Leading by Example

 

We take giving back very seriously, and in partnership with InSud Pharma, we fulfill our social responsibilities through Mundo Sano, a non-profit foundation whose vision is to transform the lives of populations affected by neglected diseases.

With FDA approval of Benznidazole Tablets for children 2 to 12 years of age in the United States, patients with Chagas disease now have a treatment option where they previously had none. This advance in the fight against Chagas disease is due to our collaboration with InSud Pharma, Mundo Sano, and the Drugs for Neglected Diseases initiative (DNDi).

Benznidozole is the first and only approved antimicrobial for treating Chagas disease in children ages 2 to 12. Chagas is a serious parasitic disease, and we produce this drug for the Mundo Sano Foundation which shares our mission of giving back to society.

 

Benznidazole Tablets are available in both 12.5 mg and 100 mg strengths.

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IMPORTANT RISK INFORMATION (click to expand)

What is the most important information I should know about Benznidazole Tablets?

Benznidazole Tablets can cause harm to an unborn baby or cancer. Benznidazole tablets can also cause serious skin reactions, tingling, weakness, or pain in arms, hands, legs, or feet, and changes in your white blood cell count.

Who should not take Benznidazole Tablets?

Do not take Benznidazole Tablets if you

  • have a history of hypersensitivity reactions to benznidazole or other nitroimidazole derivatives.
  • if you are taking or have taken disulfiram within the last two weeks.
  • are consuming alcoholic beverages. Do not consume alcoholic beverages or products containing propylene glycol during and for at least 3 days after therapy with Benznidazole Tablets.

Before you take Benznidazole Tablets, tell your healthcare professional about all of your medical conditions, including if you:

  • May be pregnant or are planning to become pregnant. Benznidazole Tablets can cause harm to an unborn baby. Your doctor may perform a pregnancy test before starting treatment. Use effective contraception during treatment with Benznidazole Tablets and for 5 days after the final dose.  Benznidazole Tablets may impair fertility in males of reproductive potential.
  • Are breastfeeding or plan to breastfeed. Breastfeeding is not recommended during treatment with Benznidazole Tablets
  • Drink alcohol or consume products containing propylene glycol.

Tell your healthcare professional about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What should I avoid while taking Benznidazole Tablets?

  • Do not drink alcohol or take disulfiram or products containing propylene glycol while taking Benznidazole Tablets

What are the possible side effects of Benznidazole Tablets?

Benznidazole Tablets may cause:

  • Abdominal pain
  • Skin rash
  • Decreased weight and/or decreased appetite
  • Headache or dizziness
  • Nausea and/or vomiting
  • A change in white blood cell count (such as neutropenia or leukopenia)
  • Hives and/or itching

The risk information provided here is not comprehensive. To learn more, talk about Benznidazole Tablets with your healthcare professional or pharmacist. Before taking Benznidazole Tablets, please read the full Prescribing Information here.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

What are Benznidazole Tablets?

Benznidazole Tablets are a prescription medicine used to treat children 2 to 12 years of age with Chagas disease (American trypanosomiasis) caused by Trypanosoma cruzi.

This indication is approved under accelerated approval based on the number of treated patients who became Immunoglobulin G (IgG) antibody negative against the recombinant antigens of T cruzi. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Benznidazole Tablets are a prescription medicine used to treat children 2 to 12 years of age with Chagas disease.