Patient Medication Information: uses, side effects, how to take - Delatestryl
ABOUT THIS MEDICATION
What the medication is used for:
Your doctor has prescribed this medicine because your body is not making enough testosterone. The medical term for this condition is hypogonadism.
What it does:
DELATESTRYL delivers medicine into your bloodstream by intramuscular injection. DELATESTRYL helps raise your testosterone to normal levels.
When it should not be used:
- If you have or it is suspected that you have prostate or breast cancer.
- If you have difficulty in urinating due to an enlarged prostate.
- If you have known allergy to any of its components [the active ingredient is testosterone, which may be synthesized from soy; (see “What the nonmedicinal ingredients are” in this section)]
DELATESTRYL 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 enanthate
What the nonmedicinal ingredients are:
Sesame oil and Chlorobutanol
What dosage forms it comes in:
A 200 mg/mL solution for intramuscular injection.
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.
DELATESTRYL is not recommended for use in children < 18 years of age.
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.
Before using DELATESTRYL, talk to your doctor 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 heart or blood vessel problems or a history of these problems such as heart attacks, stroke, or blood clot in the lungs or legs;
- have liver or kidney;
- have high blood pressure (hypertension);
- have diabetes;
- have breathing problems during sleep (sleep apnea).
Drug Abuse and Dependence:
DELATESTRYL contains testosterone, which is a controlled substance under Schedule G of the Food and Drugs Act.
INTERACTIONS WITH THIS MEDICATION
Tell your 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 DELATESTRYL include:
- Insulin
- Corticosteroids
- Propranolol
- Warfarin
PROPER USE OF THIS MEDICATION
Usual Dose:
The usual dose is 100-400 mg every four weeks.
What should I do if I miss a dose of DELATESTRYL?
If you missed a dose, you should consult your health care provider (physician).
What should I do in case of overdose?
In case of overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Never share your DELATESTRYL with anyone.
Every patient is different. Your doctor has prescribed DELATESTRYL specifically for your needs. To get the best results from DELATESTRYL, it is essential that you take it exactly as your doctor has prescribed.
Use DELATESTRYL only for the condition for which it was prescribed. If you have any questions or concerns about DELATESTRYL treatment, ask your health care provider or pharmacist. They can answer your questions and may be able to give you additional printed information about DELATESTRYL.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, DELATESTRYL can have side effects. The following side effects have been reported for products containing testosterone:
- increased or irregular heart rate, blood clot in the lungs or legs;
- 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.
This is not a complete list of side effects. For any unexpected effects while taking DELATESTRYL, contact your doctor or pharmacist.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
| Symptom/Effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| Common | Urinary symptoms (i.e. change in frequency/color, dribbling, pain on urination straining, weak stream, small amounts) | ✓ | ||
Common (after prolonged use) | Breast enlargement or breast pain | ✓ | ||
| Uncommon | Heart attack and stroke | |||
| Uncommon | Swelling of ankles and legs (in patients with heart, kidney or liver damage) | |||
| Uncommon | Erections that are too frequent or continue for too long | ✓ | ||
| Uncommon | Liver problems, with symptoms such as nausea, vomiting, along with yellowed or darkened skin | |||
HOW TO STORE IT
DELATESTRYL should be stored at controlled room temperature between 15°C and 30°C.
Keep out of reach of children and pets.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/news/media-room/advisories-warnings/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
This document plus the full prescribing information, prepared for health professionals can be obtained by contacting the sponsor, Bausch Health, Canada Inc., at 1-800-361-4261