Verzenio Dosage, forms & strengths
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Verzenio (abemaciclib) is a cyclin-dependent kinase inhibitor that is manufactured by Eli Lilly and Company. It is FDA-approved to decrease tumor size and increase disease-free survival rates:
- Along with hormone therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence.
- Along with an aromatase inhibitor for the treatment of postmenopausal women, and men, with HR-positive, HER2-negative advanced or metastatic (cancer has spread to other parts of the body) breast cancer.
- Along with Faslodex (fulvestrant) for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following hormone (endocrine) therapy.
- As monotherapy for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.
How does Verzenio work?
Verzenio inhibits cyclin-dependent kinases 4 and 6 (CDK4/6). In estrogen receptor-positive breast cancer cells, CDK4/6 promotes tumor growth and spread. Blocking this pathway prevents cell growth and leads to apoptosis (cell death). In clinical trials, Verzenio as monotherapy or along with antiestrogens led to a reduction in tumor size.
Verzenio dosage forms and strengths
- 50mg tablet
- 100mg tablet
- 150mg tablet
- 200mg tablet
The recommended starting dose of Verzenio when used in combination with fulvestrant, tamoxifen, or an aromatase inhibitor is 150mg twice daily, with or without food.
The recommended starting dose of Verzenio as monotherapy is 200mg twice daily, with or without food.
Dose reductions to the next lower dose may be needed if you cannot tolerate Verzenio treatment.
Verzenio dosage restrictions
- No dose modification is necessary if you have mild to moderate renal impairment.
- There are no studies on patients with severe renal impairment.
- No dose modification is necessary if you have mild to moderate hepatic impairment (Child-Pugh A or B).
- The dosing frequency should be reduced if you have severe hepatic impairment (Child-Pugh C).
How to take Verzenio
- Read the Full Prescribing Information, Instructions for Use, and Medication Guide that comes with your Verzenio.
- Take Verzenio exactly as your healthcare provider prescribes it to you. Do not change your dose or stop taking Verzenio without discussing it with them.
- Your doctor may change your dose of Verenzio if needed. Do not stop taking Verzenio or change the dose without talking to your doctor.
- Verzenio is typically taken by mouth twice daily. You should take Verzenio around the same time each day. It can be taken with or without food.
- Swallow Verenzio tablets whole. Do not chew, crush, or split the tablets before swallowing.
- If you vomit or miss a dose of Verenio, take your next dose at your regular time. Do not take extra doses or Verzenio to make up for the dose you missed.
Verzenio dosage FAQs
What are some common side effects of Verzenio?
The most common adverse reactions of Verzenio when compared to placebo in clinical studies include:
- Stomach pain
- Anemia (low red blood cell count)
- Thrombocytopenia (low platelet count)
- Loss of appetite
- Alopecia (hair loss)
- Increase creatinine level
- Dry mouth
Verzenio can cause serious side effects including:
- Life-threatening allergic reactions including angioedema, and trouble breathing
- Lung disease and problems such as chest pain and shortness of breath
- Venous thromboembolic events (VTE) such as blood clots or thrombosis
- Increased liver enzymes such as alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
- Liver problems including hepatotoxicity
Contact your healthcare provider for medical advice about any adverse effects you experience while taking Verzenio. You can report your side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What are some drug interactions with Verzenio?
When Verzenio is taken with other drugs, they may change how they work or increase the frequency and severity of side effects. Make sure your doctor is aware of all prescription drugs, over-the-counter medications, vitamins, and herbal supplements you take. Some major drug interactions with Verzenio include:
- CYP3A inhibitors such as ketoconazole
- CYP3A inducers such as rifampin
- Grapefruit juice
Are there any contraindications or precautions with Verzenio?
- Verzenio should not be taken if you have had an allergic reaction to its active ingredient, its excipients, or other abemaciclib products.
- Notify your doctor or go to the nearest hospital if you experience severe diarrhea. You should also begin antidiarrheal treatment such as Imodium (loperamide) and increase your fluid intake at the first sign of loose stools.
- Your doctor should perform blood tests to monitor your liver function and check for low white blood cell counts (neutropenia) before starting Verzenio treatment, 2 weeks for the first 2 months, monthly for the next 2 months, and as needed.
- Severe cases of interstitial lung disease/pneumonitis have been reported with Verzenio. You should be monitored for symptoms and treatment discontinued if indicated.
- Verzenio can cause fetal harm. You should be aware of the potential risk to a fetus and use effective contraception.
How long does it take for Verzenio to start working?
It can take two to four months of Verzenio treatment before you see any changes in your condition.
What is the cost of Verzenio?
Verzenio is a very expensive medication and there is no generic available. It costs around $3,500 for #14, 150mg tablets.
What is the recommended dose of Verzenio?
If you are taking Verzenio along with endocrine therapy the usual dose is 150mg twice daily. If you are taking Verzenio as monotherapy, the usual dose is 200mg twice daily.
When do Verzenio’s side effects start?
The most common adverse effect of Verzenio is diarrhea. In clinical trials, 80% to 90% of patients suffered from diarrhea which typically began in the first week of treatment.
Is it safe to use Verzenio while pregnant or breastfeeding?
Based on animal studies and its mechanism of action, Verzenio can cause fetal harm when administered during pregnancy. There is no data on whether Verzenio is found in breast milk or the effects it may have on the breastfed child. Because of the potential for serious adverse effects on breastfed infants, you should not breastfeed while taking Verzenio and for 3 weeks after the last dose. You should always discuss the risks and benefits of any medication with your healthcare provider if you are pregnant, plan on becoming pregnant, or are breastfeeding.
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