Ibrance

Name: Ibrance

Ibrance side effects
Ibrance drug
Ibrance used to treat
Ibrance is used to treat
Ibrance ibrance dosage
Ibrance 125 mg
Ibrance brand name
Ibrance dosage
Ibrance dosage forms
Ibrance 75 mg
Ibrance mg

What special precautions should I follow?

Before taking palbociclib,

tell your doctor and pharmacist if you are allergic to palbociclib, any other medications, or any of the ingredients in palbociclib capsules. Ask your pharmacist for a list of the 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. Be sure to mention any of the following: antibiotics such as clarithromycin (Biaxin, in Prevpac), nafcillin, and telithromycin (Ketek); antifungals such as itraconazole (Onmel, Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend); bosentan (Tracleer); certain medications to treat seizures such as carbamazepine (Carbatrol, Epitol, Tegretol, others) and phenytoin (Dilantin, Phenytek); ergot alkaloids such as dihydroergotamine (D.H.E 45, Migranal) and ergotamine (Ergomar, in Cafergot, in Migergot); certain medications for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) including efavirenz (Sustiva, in Atripla), etravirine (Intelence), indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra, in Viekira Pak), saquinavir (Invirase), and telaprevir (no longer available in the U.S.); fentanyl (Fentora, Lazanda, Subsys, others); immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), everolimus (Afinitor, Zortress), sirolimus (Rapamune), and tacrolimus (Astagraf XL, Prograf, Protopic); modafinil (Provigil); nefazodone; pimozide (Orap); quinidine (in Nuedexta); rifampin (Rifadin, Rifater, Rifamate); and verapamil (Calan, Covera, Verelan). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with palbociclib, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
tell your doctor and pharmacist what herbal products you are taking, especially St. John's wort.
tell your doctor if you have an infection or if you have or have ever had liver or kidney disease.
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should not become pregnant while you are taking palbociclib and for at least 2 weeks after taking the last dose. Talk to your doctor about birth control methods that you can use during your treatment. If you become pregnant while taking palbociclib, call your doctor immediately. Palbociclib may harm the fetus.

What Is Ibrance?

Palbociclib is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Palbociclib is used to treat a certain type of advanced breast cancer in postmenopausal women. Palbociclib is given in combination with another cancer medicine, either letrozole (Femara) or fulvestrant (Faslodex).

Palbociclib was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, palbociclib appeared to improve survival time. However, further studies are needed to determine if this medicine can lengthen survival time.

Palbociclib may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not use palbociclib if you are allergic to it.

To make sure palbociclib is safe for you, tell your doctor if you have:

liver disease; or
kidney disease.

Do not use palbociclib if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 2 weeks after your treatment ends.

It is not known whether palbociclib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Administration

Oral Administration

Take with food

Swallow capsules whole; do not chew, crush, or open them prior to swallowing

Do not ingest capsule if it is broken, cracked, or otherwise not intact

Missed or vomited dose: An additional dose should NOT be taken that day; the next prescribed dose should be taken at the usual time

Ibrance Precautions

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

Low white blood cell count (neutropenia) and infections. White blood cells are responsible for fighting off infections in the body. Tell your healthcare provider right away if you have some or all of the following symptoms of a low white blood cell count or infection:

getting frequent infections
chills or sweating
having a fever of 100.5 °F or higher
sore throat, or having sores in the mouth
ulcers or sores
abdominal pain

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

Ibrance Dosage

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

The dose your doctor recommends may be based on the following:
the condition being treated
other medical conditions you have
other medications you are taking
how you respond to this medication
your weight
your height
your age
your gender

The recommended dose of Ibrance (palbociclib) for the treatment of advanced (metastatic) breast cancer is 125 mg once daily for 21 days, followed by 7 days of being off of the medication. This medication should be used in combination with letrozole. Changes in dose or schedule may be required depending on how well the medication is tolerated.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of palbociclib in the elderly.

What should I avoid while taking palbociclib?

Grapefruit and grapefruit juice may interact with palbociclib and lead to unwanted side effects. Avoid the use of grapefruit products while taking palbociclib.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Palbociclib side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;
low white blood cell counts--fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing;
low red blood cells (anemia)--pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

nausea, vomiting, diarrhea, loss of appetite;
mouth sores, decreased sense of taste;
weakness, feeling tired;
numbness, tingling, or burning pain in your arms, legs, hands or feet;
abnormal liver function tests;
cold symptoms such as stuffy nose, sneezing, sore throat;
nosebleed; or
dry skin, temporary hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect palbociclib?

Other drugs may interact with palbociclib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Commonly used brand name(s)

In the U.S.

Ibrance

Available Dosage Forms:

Capsule

Pharmacologic Class: Cyclin-Dependent Kinase Inhibitor

Ibrance Dosage and Administration

Recommended Dose and Schedule

The recommended dose of Ibrance is a 125 mg capsule taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. Ibrance should be taken with food [see Clinical Pharmacology (12.3)].

Administer the recommended dose of an aromatase inhibitor when given with Ibrance. Please refer to the Full Prescribing Information for the aromatase inhibitor being used.

When given with Ibrance, the recommended dose of fulvestrant is 500 mg administered on Days 1, 15, 29, and once monthly thereafter. Please refer to the Full Prescribing Information of fulvestrant.

Patients should be encouraged to take their dose of Ibrance at approximately the same time each day.

If the patient vomits or misses a dose, an additional dose should not be taken. The next prescribed dose should be taken at the usual time. Ibrance capsules should be swallowed whole (do not chew, crush, or open them prior to swallowing). Capsules should not be ingested if they are broken, cracked, or otherwise not intact.

Pre/perimenopausal women treated with the combination Ibrance plus fulvestrant therapy should be treated with luteinizing hormone-releasing hormone (LHRH) agonists according to current clinical practice standards.

Dose Modification

The recommended dose modifications for adverse reactions are listed in Tables 1, 2, and 3.

Table 1. Recommended Dose Modification for Adverse Reactions

Dose Level	Dose
* If further dose reduction below 75 mg/day is required, discontinue.
Recommended starting dose	125 mg/day
First dose reduction	100 mg/day
Second dose reduction	75 mg/day*

Table 2. Dose Modification and Management – Hematologic Toxicities*

Grading according to CTCAE 4.0. CTCAE=Common Terminology Criteria for Adverse Events; LLN=lower limit of normal.
* Table applies to all hematologic adverse reactions except lymphopenia (unless associated with clinical events, e.g., opportunistic infections). † Absolute neutrophil count (ANC): Grade 1: ANC < LLN - 1500/mm3; Grade 2: ANC 1000 - <1500/mm3; Grade 3: ANC 500 - <1000/mm3; Grade 4: ANC <500/mm3.
Monitor complete blood counts prior to the start of Ibrance therapy and at the beginning of each cycle, as well as on Day 15 of the first 2 cycles, and as clinically indicated. For patients who experience a maximum of Grade 1 or 2 neutropenia in the first 6 cycles, monitor complete blood counts for subsequent cycles every 3 months, prior to the beginning of a cycle and as clinically indicated.
CTCAE Grade	Dose Modifications
Grade 1 or 2	No dose adjustment is required.
Grade 3	Day 1 of cycle: Withhold Ibrance, repeat complete blood count monitoring within 1 week. When recovered to Grade ≤2, start the next cycle at the same dose. Day 15 of first 2 cycles: If Grade 3 on Day 15, continue Ibrance at current dose to complete cycle and repeat complete blood count on Day 22. If Grade 4 on Day 22, see Grade 4 dose modification guidelines below. Consider dose reduction in cases of prolonged (>1 week) recovery from Grade 3 neutropenia or recurrent Grade 3 neutropenia on Day 1 of subsequent cycles.
Grade 3 neutropenia† with fever ≥38.5 ºC and/or infection	At any time: Withhold Ibrance until recovery to Grade ≤2. Resume at the next lower dose.
Grade 4	At any time: Withhold Ibrance until recovery to Grade ≤2. Resume at the next lower dose.

Table 3. Dose Modification and Management – Non-Hematologic Toxicities

CTCAE Grade	Dose Modifications
Grading according to CTCAE 4.0. CTCAE=Common Terminology Criteria for Adverse Events.
Grade 1 or 2	No dose adjustment is required.
Grade ≥3 non-hematologic toxicity (if persisting despite optimal medical treatment)	Withhold until symptoms resolve to: Grade ≤1; Grade ≤2 (if not considered a safety risk for the patient) Resume at the next lower dose.

Refer to the Full Prescribing Information for coadministered endocrine therapy dose adjustment guidelines in the event of toxicity and other relevant safety information or contraindications.

Dose Modifications for Use With Strong CYP3A Inhibitors

Avoid concomitant use of strong CYP3A inhibitors and consider an alternative concomitant medication with no or minimal CYP3A inhibition. If patients must be coadministered a strong CYP3A inhibitor, reduce the Ibrance dose to 75 mg once daily. If the strong inhibitor is discontinued, increase the Ibrance dose (after 3 to 5 half-lives of the inhibitor) to the dose used prior to the initiation of the strong CYP3A inhibitor [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

PRINCIPAL DISPLAY PANEL - 75 mg Capsule Bottle Label

NDC 0069-0187-21

Pfizer

Ibrance®
(palbociclib)
capsules

75 mg

21 Capsules

Rx only

What is Ibrance?

Ibrance (palbociclib) is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Ibrance is used in men and women to treat certain types of advanced breast cancer that has spread to other parts of the body.

In postmenopausal women, Ibrance is given in combination with a hormonal medicine called letrozole (Femara). In others, it is given together with fulvestrant (Faslodex).

Important information