STRIANT

Clinical safety rating: caution

Comprehensive clinical and safety monograph for STRIANT (STRIANT).

How it works

Testosterone replacement therapy. Testosterone is an androgen that binds to and activates androgen receptors, leading to increased protein synthesis, bone mineralization, and erythropoiesis. It also virilizes and promotes secondary sexual characteristics.

What the body does with it

Metabolism	Testosterone is metabolized primarily in the liver via reduction and conjugation. Metabolites include androsterone, etiocholanolone, and their glucuronides. It is also converted to dihydrotestosterone (DHT) via 5α-reductase in peripheral tissues and to estradiol via aromatase.
Excretion	Urinary (90% as glucuronide and sulfate conjugates, 6% as unchanged drug); fecal (6%)
Half-life	Terminal half-life approximately 10-20 minutes after IV administration; buccal administration yields an effective half-life of 1-2 hours due to prolonged absorption
Protein binding	98% bound to sex hormone-binding globulin (SHBG) and albumin
Volume of Distribution	0.5-1.0 L/kg; distributes widely into tissues with preferential binding to sex hormone receptors
Bioavailability	Buccal: approximately 18-25% compared to intravenous administration
Onset of Action	Buccal: within 30-60 minutes for testosterone replacement
Duration of Action	Buccal: 6-8 hours with twice-daily dosing maintaining serum testosterone within normal range

Classification & Brands

Dosing & administration

30 mg buccal system applied to the gum above the incisor tooth twice daily, once in the morning and once in the evening.

Dosage form	TABLET, EXTENDED RELEASE
Renal impairment	No dosage adjustment required based on renal function; however, data in severe renal impairment (CrCl <30 mL/min) are limited.
Liver impairment	Not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C). Use with caution in moderate hepatic impairment (Child-Pugh Class B) without specific dose adjustment defined.
Pediatric use	Safety and efficacy have not been established in pediatric patients under 18 years of age.
Geriatric use	No specific dosage adjustment recommended; however, frail elderly patients may be more sensitive to androgenic effects and adverse events. Use with caution and monitor closely.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for STRIANT (STRIANT).

Breastfeeding	Testosterone is excreted into breast milk but M/P ratio is unknown. It may suppress lactation and cause virilization in nursing infants. Breastfeeding is not recommended during treatment.
Teratogenic Risk	Striant (testosterone buccal system) is contraindicated in pregnant women. Testosterone is a teratogen causing virilization of female fetuses. First trimester exposure risks clitoromegaly, labioscrotal fusion, and urogenital sinus anomalies. Second and third trimester exposure may cause clitoral enlargement and other masculinizing effects. No safe trimester exists.

Warnings & precautions

■ FDA Black Box Warning

WARNING: TESTICULAR ATROPHY, AZOOSPERMIA, AND RISK OF PROSTATE CANCER. Testosterone replacement therapy may cause testicular atrophy and azoospermia. Prolonged use may increase the risk of prostate cancer. Monitor prostate-specific antigen (PSA) and perform digital rectal exams as indicated.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Known or suspected prostate cancer.","Known or suspected breast cancer in males.","Hypersensitivity to testosterone or any component of the product.","Pregnancy (testosterone is teratogenic and can cause fetal harm).","Severe lower urinary tract symptoms (LUTS) from benign prostatic hyperplasia.","Uncontrolled sleep apnea."]

Clinical Precautions

Precautions

["Risk of prostate cancer and benign prostatic hyperplasia.","Polycythemia (increase in hematocrit/hemoglobin).","Fluid retention, worsened edema in patients with preexisting cardiac, renal, or hepatic disease.","Gynecomastia, sleep apnea, and lipid profile changes.","Decreased spermatogenesis and fertility.","Potential for accelerated skeletal maturation in pediatric patients.","Monitoring required: serum testosterone, PSA, hematocrit/hemoglobin, and lipid levels."]

Clinical Tips & Counseling

Drug interactions

Loading safety data…

STRIANT

Clinical safety rating: caution

Comprehensive clinical and safety monograph for STRIANT (STRIANT).

How it works

What the body does with it

Metabolism	Testosterone is metabolized primarily in the liver via reduction and conjugation. Metabolites include androsterone, etiocholanolone, and their glucuronides. It is also converted to dihydrotestosterone (DHT) via 5α-reductase in peripheral tissues and to estradiol via aromatase.
Excretion	Urinary (90% as glucuronide and sulfate conjugates, 6% as unchanged drug); fecal (6%)
Half-life	Terminal half-life approximately 10-20 minutes after IV administration; buccal administration yields an effective half-life of 1-2 hours due to prolonged absorption
Protein binding	98% bound to sex hormone-binding globulin (SHBG) and albumin
Volume of Distribution	0.5-1.0 L/kg; distributes widely into tissues with preferential binding to sex hormone receptors
Bioavailability	Buccal: approximately 18-25% compared to intravenous administration
Onset of Action	Buccal: within 30-60 minutes for testosterone replacement
Duration of Action	Buccal: 6-8 hours with twice-daily dosing maintaining serum testosterone within normal range

Classification & Brands

Dosing & administration

30 mg buccal system applied to the gum above the incisor tooth twice daily, once in the morning and once in the evening.

Dosage form	TABLET, EXTENDED RELEASE
Renal impairment	No dosage adjustment required based on renal function; however, data in severe renal impairment (CrCl <30 mL/min) are limited.
Liver impairment	Not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C). Use with caution in moderate hepatic impairment (Child-Pugh Class B) without specific dose adjustment defined.
Pediatric use	Safety and efficacy have not been established in pediatric patients under 18 years of age.
Geriatric use	No specific dosage adjustment recommended; however, frail elderly patients may be more sensitive to androgenic effects and adverse events. Use with caution and monitor closely.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for STRIANT (STRIANT).

Breastfeeding	Testosterone is excreted into breast milk but M/P ratio is unknown. It may suppress lactation and cause virilization in nursing infants. Breastfeeding is not recommended during treatment.
Teratogenic Risk	Striant (testosterone buccal system) is contraindicated in pregnant women. Testosterone is a teratogen causing virilization of female fetuses. First trimester exposure risks clitoromegaly, labioscrotal fusion, and urogenital sinus anomalies. Second and third trimester exposure may cause clitoral enlargement and other masculinizing effects. No safe trimester exists.