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. Avoid concomitant strong 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.
Clinical Pain Advisor Articles
- History of Migraine May Be Associated With Higher Risk for Cochlear Disorders
- Radiofrequency Denervation Efficacious in Treating Thoracic Zygapophyseal Joint Pain
- Symptom Severity, Sensory Sensitivity May Indicate Pain Centralization in Chronic Overlapping Pain Conditions
- Stat Consult: Chronic Low Back Pain
- Opioid Misuse May Help Predict Alcohol Dependence Treatment Outcomes
- Consensus Guidelines for the Use of Intravenous Ketamine for Chronic Pain
- Pain Societies Issue Guidelines on Use of Ketamine for the Management of Acute Pain
- Labor Epidural Analgesia Linked to Reduced Likelihood of Successful Breastfeeding
- Novel Oral Treatment Safe, Effective for Migraine Headache Relief
- DFN-02 Nasal Spray Safe, Effective for Acute Treatment of Episodic Migraine
- OnabotulinumtoxinA May Be Effective for Chronic Migraine With Medication Overuse
- FDA Outlines Plan for Increasing Nonprescription Drug Availability
- Prescribed Opioids Difficulties Scale Effective for Assessing Concerns of Patients With Chronic Pain
- Hypoesthesia for Touch and Joint Position Linked to Chronic Pain in MS
- New Laws Are Needed to Protect Health Data Shared Online