Common Rituxan Side Effects


The most commonly reported Rituxan side effects (click to view or check a box to report):

Pyrexia (207)
Infusion Related Reaction (194)
White Blood Cell Count Decreased (192)
Dyspnoea (178)
Progressive Multifocal Leukoencephalopathy (172)
Death (149)
Neutropenia (147)
Pneumonia (138)
Chills (134)
Nausea (119)
Platelet Count Decreased (113)
Fatigue (105)
Arthralgia (102)
Hypotension (97)
Neutrophil Count Decreased (96)
Febrile Neutropenia (93)
Haemoglobin Decreased (89)
Vomiting (84)
Headache (79)
Asthenia (76)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Rituxan Side Effects Reported to FDA



Rituxan Side Effect Report#9999106
Ulcer Haemorrhage, Hypertension, Hemiparesis, Ear Infection, Bronchitis, Influenza, Fall, Weight Decreased, Recurrent Cancer
This is a report of a male patient (weight: NA) from US, suffering from the following health symptoms/conditions: basal cell carcinoma,non-hodgkin^s lymphoma, who was treated with Rituxan (dosage: NA, start time: 2012), combined with: NA. and developed a serious reaction and side effect(s): Ulcer Haemorrhage, Hypertension, Hemiparesis, Ear Infection, Bronchitis, Influenza, Fall, Weight Decreased, Recurrent Cancer after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Rituxan treatment in male patients, resulting in Ulcer Haemorrhage side effect. The patient was hospitalized.
Rituxan Side Effect Report#9994862
Infusion Related Reaction, Hypotension, Pyrexia, Chills, Back Pain, Mental Status Changes, Pallor
This report suggests a potential Rituxan (rituximab) Infusion Related Reaction side effect(s) that can have serious consequences. A 70-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Rituxan (rituximab) (dosage: Most Recent Dose On 25/mar/2013) starting NS. After starting Rituxan (rituximab) the patient began experiencing various side effects, including: Infusion Related Reaction, Hypotension, Pyrexia, Chills, Back Pain, Mental Status Changes, PallorAdditional drugs used concurrently: NA. Although Rituxan (rituximab) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Infusion Related Reaction, may still occur.
Rituxan Side Effect Report#9994569
Thrombosis, Wound, Off Label Use
This Thrombosis problem was reported by a physician from CA. A 30-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: thrombotic thrombocytopenic purpura. On
Jan 23, 2014 this consumer started treatment with Rituxan (dosage: NA). The following drugs were being taken at the same time:
  • Tylenol
  • Benadryl (canada)
  • Solu-medrol
  • Ramipril
  • Eltroxin
  • Asa
When using Rituxan, the patient experienced the following unwanted symptoms/side effects: Thrombosis, Wound, Off Label UseThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Thrombosis, may become evident only after a product is in use by the general population.
Rituxan Side Effect Report#9994349
Platelet Count Decreased, Immune Thrombocytopenic Purpura, Platelet Count Increased, Paraesthesia Oral, Hypersensitivity, Off Label Use
This Platelet Count Decreased side effect was reported by a pharmacist from CA. A 36-year-old female patient (weight:NA) experienced the following symptoms/conditions: immune thrombocytopenic purpura.The patient was prescribed Rituxan (drug dosage: 1st Rpap Dose, Last Infusion On 06/mar/2014), which was initiated on NS. Concurrently used drugs: NA..After starting to take Rituxan the consumer reported adverse symptoms, such as: Platelet Count Decreased, Immune Thrombocytopenic Purpura, Platelet Count Increased, Paraesthesia Oral, Hypersensitivity, Off Label UseThese side effects may potentially be related to Rituxan. The patient was hospitalized.
Rituxan Side Effect Report#9994343
Viith Nerve Paralysis, Scoliosis, Nasopharyngitis, Weight Decreased
This is a report of a 79-year-old male patient (weight: NA) from CA, suffering from the following health symptoms/conditions: rheumatoid arthritis,blood pressure, who was treated with Rituxan (dosage: NA, start time:
Sep 02, 2010), combined with:
  • Adalat
  • Prednisone
  • Meloxicam
  • Aspirin
  • Pariet
  • Vitamin C
  • Vitamin E
  • Vitamin B12
and developed a serious reaction and side effect(s): Viith Nerve Paralysis, Scoliosis, Nasopharyngitis, Weight Decreased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Rituxan treatment in male patients, resulting in Viith Nerve Paralysis side effect.
Rituxan Side Effect Report#9990660
Flushing, Feeling Hot, Rash, Rash
This report suggests a potential Rituxan Flushing side effect(s) that can have serious consequences. A 66-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: waldenstrom^s macroglobulinaemia and used Rituxan (dosage: D 1, 8, 15, + 22) starting
Feb 10, 2014. After starting Rituxan the patient began experiencing various side effects, including: Flushing, Feeling Hot, Rash, RashAdditional drugs used concurrently:
  • Velcade
Although Rituxan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Flushing, may still occur.
Rituxan Side Effect Report#9988723
Infusion Related Reaction, Off Label Use
This Infusion Related Reaction problem was reported by a health professional from CA. A 27-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: pemphigus. On
Mar 03, 2014 this consumer started treatment with Rituxan (dosage: Frequency: Day 1 And 15). The following drugs were being taken at the same time:
  • Cellcept
  • Acetaminophen
  • Methylprednisolone
  • Prednisone
  • Kenalog In Orabase
When using Rituxan, the patient experienced the following unwanted symptoms/side effects: Infusion Related Reaction, Off Label UseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Infusion Related Reaction, may become evident only after a product is in use by the general population.
Rituxan Side Effect Report#9988103
Knee Arthroplasty, Device Related Infection
This Knee Arthroplasty side effect was reported by a physician from US. A 50-year-old male patient (weight:NA) experienced the following symptoms/conditions: rheumatoid arthritis.The patient was prescribed Rituxan (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Rituxan the consumer reported adverse symptoms, such as: Knee Arthroplasty, Device Related InfectionThese side effects may potentially be related to Rituxan.
Rituxan Side Effect Report#9982191
Myocardial Infarction
This is a report of a 82-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: lymphoma, who was treated with Rituxan (rituximab) (dosage: 698 Unit Not Reported, 1 In 21 D, start time:
Mar 26, 2013), combined with:
  • Cyclophosphamide
  • Prednisone
  • Vincristine
  • Doxorubicin (doxorubicin/doxorubicin Hydrochloride, Doxorubicin)
  • Saha (vorinostat)
and developed a serious reaction and side effect(s): Myocardial Infarction after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Rituxan (rituximab) treatment in male patients, resulting in Myocardial Infarction side effect. The patient was hospitalized.
Rituxan Side Effect Report#9982053
Pain In Extremity, Herpes Virus Infection, Nipple Exudate Bloody, Breast Pain, Axillary Pain, Breast Disorder, Nausea, Local Swelling, Local Swelling
This report suggests a potential Rituxan Pain In Extremity side effect(s) that can have serious consequences. A 59-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: rheumatoid arthritis and used Rituxan (dosage: NA) starting NS. After starting Rituxan the patient began experiencing various side effects, including: Pain In Extremity, Herpes Virus Infection, Nipple Exudate Bloody, Breast Pain, Axillary Pain, Breast Disorder, Nausea, Local Swelling, Local SwellingAdditional drugs used concurrently: NA. Although Rituxan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pain In Extremity, may still occur.
Rituxan Side Effect Report#9982019
Pyrexia, Cough, Dyspnoea
This Pyrexia problem was reported by a health professional from US. A 81-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: chronic lymphocytic leukaemia. On
Jan 22, 2013 this consumer started treatment with Rituxan (rituximab) (100 Mg) (dosage: 600 Mg, 1 In 28 D, Intravenous). The following drugs were being taken at the same time:
  • Bendamustine (bendamustine) (bendamustine)
When using Rituxan (rituximab) (100 Mg), the patient experienced the following unwanted symptoms/side effects: Pyrexia, Cough, DyspnoeaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pyrexia, may become evident only after a product is in use by the general population.
Rituxan Side Effect Report#9981989
Hypotension
This Hypotension side effect was reported by a consumer or non-health professional from US. A 61-year-old female patient (weight:NA) experienced the following symptoms/conditions: chronic lymphocytic leukaemia.The patient was prescribed Rituxan (rituximab) (infusion, Solution) (drug dosage: Day 3 (563 Mg), Intravenous (not Otherwise Specified)), which was initiated on
Mar 19, 2013. Concurrently used drugs:
  • Bendamustine (bendamustine) (bendamustine) ((105 Mg), Intravenous (not Otherwise Specified)?)
  • Tylenol (paracetamol) (30 Min Prior (650 Mg), Oral)
  • Ondansetron (ondansetron)
  • Dexamethasone (dexamethasone)
  • Diphenhydramine (diphenhydramine Nos)
.After starting to take Rituxan (rituximab) (infusion, Solution) the consumer reported adverse symptoms, such as: HypotensionThese side effects may potentially be related to Rituxan (rituximab) (infusion, Solution). The patient was hospitalized.
Rituxan Side Effect Report#9981968
Chills
This is a report of a 57-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: immune thrombocytopenic purpura, who was treated with Rituxan (dosage: 900mg, Weekly X 4 Intravenous, start time:
Feb 06, 2013), combined with:
  • Tylenol (paracetamol)
  • Lisinopril (lisinopril)
  • Clonidine (clonidine)
  • Benadryl (diphenhydramine Hydrochloride)
  • Amlodipine (amlodipine)
  • Vicodin (hydrocodone Tartrate Paracetamol) (tablet)
  • Metronidazole (metronidazole)
  • Sildenafil (sildenafil Citrate)
and developed a serious reaction and side effect(s): Chills after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Rituxan treatment in male patients, resulting in Chills side effect.
Rituxan Side Effect Report#9981890
Respiratory Distress, Hypersensitivity
This report suggests a potential Rituxan Respiratory Distress side effect(s) that can have serious consequences. A 66-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: diffuse large b-cell lymphoma and used Rituxan (dosage: 635mg, 1 In 2 Wk, Intravenous) starting
Dec 02, 2012. After starting Rituxan the patient began experiencing various side effects, including: Respiratory Distress, HypersensitivityAdditional drugs used concurrently:
  • Cyclophosphamide (cyclophosphamide)
  • Prednisone (prednisone)
  • Vincristine (vincristine)
  • Doxorubicin (doxorubicin)
  • Emend (aprepitant)
  • Pepcid (famotidine)
  • Aloxi (palonosetron Hydrochloride) Injection, 0.25mg/5ml
  • Decadron (dexamethasone)
The patient was hospitalized. Although Rituxan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Respiratory Distress, may still occur.
Rituxan Side Effect Report#9981865
Anaphylactic Shock, Mouth Ulceration, Rash
This Anaphylactic Shock problem was reported by a consumer or non-health professional from US. A 70-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Rituxan (dosage: NA). The following drugs were being taken at the same time:
  • Bactrim (sulfamethoxazole, Trimethoprim)
When using Rituxan, the patient experienced the following unwanted symptoms/side effects: Anaphylactic Shock, Mouth Ulceration, RashAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Anaphylactic Shock, may become evident only after a product is in use by the general population.
Rituxan Side Effect Report#9981846
Sepsis
This Sepsis side effect was reported by a health professional from US. A 70-year-old male patient (weight:NA) experienced the following symptoms/conditions: chronic lymphocytic leukaemia.The patient was prescribed Rituxan (rituximab) (drug dosage: 685 Unit Not Reported), which was initiated on
Oct 08, 2012. Concurrently used drugs:
  • Bendamustine (bendamustine) (bendamustine)
.After starting to take Rituxan (rituximab) the consumer reported adverse symptoms, such as: SepsisThese side effects may potentially be related to Rituxan (rituximab). The patient was hospitalized.
Rituxan Side Effect Report#9981836
Meningitis Fungal
This is a report of a 62-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Rituxan (rituximab) (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Meningitis Fungal after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Rituxan (rituximab) treatment in male patients, resulting in Meningitis Fungal side effect.
Rituxan Side Effect Report#9981822
Flushing, Blood Pressure Increased, Restlessness, Malaise
This report suggests a potential Rituxan Flushing side effect(s) that can have serious consequences. A 60-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: rheumatoid arthritis and used Rituxan (dosage: 1 In 2 Wk) starting
Feb 28, 2013. After starting Rituxan the patient began experiencing various side effects, including: Flushing, Blood Pressure Increased, Restlessness, MalaiseAdditional drugs used concurrently:
  • Methotrexate
  • Tramadol
Although Rituxan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Flushing, may still occur.
Rituxan Side Effect Report#9981774
Pneumonia, Injection Site Inflammation, Injection Site Pruritus, Injection Site Pain, Injection Site Erythema
This Pneumonia problem was reported by a health professional from US. A 64-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: b-cell lymphoma. On
Jan 02, 2013 this consumer started treatment with Rituxan (rituximab) (dosage: Frequency Cyclic, Day 1, 8, 15 And 22 (800 Mg), Intravenous (not Otherwise Specified)). The following drugs were being taken at the same time:
  • Velcade (bortezomib) (Frequency Cyclic (3.5 Mg), Subcutaneous)
  • Bendamustine (bendamustine) (bendamustine) (Frequency Cyclic, Day 1 And 2 Of Each 35 Days (197 Mg), Intravenous (not Otherwise Specified))
  • Acyclovir (aciclovir) (aciclovir)
  • Omeprazole (omeprazole)
  • Ditropan (oxybutynin Hydrochloride)
  • Sinemet (carbidopa, Levodopa)
  • Coreg (carvedilol)
  • Prasugrel (prasugrel Hydrochloride)
When using Rituxan (rituximab), the patient experienced the following unwanted symptoms/side effects: Pneumonia, Injection Site Inflammation, Injection Site Pruritus, Injection Site Pain, Injection Site ErythemaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pneumonia, may become evident only after a product is in use by the general population.
Rituxan Side Effect Report#9981738
Pharyngeal Oedema, Cough, Infusion Related Reaction, Nasopharyngitis, Pruritus
This Pharyngeal Oedema side effect was reported by a health professional from US. A 61-year-old female patient (weight:NA) experienced the following symptoms/conditions: rheumatoid arthritis.The patient was prescribed Rituxan (drug dosage: (1000 Mg, 1 In 1 16 Wk), Intravenous (not Otherwise Specified)?), which was initiated on
Jan 24, 2013. Concurrently used drugs:
  • Methotrexate (methotrexate)
  • Folic Acid (folic Acid)
.After starting to take Rituxan the consumer reported adverse symptoms, such as: Pharyngeal Oedema, Cough, Infusion Related Reaction, Nasopharyngitis, PruritusThese side effects may potentially be related to Rituxan. The patient was hospitalized.
Rituxan Side Effect Report#9974086
Herpes Zoster, Furuncle, Rash, Hypoacusis
This is a report of a 73-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: rheumatoid arthritis, who was treated with Rituxan (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Herpes Zoster, Furuncle, Rash, Hypoacusis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Rituxan treatment in male patients, resulting in Herpes Zoster side effect. The patient was hospitalized.
Rituxan Side Effect Report#9973998
Angioedema, Pharyngeal Oedema, Swollen Tongue, Tachycardia, Anxiety
This report suggests a potential Rituxan Angioedema side effect(s) that can have serious consequences. A 50-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: rheumatoid arthritis and used Rituxan (dosage: NA) starting NS. After starting Rituxan the patient began experiencing various side effects, including: Angioedema, Pharyngeal Oedema, Swollen Tongue, Tachycardia, AnxietyAdditional drugs used concurrently: NA.The patient was hospitalized. Although Rituxan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Angioedema, may still occur.
Rituxan Side Effect Report#9973312
Swollen Tongue, Infusion Related Reaction
This Swollen Tongue problem was reported by a health professional from US. A 45-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: rheumatoid arthritis. On
Apr 10, 2013 this consumer started treatment with Rituxan (dosage: NA). The following drugs were being taken at the same time:
  • Solu-medrol (methylprednisolone Sodium Succinate)
  • Epinephrine (epinephrine)
  • Benadryl (united States) (diphenhydramine Hydrchloride)
When using Rituxan, the patient experienced the following unwanted symptoms/side effects: Swollen Tongue, Infusion Related ReactionThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Swollen Tongue, may become evident only after a product is in use by the general population.
Rituxan Side Effect Report#9973201
Neutropenia, Sepsis
This Neutropenia side effect was reported by a consumer or non-health professional from US. A 77-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Rituxan (rituximab) (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Vincristine (vincristine)
  • Adriamycin (doxorubicin) Inj. Usp 10mg/5ml
  • Cytoxan (cyclophosphamide)
.After starting to take Rituxan (rituximab) the consumer reported adverse symptoms, such as: Neutropenia, SepsisThese side effects may potentially be related to Rituxan (rituximab).
Rituxan Side Effect Report#9973128
Flushing, Swelling Face, Urticaria, Hypoaesthesia, Throat Tightness, Erythema
This is a report of a 25-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: granulomatosis with polyangiitis, who was treated with Rituxan (dosage: (1000 Mg), Intravenous (not Otherwise Specified)?, start time: 201210), combined with:
  • Solu-medrol (methylprednisolone Sodium Succinate)
  • Tylenol (paracetamol)
  • Claritin (loratadine)
and developed a serious reaction and side effect(s): Flushing, Swelling Face, Urticaria, Hypoaesthesia, Throat Tightness, Erythema after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Rituxan treatment in male patients, resulting in Flushing side effect.


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The appearance of Rituxan on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Rituxan Side Effects for Women?

Women Side Effects Reports
Pyrexia 115
Infusion Related Reaction 114
Progressive Multifocal Leukoencephalopathy 107
Dyspnoea 90
Nausea 88
White Blood Cell Count Decreased 86
Neutropenia 82
Arthralgia 80
Death 68
Pneumonia 66

What are common Rituxan Side Effects for Men?

Men Side Effects Reports
White Blood Cell Count Decreased 103
Pyrexia 91
Dyspnoea 85
Death 78
Infusion Related Reaction 78
Pneumonia 69
Progressive Multifocal Leukoencephalopathy 65
Chills 64
Neutropenia 64
Platelet Count Decreased 62

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It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Rituxan reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Rituxan Safety Alerts, Active Ingredients, Usage Information

    NDC 50242-051
    Type HUMAN PRESCRIPTION DRUG
    Proprietary Name Rituxan
    Name rituximab
    Dosage Form INJECTION, SOLUTION
    Route INTRAVENOUS
    On market since 19971126
    Labeler Genentech, Inc.
    Active Ingredient(s) RITUXIMAB
    Strength(s) 10
    Unit(s) mg/mL
    Pharma Class CD20-directed Antibody Interactions [MoA],CD20-directed Cytolytic Antibody [EPC]

    Rituxan Dosage, Warnings, Usage.

    Side Effects reported to FDA: 3811

    Rituxan safety alerts: 2014 2009 2008 2006 2004

    Reported deaths: 896

    Reported hospitalizations: 1586

    Rituxan (rituximab) - PML

    Audience: Rheumatological healthcare professionals

    [Posted 10/23/2009] Genentech and FDA notified healthcare professionals about a third case of progressive multifocal leukoencephalopathy [PML], the first case of PML in a patient with rheumatoid arthritis [RA] treated with Rituxan who has not previously received treatment with a TNF antagonist. Information to date suggests that patients with RA who receive Rituxan have an increased risk of PML. 

    Physicians should consider PML in any patient being treated with Rituxan who presents with new onset neurologic manifestations. Consultation with a neurologist, brain MRI, and lumbar puncture should be considered as clinically indicated.

    [10/2009 - Dear Healthcare Professional Letter - Genentech]

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