Alecensa
- Generic Name: alectinib capsules
- Brand Name: Alecensa
- Drug Class: Antineoplastic Tyrosine Kinase Inhibitors
Alecensa (Alectinib Capsules) side effects drug center
Alecensa Side Effects Center
What Is Alecensa?
Alecensa (alectinib) 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. This indication is approved under accelerated approval based on tumor response rate and duration of response.
What Are Side Effects of Alecensa?
Common side effects of Alecensa include fatigue, constipation, swelling, and muscle pain.
Dosage for Alecensa
The dose of Alecensa is 600 mg orally twice daily with food.
What Drugs, Substances, or Supplements Interact with Alecensa?
Alecensa may interact with other drugs. Tell your doctor all medications and supplements you use.
Alecensa During Pregnancy and Breastfeeding
Alecensa is not recommended for use during pregnancy; it may harm a fetus. Alecensa is not recommended for use while breastfeeding.
Additional Information
Our Alecensa (alectinib) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Alecensa Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- a very slow heart rate;
- a light-headed feeling, like you might pass out;
- unexplained muscle pain, tenderness, or weakness;
- lung problems--sudden chest pain or discomfort, wheezing, dry cough or cough with mucus, feeling short of breath;
- low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed, cold hands and feet;
- kidney problems--a change in your urine color, little or no urination, swelling in your feet or ankles; or
- liver problems--stomach pain (upper right side), loss of appetite, easy bruising or bleeding, feeling tired, dark urine, jaundice (yellowing of the skin or eyes).
Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.
Common side effects may include:
- anemia;
- constipation;
- swelling in your face, eyelids, hands, or lower legs;
- tired feeling; or
- muscle pain.
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.
Read the entire detailed patient monograph for Alecensa (Alectinib Capsules)
Alecensa Professional Information
SIDE EFFECTS
The following adverse reactions are discussed in greater detail in other sections of the label:
- Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
- Interstitial Lung Disease (ILD)/Pneumonitis [see WARNINGS AND PRECAUTIONS]
- Renal Impairment [see WARNINGS AND PRECAUTIONS]
- Bradycardia [see WARNINGS AND PRECAUTIONS]
- Severe Myalgia and Creatine Phosphokinase (CPK) Elevation [see WARNINGS AND PRECAUTIONS]
- Embryo-Fetal Toxicity [see WARNINGS AND PRECAUTIONS]
Clinical Trials 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.
Previously Untreated ALK-Positive Metastatic NSCLC
The safety of ALECENSA was evaluated in 152 patients with ALK-positive NSCLC in the ALEX study. The median duration of exposure to ALECENSA was 17.9 months. Patient characteristics of the ALEX study population (n=303) were: median age 56 years, age less than 65 (77%), female (56%), Caucasian (50%), Asian (46%), adenocarcinoma histology (92%), never smoker (63%), and ECOG PS 0 or 1 (93%).
Serious adverse reactions occurred in 28% of patients treated with ALECENSA; serious adverse reactions reported in 2% or more of patients treated with ALECENSA were pneumonia (4.6%), and renal impairment (3.9%). Grade ≥3 adverse events were reported for 41% of patients in the ALECENSA arm. Fatal adverse reactions occurred in 3.3% of patients treated with ALECENSA; these were renal impairment (2 patients), sudden death, cardiac arrest, and pneumonia (1 patient each). Permanent discontinuation of ALECENSA for adverse reactions occurred in 11% of patients. Adverse drug reactions that led to discontinuation of ALECENSA in 1% or more of patients were renal impairment (2.0%), hyperbilirubinemia (1.3%), increased ALT (1.3%), and increased AST (1.3%). Dose reductions and drug interruption due to adverse reactions occurred in 16% and 19% of patients, respectively, in the ALECENSA arm. The most frequent adverse reactions that led to dose modifications in the ALECENSA arm were hyperbilirubinemia (6%), increased AST (5%), increased ALT (4.6%), and pneumonia (3.3%).
Tables 3 and 4 summarize the common adverse reactions and laboratory abnormalities observed in ALEX.
Table 3: Adverse Drug Reactions (>10% for all NCI CTCAE Grades or ≥2% for Grades 3-4) in Patients Treated with ALECENSA in ALEX
| Adverse Reaction | Alecensa N = 152 | Crizotinib N= 151 | ||
| All Grades (%) | Grades 3-4 (%) | All Grades (%) | Grades 3-4 (%) | |
| Gastrointestinal | ||||
| Constipation | 34 | 0 | 33 | 0 |
| Nausea | 14 | 0.7 | 48 | 3.3 |
| Diarrhea | 12 | 0 | 45 | 2.0 |
| Vomiting | 7 | 0 | 38 | 3.3 |
| General | ||||
| Fatiguea | 26 | 1.3 | 23 | 0.7 |
| Edemab | 22 | 0.7 | 34 | 0.7 |
| Musculoskeletal | ||||
| Myalgiac | 23 | 0 | 4.0 | 0 |
| Skin | ||||
| Rashd | 15 | 0.7 | 13 | 0 |
| Nervous system | ||||
| Dysgeusiae | 3.3 | 0.7 | 19 | 0 |
| Eye | ||||
| Vision disordersf | 4.6 | 0 | 23 | 0 |
| Cardiac | ||||
| Bradycardiag | 11 | 0 | 15 | 0 |
| Renal | ||||
| Renal impairmenth | 12 | 3.9* | 0 | 0 |
| NCI CTCAE= National Cancer Institute Common Terminology Criteria for Adverse Events; MedDRA =Medical Dictionary for Regulatory Activities; SOC =System Organ Class. a Includes fatigue and asthenia. b Includes peripheral edema, edema, eyelid edema, localized edema, and face edema. c Includes myalgia and musculoskeletal pain. d Includes rash, rash maculo-papular, dermatitis acneiform, erythema, generalized rash, rash macular, rash papular, exfoliative rash, and pruritic rash. e Includes dysgeusia and hypogeusia. f Includes blurred vision, visual impairment, vitreous floaters, reduced visual acuity, and diplopia. g Includes reported cases of bradycardia and sinus bradycardia but is not based on serial ECG assessment. h Includes increased blood creatinine, creatinine renal clearance decreased, glomerular filtration rate decreased, and acute kidney injury. * Includes two Grade 5 events. | ||||
The following additional clinically significant adverse drug reactions were observed in patients treated with ALECENSA: weight gain (9.9%), photosensitivity reaction (5.3%), stomatitis (3.3%), interstitial lung disease (1.3%), and drug-induced liver injury (1.3%).
Table 4: Treatment-Emergent Worsening in Laboratory Values Occurring in> 10% of Patients in ALEX
| Parameter | ALECENSA N= 152 | Crizotinib N=151 | ||
| All Grades (%) | Grades 3–4 (%) | All Grades (%) | Grades 3–4 (%) | |
| Chemistry | ||||
| Hyperbilirubinemiaa | 54 | 5 | 4.7 | 0 |
| Increased ASTb | 50 | 6 | 56 | 11 |
| Increased alkaline phosphatasec | 50 | 0 | 44 | 0 |
| Increased ALTc | 40 | 6 | 62 | 16 |
| Increased creatininec,d | 38 | 4.1 | 23 | 0.7 |
| Increased CPKe | 37 | 2.8 | 52 | 1.4 |
| Hypocalcemiaa | 29 | 0 | 61 | 1.4 |
| Hyperglycemiaf | 22 | 2.2 | 19 | 2.3 |
| Hyponatremiag | 18 | 6 | 20 | 4.1 |
| Hypokalemiac | 17 | 2 | 12 | 0.7 |
| Hypoalbuminemiah | 14 | 0 | 57 | 3.4 |
| Hyperkalemiac | 12 | 1.4 | 16 | 1.4 |
| Hypophosphatemiai | 9 | 1.4 | 25 | 2.7 |
| Increased gamma glutamyl transferasej | 7 | 0.7 | 39 | 4.1 |
| Hematology | ||||
| Anemiac | 62 | 7 | 36 | 0.7 |
| Lymphopeniaa | 14 | 1.4 | 34 | 4.1 |
| Neutropeniac | 14 | 0 | 36 | 7 |
| Note: Based on National Cancer Institute Common Terminology Criteria for Adverse Events v4.03. Excludes patients with no post-baseline lab assessments. a n=147 for alectinib (with baseline values missing for 1 of these patients), n=148 for crizotinib. b n=147 for alectinib (with baseline values missing for 2 of these patients), n=148 for crizotinib. c n=147 for alectinib, n=148 for crizotinib. d Only patients with creatinine increases based on ULN definition. e n=143 for alectinib (with baseline values missing for 14 of these patients), n=143 for crizotinib (with baseline values missing for 13 of these patients). f n=134 for alectinib (with baseline values missing for 18 of these patients), n=131 for crizotinib (with baseline values missing for 8 of these patients). g n=147 for alectinib, n=148 for crizotinib (with baseline values missing for 1 of these patients). h n=146 for alectinib (with baseline values missing for 1 of these patients), n=148 for crizotinib (with baseline values missing for 1 of these patients). i n=145 for alectinib (with baseline values missing for 2 of these patients), n=148 for crizotinib (with baseline values missing for 4 of these patients). j n=143 for alectinib (with baseline values missing for 4 of these patients), n=148 (with baseline values missing for 5 of these patients). | ||||
ALK-Positive Metastatic NSCLC Previously Treated With Crizotinib
The safety of ALECENSA was evaluated in 253 patients with ALK-positive non-small cell lung cancer (NSCLC) treated with ALECENSA in two clinical trials, Studies NP28761 and NP28673. The median duration of exposure to ALECENSA was 9.3 months. One hundred sixty-nine patients (67%) were exposed to ALECENSA for more than 6 months, and 100 patients (40%) for more than one year. The population characteristics were: median age 53 years, age less than 65 (86%), female (55%), White (74%), Asian (18%), NSCLC adenocarcinoma histology (96%), never or former smoker (98%), ECOG Performance Status (PS) 0 or 1 (91%), and prior chemotherapy treatment (78%).
Serious adverse reactions occurred in 19% of patients; the most frequently reported serious adverse reactions were pulmonary embolism (1.2%), dyspnea (1.2%), and hyperbilirubinemia (1.2%). Fatal adverse reactions occurred in 2.8% of patients and included hemorrhage (0.8%), intestinal perforation (0.4%), dyspnea (0.4%), pulmonary embolism (0.4%), and endocarditis (0.4%). Permanent discontinuation of ALECENSA for adverse reactions occurred in 6% of patients. The most frequent adverse reactions that led to permanent discontinuation were hyperbilirubinemia (1.6%), increased ALT levels (1.6%), and increased AST levels (1.2%). Overall, 23% of patients initiating treatment at the recommended dose required at least one dose reduction. The median time to first dose reduction was 48 days. The most frequent adverse reactions that led to dose reductions or interruptions were elevations in bilirubin (6%), CPK (4.3%), ALT (4.0%), and AST (2.8%), and vomiting (2.8%).
Tables 5 and 6 summarize the common adverse reactions and laboratory abnormalities observed in Studies NP28761 and NP28673.
Table 5: Adverse Reactions in ≥ 10% (All Grades) or ≥ 2% (Grade 3–4) of Patients in Studies NP28761 and NP28673
| Adverse Reactions | ALECENSA N=253 | |
| All Grades (%) | Grades 3–4 (%)* | |
| Fatiguea | 41 | 1.2 |
| Constipation | 34 | 0 |
| Edemab | 30 | 0.8 |
| Myalgiac | 29 | 1.2 |
| Cough | 19 | 0 |
| Rashd | 18 | 0.4 |
| Nausea | 18 | 0 |
| Headache | 17 | 0.8 |
| Diarrhea | 16 | 1.2 |
| Dyspnea | 16 | 3.6e |
| Back pain | 12 | 0 |
| Vomiting | 12 | 0.4 |
| Increased weight | 11 | 0.4 |
| Vision disorderf | 10 | 0 |
| * Per Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 a Includes fatigue and asthenia. b Includes peripheral edema, edema, generalized edema, eyelid edema, and periorbital edema. c Includes myalgia and musculoskeletal pain. d Includes rash, maculopapular rash, acneiform dermatitis, erythema, generalized rash, papular rash, pruritic rash, and macular rash. e Includes one Grade 5 event. f Includes blurred vision, vitreous floaters, visual impairment, reduced visual acuity, asthenopia, and diplopia. | ||
An additional clinically significant adverse drug reaction was photosensitivity, which occurred in 9.9% of patients exposed to ALECENSA in Studies NP28761 and NP28673. Patients were advised to avoid sun exposure and to use broad-spectrum sunscreen. The incidence of Grade 2 photosensitivity was 0.4%; the remaining events were Grade 1 in severity.
Table 6: Treatment-Emergent Worsening in Laboratory Values Occurring in > 20% of Patients in Studies NP28761 and NP28673
| Parameter | ALECENSA N=250 | |
| All Grades (%) | Grades 3–4 (%)* | |
| Chemistry | ||
| Increased AST | 51 | 3.6 |
| Increased Alkaline Phosphatase | 47 | 1.2 |
| Increased CPKa | 43 | 4.6 |
| Hyperbilirubinemia | 39 | 2.4 |
| Hyperglycemiab | 36 | 2.0 |
| Increased ALT | 34 | 4.8 |
| Hypocalcemia | 32 | 0.4 |
| Hypokalemia | 29 | 4.0 |
| Increased Creatininec | 28 | 0 |
| Hypophosphatemia | 21 | 2.8 |
| Hyponatremia | 20 | 2.0 |
| Hematology | ||
| Anemia | 56 | 2.0 |
| Lymphopeniad | 22 | 4.6 |
| * Per CTCAE version 4.0 a n=218 for CPK (with baseline values missing for 91 of these patients). b n=152 for fasting blood glucose (with baseline values missing for 5 of these patients). c Only patients with creatinine increases based on ULN definition. d n=217 for lymphocytes (with baseline values missing for 5 of these patients). | ||
Read the entire FDA prescribing information for Alecensa (Alectinib Capsules)
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