TESTOSTERONE REPLACEMENT THERAPY

Transcription

1 TESTOSTERONE REPLACEMENT THERAPY Testosterone is the hormone responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These include the growth and maturation of the prostate, seminal vesicles, penis, and scrotum; development of male hair distribution (eg, facial, pubic, chest, and axillary hair); laryngeal enlargement; vocal cord thickening; and alterations in muscles and body fat. Male hypogonadism (also known as testosterone deficiency) results from insufficient secretion of testosterone and is characterized by low serum testosterone concentrations. Symptoms associated with male hypogonadism include impotence and decreased sexual desire, fatigue and loss of energy, depressed mood, and regression of secondary sexual characteristics. You have been prescribed testosterone replacement therapy because you have been diagnosed with male hypogonadism, a condition caused by your body not producing enough testosterone. Testosterone comes in different formulations. This MedscapeCME clinical practice tool will provide you with information on a number of formulations that are available in the United States. Working closely with your healthcare provider will enable you to choose the formulation that is best for you. Men with breast cancer or with known or suspected prostate cancer should not use testosterone replacement therapy. Women should also not use these medications.

2 PATCH FORMULATIONS Androderm Available as transdermal patches that deliver 2.5 milligrams or 5 milligrams of testosterone Recommended starting dose for adult males: 5 milligrams once daily Instructions for Proper Usage Apply the patch nightly to a clean, dry, non-oily area of skin on the back, abdomen, upper arm, or thigh Do not apply the patch to the scrotum. Do not apply the patch to any bony areas or other areas that might undergo prolonged pressure while you are asleep or sitting. Those areas include the deltoid region of the upper arm, the hip bone, and the ischial tuberosity ( butt bones ). Some men who have put the patch on these sites have had burn-like blister reactions.

3 Using the Transdermal Patch Effectively Apply the patch immediately after opening the pouch and removing the protective release liner. Press the patch firmly in place, making sure that there is good contact with the skin, especially around the patch's edges. Change the location where you apply the patch, and do not use the same location any more than once a week. The occlusive backing on the patch prevents others from coming in contact with the testosterone in the patch. You can keep the patch on while showering or bathing and during sexual intercourse. Things to Consider When Using the Transdermal Patch The most common adverse events reported in medical trials were skin reactions where the patch was placed. These included mild-to-moderate redness, hardening of the skin (induration), itching, burn-like blisters, and the formation of vesicles (fluid-filled sacs). Mild skin irritation may be helped by applying over-the-counter topical hydrocortisone cream after removing the patch. Skin burns have been reported in patients wearing a patch containing aluminum while in an MRI (magnetic resonance imaging) machine. Because this testosterone patch contains aluminum, it is recommended that you remove it before getting an MRI. Make sure to speak with your healthcare provider to understand all risks and benefits of this particular formulation if you choose to use it.

4 Striant Available in a buccal patch that sticks to the area between your cheek and gum and delivers 30 milligrams of testosterone Recommended starting dose for adult males: 30 milligrams twice daily Instructions for Proper Usage Insert a new patch twice a day, once in the morning and once at night (about 12 hours apart) You may find it convenient to apply your morning patch after brushing your teeth following breakfast, and the evening patch after dinner. The patch should not be chewed or swallowed. Apply the next patch approximately 12 hours after the original patch was applied. (For example, if you applied a patch at 9 AM, the next patch would be applied at 9 PM). If the patch does not stick or if it falls off within the first 8 hours of application, remove the original patch and apply a new one. This new patch will serve as replacement for that same dose. The next patch after this should be applied when the original 12 hours is finished (based on when the initial patch was placed), not 12 hours after the replacement was put on. If the patch falls off after 8 hours but before 12 hours, remove the patch and apply a new one. This replacement serves as the next dose. The next patch after this should be applied 12 hours later. It is okay if the patch sticks to your cheek and not your gum. There is no need to replace the patch if this happens. Make sure to check that the patch is in place after brushing your teeth, using mouthwash, or eating/drinking.

5 Using the Buccal Patch Effectively Clinical Practice Tool Push one patch out of the rear of the blister card. You will notice that the patch is curved on one side and flat on the other side. Before you apply the patch, locate the area on your upper gum, just above either the left or right incisor (see picture below; the incisor is the tooth just to the right or left of your two front teeth). Place the flat side of the patch on your fingertip and gently push the curved side against your upper gum. Push the patch up as high as it will go on the gum; if you have applied it correctly, the flat side will be facing your cheek. Using your finger on the outside of your upper lip, hold the patch in place for 30 seconds (see picture below); this will make the patch stick to your gum or cheek. As the patch absorbs moisture from your mouth, it will begin to soften and will mold to the shape of your gum. The patch will not dissolve completely but will remain in place for 12 hours. Remove the patch by gently sliding it to the front or back of your mouth to loosen it. Then slide it downwards from your gum to your tooth. This will prevent scratching of the gum. With each application of the patch, use the opposite side of your mouth from the previous patch application. This patch may cause any of the following side effects: Redness, irritation, swelling, and pain at the gum application site Gum infection (gingivitis) Change in how food tastes; a bitter or unusual taste in your mouth Headache

6 Note that gum-related side effects are usually temporary and should resolve within several days. However, some gum-related side effects may last up to 2 weeks. Check your gums regularly and report anything abnormal to your healthcare provider. Make sure to speak with your healthcare provider to understand all risks and benefits of this particular formulation if you choose to use it.

7 GEL FORMULATIONS Testim 1% Available in a 5-gram single-use tube Recommended starting dose for adult males: 5 grams once daily Instructions for Proper Usage Apply the gel once a day (preferably in the morning) to a clean, dry, intact area of skin on the shoulders or upper arms Do not use the gel on the abdomen or genitals (eg, penis or scrotum) If you shower or bathe in the morning, use the gel afterward. Make sure that you wash your hands with soap and water immediately after you apply the gel so that you don't spread it to others. Let the gel dry completely before you dress. Cover the area you apply the gel to with clothing only after it's dry Wait at least 2 hours before bathing, showering, or swimming so that you can absorb the proper dose of the medication into your system. Avoid skin contact (where the gel is applied) with others. If there is skin contact, the area on that person's skin should be washed with soap and water as soon as possible.

8 Using the Single-Use Tube Effectively Clinical Practice Tool Unscrew the cap and use the plastic spike (located in the recessed portion of the cap) to puncture the tube seal. Squeeze the entire contents of the tube into the palm of the hand and immediately apply and rub in to the shoulders and/or upper arms. Make sure to speak with your healthcare provider to understand all risks and benefits of this particular formulation if you choose to use it.

9 AndroGel 1% Available in a 75-gram pump and in 2.5-gram and 5-gram single-use packets Recommended starting dose for adult males: 5 grams once daily Instructions for Proper Usage Apply the gel once a day (preferably in the morning) to a clean, dry, intact area of skin on the shoulders, upper arms, and/or abdomen Do not use the gel on the genitals (eg, penis or scrotum) or on skin that has an open wound, sore, or irritation. If you shower or bathe in the morning, use the gel afterwards. Make sure that you wash your hands with soap and water immediately after you apply the gel so that you don't spread it to other people. Let the gel dry completely before you dress.

10 The areas of application should be covered by clothing once they are dry. Avoid skin contact (where the gel is applied) with others. If there is skin contact, the area on that person's skin should be washed with soap and water as soon as possible. This product is alcohol based, which is flammable until dry. Be sure to allow the gel to dry before smoking or going near an open flame. After applying the gel, wait 5-6 hours before bathing, showering, or swimming so that you can absorb the proper dose of the medication into your system. Using the Pump Effectively Prime the pump the first time you use it by pushing the plunger all the way down 3 times and discarding what comes out. This will prepare the pump for use. Next, press the plunger all the way down, pumping the gel onto your hand. This will give you 1.25 grams of the medication. For a 5-gram dose, you will need to complete a total of 4 pumps. Rub the gel onto the surfaces of your shoulders, upper arms, and/or abdomen. Alternatively, you may apply the gel directly to the skin of these areas and rub it into the skin. Wash your hands with soap and water after you apply the gel so that you don't spread it to other people. Using the Single-Use Packet Effectively The entire contents of the packet should be squeezed into the palm of the hand and immediately applied to your shoulders, upper arms, and/or abdomen. Alternatively, you may squeeze a portion of the gel from the packet into the palm of the hand and apply to an application site, rubbing it into the skin. Repeat until all the gel in the packet has been applied. Make sure to speak with your healthcare provider to understand all risks and benefits of this particular formulation if you choose to use it.

11 INJECTABLE AND SUBCUTANEOUS FORMULATIONS Delatestryl and Depo -Testosterone Available as intramuscular injectables There are a number of formulations of testosterone that are given by injection, including Delatestryl (testosterone enanthate) and Depo -Testosterone (testosterone cypionate). These formulations are given with a needle deep into the gluteal muscle (ie, intramuscular ). The injection should be given slowly and you must avoid injecting into a blood vessel Recommended starting dose for adult males: The dosage and frequency of administration can vary depending on age, but a common dosage is milligrams every 2 weeks. The dosage is adjusted according to your response and/or in the event of adverse reactions. Things to Consider When Using Testosterone Injection There have been rare reports of temporary reactions involving the urge to cough, coughing fits, and respiratory distress immediately after the injection of Delatestryl. Make sure to speak with your healthcare provider to understand all risks and benefits of this particular formulation if you choose to use it.

12 Recommended starting dose for adult males: milligrams subcutaneously every 3-6 months To calculate the amount of testosterone needed based on an intramuscular formulation, consider the following: Implant two 75-milligram pellets for each 25 milligrams of injectable testosterone required weekly. For example, if a patient requires injections of 75 milligrams per week, it is usually necessary to implant 450 milligrams (6 pellets). With injections of 50 milligrams per week, implantation of 300 milligrams (4 pellets) may suffice for approximately 3 months. It has been found that approximately 1/3 of the material is absorbed in the first month, 1/4 in the second month, and 1/6 in the third month. Adequate effect of the pellets ordinarily continues for 3-4 months and sometimes as long as 6 months. Administering the Subcutaneous Pellets Testopel Available as a pellet, placed under the skin, that delivers 75 milligrams of testosterone This formulation of testosterone comes in a pellet that is 1/8 of an inch in diameter and approximately 1/3 of an inch long. Testosterone pellets are implanted just below the skin, in your fat layer. Your healthcare provider will numb the area with local anesthetic delivered through a needle. The pellets are placed 3-4 inches below your beltline, approximately level with the top of your rear hip pocket After the pellets are implanted, the site can be closed with Steri-Strips TM (stitches are not needed). Make sure to speak with your healthcare provider to understand all risks and benefits of this particular formulation if you choose to use it.

13 Laboratory Monitoring Clinical Practice Tool Your healthcare provider should monitor your blood periodically for a number of different things, including: Serum testosterone Prostate-specific antigen (PSA) Hemoglobin and hematocrit INR (international normalized ratio) and prothrombin time Liver function Lipids (total cholesterol and HDL cholesterol) Glucose levels may be lowered in patients taking testosterone therapy; therefore, patients with diabetes may need adjustments to their insulin dosages. Potential Side Effects Side effects may occur when taking testosterone replacement therapy. These include: Liver problems: Your skin and/or the whites of your eyes turn yellow (jaundice). Your urine turns dark. Your bowel movements turn light in color. You don't feel like eating for several days or more. You feel sick to your stomach (nausea) or vomit. You have pain in your abdomen. Problems with urination: Increased urination both during the day and at night. Trouble starting your urine stream. Having an urge to go to the bathroom right away. Having a urine accident. Being unable to pass urine and/or having a weak urine flow. Extra fluid in the body (edema): Edema is swelling caused by extra fluid; this can be dangerous, especially if you have heart, kidney, or liver problems.

14 Breathing problems during sleep (sleep apnea): People with sleep apnea stop breathing for short periods of time while they are sleeping. This happens more often in patients who are overweight or who have lung disease. Penile erections that are painful, that occur too frequently, or that last for a prolonged period of time. Prostate enlargement/prostate cancer Older men using testosterone replacement therapy may have a higher risk of developing an enlarged prostate. Any man with risk factors associated with an increased likelihood of developing prostate cancer should be evaluated for the presence of prostate cancer before starting testosterone replacement therapy, as this therapy may promote the growth of existing subclinical prostate cancer. Men receiving testosterone replacement therapy should be monitored for prostate cancer according to the same guidelines used for men not taking testosterone. Breast enlargement (gynecomastia) that sometimes does not go away. Emotional changes such as depression, anxiety, and increased or decreased libido ( sex drive ). These are not all of the possible adverse effects that could occur when taking testosterone. If you experience any problems while on this medication, contact your healthcare provider.

15 Bhasin S, Cunningham GR, Hayes FJ, et al, for the Androgen Deficiency Syndromes in Men Guideline Task Force. Testosterone therapy in adult men with androgen deficiency syndromes: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2006;91: Depo -Testosterone [package insert]. Kalamazoo, Mich: Pharmacia & Upjohn Company; Food and Drug Administration. Androderm prescribing information. Available at: Accessed August 3, Food and Drug Administration. AndroGel prescribing information. Available at: df Accessed August 3, Food and Drug Administration. Delatestryl prescribing information. Available at: Accessed August 3, Food and Drug Administration. Striant prescribing information. Available at: Accessed August 3, Food and Drug Administration. Testim prescribing information. Available at: Accessed August 3, Petak SM, Nankin HR, Spark RF, et al, for the AACE Hypogonadism Task Force. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the evaluation and treatment of hypogonadism in adult male patients 2002 update. Endocr Pract. 2002;8: Testopel [prescribing information]. Rye, NY: Bartor Pharmacal Co., Inc.; 2009.