Paleno 125mg Capsule is used for:

• Treatment of hormone receptor-positive (HR-positive), HER2-negative advanced or metastatic breast cancer in combination with appropriate hormonal anticancer therapy.

The choice of combination therapy depends on the patient's previous treatment and clinical condition. Your doctor will determine whether this medicine is suitable for you.

Paleno 125mg Capsule contains Palbociclib, which blocks two proteins called cyclin-dependent kinases 4 and 6 (CDK4 and CDK6). These proteins help regulate the cell cycle, the process through which cells grow and divide.

By inhibiting these proteins, Palbociclib slows the progression of cancer cells through the cell cycle, reducing their ability to multiply. This helps control the growth of hormone receptor-positive breast cancer when used alongside appropriate hormonal anticancer therapy.

Certain medicines and herbal products can affect the amount of Palbociclib in your body, potentially increasing side effects or reducing its effectiveness. Inform your doctor about all prescription medicines, over-the-counter products, vitamins and herbal supplements you take.

• Strong CYP3A inhibitors: Medicines such as clarithromycin, itraconazole and certain antiviral medicines can increase Palbociclib levels and the risk of side effects. Your doctor may recommend an alternative or adjust your dose.

• Strong CYP3A inducers: Medicines such as rifampicin, carbamazepine and phenytoin can reduce Palbociclib levels and may make treatment less effective. Their use together should generally be avoided.

• Medicines affected by CYP3A: Palbociclib can increase the exposure to certain medicines metabolised by CYP3A. Your doctor may need to review their doses.

• Grapefruit and grapefruit juice: These may increase Palbociclib levels and should be avoided during treatment.

• St John's wort: This herbal product can reduce Palbociclib levels and should not be used during treatment.

Do not start, stop or change the dose of any medicine or supplement without consulting your doctor or pharmacist.

• Store Paleno 125mg Capsule at the temperature specified on the product packaging. The general recommended storage temperature for Palbociclib capsules is 20°C to 25°C, with permitted temperature excursions as specified in the applicable product information.

• Keep the capsules in their original packaging until use.

• Protect the medicine from conditions that may affect its quality.

• Keep the medicine out of the sight and reach of children.

• Do not use the medicine after the expiry date printed on the packaging.

• Take Paleno 125mg Capsule exactly as prescribed by your doctor.

• The usual recommended starting dose for Palbociclib capsules is 125 mg once daily for 21 consecutive days, followed by a 7-day break, completing a 28-day treatment cycle.

• Take the capsule with food, preferably at the same time each day.

• Swallow the capsule whole with water. Do not crush, chew, open or break it.

• Your doctor may adjust the dose or interrupt treatment depending on your blood test results, side effects and overall response to treatment.

• If you miss a dose or vomit after taking it, do not take an additional dose to compensate. Take the next dose at the usual scheduled time.

• Continue the treatment schedule recommended by your doctor, including the prescribed break between cycles.

Do not change the dose or stop treatment without consulting your doctor.

Paleno 125mg Capsule may cause side effects in some people. The type and severity of side effects can vary between individuals.

Common Side Effects

• Low white blood cell counts, including neutropenia

• Anaemia

• Low platelet counts

• Infections

• Tiredness or weakness

• Nausea

• Diarrhoea

• Decreased appetite

• Hair loss or thinning

• Mouth sores or inflammation of the mouth

• Rash

• Changes in liver enzyme levels

Your doctor may recommend regular blood tests to monitor your blood cell counts and liver function during treatment. Inform your doctor if side effects persist, worsen or interfere with your daily activities.

Serious Side Effects

Low blood cell counts and serious infections: Palbociclib can significantly reduce white blood cell counts, increasing the risk of infection. Contact your doctor promptly if you develop fever, chills, a persistent sore throat or other signs of infection. Seek urgent medical attention if you become seriously unwell.

Interstitial lung disease or pneumonitis: This medicine may cause inflammation or damage to the lungs. Seek immediate medical attention if you experience new or worsening difficulty breathing, persistent cough or unexplained breathlessness.

Liver problems: Contact your doctor if you develop yellowing of the skin or eyes, dark urine or other symptoms that may indicate liver problems.

• Take Paleno 125mg Capsule with food and follow your prescribed treatment schedule.

• Attend regular blood tests to monitor your blood cell counts during treatment.

• Report fever, chills or other signs of infection promptly, as this medicine can lower white blood cell counts.

• Avoid grapefruit, grapefruit juice and St John's wort during treatment.

• Inform your doctor about all medicines and supplements you take.

• Use effective contraception during treatment and for the recommended period after the final dose.

• Seek immediate medical attention if you develop new or worsening breathing difficulties.

• If you miss a dose or vomit after taking it, do not take an extra capsule. Follow your doctor's instructions.