Patient Medication Information: uses, side effects, how to take - Kyzatrex
What KYZATREX® is used for:
KYZATREX® is used to treat adult men who have low or no testosterone due to male hypogonadism. Your healthcare professional will confirm this by doing blood tests.
How KYZATREX® works:
KYZATREX® is absorbed by your digestive system and brings testosterone to your blood stream.
The ingredients in KYZATREX® are:
Medicinal ingredients: Testosterone undecanoate
Non-medicinal ingredients: DL-alphatocopheryl acetate (Vitamin E), FD&C red 40 lake, gelatin, glycerin, lecithin, Medium Chain Triglycerides, phytosterol esters, polyoxyl 40 hydrogenated castor oil, propylene glycol, propylene glycol monolaurate, Shellac Glaze, sorbitol, titanium dioxide water
KYZATREX® comes in the following dosage forms:
Capsules: 100 mg, 150 mg or 200 mg
Do not use KYZATREX® if:
- you have or might have prostate or breast cancer.
- you are allergic to this drug or any of the other ingredients in this medicine or the container.
- you are female. KYZATREX® is for adult men only.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take KYZATREX®. Talk about any health conditions or problems you may have, including if you:
- have difficulty urinating due to an enlarged prostate. Older patients may have a higher risk of having an enlarged prostate or prostate cancer;
- have bone cancer;
- are older than 65 years of age;
- have liver, kidney or heart disease
- had a stroke;
- have high blood pressure;
- have blood clotting problems;
- have diabetes;
- are obese or have lung disease
- are bedridden.
Other warnings you should know about:
Dependence and Abuse
You can get serious side effects if you take too much KYZATREX® on its own or with other similar drugs. These side effects include:
- heart and blood vessel problems which can lead to death, liver and mental health problems.
- Becoming dependent on KYZATREX®. You may get withdrawal symptoms when you take less or stop taking it suddenly.
- Always take KYZATREX® exactly as your healthcare professional has told you. You should not use testosterone to lose weight and gain muscle, or improve athletic performance as it may cause serious health problems.
- You should not use testosterone to treat sexual dysfunction or male infertility.
Check-ups and Testing: You will have regular visits with your healthcare professional before, during and at the end of your treatment. They may:
- Do a physical exam.
- Do blood tests. These will check the levels of testosterone, calcium, lipids, sugar and blood cells. The blood tests will help the healthcare professional check your blood, heart, liver, kidneys, prostate, and bone health.
- Check that your heart is working properly.
- Check your blood pressure.
- Check your breast health.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with KYZATREX®:
- Medicines used to treat blood clots, such as warfarin
- Medicines used to treat high blood pressure, like propranolol
- Insulin, used to treat diabetes
- Corticosteroids, used to treat inflammation, like hydrocortisone
- St John's wort (Hypericum perforatum), a herbal treatment used for depression
- Cyclosporine, a medicine used to treat organ rejection
- Medicines used to relieve pain, such as ibuprofen
- Medicines used to treat symptoms of colds, such as pseudoephedrine
How to take KYZATREX®:
- Take exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.
Take KYZATREX® with a meal. Swallow the capsules whole without chewing, using some water.
Usual dose:
- Adult Males: Take exactly as directed. Your healthcare professional will decide on the right dose for you.
- Your healthcare professional may change your dose, stop treatment for a period of time, or stop treatment completely. This may happen depending on your health.
Overdose:
Missed Dose:
If you missed a dose of this medication, you do not need to make up the missed dose. Skip the missed dose and continue with your next scheduled dose. Do not take two doses at the same time.
Possible side effects from using KYZATREX®:
These are not all the possible side effects you may have when taking KYZATREX®. If you experience any side effects not listed here, tell your healthcare professional.
- acne, skin rash, itching, hives, purple or red-coloured spots on body or inside the mouth or nose;
- flushing or redness of skin or any changes in skin colour;
- change in mood, aggression, agitation, confusion, depression;
- trouble sleeping
- loss of hair and baldness;
- weight gain;
- loss of appetite;
- breath odor;
- diarrhea;
- headache, dizziness;
- sore throat, fever;
- feeling of discomfort;
- abnormal blood test results
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Common | |||
| Hypertension (high or increase in blood pressure): shortness of | ✓ | ||
If you think you, or a person you are caring for, have taken too much KYZATREX®, contact a healthcare professional, hospital emergency department, or regional poison control centre or Health Canada's toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
| Serious side effects and what to do about them | |||
|---|---|---|---|
| Serious side effects and what to do about them | |||
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| breath, fatigue, dizziness or fainting, chest pain or pressure, bluish colour to your lips and skin, racing pulse or heart palpitations | |||
| Uncommon | |||
| Edema: unusual swelling of the arms, hands, legs, feet and ankles, face or airway passages | ✓ | ||
| Liver problems: yellowing of your skin and eyes (jaundice), right upper stomach area pain or swelling, nausea or vomiting, unusual dark urine, light coloured stools, unusual tiredness, unexplained loss of appetite | ✓ | ||
| Stroke (bleeding or blood clot in the brain): sudden numbness or weakness of your arm, leg, face, especially if only on one side of the body, sudden confusion, difficulty speaking or understanding others, sudden difficulty walking or loss of balance and coordination, dizziness, sudden severe headache with no known cause | ✓ | ||
| Rare | |||
| Heart problems (disorders affecting your heart muscle, valves or rhythm): Chest pain, or chest discomfort, high blood pressure, irregular heart rhythm, shortness of breath, fainting, swelling of the legs, ankles and feet, weakness | ✓ | ||
| Sexual problems: enlarged breasts, nipple and breast pain, breast swelling, testicles getting smaller, erections that are too frequent or continue for too long or too painful; frequent urge to urinate | ✓ | ||
| Sleep apnea (breathing problems while sleeping): stop breathing for | ✓ | ||
| short periods during your normal nightly sleep | |||
| Unknown | |||
| Blood clots in the legs, arms and lungs: swelling, pain, arm or leg may be warm to the touch and may appear red, chest pain that may increase with deep breathing, cough, coughing up bloody sputum, shortness of breath | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
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 (canada.ca/drug-device-reporting) 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.
Storage:
- Store between 20 and 25°C in the original bottle.
- Protect from light and moisture. Keep out of reach and sight of children.
If you want more information about KYZATREX®:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; or by calling 1- 800-656-0793.