Tecvayli 153mg (Teclistamab)

Adult administration

This drug is administered only as a subcutaneous injection. The initial dose is increased from 0.06 mg/kg to 0.3 mg/kg, then maintained with a weekly dose of 1.5 mg/kg. For patients showing a complete response or better for at least 6 months, a reduction in dosing frequency to 1.5 mg/kg every two weeks may be considered. The dosing schedule is as follows: - Day 1: 0.06 mg/kg once - Day 3: 0.3

This drug can cause severe cytokine release syndrome that may be life-threatening to the receiving patient, so it should be administered precisely according to the initial dosage. If cytokine release syndrome occurs, treatment should be immediately interrupted or withheld, and appropriate treatment should be received depending on the severity of the symptoms. This drug may also induce neurotoxicity; thus, neurological symptoms should be carefully monitored during administration, and if symptoms arise, patients should receive medical attention immediately. Patients with allergic reactions to this drug or its components should not be administered this agent. The risk of infection may increase during administration, so it is essential to monitor for signs of infection and receive preventive treatment if necessary. Women who are pregnant or may become pregnant should confirm their pregnancy status before taking this drug and must implement effective contraception for the duration of treatment and a certain period afterward. It is recommended that breastfeeding women avoid nursing during the administration period and for at least 5 months afterward. The safety and efficacy of this drug have not been established in children under 18 years of age, so it should not be used in this population. For elderly patients or those with mild to moderate renal or hepatic impairment, dose adjustments are not necessary; however, information regarding severe cases is limited. This drug may affect driving or the operation of machinery, so such activities should be avoided during administration and for a certain period afterward. There is no specific information regarding overdose, but if abnormal symptoms appear, patients should inform medical personnel immediately to receive appropriate treatment. This drug should be stored out of the reach of children, sealed to prevent air intrusion, and kept away from light. It is important to store it at refrigeration temperatures between 2°C and 8°C to maintain its potency, and check for discoloration or particulate matter before use. Any unused medicines and waste should be disposed of safely according to relevant regulations.

Serious side effects

Cytokine release syndrome (CRS), sepsis, acute kidney injury, soft tissue infections, hypoxia, febrile neutropenia, encephalopathy, immune effector cell-associated neurotoxicity syndrome (ICANS), progressive multifocal leukoencephalopathy, respiratory distress, hypotension

Mild side effects

• Hypogammaglobulinemia
• neutropenia
• anemia
• musculoskeletal pain
• fatigue
• thrombocytopenia
• injection site reactions
• upper respiratory infection
• lymphocytopenia
• diarrhea

This drug should be stored in a sealed container to prevent air ingress and kept in a dark place away from light. Additionally, to maintain the drug's effectiveness, it is important to store it at refrigeration temperatures between 2°C and 8°C.

Appearance

The injection is a colorless or pale yellow liquid contained in a colorless, transparent glass vial.

Package unit

1 - 1 vial/box [153 mg/vial (90 mg/mL)]