Ibrance 125mg Tablets

Palbociclib is a selective inhibitor of cyclin-dependent kinases (CDK) 4 and 6. These kinases are activated by binding to D-cyclins and play a crucial role in cell cycle progression from G1 to S phase. Inhibition of CDK4/6 by palbociclib prevents retinoblastoma protein (Rb) phosphorylation, thereby blocking cell cycle progression and inhibiting tumor cell proliferation.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal
Signs of bleeding: vomiting or coughing up blood, coffee ground-like vomit, blood in the urine, black, red, or tarry stools, bleeding gums, abnormal vaginal bleeding, unexplained bruises or bruises that enlarge, or uncontrollable bleeding
Dizziness
Lung problems: new or worsening symptoms such as chest pain, cough (with or without mucus), shortness of breath, or other breathing difficulties (note: lung problems can be fatal)
Signs of a blood clot: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, color change, or pain in a leg or arm, or difficulty speaking or swallowing

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you're bothered by any of the following side effects or if they persist, consult your doctor:

Hair loss
Hair thinning
Mouth irritation or mouth sores
Fatigue or weakness
Dry skin
Changes in taste
Diarrhea, vomiting, stomach upset, and decreased appetite (common side effects; discuss ways to minimize them with your doctor)
If any of these side effects bother you, don't improve, or are severe, contact your doctor for guidance

Reporting Side Effects

This list is not exhaustive. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because certain medications, such as those used to treat HIV, infections, seizures, and other conditions, should not be taken with this drug. There are many medications that interact with this drug, so it is vital to disclose all medications you are taking.
* If you are breastfeeding. You should not breastfeed while taking this medication and for 3 weeks after your last dose.

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications and health problems to ensure safe treatment. Before starting, stopping, or changing the dose of any medication, consult with your doctor to confirm that it is safe to do so with this medication.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

While taking this drug, you may be at a higher risk of developing infections, some of which can be severe or even life-threatening. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or flu.

Additionally, this medication may increase your tendency to bleed easily. To reduce the risk of injury and bleeding, exercise caution in your daily activities and use a soft toothbrush and an electric razor for personal grooming.

Regular monitoring of your blood work and other laboratory tests is crucial while taking this medication. Adhere to the schedule recommended by your doctor for these tests.

This drug is often prescribed in conjunction with other medications. It is vital to understand the warnings, benefits, and risks associated with these other drugs. If you have any questions or concerns, discuss them with your doctor.

To avoid potential interactions, refrain from consuming grapefruit and grapefruit juice while taking this medication.

Men taking this drug should be aware that it may affect their fertility. If you have concerns about fathering a child, consult your doctor.

For women, it is crucial to note that this medication can cause harm to an unborn baby. A pregnancy test will be conducted before initiating treatment to confirm that you are not pregnant. If you are capable of becoming pregnant, use effective birth control methods during treatment and for at least 3 weeks after your last dose. If you become pregnant or suspect you may be pregnant, notify your doctor immediately.

Similarly, if your sexual partner may become pregnant, it is recommended that they use birth control during your treatment and for 3 months after your last dose. If your partner becomes pregnant, contact the doctor right away.

• Strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, grapefruit juice): May significantly increase palbociclib exposure, leading to increased toxicity. Avoid concomitant use or reduce palbociclib dose.
• Strong CYP3A inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort): May significantly decrease palbociclib exposure, leading to reduced efficacy. Avoid concomitant use.

• Moderate CYP3A inhibitors (e.g., erythromycin, diltiazem, verapamil, fluconazole): May increase palbociclib exposure. Consider dose reduction if co-administration is unavoidable.
• Moderate CYP3A inducers (e.g., bosentan, efavirenz, modafinil): May decrease palbociclib exposure. Avoid if possible or monitor for reduced efficacy.

• Proton pump inhibitors (PPIs) and H2-receptor antagonists: May reduce palbociclib solubility and absorption, as palbociclib solubility is pH-dependent. Take palbociclib with food to mitigate this effect.

• Signs of infection (fever, chills, sore throat)
• Unusual bleeding or bruising
• Fatigue, weakness, dizziness (signs of anemia)
• Shortness of breath, cough, chest pain (signs of interstitial lung disease/pneumonitis)
• Diarrhea
• Nausea/vomiting
• Stomatitis/mouth sores
• Hair thinning/loss
• Rash
• Peripheral neuropathy

Ibrance can cause fetal harm when administered to a pregnant woman. Based on animal studies and its mechanism of action, Ibrance is expected to cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 3 weeks after the last dose.

It is not known whether palbociclib is excreted in human milk. Because of the potential for serious adverse reactions in breastfed infants, advise lactating women not to breastfeed during Ibrance treatment and for 3 weeks after the last dose.

The safety and effectiveness of Ibrance in pediatric patients have not been established. Not indicated for pediatric use.

No dose adjustment is required for patients ≥65 years of age. Clinical studies did not identify differences in safety or effectiveness between elderly and younger patients.

• Always administer Ibrance with food to optimize absorption and reduce variability.
• Strict adherence to the 21-day on, 7-day off schedule is crucial for efficacy and managing toxicities.
• Neutropenia is the most common and dose-limiting toxicity; monitor CBCs frequently, especially during the first two cycles.
• Educate patients on signs of infection and to report fever immediately.
• Counsel patients on drug interactions, especially with strong CYP3A inhibitors/inducers and grapefruit products.
• Dose reductions are primarily based on hematologic toxicities; follow specific dose modification guidelines provided in the prescribing information.
• Consider the potential for interstitial lung disease/pneumonitis and advise patients to report new or worsening respiratory symptoms.

• Everolimus (Afinitor) + Exemestane
• Chemotherapy (e.g., capecitabine, eribulin)
• Other endocrine therapies (e.g., tamoxifen, letrozole, anastrozole, exemestane, fulvestrant)
• PI3K inhibitors (e.g., alpelisib)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.