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Alunbrig

Last reviewed on RxList: 6/5/2020
Alunbrig Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Alunbrig?

Alunbrig (brigatinib) is a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on, or are intolerant to, crizotinib.

What Are Side Effects of Alunbrig?

Common side effects of Alunbrig include:

Dosage for Alunbrig

The dose of Alunbrig is 90 mg orally once daily for the first 7 days; if tolerated, increase to 180 mg orally once daily. Alunbrig may be taken with or without food.

What Drugs, Substances, or Supplements Interact with Alunbrig?

Alunbrig may interact with itraconazole, boceprevir, cobicistat, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, macrolide antibiotics, antifungals, conivaptan, grapefruit or grapefruit juice, rifampin, carbamazepine, phenytoin, St. John's wort, and hormonal contraceptives. Tell your doctor all medications and supplements you use.

Alunbrig During Pregnancy and Breastfeeding

Alunbrig is not recommended for use during pregnancy; it may harm a fetus. It is unknown if Alunbrig passes into breast milk. Because of the potential for adverse reactions in breastfed infants, lactating women should not breastfeed during treatment with Alunbrig and for 1 week following the final dose.

Additional Information

Our Alunbrig (brigatinib) Tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Lung Cancer Symptoms, Stages, Treatment See Slideshow
Alunbrig Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the prescribing information:

Clinical Trial 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.

The safety of ALUNBRIG was evaluated in 219 patients with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC) who received at least one dose of ALUNBRIG in ALTA after experiencing disease progression on crizotinib. Patients received ALUNBRIG 90 mg once daily continuously (90 mg group) or 90 mg once daily for 7 days followed by 180 mg once daily (90→180 mg group). The median duration of treatment was 7.5 months in the 90 mg group and 7.8 months in the 90→180 mg group. A total of 150 (68%) patients were exposed to ALUNBRIG for greater than or equal to 6 months and 42 (19%) patients were exposed for greater than or equal to one year.

The study population characteristics were: median age 54 years (range: 18 to 82), age less than 65 years (77%), female (57%), White (67%), Asian (31%), Stage IV disease (98%), NSCLC adenocarcinoma histology (97%), never or former smoker (95%), ECOG Performance Status (PS) 0 or 1 (93%), and brain metastases at baseline (69%) [see Clinical Studies].

Serious adverse reactions occurred in 38% of patients in the 90 mg group and 40% of patients in the 90→180 mg group. The most common serious adverse reactions were pneumonia (5.5% overall, 3.7% in the 90 mg group, and 7.3% in the 90→180 mg group) and ILD/pneumonitis (4.6% overall, 1.8% in the 90 mg group and 7.3% in the 90→180 mg group). Fatal adverse reactions occurred in 3.7% of patients and consisted of pneumonia (2 patients), sudden death, dyspnea, respiratory failure, pulmonary embolism, bacterial meningitis and urosepsis (1 patient each).

In ALTA, 2.8% of patients in the 90 mg group and 8.2% of patients in the 90→180 mg group permanently discontinued ALUNBRIG for adverse reactions. The most frequent adverse reactions that led to discontinuation were ILD/pneumonitis (0.9% in the 90 mg group and 1.8% in the 90→180 mg group) and pneumonia (1.8% in the 90→180 mg group only).

In ALTA, 14% of patients required a dose reduction due to adverse reactions (7.3% in the 90 mg group and 20% in the 90→180 mg group). The most common adverse reaction that led to dose reduction was increased creatine phosphokinase for both regimens (1.8% in the 90 mg group and 4.5% in the 90→180 mg group).

Table 3 and Table 4 summarize the common adverse reactions and laboratory abnormalities observed in ALTA.

Table 3: Adverse Reactions in ≥ 10% (All Grades*) or ≥ 2% (Grades 3-4) of Patients by Dose Group in ALTA (N=219)

Adverse Reactions 90 mg once daily
N = 109
90→180 mg once daily
N = 110
All Grades (%) Grades 3-4 (%) All Grades (%) Grades 3-4 (%)
Gastrointestinal Disorders
  Nausea 33 0.9 40 0.9
  Diarrhea 19 0 38 0
  Vomiting 24 1.8 23 0
  Constipation 19 0.9 15 0
  Abdominal Pain† 17 0 10 0
General Disorders And Administration Site Conditions
  Fatigue‡ 29 1.8 36 0
  Pyrexia 14 0 6.4 0.9
Respiratory, Thoracic And Mediastinal Disorders
  Cough 18 0 34 0
  Dyspnea§ 27 2.8 21 1.8‡‡
  ILD/Pneumonitis 3.7 1.8 9.1 2.7
  Hypoxia 0.9 0 2.7 2.7
Nervous System Disorders
  Headache¶ 28 0 27 0.9
  Peripheral Neuropathy# 13 0.9 13 1.8
Skin And Subcutaneous Tissue Disorders
  RashÞ 15 1.8 24 3.6
Vascular Disorders
  Hypertension 11 5.5 21 6.4
Musculoskeletal And Connective Tissue Disorders
  Muscle Spasms 12 0 17 0
  Back pain 10 1.8 15 1.8
  Myalgia** 9.2 0 15 0.9
  Arthralgia 14 0.9 14 0
  Pain in extremity 11 0 3.6 0.9
Metabolism And Nutrition Disorders
  Decreased Appetite 22 0.9 15 0.9
Eye Disorders
  Visual Disturbance†† 7.3 0 10 0.9
Infections
  Pneumonia 4.6 2.8‡‡ 10 5.5‡‡
Psychiatric Disorders
  Insomnia 11 0 7.3 0
*Per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
†Includes abdominal distension, abdominal pain, and epigastric discomfort
‡Includes asthenia and fatigue
§Includes dyspnea and exertional dyspnea
¶Includes headache and sinus headache
#Includes peripheral sensory neuropathy and paresthesia
ÞIncludes acneiform dermatitis, exfoliative rash, rash, pruritic rash, and pustular rash
**Includes musculoskeletal pain and myalgia
††Includes diplopia, photophobia, blurred vision, reduced visual acuity, visual impairment, vitreous floaters, visual field defect, macular edema, and vitreous detachment
‡‡Includes one Grade 5 event

Table 4: Laboratory Abnormalities in ≥ 20% (All Grades*) of Patients by Regimen in ALTA (N=219)

Laboratory Abnormality 90 mg once daily
N= 109
90→180 mg once daily
N=110
All Grades (%) Grades 3-4 (%) All Grades (%) Grades 3-4 (%)
Chemistry
  Increased aspartate aminotransferase 38 0.9 65 0
  Hyperglycemia† 38 3.7 49 3.6
  Increased creatine phosphokinase 27 2.8 48 12
  Increased lipase 21 4.6 45 5.5
  Increased alanine aminotransferase 34 0 40 2.7
  Increased amylase 27 3.7 39 2.7
  Increased alkaline phosphatase 15 0.9 29 0.9
  Decreased phosphorous 15 1.8 23 3.6
  Prolonged activated partial thromboplastin time 22 1.8 20 0.9
Hematology
  Anemia 23 0.9 40 0.9
  Lymphopenia 19 2.8 27 4.5
*Per CTCAE version 4.0
†Elevated blood insulin was also observed in both regimens

Read the entire FDA prescribing information for Alunbrig (Brigatinib Tablets)

QUESTION

Lung cancer is a disease in which lung cells grow abnormally in an uncontrolled way. See Answer
Related Resources for Alunbrig

© Alunbrig Patient Information is supplied by Cerner Multum, Inc. and Alunbrig Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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