Lampit (nifurtimox)

No dosing information is available for this tab.

No dosing information is available for this tab.

No dosing information is available for this tab.

No dosing information is available for this tab.

The potential for drug interactions with nifurtimox has not been studied.

Cytochrome P-450 (CYP) isoenzymes do not appear to play a major role in the metabolism of nifurtimox. In vitro studies indicate that nifurtimox is not a substrate of CYP isoenzymes. Neither nifurtimox nor its metabolites (M-4 or M-6) inhibit or induce CYP isoenzymes.

Nifurtimox is not a substrate of P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP). Neither nifurtimox nor its major metabolites (M-4 or M-6z) are inhibitors of P-gp, BCRP, organic anion transporting polypeptide (OATP), multidrug and toxin extrusion (MATE) proteins (MATE1/MATE2-K), organic anion transporter 1/3 (OAT1/OAT3), or organic cation transporter 2 (OCT2).

Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

Nifurtimox/Ethyl Alcohol

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Nifurtimox may increase the risk of the disulfiram-like reaction. In vitro studies of similar agents including other nitrofurans and nitroheterocyclic compounds demonstrated inhibition of aldehyde dehydrogenase and other alcohol-oxidizing enzymes.(1) This results in the accumulation of acetaldehyde, which is responsible for the disulfiram-like reaction.

CLINICAL EFFECTS: Concurrent use of nifurtimox with alcohol may contribute to a disulfiram-type reaction resulting in symptoms of hypotension, tachycardia, nausea, sweating, facial flushing, headache, and vomiting.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Patients should be advised that concurrent use of nifurtimox and alcohol is contraindicated. Caution patients of the possible effects that may result from ingestion or application of products that contain alcohol while taking nifurtimox.(1) Patients should be informed about unsuspected sources of alcohol such as elixirs and topical preparations. Caution is also warranted when using intravenous preparations containing alcohol solvents in patients receiving nifurtimox. Alcohol is used to improve docetaxel and paclitaxel solubility. - The quantity of alcohol in paclitaxel injection formulations (0.385-0.396 grams/mL) is similar across manufacturers. A paclitaxel 200 mg dose contains approximately 13 grams of alcohol. - The quantity of alcohol in docetaxel formulations varies approximately 3-fold depending upon the manufacturer. FDA data on alcohol content (2): Product Manufacturer Alcohol/200 mg dose Docetaxel Inj. Pfizer 6.4 grams Docetaxel Inj. Sandoz 5.5 grams Docetaxel Inj. Accord 4.0 grams Taxotere-one vial Sanofi 4.0 grams formulation Docetaxel Inj. Hospira 3.7 grams Docefrez Sun Pharma 2.9 grams Taxotere-two vial Sanofi 2.0 grams formulation

DISCUSSION: Clinical studies have not been conducted. Concomitant use of nifurtimox with alcohol may increase the incidence and severity of undesirable effects similar to other nitrofurans and nitroheterocyclic compounds.(1)

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Known hypersensitivity to nifurtimox or to any of its excipients.

*Patients who consume alcohol during treatment.

There are no contraindication contraindications for this drug.

• Depression
• Pregnancy
• Seizure disorder
• Weight loss

• Porphyria

The most common (>=5%) adverse effects of nifurtimox in clinical studies were vomiting, abdominal pain, headache, decreased appetite, nausea, fever, and rash.

Less Frequent

• Anemia

Rare or Very Rare

• Anaphylaxis
• Angioedema
• DRESS syndrome
• Drug-induced psychosis
• Dyspnea
• Hypotension
• Leukopenia
• Neutropenic disorder
• Porphyria
• Seizure disorder
• Thrombocytopenic disorder

More Frequent

• Acute abdominal pain
• Anorexia
• Fever
• Headache disorder
• Nausea
• Skin rash
• Vomiting

Less Frequent

• Eosinophilia
• Urticaria
• Weight loss

Rare or Very Rare

• Agitation
• Arthralgia
• Drowsy
• Fatigue
• General weakness
• Indifference
• Irritability
• Memory impairment
• Muscle weakness
• Myalgia
• Paresthesia
• Polyneuropathy
• Pruritus of skin
• Sleep disorder
• Symptoms of anxiety
• Syncope
• Tremor
• Vertigo

No enhanced messaging available.

Safety and effectiveness of nifurtimox have been established for pediatric patients from birth to less than 18 years of age who weigh at least 2.5 kg. Safety and efficacy have not been established in pediatric patients who weigh less than 2.5 kg.

Based on animal data, nifurtimox may cause fetal harm when administered during pregnancy. (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Available human data do not establish the presence or absence of major birth defects or miscarriage related to the use of nifurtimox.

Nifurtimox crosses the placental barrier.

Verify pregnancy status in females of reproductive potential prior to the initiation of nifurtimox. (See Females and Males of Reproductive Potential under Cautions.)

Data based on case-control and observational studies are conflicting regarding the risk of chronic Chagas disease during pregnancy with some but not all, showing an increased risk of pregnancy loss, prematurity, and neonatal mortality. While acute symptomatic Chagas disease is uncommon in pregnant women, a risk versus benefit assessment for both mother and fetus prior to administering nifurtimox should be conducted on a case-by-case basis.

If nifurtimox is administered during pregnancy, or if a patient becomes pregnant while receiving nifurtimox or within 6 months following the last dose, report exposure by calling 1-888-842-2937.

Nifurtimox is present in human breastmilk with the amount observed in infants estimated to be <15% of the recommended dose for pediatric patients with Chagas disease. Based on a small number of infants who were breastfed by mothers receiving nifurtimox, no adverse events have been reported with therapy. The effects of nifurtimox on the production of milk are unknown. Monitor infants exposed to nifurtimox through breast milk for vomiting, rash, decreased appetite, fever, and irritability. Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for nifurtimox and any potential adverse effects on the breastfed infant from the drug or underlying maternal condition.

There are no specific dosage recommendations for geriatric patients. Nifurtimox is only approved for pediatric patients.

Safety and efficacy of nifurtimox have not been established in patients 65 years of age or older. Nifurtimox is only approved for pediatric patients (newborn to less than 18 years of age).