescents:

• For the following types of juvenile idiopathic arthritis when treatment with methotrexate has not worked well enough or is not suitable for them:
• Polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in patients from the age of 2 years.
• Psoriatic arthritis in patients from the age of 12 years.
• For enthesitis-related arthritis in patients from the age of 12 years when other widely used treatments have not worked well enough or are not suitable for them.
• Severe psoriasis in patients from the age of 6 years who have had an inadequate response to (or are unable to take) phototherapies or other systemic therapies.

ETERAPEXT should not be administered to you:

• if you are hypersensitive (allergic) to etanercept or any of the other ingredients of ETERAPEXT (listed in section 6).
• if you or the child have or are at risk of developing a serious blood infection called sepsis. If you are not sure, please contact your doctor.
• if you or the child have an infection of any kind. If you are not sure, please talk to your doctor.

Warnings and precautions

Special care should be taken with ETERAPEXT:

• Allergic reactions: If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more ETERAPEXT, and contact your doctor immediately.
• Infections/surgery: If you or the child develop a new infection, or are about to have any major surgery, your doctor may wish to monitor the treatment with ETERAPEXT.
• Infections/diabetes: Tell your doctor if you or the child have a history of recurrent infections or suffer from diabetes or other conditions that increase the risk of infection.
• Infections/monitoring: If you or the child develop symptoms of an infection such as fever, chills or cough, notify your doctor immediately. Your doctor may decide to continue to monitor you or the child for the presence of infections after you or the child stop using ETERAPEXT.
• Tuberculosis: As cases of tuberculosis have been reported in patients treated with ETERAPEXT, your doctor will check for signs and symptoms of tuberculosis before starting ETERAPEXT. This may include a thorough medical history, a chest X-ray and a tuberculin test. The conduct of these tests should be recorded on the Patient Card. It is very important that you tell your doctor if you or the child have ever had tuberculosis, or have been in close contact with someone who has had tuberculosis. If symptoms of tuberculosis (such as persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy, tell your doctor immediately.
• Hepatitis B: Tell your doctor if you or the child have or have ever had hepatitis B. Your doctor should test for the presence of hepatitis B infection before you or the child begin treatment with ETERAPEXT. Treatment with ETERAPEXT may result in reactivation of hepatitis B in patients who have previously been infected with the hepatitis B virus. If this occurs, you should stop using ETERAPEXT.
• Hepatitis C: Tell your doctor if you or the child have hepatitis C. Your doctor may wish to monitor the treatment with ETERAPEXT in case the infection worsens.
• Blood disorders: Seek medical advice immediately if you or the child have any signs or symptoms such as persistent fever, sore throat, bruising, bleeding or paleness. Such symptoms may point to the existence of potentially life-threatening blood disorders, which may require discontinuation of ETERAPEXT.
• Nervous system and eye disorders: Tell your doctor if you or the child have multiple sclerosis, optic neuritis (inflammation of the nerves of the eyes) or transverse myelitis (inflammation of the spinal cord). Your doctor will determine if ETERAPEXT is an appropriate treatment.
• Congestive heart failure: Tell your doctor if you or the child have a history of congestive heart failure, because ETERAPEXT needs to be used with caution under these circumstances.
• Cancer: Tell your doctor if you have or have ever had lymphoma (a type of blood cancer) or any other cancer before you are given ETERAPEXT. Patients with severe rheumatoid arthritis, who have had the disease for a long time, may be at higher than average risk of developing lymphoma. Children and adults using ETERAPEXT may have an increased risk of developing lymphoma or another cancer. Some children and teenage patients who have received ETERAPEXT or other medicines that work the same way as ETERAPEXT have developed cancers, including unusual types, which sometimes resulted in death. Some patients receiving ETERAPEXT have developed skin cancers. Tell your doctor if you or the child develop any change in the appearance of the skin or growths on the skin.
• Chickenpox: Tell your doctor if you or the child are exposed to chickenpox when using ETERAPEXT. Your doctor will determine if preventive treatment for chickenpox is appropriate.
• Alcohol abuse: ETERAPEXT should not be used for the treatment of hepatitis related to alcohol abuse. Please tell your doctor if you or the child in your care have a history of alcohol abuse.
• Wegener’s granulomatosis: ETERAPEXT is not recommended for the treatment of Wegener’s granulomatosis, a rare inflammatory disease. If you or the child in your care have Wegener’s granulomatosis, talk to your doctor.
• Anti-diabetic medicines: Tell your doctor if you or the child have diabetes or are taking medicines to treat diabetes. Your doctor may decide if you or the child need less anti-diabetic medicine while using ETERAPEXT.

Children and adolescents

Vaccinations: If possible, children should be up to date with all vaccinations before using ETERAPEXT. Some vaccines, such as oral polio vaccine, should not be given while using ETERAPEXT. Please consult your doctor before you or the child receive any vaccines.

Inflammatory bowel disease (IBD): There have been cases of IBD in patients with juvenile idiopathic arthritis (JIA) treated with ETERAPEXT. Tell the doctor if the child develops any abdominal cramps and pain, diarrhoea, weight loss or blood in the stool.

Other medicines and ETERAPEXT

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Tell the doctor or pharmacist if you or the child are taking, have recently taken or might take any other medicines (including anakinra, abatacept or sulfasalazine), even those not prescribed by the doctor. You or the child should not use ETERAPEXT with medicines that contain the active substance anakinra or abatacept, medicines used to treat rheumatoid arthritis.

Do not share medicines prescribed for you with any other person. Always use ETERAPEXT exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Dosing for adult patients (aged 18 years or over)

Rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis including ankylosing spondylitis: The usual dose is 25 mg given twice a week or 50 mg once a week as an injection under the skin. However, your doctor may determine an alternative frequency at which to inject ETERAPEXT.

Plaque psoriasis: The usual dose is 25 mg twice a week or 50 mg once a week. Alternatively, 50 mg may be given twice a week for up to 12 weeks, followed by 25 mg twice a week or 50 mg once a week.

Your doctor will decide how long you should take ETERAPEXT and whether retreatment is needed based on your response. If ETERAPEXT has no effect on your condition after 12 weeks, your doctor may tell you to stop using this medicine.

Children and adolescent: Use in children and adolescents

The appropriate dose and frequency of dosing for the child or adolescent will depend on body weight and disease. Your doctor will determine the correct dose for the child and will prescribe an appropriate strength of ETERAPEXT (25 mg or 50 mg). ETERAPEXT is available as 25 mg pre-filled syringe, 50 mg prefilled syringe and 50 mg pre-filled pen. Thus, it is only suitable to administer ETERAPEXT to paediatric patients that require a full 25 mg or 50 mg dose. Patients weighing 62.5 kg or more may be dosed using a fixed-dose pre-filled syringe or pre-filled pen. For polyarthritis or extended oligoarthritis in patients from the age of 2 years, or enthesitis-related arthritis or psoriatic arthritis in patients from the age of 12 years, the usual dose is 0.4 mg of ETERAPEXT per kg bodyweight (up to a maximum of 25 mg) given twice weekly, or 0.8 mg of ETERAPEXT per kg of bodyweight (up to a maximum of 50 mg) given once weekly. For psoriasis in patients from the age of 6 years, the usual dose is 0.8 mg of ETERAPEXT per kg bodyweight (up to a maximum of 50 mg) and should be given once weekly. If ETERAPEXT has no effect on the child’s condition after 12 weeks, your doctor may tell you to stop using this medicine. The doctor will provide you with detailed directions for preparing and measuring the appropriate dose.

Method and route of administration

ETERAPEXT is administered by an injection under the skin (as subcutaneous injections in the thigh, abdomen, or upper arm). Alternate injection sites. New injections should be given at least 3 cm from a previous site. Do NOT inject into areas where the skin is tender, bruised, red, or hard.

ETERAPEXT can have side effects. Not all side effects reported for ETERAPEXT are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using ETERAPEXT, please consult your health care provider for advice.

If any of the following happens, stop using ETERAPEXT and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to ETERAPEXT. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Signs of serious infections, such as high fever that may be accompanied by cough, shortness of breath, chills, weakness, or a hot, red, tender, sore area on the skin or joints;
• Signs of blood disorders, such as bleeding, bruising, or paleness;
• Signs of nerve disorders, such as numbness or tingling, changes in vision, eye pain, or onset of weakness in an arm or leg;
• Signs of heart failure or worsening heart failure, such as fatigue or shortness of breath with activity, swelling in the ankles, a feeling of fullness in the neck or abdomen, night-time shortness of breath or coughing, bluish colour of the nails or the lips;
• Signs of cancers: Cancers may affect any part of the body including the skin and blood, and possible signs will depend on the type and location of the cancer. These signs may include weight loss, fever, swelling (with or without pain), persistent cough, presence of lumps or growths on the skin;
• Signs of autoimmune reactions (where antibodies are made that may harm normal tissues in the body) such as pain, itching, weakness, and abnormal breathing, thinking, sensation, or vision;
• Signs of lupus or lupus-like syndrome, such as weight changes, persistent rash, fever, joint or muscle pain, or fatigue;
• Signs of inflammation of the blood vessels such as pain, fever, redness or warmth of the skin, or itching.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Frequent infections (including colds, sinusitis, bronchitis, urinary tract infections and skin infections); injection site reactions (including bleeding, bruising, redness, itching, pain, and swelling) (these do not occur as often after the first month of treatment, some patients have developed a reaction at an injection site that was recently used);
• headache.

Less frequent:

• Serious infections (including pneumonia, deep skin infections, joint infections, blood infection, and infections at various sites);
• low red blood cell count, low white blood cell count, low neutrophil (a type of white blood cell) count;
• low blood platelet count;
• skin cancer (excluding melanoma);
• localized swelling of the skin (angioedema);
• hives (elevated patches of red or pale skin that often itch);
• eye inflammation;
• psoriasis (new or worsening);
• elevated liver blood tests (in patients also receiving methotrexate treatment, the frequency of elevated liver blood tests is common), abdominal cramps and pain, diarrhoea, weight loss or blood in the stool (signs of bowel problems);
• serious allergic reactions (including severe localized swelling of the skin and wheezing);
• lymphoma (a type of blood cancer);
• leukaemia (cancer affecting the blood and bone marrow);
• melanoma (a type of skin cancer);
• combined low platelet, red, and white blood cell count;
• nervous system disorders (with severe muscle weakness and signs and symptoms similar to those of multiple sclerosis or inflammation of the nerves of the eyes or spinal cord);
• tuberculosis;
• new onset congestive heart failure;
• seizures;
• skin rash, which may lead to severe blistering and peeling of the skin;
• lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes);
• inflammation of the liver caused by the body's own immune system (autoimmune hepatitis; in patients also receiving methotrexate treatment, the frequency is uncommon);
• immune disorder that can affect the lungs, skin and lymph nodes (sarcoidosis);
• inflammation or scarring of the lungs (in patients also receiving methotrexate treatment, the frequency of inflammation or scarring of the lungs is uncommon);
• failure of the bone marrow to produce crucial blood cells.

Frequency unknown:

• Merkel cell carcinoma (a type of skin cancer);
• Kaposi’s sarcoma (a type of cancer involving the lymph nodes or skin); excessive activation of white blood cells associated with inflammation (macrophage activation syndrome);
• recurrence of hepatitis B (a liver infection);
• worsening of a condition called dermatomyositis (muscle inflammation and weakness with an accompanying skin rash).

Side effects in children and adolescents: The side effects and their frequencies seen in children and adolescents are similar to those described above. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reactions & Quality Problem Reporting Form”, found online under SAHPRA’s publications: https://sahpra.org.za/wp-content/uploads/2020/01/6.04_ARF1_v5.1_27Jan2020.pdf By reporting side effects, you can help provide more information on the safety of ETERAPEXT.

Store all medicines out of reach of children.

• Store in a refrigerator (2 °C – 8 °C).
• Do not freeze.
• Keep the pre-filled syringes or pens in the outer carton in order to protect from light.
• ETERAPEXT may be stored at temperatures up to a maximum of 25 °C for a single period of up to four weeks; after which, it should not be refrigerated again.
• ETERAPEXT should be discarded if not used within four weeks of removal from refrigeration.
• Do not use after the expiry date stated on the label / carton.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).