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Ipilimumab Side Effects

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Common Ipilimumab Side Effects


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

Diarrhoea (259)
Colitis (180)
Dehydration (126)
Pyrexia (113)
Vomiting (112)
Nausea (89)
Neoplasm Malignant (87)
Fatigue (74)
Malignant Neoplasm Progression (70)
Hyponatraemia (60)
Hypophysitis (52)
Anaemia (51)
Decreased Appetite (49)
Abdominal Pain (49)
Renal Failure Acute (47)
Sepsis (46)
Dyspnoea (45)
Headache (42)
Hypotension (36)
Muscular Weakness (35)

➢ 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.

Ipilimumab Side Effects Reported to FDA



Ipilimumab Side Effect Report#9996898
Asthma
This is a report of a 44-year-old male patient (weight: NA) from CO, suffering from the following health symptoms/conditions: metastatic malignant melanoma, who was treated with Ipilimumab (dosage: 280gr, start time:
Feb 20, 2014), combined with: NA. and developed a serious reaction and side effect(s): Asthma after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Ipilimumab treatment in male patients, resulting in Asthma side effect.
Ipilimumab Side Effect Report#9994595
Cytomegalovirus Colitis
This report suggests a potential Ipilimumab Cytomegalovirus Colitis side effect(s) that can have serious consequences. A 62-year-old female patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: metastatic malignant melanoma and used Ipilimumab (dosage: NA) starting
May 21, 2013. After starting Ipilimumab the patient began experiencing various side effects, including: Cytomegalovirus ColitisAdditional drugs used concurrently:
  • Zaldiar
  • Tahor
  • Janumet
  • Singulair
  • Bricanyl
The patient was hospitalized. Although Ipilimumab demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cytomegalovirus Colitis, may still occur.
Ipilimumab Side Effect Report#9992819
Blood Creatine Phosphokinase Increased
This Blood Creatine Phosphokinase Increased problem was reported by a consumer or non-health professional from US. A 41-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: malignant melanoma. On
Mar 21, 2012 this consumer started treatment with Ipilimumab (dosage: Last Dose:21mar12?10 Mg/kg 90 Mins,/3 Weeks X 4 Doses?10mg/kg 90 Mins,/12 Weeks On 24,36,48,+60.). The following drugs were being taken at the same time: NA. When using Ipilimumab, the patient experienced the following unwanted symptoms/side effects: Blood Creatine Phosphokinase IncreasedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Blood Creatine Phosphokinase Increased, may become evident only after a product is in use by the general population.
Ipilimumab Side Effect Report#9992756
Alanine Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Aspartate Aminotransferase Increased, Blood Bilirubin Increased, Pyrexia, Abdominal Pain, Hypotension, Presyncope
This Alanine Aminotransferase Increased side effect was reported by a consumer or non-health professional from US. A 56-year-old male patient (weight:NA) experienced the following symptoms/conditions: haematological malignancy.The patient was prescribed Ipilimumab (drug dosage: Last Dose:12feb14?dosage:10 Mg/kg Over 90min On Day 1), which was initiated on
Jan 22, 2014. Concurrently used drugs: NA..After starting to take Ipilimumab the consumer reported adverse symptoms, such as: Alanine Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Aspartate Aminotransferase Increased, Blood Bilirubin Increased, Pyrexia, Abdominal Pain, Hypotension, PresyncopeThese side effects may potentially be related to Ipilimumab. The patient was hospitalized.
Ipilimumab Side Effect Report#9985626
Delirium, Dehydration, Diarrhoea, Lipase Increased, Hyponatraemia
This is a report of a 63-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: malignant melanoma, who was treated with Ipilimumab (dosage: 1 Df= 3 Mg/kg Or 10 Mg/kg?828 Mg?last Administered Date 28jan14, start time:
Jan 07, 2014), combined with: NA. and developed a serious reaction and side effect(s): Delirium, Dehydration, Diarrhoea, Lipase Increased, Hyponatraemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Ipilimumab treatment in male patients, resulting in Delirium side effect. The patient was hospitalized.
Ipilimumab Side Effect Report#9953570
Renal Failure, Malignant Neoplasm Progression
This report suggests a potential Ipilimumab Renal Failure side effect(s) that can have serious consequences. A 80-year-old female patient (weight: NA) from BE was diagnosed with the following symptoms/conditions: NA and used Ipilimumab (dosage: NA) starting 201310. After starting Ipilimumab the patient began experiencing various side effects, including: Renal Failure, Malignant Neoplasm ProgressionAdditional drugs used concurrently:
  • Burinex
  • Trinipatch
  • Thyroxine (1df=75 Units Nos)
  • Pantomed (1df=20 Units Nos)
  • Inderal Retard (1df=80 Units Nos)
  • Lorazepam (1df=2.5 Units Nos)
  • Lormetazepam
  • Clexane (1df=40 Units Nos)
Although Ipilimumab demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Renal Failure, may still occur.
Ipilimumab Side Effect Report#9919688
Bronchitis
This Bronchitis problem was reported by a health professional from DE. A 43-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: metastatic malignant melanoma. On
Nov 26, 2013 this consumer started treatment with Ipilimumab (dosage: 26nov13-?18dec13-). The following drugs were being taken at the same time: NA. When using Ipilimumab, the patient experienced the following unwanted symptoms/side effects: BronchitisThe 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 Bronchitis, may become evident only after a product is in use by the general population.
Ipilimumab Side Effect Report#9914254
Bronchopneumonia
This Bronchopneumonia side effect was reported by a physician from DE. A 44-year-old female patient (weight:NA) experienced the following symptoms/conditions: malignant melanoma.The patient was prescribed Ipilimumab (drug dosage: 26-nov-2013, 18-dec-2013 And 06-feb-2014), which was initiated on NS. Concurrently used drugs: NA..After starting to take Ipilimumab the consumer reported adverse symptoms, such as: BronchopneumoniaThese side effects may potentially be related to Ipilimumab. The patient was hospitalized.
Ipilimumab Side Effect Report#9912135
Malignant Neoplasm Progression, Pyrexia, Infection
This is a report of a 75-year-old male patient (weight: NA) from DE, suffering from the following health symptoms/conditions: malignant melanoma, who was treated with Ipilimumab (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Malignant Neoplasm Progression, Pyrexia, Infection after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Ipilimumab treatment in male patients, resulting in Malignant Neoplasm Progression side effect.
Ipilimumab Side Effect Report#9912129
Enterocolitis Infectious, Retinal Detachment
This report suggests a potential Ipilimumab Enterocolitis Infectious side effect(s) that can have serious consequences. A 72-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: malignant melanoma,cellulitis and used Ipilimumab (dosage: Iv Over90mins,lastdose:05/12/13, Total Dose 300mg) starting
Jun 28, 2013. After starting Ipilimumab the patient began experiencing various side effects, including: Enterocolitis Infectious, Retinal DetachmentAdditional drugs used concurrently:
  • Doxycycline
The patient was hospitalized. Although Ipilimumab demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Enterocolitis Infectious, may still occur.
Ipilimumab Side Effect Report#9896719
Pneumonia, Thrombosis
This Pneumonia problem was reported by a health professional from GB. A 66-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: small cell lung cancer. On
Oct 23, 2013 this consumer started treatment with Ipilimumab (dosage: Recent Dose 22jan14). The following drugs were being taken at the same time:
  • Carboplatin (Recent Dose 22jan14)
  • Etoposide (Recent Dose 22jan14)
When using Ipilimumab, the patient experienced the following unwanted symptoms/side effects: Pneumonia, ThrombosisThe 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 Pneumonia, may become evident only after a product is in use by the general population.
Ipilimumab Side Effect Report#9893084
Syncope
This Syncope side effect was reported by a health professional from US. A 82-year-old male patient (weight:NA) experienced the following symptoms/conditions: malignant melanoma.The patient was prescribed Ipilimumab (drug dosage: 18-sep-2013 742.7 Mg?09-oct-2013 734.1 Mg?30-oct-2013 735 Nos), which was initiated on
Dec 18, 2013. Concurrently used drugs:
  • Vemurafenib (1 Df=1920 Nos)
  • Librax (1 Df= 1 Caps?ongoing)
  • Colchicine (Ongoing)
  • Pradaxa (Ongoing)
  • Cardizem (Ongoing)
  • Glimepiride (Ongoing)
  • Synthroid (Ongoing)
  • Nadolol
.After starting to take Ipilimumab the consumer reported adverse symptoms, such as: SyncopeThese side effects may potentially be related to Ipilimumab. The patient was hospitalized.
Ipilimumab Side Effect Report#9882496
Hepatitis, Urinary Tract Infection
This is a report of a 67-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: malignant melanoma, who was treated with Ipilimumab (dosage: 1 Df=5 Mg/ml, start time:
Nov 28, 2013), combined with:
  • Crestor
  • Coaprovel (1 Df=150 / 12.5 Unit Nos)
  • Diosmin
  • Betaserc (1 Df= 24 Unit Nos)
  • Doliprane
  • Ginkgo (1 Df= 1 Tab)
  • Piascledine
and developed a serious reaction and side effect(s): Hepatitis, Urinary Tract Infection after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Ipilimumab treatment in female patients, resulting in Hepatitis side effect. The patient was hospitalized.
Ipilimumab Side Effect Report#9879884
Rheumatoid Arthritis
This report suggests a potential Ipilimumab Rheumatoid Arthritis side effect(s) that can have serious consequences. A 57-year-old male patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: small cell lung cancer and used Ipilimumab (dosage: Cycle 1:8oct13 ?cycle 2:29oct13?cycle 3:27nov13?cycle 4:17dec13) starting
Sep 27, 2013. After starting Ipilimumab the patient began experiencing various side effects, including: Rheumatoid ArthritisAdditional drugs used concurrently:
  • Carboplatin (1 Df: Auc 5.0?cycle 1:8oct13 ?cycle 2:29oct13?cycle 3:27nov13?cycle 4:17dec13)
  • Etoposide (Cycle 1:8oct13 ?cycle 2:29oct13?cycle 3:27nov13?cycle 4:17dec13)
Although Ipilimumab demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Rheumatoid Arthritis, may still occur.
Ipilimumab Side Effect Report#9874430
Granuloma Skin
This Granuloma Skin problem was reported by a consumer or non-health professional from FR. A 54-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: metastatic malignant melanoma. On
Jun 21, 2013 this consumer started treatment with Ipilimumab (dosage: 1df: 5mg/ml,10mg/kg For 12 Weeks Then Once Every 12 Weeks For 2 Years.). The following drugs were being taken at the same time: NA. When using Ipilimumab, the patient experienced the following unwanted symptoms/side effects: Granuloma SkinAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Granuloma Skin, may become evident only after a product is in use by the general population.
Ipilimumab Side Effect Report#9872298
Vision Blurred, Optic Neuritis
This Vision Blurred side effect was reported by a health professional from US. A 74-year-old male patient (weight:NA) experienced the following symptoms/conditions: metastatic malignant melanoma.The patient was prescribed Ipilimumab (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Gm-csf
.After starting to take Ipilimumab the consumer reported adverse symptoms, such as: Vision Blurred, Optic NeuritisThese side effects may potentially be related to Ipilimumab.
Ipilimumab Side Effect Report#9871467
Pyrexia, Atrial Fibrillation
This is a report of a 73-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: small cell lung cancer, who was treated with Ipilimumab (dosage: Most Recent:27dec2013, start time:
Nov 14, 2013), combined with:
  • Etoposide (Last Dose:27dec2013)
  • Carboplatin (Last Dose:27dec2013)
  • Salbutamol (1df:1 Puff)
  • Tamsulosin
  • Ramipril
  • Lactulose
  • Metoclopramide
  • Ondansetron
and developed a serious reaction and side effect(s): Pyrexia, Atrial Fibrillation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Ipilimumab treatment in male patients, resulting in Pyrexia side effect. The patient was hospitalized.
Ipilimumab Side Effect Report#9870204
Colitis, Diarrhoea, Rectal Haemorrhage
This report suggests a potential Ipilimumab Colitis side effect(s) that can have serious consequences. A 73-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: metastatic malignant melanoma and used Ipilimumab (dosage: 27dec13) starting
Dec 12, 2013. After starting Ipilimumab the patient began experiencing various side effects, including: Colitis, Diarrhoea, Rectal HaemorrhageAdditional drugs used concurrently: NA.The patient was hospitalized. Although Ipilimumab demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Colitis, may still occur.
Ipilimumab Side Effect Report#9868000
Alcohol Abuse
This Alcohol Abuse problem was reported by a consumer or non-health professional from US. A 38-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: malignant melanoma. On
Feb 26, 2013 this consumer started treatment with Ipilimumab (dosage: NA). The following drugs were being taken at the same time:
  • Depo-provera
When using Ipilimumab, the patient experienced the following unwanted symptoms/side effects: Alcohol AbuseThe 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 Alcohol Abuse, may become evident only after a product is in use by the general population.
Ipilimumab Side Effect Report#9867521
This Death side effect was reported by a physician from BE. A 78-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Ipilimumab (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Ipilimumab the consumer reported adverse symptoms, such as: These side effects may potentially be related to Ipilimumab.
Ipilimumab Side Effect Report#9852486
Hyponatraemia
This is a report of a 73-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: metastatic malignant melanoma, who was treated with Ipilimumab (dosage: NA, start time:
Dec 01, 2013), combined with:
  • Avastin
  • Amlodipine
  • Coumadin
  • Diclofenac
  • Imodium
  • Normal Saline
  • Zofran
  • Protonix
and developed a serious reaction and side effect(s): Hyponatraemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Ipilimumab treatment in female patients, resulting in Hyponatraemia side effect. The patient was hospitalized.
Ipilimumab Side Effect Report#9847843
Deafness Bilateral
This report suggests a potential Ipilimumab Deafness Bilateral side effect(s) that can have serious consequences. A 70-year-old female patient (weight: NA) from ES was diagnosed with the following symptoms/conditions: NA and used Ipilimumab (dosage: NA) starting NS. After starting Ipilimumab the patient began experiencing various side effects, including: Deafness BilateralAdditional drugs used concurrently: NA. Although Ipilimumab demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Deafness Bilateral, may still occur.
Ipilimumab Side Effect Report#9844335
Cardiac Arrest, Arteritis, Gastrointestinal Haemorrhage
This Cardiac Arrest problem was reported by a consumer or non-health professional from US. A 83-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: malignant melanoma. On
Dec 19, 2013 this consumer started treatment with Ipilimumab (dosage: NA). The following drugs were being taken at the same time:
  • Aspirin
  • Prednisone
  • Finasteride
  • Lisinopril
  • Metformin
  • Metoprolol
  • Simvastatin
When using Ipilimumab, the patient experienced the following unwanted symptoms/side effects: Cardiac Arrest, Arteritis, Gastrointestinal HaemorrhageThe 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 Cardiac Arrest, may become evident only after a product is in use by the general population.
Ipilimumab Side Effect Report#9835675
Cerebrovascular Accident
This Cerebrovascular Accident side effect was reported by a consumer or non-health professional from US. A 60-year-old male patient (weight:NA) experienced the following symptoms/conditions: malignant melanoma.The patient was prescribed Ipilimumab (drug dosage: Every 12 Weeks On Weeks 24,36,48 And 60?total Dose: 219mg, Last Dose: 04nov13), which was initiated on
Oct 14, 2013. Concurrently used drugs: NA..After starting to take Ipilimumab the consumer reported adverse symptoms, such as: Cerebrovascular AccidentThese side effects may potentially be related to Ipilimumab. The patient was hospitalized.
Ipilimumab Side Effect Report#9833979
Colitis, Diverticulitis, Diarrhoea
This is a report of a 64-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: metastatic malignant melanoma, who was treated with Ipilimumab (dosage: NA, start time:
Dec 11, 2013), combined with: NA. and developed a serious reaction and side effect(s): Colitis, Diverticulitis, Diarrhoea after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Ipilimumab treatment in male patients, resulting in Colitis side effect. The patient was hospitalized.


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The appearance of Ipilimumab 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.

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What are common Ipilimumab Side Effects for Women?

Women Side EffectsReports
Diarrhoea 98
Colitis 76
Vomiting 50
Pyrexia 49
Dehydration 45
Nausea 33
Neoplasm Malignant 33
Hypophysitis 26
Rash Maculo-papular 22
Anaemia 21

What are common Ipilimumab Side Effects for Men?

Men Side EffectsReports
Diarrhoea 160
Colitis 103
Dehydration 81
Pyrexia 64
Vomiting 62
Nausea 56
Neoplasm Malignant 53
Fatigue 52
Malignant Neoplasm Progression 51
Decreased Appetite 44

Track Your Side Effects

Note Your Observations

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.

    Ipilimumab 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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    Discuss Ipilimumab Side Effects

    Did You Have a Ipilimumab Side Effect?

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    Yes, Moderate
    Yes, Minor
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    How Effective is Ipilimumab for You?

    Exceeded Expectations
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    Not Effective

    Ipilimumab Safety Alerts, Active Ingredients, Usage Information

    More About Ipilimumab

    Side Effects reported to FDA: 1200

    Ipilimumab safety alerts: 2011

    Reported deaths: 265

    Reported hospitalizations: 982

    Yervoy (ipilimumab): Risk Evaluation and Mitigation Strategy (REMS) - Severe Immune-Mediated Adverse Reactions

    [Posted 04/06/2011]

    AUDIENCE: Hematology-Oncology

    ISSUE: Bristol-Myers Squibb informed healthcare professionals about the risk evaluation and mitigation strategy (REMS), developed in collaboration with FDA, that is required to ensure that the benefits of Yervoy outweigh the risks of severe and fatal immune-mediated adverse reactions. The Yervoy REMS consists of a Communication Plan to inform healthcare professionals of the serious risks of Yervoy, to facilitate early identification of these risks, and an overview of recommended management of patients with moderate or more severe immune-mediated adverse reactions.

    BACKGROUND: Yervoy was approved March 2011 with the Prescribing Information including a Boxed Warning stating that use of the product can result in severe and fatal immune-mediated adverse reactions due to T-cell activation and proliferation. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of Yervoy.
     
    RECOMMENDATION: Healthcare providers were advised to read the boxed warning and accompanying full Prescribing Information for a complete description of these risks and their management and were advised to discuss the risks that may be associated with therapy with patients and their caregivers. Clinicians were advised to:

    • permanently discontinue Yervoy and initiate systemic high dose corticosteroid therapy for indentified severe immune-mediated reactions.
    • assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy and endocrinopathy and evaluate clinical chemistries including liver function tests and thyroid function tests at baseline and before each dose.

     

    Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

     

    [March 2011 - Dear Healthcare Professional Letter - BMS]
    [03/25/2011 - Prescribing Information - BMS] 
    [03/25/2011 - Medication Guide - BMS]
     

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