Alecensa and Xalkori Comparison

Alecensa®(alectinib)	Xalkori®(crizotinib)
Prescription Only Alecensa is a medication that belongs to the class of tyrosine kinase inhibitors and can be used to treat non-small cell lung cancer (NSCLC) caused by a mutation in the ALK gene....	Prescription Only Xalkori is a cancer medication used to treat non-small cell lung cancer that has spread and is caused by a defect in ALK or ROS1 genes. It is also used to treat ALCL in young...
Administration
Oral with food. Learn more.	Oral. Learn more.
Dosing
600 mg twice daily. Learn more.	250 mg twice daily for metastatic NSCLC. Learn more.
Latin Shorthand
600mg BID. Learn more.	250 mg bid. Learn more.
Out-Of-Pocket Costs With Copay Card
$5. Learn more.	$0. Learn more.
Annual Cap
$25,000. Learn more.	$25,000. Learn more.
Assistance Expiration
Learn more.	6/30/2023. Learn more.
Generics
No lower-cost generic available	No lower-cost generic available
Adverse Reactions
The most common adverse reactions (incidence ≥20%) were fatigue, constipation, edema, myalgia, and anemia.. Learn more.	The most common adverse reactions (≥25%) in adult patients with NSCLC are vision disorders, nausea, diarrhea, vomiting, edema, constipation, elevated transaminases, fatigue, decreased appetite, upper respiratory infection, dizziness, and neuropathy. The most common adverse reactions (≥35%) in patients with ALCL are diarrhea, vomiting, nausea, vision disorder, headache, musculoskeletal pain, stomatitis, fatigue, decreased appetite, pyrexia, abdominal pain, cough, and pruritus. Grade 3–4 laboratory abnormalities (≥15%) are neutropenia, lymphopenia, and thrombocytopenia. The most common adverse reactions (≥35%) in adult patients with IMT are vision disorders, nausea, and edema. The most common adverse reactions (≥35%) in pediatric patients with IMT are vomiting, nausea, diarrhea, abdominal pain, rash, vision disorder, upper respiratory tract infection, cough, pyrexia, musculoskeletal pain, fatigue, edema, constipation, and headache. . Learn more.
Mechanism of Actions (MoA)
Kinase inhibitors. Learn more.	Receptor tyrosine kinase inhibitors; Cytochrome P450 2B6 inhibitors; Cytochrome P450 3A inhibitors; OCT2 inhibitors; OCT1 inhibitors. Learn more.
Special Populations
Can ALECENSA be used during pregnancy? No, ALECENSA can cause fetal harm when administered to a pregnant woman. It is advised to avoid using ALECENSA during pregnancy and advise pregnant women of the potential risk to a fetus. Can ALECENSA be used during lactation? No, there are no data on the presence of alectinib or its metabolites in human milk, the effects of alectinib on the breastfed infant, or its effects on milk production. It is advised to not breastfeed during treatment with ALECENSA and for 1 week after the final dose. Should females and males of reproductive potential use contraception during treatment with ALECENSA? Yes, females of reproductive potential should use effective contraception during treatment with ALECENSA and for 1 week after the final dose. Males with female partners of reproductive potential should also use effective contraception during treatment with ALECENSA and for 3 months following the final dose. Is ALECENSA safe for pediatric use? The safety and effectiveness of ALECENSA in pediatric patients have not been established. Is ALECENSA safe for geriatric use? Clinical studies of ALECENSA did not include a sufficient number of subjects aged 65 and older to determine whether they respond differently from younger subjects. Is ALECENSA safe for use in patients with renal or hepatic impairment? No dose adjustment is recommended for patients with mild or moderate renal impairment or mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment. However, the safety of ALECENSA in patients with severe renal impairment (creatinine clearance less than 30 mL/min) or end-stage renal disease and severe hepatic impairment (Child-Pugh C) is unknown.	Can XALKORI be used during pregnancy? XALKORI can cause fetal harm when administered to a pregnant woman based on findings from animal studies and its mechanism of action. There are no available data on the use of XALKORI during pregnancy. In animal reproduction studies, oral administration of crizotinib in pregnant rats during organogenesis at exposures similar to those expected with the maximum recommended human dose resulted in embryotoxicity and fetotoxicity. Therefore, pregnant women should be advised of the potential risk to fetus and XALKORI should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. What is the estimated background risk of birth defects and miscarriage in the U.S. general population? In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Is it safe to breastfeed while using XALKORI? There is no information regarding the presence of crizotinib or its metabolites in human milk, or the effects on the breastfed child or on milk production. Because of the potential for adverse reactions in breastfed children, women should not breastfeed during treatment with XALKORI and for 45 days after the final dose. Should pregnancy testing be performed before starting treatment with XALKORI? Yes, pregnancy testing should be performed prior to initiating XALKORI in females of reproductive potential. What should females of reproductive potential do during treatment with XALKORI? Females of reproductive potential should use effective contraception during treatment with XALKORI and for at least 45 days after the final dose because XALKORI can cause fetal harm when administered to a pregnant woman. What should males with female partners of reproductive potential do during treatment with XALKORI? Males with female partners of reproductive potential should use condoms during treatment with XALKORI and for at least 90 days after the final dose because of the potential for genotoxicity. Can XALKORI be used in pediatric patients? The safety and effectiveness of XALKORI have been established in pediatric patients 1 year of age and older with relapsed or refractory, systemic ALK-positive ALCL or with unresectable, recurrent, or refractory ALK-positive IMT. However, the safety and effectiveness have not been established in pediatric patients younger than 1 year. What percentage of patients with ALK-positive metastatic NSCLC in clinical studies of XALKORI were 65 years or older? 16% of the total number of patients with ALK-positive metastatic NSCLC in clinical studies of XALKORI were 65 years or older. What percentage of patients with ALK-positive metastatic NSCLC in clinical studies of XALKORI were 75 years or older? 3.8% of the total number of patients with ALK-positive metastatic NSCLC in clinical studies of XALKORI were 75 years or older. Were there any overall differences in safety or effectiveness observed between older patients and younger patients in clinical studies of XALKORI for ALK-positive metastatic NSCLC? No overall differences in safety or effectiveness were observed between older patients and younger patients in clinical studies of XALKORI for ALK-positive metastatic NSCLC. Were there sufficient numbers of patients age 65 years and older in clinical studies of XALKORI for ROS1-positive metastatic NSCLC to determine if they respond differently from younger patients? No, clinical studies of XALKORI in patients with ROS1-positive metastatic NSCLC did not include sufficient numbers of patients age 65 years and older to determine whether they respond differently from younger patients. What happens to crizotinib concentrations in patients with pre-existing moderate or severe hepatic impairment? Crizotinib concentrations increase in patients with pre-existing moderate or severe hepatic impairment. How should XALKORI dosage be adjusted in patients with moderate or severe hepatic impairment? XALKORI dosage should be reduced in patients with moderate or severe hepatic impairment. Is a dose adjustment recommended in patients with pre-existing mild hepatic impairment? No, a dose adjustment is not recommended in patients with pre-existing mild hepatic impairment. What happens to crizotinib exposure in patients with pre-existing severe renal impairment? Increased exposure to crizotinib occurs in patients with pre-existing severe renal impairment.

Alecensa®(alectinib)

Xalkori®(crizotinib)

Prescription Only

Alecensa is a medication that belongs to the class of tyrosine kinase inhibitors and can be used to treat non-small cell lung cancer (NSCLC) caused by a mutation in the ALK gene....

Prescription Only

Xalkori is a cancer medication used to treat non-small cell lung cancer that has spread and is caused by a defect in ALK or ROS1 genes. It is also used to treat ALCL in young...

Dosage & Administration

Administration

Oral with food. Learn more.

Oral. Learn more.

Dosing

600 mg twice daily. Learn more.

250 mg twice daily for metastatic NSCLC. Learn more.

Latin Shorthand

600mg BID. Learn more.

250 mg bid. Learn more.

Financial Assistance

Out-Of-Pocket Costs With Copay Card

$5. Learn more.

$0. Learn more.

Annual Cap

$25,000. Learn more.

Assistance Expiration

Learn more.

6/30/2023. Learn more.

Generics

No lower-cost generic available

Physician Advisory

Adverse Reactions

The most common adverse reactions (incidence ≥20%) were fatigue, constipation, edema, myalgia, and anemia.. Learn more.

The most common adverse reactions (≥25%) in adult patients with NSCLC are vision disorders, nausea, diarrhea, vomiting, edema, constipation, elevated transaminases, fatigue, decreased appetite, upper respiratory infection, dizziness, and neuropathy. The most common adverse reactions (≥35%) in patients with ALCL are diarrhea, vomiting, nausea, vision disorder, headache, musculoskeletal pain, stomatitis, fatigue, decreased appetite, pyrexia, abdominal pain, cough, and pruritus. Grade 3–4 laboratory abnormalities (≥15%) are neutropenia, lymphopenia, and thrombocytopenia. The most common adverse reactions (≥35%) in adult patients with IMT are vision disorders, nausea, and edema. The most common adverse reactions (≥35%) in pediatric patients with IMT are vomiting, nausea, diarrhea, abdominal pain, rash, vision disorder, upper respiratory tract infection, cough, pyrexia, musculoskeletal pain, fatigue, edema, constipation, and headache. . Learn more.

Mechanism of Actions (MoA)

Kinase inhibitors. Learn more.

Receptor tyrosine kinase inhibitors; Cytochrome P450 2B6 inhibitors; Cytochrome P450 3A inhibitors; OCT2 inhibitors; OCT1 inhibitors. Learn more.

Special Populations

Can ALECENSA be used during pregnancy?

No, ALECENSA can cause fetal harm when administered to a pregnant woman. It is advised to avoid using ALECENSA during pregnancy and advise pregnant women of the potential risk to a fetus.

Can ALECENSA be used during lactation?

No, there are no data on the presence of alectinib or its metabolites in human milk, the effects of alectinib on the breastfed infant, or its effects on milk production. It is advised to not breastfeed during treatment with ALECENSA and for 1 week after the final dose.

Should females and males of reproductive potential use contraception during treatment with ALECENSA?

Yes, females of reproductive potential should use effective contraception during treatment with ALECENSA and for 1 week after the final dose. Males with female partners of reproductive potential should also use effective contraception during treatment with ALECENSA and for 3 months following the final dose.

Is ALECENSA safe for pediatric use?

The safety and effectiveness of ALECENSA in pediatric patients have not been established.

Is ALECENSA safe for geriatric use?

Clinical studies of ALECENSA did not include a sufficient number of subjects aged 65 and older to determine whether they respond differently from younger subjects.

Is ALECENSA safe for use in patients with renal or hepatic impairment?

No dose adjustment is recommended for patients with mild or moderate renal impairment or mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment. However, the safety of ALECENSA in patients with severe renal impairment (creatinine clearance less than 30 mL/min) or end-stage renal disease and severe hepatic impairment (Child-Pugh C) is unknown.

Can XALKORI be used during pregnancy?

XALKORI can cause fetal harm when administered to a pregnant woman based on findings from animal studies and its mechanism of action. There are no available data on the use of XALKORI during pregnancy. In animal reproduction studies, oral administration of crizotinib in pregnant rats during organogenesis at exposures similar to those expected with the maximum recommended human dose resulted in embryotoxicity and fetotoxicity. Therefore, pregnant women should be advised of the potential risk to fetus and XALKORI should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

What is the estimated background risk of birth defects and miscarriage in the U.S. general population?

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Is it safe to breastfeed while using XALKORI?

There is no information regarding the presence of crizotinib or its metabolites in human milk, or the effects on the breastfed child or on milk production. Because of the potential for adverse reactions in breastfed children, women should not breastfeed during treatment with XALKORI and for 45 days after the final dose.

Should pregnancy testing be performed before starting treatment with XALKORI?

Yes, pregnancy testing should be performed prior to initiating XALKORI in females of reproductive potential.

What should females of reproductive potential do during treatment with XALKORI?

Females of reproductive potential should use effective contraception during treatment with XALKORI and for at least 45 days after the final dose because XALKORI can cause fetal harm when administered to a pregnant woman.

What should males with female partners of reproductive potential do during treatment with XALKORI?

Males with female partners of reproductive potential should use condoms during treatment with XALKORI and for at least 90 days after the final dose because of the potential for genotoxicity.

Can XALKORI be used in pediatric patients?

The safety and effectiveness of XALKORI have been established in pediatric patients 1 year of age and older with relapsed or refractory, systemic ALK-positive ALCL or with unresectable, recurrent, or refractory ALK-positive IMT. However, the safety and effectiveness have not been established in pediatric patients younger than 1 year.

What percentage of patients with ALK-positive metastatic NSCLC in clinical studies of XALKORI were 65 years or older?

16% of the total number of patients with ALK-positive metastatic NSCLC in clinical studies of XALKORI were 65 years or older.

What percentage of patients with ALK-positive metastatic NSCLC in clinical studies of XALKORI were 75 years or older?

3.8% of the total number of patients with ALK-positive metastatic NSCLC in clinical studies of XALKORI were 75 years or older.

Were there any overall differences in safety or effectiveness observed between older patients and younger patients in clinical studies of XALKORI for ALK-positive metastatic NSCLC?

No overall differences in safety or effectiveness were observed between older patients and younger patients in clinical studies of XALKORI for ALK-positive metastatic NSCLC.

Were there sufficient numbers of patients age 65 years and older in clinical studies of XALKORI for ROS1-positive metastatic NSCLC to determine if they respond differently from younger patients?

No, clinical studies of XALKORI in patients with ROS1-positive metastatic NSCLC did not include sufficient numbers of patients age 65 years and older to determine whether they respond differently from younger patients.

What happens to crizotinib concentrations in patients with pre-existing moderate or severe hepatic impairment?

Crizotinib concentrations increase in patients with pre-existing moderate or severe hepatic impairment.

How should XALKORI dosage be adjusted in patients with moderate or severe hepatic impairment?

XALKORI dosage should be reduced in patients with moderate or severe hepatic impairment.

Is a dose adjustment recommended in patients with pre-existing mild hepatic impairment?

No, a dose adjustment is not recommended in patients with pre-existing mild hepatic impairment.

What happens to crizotinib exposure in patients with pre-existing severe renal impairment?

Increased exposure to crizotinib occurs in patients with pre-existing severe renal impairment.

Alecensa® Alternatives