Striant

Striant

WARNINGS

  1. Prolonged use of high doses of orally active 17-alpha-alkyl androgens (e.g., methyltestosterone) have 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.
  2. Geriatric patients treated with androgens may be at an increased risk for the development of prostatic hyperplasia and prostatic carcinoma.
  3. Geriatric patients and other patients with clinical or demographic characteristics that are recognized to be associated with an increased risk of prostate cancer should be evaluated for the presence of prostate cancer prior to initiation of testosterone replacement therapy. In men receiving testosterone replacement therapy, surveillance for prostate cancer should be consistent with current practices for eugonadal men (see PRECAUTIONS: Carcinogenesis, Mutagenesis, Impairment of Fertility and Laboratory Tests).
  4. 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.
  5. Gynecomastia frequently develops and occasionally persists in patients being treated for hypogonadism.
  6. The treatment of hypogonadal men with testosterone esters may potentiate sleep apnea in some patients especially those with risk factors such as obesity or chronic lung diseases.

PRECAUTIONS

Striant® is applied to the upper gum just above the incisor tooth on either side of the mouth. Long-term data is not currently available and studies continue. Until such longer-term data become available, 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.

General

The physician should instruct patients to report any of the following:

  • Too frequent or persistent erections of the penis.
  • Any nausea, vomiting, changes in skin color, or ankle swelling.
  • Breathing disturbances, including those associated with sleep.

Information for Patients

Advise patients to carefully read the attached patient leaflet accompanying each carton of Striant® blister packaged tablets.

Advise patients to regularly inspect the gum region where they apply Striant® and to report any abnormality to their health care professional.

Laboratory Tests

  1. Hemoglobin and hematocrit levels should be checked periodically (to detect polycythemia) in patients on long-term androgen therapy.
  2. Liver function, prostate specific antigen (PSA), cholesterol and high-density lipoprotein should be checked periodically.
  3. Serum total testosterone concentrations may be checked four to twelve weeks after initiating treatment with Striant®. To capture the maximum serum concentration, an early morning sample (just prior to applying the A.M. dose) is recommended. In the infrequent circumstance where the total testosterone concentration in this sample is excessive, therapy with Striant® should be discontinued and an alternative treatment considered.

Carcinogenesis, Mutagenesis, Impairment Of fertility

Animal data

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.

Human data

There were rare reports of hepatocellular carcinoma in patients receiving long-term therapy with androgens in high doses. Withdrawal of the drugs did not lead to regression of the tumors in all cases.

Striant® has been evaluated in patients for 1 year without reports of cancer related to the product. However, safety in patients beyond 1 year has not been established.

Geriatric patients treated with androgens may be at an increased risk for the development of prostatic hyperplasia and prostatic carcinoma.

Geriatric patients and other patients with clinical or demographic characteristics that are recognized to be associated with an increased risk of prostate cancer should be evaluated for the presence of prostate cancer prior to initiation of testosterone replacement therapy.

In men receiving testosterone replacement therapy, surveillance for prostate cancer should be consistent with current practices for eugonadal men.

Pregnancy Category X (see CONTRAINDICATIONS)

Teratogenic Effects

Striant® is not indicated for women and must not be used in women.

Labor And Delivery

Striant® is not indicated for women and must not be used in women.

Nursing Mothers

Striant® is not indicated for women and must not be used in women.

Pediatric Use

Safety and effectiveness in pediatric male patients below the age of 18 have not yet been established.

Geriatric Use

Of the total number of subjects in clinical studies of Striant®, 51 patients (16.5 percent) were 65 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. However, in Study 1, in patients 65 years of age and older, the total testosterone C (0-24) value was higher by 12.7% compared to patients less than 65 years of age. In addition, the total T to DHT area-under-the curve ratio was lower in the older population compared to the younger population by 15.6%. These differences may not be clinically significant.

Last reviewed on RxList: 4/7/2014
This monograph has been modified to include the generic and brand name in many instances.

A A A

Striant - User Reviews

Striant User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Striant sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.

advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations