• Monitor for signs and symptoms of infection (fever, chills, dizziness, shortness of breath, weakness, increased bleeding or bruising) during therapy. Treat as medically appropriate. No dose adjustment is needed for Grade 1 or 2 non-hematologic toxicities. For Grade ≥3 (if persisting despite medical treatment), withhold palbociclib until symptoms resolve to Grade ≤1; Grade ≤2 (if not considered a safety risk for patient). Resume at next lower dose.
• Monitor for signs and symptoms of interstitial lung disease or pneumonitis (hypoxia, cough, dyspnea) during therapy. If symptoms are severe, permanently discontinue therapy.

Lab Test Considerations:

• Verify negative pregnancy test before starting therapy.
  • Monitor CBC prior to and at beginning of each cycle, on Day 15 of first 2 cycles, and as clinically indicated. May cause ↓ neutrophil counts; median time to first episode is 15 days and median duration of Grade ≥3 neutropenia was 7 days. May cause febrile neutropenia.
  • No dose adjustment is needed for Grade 1 or 2 hematologic toxicities. For Grade 3 Day 1 of cycle: withhold palbociclib, repeat CBC monitoring within 1 wk. When recovered to Grade ≤2, start next cycle at same dose. For Grade 3 Day 15 of first 2 cycles: If Grade 3 on Day 15, continue palbociclib at current dose to complete cycle and repeat CBC on Day 22. If Grade 4 on Day 22, withhold palbociclib until recovery to Grade ≤2. Resume at next lower dose. Consider dose reduction in cases of prolonged (>1 wk) recovery from Grade 3 neutropenia or recurrent Grade 3 neutropenia on Day 1 of subsequent cycles. For Grade 3 ANC (500–<1000/mm³) plus fever ≥38.5°C and/or infection, withhold palbociclib until recovery to Grade ≤2. Resume at next lower dose. For Grade 4, withhold palbociclib until recovery to Grade ≤2. Resume at next lower dose.
  • May cause ↓ WBC, lymphocytes, hemoglobin, and platelets.