Palbociclib (Oral route)
Cyclin-Dependent Kinase Inhibitor
Uses of This Medicine:
Palbociclib is used in combination with letrozole (postmenopausal women) or with fulvestrant (disease progression following hormonal therapy) in patients with hormone receptor (HR)-positive, HER-2 negative advanced metastatic breast cancer. It belongs to the group of medicines called antineoplastics.
Palbociclib interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by the medicine, other unwanted effects will also occur. Some of these may be serious and must be reported to your doctor.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of palbociclib in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of palbociclib in the elderly.
Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Eslicarbazepine Acetate
- St John's Wort
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Infection May decrease your body's ability to fight infection.
- Pulmonary embolism (blood clots in the lungs) Use with caution. May make this condition worse.
Proper Use of This Medicine:
Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Palbociclib is given together with letrozole or fulvestrant. It is important that you take each medicine at the right time. Follow your doctor's instructions on when to take these medicines.
Swallow the capsule whole. Do not open, crush, break, or chew it.
Take this medicine with food.
Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (capsules):
- For metastatic breast cancer with letrozole or fulvestrant:
- Adults 125 milligrams (mg) once a day for 21 days, followed by 7 days without medicine. Your doctor may adjust your dose as needed and tolerated.
- Children Use and dose must be determined by your doctor.
- For metastatic breast cancer with letrozole or fulvestrant:
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using This Medicine:
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 3 weeks after your last dose. Males who are taking this medicine, with female partners who can become pregnant must use effective birth control during and for at least 3 months after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.
If you plan to have children, talk with your doctor before using this medicine. Some men using this medicine have become infertile (unable to have children).
Palbociclib can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
Call your doctor right away if you have any symptoms of a life-threatening condition called pulmonary embolism: rapid heart rate, rapid breathing, sudden, sharp chest pain, or troubled breathing.
Do not change your dose or stop using this medicine without checking first with your doctor.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.
Side Effects of This Medicine:
- More common
- Black, tarry stools
- body aches or pain
- ear congestion
- loss of voice
- lower back or side pain
- painful or difficult urination
- pale skin
- sore throat
- stuffy or runny nose
- swelling or inflammation of the mouth
- trouble breathing
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
- Less common
- bloody nose
- chest pain
- dizziness or lightheadedness
- fast heartbeat
- sudden shortness of breath or troubled breathing
- More common
- hair loss or thinning of the hair
- lack or loss of strength
- Less common
- Burning, numbness, tingling, or painful sensation
- decreased appetite
- unsteadiness or awkwardness
- weakness in the arms, legs, or feet
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 9/15/2016