Ibrance Special Precautions

Pre/perimenopausal women: Ovarian ablation or suppression with an LHRH agonist is mandatory when pre/perimenopausal women are administered IBRANCE in combination with an aromatase inhibitor, due to the mechanism of action of aromatase inhibitors. Palbociclib in combination with fulvestrant in pre/perimenopausal women has only been studied in combination with an LHRH agonist.
Critical visceral disease: The efficacy and safety of palbociclib have not been studied in patients with critical visceral disease (see Pharmacology: Pharmacodynamics under Actions).
Haematological disorders: Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia. Appropriate monitoring should be performed (see Dosage & Administration and Adverse Reactions).
Interstitial lung disease/pneumonitis: Severe, life-threatening, or fatal ILD and/or pneumonitis can occur in patients treated with IBRANCE when taken in combination with endocrine therapy.
Across clinical studies (PALOMA-1, PALOMA-2, PALOMA-3), 1.4% of IBRANCE-treated patients had ILD/pneumonitis of any grade, 0.1% had Grade 3, and no Grade 4 or fatal cases were reported. Additional cases of ILD/pneumonitis have been observed in the post-marketing setting, with fatalities reported (see Adverse Reactions).
Patients should be monitored for pulmonary symptoms indicative of ILD/pneumonitis (e.g. hypoxia, cough, dyspnoea). In patients who have new or worsening respiratory symptoms and are suspected to have developed ILD/pneumonitis, IBRANCE should be immediately interrupted and the patient should be evaluated. IBRANCE should be permanently discontinued in patients with severe ILD or pneumonitis (see Dosage & Administration).
Infections: Since IBRANCE has myelosuppressive properties, it may predispose patients to infections.
Infections have been reported at a higher rate in patients treated with IBRANCE in randomised clinical studies compared to patients treated in the respective comparator arm.
Grade 3 and Grade 4 infections occurred respectively in 5.6% and 0.9% of patients treated with IBRANCE in any combination (see Adverse Reactions).
Patients should be monitored for signs and symptoms of infection and treated as medically appropriate (see Dosage & Administration).
Physicians should inform patients to promptly report any episodes of fever.
Hepatic impairment: IBRANCE should be administered with caution to patients with moderate or severe hepatic impairment, with close monitoring of signs of toxicity (see Dosage & Administration and Pharmacology: Pharmacokinetics under Actions).
Renal impairment: IBRANCE should be administered with caution to patients with moderate or severe renal impairment, with close monitoring of signs of toxicity (see Dosage & Administration and Pharmacology: Pharmacokinetics under Actions).
Concomitant treatment with inhibitors or inducers of CYP3A4: Strong inhibitors of CYP3A4 may lead to increased toxicity (see Interactions). Concomitant use of strong CYP3A inhibitors during treatment with palbociclib should be avoided. Coadministration should only be considered after careful evaluation of the potential benefits and risks. If coadministration with a strong CYP3A inhibitor is unavoidable, reduce the IBRANCE dose to 75 mg once daily. When the strong inhibitor is discontinued, the dose of IBRANCE should be increased (after 3-5 half-lives of the inhibitor) to the dose used prior to the initiation of the strong CYP3A inhibitor (see Interactions).
Coadministration of CYP3A inducers may lead to decreased palbociclib exposure and consequently a risk for lack of efficacy. Therefore, concomitant use of palbociclib with strong CYP3A4 inducers should be avoided. No dose adjustments are required for coadministration of palbociclib with moderate CYP3A inducers (see Interactions).
Women of childbearing potential or their partners: Women of childbearing potential or their male partners must use a highly effective method of contraception while taking IBRANCE (see Use in Pregnancy & Lactation).
Lactose: This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Sodium: This medicinal product contains less than 1 mmol (23 mg) sodium per capsule, that is to say essentially 'sodium-free'.
Effects on ability to drive and use machines: IBRANCE has minor influence on the ability to drive and use machines. However, IBRANCE may cause fatigue and patients should exercise caution when driving or using machines.