Verzenio 150mg Tablets

Abemaciclib is a selective inhibitor of cyclin-dependent kinases 4 and 6 (CDK4 and CDK6). These kinases are activated by binding to D-cyclins and play a crucial role in cell cycle progression from G1 to S phase. In cancer cells, dysregulation of CDK4/6 activity is common. Abemaciclib inhibits CDK4/6, leading to cell cycle arrest in the G1 phase and inhibition of cancer cell proliferation.

Serious Side Effects: Seek Medical Attention Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:

Allergic reactions: Rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Infections: Fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal.
Liver problems: Dark urine, fatigue, decreased appetite, stomach upset or pain, light-colored stools, vomiting, or yellow skin and eyes.
Fluid and electrolyte imbalances: Mood changes, confusion, muscle pain or weakness, irregular or rapid heartbeat, severe dizziness or fainting, increased thirst, seizures, extreme fatigue or weakness, decreased appetite, difficulty urinating or changes in urine output, dry mouth, dry eyes, or severe stomach upset or vomiting.
Unexplained symptoms: Feeling extremely tired or weak, unexplained bruising or bleeding, swelling in the arms or legs, rapid breathing, or a rapid heartbeat.
Blood clots: Chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, color changes, or pain in a leg or arm, or difficulty speaking or swallowing.
Lung problems: Shortness of breath or other breathing difficulties, new or worsening cough, or fever. In rare cases, lung problems can be fatal, so it's essential to seek medical attention immediately if you experience any of these symptoms.

Other Possible Side Effects

Like all medications, this drug can cause side effects, although not everyone will experience them. If you notice any of the following side effects, contact your doctor or seek medical help if they bother you or don't go away:

Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Hair loss or thinning
Dizziness, fatigue, or weakness
Headache
Dry mouth
Mouth irritation or sores
Joint pain
Changes in taste
Weight loss
Common cold symptoms
Nose or throat irritation

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are currently taking any of the following medications: carbamazepine, ketoconazole, phenobarbital or similar drugs, rifampin, ritonavir, or St. John's wort.
* If you are breastfeeding. Note that you should not breastfeed while taking this medication and for 3 weeks after your last dose.

This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dosage of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Diarrhea is a common side effect of this drug, and in some cases, it can be severe, leading to dehydration or infection. Diarrhea typically occurs during the first month of treatment. If you experience diarrhea, follow the instructions provided by your doctor. If you are unsure about how to manage diarrhea, consult with your doctor.

Regular blood tests will be necessary as directed by your doctor. Discuss any concerns or questions you have with your doctor.

While taking this medication, you may be at a higher risk of developing infections, some of which can be severe or life-threatening. To minimize this risk, practice good hygiene by washing your hands frequently, avoid close contact with individuals who have infections, colds, or flu, and consult with your doctor before receiving any vaccinations. Note that certain vaccines may not be effective or may increase the risk of infection when taken with this drug.

You may experience increased bleeding or bruising while taking this medication. Be cautious to avoid injuries, and use a soft toothbrush and an electric razor for personal grooming.

There is a risk of developing blood clots, which can be fatal, associated with this medication. Discuss this risk with your doctor.

Avoid consuming grapefruit or grapefruit juice while taking this medication.

If you are taking other medications in conjunction with this drug, discuss the potential risks and side effects with your doctor. Additionally, this medication may affect fertility in men, so discuss this with your doctor.

This medication can cause harm to an unborn baby. A pregnancy test will be conducted before initiating treatment to confirm that you are not pregnant. If you may become pregnant, it is crucial to use birth control while taking this medication and for a specified period after the last dose. Your doctor will advise you on the duration of birth control use. If you become pregnant while taking this medication, notify your doctor immediately.

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, grapefruit juice): May significantly increase abemaciclib exposure, leading to increased toxicity. Avoid concomitant use or reduce abemaciclib dose.
• Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's wort): May significantly decrease abemaciclib exposure, leading to reduced efficacy. Avoid concomitant use.

• Moderate CYP3A4 inhibitors (e.g., fluconazole, diltiazem, erythromycin): May increase abemaciclib exposure. Monitor for adverse reactions and consider dose reduction if necessary.
• CYP3A4 substrates (e.g., midazolam, simvastatin, lovastatin): Abemaciclib is a moderate inhibitor of CYP3A4, CYP2D6, P-gp, and BCRP. May increase concentrations of co-administered sensitive substrates.

• Weak CYP3A4 inhibitors/inducers: Clinically significant interactions are less likely but monitor.

• Diarrhea (frequency, consistency)
• Fatigue
• Nausea
• Abdominal pain
• Infections (fever, chills, sore throat)
• Signs of deep vein thrombosis (DVT) such as leg pain, swelling, redness
• Signs of pulmonary embolism (PE) such as shortness of breath, chest pain, rapid heart rate
• Signs of liver dysfunction (yellowing of skin/eyes, dark urine, right upper quadrant pain)

Verzenio can cause fetal harm when administered to a pregnant woman based on findings from animal studies and its mechanism of action. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 3 weeks after the last dose.

It is unknown if abemaciclib or its metabolites are excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment with Verzenio and for 3 weeks after the last dose.

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

No overall differences in safety or effectiveness were observed between elderly patients (≥65 years) and younger patients. No specific dose adjustment is required based on age, but monitor for increased sensitivity to adverse reactions.

• Diarrhea is the most common adverse event and can be severe. Proactive management with loperamide at the first sign of loose stools is crucial. Patients should be educated on diarrhea management before starting treatment.
• Neutropenia is also common. Regular CBC monitoring is essential, and dose interruptions/reductions are often necessary to manage this side effect.
• Liver function should be monitored closely, especially during the initial cycles, as hepatotoxicity can occur.
• Abemaciclib can be taken with or without food, but consistency in timing is recommended.
• Avoid strong CYP3A4 inhibitors (e.g., grapefruit juice, ketoconazole) and inducers (e.g., rifampin, St. John's wort) due to significant drug interactions.
• Patients should be advised to report any symptoms of deep vein thrombosis or pulmonary embolism immediately.

• Other endocrine therapies (e.g., fulvestrant, aromatase inhibitors)
• Chemotherapy regimens for HR+, HER2- metastatic breast cancer
• Everolimus + exemestane (for HR+, HER2- advanced breast cancer after progression on endocrine therapy)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.