Roctavian (Valoctocogene Roxaparvovec-rvox)
Roctavian
- Medicine Name: Roctavian
- API: Valoctocogene Roxaparvovec-rvox
- Dosage Form & Strength: Suspension for Intravenous Infusion
- Manufactured By: BioMarin Pharmaceutical Inc.
Roctavian (valoctocogene roxaparvovec-rvox) is an adeno-associated virus vector-based one-time gene therapy used for the treatment of adults with severe hemophilia A (congenital factor VIII or FVIII deficiency with factor VIII activity < 1 IU/dL) who do not have pre-existing antibodies to the virus, adeno-associated virus serotype 5 (AAV5) which is determined by a blood test.
Recommended Dosage: Roctavian is for one-time single-dose intravenous use only. The recommended dose is 6 × 1013 vector genomes per kilogram (vg/kg) body weight, administered as a single intravenous (IV) infusion. Initiate the infusion at 1 mL/min. In case well-tolerated, the infusion rate may be increased every 30 minutes by 1 mL/min up to a maximum infusion rate of 4 mL/min.
Do baseline testing to choose patients, including testing for pre-existing antibodies to adeno-associated virus serotype 5 (AAV5), FVIII inhibitor existence, and liver health evaluations.
- Infusion-related reactions (IRRs), including hypersensitivity reactions and anaphylaxis, may occur during and/or after the use of Roctavian injection. Monitor patients during and for at least three hours after completion of infusion. It is not advisable to infuse this drug faster than 4 mL/min.
- Intravenous (IV) use of a liver-directed AAV vector could cause liver enzyme elevations, mainly ALT elevation. Assess ALT and institute corticosteroid therapy in response to ALT elevations, as needed. Assess ALT and FVIII activity levels weekly and, as clinically needed, during therapy with corticosteroids. Monitor for and manage side effects secondary to corticosteroid therapy.
- Elevated FVIII activity level beyond ULN as measured by the chromogenic substrate assays (CSA), or one-stage clotting assays (OSA), or both assays may occur with Roctavian. Assess patients for the probability of thrombosis including general cardiovascular risk factors prior to and after the use of this treatment.
- Monitor respective patients through relevant clinical observations and laboratory tests for the establishment of FVIII inhibitors after the use of Roctavian. An assay can be performed to detect FVIII inhibitors in case bleeding is not controlled, or plasma FVIII activity levels scale down.
- The integration of liver-targeting AAV vector DNA into the genome may cause a theoretical risk of hepatocellular carcinoma establishment. Assess those with risk factors for hepatocellular carcinoma (such as hepatitis B/C, chronic alcohol consumption, non-alcoholic fatty liver disease, advanced age, and non-alcoholic steatohepatitis) with continuous liver ultrasound (annually) and alpha-fetoprotein testing for five years after the use of Roctavian.
- Prior to the infusion of Roctavian, ensure up to date vaccinations. Individual vaccination plans may need to be adjusted to accommodate concomitant immunosuppressive therapy. Do not administer live vaccines to patients while on immunosuppressive therapy.
- For six months after administration, men must avoid donating semen, and men and their female partners must prevent or postpone pregnancy. This medicinal product is not intended for use in lactating women.
What documents are required to import ROCTAVIAN to India?
ROCTAVIAN (valoctocogene roxaparvovec-rvox) suspension for intravenous infusion can be imported by patients or government hospitals on the name of the patients only.
The following documentation is required to import the product:
- A valid prescription from a qualified doctor.
- Patients diagnostic reports
- Patients identity proof (issued by the government of India)
The order will be confirmed only after the receipt of:
- A valid prescription from Doctor
- Import permit if applicable
ROCTAVIAN (valoctocogene roxaparvovec-rvox) is a (prescription medicine, prescription medication, or prescription drug) pharmaceutical medicine that legally requires a medical prescription to be dispensed.
IPN (Indian Pharma Network) helps import cancer medicines on the named patient supply (NPS). Indian Pharma Network is the facilitator providing input
- On availability of Roctavian in India (Mumbai, Kolkata, Hyderabad, Chennai, Ahmedabad, Delhi, Bangalore, Pune etc.)
- Medicine Price.
- Finding Genuine and reliable sources from the USA, Canada, Europe, and Australia
- Ensuring 100% transparency.
IPN (Indian Pharma Network) can facilitate the supply of ROCTAVIAN (prescription medicines) to all locations in the world and in India after fulfilling the legal requirement (if applicable).
Please contact +91-9310090915 | Toll-Free Number: 1800-889-1064 or write us at info@indianpharmanetwork.in for Roctavian price in India.
We take to guarantee quality and delivery anywhere in the world as per the buyer’s requirements.
Indian Pharma Network is able to source the ROCTAVIAN (Cancer Treatment Medicines) from across the globe and has the ability to supply. Indian Pharma offers its customers worldwide access to the best available treatment.
Indian Pharma Network (IPN) is able to dispense any valid prescription in the shortest possible time. All prescriptions are dispensed and checked by registered pharmacists and dispatched to the Patient’s address only from New Delhi, India.
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