Imdeltaraj 10 mg (Talatamab)

Adult dosage

This medication is administered by intravenous infusion over 1 hour. The initial dose regimen consists of administering 1 mg on Day 1 of Cycle 1, 10 mg on Day 8 of Cycle 1, and 10 mg on Day 15 of Cycle 1. The maintenance dose regimen involves administering 10 mg once every 2 weeks starting from Cycle 2. On Days 1 and 8 of Cycle 1, patients should be monitored in a medical facility for 22 to 24 hours following the start of the infusion, and total monitoring should be for 4 hours from the start of the infusion.

This medication may cause severe cytokine release syndrome (CRS), so the patient's condition should be closely monitored before and after administration. Moreover, it may affect the nervous system and cause neurotoxic symptoms such as confusion and decreased consciousness. In such cases, it is imperative to inform healthcare professionals immediately and receive treatment. Individuals with known allergic reactions to this medication should not take it, and regular blood tests are necessary as there may be a decrease in blood cell counts. Due to the increased risk of infection, individuals should consult healthcare professionals immediately if they experience fever or symptoms of infection. It may affect liver function, so regular liver function tests should be performed, and administration may be suspended if abnormal signs are present. Severe allergic reactions can occur; thus, symptoms of hypersensitivity should be closely observed during administration. Pregnant women or those who may become pregnant should use effective contraception for at least two months during and after treatment, as this medication may harm the fetus. The safety and efficacy of this medication in children under 18 years of age have not been established, and elderly patients or those with compromised renal or liver function should use it cautiously under medical supervision. This medication is administered by intravenous injection and should only be done under the supervision of qualified medical personnel in an appropriate medical facility.

Serious side effects

Headache, hypotension, hypoxia, cardiac dysfunction, acute respiratory distress syndrome, neurotoxicity, renal failure, liver failure, disseminated intravascular coagulation (DIC), confusion, decreased level of consciousness, disorientation, neurological adverse reactions, jaundice, severe allergic reactions, pneumonia, dyspnea, respiratory failure, pulmonary embolism

Mild side effects

• Fatigue
• fever
• taste disturbances
• decreased appetite
• nausea
• vomiting
• constipation
• musculoskeletal pain
• anemia
• cough

This medication should be stored in a tightly sealed container to protect it from air and light, and should be kept at a refrigerated temperature between 2°C and 8°C. Storing it this way will help maintain the medication's effectiveness for a longer period.

Appearance

Lyophilized vial: a white to light yellow lyophilized mass contained in a colorless transparent glass vial for injection. (Reconstituted solution from lyophilized vial: colorless to light yellow solution without visible particles)

Package unit

1 vial/box ([vial (10 mg) × 1 + IV solution stabilizer (7 mL) × 2]/box)