Valoctocogene Roxaparvovec Dosage
Medically reviewed by Drugs.com. Last updated on Apr 8, 2024.
Applies to the following strengths: rvox 20 trillion vg/mL
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Hemophilia A
6 × 10(13) vg/kg as a single IV infusion at a rate of 1 mL/min
Duration of therapy: Once
Comments:
- Do not administer this drug to patients with a positive test for antibodies to AAV5, factor VIII inhibitor, active acute or uncontrolled chronic infections, known significant hepatic fibrosis or cirrhosis, or mannitol hypersensitivity.
- To determine dose needed in mL, multiply patient body weight in kg by 3.
- To determine number of vials to be thawed, divide the patient dose volume (mL) by 8.
- Infuse the suspension through a suitable peripheral vein using an infusion catheter with an in-line filter and a programmable syringe pump.
- If tolerated, the rate of infusion may be increased every 30 minutes by 1 mL/min up to a maximum rate of 4 mL/min.
- Treatment with this drug should be carried out under the supervision of a physician experienced in hemophilia/bleeding disorder treatment.
- Safety and effectiveness of this drug in patients with prior or active factor VIII inhibitors have not been established.
Use: For the treatment of adults with severe hemophilia A without pre-existing antibodies to adeno-associated virus serotype 5
Renal Dose Adjustments
No adjustment recommended.
Liver Dose Adjustments
No adjustment recommended.
Precautions
CONTRAINDICATIONS:
- Active infections
- Hepatic fibrosis or cirrhosis
- Hypersensitivity to mannitol
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- Prior to dosing this drug, patients should be assessed for:
- absence of factor VIII inhibitors
- absence of antibodies to AAV5
- liver health status
- hepatic fibrosis
- suitability for corticosteroids and/or other immunosuppressive therapy may be evaluated
- If these tests are abnormal, the patient may not be a suitable candidate for this gene therapy.
- If liver abnormalities and/or liver function test abnormalities are detected, consult a hepatologist to assess eligibility for this drug.
- Administer this drug under the supervision of a physician experienced in the treatment of hemophilia and/or bleeding disorders.
- Do not use filter needles to extract this drug from vials.
- Do not administer as an intravenous push or bolus.
- Do not use a central line or port.
- Infuse the suspension through a suitable peripheral vein using an infusion catheter with an in-line filter and a programmable syringe pump.
- The infusion should be completed within 10 hours of the initial drug product thawing.
- Do not infuse this drug concomitantly in the same IV line with other agents.
- Maintain venous access during the subsequent observation period.
- The manufacturer product information should be consulted for more information on calculating the dose and number of vials needed.
Storage requirements:
- Store upright at -60C (minus 76F) or less in a carton until ready to use.
- Protect from light.
- During preparation and administration, after thawing, this drug can be kept at room temperature for a maximum of 10 hours, including preparation and infusion times.
- Store thawed intact vial upright at 2 to 8C and protect from light for up to 3 days (in the original carton).
- Do not refreeze.
- Treat spills with virucidal agent with proven activity against non-enveloped viruses and blot using absorbent materials.
Preparation technique:
- The manufacturer product information should be consulted.
IV compatibility:
- The manufacturer product information should be consulted.
General:
- Perform baseline testing to select patients for treatment with this drug.
- For information on US FDA-approved tests visit: http://www.fda.gov/CompanionDiagnostics.
- Advise patients to contact BioMarin Pharmaceutical Inc. (1-866-906-6100) if they are diagnosed with any malignancy.
- There is limited information on the safety and effectiveness of this drug in patients with HIV infection.
Monitoring:
Hepatic: Liver enzymes, ALT
Hematologic: Factor VIII activity, factor VIII inhibitors
Oncologic: Malignancy, hepatocellular carcinoma
Patient advice:
- Read the US FDA-approved patient labeling (Patient Information).
- Infusion reactions including anaphylaxis may occur.
- Immediately notify medical staff if symptoms indicative of infusion reactions or thrombotic events develop.
- Seek medical attention in case of a new or recurrent reaction.
- This drug may cause an elevation of certain liver enzymes. Weekly blood test may be needed for at least 26 weeks to monitor liver enzyme levels.
- Tapering factor VIII concentrates and hemostatic agents is encouraged.
- Do not consume alcohol for at least one year after treatment.
- Confirm with your health care provider prior to using any medications, herbal products, or supplements.
- Elevated factor VIII activity above the upper limit of normal may occur, which may increase the risk of a thromboembolic event.
- For 6 months after administration, men must not donate semen, and male patient and/or female partner must avoid or postpone pregnancy.
- Use adequate methods of contraception.
- Do not donate blood, organs, tissues, and cells for transplantation after treatment with this drug.
More about valoctocogene roxaparvovec
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