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Testosterone Release: Please read and sign

Indications and Usage for Testosterone Cypionate

Testosterone Cypionate Injections, USP is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone.

Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy.

Hypogonadotropic hypogonadism (congenital or acquired)-idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma or radiation.

Contraindications

  • Known hypersensitivity to the drug
  • Males with carcinoma of the breast
  • Males with known or suspected carcinoma of the prostate gland
  • Women who are or who may become pregnant
  • Patients with serious cardiac, hepatic or renal disease

Warnings

Hypercalcemia may occur in immobilized patients. If this occurs, the drug should be discontinued. Prolonged use of high doses of androgens (principally the 17-a alkyl- androgens) has been associated with development of hepatic adenomas, hepatocellular carcinoma, and pelisses hepatis - all potentially life threatening complications.

Geriatric patients treated with androgens may be at an increased risk of developing prostatic hypertrophy and prostatic carcinoma although conclusive evidence to support this concept is lacking. Edema, with or without congestive heart failure, may be a serious complication in patients with pre-easting cardiac, renal or hepatic disease.

Gynecomastia may develop and occasionally persists in patients being treated for hypogonadism. This product contains benzyl alcohol, Benzyl alcohol has been reported to be associated with a fatal “Gasping Syndrome” in premature infants.

Androgen therapy should be used cautiously in healthy males with delayed puberty. The effect on bone maturation should be monitored by assessing bone age of the wrist and hand every 6 months. In children, androgen treatment may accelerate bone maturation without producing compensatory gain in linear growth. This adverse effect may result in compromised adult stature. The younger the child the greater the risk of compromising final mature height.

This drug has not been shown to be safe and effective for the enhancement of athletic performance. Because of the potential risk of serous adverse health effects, this drug should not be used for such purpose.

Precautions

General

Patients with benign prostatic hypertrophy may develop acute urethral obstruction. Priapism or excessive sexual stimulation may develop. Oligospermia may occur after prolonged administration or excessive dosage. If any of these effects appear, the androgen should be stopped and if restarted, a lower dosage should be utilized.

Testosterone Cypionate should not be used interchangeably with testosterone propionate because of differences in duration of action. Testosterone Cypionate is not for intravenous use.

Information for patients

Patients should be instructed to report any of the following: nausea, vomiting, changes in skin color, ankle swelling, too frequent or persistent erections of the penis.

Laboratory tests

Hemoglobin and hematocrit levels (to detect polycythemia) should be checked periodically in patients receiving long-term androgen administration.
Serum cholesterol may increase during androgen therapy.

Drug interactions

Androgens may increase sensitivity to oral anticoagulants. Dosage of the anticoagulant may require reduction in order to maintain satisfactory therapeutic hypoprothrombinemia.

Concurrent administration of oxypenbutazone and androgens may result in elevated serum levels of oxypenbutazone.

In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements.

Drug/laboratory test interferences

Androgens may decrease levels of thyroxine-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.

Carcinogenesis

Animal Data

Testosterone has been tested by subcutaneous injection and implantation in mice and rats. The implant induced cervical-uterine tumors in mice, 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 are 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. Geriatric patients treated with androgens may be at an increased risk of developing prostatic hypertrophy and prostatic carcinoma although conclusive evidence to support this concept is lacking.

Pregnancy

Teratogenic Effects

Pregnancy Category X (see contraindications above) Nursing mothers

Testosterone cypionate injection is not recommended for use in nursing mothers.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 12 years have not been established.

Adverse Reactions

The following adverse reactions in the male have occurred with some androgens:

  • Endocrine and urogenital: Gynecomastia and excessive frequency and duration of penile erections. Oligospermia may occur at high dosages.
  • Skin and appendages: Hirsutism, male pattern baldness, seborrhea, and acne.
  • Fluid and electrolyte disturbances: Retention of sodium, chloride, water, potassium, calcium and inorganic phosphates.
  • Gastrointestinal: Nausea, cholestatic jaundice, alterations in liver function tests, rarely hapatocellular neoplasms and pelisses hepatic (see WARNINGS).
  • Hematologic: Suppression of clotting factors II, V, VII and X, bleeding in patients on concomitant anticoagulant therapy, and polycythemia.
  • Nervous system: Increased or decreased libido, headache, anxiety, andxiety, depression and generalized paresthesia.
  • Allergic: Hypersensitivity, including skin manifestations and anaphylactoid factions.

Miscellaneous: Inflammation and pain at the site of intramuscular injection.

I understand that VRC and Staff will use and/or disclose my personal health information for the sole purpose of carrying out treament, obtaining payment, evaluation the quality of services provided and any administrative operations. I understand that I have the right to restrict how my information is used for treament, payment, or administrative operations if I notify the practice of my wishes. I understand that VRC and Staff does not allow the use of my information for marketing, fundraising, solicitation, or research studies. I hereby consent to the use and disclosure of my personal health information for the provision of treatment, facilitation of payment, evaluation of service quality, or administrative operations.

I hereby release VRC and Staff, his medical staff and technicians from any liability arising out of the services associated with treatments received from TRT. I certify that the preceding medical and personal history are true and correct. I am aware of the above stated office policies and will abide by them. I am aware that it is my responsibility to inform VRC and Staff of any medical changes, health changes, new or changed medications as this will alter the results of my treatment. A current medical history is essential for the caregiver to execute the appropriate treatment procedures.

Today's Date: January 2, 2025

First Participant's Name

First Name*

Last Name*
First Participant's Age Acknowledgment*
First Participant's Date of Birth*
I certify that I am 18 years of age or older
First Participant's Information
I have not had a prostate exam and am declining to have one before starting Testosterone Replacement Therapy. I want to refuse this exam at this time and take full responsibility for any prostate abnormality in the future.*
No
Yes
First Participant's Signature*
Second Participant's Name

First Name*

Last Name*
Second Participant's Date of Birth*
Second Participant's Information
I have not had a prostate exam and am declining to have one before starting Testosterone Replacement Therapy. I want to refuse this exam at this time and take full responsibility for any prostate abnormality in the future.*
No
Yes
Third Participant's Name

First Name*

Last Name*
Third Participant's Date of Birth*
Third Participant's Information
I have not had a prostate exam and am declining to have one before starting Testosterone Replacement Therapy. I want to refuse this exam at this time and take full responsibility for any prostate abnormality in the future.*
No
Yes
Fourth Participant's Name

First Name*

Last Name*
Fourth Participant's Date of Birth*
Fourth Participant's Information
I have not had a prostate exam and am declining to have one before starting Testosterone Replacement Therapy. I want to refuse this exam at this time and take full responsibility for any prostate abnormality in the future.*
No
Yes
Fifth Participant's Name

First Name*

Last Name*
Fifth Participant's Date of Birth*
Fifth Participant's Information
I have not had a prostate exam and am declining to have one before starting Testosterone Replacement Therapy. I want to refuse this exam at this time and take full responsibility for any prostate abnormality in the future.*
No
Yes
Sixth Participant's Name

First Name*

Last Name*
Sixth Participant's Date of Birth*
Sixth Participant's Information
I have not had a prostate exam and am declining to have one before starting Testosterone Replacement Therapy. I want to refuse this exam at this time and take full responsibility for any prostate abnormality in the future.*
No
Yes
Seventh Participant's Name

First Name*

Last Name*
Seventh Participant's Date of Birth*
Seventh Participant's Information
I have not had a prostate exam and am declining to have one before starting Testosterone Replacement Therapy. I want to refuse this exam at this time and take full responsibility for any prostate abnormality in the future.*
No
Yes
Eighth Participant's Name

First Name*

Last Name*
Eighth Participant's Date of Birth*
Eighth Participant's Information
I have not had a prostate exam and am declining to have one before starting Testosterone Replacement Therapy. I want to refuse this exam at this time and take full responsibility for any prostate abnormality in the future.*
No
Yes
Ninth Participant's Name

First Name*

Last Name*
Ninth Participant's Date of Birth*
Ninth Participant's Information
I have not had a prostate exam and am declining to have one before starting Testosterone Replacement Therapy. I want to refuse this exam at this time and take full responsibility for any prostate abnormality in the future.*
No
Yes
Tenth Participant's Name

First Name*

Last Name*
Tenth Participant's Date of Birth*
Tenth Participant's Information
I have not had a prostate exam and am declining to have one before starting Testosterone Replacement Therapy. I want to refuse this exam at this time and take full responsibility for any prostate abnormality in the future.*
No
Yes
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Parent(s) or court-appointed legal guardian(s) must sign for any participating minor (those under 18 years of age) and agree that they and the minor are subject to all the terms of this document, as set forth above.


By signing below the parent or court-appointed legal guardian agrees that they are also subject to all the terms of this document, as set forth above.
Parent or Guardian's Name

First Name*

Last Name*

Phone*
Parent or Guardian's Age Acknowledgment*
Parent or Guardian's Date of Birth*
I certify that I am 18 years of age or older
Parent or Guardian's Information
I have not had a prostate exam and am declining to have one before starting Testosterone Replacement Therapy. I want to refuse this exam at this time and take full responsibility for any prostate abnormality in the future.*
No
Yes
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