Generic Name and Formulations:
Abemaciclib 50mg, 100mg, 150mg, 200mg; tabs.
Lilly, Eli and Company
Indications for VERZENIO:
In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer. In combination with fulvestrant for the treatment of women with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following 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.
Swallow whole. Take at the same time every day. In combination with fulvestrant or an aromatase inhibitor (see full labeling): 150mg twice daily; in pre/perimenopausal women (in combination with fulvestrant): also treat with a gonadotropin-releasing hormone agonist according to current practice standards. Monotherapy: 200mg twice daily. All: continue until disease progression or unacceptable toxicity. Dose modifications for adverse reactions, concomitant strong CYP3A4 inhibitors: see full labeling. Severe hepatic impairment: reduce frequency to once daily.
Advise patients to initiate antidiarrheal (eg, loperamide) and increase fluids at first sign of loose stools; discontinue if Grade 3/4 diarrhea occurs or hospitalization required, until resolves to ≤Grade 1, then resume at next lower dose. Monitor CBCs and LFTs prior to initiation and every 2 weeks for the first 2 months, then monthly for the next 2 months, and as clinically indicated. Dose interruption/reduction/discontinuation or delay in starting treatment cycles if Grade 3/4 neutropenia, persistent/recurrent Grade 2 or Grade 3/4 transaminase elevation occurs. Monitor for signs/symptoms of venous thromboembolic events; treat appropriately. Severe hepatic impairment (Child-Pugh C): see Adult. Embryo-fetal toxicity. Females of reproductive potential should use effective contraception during therapy and for at least 3 weeks after last dose. Pregnancy; exclude status prior to initiation. Nursing mothers: not recommended (during and for at least 3 weeks after the last dose).
Avoid concomitant ketoconazole, grapefruit products. Concomitant other strong CYP3A inhibitors: reduce abemaciclib dose; moderate inhibitors: monitor and consider reducing dose. Avoid concomitant strong or moderate CYP3A inducers (eg, rifampin): consider alternative agents.
Diarrhea, neutropenia, nausea, abdominal pain, infections, fatigue, anemia, leukopenia, decreased appetite, vomiting, headache, alopecia, thrombocytopenia; venous thrombosis, pulmonary embolism, hepatotoxicity.
Sign Up for Free e-newsletters
Psychiatry Advisor Articles
- Link Identified Between Cured Meat and Mania in Bipolar Disorder
- Suicide Attempts Associated With Sleep and Circadian Rhythm Disturbances in Bipolar Disorder
- First-Episode Delusional Disorder vs Schizophrenia: Assessment of Outcomes
- Anatomical Patterns Present in Childhood ADHD May Predict Phenotypic Variation
- History of ADHD Associated With Increased Risk for Basal Ganglia and Cerebellum Disorders
- The Opioid System: The Foundation for Social Risk and Reward
- Correctional Psychiatry: Challenges and Rewards
- Those Left Behind: Working With Suicide-Bereaved Families
- The Impact of Deafness on Hallucinations and Delusions
- Is Mandatory Reporting of Child Maltreatment in the Best Interests of the Child?
- Institutional Rearing Associated With Psychopathology Risk in Children
- Perinatal Mood and Anxiety Screening: Recommendations and Controversies
- Few Seniors Who Self-Harm Referred for Mental Health Care
- Violent Video Games Tied to Physical Aggression
- Vortioxetine Beats Escitalopram in Improving SSRI-Induced Sexual Dysfunction