Moxidectin

Moxidectin is a prescription medication used for the treatment of Onchocerciasis (River Blindness) due to Onchocerca volvulus. 

• Moxidectin is available under the following different brand names: Moxidectin.

Common side effects of Moxidectin include:

• Nausea, and
• Abnormal laboratory results,
• Itching,
• Musculoskeletal pain,
• Flu-like illness,
• Fast heart rate,
• Low blood pressure,
• Lymph-node pain,
• Cough,
• Rash,
• Abdominal pain,
• Dizziness,
• Diarrhea,
• Low blood sodium, and
• Swelling of the extremities

Serious side effects of Moxidectin include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Itching,
• Headache,
• Fever,
• Rash,
• Lightheadedness,
• Nausea,
• Fainting,
• Unusual thirst,
• Blurred vision,
• Cold, clammy, or pale skin,
• Dizziness,
• Fast heartbeats,
• Swelling,
• Tenderness and pain in the lymph nodes,
• Joint pain,
• Muscle pain,
• Chills,
• Numbness and tingling in the arms, hands, legs, or feet,
• Weakness,
• Conjunctivitis,
• Eye pain,
• Itchy eyes,
• Eyelid swelling,
• Blurred vision,
• Increased sensitivity to light,
• Changes in visual acuity,
• Changes in skin color and swelling,
• Discomfort of the eyes, and
• Watery eyes

Rare side effects of Moxidectin include:

• None 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Tablet

• 2 mg

Onchocerciasis

Adult dosage

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

Pediatric dosage

• Below 12 years: Safety and efficacy not established.
• Above 12 years
  • 8 mg (four 2-mg tablets) orally as a single dose administered with or without food.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Moxidectin has no noted severe interactions with any other drugs.
• Moxidectin has no noted serious interactions with any other drugs.
• Moxidectin has no noted moderate interactions with any other drugs.
• Moxidectin has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Moxidectin?”

Long-Term Effects

See “What Are Side Effects Associated with Using Moxidectin?”

Cautions

• Patients may develop symptomatic orthostatic hypotension with the 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 may develop a serious or even fatal encephalopathy following treatment; moxidectin has not been studied in patients co-infected with Loa; before 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 acrodermatitis (soda) may be more likely than others to experience severe edema and worsening of acrodermatitis following moxidectin; manage with symptomatic treatment in patients who have experienced edema and worsening acrodermatitis.
• 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 include pruritus, headache, pyrexia, rash, urticaria, hypotension (.g, 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.

Pregnancy and Lactation

• 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.
• 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
  • In a pre-postnatal study in rats, oral gavage administration at a dose less than 2-times recommended human dose based on BSA comparison during the lactation period resulted in adverse clinical signs, weight loss, and increased mortality in rat pups suggesting moxidectin in lactation milk was responsible for the adverse effects.
  • Because of serious findings from rat pre-postnatal studies including weight loss and death, advise women that breastfeeding is not recommended at the time of treatment and for 7 days after treatmentx