Tekvayli 30 mg (teclistamab)

Adult administration

This medication is administered only as a subcutaneous injection. The recommended initial dose is 0.06 mg/kg, which may be increased to 0.3 mg/kg, followed by a maintenance dose of 1.5 mg/kg administered weekly. In patients showing a complete response or higher for a minimum of 6 months, consideration can be given to reducing the frequency of administration to every two weeks at 1.5 mg/kg until disease progression or unacceptable toxicity occurs. Initial dosing schedule.

This drug may cause a serious side effect known as cytokine release syndrome, which can be life-threatening to the patients receiving it. To reduce the risk of this side effect, it should be administered per the prescribed dosage and schedule, especially during the initial treatment. If cytokine release syndrome occurs, the administration of this medication should be paused until symptoms improve, or in severe cases, completely discontinued. Moreover, this drug may manifest immune-mediated neurological toxicities, which are immune-related side effects, so neurological symptoms should be closely monitored during treatment. If neurological symptoms develop, immediate medical attention is necessary, and drug administration should be stopped if required. This medication should not be used in patients with known allergic reactions to any of its components. During administration, the risk of infection may increase, so symptoms of infection should be carefully monitored, and preventive treatment should be considered if needed. Particularly, patients with hepatitis B virus should monitor for virus reactivation during and after treatment. It is not recommended for use in pregnant women, and women of childbearing potential should confirm pregnancy status before treatment initiation and use effective contraception during treatment and for a specified period afterward. Breastfeeding women should avoid nursing during the administration period and for at least 5 months afterward. The safety and efficacy of this drug in children under 18 years of age have not been established, and dose adjustment is not necessary for elderly patients over 65 years of age. Dose adjustment is not required for patients with mildly impaired renal or liver function, but information on severe patients is limited. This medication requires caution when driving or operating machinery, especially when neurological symptoms are present, and hazardous activities should be avoided. In case of overdose, immediately notify a healthcare professional and receive appropriate treatment. Store in a sealed container to protect from air and light, and maintain at a refrigerated temperature between 2 degrees and 8 degrees Celsius. Proper storage preserves the integrity and efficacy of the drug's components.

Serious side effects

Rash, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough + fever, jaundice (yellowing of skin or eyes), profound fatigue, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urine changes.

Mild side effects

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

This medication must be stored in a sealed container to protect it from air and light, and it should be maintained at a refrigerated temperature between 2 and 8 degrees Celsius. Proper storage ensures that the drug components remain unchanged and effective.

Appearance

A colorless or pale yellow solution in a colorless, transparent glass vial.

Package unit

1 - 1 vial/box [30 mg/vial (10 mg/mL)]