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Verzenio

Generic name: abemaciclib [a-BEM-a-SYE-klib]
Drug class: CDK 4/6 inhibitors

What is Verzenio?

Verzenio is an oral prescription medication that can be used with other cancer therapies to treat patients who have HR-positive but HER2-negative cancer. Adults are treated with Verzenio when cancer spreads to another part of the body after previous treatments have failed. Abemaciclib is a member of a group of drugs called kinase inhibitors.Verzenio, also known as a CDK4/6 inhibitor, is a CDK4/6-targeted treatment. The drug works within the cells to stop CDK4/6 and cancer cell growth.Verzenio can be used with aromatase inhibitors such as anastrozole, exemestane, or letrozole to treat early hormone-receptor-positive breast cancer.

Verzenio can also be used in conjunction with fulvestrant to treat certain types of advanced, hormone-receptor-positive breast cancers (breast tumors that depend on estrogen for growth) and breast cancers that have spread after being treated with anti estrogen medications such as tamoxifen.

Verzenio can also be used in conjunction with other hormone-receptor-positive treatments such as anastrozole, exemestane, or letrozole to treat advanced or metastatic breast cancer.Verzenio can also be used to treat breast cancers that are hormone receptor positive, have spread to different parts of the body, or have already received anti-oestrogen medications and chemotherapy.

Abemaciclib blocks the abnormal protein signaling cancer cells from growing by blocking its action. It can slow down or even stop cancer cell growth.Verzenio can be used with tamoxifen or an aromatase inhibitor. Please read all the patient information for each prescribed medication. If you're not sure, ask your doctor.

Warnings

Verzenio may cause serious diarrhea. This can result in dehydration and infections. If you experience diarrhea, call your doctor immediately. Take anti-diarrhoea medication such as Loperamide or Imodium.

Abemaciclib may cause serious infections, blood clots, and liver damage. Contact your doctor immediately if you experience any of the following symptoms: Fever; chills; easy bleeding or bruising; unusual fatigue; stomach pain on your right side; chest discomfort; breathlessness; rapid breathing or heartbeats

Before you take this drug

Verzenio should be avoided if the abemaciclib or other components found in Verzenio are allergens.

Tell your doctor about any of the following to ensure that this medication is right for you:

  • Fever, chills, or any other sign of an infection
  • Lung or respiratory problems
  • Blood clots
  • Liver or kidney disease

Abemaciclib can harm an unborn child. A pregnancy test may be needed to confirm that you are not expecting. Verzenio should be used with effective birth control for 3 weeks following your last dosage. Inform your physician immediately if you become pregnant.

You may have a harder time getting a woman to fall pregnant if you use this medication.While taking this medication and for 3 weeks following your last dose, you should refrain from breastfeeding.

How to take Verzenio?

Verzenio should be taken exactly as directed by your physician. Read all the instructions and directions that come with your medication. Sometimes your doctor will change the dose.You can take the medication with or without eating.Do not chew or crush the tablet. Use a tablet that is not cracked, damaged, or broken.

Do not take another Verzenio dose if you vomit soon after taking it. Do not miss your scheduled dose.If you experience diarrhea after taking Verzenio, call your doctor. Take anti-diarrhoea medication such as Imodium (loperamide) immediately to treat the diarrhea. Call your doctor and drink extra fluids.

You will have to test your blood often, and cancer treatment may be delayed depending on the results.Stay away from excess heat and moisture at room temperature.

Details on dosage

Adult dose for breast cancer:

In combination with a full-vesterant or an aromatase inhibitor:
Take 150 mg orally twice a day.
MONOTHERAPY:
Take 200 mg orally twice a day.
Duration of Treatment: until disease progression or unacceptable toxicities
Comments:
If using this drug in combination with fulvestrant on pre- or postmenopausal women, treat these patients with a gonadotropin-releasing hormone agonist according to current clinical practice standards.
If you are using fulvestrant in conjunction with the drug, it is recommended that the dose be 500 mg on Days 1, 15, and 29. Then once a month thereafter. Please refer to the product information provided by the manufacturer for further information.
Uses:
Combining an aromatase-inhibitor with a hormone-based treatment for women postmenopausal with advanced or metastatic cancer that is human epidermal growth factor receptor 2 (HER2) negative and has measurable HR
Combination with fulvestrant in women with advanced or metastatic breast cancers that are hormone receptor-positive (HR) but not human epidermal growth factor receptor-2 (HER2) negative and who have progressed after endocrine treatment
As monotherapy in adult patients with metastatic or advanced HR-positive breast cancer who have progressed after endocrine treatment and previous chemotherapy.

What happens if I miss the dose?

If you are almost due for the next dose, skip the missed one. Never take more than one dose at a time.

What happens if I overdose?

Call 1-800-222-1222 for poison help or seek immediate medical attention.

Avoid this

Grapefruit can interact with abemaciclib, causing side effects. Avoid consuming grapefruit products.

Side effects of Verzenio

If you experience any of the following symptoms of an allergy to Verzenio, seek immediate medical attention: Hives, difficulty breathing, swelling in your mouth, face, lips, or throat

Abemaciclib may cause serious side effects. If you experience:

  • Severe or ongoing diarrhea;
  • Symptoms of an infection: fever, chills, throat soreness, body aches and pains, unusual fatigue, lack of appetite or bruising, bleeding, etc.
  • Liver problems: loss of appetite (upper right), fatigue, itching, and dark urine.
  • Low blood counts; fever, chills, and tiredness; mouth sores or skin sores Easy bruising. Unusual bleeding. Pale skin. Cold hands and feet. Feeling light-headed.
  • Symptoms of lung inflammation include sudden chest pains, wheezing and dry coughing, or feeling out of breath.
  • Signs of a Blood Clot Deep in Your Body or Lung: Chest Pain, Sudden Cough or Shortness of Breath, Dizziness, Coughing Up Blood, or Pain, Swelling, or Warmth in Arms or Legs

If you experience certain side effects, your cancer treatment may be halted or delayed.

Common Verzenio side effects may include:

  • Diarrhea, nausea, vomiting, and stomach pain;
  • Loss of appetite
  • Hair loss;
  • Infections;
  • Feeling tired
  • Headache
  • Low blood cell counts

There may be other side effects. For medical advice on side effects, call your doctor. Report side effects by calling the FDA at 1-800-FDA-1088.

Interaction with other drug

It is sometimes not safe to take certain medications at the same time. Some medicines can cause your blood level of another drug to increase, causing side effects and/or a decrease in effectiveness.

Inform your doctor of all other medications you are taking, including:

  • Ketoconazole.

The list below is not exhaustive. Abemaciclib may also interact with other drugs, such as prescription or over-the-counter medications, vitamins, and herbal products. This list does not include all drug interactions.

DRUG STATUS

Availability

Prescription only

Pregnancy & Lactation

CSA Schedule*
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