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Abemaciclib

Name of the generic: abemaciclib [ a-BEM a-SYE-lib“a-BEM-aSYE-lib”

Brand name: Verzenio

Dosage format: oral tablet (100 mg, 150 mg, 200 mg, 50 mg)

Drug class: CDK 4/6 inhibitors

What is Abemaciclib?

Abemaciclib is part of a class of medicines known as Kinase inhibitors. Abemaciclib acts by blocking the actions of an unnatural protein that causes cancer cells to grow. This will stop and slow the growth of the cancer. 

Abemaciclib can be used in conjunction with an anti-aromatase agent, such as anastrozole (Arimidex) or exemestane (Aromasin) and letrozole (Femara) to treat a particular kind of hormone receptor-positive early breast cancer.

Abemaciclib can also be used in conjunction with the drug fulvestrant (Faslodex) in order to fight a particular kind of hormone receptor-positive, aggressive breast cancer (breast cancer that relies on hormones like estrogen to expand) and breast cancers that have spread to different areas of the body following treatment with antiestrogen medications like tamoxifen.

Abemaciclib may also be used alongside anastrozole (Arimidex) or exemestane (Aromasin), as well as letrozole (Femara) as a primary treatment for hormone receptor-positive advanced breast cancer or breast cancers that have spread to various areas within the human body.

Abemaciclib can also be administered on its own for treating a particular kind of hormone receptor-positive advanced breast cancer or cancer which has spread to different regions of the body for those who have been treated with antiestrogen medicine and chemotherapy.

Warnings

Abemaciclib may result in extreme diarrhea and could lead to the loss of fluids or infections.

Contact your doctor as soon as you notice diarrhea. Drink extra fluids and begin taking anti-diarrhea medication like loperamide ( Imodium).

Abemaciclib can lead to blood clots and liver problems and can cause severe or fatal illnesses.

Call your doctor immediately if you notice symptoms like fever, chills, achy skin, bleeding or bruising, fatigue, lack of appetite or stomach discomfort, and chest pain. Breathing problems, shortness of breath, rapid breathing, rapid heartbeats, or swelling or pain in your legs or arms.

We Highly Recommend you to Consult with your doctor When you are Taking this Medicine. 

Inform your physician and pharmacist if you have an allergy to Abemaciclib or any other medication and/or any components in the tablets of Abemaciclib.

To ensure that Abemaciclib is suitable for you, ask your doctor if you previously had:

  • An illness that causes chills, fever, or other indications of infection

  • Breathing or lung problems;

  • Blood clots, or

  • Kidney or liver disease.

Abemaciclib

can cause harm to an unborn baby.

You may need an ultrasound test to be sure that you're not expecting. Utilize effective contraception with Abemaciclib for a minimum of 3 weeks following the last dose. Inform your doctor immediately when you are pregnant.

It might be more difficult to get pregnant if you're Abemaciclib.

You shouldn't be nursing while taking this medicine and for a minimum of 3 weeks following the last dose.

How to Take Abemaciclib?

Abemaciclib is taken exactly as directed by your physician. Follow all instructions on your prescription label, and go through all medication guides and instructions. The doctor might modify your dose.

Use the medicine daily at the same time every day, either with or without meals.

Suck the tablet up whole and don't break, crush, or damage it. Don't use a broken, damaged, cracked, or broken tablet.

If you experience vomiting shortly after Abemaciclib use, Do not take a second dose. The next dose should be taken in the same way as you were scheduled.

Consult your physician when you are experiencing diarrhea you are taking Abemaciclib.

Start taking anti-diarrhea medication such as Loperamide (Imodium) to cure diarrhea. Drink plenty of fluids and consult your doctor.

Your blood needs to be analyzed regularly, and your treatment for cancer could be delayed depending on the results.

You need to keep this at room temperature and must stay far away from moisture and heat. 

What Happens If I Miss a Dose?

Do not take the medicine for as long as you can. However, do not take your missed dosage if it's nearing the time to take the next dose. We highly recommend that you don't take two doses at one time. 

What Happens If I Overdose?

Get medical attention in an emergency or contact for help at the Poison Help line at 1-800-222-1222.

What Should be Avoided Using Abemaciclib?

Grapefruit could interact with Abemaciclib and trigger negative side effects. Avoid consuming grapefruit products.

Side Effects of

Abemaciclib

Take immediate medical attention. Get medical attention immediately if you show

symptoms of an Abemaciclib-related allergic reaction. This could include

itching or breathing difficulties and swelling of your lips, face, and throat.

Abemaciclib may cause serious side effects. Consult your physician immediately in case you experience the following:

  • severe or ongoing diarrhea;
  • Indications of symptoms of infection include fever, chills, sore throat, body aches, strange hunger, fatigue, bleeding, or bruising;
  • Liver issues - weight loss, gastric discomfort (upper right side); Itching, fatigue, and dark urine; stools that are clay-colored; jaundice (yellowing of the eyes or skin);
  • Low blood cells (fever, chills, fatigue, oral sores, and skin sores easily bruising, unusual bleeding, pale skin, cold feet, and hands feeling lightheaded or weak;
  • Indications of lung inflammation A sudden chest pain, wheezing, dry cough or hacking, or feeling tired or
  • Symptoms that a blood clot is deep inside the body or the lungs

    include chest pain, rapid coughing, breathing problems, dizziness, sweating blood, swelling, pain, or the sensation of warmth in your arms and legs.

Your treatment for cancer could be delayed or discontinued permanently in the event of certain negative side consequences.

Common side effects of Abemaciclib could include:

  • Diarrhea, nausea, vomiting, and stomach pain;

  • Lack of appetite

  • Hair loss;

  • Infections;

  • Being tired;

  • Headache Or

  • Low count of blood cells.

This isn't a complete list of possible side effects, and other effects may also be present. Contact your physician for advice regarding medical adverse effects. If you face any adverse reaction then report here FDA at 1-800-FDA-1088.

Details on Dosage

Adult Abemaciclib Dosage for Breast Cancer:

IN COMBINATION WITH A FULVESTRANT OR AN AROMATASE INHIBITOR:

150 mg taken orally twice every day

MONOTHERAPY:

200 mg taken orally twice every day

The Duration Of Therapy Up to the disease progresses, or there is unacceptable toxicity.

Comments:

-If used in conjunction with fulvestrant, pre/perimenopausal women should be treated with a gonadotropin-releasing hormone agonist in accordance with current clinical practice guidelines.

If used in conjunction with this medication, the recommended dosage of fulvestrant should be 500 mg for days 1, 15, 29, and 31 and then every month thereafter with the manufacturer's information on the product for fulvestrant.

Uses:

In conjunction with an aromatase inhibitor for the first endocrine-based treatment for postmenopausal women suffering from hormone receptor (HR)-positive human epidermal factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.

In conjunction with fulvestrant women who have hormone receptor (HR)-positive human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancers with the progression of disease following endocrine therapy

As monotherapy for patients with HER2-negative, HR-positive metastatic, or advanced breast cancers that have progressed after endocrine therapy or prior chemotherapy for metastatic cancer.

What other drugs can Alter Abemaciclib?

There is a time when you don't need to take some medications immediately. Certain drugs may affect the blood levels of other medications you take, which could create side effects or render the medication less effective.

You need to inform your doctor when you are taking these other medications that are listed below:

  • Ketoconazole.

This list isn't comprehensive. Other medications can affect abemaciclib as well, such as prescription or OTC medicines, vitamins, and herbal products. There are many possible interactions between drugs that are included here.

DRUG STATUS

Availability

Prescription only

Pregnancy & Lactation

CSA Schedule*

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