Lampit

Last updated on RxList: 1/22/2021
Lampit Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Lampit?

Lampit (nifurtimox) is a nitrofuran antiprotozoal, 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.

What Are Side Effects of Lampit?

Side effects of Lampit include:

Dosage for Lampit

The dosage of Lampit in pediatric patients (birth to less than 18 years of age) is 8 to 10 mg/kg in patients 40 kg or greater, and 10 to 20 mg/kg in patients less than 40 kg.

Lampit In Children

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 safety and effectiveness of Lampit have not been established in pediatric patients weighing less than 2.5 kg.

What Drugs, Substances, or Supplements Interact with Lampit?

Lampit may interact with other medicines such as:

  • alcohol

Tell your doctor all medications and supplements you use.

Lampit During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Lampit; it may harm a fetus. Pregnancy testing is recommended for females of reproductive potential prior to initiating treatment with Lampit. Lampit passes into breast milk. Monitor infants exposed to Lampit through breast milk for vomiting, rash, decreased appetite, fever, and irritability. Consult your doctor before breastfeeding.

Additional Information

Our Lampit (nifurtimox) Tablets, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Bowel regularity means a bowel movement every day. See Answer
Lampit Consumer Information

Get emergency medical help if the child has signs of an allergic reaction: hives, itching; feeling light-headed; difficult breathing; swelling of the face, lips, tongue, or throat.

Call your doctor at once if the child has:

  • a decreased appetite and weight loss;
  • new or worsening symptoms of a pre-existing condition (such as a brain injury, seizures, behavior changes, or mental health problems); or
  • worsening symptoms of porphyria (dark urine, severe stomach pain, muscle pain, numbness, tingling, mental changes, or skin sensitivity to light).

Common side effects may include:

  • stomach pain, nausea, vomiting;
  • loss of appetite;
  • fever;
  • rash; or
  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Lampit (Nifurtimox Tablets)

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Lampit Professional Information

SIDE EFFECTS

The following serious or otherwise important adverse reactions are discussed elsewhere in the labeling:

  • Potential for Genotoxicity, Carcinogenicity, and Mutagenicity [see WARNINGS AND PRECAUTIONS]
  • Worsening of Neurological and Psychiatric Conditions [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity [see WARNINGS AND PRECAUTIONS]
  • Decreased Appetite and Weight Loss [see WARNINGS AND PRECAUTIONS]
  • Porphyria [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety data described below reflect exposure to LAMPIT in one prospective, randomized, double-blind trial (Trial 1). 330 pediatric patients 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 and were followed up for one year after end of treatment. LAMPIT was administered three times a day with food using a body weight-based dosing. The median treatment duration was 61 days for subjects in the 60-day regimen. The majority (86.7%) of the study population was ≥2 to <18 years of age at randomization.

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. Adverse reactions were reported for 213 of 330 (64.5%) patients. The proportion of patients with adverse reactions was higher in the 60-day regimen (67.1%) compared with the 30-day regimen (59.5%). Most patients with adverse reactions had mild (76.5%) or moderate (22.0%) reactions.

The most frequently reported adverse reactions in patients treated with LAMPIT for 60 days were vomiting (14.6%), abdominal pain (13.2%), headache (12.8%), decreased appetite (10.5%), nausea (8.2%), pyrexia (7.3%), rash (5.5%).

Adverse reactions occurring in ≥1% of LAMPIT-treated patients are shown in Table 3.

Table 3 Adverse Reactions Reported in (≥1%) Pediatric Patients with Chagas Disease in Trial 1 Treated with LAMPIT for 60 days

System Organ ClassAdverse ReactionsIncidence
Blood and lymphatic system disordersAnemia2.7%
Eosinophilia2.3%
Gastrointestinal disordersVomiting14.6%
Abdominal paina13.2%
Nausea8.2%
Diarrhea4.6%
General disorders and administration site conditionsPyrexia7.3%
InvestigationsWeight decreased2.7%
Metabolism and nutrition disordersDecreased appetite10.5%
Nervous system disordersHeadache12.8%
Dizziness2.7%
Skin and subcutaneous tissue disordersRashb5.5%
Urticaria2.3%
a Abdominal pain includes abdominal pain and abdominal pain upper
b Rash includes rash, rash macular, rash maculo-papular, rash morbilliform, and rash papular.

Other adverse reactions occurring in 0.1% to less than 1% of patients treated with LAMPIT for 60 days included asthenia, vertigo, arthralgia, myalgia, paresthesia, tremor, irritability, anxiety, pruritus, fatigue, somnolence, seizure, syncope, neutropenia, leukopenia.

Postmarketing Experience

The following safety data were derived during postmarketing surveillance of nifurtimox from outside the United States, including literature data for all age groups (pediatric and adult populations). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Table 4: Postmarketing Adverse Reactions Reported in Pediatric and Adult Populations Treated with Nifurtimox

System Organ ClassAdverse Reaction
Immune system disordersHypersensitivity reactions, including anaphylaxis
Ear and labyrinth disordersVertigo
Skin and subcutaneous tissue disordersAngioedema
Drug reaction with eosinophilia and systemic symptoms (DRESS)
Musculoskeletal, connective tissue and bone disordersMuscle weakness
Nervous system disordersAmnesia
Polyneuropathy
Psychiatric disordersApathy
Agitation
Psychotic behavior
Sleep disorder
Blood and lymphatic system disordersThrombocytopenia

Read the entire FDA prescribing information for Lampit (Nifurtimox Tablets)

© Lampit Patient Information is supplied by Cerner Multum, Inc. and Lampit Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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