Testosterone (buccal): Difference between revisions

Testosterone (buccal)
	Adult Indications & Dosage
	Pediatric Indications & Dosage
	Contraindications
	Warnings & Precautions
	Adverse Reactions
	Drug Interactions
	Use in Specific Populations
	Administration & Monitoring
	Overdosage
	Pharmacology
	Clinical Studies
	How Supplied
	Images
	Patient Counseling Information
	Precautions with Alcohol
	Brand Names
	Look-Alike Names

VisualWikitext

Revision as of 16:54, 12 May 2015

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Turky Alkathery, M.D. [2]

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Overview

Testosterone (buccal) is a steroid hormone from the androgen group that is FDA approved for the treatment of deficiency or absence of endogenous testosterone. Common adverse reactions include gum or mouth irritation, bitter taste, gum pain, gum tenderness, headache, gum edema and taste perversion.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Striant is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:

Primary hypogonadism (congenital or acquired) – testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone levels and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. Hypogonadotropic hypogonadism (congenital or acquired) – idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary hypothalamic injury from tumors, trauma, or radiation. These patients have low serum testosterone levels but have gonadotropins in the normal or low range. Limitations of use:

Safety and efficacy of Striant in males less than 18 years old have not been established [see Use in Specific Populations (8.4)].

Dosage

2.1 Dosage Information The recommended dosage for Striant is the application of one buccal system (30 mg) to the gum region twice daily; morning and evening (about 12 hours apart).

To ensure proper dosing, serum testosterone concentrations should be measured. Morning, pre-dose serum testosterone concentrations should be measured at 4 to 12 weeks after initiation of therapy to ensure proper serum testosterone concentrations are achieved. Striant therapy should be discontinued if serum testosterone concentrations are consistently outside of the normal range (300 to 1050 ng/dL) despite the use of one buccal system applied twice daily.

2.2 Administration Instructions Striant should be placed in a comfortable position just above the incisor tooth (on either side of the mouth). With each application, Striant should be rotated to alternate sides of the mouth.

Upon opening the packet, the rounded side surface of the buccal system should be placed against the gum and held firmly in place with a finger over the lip and against the product for 30 seconds to ensure adhesion. Striant is designed to stay in position until removed. If the buccal system fails to properly adhere to the gum or should fall off during the 12-hour dosing interval, the old buccal system should be removed and a new one applied.

If the buccal system falls out of position within the first 8 hours of dosing, replace with a new system and continue for a total of 12 hours from the placement of the first system. If the system falls out of position after 8 hours of dosing, a new buccal system should be applied and it may remain in place for 12 hours then continue with the next regularly scheduled dosing.

Patients should take care to avoid dislodging the buccal system. Patients should check to see if Striant is in place following consumption of food or alcoholic/non-alcoholic beverages. Striant should not be chewed or swallowed. To remove Striant, gently slide it downwards from the gum toward the tooth to avoid scratching the gum. The Striant buccal system should be removed before routine morning and evening oral care is performed, followed by application of a new buccal system.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Testosterone (buccal) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Testosterone (buccal) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Testosterone (buccal) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Testosterone (buccal) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Testosterone (buccal) in pediatric patients.

Contraindications

Striant is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)]. Striant is contraindicated in women who are or may become pregnant, or who are breastfeeding. Striant may cause fetal harm when administered to a pregnant woman. Striant may cause serious adverse reactions in nursing infants. Exposure of a fetus or nursing infant to androgens may result in varying degrees of virilization [see Use in Specific Populations (8.1, 8.3)].

Warnings

5.1 Gum-Related Adverse Reactions and Limited Long-Term Information on Oral Safety Gum-related adverse reactions, including severe gum irritation, were reported in clinical trials of Striant. Long-term clinical trial data on gum safety is available in only a limited number of patients (117 patients, 51 patients and 48 patients with at least 6 months, 1 year, and 2 years of exposure, respectively). It is recommended that patients regularly inspect their own gum region where Striant is applied. Any abnormal finding should be brought promptly to the attention of the patient’s physician. In such circumstances, dental consultation may be appropriate.

5.2 Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer Patients with BPH treated with androgens are at an increased risk for worsening of signs and symptoms of BPH. Monitor patients with BPH for worsening signs and symptoms. Patients treated with androgens may be at increased risk for prostate cancer. Evaluate patients for prostate cancer prior to initiating and during treatment with androgens [see Contraindications (4) and Adverse Reactions (6.1)]. 5.3 Polycythemia Increases in hematocrit, reflective of increases in red blood cell mass, may require lowering or discontinuation of testosterone. Check hematocrit prior to initiating treatment. It would also be appropriate to re-evaluate the hematocrit 3 to 6 months after starting treatment, and then annually. If hematocrit becomes elevated, stop therapy until hematocrit decreases to an acceptable concentration. An increase in red blood cell mass may increase the risk of thromboembolic events.

5.4 Venous Thromboembolism There have been postmarketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone products, such as Striant. Evaluate patients who report symptoms of pain, edema, warmth and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue treatment with Striant and initiate appropriate workup and management [see Adverse Reactions (6.2)].

5.5 Use in Women Due to lack of controlled evaluations in women and potential virilizing effects, Striant is not indicated for use in women.

5.6 Potential for Adverse Effects on Spermatogenesis With large doses of exogenous androgens, including Striant, spermatogenesis may be suppressed through feedback inhibition of pituitary follicle-stimulating hormone (FSH) which could possibly lead to adverse effects on semen parameters including sperm count.

5.7 Hepatic Adverse Effects Prolonged use of high doses of orally active 17-alpha-alkyl androgens (e.g., methyltestosterone) has been associated with serious hepatic adverse effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice). Peliosis hepatis can be a life-threatening or fatal complication. Long-term therapy with testosterone enanthate, which elevates blood levels for prolonged periods, has produced multiple hepatic adenomas. Testosterone is not known to produce these adverse effects. Nonetheless, patients should be instructed to report any signs or symptoms of hepatic dysfunction (e.g., jaundice). If these occur, promptly discontinue Striant while the cause is evaluated.

5.8 Edema Androgens, including Striant, may promote retention of sodium and water. Edema with or without congestive heart failure may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required [see Adverse Reactions (6.1)].

5.9 Gynecomastia Gynecomastia may develop and persist in patients being treated with androgens, including Striant, for hypogonadism.

5.10 Sleep Apnea The treatment of hypogonadal men with testosterone may potentiate sleep apnea in some patients especially those with risk factors such as obesity or chronic lung diseases.

5.11 Lipids Changes in the serum lipid profile may occur. Monitor the lipid profile periodically, particularly after starting therapy.

5.12 Hypercalcemia Androgens, including Striant, should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). Regular monitoring of serum calcium concentrations is recommended in these patients.

5.13 Decreased Thyroxine-binding Globulin Androgens, including Striant, may decrease concentrations of thyroxine-binding globulins, resulting in decreased total T4 concentrations and increased resin uptake of T3 and T4. Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Testosterone (buccal) Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Testosterone (buccal) Postmarketing Experience in the drug label.

Drug Interactions

7.1 Insulin Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may necessitate a decrease in the dose of anti-diabetic medication.

7.2 Oral Anticoagulants Changes in anticoagulant activity may be seen with androgens, therefore more frequent monitoring of the international normalized ratio (INR) and prothrombin time are recommended in patients taking warfarin, especially at the initiation and termination of androgen therapy.

7.3 Corticosteroids The concurrent use of testosterone with corticosteroids may result in increased fluid retention and requires careful monitoring, particularly in patients with cardiac, renal or hepatic disease.

9 DRUG ABUSE AND DEPENDENCE 9.1 Controlled Substance Striant contains testosterone, a Schedule III controlled substance in the Controlled Substances Act.

9.2 Abuse Anabolic steroids, such as testosterone, are abused. Abuse is often associated with adverse physical and psychological effects.

9.3 Dependence Although drug dependence is not documented in individuals using therapeutic doses of anabolic steroids for approved indications, dependence is observed in some individuals abusing high doses of anabolic steroids. In general, anabolic steroid dependence is characterized by any three of the following:

Taking more drug than intended Continued drug use despite medical and social problems Significant time spent in obtaining adequate amounts of drug Desire for anabolic steroids when supplies of the drugs are interrupted Difficulty in discontinuing use of the drug despite desires and attempts to do so Experience of a withdrawal syndrome upon discontinuation of anabolic steroid use

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): X Striant is contraindicated in pregnant women or in women who may become pregnant. Testosterone is teratogenic and may cause fetal harm. Exposure of a fetus to androgens such as testosterone may result in varying degrees of virilization. If a woman becomes pregnant while taking Striant, she should be apprised of the potential hazard to the fetus.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Testosterone (buccal) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Testosterone (buccal) during labor and delivery.

Nursing Mothers

Although it is not known how much testosterone transfers into human milk, Striant is contraindicated in nursing women because of the potential for virilization in nursing infants. Testosterone and other androgens may adversely affect lactation.

Pediatric Use

Safety and effectiveness of Striant in males less than 18 year of age have not been established. Improper use may result in acceleration of bone age and premature closure of the epiphyses.

Geriatic Use

Of the total number of subjects in clinical studies of Striant, 51 patients (17%) were 65 years of age and older. There is insufficient long-term safety data in geriatric patients to assess the potentially increased risks of cardiovascular disease and prostate cancer.

Gender

There is no FDA guidance on the use of Testosterone (buccal) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Testosterone (buccal) with respect to specific racial populations.

Renal Impairment

No studies were conducted in patients with renal impairment.

Hepatic Impairment

No studies were conducted in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Testosterone (buccal) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Testosterone (buccal) in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Testosterone (buccal) Administration in the drug label.

Monitoring

There is limited information regarding Testosterone (buccal) Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Testosterone (buccal) and IV administrations.

Overdosage

There is one report of acute overdosage with testosterone enanthate injection: testosterone levels of up to 11,400 ng/dL were implicated in a cerebrovascular accident.

Oral ingestion of Striant is not expected to result in clinically significant serum testosterone concentrations due to extensive first-pass (hepatic) metabolism.

Treatment of overdosage would consist of discontinuation of Striant together with appropriate symptomatic and supportive care.

Pharmacology



Testosterone (buccal)
Systematic (IUPAC) name
(8R,9S,10R,13S,14S,17S)- 17-hydroxy-10,13-dimethyl- 1,2,6,7,8,9,11,12,14,15,16,17- dodecahydrocyclopenta[a]phenanthren-3-one
Identifiers
CAS number	58-22-0 57-85-2 (propionate ester)
ATC code	G03BA03
PubChem	6013
DrugBank	DB00624
Chemical data
Formula	Template:OrganicBox atom Template:OrganicBox atom Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox atom Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox
Mol. mass	288.42
SMILES	eMolecules & PubChem
Physical data
Melt. point	155 °C (311 °F)
Spec. rot	+110.2°
SEC Combust	−11080 kJ/mol
Pharmacokinetic data
Bioavailability	Low (due to extensive first pass metabolism)
Metabolism	Liver, testis and prostate
Half life	2–4 hours
Excretion	Urine (90%), feces (6%)
Therapeutic considerations
Licence data	US
Pregnancy cat.	X(US) Contraindicated due to teratogenic effects
Legal status	Schedule IV(CA) Schedule III(US) Template:Unicode Prescription only
Routes	Intramuscular injection, transdermal (cream, gel, or patch), sub-'Q' pellet

Mechanism of Action

Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis and scrotum; the development of male hair distribution, such as facial, pubic, chest and axillary hair; laryngeal enlargement, vocal chord thickening, alterations in body musculature and fat distribution. Testosterone and DHT are necessary for the normal development of secondary sex characteristics. Male hypogonadism results from insufficient secretion of testosterone and is characterized by low serum testosterone concentrations. Signs/symptoms associated with male hypogonadism include erectile dysfunction and decreased sexual desire, fatigue and loss of energy, mood depression, regression of secondary sexual characteristics and osteoporosis.

Male hypogonadism can present as primary hypogonadism caused by defects of the gonads, such as Klinefelter’s Syndrome or Leydig cell aplasia while secondary hypogonadism is the failure of the hypothalamus or pituitary to produce sufficient gonadotropins (FSH, LH).

Structure

Striant (testosterone buccal system) mucoadhesive is for buccal administration only. It contains testosterone, an androgen.

Striant is designed to adhere to the gum or inner cheek. It provides a controlled and sustained release of testosterone through the buccal mucosa as the buccal system gradually hydrates. Application of Striant twice a day, in the morning and in the evening, provides continuous systemic delivery of testosterone.

Striant is a white to off-white colored, monoconvex, tablet-like, mucoadhesive buccal system. Striant adheres to the gum tissue above the incisors, with the flat surface facing the cheek mucosa.

The active ingredient in Striant is testosterone (SEE FIGURE 1). Each buccal system contains 30 mg of testosterone. Testosterone USP is practically white crystalline powder chemically described as 17-beta hydroxyandrost-4-en-3-one.

Figure 1: Chemical Structure of Testosterone

Pharmacodynamics

No pharmacodynamic studies were conducted using Striant.

Pharmacokinetics

There is limited information regarding Testosterone (buccal) Pharmacokinetics in the drug label.

Nonclinical Toxicology

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity

Testosterone has been tested by subcutaneous injection and implantation in mice and rats. In mice, the implant induced cervical-uterine tumors, which metastasized in some cases. There is suggestive evidence that injection of testosterone into some strains of female mice increases their susceptibility to hepatoma. Testosterone is also known to increase the number of tumors and decrease the degree of differentiation of chemically induced carcinomas of the liver in rats.

Mutagenesis

Testosterone was negative in the in vitro Ames and in the in vivo mouse micronucleus assays.

Impairment of Fertility

The administration of exogenous testosterone has been reported to suppress spermatogenesis in the rat, dog and non human primates, which was reversible on cessation of the treatment.

Clinical Studies

There is limited information regarding Testosterone (buccal) Clinical Studies in the drug label.

How Supplied

There is limited information regarding Testosterone (buccal) How Supplied in the drug label.

Storage

There is limited information regarding Testosterone (buccal) Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Testosterone (buccal) |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Testosterone (buccal) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

See FDA-Approved Patient Labeling (Patient Information).

Patients should be informed of the following:

17.1 Men with Known or Suspected Prostate or Breast Cancer Men with known or suspected prostate or breast cancer should not use Striant [see Contraindications (4) and Warnings and Precautions (5.2)].

17.2 Gum-Related Adverse Reactions Gum-related adverse reactions, including severe gum irritation, were reported in clinical trials of Striant. Advise patients to regularly inspect the gum region where they apply Striant and to report any abnormality to their health care professional.

17.3 Potential Adverse Reactions with Androgens Patients should be informed that treatment with androgens, such as Striant, may lead to adverse reactions that include:

Changes in urinary habits such as increased urination at night, trouble starting their urine stream, passing urine many times during the day, having an urge that they have to go to the bathroom right away, having a urine accident, being unable to pass urine and having a weak urine flow Breathing disturbances, including those associated with sleep, or excessive daytime sleepiness Too frequent or persistent erections of the penis Nausea, vomiting, changes in skin color, or ankle swelling 17.4 Patients Should be Advised of these Application Instructions Advise patients to carefully read the patient information accompanying each carton of Striant blister packaged tablets. Morning and evening oral care should be timed to coincide with removal of the residual old system and application of a new buccal system. Before morning and evening oral care, the residual Striant buccal system residual should be removed, then oral care should be performed. Following oral care, a new buccal system should be applied. Upon opening the packet, the rounded side surface of the buccal system should be placed against the gum and held firmly in place with a finger over the lip and against the product for 30 seconds to ensure adhesion. Striant should be placed in a comfortable position just above the incisor tooth (on either side of the mouth). With each application, Striant should be rotated to alternate sides of the mouth. Striant is designed to stay in position until removed. If the buccal system fails to properly adhere to the gum or falls off within the first 8 hours of dosing, replace with a new system and continue for a total of 12 hours for the placement of the first system. If the system falls out of position after 8 hours of dosing, a new buccal system should be applied and it may remain in place for 12 hours then continue with the next regularly scheduled dosing. Patients should take care to avoid dislodging the buccal system. Patients should check to see if Striant is in place following consumption of food or alcoholic/non-alcoholic beverages. Striant should not be chewed or swallowed.

Precautions with Alcohol

Alcohol-Testosterone (buccal) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Testosterone (buccal) Brand Names in the drug label.

Look-Alike Drug Names

Testoderm - Testoderm TTS^[1]
Testoderm - Testoderm with Adhesive^[1]
Testoderm with Adhesive - Testoderm TTS^[1]

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

↑ ^1.0 ^1.1 ^1.2 "https://www.ismp.org". External link in |title= (help)

[www.ismp.org-1] 1.0 ^1.1 ^1.2 "https://www.ismp.org". External link in |title= (help)

[1]

@@ Line 6: / Line 6: @@
 |indicationType=treatment
 |indication=deficiency or absence of endogenous testosterone
+|adverseReactions=gum or mouth irritation, bitter taste, gum pain, gum tenderness, headache, gum edema and taste perversion
 |blackBoxWarningTitle=<b><span style="color:#FF0000;">TITLE</span></b>
 |blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
+|fdaLIADAdult====Indications===
+Striant is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:
+Primary hypogonadism (congenital or acquired) – testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone levels and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.
+Hypogonadotropic hypogonadism (congenital or acquired) – idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary hypothalamic injury from tumors, trauma, or radiation. These patients have low serum testosterone levels but have gonadotropins in the normal or low range.
+Limitations of use:
+Safety and efficacy of Striant in males less than 18 years old have not been established [see Use in Specific Populations (8.4)].
+===Dosage===
+.1 Dosage Information
+The recommended dosage for Striant is the application of one buccal system (30 mg) to the gum region twice daily; morning and evening (about 12 hours apart).
+To ensure proper dosing, serum testosterone concentrations should be measured. Morning, pre-dose serum testosterone concentrations should be measured at 4 to 12 weeks after initiation of therapy to ensure proper serum testosterone concentrations are achieved. Striant therapy should be discontinued if serum testosterone concentrations are consistently outside of the normal range (300 to 1050 ng/dL) despite the use of one buccal system applied twice daily.
+.2 Administration Instructions
+Striant should be placed in a comfortable position just above the incisor tooth (on either side of the mouth). With each application, Striant should be rotated to alternate sides of the mouth.
+Upon opening the packet, the rounded side surface of the buccal system should be placed against the gum and held firmly in place with a finger over the lip and against the product for 30 seconds to ensure adhesion. Striant is designed to stay in position until removed. If the buccal system fails to properly adhere to the gum or should fall off during the 12-hour dosing interval, the old buccal system should be removed and a new one applied.
+If the buccal system falls out of position within the first 8 hours of dosing, replace with a new system and continue for a total of 12 hours from the placement of the first system. If the system falls out of position after 8 hours of dosing, a new buccal system should be applied and it may remain in place for 12 hours then continue with the next regularly scheduled dosing.
+Patients should take care to avoid dislodging the buccal system. Patients should check to see if Striant is in place following consumption of food or alcoholic/non-alcoholic beverages. Striant should not be chewed or swallowed. To remove Striant, gently slide it downwards from the gum toward the tooth to avoid scratching the gum. The Striant buccal system should be removed before routine morning and evening oral care is performed, followed by application of a new buccal system.
 |offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Testosterone (buccal) in adult patients.
 |offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Testosterone (buccal) in adult patients.
 |offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Testosterone (buccal) in pediatric patients.
 |offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Testosterone (buccal) in pediatric patients.
+|contraindications=Striant is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)].
+Striant is contraindicated in women who are or may become pregnant, or who are breastfeeding. Striant may cause fetal harm when administered to a pregnant woman. Striant may cause serious adverse reactions in nursing infants. Exposure of a fetus or nursing infant to androgens may result in varying degrees of virilization [see Use in Specific Populations (8.1, 8.3)].
+|warnings=5.1 Gum-Related Adverse Reactions and Limited Long-Term Information on Oral Safety
+Gum-related adverse reactions, including severe gum irritation, were reported in clinical trials of Striant. Long-term clinical trial data on gum safety is available in only a limited number of patients (117 patients, 51 patients and 48 patients with at least 6 months, 1 year, and 2 years of exposure, respectively). It is recommended that patients regularly inspect their own gum region where Striant is applied. Any abnormal finding should be brought promptly to the attention of the patient’s physician. In such circumstances, dental consultation may be appropriate.
+.2 Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer
+Patients with BPH treated with androgens are at an increased risk for worsening of signs and symptoms of BPH. Monitor patients with BPH for worsening signs and symptoms.
+Patients treated with androgens may be at increased risk for prostate cancer. Evaluate patients for prostate cancer prior to initiating and during treatment with androgens [see Contraindications (4) and Adverse Reactions (6.1)].
+.3 Polycythemia
+Increases in hematocrit, reflective of increases in red blood cell mass, may require lowering or discontinuation of testosterone. Check hematocrit prior to initiating treatment. It would also be appropriate to re-evaluate the hematocrit 3 to 6 months after starting treatment, and then annually. If hematocrit becomes elevated, stop therapy until hematocrit decreases to an acceptable concentration. An increase in red blood cell mass may increase the risk of thromboembolic events.
+.4 Venous Thromboembolism
+There have been postmarketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone products, such as Striant. Evaluate patients who report symptoms of pain, edema, warmth and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue treatment with Striant and initiate appropriate workup and management [see Adverse Reactions (6.2)].
+.5 Use in Women
+Due to lack of controlled evaluations in women and potential virilizing effects, Striant is not indicated for use in women.
+.6 Potential for Adverse Effects on Spermatogenesis
+With large doses of exogenous androgens, including Striant, spermatogenesis may be suppressed through feedback inhibition of pituitary follicle-stimulating hormone (FSH) which could possibly lead to adverse effects on semen parameters including sperm count.
+.7 Hepatic Adverse Effects
+Prolonged use of high doses of orally active 17-alpha-alkyl androgens (e.g., methyltestosterone) has been associated with serious hepatic adverse effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice). Peliosis hepatis can be a life-threatening or fatal complication. Long-term therapy with testosterone enanthate, which elevates blood levels for prolonged periods, has produced multiple hepatic adenomas. Testosterone is not known to produce these adverse effects. Nonetheless, patients should be instructed to report any signs or symptoms of hepatic dysfunction (e.g., jaundice). If these occur, promptly discontinue Striant while the cause is evaluated.
+.8 Edema
+Androgens, including Striant, may promote retention of sodium and water. Edema with or without congestive heart failure may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required [see Adverse Reactions (6.1)].
+.9 Gynecomastia
+Gynecomastia may develop and persist in patients being treated with androgens, including Striant, for hypogonadism.
+.10 Sleep Apnea
+The treatment of hypogonadal men with testosterone may potentiate sleep apnea in some patients especially those with risk factors such as obesity or chronic lung diseases.
+.11 Lipids
+Changes in the serum lipid profile may occur. Monitor the lipid profile periodically, particularly after starting therapy.
+.12 Hypercalcemia
+Androgens, including Striant, should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). Regular monitoring of serum calcium concentrations is recommended in these patients.
+.13 Decreased Thyroxine-binding Globulin
+Androgens, including Striant, may decrease concentrations of thyroxine-binding globulins, resulting in decreased total T4 concentrations and increased resin uptake of T3 and T4. Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.
+|drugInteractions=7.1 Insulin
+Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may necessitate a decrease in the dose of anti-diabetic medication.
+.2 Oral Anticoagulants
+Changes in anticoagulant activity may be seen with androgens, therefore more frequent monitoring of the international normalized ratio (INR) and prothrombin time are recommended in patients taking warfarin, especially at the initiation and termination of androgen therapy.
+.3 Corticosteroids
+The concurrent use of testosterone with corticosteroids may result in increased fluid retention and requires careful monitoring, particularly in patients with cardiac, renal or hepatic disease.
+DRUG ABUSE AND DEPENDENCE
+.1 Controlled Substance
+Striant contains testosterone, a Schedule III controlled substance in the Controlled Substances Act.
+.2 Abuse
+Anabolic steroids, such as testosterone, are abused. Abuse is often associated with adverse physical and psychological effects.
+.3 Dependence
+Although drug dependence is not documented in individuals using therapeutic doses of anabolic steroids for approved indications, dependence is observed in some individuals abusing high doses of anabolic steroids. In general, anabolic steroid dependence is characterized by any three of the following:
+Taking more drug than intended
+Continued drug use despite medical and social problems
+Significant time spent in obtaining adequate amounts of drug
+Desire for anabolic steroids when supplies of the drugs are interrupted
+Difficulty in discontinuing use of the drug despite desires and attempts to do so
+Experience of a withdrawal syndrome upon discontinuation of anabolic steroid use
+|FDAPregCat=X
+|useInPregnancyFDA=Striant is contraindicated in pregnant women or in women who may become pregnant. Testosterone is teratogenic and may cause fetal harm. Exposure of a fetus to androgens such as testosterone may result in varying degrees of virilization. If a woman becomes pregnant while taking Striant, she should be apprised of the potential hazard to the fetus.
+|useInNursing=Although it is not known how much testosterone transfers into human milk, Striant is contraindicated in nursing women because of the potential for virilization in nursing infants. Testosterone and other androgens may adversely affect lactation.
+|useInPed=Safety and effectiveness of Striant in males less than 18 year of age have not been established. Improper use may result in acceleration of bone age and premature closure of the epiphyses.
+|useInGeri=Of the total number of subjects in clinical studies of Striant, 51 patients (17%) were 65 years of age and older. There is insufficient long-term safety data in geriatric patients to assess the potentially increased risks of cardiovascular disease and prostate cancer.
+|useInRenalImpair=No studies were conducted in patients with renal impairment.
+|useInHepaticImpair=No studies were conducted in patients with hepatic impairment.
+|overdose=There is one report of acute overdosage with testosterone enanthate injection: testosterone levels of up to 11,400 ng/dL were implicated in a cerebrovascular accident.
+Oral ingestion of Striant is not expected to result in clinically significant serum testosterone concentrations due to extensive first-pass (hepatic) metabolism.
+Treatment of overdosage would consist of discontinuation of Striant together with appropriate symptomatic and supportive care.
 |drugBox={{Drugbox2| Verifiedfields = changed
 | Watchedfields = changed
@@ Line 68: / Line 172: @@
 | sec_combustion = −11080 kJ/mol
 }}
+|mechAction=Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis and scrotum; the development of male hair distribution, such as facial, pubic, chest and axillary hair; laryngeal enlargement, vocal chord thickening, alterations in body musculature and fat distribution. Testosterone and DHT are necessary for the normal development of secondary sex characteristics. Male hypogonadism results from insufficient secretion of testosterone and is characterized by low serum testosterone concentrations. Signs/symptoms associated with male hypogonadism include erectile dysfunction and decreased sexual desire, fatigue and loss of energy, mood depression, regression of secondary sexual characteristics and osteoporosis.
+Male hypogonadism can present as primary hypogonadism caused by defects of the gonads, such as Klinefelter’s Syndrome or Leydig cell aplasia while secondary hypogonadism is the failure of the hypothalamus or pituitary to produce sufficient gonadotropins (FSH, LH).
+|structure=Striant (testosterone buccal system) mucoadhesive is for buccal administration only. It contains testosterone, an androgen.
+Striant is designed to adhere to the gum or inner cheek. It provides a controlled and sustained release of testosterone through the buccal mucosa as the buccal system gradually hydrates. Application of Striant twice a day, in the morning and in the evening, provides continuous systemic delivery of testosterone.
+Striant is a white to off-white colored, monoconvex, tablet-like, mucoadhesive buccal system. Striant adheres to the gum tissue above the incisors, with the flat surface facing the cheek mucosa.
+The active ingredient in Striant is testosterone (SEE FIGURE 1). Each buccal system contains 30 mg of testosterone. Testosterone USP is practically white crystalline powder chemically described as 17-beta hydroxyandrost-4-en-3-one.
+Figure 1: Chemical Structure of Testosterone
+|PD=No pharmacodynamic studies were conducted using Striant.
+|nonClinToxic=13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
+Carcinogenicity
+Testosterone has been tested by subcutaneous injection and implantation in mice and rats. In mice, the implant induced cervical-uterine tumors, which metastasized in some cases. There is suggestive evidence that injection of testosterone into some strains of female mice increases their susceptibility to hepatoma. Testosterone is also known to increase the number of tumors and decrease the degree of differentiation of chemically induced carcinomas of the liver in rats.
+Mutagenesis
+Testosterone was negative in the in vitro Ames and in the in vivo mouse micronucleus assays.
+Impairment of Fertility
+The administration of exogenous testosterone has been reported to suppress spermatogenesis in the rat, dog and non human primates, which was reversible on cessation of the treatment.
+|fdaPatientInfo=See FDA-Approved Patient Labeling (Patient Information).
+Patients should be informed of the following:
+.1 Men with Known or Suspected Prostate or Breast Cancer
+Men with known or suspected prostate or breast cancer should not use Striant [see Contraindications (4) and Warnings and Precautions (5.2)].
+.2 Gum-Related Adverse Reactions
+Gum-related adverse reactions, including severe gum irritation, were reported in clinical trials of Striant. Advise patients to regularly inspect the gum region where they apply Striant and to report any abnormality to their health care professional.
+.3 Potential Adverse Reactions with Androgens
+Patients should be informed that treatment with androgens, such as Striant, may lead to adverse reactions that include:
+Changes in urinary habits such as increased urination at night, trouble starting their urine stream, passing urine many times during the day, having an urge that they have to go to the bathroom right away, having a urine accident, being unable to pass urine and having a weak urine flow
+Breathing disturbances, including those associated with sleep, or excessive daytime sleepiness
+Too frequent or persistent erections of the penis
+Nausea, vomiting, changes in skin color, or ankle swelling
+.4 Patients Should be Advised of these Application Instructions
+Advise patients to carefully read the patient information accompanying each carton of Striant blister packaged tablets.
+Morning and evening oral care should be timed to coincide with removal of the residual old system and application of a new buccal system.
+Before morning and evening oral care, the residual Striant buccal system residual should be removed, then oral care should be performed.
+Following oral care, a new buccal system should be applied.
+Upon opening the packet, the rounded side surface of the buccal system should be placed against the gum and held firmly in place with a finger over the lip and against the product for 30 seconds to ensure adhesion.
+Striant should be placed in a comfortable position just above the incisor tooth (on either side of the mouth). With each application, Striant should be rotated to alternate sides of the mouth.
+Striant is designed to stay in position until removed. If the buccal system fails to properly adhere to the gum or falls off within the first 8 hours of dosing, replace with a new system and continue for a total of 12 hours for the placement of the first system. If the system falls out of position after 8 hours of dosing, a new buccal system should be applied and it may remain in place for 12 hours then continue with the next regularly scheduled dosing.
+Patients should take care to avoid dislodging the buccal system. Patients should check to see if Striant is in place following consumption of food or alcoholic/non-alcoholic beverages. Striant should not be chewed or swallowed.
 |alcohol=Alcohol-Testosterone (buccal) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
 |lookAlike=*Testoderm - Testoderm TTS<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title =https://www.ismp.org | url = https://www.ismp.org | publisher =  | date =  | accessdate = }}</ref>
@@ Line 73: / Line 228: @@
 *Testoderm with Adhesive - Testoderm TTS<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title =https://www.ismp.org | url = https://www.ismp.org | publisher =  | date =  | accessdate = }}</ref>
 }}
 [[Category:Androgens]]
 [[Category:Drug]]

Testosterone (buccal): Difference between revisions

Revision as of 16:54, 12 May 2015

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