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Pemazyre is a brand name for Pemigatinib. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Pemazyre monotherapy is indicated for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.
Verbatim from this product's EMA label. Tap a section to expand.
Therapy should be initiated by a physician experienced in the diagnosis and treatment of patients with biliary tract cancer. FGFR 2 fusion positivity status must be known prior to initiation of Pemazyre therapy. Assessment for FGFR 2 fusion positivity in tumor specimen should be performed with an appropriate diagnostic test.
5 mg pemigatinib taken once daily for 14 days followed by 7 days off therapy. If a dose of pemigatinib is missed by 4 or more hours or vomiting occurs after taking a dose, an additional dose should not be administered and dosing should be resumed with the next scheduled dose.
Treatment should be continued as long as the patient does not show evidence of disease progression or unacceptable toxicity. 5 mg/dL and adding a phosphate-lowering therapy should be considered when level is > 7 mg/dL. The dose of phosphate-lowering therapy should be adjusted until serum phosphate level returns to < 7 mg/dL.
4). Discontinuing phosphate-lowering therapy and diet should be considered during Pemazyre treatment breaks or if serum phosphate level falls below normal range. 4). Dose adjustment due to drug interaction Concomitant use of pemigatinib with strong CYP3A4 inhibitors Concurrent use of strong CYP3A4 inhibitors, including grapefruit juice, should be avoided during treatment with pemigatinib.
5). Management of toxicities Dose modifications or interruption of dosing should be considered for the management of toxicities. Pemigatinib dose reductions levels are summarised in table 1. 5 mg pemigatinib once daily. Dose modifications for hyperphosphataemia are provided in table 2.
5 mg/dL - ≤ 7 mg/dL • pemigatinib should be continued at current dose. > 7 mg/dL - ≤ 10 mg/dL • pemigatinib should be continued at current dose, phosphate- lowering therapy should be initiated, serum phosphate should be monitored weekly, dose of phosphate lowering therapy should be adjusted as needed until level returns to < 7 mg/dL.
• pemigatinib should be withheld if levels do not return to <7 mg/dL within 2 weeks of starting a phosphate lowering therapy. pemigatinib and phosphate-lowering therapy should be restarted at the same dose when level returns to < 7 mg/dL.
• Upon recurrence of serum phosphate at > 7 mg/dL with phosphate-lowering therapy, pemigatinib should be reduced 1 dose level. > 10 mg/dL • pemigatinib should be continued at current dose, phosphate- lowering therapy should be initiated, serum phosphate should be monitored weekly and dose of phosphate lowering therapy should be adjusted as needed until level returns to < 7 mg/dL.
3 %). 4 %). No serious adverse reaction led to pemigatinib dose reduction. 7 %) led to dose interruption. 7 %) led to dose discontinuation. 7 %). 9 Tabulated list of adverse reactions Adverse reactions are presented in table 4. Frequency categories are very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Table 4:
Adverse reactions reported in clinical studies System organ class Frequency Adverse reactions Metabolism and nutrition disorders Very common Hyponatraemia, Hyperphosphataemiaa, Hypophosphataemiab Nervous system disorders Very common Dysgeusia Eye disorders Very common Dry eye Common Serous retinal detachmentc, Punctate keratitis, Vision blurred, Trichiasis Gastrointestinal disorders Very common Nausea, Stomatitis, Diarrhoea, Constipation, Dry mouth Skin and subcutaneous tissue disorders Very common Palmar-plantar erythrodysaesthesia syndrome, Nail toxicityd, Alopecia, Dry skin Common Hair growth abnormal Uncommon Cutaneous calcification Musculoskeletal and connective tissue disorders Very common Arthralgia General disorders and administration site conditions Very common Fatigue Investigations Very common Blood creatinine increased a Includes Hyperphosphataemia and Blood phosphorous increased.
See below “Hyperphosphataemia”. b Includes Hypophosphataemia and Blood phosphorous decreased c Includes Serous retinal detachment, Retinal detachment, Detachment of retinal pigmented epithelium, Retinal thickening, Subretinal fluid, Chorioretinal folds, Chorioretinal scar, and Maculopathy.
See below “Serous retinal detachment”. 5 % of all patients treated with pemigatinib. 7 % of patients, respectively. Hyperphosphataemia usually develops within the first 15 days. None of the reactions were ≥ Grade 3 in severity, serious or led to discontinuation of pemigatinib.
4. Moderate decrease in visual acuity (best corrected visual acuity 20/40 or better or ≤ 3 lines of decreased vision from baseline); limiting instrumental activities of daily living • pemigatinib should be withheld until resolution.
If improved on subsequent examination, pemigatinib should be resumed at the next lower dose level. • If it recurs, symptoms persist or examination does not improve, permanent discontinuation of pemigatinib should be considered based on clinical status.
Marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or > 3 lines decreased vision from baseline up to 20/200); limiting activities of daily living • pemigatinib should be withheld until resolution. If improved on subsequent examination, pemigatinib may be resumed at 2 dose levels lower.
• If it recurs, symptoms persist or examination does not improve, permanent discontinuation of pemigatinib should be considered, based on clinical status. Visual acuity worse than 20/200 in affected eye; limiting activities of daily living • pemigatinib should be withheld until resolution.
If improved on subsequent examination, pemigatinib may be resumed at 2 dose levels lower. • If it recurs, symptoms persist or examination does not improve, permanent discontinuation of pemigatinib should be considered, based on clinical status.
1). Renal impairment Dose adjustment is not required for patients with mild, moderate renal impairment or End Stage Renal Disease (ESRD) on haemodialysis. 2). Hepatic impairment Dose adjustment is not required for patients with mild or moderate hepatic impairment.
2). Paediatric population The safety and efficacy of Pemazyre in patients less than 18 years of age have not been established. No data are available. Method of administration Pemazyre is for oral use. The tablets should be taken at approximately the same time every day.
1. 5).
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• pemigatinib should be withheld if levels continue > 10 mg/dL for 1 week. pemigatinib and phosphate-lowering therapy should be restarted 1 dose level lower when serum phosphate is <7 mg/dL. • If there is recurrence of serum phosphate > 10 mg/dL following 2 dose reductions, pemigatinib should be permanently discontinued.
Dose modifications for serous retinal detachment are provided in table 3.
Table 3:
Dose modifications for serous retinal detachment Adverse reaction pemigatinib dose modification Asymptomatic • pemigatinib should be continued at current dose. Monitoring should be performed as described in section
7 % of patients. These results suggest that dietary phosphate restriction and/or administration of phosphate-lowering therapy along with the 1-week dose holiday were effective strategies for managing this on-target effect of pemigatinib.
4. 8 % of all patients treated with pemigatinib. 7 %). 7 %) led to dose interruption. None of the reactions led to dose reduction or discontinuation. 4. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 10 professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Patients should not crush, chew, split or dissolve the tablets. Pemigatinib may be taken with or without food. 1. 5). 1). 2). Soft tissue mineralization, including cutaneous calcification, calcinosis and non-uraemic calciphylaxis have been observed with pemigatinib treatment.
2). 8). Hypophosphataemia Discontinuing phosphate-lowering therapy and diet should be considered during pemigatinib treatment breaks or if serum phosphate level falls below normal range. 2). 3 % of participants. None of the events were serious, led to discontinuation or to dose reduction.
4 % of participants. 6 For patients presenting with hyperphosphataemia or hypophosphataemia, additional close monitoring and follow-up is recommended regarding dysregulation of bone mineralization. 8). 7). Ophthalmological examination, including optical coherence tomography (OCT) should be performed prior to initiation of therapy and every 2 months for the first 6 months of treatment, every 3 months afterwards, and urgently at any time for visual symptoms.
2). During the conduct of the clinical study, there was no routine monitoring, including OCT, to detect asymptomatic serous retinal detachment; therefore, the incidence of asymptomatic serous retinal detachment with pemigatinib is unknown.
Careful consideration should be taken with patients that have clinically significant medical eye disorders, such as retinal disorders, including but not limited to, central serous retinopathy, macular/retinal degeneration, diabetic retinopathy, and previous retinal detachment.
8). Patients should use ocular demulcents, in order to prevent or treat dry eye, as needed. 3), pemigatinib can cause foetal harm when administered to a pregnant woman. Pregnant women […]