Verzenio 200mg Tablets

Abemaciclib is a potent, selective, orally bioavailable inhibitor of cyclin-dependent kinases (CDK) 4 and 6. These kinases are activated by binding to D-cyclins and play a key role in regulating cell cycle progression from G1 to S phase. In HR-positive, HER2-negative breast cancer, CDK4/6 activity is often dysregulated, leading to uncontrolled cell proliferation. Abemaciclib inhibits CDK4/6, thereby blocking cell cycle progression, inducing cellular senescence, and apoptosis in cancer cells.

Urgent Side Effects: Seek Medical Help Right Away

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 immediate medical attention:

Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of fluid and electrolyte problems, including:
+ Mood changes
+ Confusion
+ Muscle pain or weakness
+ Abnormal heartbeat
+ Severe dizziness or fainting
+ Increased thirst
+ Seizures
+ Extreme fatigue or weakness
+ Decreased appetite
+ Urination problems (difficulty starting or stopping)
+ Dry mouth
+ Dry eyes
+ Severe stomach upset or vomiting
Unexplained fatigue or weakness
Unexplained bruising or bleeding
Swelling in the arms or legs
Rapid breathing
Rapid heartbeat
Signs of a blood clot, such as:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, color change, or pain in a leg or arm
+ Difficulty speaking or swallowing
Signs of lung problems, including:
+ Shortness of breath
+ Trouble breathing
+ New or worsening cough
+ Fever

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:

Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Hair loss
Hair thinning
Dizziness
Fatigue
Weakness
Headache
Dry mouth
Mouth irritation or sores
Joint pain
Change in taste
Weight loss
Common cold symptoms
Nose or throat irritation

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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 allergic reaction you experienced.
If you are currently taking or plan to take 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 conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Do not start, stop, or change the dose 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.

While taking this drug, you may experience diarrhea, which can sometimes be severe and lead to dehydration or infection. Diarrhea typically occurs during the first month of treatment. If you develop 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.

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 medication.

This medication may increase your risk of bleeding. Take precautions to avoid injury, and use a soft toothbrush and an electric razor for personal grooming.

There is a risk of developing blood clots while taking this drug, which can be fatal in some cases. Discuss this risk with your doctor.

Avoid consuming grapefruit and 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. This medication may also affect fertility in men, so discuss this with your doctor.

This drug 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, you must 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 CYP3A inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, cobicistat, grapefruit juice)

• Moderate CYP3A inhibitors (e.g., fluconazole, diltiazem, erythromycin, verapamil) - dose reduction of abemaciclib may be needed.
• Strong CYP3A inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort) - avoid co-administration.

• CYP3A substrates with narrow therapeutic index (e.g., midazolam, alfentanil, cyclosporine, everolimus, sirolimus, tacrolimus) - monitor for increased exposure of substrate.
• P-glycoprotein (P-gp) substrates (e.g., digoxin, dabigatran) - monitor for increased exposure of substrate.

• Diarrhea (frequency, severity, hydration status)
• Fatigue
• Nausea/Vomiting
• Abdominal pain
• Signs of infection (fever, chills, sore throat)
• Symptoms of interstitial lung disease/pneumonitis (new or worsening cough, dyspnea, chest pain)
• Signs of venous thromboembolism (pain, swelling, warmth in leg, shortness of breath, chest pain)

Verzenio can cause fetal harm when administered to a pregnant woman. Based on animal studies and its mechanism of action, abemaciclib can cause embryo-fetal toxicity. Advise pregnant women of the potential risk to a fetus.

It is not known whether abemaciclib or its metabolites are excreted in human milk. Because of the potential for serious adverse reactions in breastfed infants, advise lactating 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 patients ≥65 years of age and younger patients. No dose adjustment is required based on age.

• Diarrhea is the most common adverse event, occurring early in treatment. Proactive management with antidiarrheals (e.g., loperamide) at the first sign of loose stools is crucial to prevent dehydration and dose interruptions.
• Neutropenia is also common but typically non-febrile and manageable with dose modifications. Regular CBC monitoring is essential.
• Liver function tests must be monitored closely, especially during the first few months of treatment, due to the risk of hepatotoxicity.
• Abemaciclib has shown activity in patients with brain metastases, which is a notable advantage compared to some other CDK4/6 inhibitors.
• Patients should be educated on the importance of avoiding strong CYP3A inhibitors, including grapefruit products, due to the risk of increased abemaciclib exposure and toxicity.

• Other endocrine therapies (e.g., aromatase inhibitors, fulvestrant)
• Chemotherapy (e.g., capecitabine, eribulin)
• Targeted therapies (e.g., everolimus, alpelisib)

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 this 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 seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.