Onchocerciasis: Children ≥12 years and Adolescents: Oral: 8 mg as a single dose
Children ≥12 years and Adolescents: Oral:
CrCl ≥30 mL/minute: No dosage adjustment necessary.
CrCl <30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Moxidectin (United States: Not available): Drug information")
Onchocerciasis:
Note: For individuals from Loa loa–endemic areas, rule out co-infection prior to moxidectin administration to avoid life-threatening encephalopathy.
Oral: 8 mg as a single dose.
CrCl ≥30 mL/minute: No dosage adjustment necessary.
CrCl <30 mL/minute or ESRD: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Cardiovascular: Tachycardia (39%), postural orthostatic tachycardia (34%), hypotension (30%), orthostatic hypotension (22%), peripheral edema (11%)
Central nervous system: Headache (58%), chills (≤27%), lymph node pain (13%), dizziness (12%)
Dermatologic: Pruritus (65%), skin rash (37%)
Endocrine & metabolic: Hyponatremia (12%)
Gastrointestinal: Abdominal pain (31%), diarrhea (≤15%), enteritis (≤15%), gastroenteritis (≤15%)
Hematologic & oncologic: Eosinophilia (18% to 74%; severe: 18%), lymphocytopenia (48%: grade 3: 23%), leukocytosis (25%), neutropenia (20%: grade 4: 7%)
Neuromuscular & skeletal: Musculoskeletal pain (64%)
Respiratory: Flu-like symptoms (23%), cough (17%)
Miscellaneous: Fever (≤27%)
1% to 10%:
Cardiovascular: Symptomatic orthostatic hypotension (5%)
Endocrine & metabolic: Increased gamma-glutamyl transferase (3%)
Hematologic & oncologic: Eosinopenia (5%)
Hepatic: Hyperbilirubinemia (3%), increased serum alanine aminotransferase (1%), increased serum aspartate aminotransferase (1%)
Ophthalmic: Eye pain (8%), eye pruritus (7%), visual impairment (3%; including blurred vision, low vision acuity), allergic conjunctivitis (2%), eyelid edema (2%), conjunctival hyperemia (≤2%), ocular hyperemia (≤2%), increased lacrimation (1%)
Frequency not defined: Dermatologic: Mazzotti reaction
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Mazzoti reaction: Moxidectin treatment may cause cutaneous, ophthalmological, and/or systemic reactions (Mazzoti reaction) of varying severity, due to allergic and inflammatory host responses to the death of microfilariae. These reactions generally occur and resolve in the first week post-treatment. Risk may be increased in patients with higher microfilarial burden. Treatment of severe Mazzoti reactions is not definitive, but includes supportive care (eg, hydration and/or parenteral corticosteroids) to treat postural hypotension. Antihistamines and/or aspirin have been used for most mild to moderate reactions.
• Orthostatic hypotension: Orthostatic hypotension may occur, most commonly on the first 1 to 2 days after treatment. Decrease in blood pressure was transient and managed by resuming recumbency.
Disease-related concerns:
• Loiasis: Pretreatment assessment for loiasis is recommended in any patient with exposure to Loa loa-endemic areas; serious, sometimes fatal, encephalopathy may occur following treatment with moxidectin in onchocerciasis patients with concomitant loiasis.
Other warnings/precautions:
• Hyperreactive onchodermatitis: Patients with hyperreactive dermatitis (sowda) may be at increased risk for severe edema and worsening of onchodermatitis following treatment with moxidectin.
There are no plans for commercial distribution of moxidectin in the US. Product will be available for onchocerciasis endemic parts of the world.
Tablet, oral
Generic: 2 mg [500s] [contains lactose, sodium lauryl sulfate]
Oral: May be taken without regard to food
Oral: Administer without regard to meals.
Store below 30°C (86°F). Protect from light. Once opened, administer within 24 hours. Discard unused tablets.
Treatment of onchocerciasis due to Onchocerca volvulus (FDA approved in ages ≥12 years and adults). Note: Moxidectin tablets do not kill adult O. volvulus.
None known.
There are no known significant interactions.
Patients who could become pregnant were required to use long-acting contraception during clinical studies (Awadzi 2014; Korth-Bradley 2011), likely due to the long terminal half-life of moxidectin.
Adverse events were observed in some animal reproduction studies.
Skin microfilarial counts; screening for loiasis prior to treatment in patients exposed to Loa loa-endemic areas; signs and symptoms of Mazzotti reaction, including symptomatic orthostatic hypotension
Moxidectin, an anthelminthic agent, is active against the microfilariae of O. volvulus, but not effective in killing the adult worms. Studies with other nematodes suggest moxidectin binds to glutamate-gated chloride ions channels, gamma-aminobutyric acid (GABA) receptors, and/or APT-binding cassette transporters. This leads to increased permeability, influx of chloride ions, hyperpolarization, and muscle paralysis. There is also a reduction in motility of all stages of the parasite, excretion of immunomodulatory proteins, and the fertility of both male and female adult worms.
Distribution: Vd: 2,421 ± 1,658 L
Protein binding: Unknown
Metabolism: Minimal
Half-life elimination: 23.3 days (559 hours)
Time to peak: 4 hours
Excretion: Feces: 2% (as unchanged drug)
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