Verzenio 150 mg 14 Tablets

Product Description:

VERZENIO is a kinase inhibitor indicated:

• In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.


• In combination with fulvestrant for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.


• As monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.

How to use:

• When used in combination with fulvestrant or an aromatase inhibitor, the recommended dose of VERZENIO is 150 mg taken orally twice daily.


• When given with VERZENIO, refer to the Full Prescribing Information for the recommended dose of the aromatase inhibitor being used.


• When given with VERZENIO, the recommended dose of fulvestrant is 500 mg administered on Days 1, 15, and 29; and once monthly thereafter. Refer to the Full Prescribing Information for fulvestrant.


• Pre/perimenopausal women treated with the combination of VERZENIO plus fulvestrant should be treated with a gonadotropin-releasing hormone agonist according to current clinical practice standards.


• When used as monotherapy, the recommended dose of VERZENIO is 200 mg taken orally twice daily.


• Continue treatment until disease progression or unacceptable toxicity. VERZENIO may be taken with or without food.


• Instruct patients to take their doses of VERZENIO at approximately the same times every day.


• If the patient vomits or misses a dose of VERZENIO, instruct the patient to take the next dose at its scheduled time.


• Instruct patients to swallow VERZENIO tablets whole and not to chew, crush, or split tablets before swallowing.


• Instruct patients not to ingest VERZENIO tablets if broken, cracked, or otherwise not intact.

Caution & Warnings:

Diarrhea:-

• Episodes of diarrhea have been associated with dehydration and infection,Instruct patients that at the first sign of loose stools, they should start antidiarrheal therapy such as loperamide, increase oral fluids, and notify their healthcare provider for further instructions and appropriate follow up. For Grade 3 or 4 diarrhea, or diarrhea that requires hospitalization, discontinue VERZENIO until toxicity resolves to ≤Grade 1, and then resume VERZENIO at the next lower dose.

 Neutropenia:-

• 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 clinicallyindicated.


• Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia.

Hepatotoxicity:-

• Monitor liver function tests (LFTs) 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. Dose interruption, dose reduction, dose discontinuation, or delay in starting treatment cycles is recommended for patients who develop persistent or recurrent Grade 2, or Grade 3 or 4, hepatic transaminase elevation.

Venous Thromboembolism:-

• Monitor patients for signs and symptoms of venous thrombosis and pulmonary embolism and treat as medically appropriate.

Embryo-Fetal Toxicity :-

• Advise pregnant women of the potential risk to a fetus.


• Advise females of reproductive potential to use effective contraception during treatment with VERZENIO and for at least 3 weeks after the last dose

Ingredients:

• VERZENIO (abemaciclib) tablets are provided as immediate-release oval white, beige, or yellow tablets.

Inactive ingredients are as follows:

• Excipients—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, and iron oxide red.

Product Details: