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Caprelsa (Vandetanib) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The following serious adverse reactions are discussed elsewhere in the label:

  • •QT Prolongation and Torsades de Pointes [see Boxed Warning, Warnings and Precautions ]
  • •Skin Reactions and Stevens-Johnson Syndrome [see Warnings and Precautions ]
  • •Interstitial Lung Disease [see Warnings and Precautions ]
  • •Ischemic Cerebrovascular Events [see Warnings and Precautions ]
  • •Hemorrhage [see Warnings and Precautions ]
  • •Heart Failure [see Warnings and Precautions ]
  • •Diarrhea [see Warnings and Precautions ]
  • •Hypothyroidism [see Warnings and Precautions ]
  • •Hypertension [see Warnings and Precautions ]
  • •Reversible Posterior Leukoencephalopathy Syndrome [see Warnings and Precautions ]
  • •Embryofetal Toxicity [see Warnings and Precautions ]

Clinical Studies 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 practice.

Patients with unresectable locally advanced or metastatic medullary thyroid cancer were treated with CAPRELSA 300 mg (n=231) or Placebo (n=99). The population exposed to CAPRELSA was 58% male, 94% white, and had a median age of 50 years. The data described below reflect a median exposure to CAPRELSA for 607 days.

The most commonly reported adverse drug reactions which occurred in >20% of CAPRELSA-treated patients and with a between-arm difference of ≥5% included, in order of decreasing frequency: diarrhea/colitis, rash, acneiform dermatitis, hypertension, nausea, headache, upper respiratory tract infection, decreased appetite, and abdominal pain.

Among CAPRELSA-treated patients, dose interruption occurred in 109 (47%) and dose reduction occurred in 83 (36%). Adverse reactions led to study treatment discontinuation in 28 of 231 patients (12%) receiving CAPRELSA and in 3 of 99 patients (3.0%) receiving placebo. Adverse reactions leading to permanent discontinuation in 2 or more (≥0.9%) patients treated with CAPRELSA were: asthenia (1.7%), rash (1.7%), diarrhea (0.9%), fatigue (0.9%), pyrexia (0.9%), elevated creatinine (0.9%), QT prolongation (0.9%), and hypertension (0.9%).

Table 1 - Per-Patient Incidence of Selected Adverse Reactions Occurring at a Higher Incidence in CAPRELSA-Treated Patients During Randomized Treatment [Between-Arm Difference of ≥ 5% (All Grades) 1 ]

System Organ Class

  •   Preferred Term

CAPRELSA 300 mg

N=231

Placebo

N=99

All Grades (%)

Grade 3-4 (%)

All Grades (%)

Grade 3-4 (%)

Gastrointestinal Disorders

  •  Diarrhea/Colitis

57

11

27

2

  •  Nausea

33

1

16

0

  •  Abdominal Pain 2

21

3

11

0

  •  Vomiting

15

1

7

0

  •  Dyspepsia

11

0

4

0

  •  Dry Mouth

9

0

3

0

Skin and Cutaneous Disorders

  •  Rash 3

53

5

12

0

  •  Dermatitis Acneiform/Acne

35

1

7

0

  •  Dry Skin

15

0

5

0

  •  Photosensitivity Reaction

13

2

0

0

  •  Pruritus

11

1

4

0

  •  Nail abnormalities 4

9

0

0

0

  •  Alopecia

8

N/A

0

N/A

Vascular Disorders

  •  Hypertension/Hypertensive Crisis/Accelerated Hypertension

33

9

5

1

Nervous System Disorders

  •  Headache

26

1

9

0

  •  Dysgeusia

8

0

3

0

General Disorders

  •  Fatigue 5

24

6

23

1

Infections

Upper Respiratory Tract Infections 6

23

0

16

0

Metabolic and Nutritional Disorders

  •  Decreased Appetite

21

4

12

0

  •  Hypocalcemia

11

2

3

0

Investigations

  •  ECG QT Prolonged 7

14

8

1

1

Eye Disorders

  •  Corneal Abnormalities 8

13

0

1

0

  •  Blurred Vision

9

0

1

0

Renal Disorders

  •  Proteinuria

10

0

2

0

Psychiatric Disorders

  •  Depression

10

2

3

0

Endocrine Disorders

  •  Hypothyroidism

6

0

0

0

Musculoskeletal Disorders

  •  Muscle Spasms

6

0

1

0

1 CTCAE version 3 was used to grade adverse events.
2 Includes abdominal pain, abdominal pain upper, lower abdominal pain and abdominal discomfort.
3 Includes rash, rash (erythematous, generalized, macular, maculo-papular, papular, pruritic, and exfoliative), dermatitis, dermatitis bullous, generalized erythema, and eczema.
4 Includes nail disorder, nail bed inflammation, nail bed tenderness, paronychia, nail bed infection, and nail infection.
5 Included in Table 1 due to the increased incidence of severe fatigue in the CAPRELSA group compared to the placebo group.
6 Includes laryngitis, nasopharyngitis, pharyngitis, sinusitis, upper respiratory tract infection, acute sinusitis, rhinitis, and tracheitis.
7 69% had QT prolongation >450ms and 7% had QT prolongation >500ms by ECG using Fridericia correction.
8 Includes corneal edema, corneal opacity, corneal dystrophy, corneal pigmentation, keratopathy, arcus lipoides, corneal deposits, acquired corneal dystrophy.

Clinically important uncommon adverse drug reactions in patients who received CAPRELSA versus patients who received placebo included pancreatitis (0.4% vs. 0%) and heart failure (0.9% vs. 0%).

Blurred vision was more common in patients who received CAPRELSA versus patients who received placebo for medullary thyroid cancer (9% vs. 1%, respectively). Scheduled slit lamp examinations revealed corneal opacities (vortex keratopathies) in treated patients, which can lead to halos and decreased visual acuity. Perform ophthalmologic examination, including slit lamp examination, in patients who report visual changes.

Class effects

CAPRELSA is an inhibitor of vascular endothelial growth factor receptor (VEGFR) signaling. Inhibition of VEGFR signaling can result in intestinal perforation. Intestinal perforation occurred in 0.4% of CAPRELSA treated patients versus 0% of placebo treated patients.

The incidence of Grade 1-2 bleeding events was 14% in patients receiving CAPRELSA compared with 7% on placebo in the randomized portion of the medullary thyroid cancer (MTC) study.

Table 2 - Per-Patient Incidence of Selected Laboratory Abnormalities in Patients with MTC Occurring at a Higher Incidence in CAPRELSA-Treated Patients [Between-Arm Difference of ≥ 5% (All Grades) 1 ]
Laboratory Abnormalities CAPRELSA 300 mg
N=231
Placebo
N=99

All

Grades

(%)

Grade 3–4

(%)

All

Grades

(%)

Grade 3–4

(%)

Chemistries

  •  Hypocalcemia

57

6

25

3

  •  ALT Increased

51

2

19

0

  •  Hypoglycemia

24

0

7

1

  •  Creatinine Increased

16

0

1

0

  •  Hypomagnesemia

7

<1

2

0

Hematologic

  •  Neutropenia

10

<1

5

2

  •  Thrombocytopenia

9

0

3

0

1 CTCAE version 3 was used to grade laboratory abnormalities.

No patient with a Grade 3-4 ALT elevation had a concomitant increase in bilirubin in the MTC study.



REPORTS OF SUSPECTED CAPRELSA SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Caprelsa side effects / adverse reactions in 64 year old male

Reported by a consumer/non-health professional from United States on 2012-05-22

Patient: 64 year old male

Reactions: Blood Pressure Increased, Dyspnoea, Diarrhoea, Rash, Musculoskeletal Chest Pain

Suspect drug(s):
Caprelsa

Other drugs received by patient: Hyrdocodone-Acetaminophen; Docusate Sodium; Senna Leaves; Avodart; Levothyroxine Sodium; Calcitriol; Famotidine; Multivital



Possible Caprelsa side effects / adverse reactions in 54 year old male

Reported by a consumer/non-health professional from United States on 2012-05-23

Patient: 54 year old male

Reactions: Gastrointestinal Haemorrhage, Pain in Extremity, Acne, Rash, Ascites

Adverse event resulted in: hospitalization

Suspect drug(s):
Caprelsa

Other drugs received by patient: Doxycycline Hyclate



Possible Caprelsa side effects / adverse reactions in 65 year old male

Reported by a physician from United States on 2012-05-23

Patient: 65 year old male weighing 81.0 kg (178.2 pounds)

Reactions: Electrocardiogram QT Prolonged

Suspect drug(s):
Caprelsa
    Administration route: Oral
    Start date: 2011-12-02
    End date: 2012-01-24

Caprelsa
    Administration route: Oral
    Indication: Thyroid Cancer
    Start date: 2011-11-10
    End date: 2011-11-23

Other drugs received by patient: Remeron; Synthroid; Oxycodone/acetaminophen; Ondasetron HCL; Morphine Sulfate; Fluoxetine Hydrochloride; Niacin; Omeprazole; Prednisone TAB; Guaifenesin



See index of all Caprelsa side effect reports >>

Drug label data at the top of this Page last updated: 2014-03-31

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