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.
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 and ADVERSE REACTIONS].
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.
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].
Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of major adverse cardiovascular events (MACE), such as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, with the use of testosterone compared to non-use. Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men. Patients should be informed of this possible risk when deciding whether to use or to continue to use Striant.
Use In Women
Due to lack of controlled evaluations in women and potential virilizing effects, Striant is not indicated for use in women.
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.
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.
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].
Changes in the serum lipid profile may occur. Monitor the lipid profile periodically, particularly after starting therapy.
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.
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.
Patient Counseling Information
See FDA-Approved Patient Labeling (PATIENT INFORMATION).
Patients should be informed of the following:
Men With Known Or Suspected Prostate Or Breast Cancer
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.
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
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.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
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.
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.
Use In Specific Populations
Pregnancy Category 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.
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.
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.
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.
No studies were conducted in patients with renal impairment.
No studies were conducted in patients with hepatic impairment.
Last reviewed on RxList: 9/8/2015
This monograph has been modified to include the generic and brand name in many instances.
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