Menu

Ramiven

SKU:{{ product.sku }}
Model: {{ product.model }}
weight: {{ product.weight }} product.

{{ variable.name }}

{{ value.name }}
Abemaciclib Instructions

Common name: Abemaciclib
Trade name: Verzenio
Full names: Abemaciclib, Bomacicillin, Verzenio


Indications:
Hormone receptor-positive (HR+) and HER2-negative (HER2-) breast cancer, and it is advanced or has metastasized (spread to other parts of the body).
This product is used together with fulvestrant for women whose breast cancer has worsened after hormone therapy.
For use alone, in women and men with breast cancer whose disease has progressed after hormone therapy, and in patients with breast cancer who have previously received chemotherapy for metastatic disease.
It is used with aromatase inhibitors as first-line hormonal therapy for breast cancer in postmenopausal women.


Usage and dosage:
Abeciclib tablets, taken orally, 2 times a day, recommended at a fixed time, can be taken with food.
With aromatase inhibitors: Abemaciclib, 150 mg orally twice daily;
With fulvestrant: Abemaciclib: 150 mg orally, twice daily; Fulvestrant, 500 mg intramuscularly on days 1, 15 and 29, then monthly.


Adverse reactions:
Abeciclib may cause side effects: nausea, vomiting, stomach pain, constipation, mouth sores, loss of appetite, weight loss, hair loss, itching, rash, headache, taste change, dizziness, etc.
Common serious side effects include: joint pain, fatigue, upper right abdominal pain, edema of limbs or joints, wheezing, chest pain, shortness of breath, rapid heartbeat, fever, chills, cough or other signs of infection, pale skin, etc.


Contraindications:
Do not eat grapefruit or drink grapefruit juice while taking this medicine.


Notes:
1. Drug allergy; if you are allergic to abeciclib, any other drugs, or any ingredients in abeciclib tablets, please inform your doctor and pharmacist in time.
2. Drug interactions: before taking abeciclib, if you have taken any of the following drugs: clarithromycin (Biaxin, in Prevpac), diltiazem (Cardizem, Tiazac, others), itraconazole (Sporanox), Ketoconazole (Nizoral), rifampicin (Rifadin, Rimactane, in Rifater), and verapamil (Calan, Verelan, others). Tell your doctor. Your doctor may need to change the dose of the drug or carefully monitor you for side effects.
3. If you have other illnesses; if you have fever, chills or any other signs of infection, or if you have or have had liver or kidney disease, please tell your doctor.
4. Contraception; abeciclib may harm the fetus, so strict contraception is required. Tell your doctor if you are pregnant or plan to become pregnant. You need to take a pregnancy test before starting treatment and should use birth control to prevent pregnancy during treatment and for at least 3 weeks after the last dose.
5. During breastfeeding, please note that you should not breastfeed while taking abeciclib and for at least 3 weeks after the last dose.
6. Affects fertility; this drug may reduce male fertility.
7. Diarrhea: Abexiclib often causes severe diarrhea. You need to drink a lot of fluids and take anti-diarrhea drugs to prevent dehydration. If you experience extreme thirst, dry mouth or skin, decreased urine output, or rapid heartbeat, you need to inform your doctor immediately.


Storage:
Keep sealed at room temperature and kept out of the reach of children.


Mechanism of action:
Abemaciclib is an oral cyclin-dependent kinase CDK4/6 inhibitor. In HR+, HER2 breast cancer cells, CDK4 and CDK6 promote the phosphorylation of retinoblastoma protein and promote cell cycle advancement and cell proliferation. Abemaciclib can inhibit the phosphorylation of Rb and block cells from advancing from the G1 phase to the S phase of the cell cycle, thereby leading to cell senescence and apoptosis.


Safety and Efficacy:
The monotherapy approval of VERZENIO is based on results from the Phase 2 MONARCH1 trial, which enrolled 132 patients with HR+/HER2- metastatic breast cancer that progressed during or after endocrine therapy and chemotherapy. The investigator-assessed ORR was 19.7% (95% CI, 13.3%-27.5%), and the median duration of response was 8.6 months. The independently assessed ORR was 17.4% (95% CI, 11.4%-25.0%), and the median duration of response was 7.2 months.
The approval of abemaciclib and fulvestrant was based on results from the phase III MONARCH2 trial, which randomized patients to abemaciclib plus fulvestrant (n = 446) or fulvestrant plus placebo (n = 223). The study included primarily postmenopausal women (82%), with the remainder premenopausal or perimenopausal. Median PFS was 16.4 months (95% CI, 14.4-19.3) with abemaciclib and 9.3 months (95% CI, 7.4-12.7) with fulvestrant alone (HR, 0.553; 95% CI, 0.449-0.681; P < .001). The ORR in patients with measurable disease was 48.1% and 21.3% for abemaciclib and control, respectively.