Testosterone Cypionate Injection, USP: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Your doctor has prescribed Testosterone Cypionate Injection USP because your body is not making enough testosterone. The medical term for this condition is hypogonadism.

What it does:

Testosterone Cypionate Injection USP delivers testosterone into the bloodstream through an injection into your gluteal muscle. Testosterone Cypionate Injection USP helps raise your testosterone to normal levels.

When it should not be used:

• if you have prostate or breast cancer (confirmed or suspected

  by your doctor);

• if you have difficulty in urinating due to an enlarged prostate;

• if you have a known allergy or sensitivities to any of the

  ingredients contained in Testosterone Cypionate Injection USP, including testosterone USP that is chemically synthesized from soy (see What the medicinal ingredient is and What the nonmedicinal ingredients are in this section).

Testosterone Cypionate Injection USP should NOT be used by women. Pregnant and breast feeding women are especially at risk. Testosterone may cause harm to your unborn baby.

What the medicinal ingredient is:

Testosterone Cypionate

What the nonmedicinal ingredients are:

Benzyl alcohol, ethyl oleate.

What dosage forms it comes in:

Testosterone Cypionate Injection USP is available in one strength, 100 mg testosterone cypionate/mL.

Testosterone Cypionate Injection USP is available single dose ampoules of 2 mL each, 5 ampoule per carton.

WARNINGS AND PRECAUTIONS

There is very little information from clinical trials with testosterone in the older male (>65 years of age) to support safe use for a long period of time.

You should not use testosterone in an attempt to reduce weight and increase muscle or improve athletic performance as it may cause serious health problems.

You should not use testosterone to treat sexual dysfunction or male infertility.

Testosterone Cypionate Injection USP contains benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants.

BEFORE you use Testosterone Cypionate Injection USP talk to your doctor or pharmacist if you:

• have difficulty urinating due to an enlarged prostate. Older patients may have a higher risk of developing an enlarged prostate or prostate cancer;
• have prostate cancer (confirmed or suspected);
• have liver, kidney or heart disease;
• have high blood pressure (hypertension);
• have diabetes;
• have breathing problems during sleep (sleep apnea).

Drug Abuse and Dependence: Testosterone Cypionate Injection USP contains testosterone, which is a controlled substance under Schedule G of the Food and Drugs Act.

INTERACTIONS WITH THIS MEDICATION

Tell you doctor or pharmacist if you are taking or have recently taken any other drugs or herbal products, even those without a prescription.

Drugs that may interact with Testosterone Cypionate Injection USP include:

• insulin
• corticosteriods
• propranolol
• warfarin

PROPER USE OF THIS MEDICATION

Testosterone Cypionate Injection USP should be used only under the supervision of a doctor with regular follow-up

Usual Dose:

To treat hypogonadism, 200 mg is given intramuscularly (injection into the muscle) every two weeks.

Cytex Testosterone Cypionate Injection, USP Prescribing Information Page 17 of 17 Overdose:

Contact your doctor of pharmacist immediately if you suspect an overdose.

Missed Dose:

If you have missed a dose of Testosterone Cypionate Injection USP, you should contact your doctor to schedule your next injection.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines, Testosterone Cypionate Injection USP can have side effects. The following side effects have been reported for testosterone products:

• skin irritation or redness or rash at the application site;
• increased prostatic specific antigen (PSA);
• enlarged prostate (benign prostatic hyperplasia);

• an increase in red blood cell count (hematocrit and

  hemoglobin);

• acne;
• change in mood, depression;
• prolonged or painful erection;
• sleep disturbances caused by breathing problems;
• aggression or aggressive behaviour;
• breast enlargement and breast pain;
• loss of hair and baldness;
• high blood pressure;
• weight gain;

• headache, dizziness.

  SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN

  AND WHAT TO DO ABOUT THEM Symptom/effect Talk with your Stop taking

  doctor or drug and pharmacist call your Only if In all doctor or severe cases pharmacist Common Urinary symptoms (i.e.

  change in frequency/colour,

  dribbling, pain on urination √ straining, weak stream,

  small amounts)

Common Breast enlargement or breast

(after pain

prolonged √ use)

Uncommon Swelling of ankles and legs

(in patients with heart, √ kidney or liver damage)

Erections that are too

frequent or continue for √ too long, or are painful.

Liver problems with

symptoms such as

nausea, vomiting, along √ with yellow or darkened skin

This is not a complete list of side effects. For any unexpected effects while taking Testosterone Cypionate Injection USP, contact your doctor or pharmacist.

HOW TO STORE IT

Store Testosterone Cypionate Injection USP between 15 and 30°C. Protect from light. Keep out of reach of children and pets.

REPORTING SUSPECTED SIDE EFFECTS To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:

Toll-free telephone: 1 866-234-2345

Toll-free fax: 1 866-678-6789

By email: cadrmp@hc-sc.gc.ca

By regular mail:

Canadian Adverse Drug Reaction Monitoring Program (CADRMP)

Marketed Health Products Directorate

Health Canada

Tunney's Pasture, AL 0701C

Ottawa ON K1A 0K9

NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.

MORE INFORMATION

This document, plus the full Prescribing Information prepared for health professionals, can be obtained by contacting the sponsor, Cytex Pharmaceuticals Inc., at: 1-888-453-1230 or

by written request at:

5545 Macara Street

Halifax, Nova Scotia

B3K 1W1

or by e-mail at :

cytex@eastlink.ca

Revised: December 21, 2007