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Drug overview for ALECENSA (alectinib hydrochloride):
Generic name: ALECTINIB HYDROCHLORIDE (al-EK-ti-nib)
Drug class: Antineoplastic - Protein-Tyrosine Kinase Inhibitors
Therapeutic class: Antineoplastics
Alectinib hydrochloride, an inhibitor of several receptor tyrosine kinases including anaplastic lymphoma kinase (ALK), is an antineoplastic agent.
No enhanced Uses information available for this drug.
Generic name: ALECTINIB HYDROCHLORIDE (al-EK-ti-nib)
Drug class: Antineoplastic - Protein-Tyrosine Kinase Inhibitors
Therapeutic class: Antineoplastics
Alectinib hydrochloride, an inhibitor of several receptor tyrosine kinases including anaplastic lymphoma kinase (ALK), is an antineoplastic agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for ALECENSA (alectinib hydrochloride) have been approved by the FDA:
Indications:
Anaplastic lymphoma kinase positive non-small cell lung cancer
Professional Synonyms:
ALK positive NSCLC
Indications:
Anaplastic lymphoma kinase positive non-small cell lung cancer
Professional Synonyms:
ALK positive NSCLC
The following dosing information is available for ALECENSA (alectinib hydrochloride):
Dosage of alectinib hydrochloride is expressed in terms of alectinib.
When dosage reduction is necessary, an initial dosage reduction to 450 mg twice daily is recommended. If further dosage reduction is necessary, the dosage should be reduced to 300 mg twice daily. If a dosage of 300 mg twice daily is not tolerated, alectinib should be discontinued.
When dosage reduction is necessary, an initial dosage reduction to 450 mg twice daily is recommended. If further dosage reduction is necessary, the dosage should be reduced to 300 mg twice daily. If a dosage of 300 mg twice daily is not tolerated, alectinib should be discontinued.
Alectinib hydrochloride is administered orally twice daily with food. The capsules should be swallowed whole and should not be dissolved or opened. If a dose of alectinib is missed or vomiting occurs after administration of a dose, take the next dose at the regularly scheduled time.
Do not store the capsules at temperatures above 30degreesC. Store in the original container to protect the drug from light and moisture.
Do not store the capsules at temperatures above 30degreesC. Store in the original container to protect the drug from light and moisture.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ALECENSA 150 MG CAPSULE | Maintenance | Adults take 4 capsules (600 mg) by oral route 2 times per day |
No generic dosing information available.
The following drug interaction information is available for ALECENSA (alectinib hydrochloride):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for ALECENSA (alectinib hydrochloride):
Drug contraindication overview.
*None.
*None.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Lactation |
There are 6 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Bradycardia |
| Child-pugh class C hepatic impairment |
| Disease of liver |
| Gastrointestinal perforation |
| Myopathy with CK elevation |
| Pregnancy |
There are 0 moderate contraindications.
The following adverse reaction information is available for ALECENSA (alectinib hydrochloride):
Adverse reaction overview.
Adverse effects reported in 20% or more of patients receiving alectinib in clinical trials include hepatotoxicity, constipation, fatigue, myalgia, edema, rash, and cough.
Adverse effects reported in 20% or more of patients receiving alectinib in clinical trials include hepatotoxicity, constipation, fatigue, myalgia, edema, rash, and cough.
There are 19 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Anemia Hepatitis Hypokalemia Increased alanine transaminase Increased aspartate transaminase |
Abnormal hepatic function tests Bradycardia Dyspnea Hyperbilirubinemia Hyperkalemia Kidney disease with reduction in glomerular filtration rate (GFr) Lymphopenia |
| Rare/Very Rare |
|---|
|
Endocarditis Gastrointestinal perforation Hemolytic anemia Hemorrhage Interstitial lung disease Interstitial pneumonitis Pulmonary thromboembolism |
There are 18 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Constipation Edema Fatigue Hyperglycemia Increased creatine kinase level Musculoskeletal pain Myalgia |
Back pain Cough Diarrhea Headache disorder Nausea Skin photosensitivity Skin rash Stomatitis Visual changes Vomiting Weight gain |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for ALECENSA (alectinib hydrochloride):
Safety and efficacy of alectinib have not been established in pediatric patients. In animal toxicology studies, alectinib has been associated with changes in growing teeth (discoloration, changes in tooth size, histopathologic disarrangement of ameloblast and odontoblast layers) and bones (decreases in trabecular bone, increased osteoclast activity).
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Based on findings from animal studies and its mechanism of action, alectinib may cause fetal harm if administered to pregnant females.
It is not known whether alectinib or its metabolites are distributed into human milk. Because of the potential for serious adverse reactions to alectinib in nursing infants, women should be advised not to breast-feed while receiving the drug and for 1 week after the last dose.
In clinical studies, 19% of 533 patients were 65 years of age and older and 3.2% were 75 years of age and older. No overall differences in effectiveness based on age were observed. Exploratory analysis suggests that patients 65 years of age or older experience an increased incidence of serious adverse events (38% versus 25%), more adverse events leading to treatment discontinuation (18% versus 6%), and more adverse events leading to dose modifications (48% versus 35%) as compared to patients younger than 65 years of age.
The following prioritized warning is available for ALECENSA (alectinib hydrochloride):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ALECENSA (alectinib hydrochloride)'s list of indications:
| ALK positive non-small cell lung cancer | |
| C34 | Malignant neoplasm of bronchus and lung |
| C34.0 | Malignant neoplasm of main bronchus |
| C34.00 | Malignant neoplasm of unspecified main bronchus |
| C34.01 | Malignant neoplasm of right main bronchus |
| C34.02 | Malignant neoplasm of left main bronchus |
| C34.1 | Malignant neoplasm of upper lobe, bronchus or lung |
| C34.10 | Malignant neoplasm of upper lobe, unspecified bronchus or lung |
| C34.11 | Malignant neoplasm of upper lobe, right bronchus or lung |
| C34.12 | Malignant neoplasm of upper lobe, left bronchus or lung |
| C34.2 | Malignant neoplasm of middle lobe, bronchus or lung |
| C34.3 | Malignant neoplasm of lower lobe, bronchus or lung |
| C34.30 | Malignant neoplasm of lower lobe, unspecified bronchus or lung |
| C34.31 | Malignant neoplasm of lower lobe, right bronchus or lung |
| C34.32 | Malignant neoplasm of lower lobe, left bronchus or lung |
| C34.8 | Malignant neoplasm of overlapping sites of bronchus and lung |
| C34.80 | Malignant neoplasm of overlapping sites of unspecified bronchus and lung |
| C34.81 | Malignant neoplasm of overlapping sites of right bronchus and lung |
| C34.82 | Malignant neoplasm of overlapping sites of left bronchus and lung |
| C34.9 | Malignant neoplasm of unspecified part of bronchus or lung |
| C34.90 | Malignant neoplasm of unspecified part of unspecified bronchus or lung |
| C34.91 | Malignant neoplasm of unspecified part of right bronchus or lung |
| C34.92 | Malignant neoplasm of unspecified part of left bronchus or lung |
| C39.9 | Malignant neoplasm of lower respiratory tract, part unspecified |
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