Nifurtimox
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
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.
Dosing in liver impairment
Hepatic Impairment The effect of hepatic impairment on the pharmacokinetics of nifurtimox is unknown [Clinical Pharmacology] . Administer LAMPIT under close medical supervision.
Preparation and administration
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] .
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] .
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] .
Discontinue consumption of alcohol during treatment with LAMPIT [see Contraindications and Drug Interactions] .
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.
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.
Drug interactions
Check nifurtimox against a medication listLabel text (1 paragraph)
Concomitant use of LAMPIT with alcohol may increase the incidence and severity of undesirable effects similar to other nitrofurans and nitroheterocyclic compounds. LAMPIT is contraindicated in patients who consume alcohol during treatment [see Dosage and Administration ( 2.2 ) Contraindications ( 4 )].
Contraindications
4 CONTRAINDICATIONS LAMPIT tablets are contraindicated in: • Patients with known hypersensitivity to nifurtimox or any of the excipients in LAMPIT [see Warnings and Precautions ( 5.4 )]. • Patients who consume alcohol during treatment [see Drug Interactions ( 7 )] • Known hypersensitivity to nifurtimox or to any of the excipients in LAMPIT. ( 4 ) • Alcohol consumption during treatment. (4)
Pregnancy and lactation
Pregnancy
8.1 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…
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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