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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
FDA Approves Oral Testosterone Replacement Therapy Kyzatrex
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<blockquote data-quote="madman" data-source="post: 229627" data-attributes="member: 13851"><p>[ATTACH=full]24531[/ATTACH]</p><p>[ATTACH=full]26255[/ATTACH]</p><p><strong>KYZATREX (testosterone undecanoate) capsules, for oral use, CIII, Initial U.S. approval: 1953</strong></p><p><strong></strong></p><p><strong></strong></p><p><strong>2.3 Recommended Dosage and Administration </strong></p><p></p><p><em><strong><u>Individualize the dosage of KYZATREX based on the patient’s serum testosterone concentration response to the drug</u>. The recommended starting dose is 200 mg orally twice daily, once in the morning and once in the evening. Take KYZATREX with food.</strong></em></p><p></p><p></p><p><strong>Dosage Adjustment </strong></p><p></p><p><em><strong>Check serum testosterone concentrations <u>7 days after starting treatment or after dosage adjustment, 3 to 5 hours after the morning dose</u>.</strong> Adjust the KYZATREX dose as necessary as shown in Table 1. Thereafter, periodically monitor serum testosterone concentrations. </em></p><p><em></em></p><p><em><strong>The minimum recommended dose is 100 mg once daily in the morning. The maximum recommended dose is 400 mg twice daily.</strong> For total daily doses greater than 100 mg, administer the same dose in the morning and evening.</em></p><p><em></em></p><p><em>[ATTACH=full]24404[/ATTACH]</em></p><p><em>[ATTACH=full]24405[/ATTACH]</em></p><p><em></em></p><p><em></em></p><p><em><strong>3 DOSAGE FORMS AND STRENGTHS</strong></em></p><p><em><strong></strong></em></p><p><em><strong>Capsules:</strong></em></p><p><em><strong></strong></em></p><p><em><strong>• 100 mg, oval, opaque, white, imprinted with “MP100” in red ink </strong></em></p><p><em><strong>• 150 mg, oblong, opaque, white, imprinted with “MP150” in red ink </strong></em></p><p><em><strong>• 200 mg, oblong, opaque, white, imprinted with “MP200” in red ink</strong></em></p><p><em><strong></strong></em></p><p><em><strong></strong></em></p><p><em><strong>11 DESCRIPTION</strong></em></p><p><em></em></p><p><em>KYZATREX is provided as a gelatin capsule containing testosterone undecanoate, a fatty acid ester of testosterone. Testosterone undecanoate is a white to off-white yellow crystalline powder. Testosterone, an androgen, is formed by cleavage of the ester side chain of testosterone undecanoate.</em></p><p><em></em></p><p><em>Testosterone undecanoate is chemically described as 17β-hydroxyandrost-4-en-3-one undecanoate. It has the empirical formula of C30H48O3 and a molecular weight of 456.7 g/mol.<strong> The structural formula for testosterone undecanoate is presented in Figure 1.</strong></em></p><p><em></em></p><p><em>[ATTACH=full]24406[/ATTACH]</em></p><p><em></em></p><p><em><strong>KYZATREX (testosterone undecanoate) capsules for oral use are available in three dosage strengths- 100 mg, 150 mg, and 200 mg.</strong> The 100 mg strength is an opaque, white capsule imprinted with “MP100” in red ink. The 150 mg strength is an opaque white capsule imprinted with “MP150” in red ink. The 200 mg strength is an opaque white capsule imprinted with “MP200” in red ink.<strong> All capsule strengths also contain DL-alpha-tocopheryl acetate (Vitamin E), phytosterol esters, polyoxyl 40 hydrogenated castor oil, and propylene glycol monolaurate as inactive ingredients.</strong></em></p><p><em><strong></strong></em></p><p><em><strong>Gelatin capsule shells are composed of the following inactive ingredients:</strong> gelatin, glycerin, purified water, sorbitol, and titanium dioxide.</em></p><p><em></em></p><p><em></em></p><p><em><strong>12.3 Pharmacokinetics </strong></em></p><p><em><strong></strong></em></p><p><em><strong>Absorption </strong></em></p><p><em></em></p><p><em>KYZATREX was taken orally at a starting dose of 200 mg twice per day with meals in a multicenter, open-label trial in hypogonadal males. The dose was adjusted, as needed, on Days 28 and 56 from a minimum dose of 100 mg (morning-only) to a maximum dose of 400 mg twice per day based on the plasma testosterone concentration obtained by a single blood draw collected 3 to 5 hours after the morning dose. The average daily NaF/EDTA plasma testosterone concentration was 393.3 (±113.6) ng/dL after 90 days of treatment (normal eugonadal range in NaF/EDTA plasma: 222-800 ng/dL. Note that the titration scheme for use in clinical practice is based on serum total testosterone [see Dosage and Administration (2.2)].</em></p><p><em></em></p><p><em>KYZATREX is expected to produce testosterone concentrations that approximate normal concentrations seen in healthy men.</em></p><p><em></em></p><p><em><strong>Table 5 summarizes the pharmacokinetic (PK) parameters for plasma total testosterone in patients completing at least 90 days of KYZATREX treatment administered daily</strong></em></p><p><em><strong>[ATTACH=full]24407[/ATTACH]</strong></em></p><p><em><strong></strong></em></p><p><em><strong></strong></em></p><p><em><strong>Figure 2 summarizes the mean plasma total testosterone profile at the final PK visit.</strong></em></p><p><em><strong>[ATTACH=full]24408[/ATTACH]</strong></em></p><p><em><strong></strong></em></p><p><em><strong>When KYZATREX was given with breakfast containing 16%, 33%, and 45% fat, the exposure (AUC0-24 hr) of <u>testosterone was increased by 37%, 87%, and 94%, respectively, compared to when given under fasted conditions</u>.</strong> The primary efficacy and safety study was conducted under fed conditions regardless of the type of meals and the primary efficacy endpoint of achieving testosterone Cavg in normal testosterone range was met</em></p><p><em></em></p><p><em><strong>There was no effect on testosterone PK when KYZATREX was administered with 20% alcohol along with a high-fat meal versus a high-fat meal alone.</strong></em></p></blockquote><p></p>
[QUOTE="madman, post: 229627, member: 13851"] [ATTACH type="full" alt="Screenshot (16298).png"]24531[/ATTACH] [ATTACH type="full"]26255[/ATTACH] [B]KYZATREX (testosterone undecanoate) capsules, for oral use, CIII, Initial U.S. approval: 1953 2.3 Recommended Dosage and Administration [/B] [I][B][U]Individualize the dosage of KYZATREX based on the patient’s serum testosterone concentration response to the drug[/U]. The recommended starting dose is 200 mg orally twice daily, once in the morning and once in the evening. Take KYZATREX with food.[/B][/I] [B]Dosage Adjustment [/B] [I][B]Check serum testosterone concentrations [U]7 days after starting treatment or after dosage adjustment, 3 to 5 hours after the morning dose[/U].[/B] Adjust the KYZATREX dose as necessary as shown in Table 1. Thereafter, periodically monitor serum testosterone concentrations. [B]The minimum recommended dose is 100 mg once daily in the morning. The maximum recommended dose is 400 mg twice daily.[/B] For total daily doses greater than 100 mg, administer the same dose in the morning and evening. [ATTACH type="full" alt="Screenshot (16186).png"]24404[/ATTACH] [ATTACH type="full" alt="Screenshot (16187).png"]24405[/ATTACH] [B]3 DOSAGE FORMS AND STRENGTHS Capsules: • 100 mg, oval, opaque, white, imprinted with “MP100” in red ink • 150 mg, oblong, opaque, white, imprinted with “MP150” in red ink • 200 mg, oblong, opaque, white, imprinted with “MP200” in red ink 11 DESCRIPTION[/B] KYZATREX is provided as a gelatin capsule containing testosterone undecanoate, a fatty acid ester of testosterone. Testosterone undecanoate is a white to off-white yellow crystalline powder. Testosterone, an androgen, is formed by cleavage of the ester side chain of testosterone undecanoate. Testosterone undecanoate is chemically described as 17β-hydroxyandrost-4-en-3-one undecanoate. It has the empirical formula of C30H48O3 and a molecular weight of 456.7 g/mol.[B] The structural formula for testosterone undecanoate is presented in Figure 1.[/B] [ATTACH type="full" alt="Screenshot (16190).png"]24406[/ATTACH] [B]KYZATREX (testosterone undecanoate) capsules for oral use are available in three dosage strengths- 100 mg, 150 mg, and 200 mg.[/B] The 100 mg strength is an opaque, white capsule imprinted with “MP100” in red ink. The 150 mg strength is an opaque white capsule imprinted with “MP150” in red ink. The 200 mg strength is an opaque white capsule imprinted with “MP200” in red ink.[B] All capsule strengths also contain DL-alpha-tocopheryl acetate (Vitamin E), phytosterol esters, polyoxyl 40 hydrogenated castor oil, and propylene glycol monolaurate as inactive ingredients. Gelatin capsule shells are composed of the following inactive ingredients:[/B] gelatin, glycerin, purified water, sorbitol, and titanium dioxide. [B]12.3 Pharmacokinetics Absorption [/B] KYZATREX was taken orally at a starting dose of 200 mg twice per day with meals in a multicenter, open-label trial in hypogonadal males. The dose was adjusted, as needed, on Days 28 and 56 from a minimum dose of 100 mg (morning-only) to a maximum dose of 400 mg twice per day based on the plasma testosterone concentration obtained by a single blood draw collected 3 to 5 hours after the morning dose. The average daily NaF/EDTA plasma testosterone concentration was 393.3 (±113.6) ng/dL after 90 days of treatment (normal eugonadal range in NaF/EDTA plasma: 222-800 ng/dL. Note that the titration scheme for use in clinical practice is based on serum total testosterone [see Dosage and Administration (2.2)]. KYZATREX is expected to produce testosterone concentrations that approximate normal concentrations seen in healthy men. [B]Table 5 summarizes the pharmacokinetic (PK) parameters for plasma total testosterone in patients completing at least 90 days of KYZATREX treatment administered daily [ATTACH type="full" alt="Screenshot (16188).png"]24407[/ATTACH] Figure 2 summarizes the mean plasma total testosterone profile at the final PK visit. [ATTACH type="full" alt="Screenshot (16189).png"]24408[/ATTACH] When KYZATREX was given with breakfast containing 16%, 33%, and 45% fat, the exposure (AUC0-24 hr) of [U]testosterone was increased by 37%, 87%, and 94%, respectively, compared to when given under fasted conditions[/U].[/B] The primary efficacy and safety study was conducted under fed conditions regardless of the type of meals and the primary efficacy endpoint of achieving testosterone Cavg in normal testosterone range was met [B]There was no effect on testosterone PK when KYZATREX was administered with 20% alcohol along with a high-fat meal versus a high-fat meal alone.[/B][/I] [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
FDA Approves Oral Testosterone Replacement Therapy Kyzatrex
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