Riferimento farmaci
Rozanolixizumab
Rozanolixizumab is a medicine in the class miscellaneous. It is used for myasthenia gravis.
- Classe del farmaco: Miscellaneous
- Indicato per: myasthenia gravis
Ultimo aggiornamento Fonti: US FDA label
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In breve
- Classe del farmaco
- Miscellaneous
- Codice ATC
- L04AL02
- Forme farmaceutiche comuni
- iniezione
- Dosaggi comuni
- 140 mg/ml
- Interazioni note
- 26 (Maggiore: 1 · Moderata: 25)
- Nomi commerciali
- 2
- Paesi e mercati
- 2
Per cosa si usa
Come agisce
Humanized IgG4 monoclonal antibody that binds the neonatal Fc receptor (FcRn), reducing circulating IgG.
Dose abituale nell'adulto (sintesi del foglio illustrativo)
Generalized myasthenia gravis, body weight less than 50 kg: 420 mg (3 mL), subcutaneous infusion, once weekly for 6 weeks
Gravidanza e allattamento
- Gravidanza
- Unknown Limited human data. US label: in monkeys it caused embryo death, low offspring weight and weak immune function at 10 to 30 times the human dose without maternal toxicity; the EU label reads the same studies as low IgG only. It lowers IgG passed to the baby; weigh live vaccines for the infant.
- Allattamento
- Unknown No human milk data; IgG passes into milk. US label: weigh benefits. EU label: a risk cannot be excluded in the first days after birth; afterwards consider use only if the benefit outweighs the risk. No LactMed record. A large antibody, so infant absorption is likely low.
Effetti indesiderati segnalati
- Headache
- Infections
- Diarrhea
- Pyrexia
- Hypersensitivity reactions
- Nausea
Chi deve prestare attenzione
- Infections: may increase infection risk; delay in active infection, monitor, and consider withholding for serious infection.
- Live or live-attenuated vaccines are not recommended during treatment because of reduced IgG.
- Aseptic meningitis: serious cases reported; start diagnostic workup and treatment if symptoms develop.
Informare il farmacista o il medico di gravidanza o allattamento, malattie renali o epatiche, allergie e di ogni altro farmaco o integratore assunto.
Interazioni principali (26)
- Rozanolixizumab + Upadacitinib Major
- Abatacept + Rozanolixizumab Moderate
- Adalimumab + Rozanolixizumab Moderate
- Ado-trastuzumab + Rozanolixizumab Moderate
- Basiliximab + Rozanolixizumab Moderate
- Bevacizumab + Rozanolixizumab Moderate
- Denosumab + Rozanolixizumab Moderate
- Etanercept + Rozanolixizumab Moderate
- Galcanezumab + Rozanolixizumab Moderate
- Golimumab + Rozanolixizumab Moderate
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- Dosing by age, kidney and liver function, and further dose lines
- Renal and hepatic dose adjustments
- How to give it
- Pharmacokinetics
- Patient counselling points
- IV preparation and dilution
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Altri farmaci della stessa classe
Domande frequenti
What is Rozanolixizumab used for?
Rozanolixizumab is a medicine in the class miscellaneous. It is used for Myasthenia gravis.
What side effects have been reported with Rozanolixizumab?
Headache, Infections, Diarrhea, Pyrexia, Hypersensitivity reactions, Nausea.
Can Rozanolixizumab be taken in pregnancy or while breastfeeding?
Pregnancy: Unknown. Limited human data. US label: in monkeys it caused embryo death, low offspring weight and weak immune function at 10 to 30 times the human dose without maternal toxicity; the EU label reads the same studies as low IgG only. It lowers IgG passed to the baby; weigh live vaccines for the infant. Breastfeeding: Unknown. No human milk data; IgG passes into milk. US label: weigh benefits. EU label: a risk cannot be excluded in the first days after birth; afterwards consider use only if the benefit outweighs the risk. No LactMed record. A large antibody, so infant absorption is likely low.
What does Rozanolixizumab interact with?
MediHelp lists 26 known interactions for Rozanolixizumab. Major: 1 · Moderate: 25. The most serious include Upadacitinib, Abatacept, Adalimumab.
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