Posology : מינונים

4.2   Posology and method of administration

MINJUVI 200 mg 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.
The premedication 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).

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 200 mg 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.

Posology
The recommended dose of MINJUVI 200 mg 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 Summary of Product Characteristics (SmPC).
MINJUVI 200 mg 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 200 mg infusions as single agent on day 1 and 15 of each 28-day cycle, until disease progression or unacceptable toxicity.

Dose modifications
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                                         • Interrupt MINJUVI 200 mg infusion reactions                                                  immediately and manage signs and symptoms.
• Once signs and symptoms resolve or reduce to Grade 1, resume MINJUVI
200 mg infusion at no more than 50% of
Grade 2 (moderate)                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.
• Interrupt MINJUVI 200 mg infusion immediately and manage signs and symptoms.
• Once signs and symptoms resolve or reduce to Grade 1, resume MINJUVI
200 mg infusion at no more than 25% of
Grade 3 (severe)                  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.

Adverse reaction                    Severity                       Dosage modification • Stop the infusion immediately and
Grade 4 (life-threatening)        permanently discontinue MINJUVI 200 mg.
Myelosuppression                                         • Withhold MINJUVI 200 mg and lenalidomide and monitor complete blood count weekly until platelet count
Platelet count of less than       is 50,000/µL or higher.
50,000/µL                       • Resume MINJUVI 200 mg 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   • Withhold MINJUVI 200 mg and
1,000/µL for at least 7 days      lenalidomide and monitor complete blood count weekly until neutrophil or                                count is 1,000/µL or higher.
• Resume MINJUVI 200 mg at the same
Neutrophil count of less than     dose and lenalidomide at a reduced dose 1,000/µL with an increase of      if neutrophils return to ≥ 1000/µL. Refer body temperature to 38 °C or      to the lenalidomide SmPC for dosage higher                            modifications.
 or

Neutrophil count less than 500/µL
Special populations

Paediatric population
The safety and efficacy of MINJUVI 200 mg in children under 18 years have not been established.
No data are available.

Elderly
No dose adjustment is needed for elderly patients (≥ 65 years).
Renal impairment
No dose adjustment is needed for patients with mild or moderate renal impairment (see section 5.2).
There are no data in patients with severe renal impairment for dosing recommendations.

Hepatic impairment
No dose adjustment is needed for patients with mild hepatic impairment (see section 5.2). There are no data in patients with moderate or severe hepatic impairment for dosing recommendations.

Method of administration
MINJUVI 200 mg is for intravenous use after reconstitution and dilution.
•    For the first infusion of cycle 1, the intravenous infusion rate should be 70 mL/h for the first 30 minutes. Afterwards, the rate should be increased to complete the first infusion within a 2.5-hour period.
•    All subsequent infusions should be administered within a 1.5 to 2-hour period.
•    In case of adverse reactions, consider the recommended dose modifications provided in Table 1.
•    MINJUVI 200 mg must not be co-administered with other medicinal products through the same infusion line.
•    MINJUVI 200 mg must not be administered as an intravenous push or bolus.
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.