moxidectin (Rx)

Brand and Other Names:
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 2mg

Onchocerciasis

Indicated for treatment of onchocerciasis (river blindness) due to Onchocerca volvulus

8 mg (four 2-mg tablets) PO as a single dose administered with or without food

Dosage Modifications

Hepatic impairment: Unknown

Renal impairment

  • Mild-to-moderate (CrCl 30-89 mL/min): No dosage adjustment necessary
  • Severe (CrCl 15-29 mL/min) or end-stage renal disease: Safety is unknown

Dosing Considerations

Limitations of use

  • Does not kill adult O. volvulus parasites; follow-up advised
  • Safety and efficacy of repeat administration in patients with O. volvulus not studied

Dosage Forms & Strengths

tablet

  • 2mg

Onchocerciasis

Indicated for treatment of onchocerciasis (river blindness) due to O volvulus in patients aged ≥12 years

<12 years: Safety and efficacy not established

≥12 years

  • 8 mg (four 2-mg tablets) PO as a single dose administered with or without food
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Adverse Effects

>10%

Eosinophilia (74%)

Pruritus (65%)

Musculoskeletal pain (64%)

Headache (58%)

Lymphocytopenia (48%)

Tachycardia (39%)

Rash (37%)

Orthostatic tachycardia (34%)

Abdominal pain (31%)

Hypotension (30%)

Pyrexia/chills (27%)

Leukocytosis (25%)

Influenza like illness (23%)

Grade 3 lymphocytopenia (<0.5 x 10^9/L) (23%)

Orthostatic hypotension (22%)

Neutropenia (20%)

Nonorthostatic tachycardia (18%)

Severe eosinophilia (>5 x 10^9) (18%)

Cough (17%)

Diarrhea/gastroenteritis/enteritis (15%)

Lymph node pain (13%)

Dizziness (12%)

Hyponatremia (12%)

Peripheral swelling (11%)

1-10%

Eye pain (8%)

Eye pruritus (7%)

Grade 4 neutrophils (<0.5 x 10^9/L) (7%)

Eosinopenia (<0.045 x 10^9/L) (5%)

Visual impairment (3%)

Gamma-glutamyltransferase (>5x ULN) (3%)

Eyelid edema (2%)

Conjunctivitis allergic (2%)

Ocular discomfort (2%)

Ocular and conjunctival hyperemia (2%)

Bilirubin (>2x ULN) (1.4%)

AST (>5x ULN) (1%)

ALT (>5x ULN) (1%)

Lacrimation increased (1%)

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Warnings

Contraindications

None

Cautions

Patients may develop symptomatic orthostatic hypotension with inability to stand without support after lying down for 5 minutes; patients experiencing dizziness or lightheadedness after administration should lie down until symptoms resolve

Patients with onchocerciasis who are also infected with Loa loa may develop a serious or even fatal encephalopathy following treatment; moxidectin has not been studied in patients co-infected with Loa loa; prior to treatment, patients who warrant treatment and have had exposure to Loa loa-endemic areas are recommended to undergo diagnostic screening for loiasis

Patients with hyper-reactive onchodermatitis (sowda) may be more likely than others to experience severe edema and worsening of onchodermatitis following moxidectin; manage with symptomatic treatment in patients who have experienced edema and worsening onchodermatitis

Cutaneous, ophthalmological, and/or systemic adverse reactions

  • Cutaneous, ophthalmological, and/or systemic reactions of varying severity (Mazzotti reaction) may occur; these adverse reactions are due to allergic and inflammatory host responses to the death of microfilariae
  • Clinical manifestations of Mazzotti reaction includes pruritus, headache, pyrexia, rash, urticaria, hypotension (eg, symptomatic orthostatic hypotension, dizziness), tachycardia, edema, lymphadenopathy, arthralgia, myalgia, chills, paresthesia, and asthenia
  • Ophthalmological manifestations include conjunctivitis, eye pain, eye pruritus, eyelid swelling, blurred vision, photophobia, visual acuity changes, hyperemia, ocular discomfort, and watery eyes
  • Laboratory changes include eosinophilia, eosinopenia, lymphocytopenia, neutropenia, and increases in alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT), and lactate dehydrogenase (LDH); proteinuria also reported
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Pregnancy & Lactation

Pregnancy

Limited available data on use in pregnant women are insufficient to establish whether there is a moxidectin-associated risk for major birth defects and miscarriage

Animal data

  • Daily parental oral administration of dietary moxidectin to rats prior to mating, and through mating, gestation, and lactation, was associated with decreased survival and body weights for first-generation offspring, without maternal toxicity, at moxidectin doses less than 2 times the recommended human dose based on body surface area comparison

Lactation

Moxidectin was detected in the milk of lactating women following a single moxidectin dose

There are no data on the effects of moxidectin on the breastfed infant or milk production

Consider the benefits of breastfeeding along with the mother’s clinical need for moxidectin and any potential adverse effects on the breastfed child from moxidectin or from the underlying maternal condition

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

The mechanism of action against O. volvulus is not known

Moxidectin is active against the microfilariae of O. volvulus

Studies suggest that moxidectin is not effective for killing the adult worms; however, it inhibits intrauterine embryogenesis and release of microfilariae from the adult worms

Absorption

Peak plasma concentration: 58.9 ng/mL (healthy subjects); 63.1 ng/mL (patients with onchocerciasis)

Peak plasma time: 4 hr (healthy subjects and patients with onchocerciasis)

AUC: 3387 ng·hr/mL (healthy subjects); 2738 ng·hr/mL (patients with onchocerciasis)

Mean peak plasma concentrations and AUC increased on average by 34% and 39%, respectively, when administered with a standard high-fat meal (900 calories, with a nutritional distribution of ~55% fat, 31% carbohydrates, and 14% protein) compared with fasted conditions

Distribution

Vd: 2421 L

Metabolism

Hepatic metabolism of moxidectin is minimal

Excretion

Half-life: 784 hr (healthy subjects); 559 hr (patients with onchocerciasis)

Clearance: 3.5 L/hr

Excretion: Feces (2%, unchanged)

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Administration

Oral Administration

Administer with or without food as a single dose

Storage

Tablets: Store <30°C (86°F)

Protect from light

Once open, use full contents of the container within 24 hr; discard any unused content

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.