IMPORTANT SAFETY INFORMATION
BOXED WARNINGS: FATAL INFUSION-RELATED REACTIONS, SEVERE
MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION, PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY
- Infusion-Related Reactions: Rituximab product administration can result in serious, including
fatal, infusion-related reactions. Deaths within 24 hours of rituximab infusion have occurred.
Approximately 80% of fatal infusion-related reactions occurred in association with the first
infusion. Monitor patients closely. Discontinue RIABNI® infusion for severe reactions and
provide medical treatment for Grade
3 or 4 infusion-related reactions.
- Severe Mucocutaneous Reactions: Severe, including fatal, mucocutaneous reactions can occur in patients receiving rituximab products.
Discontinue RIABNI® in patients who experience a severe mucocutaneous reaction. The safety of readministration of RIABNI® to patients
with severe mucocutaneous reactions has not been determined.
- Hepatitis B Virus (HBV) Reactivation: HBV reactivation can occur in patients treated with
rituximab products, in some cases resulting in fulminant hepatitis, hepatic failure, and death.
Screen all patients for HBV infection before treatment initiation, and monitor patients during and
after treatment with RIABNI®. Discontinue RIABNI® and concomitant medications
in the event of HBV reactivation.
- Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving rituximab products.
Discontinue RIABNI® and consider discontinuation or reduction of any concomitant chemotherapy or immunosuppressive therapy in
patients who develop PML.
Warnings and Precautions
Infusion-Related Reactions (IRR)
- Rituximab products can cause severe, including fatal, infusion-related reactions. Severe reactions
typically occurred during the first infusion with time to onset of 30-120 minutes.
- Rituximab product-induced infusion-related reactions and sequelae include urticaria, hypotension,
angioedema, hypoxia, bronchospasm, pulmonary infiltrates, acute respiratory distress syndrome,
myocardial infarction, ventricular fibrillation, cardiogenic shock, anaphylactoid events, or death.
- Premedicate patients with an antihistamine and acetaminophen prior to dosing. For patients with
Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis
(MPA), methylprednisolone 100 mg intravenously or its equivalent is recommended 30 minutes prior to each
infusion. Institute medical management (eg, glucocorticoids, epinephrine, bronchodilators, or oxygen)
for infusion-related reactions as needed. Depending on the severity of the infusion-related reaction and
the required interventions, temporarily or permanently discontinue RIABNI®. Resume infusion
at a minimum of 50% reduction in rate after symptoms have resolved.
- Closely monitor the following patients: those with pre-existing cardiac or pulmonary conditions, those
who experienced prior cardiopulmonary adverse reactions, and those with high numbers of circulating
malignant cells (≥25,000/mm3).
Severe Mucocutaneous Reactions
- Mucocutaneous reactions, some with fatal outcome, can occur in patients receiving rituximab products.
These reactions include paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis,
vesiculobullous dermatitis, and toxic epidermal necrolysis.
- The onset of these reactions has been variable and includes reports with onset on the first day of
rituximab exposure. Discontinue RIABNI® in patients who experience a severe mucocutaneous
reaction. The safety of readministration of rituximab products to patients with severe mucocutaneous
reactions has not been determined.
Hepatitis B Virus (HBV) Reactivation
- Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure,
and death, can occur in patients treated with drugs classified as CD20-directed cytolytic antibodies,
including rituximab products. Cases have been reported in patients who are hepatitis B surface antigen
(HBsAg) positive and also in patients who are HBsAg negative but are hepatitis B core antibody
(anti-HBc) positive. Reactivation also has occurred in patients who appear to have resolved hepatitis B
infection (i.e., HBsAg negative, anti-HBc positive and hepatitis B surface antibody [anti-HBs]
positive).
- HBV reactivation is defined as an abrupt increase in HBV replication manifesting as a rapid increase in
serum HBV DNA level or detection of HBsAg in a person who was previously HBsAg negative and anti-HBc
positive. Reactivation of HBV replication is often followed by hepatitis, i.e., increase in transaminase
levels. In severe cases, increase in bilirubin levels, liver failure, and death can occur.
- Screen all patients for HBV infection by measuring HBsAg and anti-HBc before initiating treatment with
RIABNI®. For patients who show evidence of prior hepatitis B infection (HBsAg positive
[regardless of antibody status] or HBsAg negative but anti-HBc positive), consult with physicians with
expertise in managing hepatitis B regarding monitoring and consideration for HBV antiviral therapy
before and/or during RIABNI® treatment.
- Monitor patients with evidence of current or prior HBV infection for clinical and laboratory signs of
hepatitis or HBV reactivation during and for several months following RIABNI® therapy. HBV
reactivation has been reported up to 24 months following completion of rituximab therapy.
- In patients who develop reactivation of HBV while on RIABNI®, immediately discontinue
RIABNI® and any concomitant chemotherapy, and institute appropriate treatment. Insufficient
data exist regarding the safety of resuming rituximab product treatment in patients who develop HBV
reactivation. Resumption of RIABNI® treatment in patients whose HBV reactivation resolves
should be discussed with physicians with expertise in managing HBV.
Progressive Multifocal Leukoencephalopathy (PML)
- JC virus infection resulting in multifocal leukoencephalopathy (PML) and death can occur in rituximab
product-treated patients with hematologic malignancies or with autoimmune diseases. The majority of
patients with hematologic malignancies diagnosed with PML received rituximab in combination with
chemotherapy or as part of a hematopoietic stem cell transplant. The patients with autoimmune diseases
had prior or concurrent immunosuppressive therapy. Most cases of PML were diagnosed within 12 months of
their last infusion of rituximab.
- Consider the diagnosis of PML in any patient presenting with new-onset neurologic manifestations.
Evaluation of PML includes, but is not limited to, consultation with a neurologist, brain MRI, and
lumbar puncture. Discontinue RIABNI® and consider discontinuation or reduction of any
concomitant chemotherapy or immunosuppressive therapy in patients who develop PML.
Tumor Lysis Syndrome (TLS)
-
Acute renal failure, hyperkalemia, hypocalcemia, hyperuricemia, or hyperphosphatemia from tumor lysis,
some
fatal, can occur within 12−24 hours after the first infusion of RIABNI® in patients with
non-Hodgkin’s
lymphoma (NHL). A high number of circulating malignant cells (≥25,000/mm3), or high tumor
burden,
confers a greater risk of TLS.
-
Administer aggressive intravenous hydration and anti-hyperuricemic therapy in patients at high risk for
TLS.
Correct electrolyte abnormalities, monitor renal function and fluid balance, and administer supportive
care,
including dialysis as indicated.
Infections
- Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can occur during
and following the completion of rituximab product-based therapy. Infections have been reported in some
patients with prolonged hypogammaglobulinemia (defined as hypogammaglobulinemia >11 months after
rituximab exposure).
- New or reactivated viral infections included cytomegalovirus, herpes simplex virus, parvovirus B19,
varicella zoster virus, West Nile virus, and hepatitis B and C. Discontinue RIABNI® for
serious infections and institute appropriate anti-infective therapy.
- RIABNI® is not recommended for use in patients with severe, active infections.
Cardiovascular Adverse Reactions
- Cardiac adverse reactions, including ventricular fibrillation, myocardial infarction, and cardiogenic
shock may occur in patients receiving rituximab products. Discontinue infusions for serious or
life-threatening cardiac arrhythmias. Perform cardiac monitoring during and after all infusions of
RIABNI® for patients who develop clinically significant arrhythmias, or who have a history of
arrhythmia or angina.
Renal Toxicity
- Severe, including fatal, renal toxicity can occur after rituximab product administration in patients
with NHL. Renal toxicity has occurred in patients who experience TLS and in patients with NHL
administered concomitant cisplatin therapy during clinical trials. The combination of cisplatin and
RIABNI® is not an approved treatment regimen. Monitor closely for signs of renal failure and
discontinue RIABNI® in patients with a rising serum creatinine or oliguria.
Bowel Obstruction and Perforation
- Abdominal pain, bowel obstruction and perforation, in some cases leading to death, can occur in patients
receiving rituximab products in combination with chemotherapy. In postmarketing reports, the mean time
to documented gastrointestinal perforation was 6 (range 1−77) days in patients with NHL. Evaluate
if symptoms of obstruction such as abdominal pain or repeated vomiting occur.
Immunization
- The safety of immunization with live viral vaccines following rituximab product therapy has not been
studied, and vaccination with live virus vaccines is not recommended before or during treatment.
-
For patients treated with RIABNI®, physicians should review the patient’s vaccination status and
patients should, if possible, be brought up to date with all immunizations in agreement with current
immunization guidelines prior to initiating RIABNI®; administer non-live vaccines at least 4 weeks prior
to a course of RIABNI®.
- The effect of rituximab products on immune responses was assessed in a randomized, controlled study in
patients with RA treated with rituximab and methotrexate (MTX) compared to patients treated with MTX
alone.
- A response to pneumococcal vaccination (a T-cell independent antigen) as measured by an increase in
antibody titers to at least 6 of 12 serotypes was lower in patients treated with rituximab plus MTX as
compared to patients treated with MTX alone (19% vs 61%). A lower proportion of patients in the
rituximab plus MTX group developed detectable levels of anti-keyhole limpet hemocyanin antibodies (a
novel protein antigen) after vaccination compared to patients on MTX alone (47% vs 93%).
- A positive response to tetanus toxoid vaccine (a T-cell dependent antigen with existing immunity) was
similar in patients treated with rituximab plus MTX compared to patients on MTX alone (39% vs 42%). The
proportion of patients maintaining a positive Candida skin test (to evaluate delayed type
hypersensitivity) was also similar (77% of patients on rituximab plus MTX vs 70% of patients on MTX
alone).
- Most patients in the rituximab-treated group had B-cell counts below the lower limit of normal at the
time of immunization. The clinical implications of these findings are not known.
Embryo-Fetal Toxicity
- Based on human data, rituximab products can cause fetal harm due to B-cell lymphocytopenia in infants
exposed in utero. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive
potential to use effective contraception with RIABNI® and for 12 months after the last dose.
Concomitant Use with Biologic Agents and DMARDs Other Than MTX
- Limited data are available on the safety of the use of biologic agents or DMARDs other than MTX in RA patients exhibiting peripheral
B-cell depletion following treatment with rituximab. Observe patients closely for signs of infection if biologic agents and/or DMARDs
are used concomitantly. Use of concomitant immunosuppressants other than corticosteroids has not been studied in GPA, MPA, or PV
patients exhibiting peripheral B-cell depletion following treatment with rituximab products.
Use in Patients With RA Who Had No Prior Inadequate Response to Tumor Necrosis Factor (TNF) Antagonists
- While the efficacy of rituximab was supported in 4 controlled trials in patients with RA with prior inadequate responses to nonbiologic
DMARDs and in a controlled trial in MTX-naïve patients, a favorable risk-benefit relationship has not been established in these populations.
The use of RIABNI® in patients with RA who have not had prior inadequate response to one or more TNF antagonists is not recommended.
Additional Important Safety Information
Adverse Reactions
Clinical Trials Experience in NHL and CLL
- The most common Grade 3 or 4 adverse reactions in clinical trials of NHL and chronic lymphocytic
leukemia (CLL) were infusion-related reactions, neutropenia, leukopenia, anemia, thrombocytopenia, and
infections. Additionally, lymphopenia and lung disorder were seen in NHL trials; and febrile
neutropenia, pancytopenia, hypotension, and hepatitis B were seen in CLL trials.
- The most common adverse reactions (incidence ≥25%) in clinical trials of NHL and CLL were
infusion-related reactions. Additionally, fever, lymphopenia, chills, infection, and asthenia were seen
in NHL trials; and neutropenia was seen in CLL trials.
Clinical Trials Experience in RA
- Among all exposed patients, adverse reactions reported in greater than 10% of patients include
infusion-related reactions, upper respiratory tract infection, nasopharyngitis, urinary tract infection,
and bronchitis.
- In placebo-controlled studies, adverse reactions reported in ≥5% of patients were hypertension (8% vs
5%), nausea (8% vs 5%), upper respiratory tract infection (7% vs 6%), arthralgia (6% vs 4%), pyrexia (5%
vs 2%), and pruritus (5% vs 1%) of rituximab-treated vs placebo, respectively.
Infusion-Related Reactions
- In the rituximab RA pooled, placebo-controlled studies, incidence of any adverse event within 24
hours of an infusion was 32% vs 23% after the first infusion, and 11% vs 13% after the second
infusion in the rituximab-treated patients and placebo group, respectively. Incidence of acute
infusion-related reactions was 27% vs 19% after the first infusion, 9% vs 11% after the second
infusion in the rituximab-treated patients and placebo group, respectively.
- Serious acute infusion-related reactions were experienced by <1% of patients in either treatment
group. Acute infusion-related reactions required dose modification (stopping, slowing, or
interruption of the infusion) in 10% and 2% of patients receiving rituximab or placebo,
respectively, after the first course.
Infections
- In the pooled, placebo controlled studies, incidence of any type of infection was 39% vs 34%,
rituximab-treated vs placebo. The most common infections were nasopharyngitis, upper respiratory
tract infections, urinary tract infections, bronchitis, and sinusitis. The incidence of serious
infections was 2% vs 1%, rituximab-treated vs placebo group.
- In the experience with rituximab in 2578 RA patients, the rate of serious infection was 4.31 per 100
patient-years. The most common serious infections (≥0.5%) were pneumonia or lower respiratory
tract infections, cellulitis, and urinary tract infections. Fatal serious infections included
pneumonia, sepsis, and colitis. Rates of serious infection remain stable in patients receiving
subsequent courses.
- In 185 rituximab-treated RA patients with active disease, subsequent treatment with a biologic
DMARD, the majority of which were TNF antagonists, did not appear to increase the rate of serious
infection.
Cardiovascular Adverse Reactions
- In the pooled, placebo-controlled studies, incidence of serious cardiovascular reactions was 1.7% vs
1.3% rituximab-treated vs placebo. Three cardiovascular deaths occurred during the double-blind
period of the RA studies including all rituximab regimens (3/769=0.4%) compared to none in the
placebo treatment group (0/389).
- In the experience with rituximab in 2578 RA patients, the rate of myocardial infarction (MI) was
consistent with MI rates in the general RA population. RIABNI® should be discontinued in
the event of a serious or life-threatening cardiac event.
Hypophosphatemia and Hyperuricemia
- In the pooled, placebo-controlled studies, newly occurring hypophosphatemia (<2.0 mg/dL) was 12%
vs 10%, rituximab-treated vs placebo, respectively. Hypophosphatemia was more common in patients who
received corticosteroids. Newly occurring hyperuricemia (>10 mg/dL) was observed in 1.5% vs 0.3%,
rituximab-treated vs placebo, respectively.
Retreatment in Patients With RA
- In the experience with rituximab in RA patients, 2578 patients have been exposed to rituximab and
have received up to 10 courses of rituximab in RA clinical trials, with 1890, 1043, and 425 patients
having received at least 2, 3, and 4 courses, respectively. Most of the patients who received
additional courses did so 24 weeks or more after the previous course and none were retreated sooner
than 16 weeks. The rates and types of adverse reactions reported for subsequent courses of rituximab
were similar to rates and types seen for a single course of rituximab. In RA Study 2, where all
patients initially received rituximab, the safety profile of patients who were retreated with
rituximab was similar to those who were retreated with placebo.
Immunogenicity
- A total of 273/2578 (11%) patients with RA tested positive for anti-rituximab antibodies at any time
after receiving rituximab. Anti-rituximab antibody positivity was not associated with increased
infusion-related reactions or other adverse reactions. Upon further treatment, the proportions of
patients with infusion-related reactions were similar between anti-rituximab antibody positive and
negative patients, and most reactions were mild to moderate.
- Four anti-rituximab antibody positive patients had serious infusion-related reactions, and the
temporal relationship between anti-rituximab antibody positivity and infusion-related reaction was
variable. The clinical relevance of anti-rituximab antibody formation in rituximab-treated patients
is unclear.
Clinical Trials Experience in GPA and MPA
- Adverse reactions reported in ≥15% of rituximab-treated patients were infections, nausea, diarrhea,
headache, muscle spasms, anemia, peripheral edema, infusion-related reactions.
Induction Treatment of Patients with Active GPA/MPA (GPA/MPA Study 1)
Infusion-Related Reactions
- In GPA/MPA Study 1, 12% vs 11% (rituximab-treated vs cyclophosphamide) of patients experienced at
least one infusion-related reaction. Infusion-related reactions included cytokine release syndrome,
flushing, throat irritation, and tremor. In the rituximab group, the proportion of patients
experiencing an infusion-related reaction was 12%, 5%, 4%, and 1% following the first, second,
third, and fourth infusions, respectively. Patients were premedicated with antihistamine and
acetaminophen before each rituximab infusion and were on background oral corticosteroids, which may
have mitigated or masked an infusion-related reaction; however, there is insufficient evidence to
determine whether premedication diminishes the frequency or severity of infusion-related reactions.
Infections
- In GPA/MPA Study 1, 62% vs 47% (rituximab-treated vs cyclophosphamide-treated, respectively) of
patients experienced an infection by Month 6. The most common infections in the rituximab group were
upper respiratory tract infections, urinary tract infections, and herpes zoster. The incidence of
serious infections was 11% vs 10% (rituximab-treated vs cyclophosphamide, respectively), with rates
of approximately 25 and 28 per 100 patient-years, respectively. The most common serious infection
was pneumonia.
Hypogammaglobulinemia
- Hypogammaglobulinemia (IgA, IgG, or IgM below the lower limit of normal) has been observed in
patients with GPA and MPA treated with rituximab in GPA/MPA Study 1. At 6 months, in the rituximab
group, 27%, 58%, and 51% of patients with normal immunoglobulin levels at baseline had low IgA, IgG,
and IgM levels, respectively compared to 25%, 50%, and 46% in cyclophosphamide group.
Immunogenicity
- A total of 23/99 (23%) rituximab-treated patients with GPA or MPA tested positive for anti-rituximab
antibodies by 18 months in GPA/MPA Study 1. The clinical relevance of anti-rituximab antibody
formation in rituximab-treated patients is unclear.
Treatment of Patients with GPA/MPA who have Achieved Disease Control with Induction Treatment (GPA/MPA Study
2)
- In GPA/MPA Study 2, the safety profile was consistent with the known safety profile of rituximab in
immunologic indications.
Infusion-Related Reactions
- In GPA/MPA Study 2, 7/57 (12%) patients in the non-U.S.-licensed rituximab arm reported
infusion-related reactions. The incidence of IRR symptoms was highest during or after the first
infusion (9%) and decreased with subsequent infusions (<4%). One patient had two serious IRRs,
two IRRs led to a dose modification, and no IRRs were severe, fatal, or led to withdrawal from the
study.
Infections
- In GPA/MPA Study 2, 30/57 (53%) patients in the non-U.S.-licensed rituximab arm and 33/58 (57%) in
the azathioprine arm reported infections. The incidence of all grade infections was similar between
the arms. The incidence of serious infections was similar in both arms (12%). The most commonly
reported serious infection in the group was mild or moderate bronchitis.
Clinical Trials Experience in Pemphigus Vulgaris (PV)
-
Adverse reactions reported in ≥15% of rituximab-treated patients were infusion-related reactions, depression, upper respiratory tract
infection/ nasopharyngitis, headache (other important adverse reactions include infections)
PV Study 1
-
The clinical study did not include sufficient number of patients to allow for direct comparison of adverse reaction rates between
treatment groups. The safety profile of the non-U.S.-licensed rituximab in patients with PV was consistent with that observed in patients
with rituximab treated RA and GPA and MPA.
Infusion-Related Reactions
- In PV Study 1, 22/38 (58%) patients in the non-U.S.-licensed rituximab + short term prednisone arm reported infusion-related reactions.
The proportion of patients experiencing an infusion-related reaction for the first, second, third, and fourth infusions was 29%, 40%, 13%,
and 10%, respectively. One patient had a serious IRR (arthralgia) associated with the Month 12 maintenance infusion. No patients in the
group treated with non-U.S.-licensed rituximab withdrew due to adverse reactions.
Infections
- In PV Study 1, 14/38 (37%) patients in the non-U.S.-licensed rituximab + short term prednisone arm experienced treatment-related
infections compared to 15/36 (42%) patients in the prednisone group. The most common infections in the group treated with non-U.S.-
licensed rituximab were herpes simplex, herpes zoster, bronchitis, urinary tract infection, fungal infection, and conjunctivitis. Three
patients (8%) in the group treated with non-U.S.-licensed rituximab experienced a total of 5 serious infections (Pneumocystis jirovecii
pneumonia, infective thrombosis, intervertebral discitis, lung infection, Staphylococcal sepsis) and 1 patient (3%) in the prednisone group
experienced 1 serious infection (Pneumocystis jirovecii pneumonia).
PV Study 2
Infusion-Related Reactions
- In PV Study 2, infusion-related reactions occurred primarily at the first infusion and frequency decreased with subsequent infusions. The
proportion of patients experiencing an infusion-related reaction for the first, second, third, and fourth infusion was 17.9%, 4.7%, 3.5%, and
3.5%, respectively.
- In 11/15 patients who experienced at least one IRR, the IRRs were Grade 1 or 2. In 4/15 patients, Grade ≥ 3 infusion-related reactions were
reported and led to discontinuation of rituximab treatment; three of the four patients experienced serious [life-threatening] infusionrelated
reactions. Serious infusion-related reactions occurred at the first (2 patients) or second (1 patient) infusion and resolved with
symptomatic treatment.
Infections
- In PV Study 2, 42/67 patients (62.7%) in the rituximab arm experienced infections. The most common infections in the rituximab arm
were upper respiratory tract infection, nasopharyngitis, oral candidiasis and urinary tract infection. Six patients (9%) in the rituximab arm
experienced serious infections.
Laboratory Abnormalities
- In PV Study 2, in the rituximab arm, transient decreases in T-cell lymphocytes and phosphorus level were very commonly observed postinfusion.
In some cases, treatment of hypophosphatemia was required.
- Hypogammaglobulinemia (IgG or IgM below the lower limit of normal), including prolonged hypogammaglobulinemia (defined as Ig
levels below lower limit of normal for at least 4 months) was observed in PV Study 2. Based on levels below the lower limit of normal
measured at Week 16, Week 24, Week 40, and Week 52, 16.4% (11/67) of patients with normal baseline immunoglobulins had prolonged
hypogammaglobulinemia (10 patients – IgM, 1 patient – both IgG and IgM) after treatment with rituximab.
Pregnancy and Nursing Mothers
- Based on human data, rituximab products can cause adverse developmental outcomes including B-cell
lymphocytopenia in infants exposed in utero. Advise pregnant women of the risk to a fetus. There are
limited data on the presence of rituximab products in human milk and the effect on the breastfed child,
and there are no data on the effect on milk production. Rituximab is detected in the milk of lactating
cynomolgus monkeys, and maternal IgG is present in human breast milk. Rituximab has also been reported
to be excreted at low concentrations in human breast milk. Given that the clinical significance of this
finding for children is not known, advise women not to breastfeed during treatment with
RIABNI® and for 6 months after the last dose due to the potential for serious adverse
reactions in breastfed children.
Attention Healthcare Provider: Provide Medication Guide to patient prior to
RIABNI® infusion and advise patients to read guide.
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to
Amgen at 1-800-772-6436.
Please see the full Prescribing
Information, including BOXED WARNINGS and Medication Guide, for additional
Important Safety Information.
Indications
Non-Hodgkin’s Lymphoma (NHL)
RIABNI® (rituximab-arrx) is indicated for the treatment of adult patients with:
- Relapsed or refractory, low‑grade or follicular, CD20‑positive, B‑cell NHL as a single agent.
- Previously untreated follicular, CD20‑positive, B‑cell NHL in combination with first line chemotherapy
and, in patients achieving a complete or partial response to a rituximab product in combination with
chemotherapy, as single‑agent maintenance therapy.
- Non‑progressing (including stable disease), low‑grade, CD20‑positive, B‑cell NHL as a single agent after
first‑line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
- Previously untreated diffuse large B‑cell, CD20‑positive NHL in combination with cyclophosphamide,
doxorubicin, vincristine, prednisone (CHOP) or other anthracycline‑based chemotherapy regimens.
Chronic Lymphocytic Leukemia (CLL)
- RIABNI®, in combination with fludarabine and cyclophosphamide (FC), is indicated
for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL.
Rheumatoid Arthritis (RA)
- RIABNI®, in combination with methotrexate, is indicated for the treatment of adult patients
with moderately- to severely- active rheumatoid arthritis who have had an inadequate response to one or
more TNF antagonist therapies.
Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA)
- RIABNI®, in combination with glucocorticoids, is indicated for the treatment of
adult patients with Granulomatosis and Polyangiitis (GPA) (Wegener’s Granulomatosis) and
Microscopic Polyangiitis (MPA).
Pemphigus Vulgaris (PV)
- RIABNI® is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris (PV).
RIABNI® is a registered trademark of Amgen Inc.
Rituxan® is a registered trademark of Biogen.
Truxima® is a registered trademark of Teva Pharmaceuticals.
Ruxience® is a trademark of Pfizer.
