Lampit

(Nifurtimox)

Check Drug InteractionsCheck known drug interactions.

Dosage & Administration

* •LAMPIT tablets must be taken with food

Dosage of LAMPIT in Pediatric Patients (birth^a to less than 18 years of age) (2.2)
Body Weight Group	Total Daily Dose of nifurtimox (mg/kg)
41 kg or greater	8 to 10
Less than 41 kg	10 to 20

^aTerm newborn with body weight greater than or equal to 2.5 kg

* •Administer LAMPIT tablets orally, three times daily with food for 60 days. (

2.2 Recommended Dosage in Pediatric Patients

* •Administer LAMPIT (30 mg and 120 mg) tablets orally three times a day with food.
* •Total daily recommended dosages of LAMPIT are based on the body weight of the patient (see Table 1).
* •Adjust LAMPIT dosage accordingly if body weight decreases during treatment

[see Warnings and Precautions ].

* •The recommended duration of treatment with LAMPIT is 60 days.

Table 1: Total Daily Recommended Dosages of LAMPIT Based on Body Weight

Age

Body weight group

Total daily dose of nifurtimox (mg/kg)

Birth^ato less than 18 years

41 kg or greater

8 to 10

Less than 41 kg

10 to 20

^aTerm newborn with body weight of greater than or equal to 2.5 kg

Table 2: Individual Dosages Based on Body Weight in Pediatric Patients (Birth^ato Less than 18 years of age)

Body weight (kg)	Dose (mg)	Number of LAMPIT 30 mg tablets per dose (3 x Daily)	Number of LAMPIT 120 mg tablets per dose (3 x Daily)
2.5 kg to 4.5 kg	15 mg	½ tablet	—
4.6 kg to less than 9 kg	30 mg	1 tablet	—
9 kg to less than 13 kg	45 mg	1 ½ tablets	—
13 kg to less than 18 kg	60 mg	2 tablets	½ tablet
18 kg to less than 22 kg	75 mg	2 ½ tablets	—
22 kg to less than 27 kg	90 mg	3 tablets	—
27 kg to less than 35 kg	120 mg	4 tablets	1 tablet
35 kg to less than 41 kg	180 mg	—	1 ½ tablets
41 kg to less than 51 kg	120 mg	—	1 tablet
51 kg to less than 71 kg	180 mg	—	1 ½ tablets
71 kg to less than 91 kg	240 mg	—	2 tablets
91 kg or greater	300 mg	—	2 ½ tablets

^aTerm newborn with body weight of greater than or equal to 2.5 kg

)
* •Obtain a pregnancy test in females of reproductive potential prior to initiating treatment with LAMPIT (

2.3 Pregnancy Testing Prior to Initiating LAMPIT

Obtain a pregnancy test in females of reproductive potential prior to initiating treatment with LAMPIT

[see Warnings and Precautions and Use in Specific Populations ].

8.3 Females and Males of Reproductive Potential

Pregnancy Testing

Pregnancy testing is recommended for females of reproductive potential prior to initiating treatment with LAMPIT.

Contraception

Females

LAMPIT may cause fetal harm when administered to a pregnant woman

[see Use in Specific Populations ]

. Advise females of reproductive potential to use effective contraception during treatment with LAMPIT and for 6 months after the final dose.

Males

Due to the potential for genotoxicity, advise male patients with female partners of reproductive potential to use condoms during treatment and for 3 months after the final dose of LAMPIT

[see Nonclinical Toxicology (13.1)].

Infertility

Males

Based on findings in rodents, LAMPIT may impair fertility in males of reproductive potential. These effects on fertility were not reversible in 75% of the animals at 11 weeks after dosing

[see Nonclinical Toxicology (13.1)].

)

* •See Full Prescribing Information for additional important administration instructions. and Use in Specific Populations ].

2.5 Preparation of a Slurry of LAMPIT as an Alternate Method of Administration

For patients who are unable to swallow whole or half tablets, LAMPIT tablet can be dispersed in water and administered as outlined below.

* •Place approximately 2.5 mL of water into a spoon.
* •Place the prescribed dose into the water.
* •Allow the tablet(s) to disintegrate (typically less than 30 seconds).
* •A slurry (liquid suspension) is formed.
* •Take the slurry immediately with food.

)

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Lampit Prescribing Information

Warnings and Precautions, Embryo-Fetal Toxicity (

5.2 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 rats, and rabbits during organogenesis was associated with reduced maternal body weights in rats, 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

[see Use in Specific Populations ].

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

[see Dosage and Administration ]

. 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

[see Use in Specific Populations and Clinical Pharmacology ].

) 2/2023

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

[see Clinical Studies (

14 CLINICAL STUDIES

Clinical Study Overview

The safety and efficacy of LAMPIT for the treatment of Chagas disease in pediatric patients birth to <18 years of age and weighing at least 2.5 kg were demonstrated in one prospective, randomized, double-blind trial conducted in Argentina, Bolivia and Colombia (Trial 1, NCT02625974). This trial consisted of 2 parts, Part 1 which included treatment with LAMPIT and one year post-treatment follow-up and Part 2, which included an additional three-years of follow up.

Trial 1: Treatment with LAMPIT including One Year Post-treatment Follow-up (Part 1)

Pediatric patients (n=330) with serologic evidence of

T. cruzi

infection and without Chagas disease-related cardiac or gastrointestinal symptoms were randomly assigned in a 2:1 fashion to a 60-day (n=219) or a 30-day (n=111) LAMPIT treatment regimen. Patients were followed up for one year. LAMPIT was administered three times a day with food using the following body weight-based dosing regimens: pediatric patients weighing less than 41 kg received a total daily dose of 10-20 mg/kg, and those weighing 41 kg or more received a total daily dose of 8-10 mg/kg

[see Dosage and Administration ]

. Chagas disease diagnosis was confirmed by direct observation of

T. cruzi

by concentration test in patients <8 months of age at randomization and by demonstrating positive results for both the lysate enzyme-linked immunosorbent assay (ELISA) and the recombinant ELISA in patients ≥8 months to <18 years of age at randomization.

Serological response to treatment was defined as ≥20% decrease in optical density measured by lysate and recombinant ELISA in subjects >8 months to <18 years or seroconversion to negative (defined as negative immunoglobulin G concentration in all patients) at 1-year post-treatment follow-up.

The results for both the lysate ELISA and the recombinant ELISA (Table 5) showed superiority in favor of the LAMPIT 60-day arm compared to the LAMPIT 30-day arm (not an approved dosing regimen).

Table 5: Efficacy Results using Lysate ELISA and Recombinant ELISA at 1 year Post-Treatment

	Lysate ELISA		Recombinant ELISA
	60-Day N=219	30-Day* N=111	60-Day N=219	30-Day* N=111
Serological 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.

The F29 ELISA detects antibodies to recombinant antigens obtained from the flagellar protein F29 of

T. cruzi

. Of the 214 patients who were seropositive for the assay at baseline, 46 of 142 (32.4%) in the 60-day LAMPIT treatment arm and 20 of 72 (27.8%) in the 30-day LAMPIT treatment arm (not an approved dosing regimen) seroconverted to negative at the 1-year post-treatment follow-up. Twenty of 59 (33.9%, 95% CI: 22.1%, 47.4%) patients between 6 and 12 years of age in the 60-day arm seroconverted to negative at the 1-year post-treatment follow-up. A similar seroconversion rate was observed in patients 6 and 12 years of age in the 30-day treatment arm. These rates were higher than the 2.8% conversion rate from historical data¹for untreated patients between 6 and 12 years old at 12 months using the F29 ELISA.

Trial 1: Additional Three-years of Follow-up (Part 2)

To determine the seroconversion rate in patients treated with LAMPIT at the 4-year time point, a total of 295 (197 in the 60-day regimen and 98 in the 30-day regimen) of the 330 pediatric patients were followed for another 3 years after the end of Part 1. Seroconversion to negative confirmed by three assays, lysate ELISA, recombinant ELISA and IHA, was evaluated in patients in the 60-day treatment arm by age group (Table 6) in Part 2. Patients were considered as seroconverted to negative if all three test results were negative. All seroconversions at 4 years post-treatment were from patients who were <2 years of age at baseline. Nine of 11 (81.8%) patients in the 60-day treatment arm who were <8 months of age at baseline seroconverted to negative at 4 years post-treatment. Among 39 patients in the 60-day treatment arm who were 0 to 4 years of age at baseline, 9 (23.1%) seroconverted for 2 or more consecutive years, which was higher than the 0% conversion rate from historical data²for untreated patients infected between 0 and 4 years of age during long-term follow-up.

Table 6: Efficacy Results using Seroconversion to Negative Confirmed by Lysate ELISA, Recombinant ELISA and IHA at 4 years Post-Treatment

Age Group	60-Day N=197 n (%)
0 to <8 months*	9/11 (81.8%)
8 months to <2 years	3/15 (20.0%)
2 to 17 years	0/171

* A positive

T. cruzi

concentration test was required for subjects <8 months of age at baseline for enrollment

The efficacy of LAMPIT in pediatric patients 5 to <18 years of age was extrapolated from efficacy established in the younger pediatric population between 0 and 4 years of age. Biologically, it is expected that LAMPIT would have the same effect on

T. cruzi

in all pediatric age groups. The pathogenesis of Chagas disease is the same across the pediatric population; however, older patients may have a longer duration of infection than younger patients. Given longer duration of infection, time to seroconversion is expected to be longer. Based on published studies, younger pediatric patients seroconvert faster.^2,3The lack of seroconversion to negative on traditional assays in older pediatric patients in Trial 1 is not unexpected given the duration of follow up of 4 years. It is expected that seroconversion rates would increase in older pediatric age groups over time. Supportive evidence of efficacy was provided by data on seroconversion to negative by the F29 ELISA.

)].

•LAMPIT tablets must be taken with food

Dosage of LAMPIT in Pediatric Patients (birth^a to less than 18 years of age) (2.2)
Body Weight Group	Total Daily Dose of nifurtimox (mg/kg)
41 kg or greater	8 to 10
Less than 41 kg	10 to 20

^aTerm newborn with body weight greater than or equal to 2.5 kg

•Administer LAMPIT tablets orally, three times daily with food for 60 days. (

2.2 Recommended Dosage in Pediatric Patients

•Administer LAMPIT (30 mg and 120 mg) tablets orally three times a day with food.
•Total daily recommended dosages of LAMPIT are based on the body weight of the patient (see Table 1).
•Adjust LAMPIT dosage accordingly if body weight decreases during treatment
[see Warnings and Precautions ].
•The recommended duration of treatment with LAMPIT is 60 days.

Table 1: Total Daily Recommended Dosages of LAMPIT Based on Body Weight

Age

Body weight group

Total daily dose of nifurtimox (mg/kg)

Birth^ato less than 18 years

41 kg or greater

8 to 10

Less than 41 kg

10 to 20

^aTerm newborn with body weight of greater than or equal to 2.5 kg

Table 2: Individual Dosages Based on Body Weight in Pediatric Patients (Birth^ato Less than 18 years of age)

Body weight (kg)	Dose (mg)	Number of LAMPIT 30 mg tablets per dose (3 x Daily)	Number of LAMPIT 120 mg tablets per dose (3 x Daily)
2.5 kg to 4.5 kg	15 mg	½ tablet	—
4.6 kg to less than 9 kg	30 mg	1 tablet	—
9 kg to less than 13 kg	45 mg	1 ½ tablets	—
13 kg to less than 18 kg	60 mg	2 tablets	½ tablet
18 kg to less than 22 kg	75 mg	2 ½ tablets	—
22 kg to less than 27 kg	90 mg	3 tablets	—
27 kg to less than 35 kg	120 mg	4 tablets	1 tablet
35 kg to less than 41 kg	180 mg	—	1 ½ tablets
41 kg to less than 51 kg	120 mg	—	1 tablet
51 kg to less than 71 kg	180 mg	—	1 ½ tablets
71 kg to less than 91 kg	240 mg	—	2 tablets
91 kg or greater	300 mg	—	2 ½ tablets

^aTerm newborn with body weight of greater than or equal to 2.5 kg

)

•Obtain a pregnancy test in females of reproductive potential prior to initiating treatment with LAMPIT (
2.3 Pregnancy Testing Prior to Initiating LAMPIT
Obtain a pregnancy test in females of reproductive potential prior to initiating treatment with LAMPIT
[see Warnings and Precautions and Use in Specific Populations ].
,
8.3 Females and Males of Reproductive Potential
Pregnancy Testing
Pregnancy testing is recommended for females of reproductive potential prior to initiating treatment with LAMPIT.
Contraception
Females
LAMPIT may cause fetal harm when administered to a pregnant woman
[see Use in Specific Populations ]
. Advise females of reproductive potential to use effective contraception during treatment with LAMPIT and for 6 months after the final dose.
Males
Due to the potential for genotoxicity, advise male patients with female partners of reproductive potential to use condoms during treatment and for 3 months after the final dose of LAMPIT
[see Nonclinical Toxicology (13.1)].
Infertility
Males
Based on findings in rodents, LAMPIT may impair fertility in males of reproductive potential. These effects on fertility were not reversible in 75% of the animals at 11 weeks after dosing
[see Nonclinical Toxicology (13.1)].
)
.
•See Full Prescribing Information for additional important administration instructions. and Use in Specific Populations ].

2.5 Preparation of a Slurry of LAMPIT as an Alternate Method of Administration

For patients who are unable to swallow whole or half tablets, LAMPIT tablet can be dispersed in water and administered as outlined below.

•Place approximately 2.5 mL of water into a spoon.
•Place the prescribed dose into the water.
•Allow the tablet(s) to disintegrate (typically less than 30 seconds).
•A slurry (liquid suspension) is formed.
•Take the slurry immediately with food.

)

Patients with Renal and or Hepatic Impairment: Administer LAMPIT under close medical supervision. (
8.6 Renal Impairment
The effect of renal impairment on the pharmacokinetics of nifurtimox is unknown
[see Clinical Pharmacology ]
. Published literature suggests that blood concentrations of nifurtimox were increased in patients with End Stage Renal Disease (ESRD) requiring hemodialysis
[see, Clinical Pharmacology ].
Administer LAMPIT under close medical supervision.
,
8.7 Hepatic Impairment
The effect of hepatic impairment on the pharmacokinetics of nifurtimox is unknown
[Clinical Pharmacology ]
. Administer LAMPIT under close medical supervision.
7)

LAMPIT tablets are contraindicated in:

•Patients with known hypersensitivity to nifurtimox or any of the excipients in LAMPIT
[see Warnings and Precautions (
5.5 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
[see Dosage and Administration ].
)].
•Patients who consume alcohol during treatment
[see Drug Interactions ]

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