Altebrel (Etanercept) – For Treatment of Various Inflammatory Diseases

Altebrel contains the active ingredient called Etanercept with protein structure. It belongs to a group of medicines called Tumor Necrosis Factor (TNF) Blocking Agent. Altebrel is produced by recombinant DNA technology in a Chinese Hamster Ovary (CHO). This medicine blocks the activity of TNF-α and as a result, helps to improve the inflammation process in your body.

It is used to treat:

• Rheumatoid Arthritis: Altebrel helps in the treatment of moderate to severe Rheumatoid Arthritis in adults. If you did not respond well to other treatments, you will be given Altebrel in combination with Methotrexate. If Methotrexate is not appropriate for the patient, then Altebrel will be prescribed alone.

• Psoriatic Arthritis: Altebrel may be effective in clearing skin and improving the quality of life in adults.

• Axial spondyloarthritis (Ankylosing spondylitis and Non-radiographic Axial spondyloarthritis): if your active Ankylosing spondylitis does not respond well to other treatments, then Altebrel will be prescribed.

• Juvenile Idiopathic Arthritis: if Methotrexate does not respond well to the patients, then Altebrel will be prescribed for the following types of Juvenile Idiopathic Arthritis. Polyarthritis and extended oligoarthritis in patients from the age of 2 years. Psoriatic Arthritis in patients from the age of 12 years.

• Enthesitis-related Arthritis: in patients from the age of 12 years with inadequate response to other medicines.

• Plaque psoriasis: In patients with severe disease and inadequate response to other medicines from the age of 6 years who are candidates for phototherapy or systemic, Altebrel will be prescribed.

• If you have had an allergic reaction to Etanercept or any of the other ingredients present in this product

• If you have an infection that has spread throughout your whole body

• If you have an active infection

It is expected that Altebrel will be effective in adults and children, three months after the first injection and maintained with continuous treatment.

Before using Altebrel, tell your doctor if you:

• Have had an allergic reaction to Altebrel

• Have an infection, are being treated for infection, or have symptoms of an infection

• Get a lot of infections that do not go away or infections that keep coming back

• If you had any recurrent infections in the past such as diabetes, HIV, or a weak immune system that might increase the chance of infections

• Have diabetes

• Have tuberculosis (TB) or have been in close contact with someone with tuberculosis (TB), or were born in, lived in, or traveled where there is more risk for getting tuberculosis (TB)

• If you were born, lived, traveled, or have lived in an area (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections, such as coccidioidomycosis, histoplasmosis, or blastomycosis. These infections may happen or become more severe if you use Altebrel. Ask your doctor if you are unsure if you have lived in these areas

• Have or have had hepatitis B

• Are scheduled for major surgery

• If you have been treated for congestive heart failure

• If you have or have had persistent numbness, tingling, and muscle weakness or a disease such as multiple sclerosis or Guillain-bare or Guillain-bare-like syndrome which can cause the inflammation of the nervous system.

• Have or have had cancer

• Have been in close contact with someone with varicella zoster

• Have recently received or planning to receive a vaccine. You shouldn’t receive live vaccines when taking Altebrel

• have developed any changes in your skin appearance

• Are pregnant or planning to become pregnant. Altebrel can harm your unborn baby.

• Are breastfeeding or planning to breastfeed. Altebrel can pass into your breast milk.

Also, tell your doctor about all the medicines you take including prescriptions, over-the-counter medicines, vitamins, and herbal supplements.

Taking Altebrel with Anakinra and Abatacept is not recommended as it may increase your risk of getting a serious infection.

Etanercept together with cyclophosphamide may increase the risk of solid cancers.

If you have Rheumatoid Arthritis, Psoriatic Arthritis, or Axial spondyloarthritis, the recommended dosage is 50 mg weekly subcutaneously. Use the 50 mg single-use pre-filled injection once weekly or 25 mg single-use pre-filled injection weekly twice.

Your doctor will tell you whether the two injections with the 25 mg pre-filled syringe should be given on the same day once a week or on two different days ( 3 or 4 days apart )in the same week.

If you have Plaque Psoriasis, the recommended initial dose of Altebrel is a 50 mg dose twice a week (3 or 4 days apart) for 3 months. After 3 months, your doctor will tell you to reduce your dose to 50 mg once per week. Use the 50mg single-use prefilled syringe once weekly or 25 mg single-use pre-filled injection weekly twice.

• Juvenile Idiopathic Arthritis: the recommended dose for children with Juvenile Idiopathic Arthritis depends on the child’s body weight.

• 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 recommended dosage is 0.4 mg of Altebrel per kg body weight (up to a maximum of 25 kg) given twice weekly or 0.8 mg of Altebrel per kg body weight (up to a maximum of 50 kg) given once weekly.

• For psoriasis in patients from the age of 6 years: the usual dosage is 0.8 mg of Altebrel per kg body weight (up to a maximum of 50 kg) and should be given once weekly. If Altebrel has no effect on the child’s condition after 12 weeks, your doctor may stop the treatment.

The risk of inflammatory bowel disease (IBD) may be increased in children with Altebrel injection if your child develops new signs of diarrhea, abdominal

• Altebrel is administered by subcutaneous injection

• Altebrel injection can be done before or after your meal

Very common side effects:

Injection site reactions and infections include colds, sinusitis, bronchitis, urinary tract infections, and skin infections.

Common side effects:

Allergic reactions, itching, and fever

Uncommon side effects:

Pneumonia, deep skin infections, joint infections, blood infection, low platelet count, swelling of the skin, inflammation of the blood vessels, skin cancer, new or worsening psoriasis, and eye inflammation.

• Allergic reactions. Symptoms of a serious allergic reaction include trouble breathing, hives, and swelling of your eyes, lips, face, or mouth

• Serious infections. These include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria. Symptoms related to tuberculosis (TB) include a cough, low-grade fever, weight loss, or loss of body fat and muscle.

• Blood problems (decreased blood cells that help fight infections or stop bleeding): Symptoms include bruising or bleeding very easily, a fever that does not go away, or looking very pale.
• Heart failure (new or worsening). Symptoms include sudden weight gain, shortness of breath, and swelling of your ankles or feet.

• Malignancies: patients with Rheumatoid Arthritis, Psoriatic Arthritis, Plaque Psoriasis, or Juvenile Idiopathic Arthritis may be at a higher risk of developing lymphoma (a type of blood cancer). For Adults and children taking TNF-α blocker medicines including Altebrel. the chances of getting lymphoma or other cancer may increase.

• Immune reactions include a lupus-like syndrome. Symptoms include shortness of breath, joint pain, chest discomfort or pain that does not go away, or rash on your cheeks or arms that gets worse in the sun.

• Liver problems. Symptoms include poor appetite or vomiting, feeling very tired, skin or eyes that look yellow, and pain on the right side of your stomach (abdomen). These problems can lead to liver failure and death.

• Inflammation of the blood vessels: symptoms include fever, pain, redness or warm skin, or itching.

• Nervous system problems. Signs and symptoms include weakness in your arms or legs, numbness or tingling, problems with your vision, and dizziness.

• Skin rash leads to severe blistering and peeling of the skin (Stevens-Johnson)

• An immune disorder that can affect the lungs, skin, and lymph nodes (sarcoidosis)

• Bone marrow suppression

• Toxic epidermal necrolysis (A potentially life-threatening severe skin disease)

• Peripheral demyelinating events (A nervous system disease)

• Excessive activation of white blood cells associated with inflammation (Macrophage Activation Syndrome)

• Leukemia

• Carcinoma

• Recurrence of hepatitis B (a liver infection)

• Worsening of a condition called dermatomyositis (muscle inflammation and weakness with an accompanying skin rash)

• Store in a refrigerator( 2°C- 8°C .) Do not freeze.

• Keep this medicine out of the reach of children.

• Keep the pre-filled syringes in the outer carton in order to protect them from light.

The active ingredient is Etanercept.

Other ingredients are Sucrose, Sodium chloride, L-arginine hydrochloride, Sodium phosphate monobasic dihydrate, Sodium phosphate dibasic, and water for injection.