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Yervoy (Ipilimumab) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The following adverse reactions are discussed in greater detail in other sections of the labeling.

  • ●Immune-mediated enterocolitis [see Warnings and Precautions].
  • ●Immune-mediated hepatitis [see Warnings and Precautions].
  • ●Immune-mediated dermatitis [see Warnings and Precautions].
  • ●Immune-mediated neuropathies [see Warnings and Precautions].
  • ●Immune-mediated endocrinopathies [see Warnings and Precautions].
  • ●Other immune-mediated adverse reactions, including ocular manifestations [see Warnings and Precautions].

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared with rates in other clinical trials or experience with therapeutics in the same class and may not reflect the rates observed in clinical practice.

The clinical development program excluded patients with active autoimmune disease or those receiving systemic immunosuppression for organ transplantation. Exposure to YERVOY 3 mg/kg for 4 doses given by intravenous infusion in previously treated patients with unresectable or metastatic melanoma was assessed in a randomized, double-blind clinical study (Study 1). [See Clinical Studies.] One hundred thirty-one patients (median age 57 years, 60% male) received YERVOY as a single agent, 380 patients (median age 56 years, 61% male) received YERVOY with an investigational gp100 peptide vaccine (gp100), and 132 patients (median age 57 years, 54% male) received gp100 peptide vaccine alone. Patients in the study received a median of 4 doses (range: 1–4 doses). YERVOY was discontinued for adverse reactions in 10% of patients.

The most common adverse reactions (≥5%) in patients who received YERVOY at 3 mg/kg were fatigue, diarrhea, pruritus, rash, and colitis.

Table 1 presents selected adverse reactions from Study 1, which occurred in at least 5% of patients in the YERVOY-containing arms and with at least 5% increased incidence over the control gp100 arm for all-grade events and at least 1% incidence over the control group for Grade 3–5 events.

Table 1:     Selected Adverse Reactions in Study 1
a   Incidences presented in this table are based on reports of adverse events regardless of causality.

Percentage (%) of Patientsa

YERVOY
3 mg/kg
n=131

YERVOY
3 mg/kg+gp100
n=380

gp100
n=132

System Organ Class/
Preferred Term

Any
Grade

Grade
3–5

Any
Grade

Grade
3–5

Any
Grade

Grade
3–5

Gastrointestinal Disorders

    Diarrhea

32

5

37

4

20

1

    Colitis

8

5

5

3

2

0

Skin and Subcutaneous Tissue Disorders

    Pruritus

31

0

21

<1

11

0

    Rash

29

2

25

2

8

0

General Disorders and Administration Site Conditions

    Fatigue

41

7

34

5

31

3

Table 2 presents the per-patient incidence of severe, life-threatening, or fatal immune-mediated adverse reactions from Study 1.

Table 2:     Severe to Fatal Immune-mediated Adverse Reactions in Study 1
a   Including fatal outcome.
b   Including intestinal perforation.
c   Underlying etiology not established.

Percentage (%) of Patients

YERVOY
3 mg/kg
n=131

YERVOY
3 mg/kg+gp100
n=380

Any Immune-mediated Adverse Reaction

15

12

Enterocolitis a,b

7

7

Hepatotoxicity a

1

2

Dermatitis a

2

3

Neuropathy a

1

<1

Endocrinopathy

4

1

    Hypopituitarism

4

1

    Adrenal insufficiency

0

1

Other

    Pneumonitis

0

<1

    Meningitis

0

<1

    Nephritis

1

0

    Eosinophiliac

1

0

    Pericarditisa,c

0

<1

Across clinical studies that utilized YERVOY doses ranging from 0.3 to 10 mg/kg, the following adverse reactions were also reported (incidence less than 1% unless otherwise noted): urticaria (2%), large intestinal ulcer, esophagitis, acute respiratory distress syndrome, renal failure, and infusion reaction.

Based on the experience in the entire clinical program for melanoma, the incidence and severity of enterocolitis and hepatitis appear to be dose dependent.

Immunogenicity

In clinical studies, 1.1% of 1024 evaluable patients tested positive for binding antibodies against ipilimumab in an electrochemiluminescent (ECL) based assay. This assay has substantial limitations in detecting anti-ipilimumab antibodies in the presence of ipilimumab. Infusion-related or peri-infusional reactions consistent with hypersensitivity or anaphylaxis were not reported in these 11 patients nor were neutralizing antibodies against ipilimumab detected.

Because trough levels of ipilimumab interfere with the ECL assay results, a subset analysis was performed in the dose cohort with the lowest trough levels. In this analysis, 6.9% of 58 evaluable patients, who were treated with 0.3 mg/kg dose, tested positive for binding antibodies against ipilimumab.

Immunogenicity assay results are highly dependent on several factors including assay sensitivity and specificity, assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of incidence of antibodies to YERVOY with the incidences of antibodies to other products may be misleading.



REPORTS OF SUSPECTED YERVOY SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Yervoy. The information is not vetted and should not be considered as verified clinical evidence.

Possible Yervoy side effects / adverse reactions in 56 year old female

Reported by a consumer/non-health professional from Germany on 2011-10-03

Patient: 56 year old female

Reactions: Blood Thyroid Stimulating Hormone Decreased, Pyrexia

Adverse event resulted in: hospitalization

Suspect drug(s):
Yervoy



Possible Yervoy side effects / adverse reactions in 67 year old female

Reported by a physician from Germany on 2011-10-04

Patient: 67 year old female weighing 65.0 kg (143.0 pounds)

Reactions: Dyspnoea, Restlessness, Sensation of Heaviness, General Physical Health Deterioration, Sinus Tachycardia, Hyperthyroidism, Decreased Appetite, Pneumonitis

Suspect drug(s):
Yervoy



Possible Yervoy side effects / adverse reactions in 45 year old male

Reported by a pharmacist from United States on 2011-10-04

Patient: 45 year old male

Reactions: Dyspnoea, Haemoptysis, Coagulopathy, General Physical Health Deterioration, Cardiomyopathy, Cardiogenic Shock, Acute Hepatic Failure, Bradycardia, Acute Respiratory Failure, Renal Failure Acute, Pulseless Electrical Activity, Cough

Adverse event resulted in: death, life threatening event, hospitalization

Suspect drug(s):
Yervoy

Other drugs received by patient: Interleukin; Prednisone; Multi-Vitamin; Levothyroxine; Interferon; Omega-3 Polyunsaturated Acids; Oxycodone/acetaminophen; Furosemide; Cholecalciferol



See index of all Yervoy side effect reports >>

Drug label data at the top of this Page last updated: 2013-12-05

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