ABEMACICLIB

Background and Date of Approval

Abemaciclib is an anticancer medication containing the active ingredient Abemaciclib. It is a prescription medication that belongs to a class of drugs known as cyclin-dependent kinase (CDK) inhibitors. It is used to treat certain types of cancer, including breast cancer, that has spread to other parts of the body. Cancer is a condition in which cells multiply in an uncontrolled and abnormal manner. This medication works by inhibiting the proteins called cyclin-dependent kinases that play a significant role in the rapid multiplication of cancer cells. This medicine is intended for oral use only and is given in combination with other hormonal medications. Abemaciclib was developed by Eli Lilly and Company and was first approved by the US Food and Drug Administration (FDA) in 2017 for the treatment of advanced or metastatic breast cancer. Since then, it has been approved for use in other countries and in treating other types of cancer.

Uses

Abemaciclib is a single-agent treatment for advanced or metastatic breast cancer that has progressed despite other treatments, or in combination with other drugs as a first-line treatment. In combination with other drugs, it is also used in the treatment of advanced or metastatic breast cancer, non-small cell lung cancer, endometrial cancer and pediatric patients with neuroblastoma.

How is it administered?

Abemaciclib is usually taken orally, with or without food. The tablets should be swallowed whole with a glass of water and not crushed, chewed or broken. The dosage and frequency will depend on various factors, including the patient's age, weight, overall health, and the type and stage of cancer being treated. It's important to follow the dosing instructions provided by a healthcare provider, and not to adjust the dosage or frequency without consulting with them first. If a dose is missed, it should be taken as soon as possible unless it's within 6 hours of the next scheduled dose. In that case, the missed dose should be skipped and the regular dosing schedule resumed. It is important not to take a double dose to make up for a missed dose.

Side Effects

Abemaciclib is associated with a range of adverse effects, both common and serious in nature. Frequently reported adverse effects include fatigue, diarrhoea, nausea, vomiting, decreased appetite, headache, and infections. Fatigue and diarrhoea represent the most commonly observed adverse effects and can be severe in some cases. Nausea, vomiting, and decreased appetite may also develop and may require medical management. Headache constitutes another common adverse effect with severity ranging from mild to severe. The medicine can also suppress the immune system, which increases the risk of infections. Serious adverse effects may include blood clots, liver problems, interstitial lung disease, and fetal harm if used during pregnancy. Patients should seek immediate medical attention if they experience symptoms such as chest pain, shortness of breath, yellowing of the skin or eyes, or persistent cough. It is important to note that not all patients will experience these adverse effects, and some may experience different adverse effects not listed here. Patients should discuss any concerns about medication adverse effects with their healthcare provider.

Warnings

Abemaciclib comes with several warnings and precautions that patients should be aware of. These include a risk of severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, which can be life-threatening. Additionally, it can cause heart problems, including heart failure and decreased heart function, and lung problems, including interstitial lung disease and pneumonitis. It can also cause eye problems, including retinal vein occlusion and uveitis, and patients should be monitored for any changes in vision or eye pain. During pregnancy it can cause harmful effect on developing foetus. Breastfeeding while taking it also can cause harmful effect infant.

Precautions

To ensure the safe use of Abemaciclib, patients should inform their healthcare provider of any medical conditions they have, disclose all medications they are taking, avoid exposure to sunlight and tanning beds, use sunscreen and wear protective clothing when outdoors, and stay hydrated by drinking plenty of fluids. Breastfeeding should be avoided while taking it and for at least 4 months after the final dose. Women of reproductive age should use effective contraception during treatment and for at least 4 months after the final dose. It is important for patients taking it to be aware of these potential risks and report any new or worsening symptoms to their healthcare provider immediately. It is important to follow these precautions to reduce the risk of potential side effects and to ensure that Abemaciclib is effective in treating the intended condition.

Word of Advice

Patients prescribed Abemaciclib should adhere to their healthcare provider's instructions and report any side effects or concerns without delay. This medication can cause serious side effects, necessitating careful monitoring of symptoms and prompt medical attention should concerning health changes occur. Patients should avoid alcohol and observe any safety recommendations provided by their healthcare provider during treatment. Attending all scheduled appointments and follow-up visits with the healthcare provider is essential to ensure treatment efficacy and appropriate management of side effects. With proper monitoring and management, Abemaciclib may serve as an effective treatment option for certain types of cancer.

References

Eli Lilly Nederland BV, Electronic medicines compendium (emc), [Revised on May 2022] [ Accessed on 29 March 2023], https://www.medicines.org.uk/emc/files/pil.11046.pdf Lilly USA, US Food and Drug Administration, [Revised on October 2021] [Accessed on 29 March2023], https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208716s006s007s008lbl.pdf DeVita, Hellman, and Rosenberg's Cancer: Principles & Practice of Oncology Authors,11th Edition, 2018, 1006-1022 Bruce A. Chabner, Dan L. Longo, Cancer Chemotherapy and Biotherapy: Principles and Practice, Edition: 6th, 2019, 501-502

Frequently Asked Questions

What is Abemaciclib used for?

Abemaciclib is used to treat certain types of cancer, including advanced or metastatic breast cancer, advanced or metastatic non-small cell lung cancer, advanced or metastatic hormone receptor-positive, HER2-negative endometrial cancer, and high-risk neuroblastoma in paediatric patients.

How should Abemaciclib be taken?

Abemaciclib is typically taken orally, with or without food, as prescribed by a healthcare provider. The tablets should be swallowed whole with a glass of water and not crushed, chewed or broken.

What are the potential side effects of Abemaciclib?

Common side effects of Abemaciclib may include diarrhoea, nausea, vomiting, fatigue, decreased appetite, abdominal pain, headache, and low white blood cell count. Less common but more serious side effects may include liver problems, blood clots, and pulmonary embolism.

Can Abemaciclib be taken during pregnancy?

Abemaciclib should not be used during pregnancy unless necessary and the potential benefits outweigh the potential risks to the foetus. Women of childbearing age should use effective contraception while taking it and for at least three weeks after the last dose.

How long will I need to take Abemaciclib?

The length of treatment with Abemaciclib will depend on a variety of factors, including the type and stage of cancer being treated, how well the medication is tolerated, and the patient's response to treatment.

Can Abemaciclib be taken with other medications?

Abemaciclib may interact with other medications, so it's important to inform your healthcare provider about all medications, supplements, and herbal products you are taking.

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Written By: Muskan Patel, M.Pharm

Reviewed By: Dr. Vishwa Patel, MBBS