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Abemaciclib

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Pronunciation

Uh-BEH-muh-SY-klib

Abemaciclib
Abemaciclib

Indication

  • Abemaciclib is a drug 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 is also used along with anastrozole (Arimidex), exemestane (Aromasin), or letrozole (Femara) as a first treatment of hormone receptor-positive, advanced breast cancer or breast cancer that has spread to other parts of the body.
  • Abemaciclib is also used alone to treat a certain type of hormone receptor-positive, advanced breast cancer or breast cancer that has spread to other parts of the body in people who have already been treated with an antiestrogen medication and chemotherapy.
  • It is used with fulvestrant in women whose disease got worse after treatment with hormone therapy.
  • Abemaciclib is also used alone in men and women whose disease got worse after treatment with hormone therapy and previous chemotherapy.
  • It is also being studied in the treatment of other types of cancer.

Mechanism of action

  • 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.

Drug class

It is a type of cyclin-dependent kinase inhibitor.

Other names

Also called Verzenio.

FDA warning

  • FDA is warning that palbociclib (Ibrance®), ribociclib (Kisqali®), and abemaciclib (Verzenio®) used to treat some patients with advanced breast cancers may cause rare but severe inflammation of the lungs.
  • FDA has approved new warnings about this risk to the prescribing information and Patient Package Insert for the entire class of these cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor medicines.
  • The overall benefit of CDK 4/6 inhibitors is still greater than the risks when used as prescribed.

Formulations

  • Abemaciclib comes as a tablet to take by mouth.
  • It is usually taken twice daily with or without food.
  • Take abemaciclib at around the same times every day.

Side effects

Abemaciclib may cause side effects including:

  • 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.

FDA approval history

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.

Clinical studies

  • Approval was based on MONARCH 3, a randomized (2:1), double-blinded, placebo-controlled, multicenter clinical trial in postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer.
  • A total of 493 patients were randomized to receive either abemaciclib 150 mg or placebo orally twice daily, plus physician’s choice of letrozole or anastrozole.
  • The estimated median progression-free survival (PFS) (RECIST 1.1) was 28.2 months (95% CI: 23.5, Not reached) for patients receiving abemaciclib and 14.8 months (95% CI: 11.2, 19.2) for those receiving placebo (HR 0.540; 95% CI: 0.418, 0.698; p
  • The most common adverse reactions in at least 20% of patients receiving abemaciclib in MONARCH 3 and more than 2% higher than the placebo arm were diarrhea, neutropenia, fatigue, infections, nausea, abdominal pain, anemia, vomiting, alopecia, decreased appetite, and leukopenia.

Starting dose

The recommended starting dose of abemaciclib in combination with an aromatase inhibitor is 150 mg twice daily orally with or without food.

Prescriber information

Full prescribing information is available at: Abemaciclib presriber information

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