Important Safety Information
Do not take LAMPIT tablets if you are allergic to nifurtimox, or any of the ingredients in LAMPIT or plan to drink alcohol during treatment with LAMPIT. Continue reading below
Important Safety Information
Do not take LAMPIT tablets if you are allergic to nifurtimox, or any of the ingredients in LAMPIT or plan to drink alcohol during treatment with LAMPIT. Continue reading below
What is Chagas disease?
Chagas (pronounced ˈshä-gəs) disease is an infection caused by a small parasite called Trypanosoma cruzi, which is transmitted to humans by insects called triatomines, commonly referred to as “kissing bugs.”
Although it is found mostly throughout Latin America, Chagas disease is also a health concern in the United States, where it affects an estimated 300,000 people.
How does Chagas disease spread?
It is most often spread to people by kissing bugs.
Chagas disease can also be spread:
- From pregnant mothers to their unborn children
- Through organ transplantation or blood transfusion
- By eating contaminated food
Who is at risk of Chagas disease?
People who have kissing bugs in their environment may be at risk.
Babies whose mothers had the infection while pregnant are also at risk of Chagas disease and should be tested after birth.
What are the symptoms of Chagas disease?
Many people have no symptoms or only mild flu-like symptoms after being bitten and may not realize they are infected.
Some symptoms that may appear soon after being infected (the acute phase) include:
Fever
Body aches
Tiredness
Swelling around the site of the bug bite
These symptoms may last from a few weeks up to 3 months.
After the acute phase, the infection can sometimes last for years. Long-term infection may lead to heart or gastrointestinal (GI) problems that may become serious over time.
The risk of serious complications is higher in people with immune disorders, such as human immunodeficiency virus (HIV), or in those who have received an organ transplant.
Do babies have symptoms?
Babies who become infected by their mothers during pregnancy can have symptoms, which can sometimes be serious. However, it can be hard to tell if these symptoms are caused by Chagas disease, so blood tests should be done.
How is Chagas disease diagnosed?
Chagas disease can be diagnosed from a blood test.
How is it treated?
Chagas disease is caused by the parasite Trypanosoma cruzi, and it is treated by taking an antiparasitic medicine. Only 2 of these medicines are available in the world to treat the infection.
LAMPIT is the only FDA-approved treatment for Chagas disease caused by the parasite Trypanosoma cruzi for children of all ages, from birth to younger than 18 years, who weigh at least 5.5 pounds (2.5 kg).
What is LAMPIT?
LAMPIT® is a prescription medicine used to treat Chagas disease caused by the parasite Trypanosoma cruzi in children less than 18 years of age weighing at least 5.5 pounds (2.5 kg). It is not known if LAMPIT is safe and effective in children weighing less than 5.5 pounds (2.5 kg).
Important Safety Information
Do not take LAMPIT tablets if you:
- Are allergic to nifurtimox, or any of the ingredients in LAMPIT
- Plan to drink alcohol during treatment with LAMPIT
Before taking LAMPIT, tell your healthcare provider about all your medical conditions, including if you:
- have a history of brain injury, seizures, mental health problems or behavioral changes.
- have kidney problems or are on dialysis.
- have liver problems.
- have a genetic problem called porphyria. Taking LAMPIT can make your symptoms of porphyria including dark urine, severe stomach pain, muscle pain, tingling, numbness, mental changes or skin sensitivity to light worse.
- are pregnant, plan to become pregnant, or think you may be pregnant. LAMPIT can harm your unborn baby.
For females who are able to become pregnant:
- Your healthcare provider should do a pregnancy test before you start taking LAMPIT to make sure that you are not pregnant.
- You should use effective forms of birth control during treatment with LAMPIT and for 6 months after your last dose of LAMPIT. Talk to your healthcare provider about what forms of birth control may be right for you.
- Call your healthcare provider right away if you become pregnant or think you are pregnant during treatment with LAMPIT.
For males:
- LAMPIT may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.
- You should use a condom with female partners who are able to become pregnant, during treatment with LAMPIT and for 3 months after your last dose of LAMPIT.
- are breastfeeding or plan to breastfeed. LAMPIT can pass into breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with LAMPIT. If you take LAMPIT and breastfeed, monitor your baby for vomiting, rash, decreased appetite, fever, and irritability.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of LAMPIT?
LAMPIT may cause serious side effects, including:
- Worsening of symptoms related to brain injury, seizures, mental health problems or behavior changes in people with a history of these problems. Call your healthcare provider right away if any of these problems get worse during treatment with LAMPIT.
- Allergic reactions. Allergic reactions can happen when taking nifurtimox, the active ingredient in LAMPIT, or with changes in your immune system caused by Chagas disease during treatment with LAMPIT. These allergic reactions can include low blood pressure, swelling of the face and tongue (angioedema), shortness of breath, itching, rash or other skin problems. Call your healthcare provider or get emergency medical help if you get any of these signs and symptoms of an allergic reaction during treatment with LAMPIT.
- Loss of appetite and weight loss. Your healthcare provider should check your weight every 14 days to see if your dose of LAMPIT may need to be changed.
The most common side effects of LAMPIT include: vomiting, abdominal pain, headache, decreased appetite, nausea, fever, and rash.
These are not all the possible side effects of LAMPIT. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
Please see the full Prescribing Information for additional information.
You are encouraged to report side effects or quality complaints of products to the FDA by visiting www.fda.gov/medwatch or calling 1‑800‑FDA‑1088.
For Bayer products, you can report these directly to Bayer by clicking here.
BAYER, the Bayer Cross, and LAMPIT are registered trademarks of Bayer.
All other trademarks are the property of their respective owners.
© 2023 Bayer. All rights reserved.
Site Last Modified 06/2023