Moxidectin
- Generic Name: moxidectin tablets
- Brand Name: Moxidectin
- Drug Class: Anthelmintics
Moxidectin (Moxidectin Tablets) side effects drug center
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- increased or decreased white blood cell counts,
- itching,
- musculoskeletal pain,
- headache,
- fast heart rate,
- rash,
- abdominal pain,
- low blood pressure (hypotension),
- fever,
- flu-like illness,
- cough,
- lymph node pain,
- dizziness,
- diarrhea,
- low blood sodium, and
- swelling of extremities
- Cutaneous, Ophthalmological and/or Systemic Adverse Reactions [see WARNINGS AND PRECAUTIONS]
- Symptomatic Orthostatic Hypotension [see WARNINGS AND PRECAUTIONS]
- Encephalopathy in Loa loa Co-infection [see WARNINGS AND PRECAUTIONS]
- Edema and Worsening of Onchodermatitis [see WARNINGS AND PRECAUTIONS]
Moxidectin is an anthelmintic indicated for the treatment of onchocerciasis due to Onchocerca volvulus in patients aged 12 years and older. Common side effects of moxidectin include:
The dose of moxidectin is 8 mg (four 2 mg tablets) as a single oral dose, with or without food. Moxidectin may interact with other drugs. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using moxidectin; it is unknown how it would affect a fetus. Moxidectin passes into breast milk but its effects on nursing infants are unknown. Consult your doctor before breastfeeding.
Our Moxidectin Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Moxidectin Professional Information
SIDE EFFECTS
The following clinically significant adverse reactions are described in greater detail in other labeling sections:
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.
The safety of Moxidectin Tablets was evaluated in two randomized, double-blind, active-controlled studies (Trial 1 and Trial 2) [see Clinical Studies]. In Trial 1, 978 patients received Moxidectin Tablets as a single oral dose of 8 mg and 494 patients received ivermectin as a single oral dose of approximately 150 mcg/kg. In Trial 2, 127 patients received Moxidectin Tablets as a single oral dose ranging from 2 mg (this is not an approved dose) to 8 mg (38 received the recommended 8 mg dose) and 45 patients received ivermectin as a single oral dose of approximately 150 mcg/kg.
Most Common Adverse Reactions
No patients withdrew from either trial due to adverse reactions. Adverse Reactions reported in Trial 1 in > 10% of patients are summarized in Table 1. Most were related to physical, vital signs and laboratory changes associated with Mazzotti reaction [see WARNINGS AND PRECAUTIONS].
Table 1: Adverse Reactions Occurring in > 10% of
Moxidectin-treated Patients with Onchocerciasis in Trial 1
| Adverse Reaction | Moxidectin N = 978 n (%) |
Ivermectin N = 494 n (%) |
| Eosinophilia | 721 (74) | 390 (79) |
| Pruritus | 640 (65) | 268 (54) |
| Musculoskeletal pain a | 623 (64) | 257 (52) |
| Headache | 566 (58) | 267 (54) |
| Lymphocytopenia* | 470 (48) | 215 (44) |
| Tachycardia b | 382 (39) | 148(30) |
| Orthostatic tachycardia c | 333 (34) | 130 (26) |
| Non-orthostatic tachycardia d | 179 (18) | 57 (12) |
| Rash e | 358 (37) | 103 (21) |
| Abdominal pain f | 305 (31) | 173 (35) |
| Hypotension g | 289 (30) | 125 (25) |
| Orthostatic hypotension h | 212 (22) | 81 (16) |
| Pyrexia/Chills | 268 (27) | 88 (18) |
| Leukocytosis | 240 (25) | 125 (25) |
| Influenza like illness | 226 (23) | 102 (21) |
| Neutropenia** | 197 (20) | 112 (23) |
| Cough | 168 (17) | 88 (18) |
| Lymph node pain | 129 (13) | 28 (6) |
| Dizziness | 121 (12) | 44 (9) |
| Diarrhea/Gastroenteritis/Enteritis | 144 (15) | 84 (17) |
| Hyponatremia | 112 (12) | 65 (13) |
| Peripheral swelling | 107 (11) | 30 (6) |
| a Includes “myalgia”, “arthralgia”,
“musculoskeletal pain”, “pain” and “back pain” b Includes “orthostatic heart rate increased”, “postural orthostatic tachycardia syndrome”, “heart rate increased” and “sinus tachycardia” c Includes “orthostatic heart rate increased” and “postural orthostatic tachycardia syndrome” d Includes “heart rate increased”, “tachycardia”, and “sinus tachycardia” e Includes “rash,” “papular rash” and “urticaria” f Includes “abdominal pain”, “abdominal pain upper” and “abdominal pain lower” g Includes “orthostatic hypotension”, “blood pressure orthostatic decreased”, “blood pressure decreased”, “mean arterial pressure decreased”, “hypotension” h Includes “orthostatic hypotension”, and “blood pressure orthostatic decreased” *Lymphocytopenia is defined as absolute lymphocyte count less than 1 x 109/L **Neutropenia is defined as absolute neutrophil count less than 1 x 109/L |
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The most common adverse reactions in patients (n = 38) treated with 8 mg moxidectin in Trial 2 were similar to the adverse reactions noted in Trial 1 described in Table 1 above.
Other Adverse Reactions Reported In Clinical Trials
The following adverse reactions occurred in less than 10% of subjects receiving Moxidectin Tablets in Trial 1: Ocular Adverse Reactions: In Trial 1, the most common ocular adverse reactions (occurring in ≥ 0.5% of patients) is shown in Table 2.
Table 2: Ocular Adverse Reactions Occurring in ≥
0.5% Moxidectin-treated Patients
| Adverse Reaction | Moxidectin N = 978 n (%) |
Ivermectin N = 494 n (%) |
| Eye pain | 78 (8) | 28 (6) |
| Eye pruritus | 64 (7) | 26 (5) |
| Visual impairment* | 25 (3) | 9 (2) |
| Eyelid edema | 21 (2) | 5 (1) |
| Conjunctivitis allergic | 19 (2) | 11 (2) |
| Ocular discomfort** | 18 (2) | 11 (2) |
| Ocular and conjunctival hyperemia | 17 (2) | 3 (1) |
| Lacrimation increased | 13 (1) | 10 (2) |
| *Includes “visual impairment”, “blurred vision” and “low
vision acuity” **Includes “foreign body sensation”, “ocular discomfort” and “abnormal sensation in the eye” |
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Hepatobiliary Adverse Reactions
More patients in the moxidectin arm experienced elevation in bilirubin above the upper limit of normal and elevation in transaminases > 5x upper limit of normal. Twenty-seven (2.8%) patients in the moxidectin arm and 3 (0.6%) patients in the ivermectin arm had hyperbilirubinemia. Most of the patients had single measurements of hyperbilirubinemia without concurrent elevation in transaminases.
Nine (1%) patients in the moxidectin arm and 2 (0.4%) patients in the ivermectin arm had elevation in ALT of more than 5x upper limit of normal; ten (1%) patients in the moxidectin arm and 3 (0.6%) patients in the ivermectin arm had elevation in AST to more than 5x upper limit of normal.
Laboratory Abnormalities
Laboratory abnormalities occurring in at least 1% of patients in the Trial 1 are described in Table 3.
Table 3: Laboratory Abnormalities in at least 1% of Moxidectin-treated
Patients
| Parameter | MOXIDECTIN (N = 978) n (%) |
Ivermectin (N = 494) n (%) |
| Hematology | ||
| Severe eosinophilia (> 5 x109/L) | 173 (18) | 111 (23) |
| Grade 3 lymphocytopenia (< 0.5 x109/L) | 220 (23) | 98 (20) |
| Grade 4 Neutrophils (< 0.5 x109/L) | 65 (7) | 46 (9) |
| Eosinopenia (<0.045 x109/L) | 51 (5) | 21 (4) |
| Hepatobiliary | ||
| GGT (> 5x upper limit of normal) | 26 (3) | 16 (3) |
| Bilirubin (> 2x upper limit of normal) | 14 (1.4) | 2 (0.4) |
| AST (> 5x upper limit of normal) | 10 (1) | 3 (0.6) |
| ALT (> 5x upper limit of normal) | 9 (1) | 2 (0.4) |
Read the entire FDA prescribing information for Moxidectin (Moxidectin Tablets)
&Copy; Moxidectin Patient Information is supplied by Cerner Multum, Inc. and Moxidectin Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.