Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

MOXIDECTIN (NDA-210867)

(MOXIDECTIN)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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02/07/2025 (SUPPL-6)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

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.

Clinical Trials Experience in Adults and Pediatric Patients (12 Years to Less than 18 Years of Age)

The safety of Moxidectin Tablets was evaluated in two randomized, double-blind, active-controlled studies in patients with confirmed onchocerciasis (Trial 1 and Trial 2) [see Clinical Studies (14)]. In Trial 1, 978 patients (including 53 pediatric patients aged 12 to less than 18 years) received Moxidectin Tablets as a single oral dose of 8 mg and 494 patients received ivermectin (including 24 pediatric patients aged 12 to less than 18 years) as a single oral dose of approximately 150 mcg/kg. In Trial 2, 127 patients aged 18 years or older 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 aged 18 years or older received ivermectin as a single oral dose of approximately 150 mcg/kg.

. . .

Clinical Trials Experience in Pediatric Patients (4 Years to Less than 18 Years of Age)

The safety of Moxidectin Tablets in pediatric patients is based on data from 2 studies, Trial 1 and Trial 3 (NCT01035619).

Pediatric Patients in Trial 1

Trial 1 included 53 pediatric patients aged 12 to less than 18 years with confirmed onchocerciasis who received a single dose of Moxidectin Tablets 8 mg. Pediatric patients with confirmed infection experienced efficacy-related adverse reactions (Mazzotti reactions) such as abdominal pain, tachycardia, pyrexia, rash, peripheral swelling, and lymph node pain at a prevalence and severity similar to infected adults. Overall, the safety profile relative to age was similar across pediatric and adult patients studied in Trial 1.

Pediatric Patients in Trial 3

Trial 3 was a single-arm, open-label, age-stratified, multi-cohort, safety and pharmacokinetic trial that evaluated 36 pediatric patients aged 4 to less than 18 years with unknown O. volvulus infection status from an onchocerciasis-endemic area in Ghana. Patients were stratified by age to receive a single dose of Moxidectin Tablets as follows: aged 12 to less than 18 years received 8 mg (N = 9), 8 to less than 12 years received 8 mg (N = 9) or 6 mg (N = 9), and 4 to less than 8 years received 4 mg (N = 9). Median weight was 34.8 kg (range: 30.8 to 55.5 kg) in patients 12 to less than 18 years of age, 25.1 kg (range: 19.4 to 36.8 kg) in patients 8 to less than 12 years, and 15.6 kg (range: 13.6 to 20.6 kg) in patients 4 to less than 8 years. A majority of patients were female (58%) and 100% were black. Mazzotti reactions were not seen in this population with unknown O. volvulus infection. The most common adverse reactions in these pediatric patients were abdominal pain and diarrhea, in 3/36 (8%) patients each. No new safety signals were noted in this pediatric patient population that were not already noted in Trial 1.

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

The safety and effectiveness of Moxidectin Tablets for the treatment of onchocerciasis due to O. volvulus have been established in pediatric patients aged 4 years and older and weighing at least 13 kg. Use of Moxidectin Tablets for this indication is supported by evidence from adequate and well controlled studies in adult and pediatric patients aged 12 years and older with additional pharmacokinetics (PK) and safety data in pediatric patients aged 4 years and older [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14)].

The safety and effectiveness of Moxidectin Tablets in pediatric patients younger than 4 years of age or weighing less than 13 kg has not been established.

03/05/2021 (SUPPL-3)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

(Extensive changes; please refer to label)

8.2 Lactation

(Additions and/or revisions underlined)

Risk Summary

Moxidectin was detected in the milk of lactating women following a single 8 mg dose of Moxidectin Tablets (see Data). There are no data on the effects of Moxidectin Tablets on the breast-fed infant or milk production. In a pre-postnatal study in rats, oral gavage administration of moxidectin at a dose less than 2-times the 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 [see Use in Specific Populations (8.1), and Data].

Because of serious findings from the rat pre-postnatal study including weight loss and death, advise women that breastfeeding is not recommended at the time of treatment with Moxidectin Tablets and for 7 days after treatment.

Data

A pharmacokinetic study in twelve healthy adult lactating women who were 21 to 100 weeks post partum evaluated the concentrations of moxidectin in plasma and breast milk collected over a period of 28 days following a single 8 mg dose of Moxidectin Tablets. The mean (± SD) exposure ratio of moxidectin present in human breast milk to that of human plasma was approximately 1.77 (± 0.66) over a collection period of

28 days. The estimated mean (± SD) total infant dose, assuming the infants would consume all the breast milk collected during the study, was 0.056 mg (± 0.024 mg), which would be approximately 0.70% (± 0.30%) of the maternal dose. Relative infant dose was estimated to be 8.73% (± 0.024 mg). The effects of moxidectin or its metabolites on the breast-fed child or milk production were not evaluated.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

(Additions and/or revisions underlined)

Signs and Symptoms Associated with Microfilarial Death

Advise patients that they are likely to have flu like symptoms including malaise, myalgia, headache, tachycardia, hypotension and pruritus, most commonly during the first week after treatment.

Symptomatic Orthostatic Hypotension

Advise patients that if they feel dizzy, faint or light-headed after taking Moxidectin Tablets, they should lie down until the symptoms resolve.

Absence of Macrofilarial Activity

Advise patients that treatment with Moxidectin Tablets does not kill adult O. volvulus and that follow up evaluation is usually required.

Edema and Worsening of Onchodermatitis

Advise patients with hyper-reactive onchodermatitis that they may be more likely to experience severe adverse reactions.

Encephalopathy in Loa loa Co-infected Patients

Advise patients to report any symptoms of encephalopathy to their healthcare provider.

Lactation

Advise women that breastfeeding is not recommended at the time of treatment with Moxidectin Tablets and for 7 days after treatment.