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Brand Name : Ibrance 125mg
Composition : Palbociclib
Strength : 120 mg
Form : Capsules
Packing : Pack of 21 Capsules

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Description

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Palbociclib is an oral chemotherapy used to treat advanced breast cancer. This drug is used as part of a combination therapy. That means it is taken with other drugs. Palbociclib is generally taken in combination with letrozole

Ibrance (Palbociclip 125mg) ) is a product of Pfizer and is known as IBRANCE in other parts of the world

The drug was reviewed and approved under thefood and drug administration’s  (FDA) accelerated priority review and breakthrough therapy designation programs on February of 2015

The drug was approved for use in the European Union in November 2016 as a treatment for hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer

Palbace comes in capsule form in 125 mg dose. 1 pack has 21 capsules.

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Note:

The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.
Remember, keep this and all other medicines out of the reach of children and away from pets, never share your medicines with others, and use this medication only for the indication prescribed.
The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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How to use Palbociclib Capsule

Read the Patient Information Leaflet if available from your pharmacist before you start taking palbociclib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually once daily for 21 days, then stopping the medication for 7 days. This is one cycle of treatment. Continue taking the medication this way as directed by your doctor.

This medication comes in a capsule or tablet. The capsule should be taken with food while the tablet can be taken with or without food. Swallow the medication whole. Do not crush or chew, or open the capsules, or split the tablets.

Do not take capsules or tablets that are broken or look damaged. If you vomit after taking the medication, do not take another dose of the medication that day. Take the next dose at the usual time the next day.

The dosage is based on your medical condition, laboratory tests, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor may stop your medication for a while or reduce your dose if you get any side effects. Talk to your doctor for more details.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time on the days you are scheduled to take the medication.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

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Side Effects

Nauseavomiting, loss of appetite, diarrhea, tiredness, weaknesshair lossmouth sores, or numbness/tingling of arms/legs may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: signs of anemia (such as unusual tiredness, pale skin, fast heartbeat), easy bruising/bleeding (such as nosebleed), signs of lung problems (such as chest pain, shortness of breath).

This medication may lower your ability to fight infections. This may make you more likely to get a serious infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as fever, chills, persistent sore throatcough).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rashitching/swelling (especially of the face/tongue/throat), severe dizzinesstrouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

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Precautions

Before taking palbociclib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease.

Palbociclib can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpoxmeaslesflu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication can affect fertility in males. Ask your doctor for more details.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are using palbociclib. Palbociclib may harm an unborn baby. Men with female partners of childbearing age should use reliable forms of birth control while using this medication and for 3 months after the last dose. Women of childbearing age should have a pregnancy test before starting this medication and should ask about reliable forms of birth control while using this medication and for at least 3 weeks after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding during treatment and for at least 3 weeks after treatment with this drug is not recommended. Consult your doctor before breast-feeding.

Consult your pharmacist or physician.

Interactions

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Other medications can affect the removal of palbociclib from your body, which may affect how palbociclib works. Examples include azole antifungals (such as itraconazoleketoconazole), carbamazepine, phenytoin, rifamycins (such as rifampin), St. John’s wort, among others.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as complete blood count) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments.

Missed Dose

If you miss a dose, skip the missed dose. Take your next dose at the regular time the next day. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

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What Palbociclib Is Used For:

  • Palbociclib is used in combination with letrozole (an aromatase inhibitor) to treat postmenopausal women with estrogen receptor (ER) positive, HER2 negative advanced breast cancer.

Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.

How Palbociclib Is Given:

  • Palbociclib is a capsule. Swallow whole with water. Take within 30 minutes of a meal. Do not break, chew, crush, dissolve or open capsules.
  • Take about the same time each day.
  • Do not eat grapefruit or drink grapefruit juice while on palbociclib.
  • Capsules come in 3 sizes: 75 mg, 100 mg, and 125 mg.
  • If you miss a dose of palbociclib, take it as soon as you remember that day. If you miss taking your dose for the entire day, go back to taking your regular dose the next day. Do not take 2 doses at the same time.
  • The amount of palbociclib that you will receive depends on many factors, including your general health or other health problems, and the type of cancer or condition being treated. Your doctor will determine your exact dosage and schedule.

Side Effects:

Important things to remember about the side effects of palbociclib:

  • Most people will not experience all of the palbociclib side effects listed.
  • Palbociclib side effects are often predictable in terms of their onset, duration, and severity.
  • Palbociclib side effects will improve after therapy is complete.
  • Palbociclib side effects may be quite manageable. There are many options to minimize or prevent the side effects of palbociclib.

The following side effects are common (occurring in greater than 30%) for patients taking palbociclib:

  • Low blood counts. Your white and red blood cells and platelets may temporarily decrease. This can put you at increased risk for infection, anemia and/or bleeding.
    • Nadir: 15 days
  • Fatigue
  • Upper respiratory infection

These are less common side effects for patients receiving palbociclib:

  • Nausea
  • Mouth sores
  • Hair loss/thinning
  • Diarrhea
  • Decreased appetite
  • Vomiting
  • Peripheral neuropathy (numbness/tingling of fingers/toes)
  • Weakness
  • Nosebleeds

A rare, but serious side effect of palbociclib is blood clots in the lung (pulmonary embolus (PE)). You should seek emergency help and notify your health care provider immediately if you develop sudden chest pain and shortness of breath. Notify your health care provider within 24 hours if you notice leg or arm swelling, redness, pain and/or skin warm to touch (signs and symptoms of possible blood clot in the arm or leg.)

Not all side effects are listed above. Side effects that are very rare — occurring in less than about 10 percent of patients — are not listed here. But you should always inform your health care provider if you experience any unusual symptoms.

 

When to contact your doctor or health care provider:

Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:

  • Fever of 100.4º F (38º C) or higher, chills (possible signs of infection)
  • Sudden chest pain and shortness of breath

The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:

  • Nausea (interferes with ability to eat and unrelieved with prescribed medication)
  • Vomiting (vomiting more than 4 times in a 24 hour period)
  • Diarrhea (4 episodes in a 24-hour period)
  • Unusual bleeding or bruising
  • Black or tarry stools, or blood in your stools
  • Blood in the urine
  • Extreme fatigue (unable to carry on self-care activities)
  • Mouth sores (painful redness, swelling or ulcers)
  • Leg or arm swelling, redness, pain and/or warm to touch.

Always inform your health care provider if you experience any unusual symptoms.

Precautions:

  • Before starting palbociclib treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.). Do not take aspirin, products containing aspirin unless your doctor specifically permits this.
  • Do not eat grapefruit or grapefruit juice.
  • Do not receive any kind of immunization or vaccination without your doctor’s approval while taking palbociclib.
  • Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. This drug must not be given to a pregnant woman or a woman who intends to become pregnant.
  • For both men and women: Use contraceptives, and do not conceive a child (get pregnant) while taking palbociclib. Barrier methods of contraception, such as condoms, are recommended.
  • Do not breast feed while taking palbociclib.

Self-Care Tips:

  • Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
  • You may be at risk of infection so try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your health care provider.
  • Wash your hands often.
  • To help treat/prevent mouth sores, use a soft toothbrush, and rinse three times a day with 1 teaspoon of baking soda mixed with 8 ounces of water.
  • Use an electric razor and a soft toothbrush to minimize bleeding.
  • Avoid contact sports or activities that could cause injury.
  • To reduce nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals.
  • Avoid sun exposure. Wear SPF 15 (or higher) sunblock and protective clothing.
  • In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.
  • Get plenty of rest.
  • Maintain good nutrition.
  • Remain active as you are able. Gentle exercise is encouraged such as a daily walk.
  • If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.

Monitoring and Testing:

You will be checked regularly by your doctor while you are taking palbociclib, to monitor side effects and check your response to therapy. Periodic blood work will be obtained to monitor your complete blood count (CBC).

How Palbociclib Works:

Targeted therapy is the result of about 100 years of research dedicated to understanding the differences between cancer cells and normal cells. To date, cancer treatment has focused primarily on killing rapidly dividing cells because one feature of cancer cells is that they divide rapidly. Unfortunately, some of our normal cells divide rapidly too, causing multiple side effects.

Targeted therapy is about identifying other features of cancer cells. Scientists look for specific differences in the cancer cells and the normal cells. This information is used to create a targeted therapy to attack the cancer cells without damaging the normal cells, thus leading to fewer side effects. Each type of targeted therapy works a little bit differently but all interfere with the ability of the cancer cell to grow, divide, repair and/or communicate with other cells.

There are different types of targeted therapies, defined in three broad categories. Some targeted therapies focus on the internal components and function of the cancer cell. The targeted therapies use small molecules that can get into the cell and disrupt the function of the cells, causing them to die. There are several types of targeted therapy that focus on the inner parts of the cells. Other targeted therapies target receptors that are on the outside of the cell. Therapies that target receptors are also known as monoclonal antibodies. Antiangiogenesis inhibitors target the blood vessels that supply oxygen to the cells, ultimately causing the cells to starve.

Researchers agree that targeted therapies are not a replacement for traditional therapies. They may best be used in combination with traditional therapies. More research is needed to identify which cancers may be best treated with targeted therapies and to identify additional targets for more types of cancer.

Palbociclib (Ibrance®) is a drug that can be used along with an aromatase inhibitor to treat women with advanced hormone receptor-positive breast cancer. Palbociclib is a reversible small molecule cyclin-dependent kinase (CDK) inhibitor. The drug blocks proteins in the cell called cyclin-dependent kinase (CDK) 4 and CDK 6. In hormone positive breast cancer cells, blocking these proteins helps stop the cells from dividing to make new cells. It helps prevent the cells from moving from G1 to S cell cycle phase in the division process. This slows cancer growthThe combination of palbociclib and aromatase inhibitor (e.g. letrozole) is more effective compared with each agent alone.

Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.

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