AndroGel % is an androgen indicated for replacement Draft ANDROGEL % (testosterone gel) Prescribing Information (PI) received. These highlights do not include all the information needed to use ANDROGEL % safely and effectively. See full prescribing information for ANDROGEL. ANDROGEL®. Testosterone gel 1%. This leaflet is part III of a three-part “Product Monograph” published when ANDROGEL was approved for.
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AndroGel % | FULL Prescribing Information |
There are insufficient long-term safety data in geriatric patients using AndroGel 1. Dosage and Administration for AndroGel 1. Prior to initiating AndroGel 1. The recommended starting dose of AndroGel 1. The dose can be adjusted between a minimum of To ensure proper dosing, the dose should be titrated based on the pre-dose morning serum testosterone concentration from a single blood draw at approximately 14 days and 28 days after starting treatment or following dose adjustment.
In addition, serum testosterone concentration should be assessed periodically thereafter. Table 1 describes the dose adjustments required at each titration step. The application site and dose of AndroGel 1. Do not apply AndroGel 1. Area of application should be limited to the area that will be covered by the patient’s short sleeve t-shirt.
Patients should be instructed to use the palm of the hand to apply AndroGel 1. Application Sites for AndroGel 1. The prescribed daily dose of AndroGel 1. Once the application site is dry, the site should be covered with clothing [see Clinical Pharmacology Wash hands thoroughly with soap and water. Avoid fire, flames or smoking until the gel has dried since alcohol based products, including AndroGel 1. The patient should avoid swimming or showering or washing the administration site for a minimum of 2 hours after application [see Clinical Pharmacology To obtain a full first dose, it is necessary to prime the canister pump.
To do so, with the canister in the upright position, slowly and fully depress the actuator three times. Safely discard the gel from the first three actuations. It is only necessary to prime the pump before the first dose. After the priming procedure, fully depress the actuator once for every When using packets, the entire contents should be squeezed into the palm of the hand and immediately applied to the application sites. Repeat until entire contents have been applied.
Strict adherence to the following precautions is advised in order to minimize the potential for secondary exposure to testosterone from AndroGel 1.
AndroGel testosterone gel 1. Cases of secondary exposure resulting in virilization of children have been reported in postmarketing surveillance of testosterone gel products. Signs and symptoms have included enlargement of the penis or clitoris, development of pubic hair, increased erections and libido, aggressive behavior, anddrogel advanced bone andogel.
In most cases, these signs and symptoms regressed with removal of the exposure to testosterone gel. In a few cases, however, enlarged genitalia did not fully return to age-appropriate normal size, and bone age remained modestly greater than chronological age.
The risk of transfer was increased in some of these cases by not adhering to precautions for the appropriate use of the topical testosterone product. Children and women should avoid contact with unwashed or unclothed application sites in men using AndroGel 1. Inappropriate changes in genital size or development of pubic hair or libido androtel children, or changes in body hair distribution, significant increase in acne, or other signs of virilization in adult women should be brought to the attention of a physician and the possibility of secondary exposure to testosterone gel should also be brought to the attention of a physician.
Testosterone gel should be promptly discontinued until the cause of virilization wndrogel been identified. 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 androyel 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 li venous thromboembolic events, including deep vein thrombosis DVT and pulmonary embolism PEin patients using testosterone products such as AndroGel 1.
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 AndroGel 1. 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 MACEsuch 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 qndrogel this possible risk when deciding whether to use or to continue to use AndroGel 1. Ip has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions [see Drug Abuse and Dependence 9 ].
If testosterone abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range.
However, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events.
Due to the lack of controlled evaluations in women and potential virilizing effects, AndroGel 1. With large doses of exogenous androgens, including AndroGel 1. Prolonged use of high doses of orally active alpha-alkyl androgens e. Peliosis hepatis can be a life-threatening or fatal complication. Long-term therapy with intramuscular testosterone enanthate has produced multiple hepatic adenomas. Androgens, including AndroGel 1. Edema, with or without congestive heart failure, may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease [see Adverse Reactions 6.
Gynecomastia may develop and persist in patients being treated ;i androgens, including AndroGel 1. The treatment of hypogonadal men with testosterone may potentiate sleep apnea in some patients, especially those with risk factors sndrogel as obesity or chronic lung diseases.
Changes in serum lipid profile may require dose adjustment or discontinuation of testosterone therapy. Regular monitoring of serum calcium concentrations is recommended in these patients. Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.
Alcohol based products, including AndroGel 1. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials abdrogel another drug and may not reflect the rates observed in practice.
The first phase was a multi-center, randomized, double-blind, parallel-group, placebo-controlled period of days, in which hypogonadal men were treated with AndroGel 1. Patients could continue in an open-label, non-comparative, maintenance period for an additional days [see Clinical Studies The most common adverse reaction reported in the double-blind period was increased prostate specific antigen PSA reported in 26 AndroGel 1.
During the day, double-blind period of the clinical trial, the mean change in serum PSA value was 0.
The other three patients did not undergo repeat PSA testing. During the day, open-label period of the study, the mean change in serum PSA values was 0. The other patient did not undergo repeat PSA testing. Among previous placebo patients, 3 of 28 During the day, double-blind period of the clinical trial, 25 AndroGel 1.
These adverse reactions included 17 patients with PSA increased and 1 report each of: During the day, open-label period, 9 patients discontinued treatment because of adverse reactions.
These adverse reactions included 6 reports of PSA increased, 2 of hematocrit increased, and 1 each of triglycerides increased and prostate cancer. Neither of these patients discontinued the study due to application site adverse reactions. None of these subjects were discontinued from the study due to application site reactions. Because the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure Table 5.
Secondary Exposure to Testosterone in Children. Cases of secondary exposure to testosterone resulting in virilization of children have been reported in postmarketing surveillance of testosterone gel products. Signs and symptoms of these reported cases have included enlargement of the clitoris with surgical intervention or the penis, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age.
In most cases with androhel reported outcome, these signs and symptoms were reported to have regressed with removal of the testosterone gel exposure. In a few cases, however, enlarged genitalia did not fully return to age appropriate normal size, and bone age remained modestly greater than chronological age. In some of the cases, direct contact with the sites of application on the skin of men using testosterone gel was reported.
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 decrease insulin requirements. Changes in anticoagulant activity may be seen with androgens, therefore more frequent monitoring of international normalized ratio INR and prothrombin time are recommended in patients taking anticoagulants, especially at the initiation and termination of androgen therapy.
The concurrent use of testosterone with adrenocorticotropic hormone ACTH or corticosteroids may result in increased fluid retention and requires careful monitoring particularly in patients with cardiac, renal or hepatic disease. Pregnancy Category X [see Contraindications 4 ]: Testosterone is teratogenic and may cause fetal harm.
Exposure of a fetus to androgens may result in varying degrees of virilization. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be made aware of the potential hazard to the fetus.
Although it is not known how much testosterone transfers into human milk, AndroGel 1. Testosterone and other androgens may adversely affect lactation [see Contraindications 4 ]. The safety and effectiveness of AndroGel 1.