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IWILFIN and Relapse Reduction

IWILFIN was assessed in Study 3b, a clinical trial examining its safety and efficacy in 105 pediatric patients with high-risk neuroblastoma. All patients received IWILFIN twice daily for up to 2 years after achieving remission from upfront therapy.

To better interpret the outcomes of Study 3b, its results were compared to an external control database of similar high-risk neuroblastoma patients from another trial—Study ANBL0032, which studied pediatric patients who also achieved remission after upfront treatment but who did not go on to receive IWILFIN.

IWILFIN Side Effects

In clinical studies, IWILFIN was generally well tolerated and side effects were manageable.

Hearing loss is common during treatment with IWILFIN and can be serious. During clinical trials, hearing loss was sometimes reversible by adjusting the IWILFIN dosage

IWILFIN could cause low blood counts and failure of bone marrow to make enough platelets, red blood cells, or white blood cells. Blood count monitoring will occur before starting and during treatment with IWILFIN

IWILFIN could cause liver problems. Blood tests to monitor liver function will occur before starting and during treatment with IWILFIN

How IWILFIN Works in High-Risk Neuroblastoma

IWILFIN is a targeted therapy that disrupts the polyamine pathway that plays a role in tumor growth and development.

Also known as DFMO (difluoromethylornithine), IWILFIN works by blocking an enzyme called ornithine decarboxylase (ODC). ODC is responsible for producing polyamines (PAs), which are important to tumor formation and growth.

Learn more about IWILFIN by watching the video below.

IWILFIN Caregiver MOA Video from US WorldMeds on Vimeo.

Explore what support is available to you and your child when taking IWILFIN.

Starting IWILFIN

Important Safety Information

WHAT IS IWILFIN?

IWILFIN is a prescription medicine used to reduce the risk of relapse in adults and children with high-risk neuroblastoma (HRNB) who have had at least a partial response to certain prior therapies.

IMPORTANT SAFETY INFORMATION
Before you take IWILFIN, tell your healthcare provider about your medical conditions, including if you have hearing problems, if you are pregnant or may become pregnant, or if you are breastfeeding.

If you or your partner are able to become pregnant, use effective birth control during treatment with IWILFIN and for 1 week after the last dose. Tell your healthcare provider right away if you or your partner become pregnant during treatment. Do not breastfeed during treatment with IWILFIN and for 1 week after the last dose.

IWILFIN can cause low blood cell counts. Tell your healthcare provider right away if you develop symptoms of low blood cell counts, including fever, easy bruising or bleeding, blood in your urine or stool, feeling unusually tired or weak, shortness of breath, or chills or shivering.

IWILFIN can cause liver problems. Tell your healthcare provider right away if you develop symptoms of liver problems, including your skin or white of your eyes turning yellow; dark urine; light-colored stools; nausea or vomiting; easy bruising or bleeding; loss of appetite; or pain, aching, or tenderness on the right side of your abdomen.

Hearing loss is common during treatment with IWILFIN and can be serious. Some people have needed to use hearing aids. Tell your healthcare provider right away if you get ringing in your ears or any new or worsening hearing loss.

What are the possible side effects of IWILFIN?
The most common side effects of IWILFIN in Study 3b included ear infection; diarrhea; cough; sinus infection; pneumonia; upper respiratory tract infection; pink eye; vomiting; stuffy, runny, itchy nose or sneezing; fever; skin infection; and urinary tract infection.

These are not all the possible side effects of IWILFIN. Contact your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

WHAT IS IWILFIN?

IWILFIN is a prescription medicine used to reduce the risk of relapse in adults and children with high-risk neuroblastoma (HRNB) who have had at least a partial response to certain prior therapies.

IMPORTANT SAFETY INFORMATION
Before you take IWILFIN, tell your healthcare provider about your medical conditions, including if you have hearing problems, if you are pregnant or may become pregnant, or if you are breastfeeding.

If you or your partner are able to become pregnant, use effective birth control during treatment with IWILFIN and for 1 week after the last dose. Tell your healthcare provider right away if you or your partner become pregnant during treatment. Do not breastfeed during treatment with IWILFIN and for 1 week after the last dose.

IWILFIN can cause low blood cell counts. Tell your healthcare provider right away if you develop symptoms of low blood cell counts, including fever, easy bruising or bleeding, blood in your urine or stool, feeling unusually tired or weak, shortness of breath, or chills or shivering.

IWILFIN can cause liver problems. Tell your healthcare provider right away if you develop symptoms of liver problems, including your skin or white of your eyes turning yellow; dark urine; light-colored stools; nausea or vomiting; easy bruising or bleeding; loss of appetite; or pain, aching, or tenderness on the right side of your abdomen.

Hearing loss is common during treatment with IWILFIN and can be serious. Some people have needed to use hearing aids. Tell your healthcare provider right away if you get ringing in your ears or any new or worsening hearing loss.

What are the possible side effects of IWILFIN?
The most common side effects of IWILFIN in Study 3b included ear infection; diarrhea; cough; sinus infection; pneumonia; upper respiratory tract infection; pink eye; vomiting; stuffy, runny, itchy nose or sneezing; fever; skin infection; and urinary tract infection.

These are not all the possible side effects of IWILFIN. Contact your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.