LAMPIT Film-coated tablet Ref.[10150] Active ingredients: Nifurtimox

Source: FDA, National Drug Code (US) Revision Year: 2020

1. Indications and Usage

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) [see Clinical Studies (14)].

2. Dosage and Administration

2.1 Important Administration Instructions

LAMPIT (30 mg and 120 mg) tablets are for oral use and must be taken with food.
LAMPIT tablets are dosed by body weight of the patient [see Dosage and Administration (2.2)].
LAMPIT (30 mg and 120 mg) tablets are functionally scored tablets which can be split into one-half (15
mg and 60 mg respectively) at the scored lines by hand. Do not break LAMPIT tablets mechanically with a tablet splitting device [see Dosage and Administration (2.4) and Instructions for Use].
LAMPIT 30 mg and 120 mg tablets can be made into a slurry as an alternative method of administration for patients who cannot swallow the tablets [see Dosage and Administration (2.5)].
Discontinue consumption of alcohol during treatment with LAMPIT [see Contraindications (4) and Drug Interactions (7)].
Complete the full course of treatment to prevent recurrence of the infection.
If a dose is missed, take the missed dose as soon as possible together with food. However, if it is within 3 hours of the next scheduled dose, skip the missed dose and continue treatment as prescribed. Do not take a double dose to make up for a missed dose.

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 (5.4)].
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^a to less than 18 years	40 kg or greater	8 to 10
Birth^a to less than 18 years	Less than 40 kg	10 to 20

^a Term 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^a to 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

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

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 (5.2) and Use in Specific Populations (8.3)].

2.4 Instructions for Splitting LAMPIT Tablets

Do not break LAMPIT tablets mechanically with a tablet splitting device. A functional score line is used to divide the tablet by hand as follows:

To split LAMPIT tablet, place the tablet on a flat surface with the score line facing up.
With the tablet resting on the flat surface, apply enough downward pressure with the index finger centered on the top of the tablet to break it along the score line.

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.

16.2. Storage and Handling

Store at controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].

Store LAMPIT tablets in the original bottle with child-resistant closures and do not remove the desiccant.

Keep bottle with child-resistant closures tightly closed and protect from moisture.

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