FOR US HEALTHCARE PROFESSIONALS FOR PATIENTS

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

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

Expand your options for treating Chagas disease

Expand your options for treating Chagas disease

LAMPIT® meets important needs in the treatment of Chagas disease 

Lampit packaging

There are only 2 antiparasitic drugs available in the world to treat Chagas disease (American trypanosomiasis), caused by Trypanosoma cruzi (T. cruzi), but only LAMPIT is FDA approved for patients from birth to age younger than 18 years and weighing at least 2.5 kg.1-3 

 

Although Chagas disease may be self limiting, with only mild symptoms, the infection can become chronic and lead to serious cardiovascular (CV) and gastrointestinal (GI) complications over the long term. Infants with congenital disease are also at risk of potentially serious complications, which may be present at birth.4,5  

 

The American Academy of Pediatrics recommends treatment for all cases of acute or congenital infections in children aged younger than 18 years with early chronic infection.4  

 

With LAMPIT, you have an approved option to treat Chagas disease when it matters most. Learn more about dosing for Lampit. 

LEARN MORE

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.

How LAMPIT Works

LAMPIT is an antiprotozoal drug that is active against T. cruzi at all stages of its lifecycle.2 

1

Trypomastigotes

2

Amastigotes

3

Epimastigotes

T. Cruzi

The sensitivity of T. cruzi strains to nifurtimox from different geographic regions may vary.2 

 

LAMPIT contains nifurtimox, an antiprotozoal drug.2 Although its mechanism of action is not fully understood, studies suggest that it is metabolized/activated by Type I (oxygen insensitive) and Type II (oxygen sensitive) nitroreductases (NTR) leading to production of toxic intermediate metabolites and/or reactive oxygen species that induce DNA damage and cell death of both intracellular and extracellular forms of T. cruzi.2 

LAMPIT efficacy and safety

The safety and efficacy of LAMPIT for treatment of Chagas disease were demonstrated in a prospective, randomized, double-blind clinical trial of pediatric patients (from birth to age younger than 18 years) with confirmed serologic evidence of T. cruzi infection without Chagas disease-related CV or GI complications.2 

Study design

Patients had been randomized to receive LAMPIT 3 times daily with food, using the following weight-based dosing regimen2: 

  • Children weighing <41 kg received a total daily dose of 10 to 20 mg/kg
  • Children weighing ≥41 kg received a total daily dose of 8 to 10 mg/kg

 

Patients with serologic evidence of T. cruzi infection and without Chagas disease-related CV or Gl symptoms received treatment for either 30 days (n=111) (not an approved dosing regimen) or 60 days (n=219) and were then followed up for 1 year.2

 

Chagas disease diagnosis was confirmed by direct observation of T. cruzi by concentration test in patients aged <8 months at randomization and by demonstrating positive results for both the lysate enzyme-linked immunosorbent assay (ELISA) and the recombinant ELISA in patients aged ≥8 months to <18 years at randomization.2  

 

Serologic response was defined as a ≥20% decrease in optical density measured by lysate and recombinant ELISA or seroconversion to negative (no IgG concentration) at the 1-year post-treatment follow-up.2 

 

Efficacy results

 

Of the 214 patients who were seropositive at baseline, 46 of 142 (32.4%) in the 60-day nifurtimox treatment arm and 20 of 72 (27.8%) in the 30-day nifurtimox treatment arm (not an approved dosing regimen) seroconverted to negative at the 1-year post-treatment follow-up.2

 

Results showed superiority in favor of the 60-day regimen over the 30-day regimen.2

Efficacy results at 1-year post-treatment follow-up2 

  Lysate ELISA Recombinant ELISA
 

60 day
(n=219)

30 day*
(n=111)

60 day
(n=219)

30 day*
(n=111)

Serologic response

70 (32%) 

21 (19%)

76 (35%) 

24 (22%) 

≥20% decrease in optical density

59 (27%) 

15 (14%) 

65 (30%) 

17 (15%) 

Seroconversion

11 (5%)

6 (5%) 

11 (5%)

7 (6%)

Difference (60 day, 30 day), 95% CI; P value

 13% (3.5, 22.6); 0.007 13% (3.2, 23.0); 0.010

CI=confidence interval.

*The 30-day duration is not an approved dosing regimen

Lysate ELISA
 

60 day
(n=219)

30 day*
(n=111)

Serologic response

70 (32%)

21 (19%)

≥20% decrease in optical density

59 (27%) 

15 (14%) 

Seroconversion

11 (5%) 

6 (5%) 

Difference (60 day, 30 day), 95% CI; P value

13% (3.5, 22.6); 0.007

 

Recombinant ELISA
 

60 day
(n=219)

30 day*
(n=111)

Serologic response

76 (35%)

24 (22%)

≥20% decrease in optical density

65 (30%) 

17 (15%)

Seroconversion

11 (5%)

7 (6%)

Difference (60 day, 30 day), 95% CI; P value

 13% (3.2, 23.0); 0.010

CI=confidence interval.

*The 30-day duration is not an approved dosing regimen.

Of 59 patients aged between 6 and 12 years who were on the 60-day regimen, 20 (33.9% [95% CI: 22.1 to 47.4]) seroconverted to negative at the 1-year post-treatment follow-up.2 

 

A similar seroconversion rate was observed in patients aged between 6 and 12 years on the 30-day regimen. These rates were higher than the 2.8% conversion rate from historical data for untreated patients in the same age group at 12 months using F29 ELISA.2† 

 

†F29 ELISA detects antibodies to recombinant antigens obtained from the flagellar protein F29 of T. cruzi.

 

Adverse reactions in the clinical trial

 

Adverse reactions were reported for 213 of 330 (64.5%) patients. The percentage of patients with adverse reactions in the 60-day regimen treatment arm was higher than the percentage in the 30-day regimen treatment arm: 67.1% versus 59.5%, respectively.2

 

Most adverse reactions were mild (76.5%) or moderate (22.0%).2 

Adverse reactions reported in ≥1% of patients treated with LAMPIT for 60 days2 

System organ classAdverse reactionIncidence
Blood and lymphatic system disordersAnemia
Eosinophilia		2.7%
2.3%
GI disordersVomiting
Abdominal pain‡
Nausea
Diarrhea		14.6%
13.2%
8.2%
4.6%
General disorders and administration-site conditionsPyrexia7.3%
InvestigationsWeight decreased2.7%
Metabolism and nutrition disordersDecreased appetite10.5%
Nervous system disordersHeadache
Dizziness		12.8%
2.7%
Skin and subcutaneous tissue disordersRash§
Urticaria		5.5%
2.3%

 

‡Abdominal pain includes abdominal pain and abdominal pain upper.

§Rash includes rash, rash macular, rash maculopapular, rash morbilliform, and rash papular.

Blood and lymphatic system disorders

Adverse reaction

Incidence

Anemia

2.7%

Eosinophilia

2.3%

 

GI disorders

Adverse reaction

Incidence

Vomiting 

14.6% 

Abdominal pain‡ 

13.2% 

Nausea 

8.2% 

Diarrhea

4.6%

 

General disorders and administration-site conditions

Adverse reaction

Incidence

Pyrexia

7.3%

 

Investigations 

Adverse reaction

Incidence

Weight decreased

2.7%

 

Metabolism and nutrition disorders

Adverse reaction

Incidence

Decreased appetite

10.5%

 

Nervous system disorders 

Adverse reaction

Incidence

Headache

12.8%

Dizziness

2.7%

 

Skin and subcutaneous tissue disorders 

Adverse reaction

Incidence

Rash§ 

5.5% 

Urticaria

2.3% 

 

‡Abdominal pain includes abdominal pain and abdominal pain upper.

§Rash includes rash, rash macular, rash maculopapular, rash morbilliform, and rash papular.

 

Discontinuation of LAMPIT due to adverse reactions occurred in 14 of 330 (4.2%) patients overall: 12 of 219 (5.5%) patients in the 60-day arm, and 2 of 111 (1.8%) patients in the 30-day arm.2

LAMPIT Secure—an ongoing 3-year follow-up study

Patients in the LAMPIT study who received at least one dose from their assigned treatment regimen are being followed up for 3 years with the aim of further characterizing the efficacy and safety of LAMPIT for treatment of Chagas disease in pediatric populations. This follow-up study will provide further clinical and safety information on the 60-day treatment regimen.6 

LAMPIT body weight-adjusted dosing

  • Administer LAMPIT (30 mg and 120 mg, per dosing instructions below) tablets orally 3 times a day with food2
  • Total daily recommended dosages of LAMPIT are based on the body weight of the patient2  

DOSAGE OF LAMPIT IN PEDIATRIC PATIENTS (BIRTHII TO AGE <18 YEARS)2

Body weight group Total daily dose of nifurtimox (mg/kg)
≥41 kg 8 to 10
<41 kg 10 to 20

IITerm newborn with body weight ≥2.5 kg. 

  • Adjust LAMPIT dosage accordingly if body weight decreases during treatment2  
  • The recommended duration of treatment with LAMPIT is 60 days2 

Individual dosages based on BODY WEIGHT in pediatric patients (birth to age <18 years)2 

Body weight (kg)

Dose (mg) 

Number of LAMPIT 30-mg tablets per dose
(3 times daily) 

Number of LAMPIT 120-mg tablets per dose
(3 times daily) 

2.5 to 4.5 kg 

 15

0.5 tablet 

—

4.6 to <9 kg 

 30

1 tablet 

—

9 to <13 kg 

 45

1.5 tablets 

—

13 to <18 kg 

 60

2 tablets 

0.5 tablet

18 to <22 kg 

 75

2.5 tablets 

—

22 to <27 kg 

 90

3 tablets 

—

27 to <35 kg 

 120

4 tablets 

1 tablet 

35 to <41 kg 

 180

—

1.5 tablets 

41 to <51 kg 

 120

—

1 tablet 

51 to <71 kg 

 180

—

1.5 tablets 

71 to <91 kg 

 240

—

2 tablets 

≥91 kg 

 300

—

2.5 tablets

Term newborn with weight ≥2.5 kg.

Please see Full Prescribing Information for additional important administration instructions.

Learn how your patients can save on LAMPIT

LEARN MORE

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.

 

 

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%).

 

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. Centers for Disease Control and Prevention. Chagas disease: provider fact sheet. June 18, 2018. Accessed August 21, 2020. https://www.cdc.gov/parasites/chagas/resources/factsheet.pdf
  2. LAMPIT. Package insert. Bayer HealthCare Pharmaceuticals Inc.; 2022.
  3. BENZNIDAZOLE. Package insert. Laboratorios Liconsa S.A; 2017.
  4. Edwards MS, Stimpert KK, Montgomery SP. Addressing the challenges of Chagas disease: an emerging health concern in the United States. Infect Dis Clin Pract. 2017;25(3):118-125. doi:10.1097/ IPC.0000000000000512
  5. Kirchhoff LV. Chagas disease. In: Goldman L, Schafer AI, eds. Goldman-Cecil Medicine. 25th ed. Elsevier Saunders; 2016:2116-2120.
  6. Data on file. BAY A2502/16027/PH-40160; 2019.

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

Bayer Logo