Active Ingredient: Tafasitamab
Tafasitamab is indicated in combination with lenalidomide followed by tafasitamab monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 12 milligrams tafasitamab per kilogram of body weight, one dose, over the duration of 3 days. Afterwards, intravenous, 12 milligrams tafasitamab per kilogram of body weight, one dose, over the duration of 4 days. Afterwards, intravenous, 12 milligrams tafasitamab per kilogram of body weight, once every 7 days, 11 doses in total. Afterwards, intravenous, 12 milligrams tafasitamab per kilogram of body weight, once every 14 days.
A pre-medication 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, pre-medication is optional for subsequent infusions.
The pre-medication may include antipyretics (e.g. paracetamol), histamine H1 receptor blockers (e.g. diphenhydramine), histamine H2 receptor blockers (e.g. cimetidine),or glucocorticosteroids (e.g. methylprednisolone).
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, tafasitamab 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, pre-medication should be administered before subsequent tafasitamab infusions.
The recommended dose of tafasitamab is 12 mg per kg body weight administered as an intravenous infusion according to the following schedule:
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 Summary of Product Characteristics (SmPC). Tafasitamab 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 tafasitamab infusions as single agent on day 1 and 15 of each 28-day cycle, until disease progression or unacceptable toxicity.
Table 1 provides dose modifications 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 tafasitamab infusion immediately and manage signs and symptoms. • Once signs and symptoms resolve or reduce to Grade 1, resume tafasitamab 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 tafasitamab infusion immediately and manage signs and symptoms. • Once signs and symptoms resolve or reduce to Grade 1, resume tafasitamab 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 tafasitamab. | |
| Myelosuppression | Platelet count of less than 50,000/µL | • Withhold tafasitamab and lenalidomide and monitor complete blood count weekly until platelet count is 50,000/µL or higher. • Resume tafasitamab 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 or Neutrophil count less than 500/µL | • Withhold tafasitamab and lenalidomide and monitor complete blood count weekly until neutrophil count is 1,000/µL or higher. • Resume tafasitamab at the same dose and lenalidomide at a reduced dose if neutrophils return to ≥1000/µL. Refer to the lenalidomide SmPC for dosage modifications. |
Tafasitamab must not be co-administered with other medicinal products through the same infusion line.
Tafasitamab must not be administered as an intravenous push or bolus.
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