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).
This indication is approved under accelerated approval based on the number of treated patients who became immunoglobulin G (IgG) antibody negative or who showed an at least 20% decrease in optical density on two different IgG antibody tests against antigens of T. cruzi. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
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.
- 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: headache, vomiting, nausea, rash, decreased appetite, abdominal pain, and fever.
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.