Ibrance

The active ingredient in Ibrance is palbociclib, which is a CDK 4/6 inhibitor. Its mechanism of action involves inhibiting the activity of specific proteins known as CDK (cyclin-dependent kinase) 4/6. CDK 4/6 are proteins that help regulate cell growth. In cancer, these proteins can become overly active, causing breast cancer cells to proliferate and divide too quickly.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Ibrance. However, the following is a synopsis of the general guidelines for the use of Ibrance:

• The recommended dose of Ibrance is 125 mg once a day for 21 consecutive days, followed by a 7-day break to complete a 28-day treatment cycle.
• You can take Ibrance with or without food.
• Ibrance should be taken about the same time every day.
• Swallow the Ibrance pills or tablets whole. Do not chew or crush the capsules or tablets, and do not attempt to open them before ingesting.
• Do not take Ibrance capsules or pills that are broken, cracked, or appear damaged.
• Avoid grapefruit and grapefruit juice while taking Ibrance. Grapefruit may boost the level of Ibrance in your blood.

The most common side effects of Ibrance seen in clinical trials include:

• Hair loss.
• Low white blood cells (neutropenia).
• Tiredness.
• Decreased appetite.
• Dry skin.
• Low platelet count (thrombocytopenia) and bleeding or bruising more easily, or nosebleeds.
• Low red blood cell count (anemia).

Some individuals may experience serious side effects while using Ibrance. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Serious infections include fever, chills, disorientation, difficulty breathing, weakness, and easy bruising or bleeding.
• Lung difficulties include coughing, shortness of breath, difficulty breathing, and chest pain.
• Allergic reactions include skin rashes, itching, hives, and swelling of the face, lips, tongue, or neck.
• Serious or life-threatening blood clots in your arteries or lungs.

These are not all of the possible side effects of Ibrance. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the U.S. Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Ibrance, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• Fever, chills, or other infection-related symptoms.
• Interstitial lung disease.
• Liver or kidney issues.

There are no contraindications with Ibrance.

Ibrance typically takes several months to work. Some people may see changes immediately, while others may take longer. Your oncologist will monitor your treatment frequently to ensure that it is effective.

When Ibrance is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• CYP3A inhibitors include clarithromycin, diltiazem, erythromycin, fluconazole, ketoconazole, and verapamil. These should not be taken simultaneously with Ibrance. If a powerful CYP3A inhibitor cannot be avoided, your doctor should lower the dose of Ibrance.
• CYP3A inducers include glucocorticoids, St. John’s Wort, rifampin, carbamazepine, phenobarbital, and phenytoin. Avoid using these alongside Ibrance.
• CYP3A substrates include cyclosporin, tricyclic antidepressants, and certain chemotherapeutic drugs. When Ibrance is used in conjunction with sensitive CYP3A4 substrates with narrow therapeutic indices, the dose may need to be lowered.

The average dose is 125 mg taken orally for 21 days in a row, followed by 7 days off. The cycle repeats itself every 28 days.

If you have liver problems or are taking other medications that interact with Ibrance (palbociclib), your dose may change.

Store at room temperature and keep out of reach of children.

Pfizer Inc. is the company that manufactures Ibrance.

There are no generic versions available of this medication.

You should not stop taking Ibrance on your own; instead, speak with your healthcare provider about quitting the medicine. They will decide whether and when to quit therapy, as well as how to manage any adverse effects that may result, such as low blood cell counts or lung difficulties (pneumonitis).

Ibrance can harm your unborn baby. Females who are capable of becoming pregnant should use effective contraception while on Ibrance and for at least three weeks after the final dose. Before you begin Ibrance medication, your healthcare professional may request that you take a pregnancy test.

Males with female partners who are capable of becoming pregnant should use effective birth control during Ibrance treatment and for at least three months following the final dose. Consult your healthcare practitioner about birth control options that may be appropriate for you at this time.

If you become pregnant or suspect you are pregnant, notify your healthcare professional immediately.

It is unknown whether Ibrance goes into your breast milk. Do not breastfeed while using Ibrance or for three weeks following the last dose.