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| Product NDC Code | 43598-921 | ||||
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| Drug Name | Xeglyze |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| RxCUI drug identifier | 2475536, 2475541 |
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| Application Number | NDA206966 | ||||
| Labeler Name | Dr. Reddy's Laboratories Inc. | ||||
| Packages |
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Overdosage of Xeglyze
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.10 OVERDOSAGE If accidentally swallowed, advise patients to seek medical advice immediately and to call their local Poison Control Center at 1-800-222-1222.
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.6 ADVERSE REACTIONS Most common adverse reactions (incidence of ≥ 1%) were erythema, rash, skin burning sensation, contact dermatitis, vomiting, eye irritation, pruritus, and hair color changes. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories. Inc., at 1-888-966-8766 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug, and may not reflect the rates observed in practice. The data described below reflect exposure to a single 10-minute treatment of XEGLYZE in 349 subjects (6 months of age and older) with head lice infestation in randomized, double-blind, vehicle-controlled trials (Trials 1 and 2). Of these subjects, 21 were 6 months to 4 years of age, 166 subjects were 4 to 12 years of age, 57 subjects were 12 to 18 years of age, and 105 subjects were 18 years of age or older. Table 1 provides adverse reactions that occurred in at least 1% of subjects in the XEGLYZE group and at a greater frequency than in the vehicle group. Table 1: Adverse Reactions Occurring in ≥ 1% of the XEGLYZE Group and at a Greater Frequency than in the Vehicle Group (Trials 1 and 2) Adverse Reactions XEGLYZE N=349 Subjects (%) Vehicle N=350 Subjects (%) Erythema 14 (4.0) 6 (2) Rash 11 (3.2) 8 (2.3) Skin burning sensation 9 (2.6) 0 (0.0) Contact dermatitis 6 (1.7) 4 (1.1) Vomiting 6 (1.7) 2 (0.6) Eye irritation 4 (1.2) 2 (0.6) Hair color changes 3 (1) 0 (0.0) During the trials, subjects were monitored for new onset of scalp erythema/edema, scalp pruritus, and eye irritation. The number and percentage of subjects who developed these local adverse reactions after treatment are presented in Table 2. Table 2: Monitored Local Adverse Reactions with New Onset on Day 1 Post-Treatment (Trials 1 and 2) Adverse Reactions XEGLYZE Subjects (%)* Vehicle Subjects (%)* Scalp Erythema/Edema 11 (3.2) 5 (1.4) Scalp Pruritus 2 (1.4) 1 (0.7) Eye Irritation 6 (1.7) 5 (1.4) * For the calculation of the percentages, the denominators are the number of subjects who did not have the monitored local adverse reaction at baseline.
| Erythema | 14 (4.0) | 6 (2) |
| Rash | 11 (3.2) | 8 (2.3) |
| Skin burning sensation | 9 (2.6) | 0 (0.0) |
| Contact dermatitis | 6 (1.7) | 4 (1.1) |
| Vomiting | 6 (1.7) | 2 (0.6) |
| Eye irritation | 4 (1.2) | 2 (0.6) |
| Hair color changes | 3 (1) | 0 (0.0) |
| Scalp Erythema/Edema | 11 (3.2) | 5 (1.4) |
| Scalp Pruritus | 2 (1.4) | 1 (0.7) |
| Eye Irritation | 6 (1.7) | 5 (1.4) |
Xeglyze Drug Interactions
Information about and practical guidance on preventing clinically significant drug/drug and drug/food interactions that may occur in people taking the drug.7 DRUG INTERACTIONS In vitro studies suggest there is a potential for inhibition of cytochrome P450 (CYP) 3A4, 2B6 and 1A2 enzymes following a single application of XEGLYZE. Use of XEGLYZE with drugs that are substrates of these enzymes may lead to increased systemic concentrations of the interacting drugs. Avoid administration of drugs that are substrates of CYP3A4, CYP2B6, or CYP1A2 within 2 weeks after application of XEGLYZE. If this is not feasible, avoid use of XEGLYZE [ see Clinical Pharmacology ( 12.3 ) ]. For 2 weeks after XEGLYZE application, avoid taking drugs that are substrates of CYP3A4, CYP2B6 or CYP1A2. Otherwise, avoid use of XEGLYZE. (7)
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Abametapir (5,5’-dimethyl 2,2’-bipyridinyl) is a metalloproteinase inhibitor. Metalloproteinases have a role in physiological processes critical to egg development and survival of lice. 12.3 Pharmacokinetics Absorption The pharmacokinetics of XEGLYZE were evaluated in 3 trials, Trials A, B, and C. Each trial enrolled lice infested subjects who received a single 10-minute application of XEGLYZE. Pharmacokinetic samplings were carried out to 72 hours post-dose in adults and 8 hours post-dose in pediatric subjects in all trials. Trial A evaluated pharmacokinetics in 6 adult and 12 pediatric subjects 3 to 12 years of age. The mean (%CV) abametapir plasma maximum concentration (C max ) and area under the concentration time curve from 0 to 8 hours post-dose (AUC 0-8h ) in the adult group were 41 (66%) ng/mL and 121 (50%) ng*h/mL, respectively. The mean (%CV) C max and AUC 0-8h in the pediatric group were 73 (57%) ng/mL and 264 (62%) ng*h/mL, respectively. The mean (%CV) terminal half-life in adults was 21 (11%) hours. Trials B and C evaluated pharmacokinetics in 50 pediatric subjects 6 months to 17 years old. The pharmacokinetic results for plasma abametapir are shown in Table 3. Even though the values varied between the 2 trials, abametapir exposure increased as the age of the subject decreased. Abametapir absorption was rapid with a median T max of 0.57 to 1.54 hours. Table 3 Abametapir Pharmacokinetic Parameters in Subjects with Head Lice Infestation Study Age Group n C max (ng/mL) Mean (%CV) AUC 0-8h (ng*h/mL) Mean (%CV) B 6 months to <1 year 1 418 1057 C 5 228 (50%) 688 (43%) B 1 year to <2 years 3 209 (62%) 446 (65%) C 8 147 (49%) 406 (37%) B 2 years to <3 years 6 206 (66%) 633 (57%) C 8 160 (48%) 602 (51%) B 3 years to 17 years 12 121 (60%) 330 (49%) C 7 52 (45%) 194 (39%) Serum concentration of benzyl alcohol, an excipient in the formulation of XEGLYZE, was assessed in Trials B and C. Benzyl alcohol in serum was measurable (limit of quantitation = 0.5 µg/mL) in 7 subjects out of 39 evaluable subjects. The C max of benzyl alcohol in these 7 subjects ranged from 0.52 to 3.57 µg/mL [ see Warnings and Precautions (5) and Use in Specific Populations ( 8.4 ) ]. Distribution Abametapir and its primary human metabolite, abametapir carboxyl, are highly bound to proteins in plasma. Abametapir is 91.3 – 92.3% bound to plasma proteins, and abametapir carboxyl is 96.0% – 97.5% bound to plasma proteins. Elimination Metabolism Abametapir is extensively metabolized, primarily by the cytochrome P450 enzyme CYP1A2 to a mono-hydroxylated metabolite (abametapir hydroxyl) and further to a mono-carboxylated metabolite (abametapir carboxyl). Abametapir carboxyl is cleared slowly from the systemic circulation resulting in plasma concentration higher than that of abametapir. Based on data in adults in Trial A above, where sampling was carried out to 72 hours, the ratios of C max and AUC 0-72h between abametapir carboxyl and abametapir were about 30 and 250, respectively. The elimination half-life of abametapir carboxyl has not been well characterized but is estimated to be approximately (mean ± SD) 71 ± 40 hours or longer in adults. Excretion Excretion of abametapir and its human metabolites was not examined in patients. Drug Interaction Studies In vitro studies suggest that there is a potential for inhibition of cytochrome P450 3A4, 2B6, and 1A2 enzymes following application of XEGLYZE due to high and prolonged systemic exposure of the metabolite abametapir carboxyl [ see Drug Interactions (7) ].
| B | 6 months to <1 year | 1 | 418 | 1057 |
| C | 5 | 228 (50%) | 688 (43%) | |
| B | 1 year to <2 years | 3 | 209 (62%) | 446 (65%) |
| C | 8 | 147 (49%) | 406 (37%) | |
| B | 2 years to <3 years | 6 | 206 (66%) | 633 (57%) |
| C | 8 | 160 (48%) | 602 (51%) | |
| B | 3 years to 17 years | 12 | 121 (60%) | 330 (49%) |
| C | 7 | 52 (45%) | 194 (39%) |
Mechanism of action
Information about the established mechanism(s) of the drugÕs action in humans at various levels (for example receptor, membrane, tissue, organ, whole body). If the mechanism of action is not known, this field contains a statement about the lack of information.12.1 Mechanism of Action Abametapir (5,5’-dimethyl 2,2’-bipyridinyl) is a metalloproteinase inhibitor. Metalloproteinases have a role in physiological processes critical to egg development and survival of lice.
Pharmacokinetics
Information about the clinically significant pharmacokinetics of a drug or active metabolites, for instance pertinent absorption, distribution, metabolism, and excretion parameters.12.3 Pharmacokinetics Absorption The pharmacokinetics of XEGLYZE were evaluated in 3 trials, Trials A, B, and C. Each trial enrolled lice infested subjects who received a single 10-minute application of XEGLYZE. Pharmacokinetic samplings were carried out to 72 hours post-dose in adults and 8 hours post-dose in pediatric subjects in all trials. Trial A evaluated pharmacokinetics in 6 adult and 12 pediatric subjects 3 to 12 years of age. The mean (%CV) abametapir plasma maximum concentration (C max ) and area under the concentration time curve from 0 to 8 hours post-dose (AUC 0-8h ) in the adult group were 41 (66%) ng/mL and 121 (50%) ng*h/mL, respectively. The mean (%CV) C max and AUC 0-8h in the pediatric group were 73 (57%) ng/mL and 264 (62%) ng*h/mL, respectively. The mean (%CV) terminal half-life in adults was 21 (11%) hours. Trials B and C evaluated pharmacokinetics in 50 pediatric subjects 6 months to 17 years old. The pharmacokinetic results for plasma abametapir are shown in Table 3. Even though the values varied between the 2 trials, abametapir exposure increased as the age of the subject decreased. Abametapir absorption was rapid with a median T max of 0.57 to 1.54 hours. Table 3 Abametapir Pharmacokinetic Parameters in Subjects with Head Lice Infestation Study Age Group n C max (ng/mL) Mean (%CV) AUC 0-8h (ng*h/mL) Mean (%CV) B 6 months to <1 year 1 418 1057 C 5 228 (50%) 688 (43%) B 1 year to <2 years 3 209 (62%) 446 (65%) C 8 147 (49%) 406 (37%) B 2 years to <3 years 6 206 (66%) 633 (57%) C 8 160 (48%) 602 (51%) B 3 years to 17 years 12 121 (60%) 330 (49%) C 7 52 (45%) 194 (39%) Serum concentration of benzyl alcohol, an excipient in the formulation of XEGLYZE, was assessed in Trials B and C. Benzyl alcohol in serum was measurable (limit of quantitation = 0.5 µg/mL) in 7 subjects out of 39 evaluable subjects. The C max of benzyl alcohol in these 7 subjects ranged from 0.52 to 3.57 µg/mL [ see Warnings and Precautions (5) and Use in Specific Populations ( 8.4 ) ]. Distribution Abametapir and its primary human metabolite, abametapir carboxyl, are highly bound to proteins in plasma. Abametapir is 91.3 – 92.3% bound to plasma proteins, and abametapir carboxyl is 96.0% – 97.5% bound to plasma proteins. Elimination Metabolism Abametapir is extensively metabolized, primarily by the cytochrome P450 enzyme CYP1A2 to a mono-hydroxylated metabolite (abametapir hydroxyl) and further to a mono-carboxylated metabolite (abametapir carboxyl). Abametapir carboxyl is cleared slowly from the systemic circulation resulting in plasma concentration higher than that of abametapir. Based on data in adults in Trial A above, where sampling was carried out to 72 hours, the ratios of C max and AUC 0-72h between abametapir carboxyl and abametapir were about 30 and 250, respectively. The elimination half-life of abametapir carboxyl has not been well characterized but is estimated to be approximately (mean ± SD) 71 ± 40 hours or longer in adults. Excretion Excretion of abametapir and its human metabolites was not examined in patients. Drug Interaction Studies In vitro studies suggest that there is a potential for inhibition of cytochrome P450 3A4, 2B6, and 1A2 enzymes following application of XEGLYZE due to high and prolonged systemic exposure of the metabolite abametapir carboxyl [ see Drug Interactions (7) ].
| B | 6 months to <1 year | 1 | 418 | 1057 |
| C | 5 | 228 (50%) | 688 (43%) | |
| B | 1 year to <2 years | 3 | 209 (62%) | 446 (65%) |
| C | 8 | 147 (49%) | 406 (37%) | |
| B | 2 years to <3 years | 6 | 206 (66%) | 633 (57%) |
| C | 8 | 160 (48%) | 602 (51%) | |
| B | 3 years to 17 years | 12 | 121 (60%) | 330 (49%) |
| C | 7 | 52 (45%) | 194 (39%) |
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.4 CONTRAINDICATIONS None. None. (4)
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.11 DESCRIPTION The active pharmacological ingredient in XEGLYZE (abametapir) Lotion is the pediculicide, abametapir, which is a dipyridyl compound. The chemical name of abametapir is 5,5'-dimethyl-2,2'-bipyridinyl. The structural formula is: The empirical formula is C 12 H 12 N 2 and the molecular weight is 184.24. XEGLYZE is a white to off-white oil in water emulsion, containing 0.74% [weight by weight] of abametapir, intended for topical administration. XEGLYZE contains the following inactive ingredients: benzyl alcohol 2.0% , butylated hydroxytoluene, Carbomer Homopolymer Type C, light mineral oil, polysorbate 20, trolamine and water.
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.2 DOSAGE AND ADMINISTRATION For topical use only. XEGLYZE is not for oral, ophthalmic, or intravaginal use. Treatment with XEGLYZE involves a single application. Shake well before use. Apply XEGLYZE to dry hair in an amount (up to the full content of one bottle) sufficient to thoroughly coat the hair and scalp. Massage XEGLYZE into the scalp and throughout the hair. Avoid contact with eyes. Leave on the hair and scalp for 10 minutes and then rinse off with warm water. Wash hands after application. Hair may be shampooed any time after the treatment. Discard any unused product. Do not flush contents down sink or toilet. For topical use only. Not for oral, ophthalmic, or intravaginal use. (2) Shake well before use. (2) Apply XEGLYZE to dry hair in an amount sufficient (up to the full content of one bottle) to thoroughly coat the hair and scalp. Avoid contact with eyes. (2) Massage XEGLYZE into the scalp and throughout the hair; leave on the hair and scalp for 10 minutes and then rinse off with warm water. (2) Massage XEGLYZE into the scalp and throughout the hair; leave on the hair and scalp for 10 minutes and then rinse off with warm water. (2)
Dosage forms and strengths
Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance.3 DOSAGE FORMS AND STRENGTHS Lotion, 0.74% [weight by weight], a viscous white to off-white oil in water emulsion, containing abametapir. Lotion: 0.74% [weight by weight]. (3)
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.1 INDICATIONS AND USAGE XEGLYZE is indicated for the topical treatment of head lice infestation in patients 6 months of age and older. XEGLYZE should be used in the context of an overall lice management program: Wash (with hot water) or dry-clean all recently worn clothing, hats, used bedding and towels Wash personal care items such as combs, brushes, and hair clips in hot water Use a fine-tooth comb or special nit comb to remove dead lice and nits XEGLYZE is a pediculicide indicated for the topical treatment of head lice infestation in patients 6 months of age and older. XEGLYZE should be used in the context of an overall lice management program: Wash (with hot water) or dry-clean all recently worn clothing, hats, used bedding and towels Wash personal care items such as combs, brushes and hair clips in hot water Use a fine-tooth comb or special nit comb to remove dead lice and nits (1)
Spl product data elements
Usually a list of ingredients in a drug product.Xeglyze abametapir Abametapir Abametapir Water Polysorbate 20 CARBOMER HOMOPOLYMER TYPE C Trolamine Butylated Hydroxytoluene Benzyl Alcohol Light Mineral Oil structure FigureA FigureB FigureC FigureD FigureE FigureF draft-container-label draft-carton-label
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility Long-term studies in animals have not been conducted to evaluate the carcinogenic potential of XEGLYZE or abametapir. Abametapir was not mutagenic or clastogenic based on the results of two in vitro genotoxicity tests (Ames test and human lymphocyte chromosomal aberration assay) and one in vivo genotoxicity test (rat micronucleus assay). No effects on fertility have been observed in rats following repeated oral doses of up to 75 mg/kg/dayabametapir (50 times the MRHD based on C max comparisons).
Nonclinical toxicology
Information about toxicology in non-human subjects.13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility Long-term studies in animals have not been conducted to evaluate the carcinogenic potential of XEGLYZE or abametapir. Abametapir was not mutagenic or clastogenic based on the results of two in vitro genotoxicity tests (Ames test and human lymphocyte chromosomal aberration assay) and one in vivo genotoxicity test (rat micronucleus assay). No effects on fertility have been observed in rats following repeated oral doses of up to 75 mg/kg/dayabametapir (50 times the MRHD based on C max comparisons).
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.CONTAINER LABEL NDC 43598-921-11 Xeglyze (abametapir) Lotion, 0.74% For topical use on the scalp hair and scalp only. Rx only 200 g
CARTON LABEL NDC 43598-921-11 Xeglyze (abametapir) Lotion, 0.74% For topical use on the scalp hair and scalp only. Rx only 200 g
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Manufactured by Groupe Parima Inc., for Dr. Reddy’s Laboratories, S.A. Elisabethenanlage 11, 4051 Basel, Switzerland Distributed by Dr. Reddy’s Laboratories Inc., 107 College Road East, Princeton, NJ 08540 XEGLYZE TM is a registered trademark of Dr. Reddy’s Laboratories, S.A. Issued: 01/2022
Instructions for Use XEGLYZE (zeg' lyze) (abametapir) Lotion Important: XEGLYZE is for use on scalp hair and scalp only. Do not use XEGLYZE in your mouth, eyes, or vagina. Before you use XEGLYZE, it is important that you read the Patient Information and Instructions for Use. Be sure that you read, understand, and follow these Instructions for Use so that you use XEGLYZE the right way. Ask your healthcare provider or pharmacist if you have questions about the right way to use XEGLYZE. Step 1: Your hair and scalp must be dry before you apply XEGLYZE. Shake XEGLYZE bottle well right before use. Step 2: Remove the cap and apply XEGLYZE directly to dry hair and scalp. Step 3: Completely cover your scalp and hair closest to the scalp first, and then apply outwards towards the ends of your hair. Step 4: Rub XEGLYZE throughout your hair and scalp. Use enough XEGLYZE to completely cover your entire scalp and all of your hair so that all lice and eggs are exposed to the lotion. You may need to use the full bottle. Be sure that each hair is coated from the scalp to the tip. Step 5: Leave XEGLYZE on your hair and scalp for 10 minutes after it has been applied. Use a timer or clock. Start timing after you have completely covered your hair and scalp with XEGLYZE. You or anyone who helps you apply XEGLYZE should wash their hands after application. Step 6: After 10 minutes, rinse XEGLYZE from your hair and scalp with warm water. A fine-tooth comb or special nit comb may be used to remove dead lice and nits. You may shampoo your hair any time after the treatment. How do I stop the spread of lice? To help prevent the spread of lice from one person to another, here are some steps you can take: Avoid direct head-to-head contact with anyone known to have live, crawling lice. Do not share combs, brushes, hats, scarves, bandannas, ribbons, barrettes, hair bands, towels, helmets, or other hair-related personal items with anyone else, whether they have lice or not. Disinfect combs and brushes used by an infected person by soaking them in hot water (at least 130°F) for 5 to 10 minutes. Avoid sleepovers and slumber parties during lice outbreaks. Lice can live in bedding, pillows, and carpets that have recently been used by someone with lice. Machine wash and dry clothing, bed linens, and other items used by anyone having lice. Machine wash at high temperatures (130°F) and the high heat drying cycle. Clothing and items that are not washable can be dry-cleaned OR sealed in a plastic bag and stored for 2 weeks. These Instructions for Use have been approved by the U.S. Food and Drug Administration. Issued: 01/2022
Xeglyze: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.17 PATIENT COUNSELING INFORMATION Advise the patient or caregiver to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Inform the patient and caregiver of the following instructions: Do not ingest XEGLYZE. Keep out of reach of children. Use on children should be under the direct supervision of an adult because of the risk of benzyl alcohol toxicity [ see Warnings and Precautions (5 ) and Use in Specific Populations (8.4) ]. Avoid contact with eyes. Wash hands after application. Hair may be shampooed any time after the treatment. Treatment with XEGLYZE involves a single application. Do not re-treat. Discard any unused portion. Do not flush contents down sink or toilet. Manufactured by Groupe Parima Inc., for Dr. Reddy’s Laboratories, S.A. Elisabethenanlage 11, 4051 Basel, Switzerland Distributed by Dr. Reddy’s Laboratories Inc., 107 College Road East, Princeton, NJ 08540 Xeglyze TM is a registered trademark of Dr. Reddy’s Laboratories, S.A. Issued: 01 / 2022
Spl patient package insert
Information necessary for patients to use the drug safely and effectively.PATIENT INFORMATION XEGLYZE (zeg’ lyze) (abametapir) Lotion Important: XEGLYZE is for use on scalp hair and scalp only. Do not use XEGLYZE in your mouth, eyes, or vagina. What is XEGLYZE? XEGLYZE is a prescription medicine used to get rid of head lice in people 6 months of age and older. After XEGLYZE is rinsed off, a fine-tooth comb may be used to remove dead lice and nits from the hair and scalp. All personal items exposed to the hair or lice should be washed in hot water or dry-cleaned. See “How do I stop the spread of lice?” at the end of the XEGLYZE Instructions for Use. It is not known if XEGLYZE is safe and effective in children under 6 months of age. Before you use XEGLYZE, tell your healthcare provider if you or your child: have any skin conditions or sensitivities have any other medical conditions are pregnant or plan to become pregnant. It is not known if XEGLYZE can harm your unborn baby are breastfeeding or plan to breastfeed. It is not known if XEGLYZE passes into your breast milk. How should I use XEGLYZE? See the “Instructions for Use” for detailed information about the right way to apply XEGLYZE. Use XEGLYZE exactly as your healthcare provider tells you to use it. Your healthcare provider will prescribe the treatment that is right for you. Do not change your treatment without talking to your healthcare provider. Use XEGLYZE on dry hair. Completely cover all of your hair and scalp with XEGLYZE. Children will need an adult to apply XEGLYZE for them. Do not swallow XEGLYZE. If swallowed, call your Poison Control Center at 1-800-222-1222. Do not get XEGLYZE into your eyes. If XEGLYZE gets in your eye, gently flush with water. Wash your hands after you apply XEGLYZE. You may shampoo your hair any time after the treatment. When you complete your dose of XEGLYZE, do not use XEGLYZE again. Throw away any unused XEGLYZE. Do not flush XEGLYZE down sink or toilet. What are the possible side effects of XEGLYZE? The most common side effects of XEGLYZE include: Redness of the skin or scalp Rash Burning sensation of the skin Skin irritation Vomiting Eye irritation Itchy scalp Changes in your hair color Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of XEGLYZE. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. How should I store XEGLYZE? Store upright at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F and 86°F) [See USP Controlled Room Temperature]. Do not refrigerate or freeze XEGLYZE. Discard (throw away) any unused product. Keep XEGLYZE and all medicines out of reach of children. General information about the safe and effective use of XEGLYZE Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use XEGLYZE for a condition for which it was not prescribed. Do not give XEGLYZE to other people, even if they have the same symptoms you have. It may harm them. You can also ask your pharmacist or healthcare provider for information about XEGLYZE that is written for health professionals. What are the ingredients in XEGLYZE? Active ingredient: abametapir Inactive ingredients: benzyl alcohol 2.0%, butylated hydroxytoluene, carbomer homopolymer type C, light mineral oil, polysorbate 20, trolamine and water. Manufactured by Groupe Parima, Inc., for Dr. Reddy’s Laboratories, S.A. Elisabethenanlage 11, 4051 Basel, Switzerland XEGLYZE is a registered trademark of Dr. Reddy’s Laboratories, S.A. Distributed by Dr. Reddy’s Laboratories, Inc., 107 College Road East, Princeton, NJ 08540. This Patient Information has been approved by the U.S. Food and Drug Administration Issued: 01/2022
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| Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of XEGLYZE. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. | ||
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| Manufactured by Groupe Parima, Inc., for Dr. Reddy’s Laboratories, S.A. Elisabethenanlage 11, 4051 Basel, Switzerland XEGLYZE is a registered trademark of Dr. Reddy’s Laboratories, S.A. | Distributed by Dr. Reddy’s Laboratories, Inc., 107 College Road East, Princeton, NJ 08540. | |
Clinical studies
This field may contain references to clinical studies in place of detailed discussion in other sections of the labeling.14 CLINICAL STUDIES Two identical multi-center, randomized, double-blind, vehicle-controlled trials (Trials 1 and 2) were conducted in 704 subjects 6 months of age and older with head lice infestation. All subjects received a single application of either XEGLYZE or vehicle control. For the evaluation of efficacy, the youngest subject from each household was considered to be the index subject of the household (N=216). Other enrolled infested household members received the same treatment as the youngest subject and were evaluated for all efficacy and safety parameters. Index subjects ranged from 6 months to 49 years of age (mean 7 years), and approximately 85% of the index subjects were female, and 95% of the index subjects were Caucasian. Efficacy was assessed as the proportion of index subjects who were treated with a single 10-minute application and were free of live lice at all follow-up visits on Days 1, 7, and 14. Subjects with live lice at any time up to the final evaluation were considered treatment failures. Table 4 presents the proportion of subjects who were free of live lice at all visits Day 1 through Day 14 in Trials 1 and 2. Table 4: Proportion of Index Subjects Free of Live Lice at All Visits Days 1 Through 14 After Treatment Trial 1 Trial 2 XEGLYZE (N=53) Vehicle (N=55) XEGLYZE (N=55) Vehicle (N=53) Treatment Success 43 (81.1%) 28 (50.9%) 45 (81.8%) 25 (47.2%)
| Treatment Success | 43 (81.1%) | 28 (50.9%) | 45 (81.8%) | 25 (47.2%) |
Geriatric use
Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.8.5 Geriatric Use Clinical studies of XEGLYZE did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger subjects.
Labor and delivery
Information about the drug’s use during labor or delivery, whether or not the use is stated in the indications section of the labeling, including the effect of the drug on the mother and fetus, on the duration of labor or delivery, on the possibility of delivery-related interventions, and the effect of the drug on the later growth, development, and functional maturation of the child.8.2 Labor and Delivery Risk Summary No data are available regarding the presence of abametapir in human milk or the effects of abametapir on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for XEGLYZE and any potential adverse effects on the breastfed child from XEGLYZE or from the underlying maternal condition.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.8.4 Pediatric Use The safety and effectiveness of XEGLYZE have been established in pediatric patients 6 months of age and older [ see Clinical Pharmacology (12) and Clinical Studies ( 14 ) ]. The safety and effectiveness of XEGLYZE have not been established in pediatric patients below the age of 6 months. XEGLYZE is not recommended in pediatric patients under 6 months of age because of the potential for increased systemic absorption due to a high ratio of skin surface to body mass and the potential for an immature skin barrier. XEGLYZE contains benzyl alcohol. Benzyl alcohol has been associated with serious adverse reactions and death in neonates and low birth-weight infants. The “gasping syndrome” (characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine) has been associated with intravenously administered benzyl alcohol dosages >99 mg/kg/day in neonates and low birthweight infants. Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. The minimum amount of benzyl alcohol at which toxicity may occur is not known. Premature and low-birthweight infants, as well as patients receiving high dosages, may be more likely to develop toxicity [ see Warnings and Precautions (5.1) ]. Because of the risk of accidental ingestion, XEGLYZE should be administered to pediatric patients only under direct adult supervision [ see Warnings and Precautions (5.2) ].
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)8.1 Pregnancy Risk Summary There are no available data on XEGLYZE use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In embryofetal development studies conducted with oral administration of abametapir during organogenesis, no evidence of fetal harm or malformations, independent of maternal toxicity were observed in pregnant rats and rabbits at doses that produced exposures up to 50 times and equivalent to the maximum recommended human dose (MRHD) in rats and rabbits, respectively. The highest dose evaluated in rabbits was limited due to maternal toxicity associated with the vehicle used in the study (see Data). The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Systemic embryofetal development studies were performed in rats and rabbits. Oral doses of 10, 25 and 75 mg/kg/day abametapir were administered during the period of organogenesis (gestational days 6 – 17) to pregnant rats. In the presence of maternal toxicity, embryofetal toxicity (lower fetal body weights and delayed ossification) was noted at 75 mg/kg/day. No treatment related effects on malformations were noted at 75 mg/kg/day (50 times the MRHD based on C max comparisons). Oral doses of 4, 16 and 40 mg/kg/day abametapir were administered during the period of organogenesis (gestational days 6 – 19) to pregnant rabbits. No treatment related effects on embryofetal toxicity or malformations were noted at 40 mg/kg/day (~1 time the MRHD based on C max comparisons). Maternal toxicity related to the vehicle limited the maximum dose in pregnant rabbits. In a perinatal and postnatal development study in rats, oral doses of 10, 25 and 75 mg/kg/day were administered from the beginning of organogenesis (gestational day 6) through the end of lactation (lactation day 20). In the presence of maternal toxicity, embryofetal lethality, and decreased fetal body weight gain were noted at 75 mg/kg/day. No treatment related effects on postnatal development were noted at 75 mg/kg/day (47 times the MRHD based on C max comparisons).
Use in specific populations
Information about use of the drug by patients in specific populations, including pregnant women and nursing mothers, pediatric patients, and geriatric patients.8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no available data on XEGLYZE use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In embryofetal development studies conducted with oral administration of abametapir during organogenesis, no evidence of fetal harm or malformations, independent of maternal toxicity were observed in pregnant rats and rabbits at doses that produced exposures up to 50 times and equivalent to the maximum recommended human dose (MRHD) in rats and rabbits, respectively. The highest dose evaluated in rabbits was limited due to maternal toxicity associated with the vehicle used in the study (see Data). The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Systemic embryofetal development studies were performed in rats and rabbits. Oral doses of 10, 25 and 75 mg/kg/day abametapir were administered during the period of organogenesis (gestational days 6 – 17) to pregnant rats. In the presence of maternal toxicity, embryofetal toxicity (lower fetal body weights and delayed ossification) was noted at 75 mg/kg/day. No treatment related effects on malformations were noted at 75 mg/kg/day (50 times the MRHD based on C max comparisons). Oral doses of 4, 16 and 40 mg/kg/day abametapir were administered during the period of organogenesis (gestational days 6 – 19) to pregnant rabbits. No treatment related effects on embryofetal toxicity or malformations were noted at 40 mg/kg/day (~1 time the MRHD based on C max comparisons). Maternal toxicity related to the vehicle limited the maximum dose in pregnant rabbits. In a perinatal and postnatal development study in rats, oral doses of 10, 25 and 75 mg/kg/day were administered from the beginning of organogenesis (gestational day 6) through the end of lactation (lactation day 20). In the presence of maternal toxicity, embryofetal lethality, and decreased fetal body weight gain were noted at 75 mg/kg/day. No treatment related effects on postnatal development were noted at 75 mg/kg/day (47 times the MRHD based on C max comparisons). 8.2 Labor and Delivery Risk Summary No data are available regarding the presence of abametapir in human milk or the effects of abametapir on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for XEGLYZE and any potential adverse effects on the breastfed child from XEGLYZE or from the underlying maternal condition. 8.4 Pediatric Use The safety and effectiveness of XEGLYZE have been established in pediatric patients 6 months of age and older [ see Clinical Pharmacology (12) and Clinical Studies ( 14 ) ]. The safety and effectiveness of XEGLYZE have not been established in pediatric patients below the age of 6 months. XEGLYZE is not recommended in pediatric patients under 6 months of age because of the potential for increased systemic absorption due to a high ratio of skin surface to body mass and the potential for an immature skin barrier. XEGLYZE contains benzyl alcohol. Benzyl alcohol has been associated with serious adverse reactions and death in neonates and low birth-weight infants. The “gasping syndrome” (characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine) has been associated with intravenously administered benzyl alcohol dosages >99 mg/kg/day in neonates and low birthweight infants. Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. The minimum amount of benzyl alcohol at which toxicity may occur is not known. Premature and low-birthweight infants, as well as patients receiving high dosages, may be more likely to develop toxicity [ see Warnings and Precautions (5.1) ]. Because of the risk of accidental ingestion, XEGLYZE should be administered to pediatric patients only under direct adult supervision [ see Warnings and Precautions (5.2) ]. 8.5 Geriatric Use Clinical studies of XEGLYZE did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger subjects.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.16 HOW SUPPLIED/STORAGE AND HANDLING XEGLYZE is a white to off-white oil in water emulsion containing 0.74% [weight by weight] abametapir and supplied in a polyvinyl chloride (PVC) safety-coated single-use round amber glass bottle affixed with a polypropylene child resistant cap (NDC # 43598-921-11) featuring a tri-foil inner liner. The container is filled to a nominal 200 g (approximately 7 oz. or 210 mL) of the lotion. Store upright at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F and 86°F) [See USP Controlled Room Temperature]. Do not refrigerate or freeze.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API