Ensacove (ensartinib) Uses and Dosage

Ensacove (generic name: ensartinib) is an oral medication recently approved by USFDA for the treatment of adults with non-small cell lung cancer (NSCLC) that is locally advanced or metastatic and is characterized by an abnormal anaplastic lymphoma kinase (ALK) gene.

What is Non-small cell lung cancer (NSCLC) ?

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for about 85% of all lung cancer cases. It refers to a group of lung cancers that behave similarly, including three primary subtypes:

Adenocarcinoma

• The most common type of NSCLC.

• Often occurs in the outer parts of the lungs.

• More likely to develop in non-smokers, although it is still strongly linked to smoking.

• Typically grows slower than other types and may be detected before it spreads.

Squamous Cell Carcinoma

• Arises in the thin, flat cells lining the airways.

• Usually found in the central parts of the lungs, near the main bronchial tubes.

• Closely associated with a history of smoking.

Large Cell Carcinoma

• Can occur in any part of the lung.

• Grows and spreads more quickly than the other types of NSCLC.

• Less common than adenocarcinoma and squamous cell carcinoma.

Causes and Risk Factors

The primary risk factors for NSCLC include:

• Smoking: The leading cause, although nonsmokers can also develop NSCLC.

• Exposure to secondhand smoke.

• Environmental toxins: Such as radon gas, asbestos, and air pollution.

• Family history of lung cancer.

• Occupational exposure: To chemicals like arsenic and diesel exhaust.
  

Symptoms

NSCLC symptoms often develop in later stages and may include:

• Persistent cough.

• Shortness of breath.

• Chest pain.

• Unexplained weight loss.

• Fatigue.

• Blood in sputum (hemoptysis).

Diagnosis of NSCLC

Diagnosis usually involves:

1. Imaging tests: Chest X-rays, CT scans, or PET scans to detect abnormalities.

2. Biopsy: Sampling lung tissue to confirm the cancer type.

3. Molecular testing: To identify specific genetic mutations for targeted therapy.

Treatment of NSCLC

Treatment depends on the cancer stage and may include:

• Surgery: To remove localized tumors.

• Radiation therapy: To target and kill cancer cells.

• Chemotherapy: To destroy cancer cells throughout the body.

• Targeted therapy: Drugs designed to attack specific genetic mutations in the cancer cells.

• Immunotherapy: Stimulates the immune system to fight cancer.

Early diagnosis and personalized treatment approaches have significantly improved outcomes for many NSCLC patients.

Indication of Ensacove

Ensacove is specifically indicated for patients with ALK-positive NSCLC, as determined by an FDA-approved test. It is intended for use in individuals who have not previously been treated with ALK inhibitors.

Dosage of Ensacove

The recommended dosage of Ensacove is 225 mg taken orally once daily, with or without food. Treatment should continue until disease progression or the occurrence of unacceptable toxicity.

How to Take Ensacove (Administration)

Ensacove Capsules should be swallowed whole; do not crush or chew them.

If a dose is missed, it should be taken as soon as possible on the same day, and the regular dosing schedule should be resumed the next day. Extra doses should not be taken to make up for a missed dose.

In cases of vomiting after taking Ensacove, an additional dose should not be taken; the next dose should be taken at the regular scheduled time.

Dose Modifications for Adverse Reactions:

In the event of adverse reactions, dose adjustments may be necessary:

First dose reduction: 200 mg orally once daily.

Second dose reduction: 150 mg orally once daily.

If a patient is unable to tolerate the 150 mg dose, discontinuation of Ensacove should be considered.

Monitoring:

Regular monitoring is essential during treatment with Ensacove:

Liver function tests: Assess at baseline and periodically during treatment.

Blood glucose levels: Monitor fasting serum glucose prior to initiation and periodically thereafter.

Heart rate: Regular monitoring is recommended due to the risk of bradycardia.

Ophthalmologic evaluation: Conduct if new or worsening visual symptoms occur.

Creatine phosphokinase (CPK) levels: Monitor during treatment, especially if unexplained muscle pain or weakness occurs.

Serum uric acid levels: Assess prior to initiation and periodically during treatment.

Warnings and Precautions:

Interstitial Lung Disease (ILD)/Pneumonitis: Monitor for new or worsening respiratory symptoms; discontinue if confirmed.

Hepatotoxicity: Monitor liver function tests; withhold, reduce dose, or discontinue based on severity.

Dermatologic Reactions: Monitor for severe skin reactions; manage with supportive care and consider dose modifications.

Bradycardia: Monitor heart rate; adjust dose or discontinue if clinically significant bradycardia occurs.

Hyperglycemia: Monitor blood glucose levels; initiate or adjust anti-hyperglycemic treatment as needed.

Visual Disturbances: Obtain ophthalmologic evaluation if visual symptoms develop; manage as appropriate.

Increased CPK: Monitor CPK levels; withhold treatment if significantly elevated and resume at reduced dose upon recovery.

Hyperuricemia: Monitor serum uric acid; initiate urate-lowering therapy if necessary.

Common Adverse Reactions: The most common side effects (≥20%) include:

Rash and itching

Tiredness

Muscle or bone pain

Fever

Constipation

Coughing

Nausea

Skin swelling (edema)

Vomiting

Laboratory changes (such as decreased white blood cell counts, increased levels of liver and pancreatic enzymes, changes in blood levels of phosphate, magnesium, sodium, and potassium, decreased hemoglobin, increased bilirubin levels)

Patients should be advised to report any severe or persistent adverse reactions to their healthcare provider promptly.

For comprehensive information, including detailed safety and efficacy data, healthcare providers should consult the full prescribing information.

Who Manufactures Ensacove

Ensacove (generic name: ensartinib) is an anaplastic lymphoma kinase (ALK) inhibitor developed and marketed by Xcovery Holdings, Inc., an oncology-focused pharmaceutical company.

Xcovery Holdings collaborated with Betta Pharmaceuticals Co., Ltd., a Chinese pharmaceutical company specializing in innovative drug development, in the development of ensartinib.

On December 18, 2024, the U.S. Food and Drug Administration (FDA) approved Ensacove for the treatment of adult patients with ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).

This approval marks a significant milestone, as Ensacove is among the first innovative targeted lung cancer drugs developed by a Chinese company to receive global market approval.

Pricing:

As of December 2024, specific pricing information for Ensacove (ensartinib) has not been publicly disclosed. The cost of prescription medications like Ensacove can vary based on factors such as insurance coverage, pharmacy pricing, and regional differences.

For the most accurate and current pricing details, it's recommended to consult directly with healthcare providers, local pharmacies, or insurance companies. They can provide personalized information based on individual circumstances and coverage plans.

Additionally, patient assistance programs may be available to help offset costs for eligible individuals. Information about such programs can often be obtained through the manufacturer's website or by inquiring with healthcare providers.

For full details connect to :

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ensartinib-alk-positive-locally-advanced-or-metastatic-non-small-cell-lung-cancer