Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

Infusion-related reactions
Infusion-related reactions may occur and have been reported more frequently during the first infusion (see section 4.8). Patients should be monitored closely throughout the infusion. Patients should be advised to contact their healthcare professionals if they experience signs and symptoms of infusion-related reactions including fever, chills, rash or breathing problems within 24 hours of infusion. A premedication should be administered to patients prior to starting tafasitamab infusion.
Based on the severity of the infusion-related reaction, tafasitamab infusion should be interrupted or discontinued and appropriate medical management should be instituted (see section 4.2).

Myelosuppression
Treatment with tafasitamab can cause serious and/or severe myelosuppression including neutropenia, thrombocytopenia and anaemia (see section 4.8). Complete blood counts should be monitored throughout treatment and prior to administration of each treatment cycle. Based on the severity of the adverse reaction, tafasitamab infusion should be withheld (see Table 1). Refer to the lenalidomide SmPC for dosage modifications.

Neutropenia
Neutropenia, including febrile neutropenia, has been reported during treatment with tafasitamab.
Administration of granulocyte colony-stimulating factors (G-CSF) should be considered, in particular in patients with Grade 3 or 4 neutropenia. Any symptoms or signs of developing infection should be anticipated, evaluated and treated.

Thrombocytopenia
Thrombocytopenia has been reported during treatment with tafasitamab. Withholding of concomitant medicinal products that may increase bleeding risk (e.g. platelet inhibitors, anticoagulants) should be considered. Patients should be advised to report signs or symptoms of bruising or bleeding immediately.

Infections
Fatal and serious infections, including opportunistic infections, occurred in patients during treatment with tafasitamab. Tafasitamab should be administered to patients with an active infection only if the infection is treated appropriately and well controlled. Patients with a history of recurring or chronic infections may be at increased risk of infection and should be monitored appropriately.
Patients should be advised to contact their healthcare professionals if fever or other evidence of potential infection, such as chills, cough or pain on urination, develops.

Progressive Multifocal Leukoencephalopathy
Progressive multifocal leukoencephalopathy (PML) has been reported during combination therapy with tafasitamab. Patients should be monitored for new or worsening neurological symptoms or signs that may be suggestive of PML. The symptoms of PML are nonspecific and can vary depending on the affected region of the brain. These include altered mental status, memory loss, speech impairment, motor deficits (hemiparesis or monoparesis), limb ataxia, gait ataxia, and visual symptoms such as 
hemianopia and diplopia. If PML is suspected, further dosing of tafasitamab must be immediately suspended. Referral to a neurologist should be considered. Appropriate diagnostic measures may include MRI scan, cerebrospinal fluid testing for JC viral DNA and repeat neurological assessments. If PML is confirmed, tafasitamab must be permanently discontinued.

Tumour lysis syndrome
Patients with high tumour burden and rapidly proliferative tumour may be at increased risk of tumour lysis syndrome. In patients with DLBCL, tumour lysis syndrome during treatment with tafasitamab has been observed. Appropriate measures/prophylaxis in accordance with local guidelines should be taken prior to treatment with tafasitamab. Patients should be monitored closely for tumour lysis syndrome during treatment with tafasitamab.

Immunisations
The safety of immunisation with live vaccines following tafasitamab therapy has not been investigated and vaccination with live vaccines is not recommended concurrently with tafasitamab therapy.

Excipient
This medicinal product contains 37.0 mg sodium per 5 vials (the dose of a patient weighing 83 kg), equivalent to 1.85% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

Effects on Driving

4.7   Effects on ability to drive and use machines

MINJUVI 200 mg has no or negligible influence on the ability to drive and use machines. However, fatigue has been reported in patients taking tafasitamab and this should be taken into account when driving or using machines.