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Minjuvi is a brand name for Tafasitamab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: MINJUVI is indicated in combination with lenalidomide followed by MINJUVI 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). MINJUVI is indicated in combination with lenalidomide and…
Verbatim from this product's EMA label. Tap a section to expand.
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.
Summary of the safety profile Patients with relapsed or refractory DLBCL The safety of tafasitamab in patients with DLBCL was evaluated in the open-label, multicentre, single- arm phase 2 study L-MIND in 81 patients with relapsed or refractory DLBCL.
Patients received tafasitamab 12 mg/kg intravenously in combination with lenalidomide for a maximum of 12 cycles, followed by tafasitamab monotherapy until disease progression or unacceptable toxicity. 7 months. The most common adverse reactions were: infections (73%), neutropenia (51%), asthenia (40%), anaemia (36%), diarrhoea (36%), thrombocytopenia (31%), cough (26%), oedema peripheral (24%), pyrexia (24%), decreased appetite (22%).
The most common serious adverse reactions were infection (26%) including pneumonia (7%), and febrile neutropenia (6%). Permanent discontinuation of tafasitamab due to an adverse reaction occurred in 15% of patients. 5%). The frequency of dose modification or interruption due to adverse reactions was 65%.
The most common adverse reactions leading to tafasitamab treatment interruption were blood and lymphatic system disorders (41%). Patients with relapsed or refractory FL after at least one line of systemic therapy The safety of tafasitamab in patients with FL was evaluated in the randomised, double-blind, placebo- controlled multicenter phase 3 study inMIND in 652 patients, including 546 participants with relapsed or refractory (R/R) follicular lymphoma and 106 participants with R/R marginal zone lymphoma.
Patients received tafasitamab 12 mg/kg (n = 327) or placebo (n = 325) intravenously in combination with rituximab 375 mg/m2 intravenously (for a maximum of 5 cycles) and lenalidomide 20 mg orally (for a maximum of 12 cycles). Tafasitamab treatment was stopped after 12 cycles.
Among patients who received tafasitamab, 83% were exposed for 6 months or longer. The median duration of exposure to tafasitamab was 322 days. 4%). 8%). 6% of patients. 9%). 9%. 7%). Tabulated list of adverse reactions Adverse reactions reported for tafasitamab in clinical trials are listed by MedDRA System Organ Class and by frequency.
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. 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.
2). 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. 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.
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• 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. […]
The adverse reaction frequencies from clinical trials are based on all-cause adverse event frequencies, where a proportion of the events for an adverse reaction may have other causes than the medicinal product, such as the disease, other medicines or unrelated causes.
Frequencies are defined as follows: 9 very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); and not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. g. bronchopulmonary aspergillosis, bronchitis, pneumonia and urinary tract infection) Common Sepsis (including neutropenic sepsis) Neoplasms benign, malignant and unspecified (incl.
g. rash, rash maculopapular, rash pruritic, rash erythematous) Common Pruritus, alopecia, erythema, hyperhidrosis Musculoskeletal and connective tissue disorders Very common Back pain, muscle spasms Common Arthralgia, pain in extremity, musculoskeletal pain Renal and urinary disorders Common Blood creatinine increased General disorders and administration site conditions Very common Asthenia++ , oedema peripheral, pyrexia […]
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. Tumour lysis syndrome has been reported during treatment with tafasitamab.
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. CD19-negative or CD20-negative disease There are no data available on patients with CD19-negative or CD20-negative FL treated with tafasitamab in combination with lenalidomide and rituximab, and it is possible that patients with CD19-negative or CD20-negative FL may have less benefit compared to patients with CD19-positive and CD20-positive FL.
The potential risks and benefits associated with treatment of patients with CD19-negative or CD20-negative FL with tafasitamab in combination with lenalidomide and rituximab should be considered. 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.
85% of the WHO recommended maximum daily intake of 2 g sodium for an adult. 0 mg of polysorbate 20 per 5 vials. Polysorbate 20 may cause allergic reactions.