Verzenio

Verzenio is a prescription medication used to treat breast cancer that is hormone receptor (HR) positive. Verzenio is sometimes used in combination with fulvestrant.

Verzenio belongs to a group of drugs called kinase inhibitors. These help by slowing or stopping the spread of cancer by blocking a protein that helps the cancer cells grow.

This medication comes in tablet form and is taken usually 2 times a day with or without food.

Do not chew, divide, or break Verzenio tablets. Swallow tablets whole. Do not take Verzenio tablets if broken or cracked.

Common side effects of Verzenio include diarrhea, low blood cell count, and nausea.

Verzenio is a prescription medicine used:

• in combination with fulvestrant to treat women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), whose disease has progressed after hormonal therapy.
• alone to treat adults with HR-positive, HER2-negative advanced breast cancer or metastatic breast cancer whose disease has progressed after hormonal therapy and prior chemotherapy.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Verzenio. See the “Verzenio Precautions” section.

Common side effects of Verzenio include the following:

• diarrhea
• low blood cell counts
• nausea
• abdominal pain
• infections
• tiredness
• decreased appetite
• vomiting
• headache

This is not a complete list of Verzenio side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), delavirdine (Rescriptor), and nefazodone
• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), and St John's wort

This is not a complete list of Verzenio drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Verzenio including the following:

• lowered blood count. This may cause certain symptoms and may increase the risk that you will develop a serious or life-threatening infection or bleeding. If you experience any of the following symptoms, call your doctor immediately: fever, chills, sore throat, ongoing cough and congestion, or other signs of infection; unusual bleeding or bruising; bloody or black, tarry stools; bloody vomit; or vomiting blood or brown material that resembles coffee grounds.
• diarrhea. Diarrhea is a common problem caused by Verzenio. Diarrhea is most common in the first month of Verzenio treatment. Diarrhea can lead to dehydration or an infection. If you have any loose stools, tell your doctor immediately and drink more fluids.
• a decline in liver function. Tell your healthcare provider about any signs or symptoms of liver damage such as loss of appetite or losing weight, nausea or vomiting, feeling tired, stomach pain, dark urine, light-colored stools, yellowing of your skin or the whites of your eyes, fever, or rash.
• blood clots. Verzenio can cause serious blood clots in the veins or in the lungs. Tell your healthcare provider right away if you have any of the symptoms of a blood clot including pain or swelling in the arms or legs, shortness of breath, chest pain, quick breathing, or quick heartbeat.

Do not take Verzenio if you are allergic to Verzenio or to any of its ingredients.

Grapefruit and grapefruit juice may interact with Verzenio and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before taking Verzenio, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Verzenio or to any of its ingredients
• have signs of an infection such as fever or chills
• have liver problems
• have kidney problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

It is recommended that females use effective contraception during Verzenio treatment and for at least 3 weeks after the last dose.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Verzenio crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Verzenio. 

It is recommended for lactating women to not breastfeed during Verzenio treatment and for at least 3 weeks after the last dose.

Take Verzenio exactly as prescribed.

Verzenio comes in tablet form and is taken twice a day. Take with or without food.

Do not chew, divide, or break Verzenio tablets. Swallow tablets whole. Do not take Verzenio tablets if broken or cracked.

If you vomit or miss a dose, take your next dose at the regular time. Do not take two doses of Verzenio at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

When used with fulvestrant, the recommended dose of Verzenio for the treatment of breast cancer is 150 mg twice daily.

When Verzenio is used alone, the recommended dose of Verzenio for the treatment of breast cancer is 200 mg twice daily.

Always take Verzenio at approximately the same time every day. 

If you take too much Verzenio, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Verzenio at room temperature.
• Keep this and all medicines out of the reach of children.