AUDIENCE: Patient, Health Professional, Oncology
ISSUE: 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.
BACKGROUND: CDK 4/6 inhibitors are a class of prescription medicines that are used in combination with hormone therapies to treat adults with hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative advanced or metastatic breast cancer that has spread to other parts of the body. CDK 4/6 inhibitors block certain molecules involved in promoting the growth of cancer cells. FDA approved palbociclib in 2015, and both ribociclib and abemaciclib in 2017. CDK 4/6 inhibitors have been shown to improve the amount of time after the start of treatment the cancer does not grow substantially, and the patient is alive, called progression-free survival (See List of FDA-Approved CDK 4/6 Inhibitors below).
RECOMMENDATION: Patients should notify your health care professional right away if you have any new or worsening symptoms involving your lungs, as they may indicate a rare but life-threatening condition that can lead to death. Symptoms to watch for include:
- Difficulty or discomfort with breathing
- Shortness of breath while at rest or with low activity
Do not stop taking your medicine without first talking to your health care professional. All medicines have side effects even when used correctly as prescribed, but in general the benefits of taking these medicines outweigh these risks. It is important to know that people respond differently to all medicines depending on their health, the diseases they have, genetic factors, other medicines they are taking, and many other factors. Specific risk factors to determine how likely it is that a particular person will experience severe lung inflammation when taking palbociclib, ribociclib, or abemaciclib have not been identified.
Health care professionals should monitor patients regularly for pulmonary symptoms indicative of interstitial lung disease (ILD) and/or pneumonitis. Signs and symptoms may include:
- Interstitial infiltrates on radiologic exams in patients in whom infectious, neoplastic, and other causes have been excluded.
Interrupt CDK 4/6 inhibitor treatment in patients who have new or worsening respiratory symptoms, and permanently discontinue treatment in patients with severe ILD and/or pneumonitis.
For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Abemaciclib (brand name – Verzenio), is an FDA-approved drug used to treat a hormone receptor-positive, advanced breast cancer (breast cancer that depends on hormones such as estrogen to grow) or the breast cancer that has spread to other parts of the body after treatment with an anti-estrogen medication such as tamoxifen (Nolvadex).
Abemaciclib can be used as the first treatment of hormone receptor-positive, advanced breast cancer or breast cancer that has spread to other body parts when used in combination with certain other drugs. It is used in people who have already been treated with an antiestrogen medication and chemotherapy.
It is in a class of medications called kinase inhibitors and 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.
Common side effects of Verzenio include nausea, vomiting, abnormal weight loss, abdominal pain, and constipation. Other side effects may range from mild symptoms, such as rash and headache, to serious side effects, such as shortness of breath and chest pain. Let us walk you through all the relevant details you need to know about abemaciclib.
How should I take Abemaciclib?
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 time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take abemaciclib exactly as directed. Do not take more or less of it or more often than your doctor prescribes.
Swallow the tablets whole; do not split, chew, or crush them. Do not take tablets that are broken, cracked, or damaged in any way.
If you vomit after taking abemaciclib, do not take another dose. Continue your regular dosing schedule.
Your doctor may decrease your dose or temporarily or permanently stop your treatment if you experience certain side effects. This depends on how well the medication works for you and the side effects you experience. Be sure to tell your doctor how you are feeling during your treatment with abemaciclib.
What are the side effects of abemaciclib (Verzenio)?
- Vomiting (Emesis)
- Abdominal Pain (Bellyache)
- sores on the lips, mouth, or throat
- Appetite loss (Anorexia)
- Abnormal weight loss
- Hair Loss (Alopecia)
- Excessive itching (Pruritus)
- Abnormal taste (Dysgeusia)
- Dizziness (Vertigo)
- Joint Pain (Arthralgia)
Use ankr.us to track symptoms associated with the use of abemaciclib.
Serious side effects
Call your doctor immediately if you experience
- Fatigue (Tiredness)
- Pain in the upper right part of the stomach
- Yellowing of the skin or eyes
- Appetite loss (Anorexia)
- Haemorrhage (Bleeding) or Bruising
- Pain in arms or legs
- Swelling of the hands, feet, legs or ankles
- Shortness of breath (Dyspnea)
- Chest Pain
- Rapid breathing
- Fast, irregular, or pounding heartbeat
- Fever, chills, cough or other signs of infection
- Pale skin
Abemaciclib (Verzenio) may cause other side effects. If unusual problems develop, call your doctor.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
What special precautions should I follow?
Before taking abemaciclib or Verzenio
- tell your doctor and pharmacist if you are allergic to any product or its ingredients.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
- tell your doctor if you have a fever, chills, or any other signs of an infection or if you have or have ever had liver or kidney disease.
- tell your doctor if you are pregnant or plan to become pregnant. Along with this, you will need to take a pregnancy test before you start treatment and should use birth control to prevent pregnancy during your treatment and for at least 3 weeks after your final dose.
While you are on abemaciclib or Verzenio
- if you become pregnant while taking abemaciclib, call your doctor immediately. Abemaciclib may harm the fetus.
- tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while taking abemaciclib and for at least 3 weeks after your final dose.
- you should know that this medication may decrease fertility in men. Talk to your doctor about the risks of taking abemaciclib.
- you should know that abemaciclib (verzenio) often causes diarrhea, which can be severe. Call your doctor immediately if you experience dehydration symptoms: extreme thirst, dry mouth or skin, decreased urination, or fast heartbeat.
You can better manage these conditions by using ankr app.
I forgot a dose. What should I do?
Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
In case of an emergency/overdose
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.
How should I safely store and dispose of Abemaciclib (Verzenio)?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org
You can dispose of unneeded medications in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.
What special dietary instructions should I follow?
Do not eat grapefruit or drink grapefruit juice while taking this medication.
Last Revised – 02/16/2023
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