Alecensa

Approved Uses

Alecensa is primarily used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC). It is specifically indicated for cases where the cancer is ALK-positive, meaning the cancer cells have a specific mutation in the anaplastic lymphoma kinase (ALK) gene.

This medication is used in the following situations:

• Metastatic Lung Cancer: It is used to treat ALK-positive NSCLC that has already spread to other parts of the body.
• Post-Surgery Treatment: It may be used as an adjuvant treatment, which means it is given after the surgical removal of a tumor to help prevent the cancer from returning in patients with ALK-positive NSCLC.

Before starting this treatment, a healthcare provider will perform a specific test to confirm that the cancer is ALK-positive, as the drug is only effective for this genetic profile.

Targeting ALK Proteins

Alecensa is a type of targeted therapy known as a kinase inhibitor. It is specifically used to treat non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) positive. In this form of cancer, a genetic rearrangement causes the body to produce an abnormal ALK protein. This protein acts as a signal that tells cancer cells to divide and multiply rapidly.

Alecensa works by identifying and attaching to these abnormal ALK proteins. By blocking the protein's activity, the medication interferes with the growth signals, which can help to:

• Slow down or stop the growth of the tumor.
• Prevent cancer cells from spreading to other parts of the body.
• Shrink existing tumors.

Crossing the Blood-Brain Barrier

A key characteristic of Alecensa is its ability to cross the blood-brain barrier. This is a protective membrane that prevents many substances and medications from entering the brain and central nervous system. Because Alecensa can pass through this barrier, it is effective at treating cancer cells that have spread to the brain and may help prevent the development of new tumors in the central nervous system.

Common Side Effects

While taking Alecensa, some individuals may experience mild to moderate side effects. Common symptoms include:

• Fatigue and exhaustion
• Constipation
• Swelling in the hands, feet, or around the eyes
• Muscle aches or pains
• Coughing
• Headache
• Nausea
• Skin rash

Serious Side Effects

Alecensa can cause serious complications that require prompt medical evaluation. Seek medical help if you notice:

• Liver issues: Signs include yellowing of the skin or eyes, dark-colored urine, or pain in the upper right side of the abdomen.
• Lung inflammation: New or worsening breathing difficulties, shortness of breath, or fever.
• Slow heart rate: Feeling dizzy, lightheaded, or fainting due to a decreased heart rate.
• Muscle damage: Severe or persistent muscle pain and weakness.
• Kidney problems: Changes in urination or significant swelling in the lower limbs.

Alecensa may also increase your sensitivity to sunlight. It is recommended to use sunscreen and wear protective clothing while outdoors during treatment and for a short period after stopping the medication.

Liver Toxicity

Alecensa can cause serious liver injury. Healthcare providers typically monitor liver function through blood tests every two weeks for the first three months of treatment, and then once a month or as needed. Signs of liver problems may include yellowing of the skin or eyes, dark urine, or pain on the right side of the stomach area.

Lung Problems

Severe or life-threatening inflammation of the lungs, known as interstitial lung disease or pneumonitis, can occur. It is important to monitor for new or worsening respiratory symptoms, such as shortness of breath, cough, or fever.

Heart Rate and Blood Pressure

This medication may cause a slow heartbeat (bradycardia). Heart rate and blood pressure are usually checked regularly. Symptoms of a slow heart rate can include dizziness, lightheadedness, or feeling faint.

Muscle Pain and Kidney Issues

Increased levels of an enzyme called creatine phosphokinase (CPK) and muscle pain (myalgia) are common. Severe muscle issues can sometimes lead to kidney problems. Healthcare providers may monitor CPK levels during treatment.

Hemolytic Anemia

A condition where red blood cells are destroyed faster than they can be made (hemolytic anemia) has been reported. If symptoms of anemia occur, such as pale skin or extreme tiredness, a healthcare provider may perform blood tests.

Sun Sensitivity

Alecensa can make the skin more sensitive to sunlight (photosensitivity). It is recommended to avoid prolonged sun exposure and use broad-spectrum sunscreen and protective clothing while taking this medicine and for seven days after the final dose.

Pregnancy and Reproduction

This medication can cause harm to a developing fetus. Effective contraception should be used by both females and males with female partners of reproductive potential during treatment and for a specific duration after the last dose.

Pregnancy

Alecensa may cause fetal harm when administered to a pregnant woman. Animal studies have indicated that the medication can lead to birth defects or pregnancy loss. It is important to inform a healthcare provider if you are pregnant or planning to become pregnant before starting this treatment.

Contraception Requirements

Because of the potential risks to a fetus, healthcare providers recommend using effective birth control during treatment. The specific timelines for contraception include:

• For women: Use effective birth control during treatment and for at least 1 week after the final dose.
• For men: Men with female partners who are able to become pregnant should use effective birth control during treatment and for 3 months after the final dose.

Breastfeeding

It is currently unknown if Alecensa passes into human breast milk. Because of the potential for serious adverse reactions in a nursing infant, breastfeeding is not recommended during treatment and for 1 week after the final dose. Patients should discuss alternative feeding options with their healthcare team.

Available Forms

Alecensa is supplied as a hard capsule intended for oral administration. It is taken by mouth, typically twice a day with food.

Administration Considerations

• Capsules should be swallowed whole.
• Do not open, crush, dissolve, or chew the capsules.
• If a capsule is damaged or broken, avoid touching the powder inside.

FDA Approval History

Alecensa was first granted accelerated approval by the U.S. Food and Drug Administration (FDA) in December 2015. It received full approval in November 2017 for the treatment of patients with metastatic ALK-positive non-small cell lung cancer (NSCLC).

Approved Indications

The FDA has approved Alecensa for the following uses:

• Metastatic NSCLC: For the treatment of patients whose lung cancer has spread to other parts of the body and tests positive for the ALK gene mutation.
• Adjuvant Treatment: In April 2024, the FDA expanded the approval to include use as an adjuvant treatment (treatment after the primary tumor is surgically removed) for patients with ALK-positive NSCLC whose tumors are at least 4 centimeters or whose cancer has spread to the lymph nodes.

Regulatory Status and Safety

Alecensa is a prescription-only medication. There are currently no Boxed Warnings or Risk Evaluation and Mitigation Strategies (REMS) required by the FDA for this drug. It was granted Breakthrough Therapy Designation and Priority Review during its clinical development for both metastatic and adjuvant settings due to its potential to address unmet medical needs in lung cancer treatment.

Insurance and Coverage

The out-of-pocket cost for Alecensa is largely determined by your health insurance plan. Most plans require prior authorization for this medication, and your specific co-pay or co-insurance will depend on your plan's specialty drug tier.

Generic Availability

Alecensa is a brand-name medication, and there is currently no generic version of alectinib available. Generic drugs usually cost less than brand-name versions, so the lack of a generic option may contribute to higher costs.

Financial Assistance Programs

The manufacturer may offer support programs to help reduce the cost for eligible patients. These options often include:

• Co-pay cards: For patients with commercial insurance to help lower monthly out-of-pocket expenses.
• Patient assistance programs: For individuals who are uninsured or underinsured and meet specific income requirements.

Patients should consult with their healthcare provider or a financial counselor at their treatment center to explore available resources.