Question 1

What is Xalkori?

Accepted Answer

Xalkori is a prescription medication that works by blocking the action of abnormal proteins that signal cancer cells to multiply. By interfering with these signals, the drug helps to slow or stop the growth and spread of tumors.

As a targeted therapy, this medication focuses on specific molecular pathways involved in the development of certain cancers. It is designed to inhibit the activity of enzymes that contribute to the progression of malignant cells.

Question 2

What is Xalkori used for?

Accepted Answer

Xalkori is used to treat ALK-positive non-small cell lung cancer and ROS1-positive non-small cell lung cancer .

Question 3

How does Xalkori work?

Accepted Answer

Targeting Cancer Growth Signals

Xalkori belongs to a class of medications called kinase inhibitors. It works by targeting and blocking the activity of specific proteins in the body, including:

ALK (anaplastic lymphoma kinase)

ROS1

c-MET (hepatocyte growth factor receptor)

In certain types of cancer, these proteins are abnormal or overactive due to genetic changes. These abnormal proteins act like a permanent "on" switch, sending constant signals that tell cancer cells to divide, grow, and spread throughout the body.

How the Medication Works

Xalkori is designed to bind to these specific proteins and interfere with their signaling pathways. By blocking these signals, the medication can:

Slow down or stop the growth of the tumor.

Cause cancer cells to die.

Prevent the cancer from spreading to other parts of the body.

Because Xalkori targets specific proteins found mainly on cancer cells, it is considered a targeted therapy. Before starting treatment, doctors perform specialized tests to confirm that the tumor has the specific genetic markers, such as ALK or ROS1, that Xalkori is designed to treat.

Question 4

What are the active ingredients in Xalkori?

Accepted Answer

The active ingredient in Xalkori is crizotinib .

Question 5

What are the side effects of Xalkori?

Accepted Answer

Common side effects of Xalkori may include:

vision disorders

diarrhea

nausea

and others

Always consult with a healthcare professional about potential side effects.

Question 6

What drug class is Xalkori?

Accepted Answer

Xalkori belongs to the ALK and ROS1 tyrosine kinase inhibitor drug class.

Question 7

What is the dosage of Xalkori and how do I take it?

Accepted Answer

How to Take Xalkori

Xalkori comes as a capsule to be taken by mouth. It is usually taken twice a day. It is important to take this medication at approximately the same times every day to maintain a consistent amount of medicine in your body. You may take Xalkori with or without food.

Administration Instructions

Swallow capsules whole: Do not crush, chew, dissolve, or open the capsules before swallowing.

Vomiting: If you vomit after taking a dose of Xalkori, do not take an additional dose. Wait and take your next scheduled dose at the regular time.

Missed Doses

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take two doses at once to make up for a missed one. Consult your healthcare provider if you are unsure when to take your next dose after missing one.

Question 8

Is Xalkori safe during pregnancy and breastfeeding?

Accepted Answer

Pregnancy

Xalkori may cause fetal harm when administered to a pregnant woman. Before starting treatment, healthcare providers typically perform a pregnancy test for individuals who can become pregnant to ensure they are not pregnant.

Because of the risks to a developing baby, the following precautions are usually recommended:

Contraception for women: Use effective birth control during treatment and for at least 4 months after the final dose.

Contraception for men: Use condoms during treatment and for at least 4 months after the final dose when with a partner who can become pregnant.

If you become pregnant or think you might be pregnant while taking this medication, notify your healthcare provider immediately.

Breastfeeding

It is not known if Xalkori passes into breast milk. Because of the potential for serious adverse reactions in a nursing child, it is recommended that individuals do not breastfeed while taking this medication and for 45 days after the last dose. Patients should discuss the best way to feed their baby with a healthcare professional during this time.

Question 9

What forms and strengths does Xalkori come in?

Accepted Answer

Xalkori is available in two oral formulations:

Capsules: These are intended to be swallowed whole.

Oral Pellets: These are provided in a capsule that must be opened. The pellets are then sprinkled on soft food or mixed with a liquid for administration.

The medication is available in various strengths to accommodate different dosing requirements for adults and children.

Question 10

What is the FDA approval status of Xalkori?

Accepted Answer

FDA Approval History

Xalkori was first granted accelerated approval by the U.S. Food and Drug Administration (FDA) in 2011. Since its initial release, the FDA has expanded its approved uses to include several different types of cancer characterized by specific genetic alterations.

Approved Indications

The FDA has approved Xalkori for the following uses:

Non-Small Cell Lung Cancer (NSCLC): For adults with metastatic NSCLC whose tumors are positive for the ALK (anaplastic lymphoma kinase) or ROS1 gene.

Anaplastic Large Cell Lymphoma (ALCL): For pediatric patients (1 year and older) and young adults with ALK-positive systemic ALCL that has returned or did not respond to other treatments.

Inflammatory Myofibroblastic Tumor (IMT): For adults and pediatric patients (1 year and older) with ALK-positive IMT that cannot be removed by surgery, has returned, or did not respond to other treatments.

Regulatory Requirements

Xalkori is a prescription medication. Before starting treatment, the FDA requires healthcare providers to confirm the presence of the ALK or ROS1 biomarkers using an FDA-approved diagnostic test. This ensures the medication is targeted to patients with the specific genetic profiles that the drug is designed to treat.

Safety Monitoring

While Xalkori does not currently have a boxed warning, the FDA monitors its safety profile for serious risks. These include potential liver toxicity, interstitial lung disease (lung inflammation), heart rhythm changes (QT prolongation), and vision loss. Healthcare providers are advised to monitor patients regularly for these conditions during treatment.

Question 11

What should I know about Xalkori and fda?

Accepted Answer

FDA Approval History

Xalkori (crizotinib) first received FDA approval in August 2011. It was initially approved under the agency's accelerated approval program, which allows for earlier access to drugs that treat serious conditions based on promising clinical trial data. Since then, the FDA has expanded its approved uses to include several different conditions characterized by specific genetic mutations.

Approved Indications

Non-Small Cell Lung Cancer (NSCLC): Xalkori is approved for adults with metastatic NSCLC whose tumors are positive for the anaplastic lymphoma kinase (ALK) or ROS1 gene.

Anaplastic Large Cell Lymphoma (ALCL): In 2021, the FDA approved Xalkori for pediatric patients 1 year of age and older and young adults with ALK-positive ALCL that has returned or did not respond to previous treatments.

Inflammatory Myofibroblastic Tumor (IMT): In 2022, the FDA approved the medication for adult and pediatric patients 1 year of age and older with ALK-positive IMT that is unresectable, recurrent, or refractory.

The FDA requires specific diagnostic tests to confirm the presence of ALK or ROS1 mutations before treatment begins, as the drug is only effective in patients with these specific genetic markers.

Xalkori

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