Abemaciclib

What is Abemaciclib?

• Abemaciclib (Verzenio) is a kinase inhibitor used to treat hormone-receptor positive (HR+), HER2-negative (HER2-) breast cancer that is advanced or has spread to other parts of the body.

Abemaciclib

What are the uses of this medicine?

Abemaciclib (Verzenio) is a prescription medicine used:

• in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) to treat adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer with a high risk of coming back as determined by your healthcare provider.
• in combination with an aromatase inhibitor as the first endocrine-based therapy to treat women who have gone through menopause (postmenopausal), and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has worsened or that has spread to other parts of the body (metastatic).
• in combination with fulvestrant to treat adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has worsened or spread to other parts of the body (metastatic) and whose disease has progressed after endocrine therapy.
• alone to treat adults with HR-positive, HER2-negative breast cancer that has worsened or that has spread to other parts of the body (metastatic) and whose disease has progressed after endocrine therapy and prior chemotherapy.

• Abemaciclib is also being studied in the treatment of other types of cancer.

How does this medicine work?

• Abemaciclib blocks certain proteins, which may help keep cancer cells from growing.
• It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells.
• Abemaciclib is an inhibitor of cyclin-dependent kinases 4 and 6 (CDK4 and CDK6).
• These kinases are activated upon binding to D-cyclins.
• In estrogen receptor-positive (ER+) breast cancer cell lines, cyclin D1 and CDK4/6 promote phosphorylation of the retinoblastoma protein (Rb), cell cycle progression, and cell proliferation.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Verzenio may affect the way other medicines work, and other medicines may affect how Verzenio works, causing serious side effects.
• Especially tell your healthcare provider if you take a medicine that contains ketoconazole.

Is this medicine FDA approved?

• On February 26, 2018, the Food and Drug Administration approved abemaciclib (Verzenio™, Eli Lilly and Company) in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.

How should this medicine be used?

Recommended dosage:

• Recommended starting dose in combination with fulvestrant, tamoxifen, or an aromatase inhibitor:150 mg twice daily.
• Recommended starting dose as monotherapy: 200 mg twice daily.

Administration:

• Verzenio may be taken with or without food.
• Swallow Verzenio tablets whole. Do not chew, crush, or split the tablets before swallowing. Do not take Verzenio tablets if they are broken, cracked, or damaged.
• Take your doses of Verzenio at about the same time every day.
• If you vomit or miss a dose of Verzenio, take your next dose at your regular time. Do not take 2 doses of Verzenio at the same time to make up for the missed dose.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Tablets: 50 mg, 100 mg, 150 mg, and 200 mg.

This medicine is available in fallowing brand namesː

• Verzenio

What side effects can this medication cause?

The most common side effects of this medicine include:

• nausea
• vomiting
• stomach pain
• constipation
• sores on the lips, mouth, or throat
• decreased appetite
• weight loss
• hair loss
• itching
• rash
• headache
• changes in taste
• dizziness
• joint pain

Serious but less common side effects:

• tiredness
• pain in the upper right part of the stomach
• yellowing of the skin or eyes
• loss of appetite
• bleeding or bruising easily
• pain in arms or legs
• swelling of the hands, feet, legs or ankles
• shortness of breath
• chest pain
• rapid breathing
• fast, irregular, or pounding heartbeat
• fever, chills, cough or other signs of infection
• pale skin
• Abemaciclib may cause other side effects.

What special precautions should I follow?

• Verzenio can cause severe cases of diarrhea, associated with dehydration and infection. Instruct patients at the first sign of loose stools to initiate antidiarrheal therapy, increase oral fluids, and notify their healthcare provider.
• Neutropenia, including febrile neutropenia and fatal neutropenic sepsis, occurred in patients treated with Verzenio. Monitor complete blood counts prior to the start of Verzenio therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated.
• Severe, life-threatening, or fatal interstitial lung disease (ILD) or pneumonitis can occur in patients treated with Verzenio and other CDK4/6 inhibitors. Severe and fatal cases of ILD/pneumonitis have been reported. Monitor for clinical symptoms or radiological changes indicative of ILD/pneumonitis. Permanently discontinue Verzenio in all patients with Grade 3 or 4 ILD or pneumonitis.
• Increases in serum transaminase levels have been observed. Perform liver function tests (LFTs) before initiating treatment with Verzenio. Monitor LFTs every two weeks for the first two months, monthly for the next 2 months, and as clinically indicated.
• Venous thromboembolic events were reported in patients treated with Verzenio. Monitor patients for signs and symptoms of thrombosis and pulmonary embolism and treat as medically appropriate.
• Based on findings from animal studies and the mechanism of action, Verzenio can cause fetal harm when administered to a pregnant woman. Advise patients of potential risk to a fetus and to use effective contraception.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Based on findings in animals and its mechanism of action, Verzenio can cause fetal harm when administered to a pregnant woman.
• There are no available human data informing the drug-associated risk.
• Advise pregnant women of the potential risk to a fetus.

Can this medicine be used in children?

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

What are the active and inactive ingredients in this medicine?

• Active ingredient: abemaciclib
• Inactive ingredients: microcrystalline cellulose 102, microcrystalline cellulose 101, lactose monohydrate, croscarmellose sodium, sodium stearyl fumarate, silicon dioxide.
• Color mixture ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, iron oxide red.

Who manufactures and distributes this medicine?

• Marketed by: Lilly USA, LLC, Indianapolis, IN , USA

What should I know about storage and disposal of this medication?

• Store Verzenio at room temperature between 68°F to 77°F (20°C to 25°C).

• Dailymed label info on Abemaciclib
• FDA Abemaciclib

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