दवा संदर्भ
Valoctocogene roxaparvovec
Valoctocogene roxaparvovec is a medicine in the class miscellaneous. It is used for hemophilia a.
- दवा वर्ग: Miscellaneous
- उपयोग: hemophilia a
अंतिम अपडेट स्रोत: EMA SmPC
केवल स्वास्थ्य पेशेवरों के लिए — मात्र संदर्भ हेतु। यह पृष्ठ संक्षिप्त सारांश है, चिकित्सकीय सलाह नहीं है और आधिकारिक लेबल या नैदानिक निर्णय का विकल्प नहीं है। दवा लिखने या देने से पहले हमेशा जाँच करें।
इस पृष्ठ की नैदानिक सामग्री केवल अंग्रेज़ी में उपलब्ध है।
मुख्य तथ्य
- दवा वर्ग
- Miscellaneous
- ATC कोड
- B02BD15
- ज्ञात अंतःक्रियाएँ
- 40 (गंभीर: 6 · मध्यम: 33 · हल्की: 1)
- ब्रांड नाम
- 1
- देश और बाज़ार
- 1
उपयोग
यह कैसे काम करती है
AAV5-based gene therapy vector that expresses B-domain deleted SQ recombinant human factor VIII (hFVIII-SQ) under a liver-specific promoter, replacing the missing factor VIII. Vector DNA forms episomal transgenes that support long-term hFVIII-SQ production.
वयस्कों की सामान्य खुराक (लेबल सारांश)
Severe haemophilia A: 6 × 1013 vg/kg body weight, intravenous, as a single infusion. Dose volume in mL = body weight in kg multiplied by 3.
गर्भावस्था और स्तनपान
- गर्भावस्था
- Unsafe Gene therapy for men with severe haemophilia A. No pregnancy data or animal studies; theoretical risk of vector DNA reaching fetal cells. EU label: should not be used in pregnancy; not recommended in women who could become pregnant. Partners of treated men: double-barrier contraception for 6 months.
- स्तनपान
- Unknown Not known if the vector or factor VIII it produces passes into milk; no LactMed record. EU label: a risk to the infant cannot be excluded; should not be used while breastfeeding. It is licensed for men, so use while breastfeeding is not expected.
रिपोर्ट किए गए दुष्प्रभाव
- ALT increased
- AST increased
- LDH increased
- CPK increased
- Nausea
- Headache
प्रतिसंकेत
- Hypersensitivity to the active substance or any excipient.
- Active infections (acute or uncontrolled chronic), or known significant hepatic fibrosis or cirrhosis.
किन्हें सावधानी रखनी चाहिए
- Only for patients demonstrated to lack anti-AAV5 antibodies by a validated assay; not indicated with a history of factor VIII inhibitors.
- Hepatic reactions (ALT increase) occur in most patients; monitor ALT and factor VIII activity and give corticosteroids as needed.
- Infusion-related reactions can occur; monitor during and after infusion.
गर्भावस्था या स्तनपान, किडनी या लिवर के रोग, एलर्जी और आप जो भी अन्य दवा या सप्लीमेंट लेते हैं, उसके बारे में अपने फार्मासिस्ट या डॉक्टर को बताएँ।
मुख्य इंटरैक्शन (40)
- Dantrolene + Valoctocogene roxaparvovec Major
- Efavirenz + Valoctocogene roxaparvovec Major
- Flutamide + Valoctocogene roxaparvovec Major
- Nevirapine + Valoctocogene roxaparvovec Major
- Propylthiouracil + Valoctocogene roxaparvovec Major
- Valoctocogene roxaparvovec + Valproic acid Major
- Allopurinol + Valoctocogene roxaparvovec Moderate
- Amiodarone + Valoctocogene roxaparvovec Moderate
- Amoxicillin-clavulanic acid + Valoctocogene roxaparvovec Moderate
- Azathioprine + Valoctocogene roxaparvovec Moderate
Pro+ सदस्यों के लिए
पूरा पेज खोलें
Valoctocogene roxaparvovec का पूरा मोनोग्राफ खोलने के लिए खाता बनाएँ और Pro+ ट्रायल शुरू करें: खुराक, गर्भावस्था और स्तनपान, दुष्प्रभाव, चेतावनियाँ और सभी इंटरैक्शन।
- 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
- IV preparation and dilution
वेब पर Pro+ को 14 दिन मुफ़्त आज़माएँ। कार्ड की ज़रूरत नहीं।
अक्सर पूछे जाने वाले प्रश्न
What is Valoctocogene roxaparvovec used for?
Valoctocogene roxaparvovec is a medicine in the class miscellaneous. It is used for Hemophilia a.
What side effects have been reported with Valoctocogene roxaparvovec?
ALT increased, AST increased, LDH increased, CPK increased, Nausea, Headache.
Can Valoctocogene roxaparvovec be taken in pregnancy or while breastfeeding?
Pregnancy: Unsafe. Gene therapy for men with severe haemophilia A. No pregnancy data or animal studies; theoretical risk of vector DNA reaching fetal cells. EU label: should not be used in pregnancy; not recommended in women who could become pregnant. Partners of treated men: double-barrier contraception for 6 months. Breastfeeding: Unknown. Not known if the vector or factor VIII it produces passes into milk; no LactMed record. EU label: a risk to the infant cannot be excluded; should not be used while breastfeeding. It is licensed for men, so use while breastfeeding is not expected.
What does Valoctocogene roxaparvovec interact with?
MediHelp lists 40 known interactions for Valoctocogene roxaparvovec. Major: 6 · Moderate: 33 · Minor: 1. The most serious include Dantrolene, Efavirenz, Flutamide.
MediHelp ऐप में पूर्ण मोनोग्राफ़, खुराक और इंटरैक्शन चेकर
MediHelp ऐप में पूरा संदर्भ खोलें, कई दवाओं की अंतःक्रियाएँ जाँचें और खुराक टूल इस्तेमाल करें।
