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Clinical Efficacy & SafetyPALOMA-2Trial Design OverviewPatient Baseline CharacteristicsPFS (Primary Endpoint)OS (Secondary Endpoint)Tumour Control (Secondary Endpoint)PALOMA-3Trial Design OverviewPatient Baseline CharacteristicsPFS (Primary Endpoint)OS (Secondary Endpoint)Tumour Control (Secondary Endpoint)SafetySafety OverviewPooled ARsPooled Laboratory AbnormalitiesPALOMA-2 AEsPALOMA-3 AEsSelected Safety FeaturesPALBACE® Long-term SafetyGI and Liver ToxicitiesEffect of PALBACE®  on QTc IntervalElderly PatientsVisceral Disease PatientsDose Reduction Effect on EfficacyReal-world EvidenceWhat are RWD and RWE?PALBACE® Development and RWDHow Does RWE Differ From RCT Evidence?What Is Meant by RWD and RWE?What Is the Value of RWE?Multiple Ongoing Real-world Studies at Varied Geographic LocationsEffectivenessWhat is the Flatiron Database?What Were the Key Features of P-REALITY?What Are the Characteristics of Patients in P-REALITY?P-REALITY Real-world Progression-free SurvivalP-REALITY Overall SurvivallP-REALITY StrengthsP-REALITY SummaryTolerability/QoLWhat is the MADELINE Study?What Were the Key Features of the MADELINE Study?What Are the Characteristics Of Patients In MADELINE?MADELINE Physician-reported AEsMADELINE Patient-reported OutcomesMADELINE Study LimitationsMADELINE SummaryDosingDosingRecommended Dosing ScheduleRecommended Dose Modifications For AEsMonitoring

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Summary of Prescibing Information

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Capsule

[PALBACE] ® Abbreviated Prescribing Information / Summary of Product Information

   

GENERIC NAME: Palbociclib

    

PRESENTATION: capsules in 75 mg, 100 mg and 125 mg.

     

INDICATION(s): A] Women: Palbociclib is indicated for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer: in combination with an aromatase inhibitor; in combination with fulvestrant in women who have received prior endocrine therapy. In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.

B] Men: Palbociclib is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with: An aromatase inhibitor as initial endocrine-based therapy; fulvestrant in patients who have received prior therapy.

  

DOSAGE AND ADMINISTRATION: The recommended dose is 125 mg of palbociclib once daily for 21 consecutive days followed by 7 days off treatment (Schedule 3/1) to comprise a complete cycle of 28 days. The treatment with palbociclib should be continued as long as the patient is deriving clinical benefit from therapy or until unacceptable toxicity occurs. Aromatase Inhibitors and fulvestrant to be administered in accordance with their prescribing information. Treatment of pre/perimenopausal women with the combination of palbociclib should always be combined with an LHRH agonist. For men treated with the combination of palbociclib plus aromatase inhibitor therapy, treatment with an LHRH agonist may be considered. Management of some adverse reactions may require temporary dose interruptions/delays and/ordose reductions, or permanent discontinuation as per dose reduction schedules, viz., first dose reduction to 100 mg/day, second reduction to 75 mg/day. Treatment to be discontinued if further dose reduction is required. Complete blood count should be monitored prior to the start of palbociclib therapy and at the beginning of each cycle, as well as on Day 15 of the first 2 cycles, and as clinically indicated. For patients who experience a maximum of Grade 1 or 2 neutropenia in the first 6 cycles, complete blood counts for subsequent cycles should be monitored every 3 months, prior to the beginning of a cycle and as clinically indicated. Absolute neutrophil counts (ANC) of ≥1,000/mm3 and platelet counts of ≥50,000/mm3 are recommended to receive palbociclib. Dosing in special populations: Elderly: No dose adjustment is necessary in patients ≥65 years of age. Hepatic Impairment: No dose adjustment of palbociclib is required for patients with mild or moderate hepatic impairment (Child-Pugh classes A and B). For patients with severe hepatic impairment (Child-Pugh class C), the recommended dose of palbociclib is 75 mg once daily on Schedule 3/1. Renal Impairment: No dose adjustment of palbociclib is required for patients with mild, moderate, or severe renal impairment (creatinine clearance [CrCl] >15 mL/min). Insufficient data are available in patients requiring haemodialysis to provide any dose adjustment recommendation in this patient population. Paediatric Population: The safety and efficacy of palbociclib in children and adolescents ≤18 years of age have not been established.

 

  • CONTRAINDICATIONS: Hypersensitivity to the active substance (microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, and hard gelatin capsule shells. The light orange, light orange/caramel and caramel opaque capsule shells contain gelatin, red iron oxide, yellow iron oxide, and titanium dioxide; and the printing ink contains shellac, titanium dioxide, ammonium hydroxide, propylene glycol and simethicone). Use of preparations containing St. John’s Wort.

  • WARNING AND PRECAUTIONS: Pre/perimenopausal women: Ovarian ablation or suppression with an LHRH agonist is mandatory when pre/perimenopausal women are administered palbociclib in combination with an aromatase inhibitor or fulvestrant. 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 when taken in combination with endocrine therapy. Across clinical trials, 1.4% of palbociclib-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. 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 immediately and evaluate the patient. Permanently discontinue palbociclib in patients with severe ILD or pneumonitis. Infections: Since palbociclib has myelosuppressive properties, it may predispose patients to infections. Infections have been reported at a higher rate in patients treated with palbociclib in randomised clinical studies compared to patients treated in the respective comparator arm. Grades 3 and 4 infections occurred respectively in 5.6% and 0.9% of patients treated with palbociclib 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 episode of fever. Hepatic impairment: Administer palbociclib with caution to patients with moderate or severe hepatic impairment, with close monitoring of toxicity signs. Renal impairment: Administer palbociclib 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. Co-administration should only be considered after careful evaluation of the potential benefits and risks. If co-administration with a strong CYP3A inhibitor is unavoidable, reduce the palbociclib dose to 75 mg once daily. When the strong inhibitor is discontinued, increase the palbociclib dose (after 3 5 half lives of the inhibitor) to the dose used prior to the initiation of the strong CYP3A inhibitor. Co-administration 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 co-administration 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. Lactose: This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.

  • Use in Special population: Women of childbearing potential/Contraception in males and females: Females of childbearing potential who are receiving this medicinal product, or their male partners should use adequate contraceptive methods (e.g., double-barrier contraception) during therapy and for at least 3 weeks or 14 weeks after completing therapy for females and males, respectively. Pregnancy: There are no or limited amount of data from the use of palbociclib in pregnant women. Studies in animals have shown reproductive toxicity. Palbociclib is not recommended during pregnancy and in women of childbearing potential not using contraception. Breast-feeding: No studies have been conducted in humans or animals to assess the effect of palbociclib on milk production, its presence in breast milk, or its effects on the breast-fed child. It is unknown whether palbociclib is excreted in human milk. Patients receiving palbociclib should not breast feed. Fertility: There were no effects on oestrous cycle (female rats) or mating and fertility in rats (male or female) in non-clinical reproductive studies. However, no clinical data have been obtained on fertility in humans. Based on male reproductive organ findings (seminiferous tubule degeneration in testis, epididymal hypospermia, lower sperm motility and density, and decreased prostate secretion) in non-clinical safety studies, male fertility may be compromised by treatment with palbociclib. Thus, men may consider sperm preservation prior to beginning therapy with palbociclib.

  • DRUG INTERACTIONS: Palbociclib is primarily metabolised by CYP3A and sulphotransferase (SULT) enzyme SULT2A1. In vivo, palbociclib is a weak, 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. No dose adjustments are needed for mild and moderate CYP3A inhibitors. 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. No dose adjustments are required for moderate CYP3A inducers. Effect of acid reducing agents: given the effect of proton pump inhibitors on palbociclib AUCinf and Cmax in fasting and fed conditions, palbociclib should be taken with food, preferably a meal. Given the reduced effect on gastric pH of H2-receptor antagonists and local antacids compared to PPIs, no clinically relevant effect of H2 receptor antagonists or local antacids on palbociclib exposure is expected when palbociclib is taken with food. Effects of palbociclib on the pharmacokinetics of other medicinal products: Palbociclib is a weak, time-dependent inhibitor of CYP3A. The dose of sensitive CYP3A substrates with a narrow therapeutic index (e.g., alfentanil, cyclosporine, dihydroergotamine, ergotamine, everolimus, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus) may need to be reduced when co-administered with palbociclib as palbociclib may increase their exposure. Drug-drug interaction between palbociclib and letrozole: Data from the drug-drug interaction (DDI) evaluation portion of a clinical study in patients with breast cancer showed that there was no drug interaction between palbociclib and letrozole when the 2 medicinal products were co-administered. Effect of tamoxifen on palbociclib exposure: Data from a DDI study in healthy male subjects indicated that palbociclib exposures were comparable when a single dose of palbociclib was co-administered with multiple doses of tamoxifen and when palbociclib was given alone. Drug-drug interaction between palbociclib and fulvestrant: Data from a clinical study in patients with breast cancer showed that there was no clinically relevant drug interaction between palbociclib and fulvestrant when the two medicinal products were co-administered. Drug-drug interaction between palbociclib and oral contraceptives: DDI studies of palbociclib with oral contraceptives have not been conducted. In vitro studies with transporters: Based on in vitro data, palbociclib is predicted to inhibit intestinal P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) mediated transport. Therefore, administration of palbociclib with medicinal products that are substrates of P-gp (e.g., digoxin, dabigatran, colchicine) or BCRP (e.g., pravastatin, rosuvastatin, sulfasalazine) may increase their therapeutic effect and adverse reactions. Based on in vitro data, palbociclib may inhibit the uptake transporter organic cationic transporter OCT1 and then may increase the exposure of medical product substrates of this transporter (e.g., metformin).

  • OVERDOSE: In the event of a palbociclib overdose, both gastrointestinal (e.g., nausea, vomiting) and haematological (e.g., neutropenia) toxicity may occur and general supportive care should be provided.

  • ADVERSE REACTION: The most common adverse reactions of any grade reported in patients receiving palbociclib in randomised clinical studies were neutropenia, infections, leukopenia, fatigue, nausea, vomiting, stomatitis, anaemia, diarrhoea, alopecia, thrombocytopenia, asthenia, pyrexia, rash, dry skin. The most common (≥2%) Grade ≥3 adverse reactions of palbociclib were neutropenia, leukopenia, infections, anaemia, aspartate aminotransferase (AST) increased, fatigue, and alanine aminotransferase (ALT) increased. Common adverse events include febrile neutropenia, dysgeusia, epistaxis, ILD/pneumonitis, blurred vision, increased lacrimation, dry eye. Uncommon AE, cutaneous lupus erythematosus was reported.

PHARMACEUTICAL PRECAUTIONS: Store below 30°C in the original package. No special requirements.

    

REFERENCE: LPDPAB102021 27-Dec-2021

    

DATE OF THIS DOCUMENT: 03 Jan 2022

    

Full prescribing Information available on request
®Trademark Proprietor – Pfizer Inc., USA
Licensed User – Pfizer Products India Private Limited, India

Summary of Prescribing Information

Clinical Efficacy & Safety

PALOMA was the first clinical trial programme to explore how a CDK4/6 inhibitor could benefit women with HR+/HER2- mBC

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Real-world Evidence

With RCT data, PALBACE® RWE can help improve the understanding of outcomes in patients with HR+/HER2- mBC

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Dosing

Recommended dosing schedule and dose modifications for AEs

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Monitoring

One scheduled monitoring provision

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Please click the Prescribing Information link to view the safety and adverse events information of PALBACE®.
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