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.

Dosage:

VINOCEDAL® is usually given at 30-25 mg/m² once weekly.

In combination with other cytostatic agents the exact dose should be taken from the treatment protocol.

VINOCEDAL® may be administered by slow bolus (6-10 minutes) after dilution in 20-50 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection or in 5 % (w/v) glucose solution for injection or by a short infusion (20-30 minutes) after dilution in 125 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection or in 5 % (w/v) glucose solution for injection. Administration should always be followed by a sodium chloride 9 mg/ml (0.9 %) infusion with at least 250 ml to fush the vein.

The maximum tolerated dose per administration: 35.4 mg/m² body surface area

The maximum total dose per administration: 60 mg

Dose Adjustment Recommendations

Vinorelbine metabolism and clearance are mostly hepatic: only 18.5 % is excreted unchanged in the urine. No prospective study relating altered metabolism of the active substance to its pharmacodynamic effects is available in order to establish guidelines for vinorelbine dose reduction in patients with impaired liver or kidney function.

Hepatic impairment

The pharmacokinetics of vinorelbine is not modified in patients presenting moderate or severe live impairment.

Nevertheless as a precautionary measure a reduced dose of 20 mg/m2 and close monitoring of haematological parameters is recommended in patients with severe liver impairment.

Renal impairment

Given the minor renal excretion, there is no pharmacokinetic rationale for reducing vinorelbine dose in patients with impaired kidney function.

Elderly

Clinical experience has not detected any significant differences among elderly patients with regard to the response rate, although greater sensitivity in some of these patients cannot be excluded. Age does not modify the pharmacokinetics of vinorelbine.

Paediatric population

The safety  and  efficacy  in  children  have  not  been  established  an  administration is therefore not recommended.

Method of Administration:

Strictly intravenous administration after appropriate dilution.

Intrathecal administration of vinorelbine may be fatal.

Precautions to be taken before handling or administering the medicinal product

For intravenous administration via syring, the calculated dose of vinorelbine tartrate is diluted to a concentration of 1.5 to 3 mg/mL with either %5 dextrose injection or %0.9 sodium chloride injection.

For administartion via an intravenous bag, the calculated dose of vinorelbine tartrate injection is diluted to a concentration of 0.5 to 2 mg/mL with %5 dextrose injection, 0.9 % sodium chloride injection, 0.45 % sodium chloride injection, 5 % dextrose in 0.45 % sodium chloride injection, Ringer’s injection or lactated Ringer’s injection.

— Administration should always be followed with at least 250 mL of a normal saline infusion to flush the vein.

• 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.