Short answer: The Kyzatrex label starts at 200 mg by mouth twice daily, morning and evening, with food. Serum testosterone is checked 7 days after starting or a change, 3 to 5 hours after the morning dose. Under 460 ng/dL the dose steps up; over 971 ng/dL it steps down. The range is 100 mg once daily to 400 mg twice daily.
This is what the FDA label says. Follow your prescriber. Your prescriber may use a different dose or pace than the label's standard schedule.
What Kyzatrex is approved for: Kyzatrex is approved as testosterone replacement therapy in adult males with low or absent natural testosterone due to primary hypogonadism (testicular failure) or hypogonadotropic hypogonadism (a pituitary or hypothalamus cause). The label says safety and efficacy have not been established in males under 18 or in men with "age-related" (late-onset) hypogonadism (section 1).
Source
KYZATREX (testosterone undecanoate) capsules, for oral use, prescribing information and Medication Guide. Marius Pharmaceuticals. DailyMed, version published October 8, 2026. DailyMed setid 7f7167a7-2a25-47e2-acf5-33f499fce971
Kyzatrex capsules are taken by mouth twice daily, once in the morning and once in the evening, with food. At 100 mg a day, the dose is taken once, in the morning (section 2.3, Medication Guide).
For total daily doses above 100 mg, the same dose is taken morning and evening. Capsules come in 50 mg, 100 mg, 150 mg and 200 mg (sections 2.3, 3).
The table below is the label's schedule, from the Dosage and Administration section. Numbers are copied exactly; the section is in brackets.
| Serum Testosterone Concentration | Current Kyzatrex Dosage | New Kyzatrex Dosage |
|---|---|---|
| Less than 460 ng/dL | 100 mg with breakfast only | 100 mg twice daily with meals |
| Less than 460 ng/dL | 100 mg twice daily with meals | 200 mg twice daily with meals |
| Less than 460 ng/dL | 200 mg twice daily with meals | 300 mg twice daily with meals |
| Less than 460 ng/dL | 300 mg twice daily with meals | 400 mg twice daily with meals |
| 460 to 971 ng/dL | — | No Dosage Change |
| More than 971 ng/dL | 400 mg twice daily with meals | 300 mg twice daily with meals |
| More than 971 ng/dL | 300 mg twice daily with meals | 200 mg twice daily with meals |
| More than 971 ng/dL | 200 mg twice daily with meals | 100 mg twice daily with meals |
| More than 971 ng/dL | 100 mg twice daily with meals | 100 mg with breakfast only |
| More than 971 ng/dL | 100 mg with breakfast only | Discontinue treatment |
Before starting, hypogonadism is confirmed by morning serum testosterone measured on at least two separate days, with both results below the normal range.
The dose is individualized based on the serum testosterone response. The starting dose is 200 mg twice daily.
Serum testosterone is checked 7 days after starting or after a dose change, 3 to 5 hours after the morning dose, and the dose is adjusted using Table 1. After that, testosterone is checked periodically.
The minimum recommended dose is 100 mg once daily in the morning and the maximum is 400 mg twice daily. If testosterone is above 971 ng/dL on 100 mg with breakfast only, treatment is discontinued.
In the 6-month study, everyone started at 200 mg twice daily and was titrated as needed to 100 mg once daily or 100, 300 or 400 mg twice daily, then stayed on that dose.
Hematocrit is checked before starting and about every 3 months. If it is high, Kyzatrex is stopped until it falls.
Blood pressure is checked periodically, especially in men with high blood pressure. Kyzatrex is not recommended with uncontrolled high blood pressure.
The lipid profile is checked periodically, particularly after starting testosterone.
The Kyzatrex label gives no missed-dose instruction. Ask your prescriber what to do if a dose is missed.
Kyzatrex is not substitutable with other oral testosterone undecanoate products.
In Dose Track you set up Kyzatrex as a protocol with the dose and schedule your prescriber gave you. A protocol can hold dose steps, each with its own dose and length in days or weeks, so a step-up plan like the one on the label can be entered once and the app moves to the next step on its own. Reminders follow the schedule, and every dose is logged with the date and time, so you can see which step you are on and when your last dose was. The app follows what you enter; it does not choose or change a dose.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.