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DRUG PROFILE OF FABHALTA.pptx by the sri

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DRUG PROFILE OF FABHALTA K. SRI VENKATA LAKSHMI IV PHARM D 320009
BRAND NAME : Fabhalta GENERIC NAME : Iptacopan IUPAC NAME : 4-[(2S,4S)-4-ethoxy-1-[(5-methoxy-7- methyl-1H-indol-4 -yl)methyl]piperidin-2-yl]benzoic acid CLASS OF DRUG : Compliment inhibitors DATE OF APPROVAL : Dec 5,2023 DOSE : 200mg ROUTE : oral
MECHANISM OF ACTION : It inhibits the activation of the AP C3 and C5 proprotein convertases and prevents the downstream cell destructive and activation of the terminal pathway. Iptacopan controls both C3b-mediated EVH and terminal complement- mediated IVH.
INDICATIONS : Fabhalta is indicated as monotherapy in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have haemolytic anaemia.
PHARMACOKINETIC PROPERTIES ABSORPTION : Peak plasma time :2hrs Steady state reached:5days DISTRIBUTION : Protein bound : 75-93% Vd (steady-state) : 288L
METABOLISM : Metabolism includes N-dealkylation, O-de- ethylation, oxidation,and dehydrogenation, mostly driven by CYP2c8(98%) with a small contribution from CYP2D6. ELIMINATION : Half life : 25hrs Clearance :7.96L/hr Excretion : feces 71.5% (16.8% unchanged) urine 24.8% (17.9% unchanged)
ADVERSE DRUG REACTION : Thrombocytopenia Headache Viral infections Nasopharyngitis Diarrhoea Bacterial infections
BLACK BOX WARNING Serious infections caused by encapsulated bacteriaIptacopan, a complement inhibitor, increases the risk of serious infections, especially those caused by encapsulated bacteria (eg, Streptococcus pneumoniae, Neisseria meningitidis, Haemophilus influenzae type B). Life-threatening and fatal infections with encapsulated bacteria have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early.
PREGNANCY Data from clinical trials are insufficient regarding use in pregnant females to identify drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes
LACTATION Data are unavailable on the presence of iptacopan or its metabolite in either human or animal milk, effects on breastfed children, or on milk productionDiscontinue breastfeeding during treatment and for 5 days after final dose
ANIMAL STUDIES Oral administration to rats during organogenesis did not cause embryo-fetal toxicity when given up to the highest dose of 1,000 mg/kg/day, which corresponds to 4-times the maximum recommended human dose (MRHD) based on area under the curve (AUC). Similarly, when administered to rabbits during organogenesis, embryo-fetal toxicity was not observed when given up to the highest dose of 450 mg/kg/day, which corresponds to 6-times the MRHD based on AUC
DRUG INTERACTIONS CYP2C8 substrate (major) CYP2C8 inducers-Monitor coadministration may decrease iptacopan exposure, which may result in loss of or reduced efficacy. Monitor clinical response and discontinue CYP2C8 inducer if loss of iptacopan efficacy is evident. Strong CYP2C8 inhibitors-Avoid coadministration strong CYP2C8 inhibitors may increase iptacopan exposure, which may result in adverse reactions.
CONTRAINDICATIONS Serious hypersensitivity to iptacopan or any of the excipients. Unresolved serious infection with encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, or Haemophilus influenzae type B.
REFERENCE

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DRUG PROFILE OF FABHALTA.pptx by the sri

  • 1. DRUG PROFILE OF FABHALTA K. SRI VENKATA LAKSHMI IV PHARM D 320009
  • 2. BRAND NAME : Fabhalta GENERIC NAME : Iptacopan IUPAC NAME : 4-[(2S,4S)-4-ethoxy-1-[(5-methoxy-7- methyl-1H-indol-4 -yl)methyl]piperidin-2-yl]benzoic acid CLASS OF DRUG : Compliment inhibitors DATE OF APPROVAL : Dec 5,2023 DOSE : 200mg ROUTE : oral
  • 3. MECHANISM OF ACTION : It inhibits the activation of the AP C3 and C5 proprotein convertases and prevents the downstream cell destructive and activation of the terminal pathway. Iptacopan controls both C3b-mediated EVH and terminal complement- mediated IVH.
  • 4. INDICATIONS : Fabhalta is indicated as monotherapy in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have haemolytic anaemia.
  • 5. PHARMACOKINETIC PROPERTIES ABSORPTION : Peak plasma time :2hrs Steady state reached:5days DISTRIBUTION : Protein bound : 75-93% Vd (steady-state) : 288L
  • 6. METABOLISM : Metabolism includes N-dealkylation, O-de- ethylation, oxidation,and dehydrogenation, mostly driven by CYP2c8(98%) with a small contribution from CYP2D6. ELIMINATION : Half life : 25hrs Clearance :7.96L/hr Excretion : feces 71.5% (16.8% unchanged) urine 24.8% (17.9% unchanged)
  • 7. ADVERSE DRUG REACTION : Thrombocytopenia Headache Viral infections Nasopharyngitis Diarrhoea Bacterial infections
  • 8. BLACK BOX WARNING Serious infections caused by encapsulated bacteriaIptacopan, a complement inhibitor, increases the risk of serious infections, especially those caused by encapsulated bacteria (eg, Streptococcus pneumoniae, Neisseria meningitidis, Haemophilus influenzae type B). Life-threatening and fatal infections with encapsulated bacteria have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early.
  • 9. PREGNANCY Data from clinical trials are insufficient regarding use in pregnant females to identify drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes
  • 10. LACTATION Data are unavailable on the presence of iptacopan or its metabolite in either human or animal milk, effects on breastfed children, or on milk productionDiscontinue breastfeeding during treatment and for 5 days after final dose
  • 11. ANIMAL STUDIES Oral administration to rats during organogenesis did not cause embryo-fetal toxicity when given up to the highest dose of 1,000 mg/kg/day, which corresponds to 4-times the maximum recommended human dose (MRHD) based on area under the curve (AUC). Similarly, when administered to rabbits during organogenesis, embryo-fetal toxicity was not observed when given up to the highest dose of 450 mg/kg/day, which corresponds to 6-times the MRHD based on AUC
  • 12. DRUG INTERACTIONS CYP2C8 substrate (major) CYP2C8 inducers-Monitor coadministration may decrease iptacopan exposure, which may result in loss of or reduced efficacy. Monitor clinical response and discontinue CYP2C8 inducer if loss of iptacopan efficacy is evident. Strong CYP2C8 inhibitors-Avoid coadministration strong CYP2C8 inhibitors may increase iptacopan exposure, which may result in adverse reactions.
  • 13. CONTRAINDICATIONS Serious hypersensitivity to iptacopan or any of the excipients. Unresolved serious infection with encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, or Haemophilus influenzae type B.