Ibrelyn Special Precautions

Pre/Perimenopausal Women: Ovarian ablation or suppression with an LHRH agonist is mandatory when pre/perimenopausal women are administered Palbociclib Capsule 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.
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.
Interstitial Lung Disease/Pneumonitis: Severe, life-threatening, or fatal ILD and/or pneumonitis can occur in patients treated with Palbociclib Capsule when taken in combination with endocrine therapy.
Additional cases of ILD/pneumonitis have been observed in the post-marketing setting, with fatalities reported.
Monitor patients 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, interrupt Palbociclib Capsule immediately and evaluate the patient. Permanently discontinue Palbociclib Capsule in patients with severe ILD or pneumonitis.
Infections: Since Palbociclib Capsule has myelosuppressive properties, it may predispose patients to infections.
Infections have been reported at a higher rate in patients treated with Palbociclib Capsule in randomised clinical studies compared to patients treated in the respective comparator arm. Grade 3 and Grade 4 infections occurred in patients treated with Palbociclib Capsule in any combination.
Patients should be monitored for signs and symptoms of infection and treated as medically appropriate.
Physicians should inform patients to promptly report any episodes of fever.
Hepatic Impairment: Administer Palbociclib Capsule with caution to patients with moderate or severe hepatic impairment, with close monitoring of signs of toxicity.
Renal Impairment: Administer Palbociclib Capsule with caution to patients with moderate or severe renal impairment, with close monitoring of signs of toxicity.
Concomitant Treatment with Inhibitors or Inducers of CYP3A4: Strong inhibitors of CYP3A4 may lead to increased toxicity. 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 Palbociclib Capsule dose to 75 mg once daily. When the strong inhibitor is discontinued, increase the Palbociclib Capsule dose (after 3-5 half-lives of the inhibitor) to the dose used prior to the initiation of the strong CYP3A inhibitor. 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.
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 Palbociclib Capsule.
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 medicine.
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 Machine: Palbociclib has minor influence on the ability to drive and use machines. However, Palbociclib may cause fatigue and patients should exercise caution when driving or using machines.