FOR US HEALTHCARE PROFESSIONALS FOR PATIENTS

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

Important Safety Information

Contraindications

LAMPIT tablets are contraindicated in patients with known hypersensitivity to nifurtimox or any of the excipients in LAMPIT and patients who consume alcohol during treatment. Continue reading below

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For pediatric patients (birth to less than 18 years of age and weighing at least 2.5 kg)1

A new treatment option for Chagas disease (American trypanosomiasis) caused by Trypanosoma cruzi

Lampit (nifurtimax) tablets Now Approved

For pediatric patients (birth to less than 18 years of age and weighing at least 2.5 kg)1

A new treatment option for Chagas disease (American trypanosomiasis) caused by Trypanosoma cruzi

Indication

LAMPIT is indicated in pediatric patients (birth to less than 18 years of age and weighing at least 2.5 kg) for the treatment of Chagas disease (American Trypanosomiasis) caused by Trypanosoma cruzi.1 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).1

Chagas Disease in the United States

Chagas disease, also known as American trypanosomiasis, is a potentially life-threatening illness caused by the protozoan parasite Trypanosoma cruzi.2,3 Most cases of Chagas disease in the United States originated in Central or South America, but the parasite may be spread through insects native to the southern United States called triatomines, and congenital transmission is also known to occur.3 Acute infection lasts 4 to 8 weeks and is usually asymptomatic. Chronic infection may last for years, and up to 30% of patients develop symptomatic disease that primarily affects the heart and gastrointestinal tract.2,3

Approximately 300,000 people living in the United States are currently infected with Chagas disease.2,3

Lampit is an approved treatment for pediatric patients (birth to less than 18 years of age and weighing at least 2.5 kg)1

Resources

Learn More About Lampit 

 

For questions about Lampit, please contact Bayer at 1-888-842-2937 or click below to read the press release.

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Learn More About Chagas Disease

 

You can learn more about Chagas disease by visiting the Centers for Disease Control and Prevention website.

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Important Safety Information

Contraindications
LAMPIT tablets are contraindicated in:

  • Patients with known hypersensitivity to nifurtimox or any of the excipients in LAMPIT
  • Patients who consume alcohol during treatment

 

Warnings and Precautions
Potential for Genotoxicity and Carcinogenicity
Genotoxicity
Genotoxicity of LAMPIT has been demonstrated in humans, in vitro in several bacterial species and mammalian cell systems, and in vivo in rodents.

 

A study evaluating the cytogenetic effect of nifurtimox in pediatric patients ranging from 7 months to 14 years of age with Chagas disease demonstrated a 13-fold increase in chromosomal aberrations.

 

Carcinogenicity
Carcinogenicity has been observed in mice and rats treated chronically with nitrofuran agents which are structurally similar to nifurtimox. Similar data have not been reported for LAMPIT. It is not known whether LAMPIT is associated with carcinogenicity in humans.

 

Embryo-Fetal Toxicity
Based on findings from animal studies, LAMPIT can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, nifurtimox administered orally to pregnant mice, rats, and rabbits during organogenesis was associated with reduced fetal body weights in rodents, and abortions, fetal death, and smaller litter sizes in rabbits at doses approximately equivalent to and 2-times, respectively, the maximum recommended human dose (MRHD) of 10 mg/kg/day. Fetal malformations were observed in pregnant rabbits administered nifurtimox doses less than the MRHD.

 

Advise pregnant women of the potential risk to a fetus. Pregnancy testing is recommended for females of reproductive potential prior to initiating treatment with LAMPIT. Advise females of reproductive potential to use effective contraception during treatment with LAMPIT and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use condoms during treatment and for 3 months after the last dose of LAMPIT.

 

Worsening of Neurological and Psychiatric Conditions
Patients with a history of brain injury, seizures, psychiatric disease, or serious behavioral alterations may experience worsening of their conditions when receiving LAMPIT. Administer LAMPIT under close medical supervision in these patients and in patients who develop neurological disturbances or psychiatric drug reactions.

 

Hypersensitivity
Cases of hypersensitivity have been reported in patients receiving therapy with nifurtimox. The hypersensitivity could be a reaction induced by nifurtimox or an immune response triggered by Chagas disease during treatment. Hypersensitivity reactions could be accompanied by hypotension, angioedema (including laryngeal or facial edema), dyspnea, pruritus, rash or other severe skin reactions. At the first sign of serious hypersensitivity, discontinue treatment with LAMPIT.

 

Decreased Appetite and Weight Loss
Decreased appetite and weight loss were reported in patients treated with LAMPIT in the clinical trials. During treatment with LAMPIT, patients can lose their appetite or experience nausea/vomiting which can result in weight loss. Check body weight every 14 days, as the dosage may have to be adjusted.

 

Porphyria
Treatment with nitrofuran derivatives, such as LAMPIT, may precipitate acute attacks of porphyria. Administer LAMPIT tablets under close medical supervision in patients with porphyria.


Adverse Reactions
The most frequently reported adverse reactions (≥1%) in patients treated with nifurtimox were vomiting (14.6%); abdominal pain (13.2%); headache (12.8%); decreased appetite (10.5%); nausea (8.2%); pyrexia (7.3%); rash (5.5%), diarrhea (4.6%), weight decreased (2.7%); anemia (2.7%), dizziness (2.7%), eosinophilia (2.3%) and urticaria (2.3%).

 

Indication

LAMPIT is indicated in pediatric patients (birth to less than 18 years of age and weighing at least 2.5 kg) for the treatment of 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 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).

 

For additional important risk and use information, please see the full Prescribing Information and Instructions for Use. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

References

  1. Lampit. Package insert. Bayer HealthCare Pharmaceuticals, Inc.; 2020.
  2. Centers for Disease Control and Prevention. Chagas disease provider fact sheet. Accessed June 23, 2020. https://www.cdc.gov/parasites/chagas/resources/factsheet.pdf
  3. Kirchhoff LV. Chagas disease. In: Goldman L, Schafer AI, eds. Goldman-Cecil Medicine. 25th ed. Elsevier Saunders; 2016:2116-2120.

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.

 

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Site Last Modified 06/2023

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