MINJUVI

/ Neopharm (Israel) 1996 Ltd.

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 infusionrelated 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).
The recommended dose is 200 mg, 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.
neopTreatment with lenalidomide should be stopped after a maximum of twelve cycles of combination therapy. Patients should continue to receive tafasitamab 200 mg infusions as single agent on day 1 and 15 of each 28-day cycle, until disease progression or unacceptable toxicity.
Method of administration
Tafasitamab 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.
• Tafasitamab 200 mg must not be co-administered with other medicinal products through the same infusion line.
• Tafasitamab 200 mg must not be administered as an intravenous push or bolus.
See prescribing information for full details.

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).

Hypersensitivity to the active substance or to any of the excipients

Infusion-related reactions
Infusion-related reactions may occur and have been reported more frequently during the first Infusion. Patients should be monitored closely throughout the 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.
Myelosuppression
Treatment with tafasitamab can cause serious and/or severe myelosuppression including neutropenia, thrombocytopenia and anaemia. 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.
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.
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.

Very common: Bacterial, viral and fungal infections, including opportunistic infections with fatal outcomes (e.g. broncho pulmonary aspergillosis, bronchitis, pneumonia and urinary tract infection), Febrile neutropenia, neutropenia, thrombocytopenia, anaemia, leukopenia, Hypokalaemia, decreased appetite, Dyspnoea, cough, Diarrhoea, constipation, vomiting, nausea, abdominal pain, Rash (includes different types of rash, e.g. rash, rash maculopapular, rash pruritic, rash erythematous), Back pain, muscle spasms, Asthenia, oedema peripheral, pyrexia.
Common: Sepsis (including neutropenic sepsis), Basal cell carcinoma, Lymphopenia, Hypogammaglobulinaemia, Hypocalcaemia, hypomagnesaemia, Headache, paraesthesia, dysgeusia, Exacerbation of chronic obstructive pulmonary disease,
nasal congestion, Hyperbilirubinaemia, transaminases increased (includes ALT and/or AST increased), Gamma-glutamyltransferase increased, Pruritus, alopecia, erythema, hyperhidrosis, Arthralgia, pain in extremity, musculoskeletal pain, Blood creatinine increased, Mucosal inflammation, Weight decreased, C-reactive protein increased, Infusion related reaction.

No interaction studies have been performed

Women of childbearing potential: Women of childbearing potential should be advised to use effective contraception during and for at least 3 months after end of treatment with tafasitamab.
Pregnancy: There are no data on the use of tafasitamab in pregnant women.
Lactation: It is not known whether tafasitamab is excreted in human milk.

In the case of an overdose, patients should be carefully observed for signs or symptoms of adverse reactions and supportive care should be administered, as appropriate.

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