Imydu Injection (Tremelimumab)

Adult administration

This medication is administered by intravenous infusion over 1 hour. When administered in combination with Durvalumab, this medication should be given first, followed by Durvalumab. This medication and Durvalumab are administered separately by intravenous infusion. The injection should be administered intravenously over 1 hour using an intravenous line with a sterile low protein binding 0.2 or 0.22 micron filter.

This medication should not be used in patients who have had allergic reactions to the active ingredient or excipients. Patients with autoimmune diseases or a history of autoimmune diseases should use this medication cautiously. Common side effects include skin rash, itching, diarrhea, abdominal pain, liver function abnormalities, fever, hypothyroidism, cough, peripheral edema, among others. In severe cases, serious adverse reactions such as hepatitis, pneumonia, or colitis may occur; if these symptoms appear, immediate consultation with healthcare professionals is necessary. Immune-mediated adverse reactions affecting the immune system, such as pneumonitis, hepatitis, colitis, thyroid disease, adrenal insufficiency, nephritis, myocarditis, or myasthenia gravis may occur. If immune-mediated adverse reactions are suspected, the cause should be identified, and treatment with immunosuppressants such as corticosteroids may be necessary as required. During administration, liver, kidney, and thyroid function tests, as well as patient symptoms, should be regularly monitored. It is advisable not to use this medication during pregnancy as it may affect the fetus, and effective contraception should be practiced during treatment and for at least 3 months after discontinuation. Breastfeeding should also be avoided as the drug may pass into breast milk and cause side effects in infants. Safety and efficacy have not been established for children and adolescents under 18 years of age. No dose adjustment is necessary for elderly patients or those with mild to moderate renal or hepatic impairment, but sufficient data is lacking for severe patients. In case of overdose, there are no specific antidotes available, and general supportive treatment should be initiated. This medication does not significantly affect the ability to drive or operate machinery; however, caution is advised as side effects may cause decreased concentration or reaction speed. During storage, maintain aseptic conditions and do not use if discoloration or particulate matter is present; immediately administer any diluted solution and discard any remaining solution.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden severe headache, lightning headache, seizures, altered consciousness, visual disturbances, paralysis, urinary changes

Mild side effects

Rash, itching, diarrhea, abdominal pain, increased aspartate aminotransferase levels, increased alanine aminotransferase levels, fever, hypothyroidism, cough, wet cough, peripheral edema, increased lipase, hyperthyroidism, pituitary insufficiency, thyroiditis, increased amylase, colitis, infections of dental and oral soft tissues, influenza, oral candidiasis, pneumonia, various upper respiratory infections, infusion-related reactions,

This medication should be stored in a sealed container to prevent exposure to air, kept in a cool place between 2 and 8 degrees Celsius. It may also be light-sensitive, so it is advisable to store it in a dark place away from direct sunlight.

Appearance

A clear or slightly opalescent, colorless to pale yellow liquid in a colorless transparent vial for injection.

Package unit

1 vial/box [vial (25mg/1.25mL)], 1 vial/box [vial (300mg/15mL)]