Minjuvibju (Tafasitamab)

Adult dosage

The recommended dose of this medication is 12 mg/kg administered as an intravenous infusion according to the following schedule: • Cycle 1: Days 1, 4, 8, 15, and 22 of the cycle. • Cycle 2 and 3: Days 1, 8, 15, and 22 of each cycle. • From Cycle 4 until disease progression: Days 1 and 15 of each cycle. Each cycle spans 28 days. Patients are recommended to take lenalidomide capsules.

This medication is administered intravenously, and infusion-related reactions such as fever, chills, rash, and difficulty in breathing may occur during infusion. Therefore, healthcare personnel should monitor the patient closely. It is recommended to premedicate patients prior to administration to prevent infusion-related reactions, and if severe reactions occur, the administration should be stopped and appropriate treatment should be provided. Bone marrow suppression may lead to neutropenia, thrombocytopenia, anemia, etc., so blood tests should be conducted frequently during the treatment period to monitor these conditions. The risk of infection may increase, thus any symptoms of infection such as fever, chills, cough, or pain during urination should be reported to healthcare personnel immediately. Neurological effects may lead to rare but serious brain disorders such as progressive multifocal leukoencephalopathy, so any new neurological symptoms should be discussed with healthcare personnel immediately. There is a risk of complications due to tumor lysis syndrome, hence prevention and monitoring for this should occur before and during treatment. It is best to avoid live vaccinations during the use of this medication, and the use during pregnancy may harm the fetus, thus women who are pregnant or could become pregnant should use effective contraceptive methods. Those with hypersensitivity to this medication should not be administered it, and safety has not been confirmed in individuals under 18 years old. Elderly patients over 65 years can be treated but should be monitored closely for potential adverse reactions. In patients with slightly impaired kidney or liver function, dosage adjustment is not required; however, data on severely impaired patients is insufficient. This medication may cause fatigue impacting driving or machine operation, hence caution is necessary. In case of overdose, adverse reactions should be monitored closely and appropriate treatment provided if necessary. This medication should be used within a specified time after dilution, should be stored refrigerated, and should be protected from direct sunlight. Unused medication should be disposed of safely and must not be mixed with other medications.

Serious side effects

• Urticaria
• severe swelling
• chest tightness
• difficulty breathing
• cold sweat
• pallor
• severe rash with high fever
• blisters
• peeling skin
• pain in mucous membranes of mouth/eyes

Mild side effects

• Weakness
• anemia
• diarrhea
• thrombocytopenia
• cough
• peripheral edema
• fever
• decreased appetite
• headache
• sensory alteration

This medication should be stored in a sealed container to prevent exposure to air and kept away from light at a refrigerated temperature between 2 to 8 degrees Celsius. Additionally, do not freeze the medication, and do not shake before use.

Appearance

A colorless transparent glass vial containing a freeze-dried white to light yellow substance. After reconstitution, it appears clear to slightly opalescent and colorless to slightly yellow.

Package unit

1 vial/box [vial (200 mg)]