TESTO-CYPMAX (testosterone cypionate)


Manufacturer: Maxtreme
Category: Injectable
Substance: testosterone cypionate
Package: 250MG 10 AMPOULES/BOX


What is testosterone?

Testosterone is a naturally occurring sex hormone that is produced in a man’s testicles. Small amounts of testosterone are also produced in a woman’s ovaries and adrenal system.

Testosterone injection is used in men and boys to treat conditions caused by a lack of this hormone, such as delayed puberty, impotence, or other hormonal imbalances.

Testosterone injection is also used in women to treat breast cancer that has spread to other parts of the body.

Important information
Do not use this medicine if you are pregnant or may become pregnant.

You should not receive testosterone if you have prostate cancer, male breast cancer, a serious heart condition, or severe liver or kidney disease.

Before taking this medicine
You should not receive testosterone if you are allergic to it, or if you have:

prostate cancer;
male breast cancer;
a serious heart condition;
severe liver disease;
severe kidney disease; or
if you are pregnant or may become pregnant.
To make sure testosterone is safe for you, tell your doctor if you have:

enlarged prostate;
heart disease or coronary artery disease;
a history of heart attack, stroke, or blood clot;
high cholesterol or triglycerides (a type of fat in the blood);
breast cancer (in men, or in women who have hypercalcemia);
liver or kidney disease;
if you are bedridden or otherwise debilitated; or
if you take a blood thinner (warfarin, Coumadin, Jantoven).
This medicine can harm an unborn baby or cause birth defects. Do not use testosterone if you are pregnant or may become pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are receiving this medicine.

It is not known whether testosterone passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How is testosterone injection given?
Testosterone is injected into a muscle. A healthcare provider will give you this injection. The injection is usually given every 2 to 4 weeks.

The length of treatment will depend on the condition being treated.

Testosterone will not enhance athletic performance and should not be used for that purpose.

While receiving this medicine, you will need frequent blood tests.

Testosterone can affect bone growth in boys who are treated for delayed puberty. Bone development may need to be checked with x-rays every 6 months during treatment.

See also: Dosage Information (in more detail)

What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your injection.

What happens if I overdose?
Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving testosterone injection?
Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Testosterone side effects
Get emergency medical help if you have any signs of an allergic reaction to testosterone: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

nausea or vomiting;
changes in skin color;
increased or ongoing erection of the penis;
impotence, ejaculation problems, decreased amounts of semen, decrease in testicle size;
painful or difficult urination;
shortness of breath (even with mild exertion);
chest pain or pressure, pain spreading to your jaw or shoulder;
swelling in your ankles or feet, rapid weight gain;
signs of a blood clot in the lung – chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
signs of a blood clot in your leg – pain, swelling, warmth, or redness in one or both legs;
high levels of calcium in the blood–stomach pain, constipation, increased thirst or urination, muscle pain or weakness, joint pain, confusion, and feeling tired or restless; or
liver problems – upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Women receiving testosterone may develop male characteristics, which could be irreversible if treatment is continued. Call your doctor at once if you notice any of these signs of excess testosterone:

changes in menstrual periods;
male-pattern hair growth (such as on the chin or chest);
hoarse or deepened voice; or
enlarged clitoris.
Common testosterone side effects (in men or women) may include:

breast swelling;
headache, anxiety;
increased facial or body hair growth, male-pattern baldness;
increased or decreased interest in sex;
numbness or tingly feeling; or
pain or swelling where the medicine was injected.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect testosterone?
Other drugs may interact with testosterone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

For the Consumer

Applies to testosterone: buccal patch extended release

Other dosage forms:

intramuscular injectable, intramuscular oil, intramuscular solution, intramuscular suspension
nasal gel/jelly
transdermal patch extended release
As well as its needed effects, testosterone may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking testosterone, check with your doctor immediately:

Incidence not known
Pain, redness, or swelling in the arm or leg
trouble breathing
If any of the following symptoms of overdose occur while taking testosterone, get emergency help immediately:

Symptoms of overdose
Blurred vision
slurred speech
sudden and severe inability to speak
temporary blindness
weakness in the arm or leg on one side of the body, sudden and severe
Some testosterone side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
Gum or mouth irritation
Less common
Bad, unusual, or unpleasant (after) taste
bleeding gums
blemishes on the skin
breast pain
change in taste
dry mouth
enlarged breasts
fear or nervousness
feeling sad or empty
gum pain or blisters
itching skin
loss of appetite
loss of interest or pleasure
lower back or side pain
mouth ulcers
noisy breathing
painful or difficult urination
passing of gas
pounding in the ears
quick to react or overreact emotionally
rapidly changing moods
redness and swelling of the gums
slow or fast heartbeat
stinging of the lips
stomach cramps, pain, fullness, or discomfort
swelling of the gums
swelling of the nose
trouble concentrating
trouble sleeping
unusual tiredness or weakness

For Healthcare Professionals
Applies to testosterone: buccal film extended release, compounding powder, intramuscular solution, nasal gel, subcutaneous implant, transdermal cream, transdermal film extended release, transdermal gel, transdermal ointment, transdermal solution

The most frequently reported side effects with this drug are edema, acne, site pain, injection site erythema, cough or dyspnea during or immediately after injection.

The most frequently reported side effects with testosterone topical are skin reaction (16.1%) and allergic contact dermatitis (up to 37%).

Very common (10% or more): Testosterone topical: Skin reaction (16.1%), burn-like blisters (12%), itching, allergic contact dermatitis (up to 37%)
Common (1% to 10%): Acne, induration, burning
Uncommon (0.1% to 1%): Alopecia, erythema, rash (including rash popular), pruritus, dry skin, folliculitis (testosterone topical)
Frequency not reported: Seborrhea, urticaria, male pattern baldness, hirsutism injection site inflammation
Postmarketing reports: Angioedema, angioneurotic edema, hyperhidrosis, discolored hair, leukocytoclastic vasculitis

Very common (10% or more): Accelerated growth
Common (1% to 10%): Increased estradiol, hypogonadism
Uncommon (0.1% to 1%): Increased blood testosterone
Frequency not reported: Signs of virilization in women (e.g., hoarseness, acne, hirsutism, menstrual irregularity, clitoral enlargement, and alopecia), precocious puberty (in prepubertal males)
Postmarketing reports: Hyperparathyroidism, prolactin increased, testosterone increased

Very common (10% or more): Testosterone buccal film: Gingivitis (32.6%)
Common (1% to 10%): Diarrhea, oily stools (due to IM injection oily solvent); Testosterone topical: Gastroesophageal reflux disease, gastrointestinal bleeding, gum or mouth irritation (9.2%), taste bitter, gum pain, gum tenderness, gum edema, taste perversion
Uncommon (0.1% to 1%): Nausea
Rare (less than 0.1%): Abdominal pain
Frequency not reported: Abdominal disorder, intraabdominal hemorrhage
Postmarketing reports: Vomiting; Testosterone buccal film: Dry mouth, gingival swelling, lip swelling, mouth ulceration, stomatitis

The majority of gum-related adverse events were transient.

Very common (10% or more): Testosterone topical: Application site pruritus (up to 37%), application site blistering (12%)
Common (1% to 10%): Injection site pain, injection site discomfort, injection site pruritus, erythema, injection site hematoma, injection site irritation, injection site inflammation; injection site reaction; Topical testosterone: Application site erythema, application site warmth, application site irritation, application site vesicles, application site exfoliation, application site burning, application site induration, bullae at application site, mechanical irritation at application site, rash at application site, contamination of application site
Postmarketing reports: Injection site abscess, procedural pain, application site swelling (topical testosterone)

Common (1% to 10%): Hot flush, hypertension
Uncommon (0.1% to 1%): Cardiovascular disorder
Frequency not reported: Venous thromboembolism
Postmarketing reports: Angina pectoris, cardiac arrest, cardiac failure, coronary artery disease, coronary artery occlusion, myocardial infarction, tachycardia, cerebral infarction, cerebrovascular accident, circulatory collapse, deep venous thrombosis, syncope, thromboembolism, thrombosis, venous insufficiency, stroke

Common (1% to 10%): Abnormal prostate examination, benign prostate hyperplasia (BPH), ejaculation disorder, prostatitis
Uncommon (0.1% to 1%): Prostate induration, prostatic disorder, testicular pain, decreased urine flow, urinary retention, urinary tract disorder, nocturia, dysuria
Rare (less than 0.1%): Micturition disorders, epididymitis, bladder irritability, impotence, inhibition of testicular function and testicular atrophy
Frequency not reported: Oligospermia, priapism, benign prostatic hyperplasia (prostatic growth to eugonadal state), excessive frequency and duration of erections; Pediatrics: Precocious sexual development, an increased frequency of erections, phallic enlargement
Postmarketing reports: Prostate infection, calculus urinary, dysuria, hematuria, urinary tract disorder, pollakiuria

Common (1% to 10%): Polycythemia, hematocrit increased
Uncommon (0.1% to 1%): Increased red blood cell count, increased hemoglobin, prolonged activated partial thromboplastin time, prolonged prothrombin time
Frequency not reported: Blood and lymphatic system disorders, suppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy
Postmarketing reports: Thrombocytopenia, anemia

Common (1% to 10%): Weight increased, appetite increased, fluid retention (sodium, chloride, water, potassium, calcium, and inorganic phosphates)
Uncommon (0.1% to 1%): Increased glycosylated hemoglobin, hypercholesterolemia, increased triglyceride
Frequency not reported: Abnormal lipids (decrease in serum LDL, HDL, and triglycerides), metabolism and nutrition disorders, hypercalcemia
Postmarketing reports: Hypoglycemia, diabetes mellitus, fluid retention, hyperlipidemia, hypertriglyceridemia, blood glucose increased

Common (1% to 10%): Back pain, hemarthrosis (testosterone topical)
Uncommon (0.1% to 1%): Arthralgia, pain in extremity, muscle spasm, muscle strain, myalgia, musculoskeletal stiffness, increased creatine phosphokinase
Frequency not reported: Pediatrics: Premature epiphyseal closure, increased bone formation
Postmarketing reports: Musculoskeletal chest pain, musculoskeletal pain, myalgia, osteopenia, osteoporosis, systemic lupus erythematosus

Nervous system
Common (1% to 10%): Headache, vertigo (topical testosterone)
Uncommon (0.1% to 1%): Migraine, tremor, dizziness
Frequency not reported: Nervousness, paresthesia
Postmarketing reports: Cerebrovascular insufficiency, reversible ischemic neurological deficiency, transient ischemic attack, amnesia

Common (1% to 10%): Prostatic specific antigen (PSA) increased, prostate cancer
Uncommon (0.1% to 1%): Prostatic intraepithelial neoplasia
Rare (less than 0.1%): Neoplasms benign, malignant, and unspecified (including cysts and polyps)

Common (1% to 10%): Fatigue, hyperhidrosis; chills, body pain, smell disorder
Uncommon (0.1% to 1%): Breast induration, breast pain, sensitive nipples, gynecomastia, increased estradiol, increased testosterone, asthenia, night sweats
Rare (less than 0.1%): Fever, malaise
Frequency not reported: Edema
Postmarketing reports: Sudden hearing loss, tinnitus, Influenza like illness

Common (1% to 10%): Irritability, insomnia, mood swings, aggression,
Uncommon (0.1% to 1%): Depression, emotional disorder, restlessness, increased libido, decreased libido
Frequency not reported: Hostility, anxiety
Postmarketing reports: Korsakoff’s psychosis nonalcoholic, male orgasmic disorder, restlessness, sleep disorder

Common (1% to 10%): Sinusitis, nasopharyngitis, upper respiratory tract infection, bronchitis
Uncommon (0.1% to 1%): Cough, dyspnea, snoring, dysphonia
Rare (less than 0.1%): Pulmonary microembolism (POME) (cough, dyspnea, malaise, hyperhidrosis, chest pain, dizziness, paresthesia, or syncope) caused by oily solutions
Frequency not reported: Sleep apnea
Postmarketing reports: Chest pain, asthma, chronic obstructive pulmonary disease, hyperventilation, obstructive airway disorder, pharyngeal edema, pharyngolaryngeal pain, pulmonary embolism, respiratory distress, rhinitis, sleep apnea syndrome

Signs and symptoms of pulmonary microemboli may occur during or immediately after the injections and are reversible.

Uncommon (0.1% to 1%): Abnormal LFT, increased AST
Rare (less than 0.1%): Abnormal hepatic function
Frequency not reported: Jaundice, benign liver tumor, malignant liver tumor, liver enlargement, peliosis hepatitis
Postmarketing reports: ALT increased, AST increased, bilirubin increased, transaminases increased, gamma-glutamyltransferase increased

Uncommon (0.1% to 1%): Hypersensitivity reactions
Frequency not reported: Anaphylactic reactions
Postmarketing reports: Anaphylactic shock

Uncommon (0.1% to 1%): Testosterone topical: Lacrimation increased
Postmarketing reports: Testosterone topical: Intraocular pressure increased, vitreous detachment

Applies to the following strength(s): 30 mg/1.5 mL ; 2.5 mg/24 hr ; 5 mg/24 hours ; cypionate 100 mg/mL ; cypionate 200 mg/mL ; 25 mg/2.5 g (1%) ; 50 mg/5 g (1%) ; 40.5 mg/2.5 g (1.62%) ; 20.25 mg/1.25 g (1.62%) ; 20.25 mg/actuation (1.62%) ; 12.5 mg/1.25 g (1%) ; enanthate 200 mg/mL ; 100 mg/mL ; propionate 100 mg/mL ; enanthate 100 mg/mL ; 50 mg/mL ; micronized ; propionate ; 10 mg/0.5 g ; 75 mg ; 6 mg/24 hr ; 4 mg/24 hr ; propionate micronized ; cypionate ; 30 mg/12 hr ; 2 mg/24 hr ; 5.5 mg/0.122 g ; 2% ; undecylate 250 mg/mL

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.
Usual Adult Dose for:

Hypogonadism – Male
Breast Cancer-Palliative
Usual Pediatric Dose for:
Delayed Puberty – Male
Additional dosage information:
Renal Dose Adjustments
Liver Dose Adjustments
Dose Adjustments
Other Comments
Usual Adult Dose for Hypogonadism – Male
-Testosterone Undecanoate: 750 mg (3 mL) IM injection followed by 750 mg (3 mL) injected after 4 weeks, then 750 mg (3 mL) every 10 weeks thereafter
-Testosterone Enanthate and Cypionate: 50 to 400 mg IM injection every 2 to 4 weeks

-2 to 6 pellets (75 mg each) implanted subcutaneously every 3 to 6 months.
-The number of pellets to be implanted depends upon the minimal daily requirements of testosterone propionate administered parenterally. Thus, implant two 75 mg pellets for each 25 mg testosterone propionate required weekly.

-The chronological and skeletal ages must be taken into consideration, both in determining the initial dose and in adjusting the dose.
-This drug should be used only if the benefits outweigh the serious risks of pulmonary oil microembolism and anaphylaxis.
-Injections more frequently than every two weeks are not recommended.
-Adequate effect of the implants (pellets) continues for three to four months, sometimes as long as six months.

-Mucoadhesive Oral Patch: Apply a 30 mg patch to the gum region twice a day; morning and evening (about 12 hours apart).

-Transdermal Film: 2 to 6 mg applied to the back, abdomen, upper arm, or upper thigh once a day, preferably at night.
-Gel (in tubes, packets or spray): 5 g applied once a day, preferably in the morning. Consult the manufacturer product information for specific dosage and additional instructions of use.
-Transdermal Solution: Initial dose is 60 mg of testosterone (1 pump actuation of 30 mg of testosterone to each axilla), applied once a day, at the same time each morning. Consult the manufacturer product information for specific dosage and additional instructions of use.

Comments: Prior to initiating therapy with this drug, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days, and that these serum testosterone concentrations are below the normal range.

-Primary hypogonadism (congenital or acquired): Testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter Syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (FSH, LH) above the normal range.
-Hypogonadotropic hypogonadism (congenital or acquired): Gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range.

Usual Adult Dose for Breast Cancer-Palliative
Testosterone Enanthate:
-200 to 400 mg IM injection every 2 to 4 weeks

-Androgen therapy can accelerate the disease. Close monitoring is recommended.
-Report any hoarseness, acne, changes in menstrual periods, or more facial hair.

-This drug may be used secondarily in women with advancing inoperable metastatic (skeletal) mammary cancer who are one to five years postmenopausal.
-Premenopausal women with breast cancer who have benefited from oophorectomy and are considered to have a hormone-responsive tumor.

Usual Pediatric Dose for Delayed Puberty – Male
-Testosterone Enanthate: 50 to 200 mg every 2 to 4 weeks for 4 to 6 months

-2 pellets (each pellet contain 75 mg of testosterone) implanted subcutaneously every 3 to 6 months
-Duration of therapy: 4 to 6 months

-The chronological and skeletal ages should be taken into consideration when determining the initial dose and when adjusting the dose.
-An X-ray of the hand and wrist to determine bone age should be obtained every six months to assess the effect of treatment on the epiphyseal centers.
-Report frequent or persistent erections.
-Androgen therapy should be used very cautiously in children and only by specialists who are aware of the adverse effects on bone maturation.

Use: To stimulate puberty in selected males with clearly delayed puberty

Renal Dose Adjustments
Testosterone Cypionate IM injection: Contraindicated in renal disease

Liver Dose Adjustments
Testosterone Cypionate IM injection: Contraindicated in liver disease

Dose Adjustments
The doses of this drug should be adjusted according to the patient’s response and the appearance of adverse reactions.

The number of pellets to be implanted depends upon the minimal daily requirements of testosterone propionate determined by a gradual reduction of the amount administered parenterally. The usual dosage is as follows:
-Implant two 75 mg pellets for each 25 mg testosterone propionate required weekly.
-Thus, for a weekly injection of 75 mg of testosterone propionate, implant six 75 mg pellets (450 mg); for weekly injections of 50 mg of testosterone propionate, implant four 75 mg pellets (300 mg) may suffice for approximately three months.
-With lower requirements by injection, correspondingly lower amounts may be implanted.

-To ensure proper dosing, serum testosterone concentrations should be measured after initiation of therapy to ensure that the desired concentrations (300 ng/dL-1050 ng/dL) are achieved.
-The topical dose can be adjusted based on the serum testosterone concentration from a single blood draw 2 to 8 hours after applying this drug and at least 14 days after starting treatment or following dose adjustment.
-If the measured serum testosterone concentration is below 300 ng/dL, the daily testosterone dose may be increased. Consult the manufacturer product information for specific dose adjustment.
-If the serum testosterone concentration exceeds 1050 ng/dL, the daily testosterone dose should be decreased. Consult the manufacturer product information for specific dose adjustment.
-If the serum testosterone concentration consistently exceeds 1050 ng/dL at the lowest daily dose therapy should be discontinued.

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) medication guide for Testosterone. For Testosterone Undecanoate, REMS includes elements to assure safe use and implementation system . For additional information: www.fda.gov/REMS

Pulmonary Oil Microembolism (POME) Reactions And Anaphylaxis:
-Serious POME reactions, involving urge to cough, dyspnea, throat tightening, chest pain, dizziness, and syncope; and episodes of anaphylaxis, including life-threatening reactions, have been reported to occur during or immediately after the administration of testosterone undecanoate injection. These reactions can occur after any injection of testosterone undecanoate during the course of therapy, including after the first dose.
-Following each injection of testosterone undecanoate observe patients in the healthcare setting for 30 minutes in order to provide appropriate medical treatment in the event of serious POME reactions or anaphylaxis.

Secondary Exposure To Topical Testosterone:
-Virilization has been reported in children who were secondarily exposed to topical testosterone products.
-Children should avoid contact with unwashed or unclothed application sites in men using testosterone topical.
-Healthcare providers should advise patients to strictly adhere to recommended instructions for use.

Safety and efficacy have not been established in patients younger than 18 years.

Testosterone Enanthate and Testosterone Implant are indicated for delayed puberty in adolescent patients.

Testosterone Cypionate: Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Data not available

Other Comments
Administration advice:
Mucoadhesive Oral Patch:
-It should be placed just above the incisor tooth.
-With each application, the patch should be rotated to the alternate side of the mouth.

IM Injection:
-Testosterone cypionate should not be used interchangeably with testosterone propionate because of differences in duration of action.
-Inject deeply into the gluteal muscle following guidelines for intramuscular administration to minimize the risk of intravascular injection.
-Special care must be taken to avoid intravasal injection.
-Following IM injection, observe patients in the healthcare setting for 30 minutes to provide appropriate medical treatment in the event of serious POME reactions or anaphylaxis.
-This drug should be inspected visually for particulate matter and discoloration prior to administration.

-Patients should wash their hands immediately with soap and water after application.
-Patients should cover the application site(s) with clothing, such as a T-shirt, after the solution has dried.
-If direct skin-to-skin contact is anticipated, patients should wash the application site thoroughly with soap and water to remove any testosterone residue.
-Apply this drug after washing, bathing, or showering to clean, dry, intact skin of the shoulders and/or upper arms, abdomen, and the sides of the body (just below the armpits).
-It is preferable to apply this drug to areas with minimal hair and body fat.

-Therapy with this drug should be adjusted to the response of the individual patient.
-A detailed examination should be performed prior starting therapy with this drug to confirm testosterone insufficiency and to exclude risks of prostatic cancer.

Limitations of use:
-Safety and efficacy of drug in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.
-Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure.

-Serum testosterone levels should be measured before start of treatment and periodically during treatment.

Patient advice:
-Report any of the following: nausea, vomiting, changes in skin color, ankle swelling, too frequent or persistent erections, hoarseness, acne, changes in menstrual periods, or more facial hair.
-Avoid smoking, fire or flame until the dose of applied topical testosterone has completely dried.
-Patients should not wash, shower or swim for at least 2 hours after applying topical testosterone.
-If unwashed or unclothed skin that has been applied with topical testosterone comes in direct contact with the skin of another person, the contact area on the other person should be washed with soap and water as soon as possible.
-Follow strictly the recommended instructions for the use of this drug.