Rituxan Hycela

Last updated on RxList: 5/18/2020
Rituxan Hycela Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Rituxan Hycela?

Rituxan Hycela (rituximab and hyaluronidase human) injection is a combination of a CD20-directed cytolytic antibody and an endoglycosidase, indicated for the treatment of adult patients with: Follicular Lymphoma (FL), Diffuse Large B-cell Lymphoma (DLBCL), and Chronic Lymphocytic Leukemia (CLL).

What Are Side Effects of Rituxan Hycela?

Common side effects of Rituxan Hycela include:

Dosage for Rituxan Hycela

The dose of Rituxan Hycela depends on the condition being treated. All patients must receive at least one full dose of a rituximab product by intravenous infusion before receiving Rituxan Hycela by subcutaneous injection.

What Drugs, Substances, or Supplements Interact with Rituxan Hycela?

Rituxan Hycela may interact with other drugs and certain vaccines. Tell your doctor all medications and supplements you use and all vaccines you recently received.

Rituxan Hycela During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Rituxan Hycela; it may harm a fetus. Females who are able to become pregnant should use birth control during treatment and for 12 months after the last dose of Rituxan Hycela. It is unknown if Rituxan Hycela passes into breast milk. Women are advised not to breastfeed during treatment and for at least 6 months after the last dose of Rituxan Hycela due to the potential for serious adverse reactions in breastfed infants.

Additional Information

Our Rituxan Hycela (rituximab and hyaluronidase human) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Rituxan Hycela Consumer Information

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Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Some side effects may occur during the injection (or within 24 hours afterward). Tell your caregiver right away if you feel itchy, dizzy, weak, light-headed, short of breath, chilled, feverish, or if you have chest pain, wheezing, a sudden cough, or pounding heartbeats or fluttering in your chest.

Rituximab may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement.

Serious and sometimes fatal infections may occur during treatment with hyaluronidase and rituximab. Call your doctor right away if you have signs of infection such as:

  • fever, sore throat, cold or flu symptoms;
  • sores or white patches in your mouth or throat;
  • pain or burning when you urinate;
  • earaches, headaches; or
  • painful skin sores with redness, warmth, or swelling.

Call your doctor at once if you have any of these other side effects, even if they occur several months after your last dose of hyaluronidase and rituximab:

  • severe stomach pain, severe vomiting;
  • right-sided upper stomach pain, loss of appetite, yellowing of your skin or eyes, and not feeling well;
  • little or no urination;
  • skin or mouth sores, or a severe skin rash with blistering, peeling, or pus;
  • chest pain, irregular heartbeats;
  • low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet;
  • low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough, trouble breathing; or
  • signs of tumor cell breakdown--tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth.

Common side effects may include:

  • low blood cell counts;
  • nausea, vomiting, constipation;
  • hair loss;
  • feeling tired;
  • cough; or
  • redness where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Rituxan Hycela (Rituximab And Hyaluronidase Human Injection)

Rituxan Hycela Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Mucocutaneous reactions [see WARNINGS AND PRECAUTIONS]
  • Hepatitis B reactivation including fulminant hepatitis [see WARNINGS AND PRECAUTIONS]
  • Progressive multifocal leukoencephalopathy [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity and other administration reactions [see WARNINGS AND PRECAUTIONS]
  • Tumor lysis syndrome [see WARNINGS AND PRECAUTIONS]
  • Infections [see WARNINGS AND PRECAUTIONS]
  • Cardiac arrhythmias [see WARNINGS AND PRECAUTIONS]
  • Renal toxicity [see WARNINGS AND PRECAUTIONS]
  • Bowel obstruction and perforation [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The data described below reflect exposure to RITUXAN HYCELA in 892 patients in four controlled trials with exposures ranging from a single injection up to 27 months of treatment.

The population included 382 patients with follicular lymphoma (FL), 369 patients with diffuse large B-cell lymphoma (DLBCL), and 141 patients with chronic lymphocytic leukemia (CLL). The median age was 60 years (range: 18-85 years, 53% were male, and 84% were White. In the SABRINA study patients with FL received a full dose of a rituximab product by intravenous infusion, followed by RITUXAN HYCELA (1,400 mg rituximab/23,400 Units hyaluronidase human), in combination with chemotherapy for up to 7 doses (i.e., total of 8 doses in combination with chemotherapy), or as monotherapy for up to 12 doses (maintenance treatment). In the MabEase study patients with DLBCL received a full dose of a rituximab product by intravenous infusion, followed by RITUXAN HYCELA (1,400 mg rituximab/23,400 Units hyaluronidase human), given in combination with chemotherapy for up to 7 doses (i.e., up to a total of 8 doses). In the SAWYER study patients with CLL on part 2 received a full dose of a rituximab product by intravenous infusion, followed by RITUXAN HYCELA (1,600 mg rituximab/26,800 Units hyaluronidase human) for up to 5 doses, in combination with fludarabine and cyclophosphamide (i.e., total of 6 doses).

The most common adverse reactions (≥ 20%) of RITUXAN HYCELA observed in patients with FL on the SABRINA study were: infections, neutropenia, nausea, constipation, cough, and fatigue.

The most common adverse reactions (≥ 20%) of RITUXAN HYCELA observed in patients with DLBCL on the MabEase study were: infections, neutropenia, alopecia, nausea, and anemia.

The most common adverse reactions (≥ 20%) of RITUXAN HYCELA observed in patients with CLL on part 2 of the SAWYER study were: infections, neutropenia, nausea, thrombocytopenia, pyrexia, vomiting, and injection site erythema.

Administration-Related Reactions (ARRs)

Administration-related reactions (ARRs) with RITUXAN HYCELA were defined as all the adverse reactions related to the administration of RITUXAN HYCELA within the 24 hours post injection.

The incidence of ARRs with RITUXAN HYCELA was 34% in FL/DLBCL in combination with chemotherapy with injection site erythema (5%), chills (3%), dyspnea, erythema, flushing, injection site pain, nausea, pruritus, pyrexia, rash, and throat irritation (2% each) being the most common ARRs. The incidence of ARRs in FL maintenance setting was 20%. The most common ARRs were injection site erythema (7%), erythema (4%), injection site pain/edema, myalgia, and rash (2% each).

The incidence of ARRs with RITUXAN HYCELA in CLL was 44%.

With the exception of Local Cutaneous Reactions, the incidence and profile of adverse reactions reported for RITUXAN HYCELA were comparable with those for rituximab. The overall incidence of adverse reactions for intravenous rituximab versus RITUXAN HYCELA in combination with chemotherapy for FL/DLBCL was 93% versus 95% (BSA ≤ 1.73 m²), 89% versus 93% (1.73 < BSA ≤ 1.92 m²), and 94% versus 94% (BSA > 1.92 m²). The overall incidence of adverse reactions for rituximab versus RITUXAN HYCELA in CLL was 89% versus 100% (BSA ≤ 1.81 m²), 97% versus 88% (1.82 < BSA ≤ 1.99 m²), and 88% versus 93% (BSA > 2.00 m²).

Summary Of Clinical Trial Experience In Follicular Lymphoma (FL)

The data in Table 1 were obtained in the SABRINA study, a two-stage randomized, controlled study in patients with previously untreated FL. The study compared patients receiving RITUXAN HYCELA (1,400 mg rituximab/23,400 Units hyaluronidase human; n=197) with patients receiving a rituximab product by intravenous infusion (375 mg/m²; n=210), both in combination with CHOP or CVP followed by maintenance treatment with RITUXAN HYCELA or a rituximab product by intravenous infusion.

The majority of patients completed all 8 cycles of combination treatment with chemotherapy (91% RITUXAN HYCELA vs. 90% rituximab). In addition, 69% of patients in each of the treatment groups completed all 20 cycles of combination plus maintenance treatment. In both RITUXAN HYCELA and rituximab groups, patients experienced similar median duration of exposure (27.1 months for each arm).

Across the two stages, the overall demographics and baseline characteristics were balanced between the treatment groups. However, there were more female patients (53%) randomized in the study than male patients (47%) and a higher proportion of females were randomized to receive RITUXAN HYCELA (59% female) compared with the rituximab group (48%). The treatment groups in the combined Stage 1 and 2 population were otherwise balanced in regard to baseline demographics, characterized by a median age of 57 years (56.0 years [range 28-85 years] for RITUXAN HYCELA and 57 years [range 28-86 years] for rituximab) and median BSA of 1.83 m² (1.80 and 1.84 m² for RITUXAN HYCELA and rituximab, respectively).

The incidence of all adverse reactions was 96% for RITUXAN HYCELA vs. 95% for rituximab (Table 1). Grade 3-4 adverse reactions were reported in 55% of patients receiving RITUXAN HYCELA vs. 53% in patients receiving rituximab. Serious adverse reactions were reported in 37% of patients receiving RITUXAN HYCELA vs. 34% of patients receiving rituximab. The most common adverse reactions (occurring in ≥ 20% of patients in any arm) were infections, neutropenia, nausea, constipation, cough, and fatigue.

A total of 36 patients died, including 14/197 patients (7%) who received RITUXAN HYCELA and 22/210 patients (10%) who received rituximab. Of these 36 patients, 19 patients (7 patients RITUXAN HYCELA [4%] vs. 12 patients rituximab [6%]) died due to adverse reactions and 13 patients (6 patients RITUXAN HYCELA [3%] vs. 7 patients rituximab [3%]) died due to disease progression.

The incidence of administration-related reactions (ARRs) due to the subcutaneous route of administration associated with RITUXAN HYCELA was assessed in combination with chemotherapy and during maintenance. Thirty patients (15%) experienced an ARR during the first administration of RITUXAN HYCELA (Cycle 2). Incidence of ARRs generally decreased at subsequent cycles with 18 patients (9%) reporting ARR at Cycle 3, 13 patients (7%) at Cycle 4, 11 patients (6%) at Cycles 5 and 6, 12 patients (7%) at Cycle 7, and 8 patients (4%) at Cycle 8. During RITUXAN HYCELA monotherapy in the maintenance setting the incidence of ARRs at each cycle was ≤ 7% and was observed in 24 patients (14%) overall. Grade 1-2 ARRs constituted 96% of the overall ARRs. Grade 3 ARRs were reported during the first administration of RITUXAN HYCELA at Cycle 2 by 2 patients. Of the reported ARRs, local cutaneous reactions with RITUXAN HYCELA were reported in 32 patients. These events resolved within a median of 2 days from the onset (range 1 to 37 days). Majority of these reactions were Grade 1 and 2 and were observed in 31 patients (16%).

Table 1: Incidence of Adverse Reactions in ≥ 5% of Patients with Previously Untreated Follicular Lymphoma Receiving RITUXAN HYCELA or Rituximab in Combination with CHOP or CVP and as Monotherapy for Maintenance Treatment

Body System/Adverse ReactionsRITUXAN HYCELA
(n=197)
Rituximab
(n=210)
All Grades %Grade 3-4 %All Grades %Grade 3-4 %
Gastrointestinal Disorders
Nausea310220
Constipation25026< 1
Diarrhea18216< 1
Abdominal Pain14012< 1
Vomiting14012< 1
Dyspepsia8070
Stomatitis6050
Abdominal Pain Upper5050
General Disorders and Administration Site Conditions
Fatigue20018< 1
Asthenia171130
Pyrexia15< 116< 1
Injection Site Erythema13000
Injection Site Pain8000
Chills8090
Chest Pain6130
Edema Peripheral5< 160
Mucosal Inflammation516< 1
Influenza Like Illness3060
Infections
Upper Respiratory Tract Infection15< 1100
Pneumonia11542
Nasopharyngitis100100
Bronchitis8< 18< 1
Urinary Tract Infection8114< 1
Sinusitis7< 140
Conjunctivitis5050
Influenza406< 1
Blood and Lymphatic System Disorders
Neutropenia32262721
Anemia155130
Febrile Neutropenia8766
Leukopenia64112
Musculoskeletal and Connective Tissue Disorders
Arthralgia13< 1100
Bone Pain10< 180
Pain In Extremity10050
Back Pain9< 112< 1
Muscle Spasms8030
Myalgia8050
Nervous System Disorders
Paresthesia160120
Headache13090
Neuropathy Peripheral12214< 1
Dizziness7070
Skin and Subcutaneous Tissue Disorders
Alopecia14< 110< 1
Pruritus10012< 1
Rash10070
Erythema9050
Respiratory, Thoracic and Mediastinal Disorders
Cough23013< 1
Dyspnea11182
Oropharyngeal Pain9080
Psychiatric Disorders
Insomnia9090
Vascular Disorders
Hypertension6160

Summary Of Clinical Trial Experience In Diffuse Large B-Cell Lymphoma (DLBCL)

The data in Table 2 were obtained in the MabEASE study, a comparative, randomized, parallel-group, multicenter study to investigate the efficacy of RITUXAN HYCELA (1,400 mg rituximab and 23,400 Units hyaluronidase human; n=369) versus 375 mg/m² a rituximab product by intravenous infusion (n=203) both in combination with CHOP (R-CHOP) in previously untreated patients with CD20-positive DLBCL.

Eighty two percent of patients receiving RITUXAN HYCELA or rituximab completed all 8 cycles of study treatment. In both RITUXAN HYCELA and rituximab treatment groups, patients experienced 4.9 months median duration of rituximab exposure in each arm.

The demographic characteristics were balanced. Most patients were White (79%) and 54% were male. The median age was 64 years and median BSA was 1.83 m².

The incidences of adverse reactions of any grade (RITUXAN HYCELA [94%] vs. rituximab [92%]) (Table 2), Grade 3-4 adverse reactions (RITUXAN HYCELA [63%] vs. rituximab [57%]), and serious adverse reactions (RITUXAN HYCELA [42%] vs. rituximab [37%]) were generally comparable between the two treatment groups. The common adverse reactions (occurring in ≥ 20% of patients in any treatment group) were neutropenia, alopecia, nausea, and anemia.

A total of 91 patients (16%) died, including 58/369 patients (16%) in RITUXAN HYCELA and 33/203 patients (16%) in rituximab. Of these patients, 44 patients (29 patients RITUXAN HYCELA [8%] vs. 15 patients rituximab [7%]) died due to adverse reactions and 35 patients (22 patients RITUXAN HYCELA [6%] vs. 13 patients rituximab [6%]) died due to disease progression. Pneumonia (4 patients RITUXAN HYCELA vs. 1 patient rituximab), septic shock (2 patients RITUXAN HYCELA vs. 3 patients rituximab), and cardiac arrest (1 patient RITUXAN HYCELA vs. 3 patients rituximab) were the most common adverse reactions leading to death.

The incidence of administration-related reactions was balanced between the RITUXAN HYCELA and rituximab groups (28% vs. 29%). Grade 1-2 ARRs constituted 97% of the overall ARRs for the RITUXAN HYCELA arm and 80% for the rituximab arm. Of the reported ARRs, local cutaneous reactions with RITUXAN HYCELA were reported in 17 patients. These events resolved within a median of 2 days from the onset (range 1 to 32 days). Majority of these reactions were Grade 1 and 2 and were observed in 16 patients (4%).

Table 2: Incidence of Adverse Reactions in ≥ 5% of Patients with Previously Untreated DLBCL Receiving RITUXAN HYCELA or Rituximab in Combination with CHOP

Body System/Adverse ReactionsRITUXAN HYCELA + CHOP
(n=369)
Rituximab + CHOP
(n=203)
All Grades %Grade 3-4 %All Grades %Grade 3-4 %
Gastrointestinal Disorders
Nausea22< 124< 1
Constipation15< 117< 1
Diarrhea141101
Vomiting11< 18< 1
Abdominal Pain7< 17< 1
Stomatitis6< 150
Dyspepsia5070
General Disorders and Administration Site Conditions
Fatigue191151
Pyrexia13< 1130
Asthenia11< 112< 1
Mucosal Inflammation8< 181
Edema Peripheral8< 140
Infections
Pneumonia7342
Blood and Lymphatic System Disorders
Neutropenia31252919
Anemia235214
Febrile Neutropenia14141211
Leukopenia7373
Lymphopenia5163
Investigations
Neutrophil Count Decreased14111411
White Blood Cell Count Decreased7475
Weight Decreased8< 14< 1
Lymphocyte Count Decreased5232
Metabolism and Nutrition Disorders
Decreased Appetite8< 19< 1
Nervous System Disorders
Neuropathy Peripheral12< 1120
Paresthesia9< 160
Headache6070
Skin and Subcutaneous Tissue Disorders
Alopecia240240
Respiratory, Thoracic and Mediastinal Disorders
Cough11< 190
Dyspnea604< 1
Psychiatric Disorders
Insomnia7< 16< 1

Summary Of Clinical Trial Experience In Chronic Lymphocytic Leukemia

The data in Table 3 were obtained in part 2 of the SAWYER study, a two-part, comparative, randomized, parallel-group, multicenter study of RITUXAN HYCELA versus a rituximab product by intravenous infusion both in combination with fludarabine and cyclophosphamide (FC) chemotherapy in patients with previously untreated CLL.

The safety analysis population in part 2 of the study included 85 patients receiving RITUXAN HYCELA (1,600 mg rituximab/26,800 Units hyaluronidase human) and 89 patients receiving 500 mg/m² rituximab. In both RITUXAN HYCELA and rituximab groups, patients had similar median duration of rituximab exposure (4.9 vs. 4.7 months). The majority of patients received all 6 cycles of study treatment (86% RITUXAN HYCELA vs. 81% rituximab).

The patient population was predominantly White (96%) and male (65%), with a median age of 60 years and median BSA of 1.9 m² (1.97 and 1.86 m² for the RITUXAN HYCELA and intravenous rituximab groups, respectively). Overall, the treatment groups were balanced with respect to demographic characteristics, with the exception of more males in the RITUXAN HYCELA arm (71% RITUXAN HYCELA vs. 60% rituximab). Baseline disease characteristics were similar between the two groups. Over half of the patients (62%) had Binet Stage B disease and the majority had typical CLL characterizations (93%), with median time from first CLL diagnosis to randomization being 18.5 months.

The incidences of adverse reactions were balanced between the two treatment groups (96% RITUXAN HYCELA vs. 91% rituximab), and the common adverse reactions (occurring in ≥ 20% of patients in any arm) were infections, neutropenia, nausea, thrombocytopenia, pyrexia, anemia, vomiting, and injection site erythema. The incidences of Grade 3-4 adverse reactions were also balanced between the two treatment groups (69% RITUXAN HYCELA vs. 71% rituximab). The incidence of serious adverse reactions was 29% for RITUXAN HYCELA and 33% for rituximab. The incidence of administration-related reactions was 44% for RITUXAN HYCELA and 45% for rituximab). Of the reported ARRs, local cutaneous reactions with RITUXAN HYCELA were reported in 15 patients. These events resolved within a median of 6 days from the onset (range 3 to 29 days). Majority of these reactions were Grade 1 and 2 and were observed in 14 patients (16%).

A total of 9 patients (5%) died, including 5 patients in the RITUXAN HYCELA group and 4 patients in the rituximab group. In the RITUXAN HYCELA group, 1 patient died due to herpes zoster infection, 1 patient died as a result of progressive multifocal leukoencephalopathy (PML) (considered by the investigator as related to rituximab), and 3 patients died due to disease progression. In the rituximab group, 2 patients died due to diarrhea and listeriosis and 2 patients died due to disease progression.

Table 3: Incidence of Adverse Reactions in ≥ 5% of Patients with Previously Untreated CLL Receiving RITUXAN HYCELA or Rituximab in Combination with FC

Body System/Adverse ReactionsRITUXAN HYCELA + FC
(n=85)
Rituximab + FC
(n=89)
All Grades %Grade 3-4 %All Grades %Grade 3-4 %
Gastrointestinal Disorders
Nausea381350
Vomiting212221
Diarrhea120113
Abdominal Pain9060
Constipation8080
General Disorders and Administration Site Conditions
Pyrexia325251
Injection Site Erythema26200
Injection Site Pain16100
Chills130101
Fatigue110100
Asthenia81172
Infections
Upper Respiratory Tract Infection130121
Respiratory Tract Infection8141
Bronchitis7060
Urinary Tract Infection2081
Pneumonia2262
Blood and Lymphatic System Disorders
Neutropenia65565852
Thrombocytopenia246269
Leukopenia19141612
Anemia135249
Febrile Neutropenia11888
Musculoskeletal and Connective Tissue Disorders
Arthralgia9010
Pain In Extremity7120
Bone Pain6020
Nervous System Disorders
Headache7090
Skin and Subcutaneous Tissue Disorders
Erythema15070
Rash120101
Pruritus8040
Respiratory, Thoracic and Mediastinal Disorders
Cough130110
Oropharyngeal Pain6030
Dyspnea4081
Psychiatric Disorders
Insomnia1070
Vascular Disorders
Hypotension1071
Hypertension0061

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to RITUXAN HYCELA and rituximab in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.

In the SABRINA study, where previously untreated patients with follicular lymphoma were treated with RITUXAN HYCELA or rituximab in combination with CVP or CHOP, the incidence of treatment-induced/enhanced anti-rituximab antibodies in the RITUXAN HYCELA group was similar to that observed in the rituximab group (2.0% RITUXAN HYCELA vs. 1.9% rituximab). The incidence of treatment-induced/enhanced anti-recombinant human hyaluronidase antibodies was 15% in the RITUXAN HYCELA group compared with 8% in the rituximab group, and the overall proportion of patients found to have anti-recombinant human hyaluronidase antibodies remained generally constant over the follow-up period in both cohorts. All patients who tested positive for anti-recombinant human hyaluronidase antibodies at any point during the study were negative for neutralizing antibodies.

In the SAWYER study, where previously untreated patients with CLL were treated with RITUXAN HYCELA or rituximab in combination with FC, the incidence of treatment-induced/enhanced anti-rituximab antibodies was 12% in the RITUXAN HYCELA group and 15% in the rituximab group. The incidence of treatment-induced/enhanced anti- recombinant human hyaluronidase antibodies was 11% in the RITUXAN HYCELA treatment arm. None of the patients who tested positive for anti-recombinant human hyaluronidase antibodies tested positive for neutralizing antibodies.

The clinical relevance of the development of anti-rituximab or anti-recombinant human hyaluronidase antibodies after treatment with RITUXAN HYCELA is not known.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of rituximab-containing products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Hematologic: prolonged pancytopenia, marrow hypoplasia, Grade 3-4 prolonged or late-onset neutropenia, hyperviscosity syndrome in Waldenstrom's macroglobulinemia, prolonged hypogammaglobulinemia
  • Cardiac: fatal cardiac failure
  • Immune/Autoimmune Events: uveitis, optic neuritis, systemic vasculitis, pleuritis, lupus-like syndrome, serum sickness, polyarticular arthritis, and vasculitis with rash.
  • Infection: viral infections, including progressive multifocal leukoencephalopathy (PML), increase in fatal infections in HIV-associated lymphoma, and a reported increased incidence of Grade 3 and 4 infections
  • Neoplasia: disease progression of Kaposi's sarcoma.
  • Skin: severe mucocutaneous reactions, pyoderma gangrenosum (including genital presentation).
  • Gastrointestinal: bowel obstruction and perforation.
  • Pulmonary: fatal bronchiolitis obliterans and fatal interstitial lung disease.

Read the entire FDA prescribing information for Rituxan Hycela (Rituximab And Hyaluronidase Human Injection)

© Rituxan Hycela Patient Information is supplied by Cerner Multum, Inc. and Rituxan Hycela Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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