Referência de medicamentos
Iptacopan
Iptacopan is a medicine in the class miscellaneous. It is used for nephropathy.
- Classe do medicamento: Miscellaneous
- Indicado para: nephropathy
Última atualização Fontes: US FDA label
Para profissionais de saúde — apenas referência. Esta página é um resumo breve, não é aconselhamento médico nem substitui a bula oficial ou o julgamento clínico. Verifique sempre antes de prescrever ou dispensar.
O conteúdo clínico desta página está disponível apenas em inglês.
Pontos-chave
- Classe do medicamento
- Miscellaneous
- Formas farmacêuticas comuns
- cápsula
- Concentrações comuns
- 200 mg
- Interações conhecidas
- 5 (Moderada: 5)
- Nomes comerciais
- 2
- Países e mercados
- 2
Para que é usado
Como funciona
Iptacopan binds Factor B of the alternative complement pathway and regulates C3 cleavage, generation of downstream effectors and amplification of the terminal pathway. In PNH it controls both C3b-mediated extravascular hemolysis and terminal complement-mediated intravascular hemolysis.
Dose habitual em adultos (resumo da bula)
PNH, IgAN, C3G: 200 mg orally twice daily, without regard to food; swallow capsules whole
Gravidez e amamentação
- Gravidez
- Unknown Human data are insufficient to show a risk; no fetal harm in rats or rabbits at 4 to 6 times human exposure. Untreated PNH or the kidney diseases it treats carry serious risks in pregnancy. US label: use may be considered after weighing risks and benefits.
- Amamentação
- Unknown No data on milk or infant effects. LactMed repeats the label advice. US label: stop breastfeeding during treatment and for 5 days after the last dose because of possible serious infant reactions (a general precaution; no specific harm is known).
Efeitos adversos relatados
- Headache
- Nasopharyngitis
- Diarrhea
- Abdominal pain
- Bacterial infection
- Viral infection
Advertências de caixa preta
- Complement inhibitor that increases the risk of serious, life-threatening or fatal infections caused by encapsulated bacteria (Streptococcus pneumoniae, Neisseria meningitidis, Haemophilus influenzae type b). Complete or update vaccination at least 2 weeks before the first dose unless delaying therapy is riskier, following ACIP recommendations. Risk persists even with vaccine antibodies. Monitor for early signs of infection and evaluate immediately. Available only through the FABHALTA REMS.
Contraindicações
- Serious hypersensitivity to iptacopan or any of the excipients.
- Initiation in patients with unresolved serious infection caused by encapsulated bacteria.
Quem deve ter cuidado
- Serious infections with encapsulated bacteria; if urgent therapy is needed in patients not up to date on vaccines, give antibacterial prophylaxis and vaccinate as soon as possible.
- Available only through the FABHALTA REMS; prescribers and pharmacies must be certified.
- PNH: after discontinuation, monitor for at least 2 weeks for signs and symptoms of hemolysis.
Informe ao farmacêutico ou ao médico sobre gravidez ou amamentação, doença renal ou hepática, alergias e todos os outros medicamentos ou suplementos que você usa.
Principais interações (5)
- Carbamazepine + Iptacopan Moderate
- Gemfibrozil + Iptacopan Moderate
- Iptacopan + Phenytoin Moderate
- Iptacopan + Rifampicin Moderate
- Iptacopan + Secobarbital Moderate
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- Dosing by age, kidney and liver function, and further dose lines
- Renal and hepatic dose adjustments
- Dosing in older adults
- How to give it
- Pharmacokinetics
- Patient counselling points
- Food interactions
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Perguntas frequentes
What is Iptacopan used for?
Iptacopan is a medicine in the class miscellaneous. It is used for Nephropathy.
What side effects have been reported with Iptacopan?
Headache, Nasopharyngitis, Diarrhea, Abdominal pain, Bacterial infection, Viral infection. Serious warning: Complement inhibitor that increases the risk of serious, life-threatening or fatal infections caused by encapsulated bacteria (Streptococcus pneumoniae, Neisseria meningitidis, Haemophilus influenzae type b).
Can Iptacopan be taken in pregnancy or while breastfeeding?
Pregnancy: Unknown. Human data are insufficient to show a risk; no fetal harm in rats or rabbits at 4 to 6 times human exposure. Untreated PNH or the kidney diseases it treats carry serious risks in pregnancy. US label: use may be considered after weighing risks and benefits. Breastfeeding: Unknown. No data on milk or infant effects. LactMed repeats the label advice. US label: stop breastfeeding during treatment and for 5 days after the last dose because of possible serious infant reactions (a general precaution; no specific harm is known).
What does Iptacopan interact with?
MediHelp lists 5 known interactions for Iptacopan. Moderate: 5. The most serious include Carbamazepine, Gemfibrozil, Phenytoin.
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