PalboCedal^®

• Palbociclib is indicated for the treatment of HR-positive (human receptor) and HER2-negative (human epidermal growth factor) advanced or metastatic breast cancer. It is used in the following ways:

  1. 1. Concomitant use with an aromatase inhibitor (a hormonal medicine for cancer)
  2. Concomitant use with fulvestrant (another hormonal medicine for cancer) in patients who have previously been treated with a hormonal medicine.

• If you are allergic to Palbociclib or any of the other ingredients of this medicine.
• Use of preparations containing St. John’s Wort (Hypericum perforatum) with palbociclib is contraindicated

• Take with or just after food or a meal.
• Swallow capsules whole. Do not chew, crush, or open capsules.
• Talk to your doctor before taking Palbociclib.
• Palbociclib may reduce the number of your white blood cells and weaken your immune system. Therefore, you may be at greater risk of getting an infection while you are taking Palbociclib. Tell your doctor if you experience signs or symptoms of an infection, such as chills or fever. You will have regular blood tests during treatment to check whether Palbociclib affects your blood cells (white blood cells, red blood cells, and platelets).
• Palbociclib may cause severe or life-threatening inflammation of the lungs during treatment that can lead to death. Tell your healthcare provider right away if you have any new or worsening symptoms including: diff iculty breathing or shortness of breath, dry cough, chest pain.
• This medicine may make you sleepy. Avoid driving or operating machinery when using this medicine.
• For oncology use only.

The recommended dose is 125 mg once a day for 21 consecutive days, followed by a 7 -day break to complete a 28-day treatment cycle. Treatment should be taken at around the same time each day. The capsules should be taken with food. The recommended dose of letrozole when given with Palbociclib is 2.5 mg taken once daily continuously throughout the 28-day cycle. Please refer to the full prescribing information of letrozole. When coadministered with Palbociclib, the recommended dose of fulvestrant is 500 mg administered on Days 29 ,15 ,1, and once monthly thereafter. Please refer to the full prescribing information of fulvestrant. Pre/perimenopausal women on the combination Palbociclib plus fulvestrant therapy should be with luteinizing hormone-releasing hormone (LHRH) agonists according to current clinical practice standards.

• Possible side effects: Like all medicines, this medicine can cause side effects, although not everybody gets them. Contact your doctor immediately if you have any of these symptoms:

fever, chills, weakness, shortness of breath, bleeding, or easy bruising which could be a sign of a serious blood disorder. Difficulty breathing, dry cough or chest pain which could be a sign of inflammation of the lungs.

• Very common side effects (may affect more than 1 in 10 people):

Infections, reduction in white blood cells, red blood cells, and blood platelets, feeling of tiredness, decreased appetite, inflammation of the mouth and lips (stomatitis), nausea, vomiting, diarrhea, rash, hair loss, weakness, fever, abnormalities in liver blood tests, dry skin.

• Common side effects (may affect up to 1 in 10 people):

Fever with a drop in the white blood cell count (febrile neutropenia), blurred vision, increased tearing, dry eye, alteration in taste (dysgeusia), nosebleed.

• Uncommon side effects (may affect up to 1 in 100 people):

Inflammation of the skin causing red scaly patches and possibly occurring together with pain in the joints and fever.

• Palbociclib is primarily metabolized by CYP3A and sulfotransferase (SULT) enzyme SULT2A1. In vivo, Palbociclib is a time-dependent inhibitor of CYP3A.
• Effect of CYP3A inhibitors: The concomitant use of strong CYP3A inhibitors including, but not limited to: clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, saquinavir, telaprevir, telithromycin, voriconazole, and grapefruit or grapefruit juice, should be avoided.
• Effect of CYP3A inducers: The concomitant use of strong CYP3A inducers including, but not limited to: carbamazepine, enzalutamide, phenytoin, rifampin, and St. John’s Wort should be avoided.

• Pregnancy: If you are pregnant or plan to be, you should consult your doctor about the use of this medicine.
• Lactation: Breastfeeding is not recommended.

• Store below 30 °C and keep away from light and moisture.
• This drug should be stored, shipped, and disposed in accordance with precautions for cytotoxic medicines.
• Keep out of the reach of children.