Moxidectin (Oral)

Moxidectin is used to treat river blindness (onchocerciasis) caused by the roundworm parasite Onchocerca volvulus.

This medicine is available only with your doctor's prescription.

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause flu-like symptoms (for example, a general feeling of discomfort or illness, unusual tiredness or weakness, joint or muscle pain, headache, fast, pounding, or irregular heartbeat or pulse, itching skin) most commonly during the first week after treatment due to the death of the parasite.

Serious skin reactions may occur during treatment with this medicine. Check with your doctor right away if you have a skin rash, hives, or itching.

Check with your doctor right away if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want your eyes to be checked by an ophthalmologist (eye doctor).

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

Moxidectin does not kill adult roundworms. Check with your doctor if you feel that this medicine is not working as it should or if your symptoms get worse.

Encephalopathy (brain problem) may occur when used in patients infected with another parasite, Loa loa. Check with your doctor right away if you have agitation, back pain, blurred vision, loss of consciousness, confusion, dizziness, drowsiness, fever, hallucinations, headache, irritability, mood or mental changes, seizures, stiff neck, unusual tiredness or weakness, or vomiting.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine compared to the benefits it may provide. Here are some important points to think about:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, such as allergies to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies conducted so far have not shown any specific problems in children aged 12 years and older that would limit the use of moxidectin. However, safety and effectiveness have not been established for children younger than 12 years.

Geriatric

Studies conducted so far have not shown any specific problems in elderly patients that would limit the use of moxidectin. However, older adults may be more sensitive to the effects of this medicine than younger adults.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medicine while breastfeeding. Weigh the potential benefits against the potential risks before using this medication during breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together even if there could be an interaction. In these situations, your doctor might want to adjust the dose, or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken with food or certain types of food because interactions may happen. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk with your healthcare professional about how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how you can use this medicine. Make sure to tell your doctor if you have any other medical problems, especially:

• Edema (swelling) or
• Hypotension (low blood pressure) or
• Onchodermatitis (sowda), hyperreactive—Use with caution. May worsen these conditions.

• Loa loa infection—Patients with a Loa loa infection are at a higher risk for encephalopathy (a brain issue).

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor right away if you have any of the following side effects:

More common

• Bone or muscle pain
• chills
• cough
• diarrhea
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dizziness
• fast, pounding, or irregular heartbeat or pulse
• fever
• headache
• itching
• rash
• stomach pain
• swelling of the face, ankles, or hands
• unusual tiredness or weakness

Less common

• Blurred vision
• burning, dry, itching, or watering of the eyes
• discharge, excessive tearing
• feeling of having something in the eye
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• trouble seeing

Other side effects not listed may also happen in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

You may take this medicine with or without food.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):For the treatment of onchocerciasis: Adults and children 12 years of age and older—8 milligrams (mg) (four 2 mg tablets) as a single dose. Children younger than 12 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Take all the medicine in the container within 24 hours of opening. Throw away any unused medicine.