Choose ALUNBRIG® (brigatinib): A Well-Established Safety Profile

Chart showing adverse reactions reported by participants in ALTA 1L.
aPer National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
bIncludes abdominal discomfort, abdominal distension, abdominal pain, abdominal pain lower, abdominal pain upper, and epigastric discomfort.
cIncludes aphthous ulcer, mouth ulceration, oral mucosal blistering and stomatitis.
dIncludes dermatitis, dermatitis acneiform, dermatitis bullous, dermatitis contact, drug eruption, erythema, palmar-plantar erythrodysesthesia syndrome, rash, rash erythematous, rash macular, rash maculo-papular, rash papular, rash pruritic, rash pustular, toxic skin eruption, urticaria.
eIncludes pruritus, allergic pruritus, and generalized pruritus.
fIncludes dyspnea and exertional dyspnea.
gIncludes hypertension and systolic hypertension.
hIncludes asthenia and fatigue.
iIncludes angioedema, eye swelling, eyelid edema, face edema, generalized edema, lip swelling, peripheral edema, periorbital edema, peripheral swelling, skin swelling, swelling and swelling face.
jIncludes muscle spasms, muscle twitching, musculoskeletal discomfort, musculoskeletal pain, and myalgia.
kIncludes headache and migraine.
lIncludes burning sensation, dysesthesia, hyperesthesia, hypoesthesia, neuralgia, peripheral neuropathy, paraesthesia, peripheral sensory neuropathy and polyneuropathy.
mIncludes blood cholesterol increased, hypercholesterolemia.
nIncludes bradycardia, heart rate decreased, sinus bradycardia.
oIncludes lower respiratory tract infection, lung infection, pneumonia, aspiration pneumonia, and cryptococcal pneumonia.
pIncludes upper respiratory tract infection and viral upper respiratory tract infection.
qIncludes cataract, glaucoma, hypermetropia, night blindness, papilloedema, photophobia, photopsia, blurred vision, reduced visual acuity, visual field defect, visual impairment, and vitreous floaters.
rIncludes Grade 5 events.

Serious adverse reactions occurred in 33% of patients receiving ALUNBRIG.1

The most common serious adverse reactions in ALTA 1L were pneumonia (4.4%), ILD/pneumonitis (3.7%), pyrexia (2.9%), dyspnea (2.2%), pulmonary embolism (2.2%), and asthenia (2.2%). Fatal adverse reactions occurred in 2.9% of patients and included pneumonia (1.5%), cerebrovascular accident (0.7%), and multiple organ dysfunction syndrome (0.7%).1

Laboratory Abnormalities in ≥20% (All Gradesa) of Patients by Arm in ALTA 1L (N=273)1

Chart showing laboratory abnormalities reported in participants in ALTA 1L.
aPer NCI CTCAE v4.3.
bDenominator for each laboratory parameter may vary and is defined as the number of patients who had both baseline and post-baseline test.
cElevated blood insulin was also observed in both arms.

Interstitial lung disease/pneumonitis1

  • In the first-line phase 3 trial, ILD/pneumonitis occurred in 5.1% of patients receiving ALUNBRIG, with Grade 3 or 4 reactions occurring in 2.2% of patients1
  • In the post-crizotinib phase 2 trial (ALTA): ILD/pneumonitis occurred in 9.1% of patients, in the 90180 mg arm. Adverse reactions consistent with ILD/pneumonitis occurred in 6.4% of patients, with Grade 3 or 4 reactions occurring in 2.7% of patients1

Long-Terma Tolerability in ALTA 1L1

  • Median duration of treatment with ALUNBRIG: 24.3 months
  • Median relative dose intensity with ALUNBRIG: 97%

Dose reductions occurred in 38% of patients receiving ALUNBRIG.1

The most common adverse reactions in ALTA 1L that led to dose reduction were increased creatine phosphokinase (15%), increased lipase (6.6%), increased amylase (4.4%), increased aspartate aminotransferase (2.2%), ILD/pneumonitis (2.2%), and hypertension (2.2%).1

Permanent discontinuation due to adverse reactions occurred in 13% of patients receiving ALUNBRIG.1

The most frequent adverse reactions in ALTA 1L that led to discontinuation were ILD/pneumonitis (3.7%) and pneumonia (2.2%).1

aBased on the median follow-up in the ALUNBRIG arm of ALTA 1L of 40.4 months.2 ILD, interstitial lung disease.

Dose Modifications

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Patient Brochure

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