Testosterone Replacement Therapy for the Aging Male

Testosterone Replacement Therapy for the Aging Male: Counseling

Insights for the Pharmacist Event Type Live Online ACPE Expiration Date 7/17/2016 Credits 1 Contact Hour Target Audience Nurses, Pharmacists, Pharmacy Technicians

Program Overview

Testosterone deficiency afflicts approximately 30% of men aged 40-79 years, with an increase

in prevalence strongly associated with aging and common medical conditions including obesity,

diabetes, and hypertension. Recent estimates show that approximately 13 million men in the

United States experience testosterone deficiency and less than 10 percent receive treatment

for the condition. Restoring testosterone levels to within the normal range by using

testosterone replacement therapy (TRT) can greatly improve quality of life. However, potential

risks for TRT exist.

Pharmacists should play a proactive role in identifying, treating, educating and monitoring

patients with low testosterone levels. Pharmacists are in a unique and influential position to

help recognize low testosterone patients and initiate patient and health care provider

treatment and education. With increasing focus on quality of life and increasing prevalence of

age-related conditions, pharmacists will find themselves dispensing more hormone

replacement products, in addition to information about the actual condition and the expected

effects of treatment.

Pharmacist Educational Objectives

Compare and contrast the mechanisms of action and roles of the medications used to treat

asthma

Provide patient counseling related to the proper use of devices used to deliver medications

used to treat asthma

Describe the role of the pharmacist in helping patients with asthma achieve optimal results

Activity Type

Knowledge

Accreditation

Pharmacist 0798-0000-13-174-L01-P

PharmCon, Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

PharmCon, Inc. has been approved as a provider of continuing education for nurses by the Maryland Nurses Association which is accredited as an approver of continuing education in nursing by the American Nurses Credentialing Center’s Commission on Accreditation.

Faculty

Tim Drake, PharmD, BCPS Associate Professor, Roseman University South Jordan, Utah Campus

Financial Support Received From

AbbVie Inc

Disclaimer

PharmCon, Inc. does not view the existence of relationships as an implication of bias or that the

value of the material is decreased. The content of the activity was planned to be balanced and

objective. Occasionally, authors may express opinions that represent their own viewpoint.

Participants have an implied responsibility to use the newly acquired information to enhance

patient outcomes and their own professional development. The information presented in this

activity is not meant to serve as a guideline for patient or pharmacy management. Conclusions

drawn by participants should be derived from objective analysis of scientific data presented

from this activity and other unrelated sources.

Testosterone Replacement Therapy for the Aging Male: Counseling Insights for the Pharmacist

© 2013 Pharmaceutical Education Consultants, Inc. unless otherwise noted. All rights reserved.

Reproduction in whole or in part without permission is prohibited.

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8/5/2013 1


Tim Drake PharmD, BCPS

This activity is supportedby an educational grantfrom AbbVie Inc.

8/5/2013 2This activity is supportedby an educational grantfrom AbbVie Inc.


AccreditationPharmacists: 0798-0000-13-174-L01-P

Faculty

Tim DrakePharmD, BCPSAssociate Professor,Roseman University South Jordan, Utah Campus

CE Credit(s)1.0 contact hour(s)

Faculty DisclosureDr. Drake has no actual or potential conflicts of interest in relation to this program.

Learning Objectives• Review the prevalence, epidemiology and pathophysiology of testosterone deficiency• Outline the risks, benefits, efficacy, and routes of administration for availabel testosterone replacement therapy (TRT)• Identify emerging TRT, including their potential risks and benefits• Counsel patients on the proper administration/application of TRT

Legal DisclaimerThe material presented here does not necessarily reflect the views of Pharmaceutical Education Consultants (PharmCon) or the companies that support educational programming. A qualified healthcare professional should always be consulted before using any therapeutic product discussed. Participants should verify all information and data before treating patients or employing any therapies described in this educational activity.

PharmCon is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing education.

Objectives

• Review the prevalence, epidemiology, and pathophysiology of testosterone deficiency

• Outline the risks, benefits, efficacy, and routes of administration for available testosterone replacement therapy (TRT)

• Identify emerging TRT, including their potential risks and benefits

• Counsel patients on the proper administration/application of TRT


Prevalence and Epidemiology

– The European Male Aging Study - a steady decrease of 0.4% per year of total testosterone and 1.3% per year of free testosterone (sex hormone binding globulin (SHBG) increases with age)

– The Baltimore Longitudinal Study of Aging - 20% of men at age 60 had a total testosterone < 325 ng/dl and that by age 80, this increased to 50%




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Pathophysiology - Hypogonadism

– Failure of the testis to produce a sufficient physiological level of testosterone due to a disruption of one or more levels of the hypothalmic-pituitary-testicular axis

– Primary, secondary or a combination of both

J Clin Endocrinol Metab, June 2010, 95(6):2536-2559


Pathophysiology

• Primary

– Failure of the testis

– Low testosterone levels

– Low sperm

– Elevated gonadotropin levels

• Secondary

– Failure of the hypothalmus or pituitary

– Low testosterone

– Low sperm

– Low or low-normal gonadotropin levels



Age-related decline in testosterone

–Both primary and secondary

–Average decline in testosterone is 1-2% per year

J Clin Endocrinol Metab 93:2737-2735


Other things that can affect

testosterone levels

– Circadian and circannual rhythms

– Illness

– Medications

– SHBG concentrations




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Conditions That Alter SHBG

Increase SHBG– Aging

– Hepatitis

– Hyperthyroidism

– Use of anticonvulsants

– Use of estrogens

– HIV

Decrease SHBG– Obesity

– Nephrotic syndrome

– Hypothyroidism

– Use of glucocorticoids, progestins and androgenic steroids

– Acromegaly

– Diabetes Melitus



Symptoms associated with deficiency

– Decreased libido

– Breast discomfort

– Loss of body hair

– Shrinking testes

– Low or zero sperm count

– Loss of BMD

– Hot flushes



Less specific symptoms

– Decreased energy, drive, self-confidence

– Depressed feelings

– Poor concentration and memory

– Sleep disturbances

– Mild anemia

– Reduced muscle bulk and strength

– Increased BMI and body fat

– Diminished physical or work performance



Diagnosis

• General threshold level at which symptoms start to occur is unknown

• For most symptoms, the threshold is equal to the lower level of the normal range for young men (300 ng/d)

• Screening not necessary.





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Diagnosis

• 2 separate morning tests of total testosterone

• If high SHBG is suspected, or if the total testosterone level is low-normal, then test free testosterone

• Test LH and FSH to rule out secondary causes

• Rule out other reversible causes of testosterone deficiency



Testosterone Therapy – Potential Benefits

Young Men Symptom Older Men

++ Libido +

Inconsistent effects Erectile Dysfunction Inconsistent effects

Inconsistent effects Self Reported Sexual Satisfaction

Inconsistent effects

+ BMD Slight +

Unknown Fractures Unknown

++ Lean Body Mass ++

+ Mood +

Not studied Cognition No effect

Not studied Lipids No effect



Adverse Effects

• Strong testosterone associated side effects– Erythrocytosis– Acne and oily skin– Detection of subclinical prostate cancer– Growth of metastatic prostate cancer– Reduced sperm production and fertility– Increased PSA

• Weak testosterone associated side effects– Gynecomastia– Male pattern balding– Growth of breast cancer– Sleep apnea J Clin Endocrinol Metab, June 2010, 95(6):2536-2559


Contraindications

• Metastatic prostate cancer

• Breast cancer





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Precautions

• Unevaluated prostate nodule or induration

• PSA> 4ng/ml (>3ng/ml in individuals at high) risk for prostate cancer

• Hematocrit >50%

• Severe BPH symptoms

• Uncontrolled or poorly controlled CHF

• Liver dysfunction



Testosterone Replacement Products

• Patches

– Androderm®

• Topical Gels

– Androgel®

– Testim®

– Fortesta®

• Topical Solution

– Axiron®

• Injectable

– Depo-Testosterone®**

– Delatestryl®**

– Testopel®

• Oral products

– Striant®

– Methitest®

– Android®

**Available generically


Testosterone Patches

• Available in 2 and 4mg/day

• Recommended starting dose 4mg/day

• Increase to 6mg/day or reduce to 2mg/day in 2 weeks after measuring total testosterone

• Test testosterone 3-12 hours after the application of a new patch

Watson Pharma. (2013). Androderm, Prescribing information. Parsippany, NJ.


Patches - Application

– clean dry area

– upper arms, back, abdomen or thighs

– 3 hours before showering or swimming

– Same time each day

– Site rotated daily

– If the patch becomes loose, press and smooth down the edges

– If the patch falls off, do not reapply.

– If the patch falls off with more than 6 hours remaining before the next application, apply a new patch





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Patches - Other Counseling Points

– Can use hydrocortisone 1% cream on areas that become red or itchy

– Remove patches before a MRI

– Remove the old patch before applying a new one



Patch Specific Side Effects

Frequent skin reactions at the application site



Topical Gels

• Androgel® 1% and 1.62% gel

• Testim® 1% gel

• Fortesta® 2% gel


Topical Gels

• All products carry the warning of the potential for transfer to a female partner or child

• All gels flammable until they are dry

• Small risk of skin irritation

• Test testosterone anytime after the patient has been using the product for at least 1 week

Auxilium Pharma . (2011). Testim, Prescribing information. Malvern, PAAbbvie Pharma. (2013). Androgel, Prescribing Information. North Chicago, IL .




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Testim® and Androgel®

• Apply to the shoulders or upper arms on the areas that would be covered by a T-shirt.

• Do not apply to the chest, abdomen or other parts of the body

• Let dry before putting on clothes

• Apply at least 2 hours before swimming, bathing or showering to allow for absorption

• Wash hands with soap and water after application

Auxilium Pharma . (2011). Testim, Prescribing information. Malvern, PAAbbvie Pharma. (2013). Androgel, Prescribing Information. North Chicago, IL .


Fortesta®

• More concentrated

• Apply to the thigh area


Topical Solution -Axiron®

– Topical testosterone solution

–30mg of testosterone per 1.5 ml

Eli Lilly and Company. (2011) AxironPrescribing Information. Indianapolis, IN


Testosterone Topical Solution

• Risk of transfer (same warnings and precautions as gels)

• Product flammable until dry

• Test levels anytime after the patient has been on the medication for at least 1 week





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Topical Solution

• 30 mg dose – 1 pump to the application device and apply to only 1 armpit

• 60 mg dose – 1 pump to the application device and apply to 1 armpit and then repeat with the other armpit

• 90 mg – Repeat the 60mg directions and then wait for the product to dry and apply 1 more pump using the application device to 1 armpit

• 120 mg – Repeat the 60mg directions and then wait for the product to dry and then repeat the process to both armpits.



Injectable Testosterone - Testopel

– Long acting pellets - implanted into the cutaneousfat space

– In-office procedure

– Dose depends on the number of pellets used

– Effects last 3-6 months

– Estimated that 1/3rd of the material is absorbed in the first month, ¼ in the second and 1/6th in the third

– Test testosterone at the end of the treatment cyclewww.slatepharma.com


Injectable Testosterone

Testosterone cypionate and enanthate– Doses range from 150-200mg injected IM every 2

weeks to 75-100mg injected weekly

– Peaks and valleys in testosterone levels

– Usually patients are supratherapeutic shortly after the shot and then testosterone levels decline gradually until the next dose

– Watch for a possible cough after injections

– Test levels midway between injections

– If crystals form in the vial, warm and roll the vial in your hands until the crystals dissolve



IM Injection

• Testosterone should be given IM in the glutealmuscle

• Use ventrogluteal site– Avoids major veins , arteries, & nerves– Thinner subcutaneous fat layer– Do not need to aspirate

• Can inform patients to use a 21 gauge needle to remove the medication and then a 23 gauge needle to inject the testosterone

• Needle size - 1.5 inches

Perry AG, Potter PA: Clinical nursing skills & techniques, ed 7, St. Louis, 2010, Mosby: 598-599




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IM injection

Perry AG, Potter PA: Clinical nursing skills & techniques, ed 7, St. Louis, 2010, Mosby: 598-599


Process for Injecting 1ml of Testosterone• Clean the injection site• Using the syringe with the 21 gauge needle, draw up 1 ml of air into

the syringe• Push the needle into the vial with the bevel side up• Inject the air into the vial• Flip the vial over and withdraw 1.5 ml of testosterone• Without removing the needle from the vial, tap the syringe to bring

air bubbles to the top of the syringe• Push 0.5ml back into the vial• Remove the needle from the vial • Pull back on the plunger to the 2ml mark• Replace the 21 gauge needle with the 23 gauge needle• Push the plunger up slowly until there is a tiny drop of medication

at the tip of the needle• Inject the testosterone into the ventrogluteal site


Oral Testosterone

Android® and Methitest®

– 17-alpha Methyltestosterone

– Not recommended due to the potential for liver toxicity



Buccal - Bioadhesive Testosterone Tablets-

Striant®

• Adhesive tablet that adheres to the gums

• The tablet applied, rounded side down, to the area right above either incisor

• Press finger to the outside of the skin above the tablet for 30 seconds

• As the tablet absorbs water, it will become soft

• Alternate sites with each dose

• Dosed every 12 hours

• If the tablet falls off before 4 hours of the new dose, apply the new dose and leave in place until the next regularly scheduled dose

• Test testosterone levels immediately before or after placement of the tablet

Columbia Laboratories, Inc. (2004) Striant Prescribing information. Livingston, NJ.




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General Monitoring Parameters

• Monitor testosterone levels 3-6 months after initiation of therapy

• Check with patient for side effects and resolution of symptoms

• Check hematocrit at baseline, at 3-6 months and then yearly– If hematocrit is >54%, stop treatment until it decreases to

normal levels. Assess patient for sleep apnea or hypoxia. Restart therapy at a lower dose

• For patients >40 years with a baseline PSA > 0.6 ng/ml– Get PSA and DRE at baseline, 3-6 months and then in

accordance with guidelines for cancer screening

• DEXA scan to test BMD in 1-2 years if that is of concern



Possible Future Formulations

• Long acting testosterone undecanoate in oil– Can be dosed every 10-14 weeks– Serum levels are maintained in the normal range in a majority of men– Large volume IM injection (4ml)– Cough immediately after injection

• Oral testosterone undecanoate– Twice daily oral dose– No liver dysfunction– Bypasses the portal system and is absorbed in the lymphatic system– Considerable variability in testosterone levels

• In-adhesive matrix patch– Apply to patch every 2 days– Some skin irritation


Questions Left Unanswered

• Long term safety of replacing testosterone

• Outcome data with fractures, heart disease and overall health

• Good validated quality of life measures


Patient Case

M.J. is a 60 year old male who has recently began to have depressive symptoms. He feels sluggish, has decreased libido and has been gaining weight. At his annual physical, his physician decides to test his testosterone levels. They come back in the low normal range. The physician has M.J. return to the lab in 1 week and retests his total testosterone, free testosterone and SHBG.




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Patient Case

• M.J.’s total testosterone is in the low-normal range, the free testosterone is low and the SHBG is in the high-normal range.

• M.J.’s physician decides to begin testosterone therapy with testosterone gel because M.J. is deathly afraid of needles.


Counseling Points

• How to avoid person to person Contact

• Monitoring— Follow up to test levels— CBC— Baseline PSA — Digital Rectal Exam— Age 60 DEXA Scan?— Check testosterone Levels 3-6 months after therapy


NOTES:


NOTES:

Testosterone Replacement Therapy for the Aging Male

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