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Drug Interaction Report

2 potential interactions and/or warnings found for the following 2 drugs:

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Interactions between your drugs

Moderate

interferon beta-1b etranacogene dezaparvovec

Applies to: Extavia (interferon beta-1b), etranacogene dezaparvovec

Consumer information for this interaction is not currently available.

MONITOR: Coadministration with other hepatotoxic agents may increase the risk of liver injury and decrease the therapeutic efficacy of fidanacogene elaparvovec and etranacogene dezaparvovec, liver-directed adeno-associated virus (AAV) vectors designed to help replace missing coagulation factor IX. Increased transaminase levels, particularly those observed in the first 3 to 4 months after administration of these agents, have been attributed to immune-mediated injury of transduced hepatocytes, which may decrease its therapeutic efficacy. In a prospective, open-label, single-arm, multinational clinical study of adult male patients with moderately severe to severe hemophilia B (n=45) receiving a single dose of fidanacogene elaparvovec (5 x 10[11] vector genomes [vg]/kg), 29 patients experienced increased transaminase levels greater than or equal to 1.5 times baseline. Of these patients, 28 received treatment with corticosteroids due to increased transaminases and/or a decline in factor IX activity, with a mean initiation time to corticosteroid therapy reported at 45 days. However, no serious adverse reactions were reported. Likewise, clinical studies with etranacogene dezaparvovec have also reported asymptomatic and mostly mild elevations in transaminases. The majority of elevated ALT levels returned to baseline; however, there were cases where they remained between 48 IU/L to 193 IU/L at two years post-administration of etranacogene dezaparvovec.

MANAGEMENT: As part of monitoring post-administration of fidanacogene elaparvovec, the manufacturer generally recommends monitoring of ALT and factor IX activity levels (e.g., one to two times a week for at least 4 months). The manufacturer of etranacogene dezaparvovec advises weekly transaminase level monitoring at weekly intervals for 3 months after its administration and, in patients with elevated levels, until those enzymes return to baseline. Initiation of corticosteroid therapy and monitoring of Factor IX activity should be considered in cases where ALT levels rise above the upper limit of normal or double baseline levels. The risk of additive hepatotoxicity and decreased therapeutic efficacy of fidanacogene elaparvovec should be considered after coadministration with other hepatotoxic agents. Alternative treatment may be required if an interaction is suspected. The manufacturer of etranacogene dezaparvovec does not provide specific recommendations concerning coadministration with other hepatotoxic agents. Local protocols and/or the product labeling of the concomitant drug(s) should be consulted for additional guidance.

Drug and food interactions

Moderate

interferon beta-1b food

Applies to: Extavia (interferon beta-1b)

Interferon beta-1b may cause liver problems, and using it with other medications that can also affect the liver such as ethanol may increase that risk. You should avoid or limit the use of alcohol while being treated with these medications. Call your doctor immediately if you have fever, chills, joint pain or swelling, unusual bleeding or bruising, skin rash, itching, loss of appetite, fatigue, nausea, vomiting, abdominal pain, dark urine, pale stools, and/or yellowing of the skin or eyes, as these may be signs and symptoms of liver damage. Talk to your doctor or pharmacist if you have any questions or concerns. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

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Therapeutic duplication warnings

No duplication warnings were found for your selected drugs.

Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.


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Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown No interaction information available.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.