Moxidectin

Moxidectin, a macrocyclic lactone, is an anthelmintic drug [see Microbiology ( 12.4 )] .

• Moxidectin Tablets are indicated for the treatment of onchocerciasis due to Onchocerca volvulus in adult and pediatric patients aged 4 years and older and weighing at least 13 kg [see Clinical Studies ( 14 )] . Limitations of Use: Moxidectin Tablets does not kill adult Onchocerca volvulus (O.

• None. None.contraindicated

Recommended Dosage in Adult Patients : Take 8 mg (four 2 mg tablets) as a single oral dose, with or without food. ( 2.1 ) Recommended Dosage in Pediatric P atients (4 Years of Age and Older and Weighing at Least 13 kg): See Table below. ( 2.2 ) Body Weight Dose Number of 2 mg Tablets 13 kg to less than 15 kg 4 mg 2 15 kg to less than 30 kg 6 mg 3 Greater than or equal to 30 kg 8 mg 4 2.1 Recommended Dosage in Adult Patients The recommended dosage of Moxidectin Tablets in adult patients is a single dose of 8 mg (four 2 mg tablets) taken orally with or without food [see Clinical Pharmacology ( 12.3 )]. 2. 2 Recommended Dosage in Pediatric Patients (4 Years of Age and Older and Weighing at Least 13 kg) The recommended dosage of Moxidectin Tablets in pediatric patients aged 4 years and older and weighing at least 13 kg is described in Table 1 below. Administer Moxidectin Tablets as a single dose taken orally with or without food [see Clinical Pharmacology ( 12.3 ) ]. Table 1: Recommended Dosage of Moxidectin Tablets in Pediatric Patients 4 Years of Age and Older and Weighing at Least 13 kg Body Weight Dose Number of 2 mg Tablets 13 kg to less than 15 kg 4 mg 2 15 kg to less than 30 kg 6 mg 3 Greater than or equal to 30 kg 8 mg 4

Cutaneous, Ophthalmological and/or Systemic Adverse Reactions of Varying Severity (Mazzotti Reaction ) : This may occur in patients with onchocerciasis following treatment with Moxidectin Tablets. Monitor patients for symptoms, including symptomatic orthostatic hypotension. ( 5.1 ) Symptomatic Orthostatic Hypotension : Episodes of symptomatic orthostatic hypotension including inability to stand without support may occur in patients following treatment with Moxidectin Tablets. ( 5.2 ) Encephalopathy in Loa loa C o- I nfected P atients : Serious or even fatal encephalopathy following treatment with Moxidectin Tablets may occur in patients co-infected with Loa loa . Assess patients for loiasis in Loa loa endemic areas prior to treatment. ( 5.3 ) Edema and Worsening of Onchodermatitis : Patients with hyper-reactive onchodermatitis (sowda) may be more likely than others to experience severe edema and aggravation of onchodermatitis. ( 5.4 ) 5.1 Cutaneous, Ophthalmological and/or Systemic Adverse Reactions Treatment with Moxidectin Tablets may cause cutaneous, ophthalmological and/or systemic reactions of varying severity (Mazzotti reaction). These adverse reactions are due to allergic and inflammatory host responses to the death of microfilariae [see Adverse Reactions ( 6.1 )]. There is a trend toward an increased incidence of these adverse reactions in patients with higher microfilarial burden.

The following clinically significant adverse reactions are described in greater detail in other labeling sections: Cutaneous, Ophthalmological and/or Systemic Adverse Reactions [see Warnings and Precautio ns ( 5.1 )] Symptomatic Orthostatic Hypotension [see Warnings and Precautions ( 5.2 )] Encephalopathy in Loa loa Co-infected Patients [see Warnings and Precautions ( 5.3 )] Edema and Worsening of Onchodermatitis [see Warnings and Precautions ( 5.4 )] The most common adverse reactions (incidence > 10%) in adult and pediatric patients (12 to less than 18 years of age) in Trial 1 were eosinophilia, pruritus, musculoskeletal pain, headache, lymphocytopenia, tachycardia, rash, abdominal pain, hypotension, pyrexia, leukocytosis, influenza-like illness, neutropenia, cough, diarrhea/gastroenteritis/enteritis, lymph node pain, dizziness, hyponatremia and peripheral swelling. ( 6.1 ) The most common adverse reactions (incidence > 5%) in pediatric patients (4 to less than 18 years of age) in Trial 3 were abdominal pain and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Medicines Development for Global Health at 1-800-MDGH-456 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under varying controlled conditions, adverse reaction rates observed in one clinical trial cannot be directly compared to rates observed in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Lactation : Breastfeeding is not recommended during treatment with Moxidectin Tablets and for 7 days after treatment. ( 8.2 ) 8.1 Pregnancy Risk Summary Available data from clinical trials on the use of Moxidectin Tablets in pregnant women are insufficient to establish whether there is a moxidectin-associated risk for major birth defects and miscarriage . Moxidectin administered orally to pregnant rats during the period of organogenesis was not associated with significant embryo-fetal developmental effects at doses of approximately 15 times the recommended human dose based on body surface area (BSA) comparison. When moxidectin was dosed orally to pregnant rabbits during the period of organogenesis, no embryo-fetal developmental effects were observed at oral doses of moxidectin up to 24 times the recommended human dose based on BSA comparison ( see Data ) . Daily administration of moxidectin by oral gavage to maternal female rats during organogenesis and through lactation was associated with decreased survival, adverse clinical signs, and decreased body weights in first-generation offspring during the lactation period at a moxidectin dose less than 2-times the recommended human dose based on BSA comparison. Additional findings in first-generation offspring at the same dose included delays in pinna unfolding, eye opening, and vaginal opening.

Metabolism

The pharmacokinetic parameters of moxidectin following a single 8 mg oral dose of Moxidectin Tablets to healthy subjects and patients with onchocerciasis under fasted conditions are shown in Table 5. Mean moxidectin C max and AUC increased approximately proportionally to dose over a dose range of 2 to 36 mg (0.25 to 4.5 times the approved recommended dose) in healthy subjects under fasted conditions.

No specific antidote is available for overdose with Moxidectin Tablets. If overdose occurs, the patient should be monitored for evidence of toxicity. Treatment of overdose with Moxidectin Tablets consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient. Supportive therapy, if indicated, should include parenteral fluids and electrolytes, respiratory support (oxygen and mechanical ventilation if necessary) and pressor agents if clinically significant hypotension is present.

• Jun 13, 2018NDANDA210867Mdgh

1. 1Abortion Spontaneous133%
2. 2Biliary Obstruction133%
3. 3Dehydration133%
4. 4Fall133%
5. 5Hepatic Encephalopathy133%
6. 6Hepatitis Fulminant133%
7. 7Multiple Drug Overdose Accidental133%
8. 8Somnolence133%
9. 9Wrong Drug Administered133%

The 10 most recently updated of 25 ClinicalTrials.gov registrations naming Moxidectin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Safety of a Single Dose of Moxidectin Compared With Ivermectin in Individuals Living in Onchocerciasis Endemic Areas and in Individuals Living in Onchocerciasis Endemic Areas With High Levels of Lymphatic Filariasis Co-endemicity Receiving Concomitant Albendazole
  Completed · Phase 3 · Interventional · 12,979 enrolled · Medicines Development for Global Health
  NCT04311671updated 2026-03-03
• Moxidectin for LF, Cote d'Ivoire (DOLF)
  Completed · Phase 3 · Interventional · 164 enrolled · Washington University School of Medicine
  NCT04410406updated 2026-01-29
• Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for Onchocerciasis
  Active not recruiting · Phase 3 · Interventional · 323 enrolled · Medicines Development for Global Health
  NCT03876262updated 2025-12-23
• Safety and Efficacy of Novel Combination Regimens for Treatment of Onchocerciasis
  Active not recruiting · Phase 2 · Interventional · 300 enrolled · Washington University School of Medicine
  NCT06070116updated 2025-12-18
• Moxidectin Versus Ivermectin as Mass Drug Administration for the Control of Onchocerciasis and Other Neglected Tropical Diseases
  Recruiting · Phase 4 · Interventional · 52,000 enrolled · Kirby Institute
  NCT07145736updated 2025-11-21
• Efficacy and Safety of Moxidectin-Albendazole Co-administration in SAC
  Completed · Phase 3 · Interventional · 224 enrolled · Jennifer Keiser
  NCT06188715updated 2025-09-19
• Better Options for Lymphatic Filariasis Treatment
  Not yet recruiting · Phase 3 · Interventional · 5,100 enrolled · Medicines Development for Global Health
  NCT07159373updated 2025-09-08
• A Pharmacokinetic and Safety Study of Moxidectin to Identify an Optimal Dose for Treatment of Children 4 to 11 Years
  Completed · Phase 1 · Interventional · 36 enrolled · Medicines Development for Global Health
  NCT03962062updated 2025-09-05
• Study of the Safety and Efficacy of Moxidectin Tablets for the Reduction of Demodex Eyelash Infestation
  Completed · Phase 4 · Interventional · 24 enrolled · Eye Research Foundation, Inc.
  NCT06795165updated 2025-08-12
• Efficacy and Safety Study of Moxidectin in Adults With Scabies
  Completed · Phase 2 · Interventional · 200 enrolled · Medicines Development for Global Health
  NCT05875441updated 2025-05-04

Frequently asked questions

How does Moxidectin work?

Moxidectin, a macrocyclic lactone, is an anthelmintic drug [see Microbiology ( 12.4 )] .

What is Moxidectin used for?

According to FDA labeling, Moxidectin carries indications including: Moxidectin Tablets are indicated for the treatment of onchocerciasis due to Onchocerca volvulus in adult and pediatric patients aged 4 years and older and weighing at least 13 kg [see Clinical Studies ( 14 )] . Limitations of Use: Moxidectin Tablets does not kill adult Onchocerca volvulus (O.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Moxidectin?

Moxidectin is classified as Other antinematodals, Chloride Channel Interactions, Membrane Transporter Interactions, Decreased Cell Membrane Integrity.

What are the brand names for Moxidectin?

Moxidectin is marketed under brand names including Advantage Multi, Bravecto Plus, Cydectin, Imoxi, Midamox, Moxisolv, NexGard Plus, Parasedge Multi.

What are the contraindications for Moxidectin?

Moxidectin labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.