Lampit
(nifurtimox)Dosage & Administration
Dosage of LAMPIT in Pediatric Patients (birtha 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
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Lampit Prescribing Information
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 ].
Important Administration Instructions
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- LAMPIT (30 mg and 120 mg) tablets are for oral use and must be taken with food.
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- LAMPIT tablets are dosed by body weight of the patient [see Dosage and Administration ].
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- 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 and Instructions for Use].
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- 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 ].
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- Discontinue consumption of alcohol during treatment with LAMPIT [see Contraindications and Drug Interactions ].
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- Complete the full course of treatment to prevent recurrence of the infection.
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- 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.
Recommended Dosage in Pediatric Patients
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- Administer LAMPIT (30 mg and 120 mg) tablets orally three times a day with food.
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- Total daily recommended dosages of LAMPIT are based on the body weight of the patient (see Table 1).
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- Adjust LAMPIT dosage accordingly if body weight decreases during treatment [see Warnings and Precautions ].
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- 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) |
Birtha to 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 (Birtha to Less than 18 years of age)
Body weight (kg) | Dose (mg) | Number of LAMPIT 30 mg tablets per dose | Number of LAMPIT |
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
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 ].
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:
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- To split LAMPIT tablet, place the tablet on a flat surface with the score line facing up.
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- 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.
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.
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- Place approximately 2.5 mL of water into a spoon.
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- Place the prescribed dose into the water.
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- Allow the tablet(s) to disintegrate (typically less than 30 seconds).
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- A slurry (liquid suspension) is formed.
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- Take the slurry immediately with food.
LAMPIT tablets are available as 30 mg and 120 mg tablets.
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- 30 mg, yellow, round, biconvex tablets, functionally scored on one side for the division of the tablet into equal doses and marked with ‘30’ on the other side.
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- 120 mg, yellow, round, biconvex tablets, functionally scored on one side for the division of the tablet into equal doses and marked with ‘120’ on the other side
Pregnancy
Risk Summary
Based on animal studies, LAMPIT may cause fetal harm when administered to a pregnant woman. Published postmarketing reports on nifurtimox use during pregnancy are insufficient to inform a drug-associated risk of birth defects and miscarriage. There are risks to the fetus associated with Chagas disease (see Clinical Considerations).
Nifurtimox administered orally to pregnant rats, and rabbits during organogenesis was associated with reduced maternal body weights in rats, and abortions, reduced maternal weight gain, and reduced numbers of live fetuses in rabbits when nifurtimox was administered orally during organogenesis at doses approximately equal to the MRHD in rats and 2-times the MRHD in rabbits. An increased incidence of a fetal skeletal malformation (fusion of caudal vertebral bodies) occurred in rabbits at nifurtimox doses approximately 0.2 times the MRHD. In a pre-postnatal study, maternal body weights and fetal body weights of first-generation offspring were reduced at doses approximately equal to or 0.5 times the MRHD, respectively, and several male offspring in the nifurtimox treatment groups exhibited slightly small testes at doses ≥0.2 times the MRHD (see Data). Advise pregnant women of the potential risk to a fetus.
There is a pregnancy safety study for LAMPIT. If LAMPIT is administered during pregnancy, or if a patient becomes pregnant while receiving LAMPIT or within six months following the last dose of LAMPIT, healthcare providers should report LAMPIT exposure by calling 1-888-842-2937.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations
Disease-associated Maternal and/or Embryo/Fetal Risk
Published data from case-control and observational studies on chronic Chagas disease during pregnancy are inconsistent in their findings. Some studies showed an increased risk of pregnancy loss, prematurity and neonatal mortality in pregnant women who have chronic Chagas disease while other studies did not demonstrate these findings. Chronic Chagas disease is usually not immediately life-threatening. Since pregnancy findings are inconsistent, treatment of chronic Chagas disease during pregnancy is not recommended due to risk of embryo-fetal toxicity from LAMPIT.
Acute symptomatic Chagas disease is rare in pregnant women; however, symptoms may be serious or life-threatening. If a pregnant woman presents with acute symptomatic Chagas disease, the risks versus benefits of treatment with LAMPIT to the mother and the fetus should be evaluated on a case-by-case basis.
Data
Animal Data
In an embryo-fetal toxicity study in pregnant rats, 15, 30, and 60 mg/kg/day nifurtimox were administered orally during the period of organogenesis (GD 6 to GD 17). Maternal body weights, body weight gain, and food consumption were reduced in the 60 mg/kg/day dose group. Treatment with nifurtimox did not produce fetal toxicity and no nifurtimox-related fetal malformations were observed. No maternal toxicity was observed at 30 mg/kg/day nifurtimox (approximately 0.5 times the MRHD based on body surface area comparison) and no adverse fetal effects were observed at 60 mg/kg/day nifurtimox (approximately equivalent to the MRHD based on body surface area comparison).
In pregnant rabbits orally administered 5, 15, and 60 mg/kg/day nifurtimox during the period of organogenesis (GD 6 to GD 20), the high dose was associated with maternal toxicity including reduced body weights and food consumption, and abortions in 8/20 high-dose dams. The mean number of live fetuses/litter and the percent of live fetuses per total implantations per group were significantly lower in the mid- and high-dose groups compared to the control group. Nifurtimox administration was associated with increased fetal and litter incidences of a skeletal malformation (fusion of caudal vertebral bodies) in fetuses in the low-dose group receiving 5 mg/kg/day (approximately equivalent to 0.2-times the MRHD based on body surface area comparison). No maternal toxicity was observed at 15 mg/kg/day which is approximately equivalent to 0.5 times the MRHD based on body surface area comparison.
In a pre-postnatal study, pregnant female rats were orally administered 15, 30, and 60 mg/kg/day nifurtimox during organogenesis and lactation [GD 6 to lactation day (LD) 21]. Maternal findings included reduced maternal body weights in high-dose dams during gestation and to a lesser degree during lactation. In first-generation offspring, body weights were significantly reduced in males and females in the high-dose group during the lactation and post-lactation periods. Physical development, neurological function, and reproduction of first-generation offspring were not substantially changed in the nifurtimox treatment groups, but 5–20% of male offspring in all the nifurtimox treatment groups exhibited slightly small testes. No adverse maternal effects or fetal effects on first-generation female offspring occurred at 30 mg/kg/day, and no adverse fetal effects on the development of male offspring occurred at 15 mg/kg/day (respectively approximately 0.5- and 0.2-times the MRHD based on body surface area comparison).
Lactation
Risk Summary
Published literature demonstrates that nifurtimox is present in human breast milk with an estimated infant daily dose of less than 15% of the recommended daily dose for pediatric patients with Chagas disease. There were no reports of adverse effects on the small number of infants who were breastfed by mothers taking nifurtimox. There is no information on the effects of nifurtimox on milk production. Monitor infants exposed to LAMPIT through breast milk for vomiting, rash, decreased appetite, pyrexia and irritability.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for LAMPIT and any potential adverse effects on the breastfed infant from LAMPIT or from the underlying maternal condition.
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)].
Pediatric Use
The safety and effectiveness of LAMPIT have been established for the treatment of Chagas disease (American Trypanosomiasis) caused by Trypanosoma cruzi in pediatric patients from birth to less than 18 years of age weighing at least 2.5 kg. The efficacy of LAMPIT was demonstrated in pediatric patients 0 to 4 years of age in Trial 1 based on seroconversion to negative on lysate ELISA, recombinant ELISA and IHA at 4 years post-treatment compared to untreated patients. The efficacy of LAMPIT in pediatric patients 5 to <18 years of age was extrapolated from efficacy established in the younger pediatric population. Supportive evidence of efficacy was provided by seroconversion to negative on the F29 ELISA [see Clinical Studies ].
The safety and effectiveness of LAMPIT has not been established in pediatric patients weighing less than 2.5 kg.
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.
Hepatic Impairment
The effect of hepatic impairment on the pharmacokinetics of nifurtimox is unknown [Clinical Pharmacology ]. Administer LAMPIT under close medical supervision.
LAMPIT tablets are contraindicated in:
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- Patients with known hypersensitivity to nifurtimox or any of the excipients in LAMPIT [see Warnings and Precautions ].
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- Patients who consume alcohol during treatment [see Drug Interactions ]
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 [see Nonclinical Toxicology ].
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 [see Nonclinical Toxicology ]. 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 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 ].
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 [see Contraindications ].
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 ].
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.