Verzenio

Approved Uses

Verzenio is primarily used to treat adults with HR-positive, HER2-negative breast cancer in the following situations:

• Early Breast Cancer: It is used after surgery in patients with node-positive cancer that has a high risk of coming back. In this setting, it is taken in combination with endocrine (hormone) therapy.
• Advanced or Metastatic Breast Cancer: It is used when the cancer has spread to other parts of the body.

Treatment Combinations

Depending on the stage of the cancer and previous treatments, Verzenio may be prescribed in different ways:

• With an Aromatase Inhibitor: Used as the first hormone-based therapy for postmenopausal women with advanced or metastatic cancer.
• With Fulvestrant: Used for advanced or metastatic cancer that has progressed after hormone therapy.
• As a Standalone Treatment: Used alone for advanced or metastatic cancer if the disease has progressed after hormone therapy and prior chemotherapy.

Mechanism of Action

Verzenio belongs to a class of medications called kinase inhibitors. Specifically, it is known as a CDK4/6 inhibitor. It works by targeting and blocking the activity of two proteins in the body:

• Cyclin-dependent kinase 4 (CDK4)
• Cyclin-dependent kinase 6 (CDK6)

These proteins play a critical role in the cell cycle, which is the process cells go through to grow and divide. In certain types of breast cancer, these proteins become overactive, causing cancer cells to multiply uncontrollably.

By inhibiting CDK4 and CDK6, Verzenio stops the cancer cells from progressing through the cell cycle. This prevents the cells from dividing and creating new cancer cells, which can help shrink tumors or slow the spread of the disease.

Common Side Effects

Many people taking Verzenio experience mild to moderate side effects. Diarrhea is the most frequent side effect and often occurs during the first month of treatment.

• Diarrhea, nausea, or vomiting
• Stomach pain and loss of appetite
• Tiredness or weakness
• Hair thinning or hair loss
• Headache or dizziness
• Cough or joint pain
• Changes in taste or mouth sores
• Dry skin

Serious Side Effects

Some side effects can be severe and require immediate medical attention. Contact a healthcare provider right away if you experience:

• Signs of infection, such as fever or chills
• Signs of a blood clot, including pain or swelling in an arm or leg, chest pain, or sudden shortness of breath
• Lung problems, such as new or worsening cough or difficulty breathing
• Liver issues, including yellowing of the skin or eyes, dark urine, or pain on the right side of the stomach
• Unusual bleeding or bruising

Verzenio can also cause changes in lab test results, such as decreased white blood cell, red blood cell, or platelet counts, and increased creatinine levels.

Diarrhea

Diarrhea is a very common side effect and can become severe, leading to dehydration or infection. It most frequently occurs during the first month of treatment. Healthcare providers typically recommend starting antidiarrheal therapy at the first sign of loose stools and increasing fluid intake.

Lung Inflammation

Verzenio can cause rare but serious or life-threatening inflammation of the lungs, known as interstitial lung disease (ILD) or pneumonitis. Patients are monitored for new or worsening pulmonary symptoms, such as shortness of breath, cough, or chest pain.

Infection and Blood Counts

This medication can significantly lower white blood cell counts, a condition called neutropenia. This increases the risk of developing serious infections. Complete blood counts are usually monitored before starting therapy, every two weeks for the first two months, and then monthly or as clinically indicated.

Blood Clots

There is an increased risk of venous thromboembolism, which includes deep vein thrombosis (clots in the legs) and pulmonary embolism (clots in the lungs). Symptoms may include pain or swelling in the extremities, chest pain, or rapid breathing.

Liver Toxicity

Verzenio may cause increases in liver enzymes, which can indicate liver injury. Liver function tests are typically performed before starting treatment and periodically thereafter. Dose adjustments or interruptions may be necessary if enzyme levels become too high.

Embryo-Fetal Toxicity

Based on its mechanism of action, Verzenio can cause fetal harm if taken during pregnancy. Effective contraception is recommended for females of reproductive potential during treatment and for at least three weeks after the final dose. The medication may also impair fertility in males.

Pregnancy

Verzenio can cause harm to a developing fetus. Healthcare providers typically require a pregnancy test before starting this medication to confirm that a patient is not pregnant.

For individuals who are able to become pregnant:

• Use effective birth control (contraception) during treatment and for at least 3 weeks after the final dose.
• Inform a healthcare provider immediately if you become pregnant or think you might be pregnant while taking this medication.

Breastfeeding

It is not known if Verzenio passes into human breast milk. Due to the potential for serious adverse reactions in a nursing infant, breastfeeding is not recommended during treatment and for at least 3 weeks after the last dose.

Fertility

Verzenio may impair fertility in males, which may affect the ability to father a child. Patients should discuss any concerns regarding reproductive health and fertility with their healthcare provider before beginning treatment.

Dosage Forms

Verzenio is supplied as a film-coated tablet intended for oral administration. These tablets should be swallowed whole and not crushed, chewed, or broken.

FDA Approval Status

Verzenio was initially approved by the U.S. Food and Drug Administration (FDA) in September 2017. It is classified as a kinase inhibitor and is used to treat adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer.

Approved Indications

The FDA has granted approval for Verzenio in several clinical settings:

• Early Breast Cancer: In combination with endocrine therapy for the treatment of patients with node-positive, early breast cancer at high risk of recurrence.
• Advanced or Metastatic Cancer: In combination with an aromatase inhibitor as the first endocrine-based therapy for postmenopausal women or men.
• Combination Therapy: In combination with fulvestrant for patients whose disease has progressed following endocrine therapy.
• Monotherapy: As a stand-alone treatment for patients with metastatic disease that has progressed after endocrine therapy and prior chemotherapy.

Regulatory Safety Communications

The FDA issued a safety communication in 2019 regarding the class of CDK4/6 inhibitors, which includes Verzenio. This warning concerns the rare but serious risk of interstitial lung disease (ILD) and pneumonitis, which is inflammation of the lungs. Healthcare providers are advised to monitor patients for pulmonary symptoms and to interrupt or discontinue treatment if severe lung inflammation occurs.

Verzenio does not currently have a Boxed Warning or a Risk Evaluation and Mitigation Strategy (REMS) program.

Insurance and Pharmacy Factors

The amount you pay for Verzenio is influenced by several factors:

• Insurance Coverage: Most commercial insurance plans and Medicare Part D cover Verzenio. However, your individual copay, coinsurance, or deductible will determine your final out-of-pocket expense.
• Specialty Pharmacies: Verzenio is a specialty medication. It is often not available at local retail pharmacies and must be ordered through a specialty pharmacy provider.
• Brand-Name Status: There is currently no generic version of Verzenio available. Brand-name medications typically cost more than generics.

Financial Support Options

If you are having difficulty affording your medication, there may be resources available to help:

• Patient Assistance Programs: The manufacturer may offer programs to help eligible patients with the cost of the drug, including savings cards for those with commercial insurance.
• Foundation Support: Some independent charitable foundations provide financial assistance to help patients pay for cancer treatments.

It is recommended to contact your insurance provider or the specialty pharmacy to get an accurate estimate of your costs before starting treatment.