MINJUVI must be administered by a healthcare professional experienced in treatment of cancer patients. Recommended premedication A premedication to reduce the risk of infusion-related reactions should be administered 30 minutes to 2 hours prior to tafasitamab infusion.
For patients not experiencing infusion-related reactions during the first 3 infusions, premedication is optional for subsequent infusions. g. g. g. g. methylprednisolone). 3 Treatment of infusion-related reactions If an infusion-related reaction occurs (Grade 2 and higher), the infusion should be interrupted.
In addition, appropriate medical treatment of symptoms should be initiated. After signs and symptoms are resolved or reduced to Grade 1, MINJUVI infusion can be resumed at a reduced infusion speed (see Table 1). If a patient has experienced a Grade 1 to 3 infusion-related reaction, premedication should be administered before subsequent tafasitamab infusions.
Combination with lenalidomide As MINJUVI is indicated in combination with lenalidomide, please refer to the lenalidomide Summary of Product Characteristics (SmPC) for the recommendations on prophylactic antithrombotic medicines. Posology Recommended dose for the treatment of adult patients with relapsed or refractory DLBCL The recommended dose of MINJUVI is 12 mg per kg body weight administered as an intravenous infusion according to the following schedule: • Cycle 1: infusion on day 1, 4, 8, 15 and 22 of the cycle.
• Cycles 2 and 3: infusion on day 1, 8, 15 and 22 of each cycle. • Cycle 4 until disease progression: infusion on day 1 and 15 of each cycle. Each cycle has 28 days. In addition, patients should self-administer lenalidomide capsules at the recommended starting dose of 25 mg daily on days 1 to 21 of each cycle.
The starting dose and subsequent dosing may be adjusted according to the lenalidomide SmPC. MINJUVI plus lenalidomide in combination is given for up to twelve cycles. Treatment with lenalidomide should be stopped after a maximum of twelve cycles of combination therapy.
Patients should continue to receive MINJUVI infusions as single agent on day 1 and 15 of each 28-day cycle, until disease progression or unacceptable toxicity. Recommended dose for the treatment of adult patients with relapsed or refractory FL after at least one line of systemic therapy The recommended dose of MINJUVI is 12 mg per kg body weight administered as an intravenous infusion according to the following schedule: • Cycle 1 to 3: infusion on day 1, 8, 15 and 22 of each cycle.
• Cycles 4 to 12: infusion on day 1 and 15 of each cycle. Each cycle has 28 days. The recommended starting dose of rituximab is 375 mg/m2 administered as an intravenous infusion according to the following schedule: • Cycle 1: on days 1, 8, 15 and 22.
• Cycles 2 to 5: on day 1 of each cycle. Each cycle has 28 days. Please refer to the SmPC of rituximab intravenous formulations for information on its method of administration and premedication and prophylactic medications. In addition, patients should self-administer lenalidomide capsules at the recommended starting dose of 20 mg daily on days 1 to 21 of each 28-day cycle.
The starting dose and subsequent dosing may be adjusted according to the lenalidomide SmPC. MINJUVI in combination with lenalidomide plus rituximab is given for up to twelve cycles for MINJUVI and lenalidomide, and five cycles for rituximab.
Treatment with rituximab should be stopped after five cycles of combination therapy. Patients should continue to receive MINJUVI infusions in combination with oral lenalidomide up to cycle twelve. Treatment with tafasitamab plus lenalidomide should be stopped after a maximum of twelve cycles.
4 Dose modifications Table 1 provides dose modifications for MINJUVI in case of adverse reactions. For dose modifications regarding lenalidomide, please also refer to the lenalidomide SmPC.
Table 1:
Dose modifications in case of adverse reactions Adverse reaction Severity Dosage modification Infusion-related reactions Grade 2 (moderate) • Interrupt MINJUVI infusion immediately and manage signs and symptoms. • Once signs and symptoms resolve or reduce to Grade 1, resume MINJUVI infusion at no more than 50% of the rate at which the reaction occurred.
If the patient does not experience further reaction within 1 hour and vital signs are stable, the infusion rate may be increased every 30 minutes as tolerated to the rate at which the reaction occurred. Grade 3 (severe) • Interrupt MINJUVI infusion immediately and manage signs and symptoms.
• Once signs and symptoms resolve or reduce to Grade 1, resume MINJUVI infusion at no more than 25% of the rate at which the reaction occurred. If the patient does not experience further reaction within 1 hour and vital signs are stable, the infusion rate may be increased every 30 minutes as tolerated to a maximum of 50% of the rate at which the reaction occurred.
• If after rechallenge the reaction returns, stop the infusion immediately. Grade 4 (life-threatening) • Stop the infusion immediately and permanently discontinue MINJUVI. Myelosuppression Platelet count of less than 50,000/μL • Withhold MINJUVI and lenalidomide and monitor complete blood count weekly until platelet count is 50,000/μL or higher.
• Resume MINJUVI at the same dose and lenalidomide at a reduced dose if platelets return to ≥ 50,000/μL. Refer to the lenalidomide SmPC for dosage modifications. Neutrophil count of less than 1,000/μL for at least 7 days or Neutrophil count of less than 1,000/μL with an increase of body temperature to 38 °C or higher • Withhold MINJUVI and lenalidomide and monitor complete blood count weekly until neutrophil count is 1,000/μL or higher.
• Resume MINJUVI at the same dose and lenalidomide at a reduced dose if neutrophils return to ≥ 1000/μL. […]