Approved Drug Label (PDF)
5
Warnings and Precautions
5.1 Infusion-Related Reactions
Additions and/or revisions underlined:
MONJUVI can cause infusion-related reactions [see Adverse Reactions (6.1)].
In L-MIND, infusion-related reactions occurred in 6% of the 81 patients with
DLBCL who received MONJUVI. Eighty percent of infusion-related reactions
occurred during cycle 1 or 2. In inMIND, infusion-related reactions occurred
in 16% of the 274 patients with FL who received MONJUVI in combination with
lenalidomide and rituximab. Signs and symptoms included fever, chills,
rash, flushing, dyspnea, and hypertension. These reactions were generally
managed with temporary interruption of the infusion and/or with supportive
medication.
Premedicate patients prior to starting MONJUVI infusion [see Dosage and Administration (2.4)].
Monitor patients frequently during infusion. Based on the severity of the
infusion-related reaction, interrupt or discontinue MONJUVI [see Dosage
and Administration (2.5)]. Institute appropriate medical management.
5.2 Myelosuppression
Additions and/or revisions underlined:
MONJUVI can cause serious or severe myelosuppression, including
neutropenia, lymphopenia, thrombocytopenia, and anemia [see Adverse Reactions (6.1)].
In L-MIND, among 81 patients with DLBCL who received MONJUVI, Grade
3 neutropenia was reported in 25%, Grade 3 thrombocytopenia in
12%, and Grade 3 anemia in 7%. Grade 4 neutropenia was reported
in 25% and Grade 4 thrombocytopenia in 6%. Neutropenia led to treatment
discontinuation in 3.7% of the patients with DLBCL. Febrile
neutropenia occurred in 12%.
In inMIND, among 274 patients with FL who received MONJUVI in combination
with lenalidomide and rituximab, new or worse Grade 3 or 4 cytopenias included
decreased neutrophils in 48% (Grade 4, 19%), decreased lymphocytes in 22%
(Grade 4, 1.8%), decreased hemoglobin in 9%, and decreased platelets in 8%
(Grade 4, 4%). Febrile neutropenia occurred in 4.4%.
Monitor CBCs before each treatment cycle and throughout treatment.
Monitor patients with neutropenia for signs of infection. Consider granulocyte
colony-stimulating factor administration. Withhold MONJUVI based on the
severity of the adverse reaction [see
Dosage and Administration (2.5)]. Refer to the lenalidomide prescribing
information for dosage modifications.
5.3 Infections
Additions and/or revisions underlined:
Fatal and serious infections, including opportunistic infections,
occurred in patients during treatment with MONJUVI and following the last dose [see Adverse Reactions (6.1)].
In L-MIND, 73% of the 81 patients with DLBCL who received MONJUVI developed
an infection. Grade 3 or higher infection occurred in 30%. Infection-related
deaths occurred in 2.5% of patients, including a case of progressive multifocal
leukoencephalophathy (PML). The most frequent Grade 3 or higher infection
was pneumonia (7%). The most frequent infections of any grade were
respiratory tract infections (51%, including pneumonias) and urinary tract
infection (17%).
Among 274 patients with
FL who received MONJUVI in combination with lenalidomide and rituximab in
inMIND, Grade 3 or higher infections occurred in 24%, including fatal
infections in 1.1% of patients. The most frequent Grade greater than or equal to 3 infections were
respiratory tract infections (19%), including Grade 3 or higher pneumonia (14%)
and COVID-19 infection (11%). Opportunistic infections of any grade occurred in
6% of patients including herpes simplex or zoster infection (5%), fungal
pneumonia (1.1%, including Pneumocytis
jirovecii pneumonia in 0.4%), and cytomegalovirus (CMV) reactivation
(0.4%).
Monitor patients for signs and symptoms of infection and manage
infections as appropriate. Consider infection prophyaxis per institutional
guidelines. Consider treatment with subcutaneous or intravenous immunoglobulin
(IVIG) as appropriate.
5.4 Embryo-Fetal Toxicity
Additions and/or revisions underlined:
Based on its mechanism of action, MONJUVI may cause fetal B-cell
depletion when administered to a pregnant woman. Advise pregnant women of the
potential risk to a fetus. Advise females of reproductive potential to use
effective contraception during treatment with MONJUVI and for 3 months after
the last dose [see Use in Specific
Populations (8.1, 8.3)].
The combination of MONJUVI with lenalidomide and of MONJUVI with
lenalidomide and rituximab is contraindicated in pregnant women because
lenalidomide can cause birth defects and death of the unborn child. Refer to
the lenalidomide prescribing information on use during pregnancy.
6
Adverse Reactions
6.1 Clinical Trials Experience
Additions and/or revisions underlined:
. . .
Relapsed or Refractory Diffuse Large B-Cell Lymphoma
The safety of MONJUVI in patients with relapsed or refractory DLBCL
was evaluated in L-MIND [see Clinical
Studies (14.1)]. Patients (N = 81) received MONJUVI 12 mg/kg intravenously
in combination with lenalidomide for a maximum of 12 cycles, followed by
MONJUVI as monotherapy until disease progression or unacceptable toxicity as
follows:
- Cycle 1: Days 1, 4, 8, 15, and 22 of the
28-day cycle;
- Cycles 2 and 3: Days 1, 8, 15, and 22 of each
28-day cycle;
- Cycles 4 and beyond: Days 1 and 15 of each
28-day cycle.
Among patients who received MONJUVI, 57% were exposed for 6 months or
longer, 42% were exposed for greater than one year, and 24% were exposed for
greater than two years.
. . .
Table 4: Adverse Reactions (greater than or equal to 10%) in Patients
with Relapsed or Refractory Diffuse Large B-Cell Lymphoma Who Received MONJUVI
in L-MIND
Extensive changes to table; please refer to label for complete
information.
Clinically relevant adverse reactions in < 10% of patients with
relapsed or refractory DLBCL who received MONJUVI in L-MIND were:
- Blood
and lymphatic system disorders: lymphopenia (6%)
. . .
Table 5: Select Laboratory Abnormalities (greater than or equal to
20%) Worsening from Baseline in Patients with
Relapsed or Refractory Diffuse
Large B-Cell Lymphoma
Who Received MONJUVI
in L-MIND
Addition of in Combination with Lenalidomide to the MONJUVI
section of table; please refer to label for complete information.
Newly added information:
Relapsed or Refractory Follicular Lymphoma
The safety of MONJUVI in patients with relapsed or refractory FL was
evaluated in the inMIND trial [see
Clinical Studies (14.2)]. Patients received MONJUVI 12 mg/kg (N = 274) or
placebo (N = 272) intravenously for a maximum of 12 cycles in combination with
lenalidomide 20 mg (Days 1-21 of Cycles 1 to 12) and rituximab 375 mg/m2
(Cycles 1 to 5). MONJUVI was administered as follows:
- Cycle 1 to 3: Days 1, 8, 15, and 22 of each
28-day cycle;
- Cycles 4 to 12: Days 1 and 15 of each 28-day
cycle.
In the MONJUVI arm, 54% of patients completed all 12 cycles. The median
age in that arm was 64 years (range: 36-88); 20% were age 75 years or older;
55% were male; 80% were White, 15% Asian, and 0.4% Black.
In the MONJUVI arm, serious adverse reactions occurred in 33% of
patients, including serious infections in 24% of patients (including pneumonia
and COVID-19 infection). Other serious adverse reactions in greater than or
equal to 2% of patients included renal insufficiency (3.3%), second primary
malignancies (2.9%), and febrile neutropenia (2.6%). Fatal adverse reactions
occurred in 1.5% of patients, including from COVID-19, sepsis, and
adenocarcinoma.
Adverse reactions led to permanent discontinuation of MONJUVI in 11% of
patients and dosage interruptions in 74%. The most frequent adverse reactions
leading to dosage interruptions of MONJUVI were neutropenia (37% of all
patients), COVID-19 (22%), pneumonia (11%), and infusion-related reaction (8%).
The most common adverse reactions (greater than or equal to 20%) in
recipients of MONJUVI, excluding laboratory abnormalities, were respiratory
tract infections (including COVID-19 infection and pneumonia), diarrhea, rash,
fatigue, constipation, musculoskeletal pain, and cough. The most common Grade 3
or 4 laboratory abnormalities (greater than or equal to 20%) were decreased
neutrophils and decreased lymphocytes.
Table 6 summarizes the adverse reactions in inMIND. Adverse reactions
occurring at least 5% more frequently in the MONJUVI arm included COVID-19
infection, pneumonia, diarrhea, pruritus, fatigue, musculoskeletal pain, and
mucositis.
Table 6: Adverse Reactions (greater
than or equal to 10%) in Patients with Relapsed or Refractory Follicular
Lymphoma Who Received MONJUVI in inMIND
Newly added table; please refer to label for complete information.
In the MONJUVI arm, clinically relevant adverse reactions in < 10% of
patients with relapsed or refractory FL included thrombosis, febrile
neutropenia, second primary malignancy, sepsis, interstitial lung disease, and
tumor lysis syndrome.
Table 7 summarizes the laboratory abnormalities in inMIND. Grade 4
laboratory abnormalities in > 1% of patients included neutrophils decreased
(19%), platelets decreased (4%) and lymphocytes decreased (1.8%).
Table 7: Select Laboratory
Abnormalities (> 20%) Worsening from Baseline in Patients with Relapsed or
Refractory Follicular Lymphoma Who Received MONJUVI in inMIND
Newly added
table; please refer to label for complete information.
8
Use in Specific Populations
8.1 Pregnancy
Additions and/or revisions underlined:
Risk Summary
Based on its mechanism of action, MONJUVI may cause fetal B-cell
depletion when administered to a pregnant woman [see Clinical Pharmacology (12.1)]. There are no available data on
MONJUVI use in pregnant women to evaluate for a drug-associated risk. Animal
reproductive toxicity studies have not been conducted with tafasitamab-cxix.
In the U.S. general population, the estimated background risk of major
birth defects and miscarriage in clinically recognized pregnancies is 2% to 4%
and 15% to 20%, respectively.
MONJUVI is administered in combination with lenalidomide, as well as
in combination with lenalidomide and rituximab for up to 12 cycles.
Lenalidomide can cause embryo-fetal harm and is contraindicated for use in
pregnancy. Refer to the lenalidomide prescribing information for additional
information. Lenalidomide is only available through a REMS program.
. . .
8.3 Females and Males of Reproductive Potential
Additions and/or revisions underlined:
MONJUVI can cause fetal B-cell depletion when administered to a pregnant
woman [see Use in Specific Populations
(8.1)].
Pregnancy Testing
Refer to the prescribing information for lenalidomide for pregnancy
testing requirements prior to initiating the combination of MONJUVI with
lenalidomide or the combination of MONJUVI with lenalidomide and rituximab .
. . .
8.5 Geriatric Use
Additions and/or revisions underlined:
Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Among the 81 patients who received MONJUVI and lenalidomide in
L-MIND, 72% were 65 years and older, while 38% were 75 years and older. Clinical studies
of MONJUVI did not include sufficient numbers of patients aged 65 and older to
determine whether effectiveness differs compared to that of younger subjects.
Patients 65 years and older had more serious adverse reactions (57%) than
younger patients (39%).
Relapsed or Refractory Follicular Lymphoma
Among the 274 patients with FL who received MONJUVI in combination with
lenalidomide and rituximab in inMIND, 137 (50%) were 65 years and older and 54
(20%) were 75 years and older. No clinically meaningful differences in safety
or effectiveness were observed between these patients and younger patients.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT INFORMATION
Additions and/or revisions underlined:
What is MONJUVI?
MONJUVI is a prescription medicine given:
- in
combination with
lenalidomide, to treat adults with certain types of diff use large B-cell
lymphoma (DLBCL) that has come back (relapsed) or that did not respond to
previous treatment (refractory) and who cannot receive a stem cell transplant.
- in
combination with a lenalidomide and rituximab, to treat adults with follicular
lymphoma (FL) that has come back or that did not respond to previous treatment.
MONJUVI should not be used and is not recommended outside of clinical
trials to treat people with a certain type of lymphoma, called marginal zone
lymphoma, that has come back or that did not respond to previous treatment.
It is not known if MONJUVI is safe and effective in children
. . .
What are the possible side effects of MONJUVI? MONJUVI may cause
serious side effects, including:
- Infusion
reactions. Your healthcare provider
will monitor you for infusion reactions during your infusion of MONJUVI.
Tell your healthcare provider right away if you get fever, chills, rash,
flushing, headache, or shortness of breath during an infusion of MONJUVI.
. . .
The most common side effects of MONJUVI when given with lenalidomide
in people with DLBCL include:
- respiratory
tract infection
- feeling
tired or weak
- diarrhea
- cough
- fever
- swelling
of lower legs or hands
- decreased
appetite
The most common side
effects of MONJUVI when given with lenalidomide and rituximab in people with FL
include:
- respiratory
tract infections
- diarrhea
- rash
- feeling
tired or weak
- muscle
and bone pain
- constipation
- cough
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