Patient Medication Information: uses, side effects, how to take - Orgovyx
Serious Warnings and Precautions
Possible serious side effects include QT prolongation (a heart rhythm condition).
- Tell your healthcare professional right away if you get any signs or symptoms like dizziness, fainting, feeling that your heart is pounding or racing (palpitations) or chest pain. Those can be symptoms of serious heart rhythm problems.
What is ORGOVYX used for?
Orgovyx is used to treat adults with advanced prostate cancer.
How does ORGOVYX work?
ORGOVYX works by blocking a step in the process that signals the testes to produce testosterone (the male sex hormone). This helps stop prostate cancer cells from growing and dividing.
What are the ingredients in ORGOVYX?
Medicinal ingredients: relugolix
Non-medicinal ingredients: carnauba wax, hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, mannitol, sodium starch glycolate, and titanium dioxide
ORGOVYX comes in the following dosage forms:
Tablets, 120 mg
Do not use ORGOVYX if:
- If you are allergic to relugolix or any of the other ingredients of this medicine or the container.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ORGOVYX. Talk about any health conditions or problems you may have, including:
A history of heart problems including heart rhythm or heart failure;
- Tell your healthcare professional right away if you get any signs or symptoms like dizziness, fainting, feeling that your heart is pounding or racing (palpitations) or chest pain.
- thyroid problems;
- kidney or liver problems;
- Osteoporosis or any condition that affects the strength of your bones. Lower levels of testosterone may lead to thinning of bones.
Other warnings you should know about:
Check-ups and testing: You will have regular visits with your healthcare professional, before, during and at the end of your treatment. They will:
- Check your pituitary and gonad glands
- Check that your heart is working properly (electrical activity)
- Do blood tests to check for prostate-specific antigen (PSA), body salts (electrolytes)
Pregnancy and breastfeeding:
Female patients
- If you are pregnant, able to get pregnant or think you are pregnant, there are specific risks you should discuss with your healthcare professional.
If you are able to become pregnant:
- Avoid becoming pregnant while you are taking ORGOVYX. Use effective birth control during your treatment and for at least 2 weeks after your last dose.
- Tell your healthcare professional right away if you become pregnant or think you may be pregnant during your treatment with ORGOVYX.
- Talk to your healthcare professional about breastfeeding while you are taking ORGOVYX.
Male patients
- Avoid fathering a child while you are taking ORGOVYX.
- During your treatment with ORGOVYX, use a condom each time you have sex with a woman who is pregnant, may be pregnant or could get pregnant. Continue using condoms until 2 weeks after your last dose.
- If, during your treatment with ORGOVYX, your sexual partner becomes pregnant or thinks she may be pregnant, tell your healthcare professional right away.
Male patients – fertility:
- Treatment with ORGOVYX may affect your ability to father a child. If you have questions about this, talk to your healthcare professional.
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 ORGOVYX:
- Medicines used to treat bacterial infections, such as erythromycin and rifampin
- Medicines that can lower blood salt levels (electrolytes) such as diuretics (water pills), laxatives, enemas (rectal injections)
- Amphotericin B, used to treat fungal infections
How to take ORGOVYX:
- Take ORGOVYX exactly as your healthcare professional tells you to take it.
Take ORGOVYX at about the same time each day, with or without food.
- Swallow ORGOVYX tablets whole. Do not crush or chew tablets.
- Take ORGOVYX for as long as your healthcare professional tells you to. Do not change your dose or stop taking ORGOVYX without talking with your healthcare provider first.
Usual dose:
Recommended adult daily dose: On the first day of your treatment, you will take three tablets (360 mg). After that, the usual dose is one tablet (120 mg) once daily.
Overdose:
| If you think you, or a person you are caring for, have taken too much ORGOVYX, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
- If you miss a dose of ORGOVYX, take the missed dose as soon as you remember on that day. Take your next dose at the usual time the next day.
- If you miss a dose by more than 12 hours, skip the missed dose. Take your next dose at your usual time the next day.
- Do not take a double dose to make up for a forgotten dose.
What are possible side effects from using ORGOVYX?
These are not all the possible side effects you may have while taking ORGOVYX. If you experience any side effects not listed here, contact your healthcare professional.
- hot flush
- muscle, joint and bone pain
- feeling tired (fatigue)
- diarrhea
- constipation
- weight gain
- high blood pressure
- sleeplessness
- dizziness
- headache
nausea
- breast enlargement in men (gynecomastia)
- low red blood cell count (anemia)
- rash
- increased sweating
- depression
- low sex drive
ORGOVYX (relugolix tablets)
ORGOVYX can cause abnormal blood test results. Your healthcare professional will do blood tests during your treatment. These will tell your healthcare professional how ORGOVYX is affecting your blood, heart, liver, kidneys, and hormones.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| UNCOMMON | |||
| Acute kidney failure (severe kidney problems): confusion; itchiness or rashes; puffiness in your face and hands; swelling in your feet or ankles; urinating less or not at all; weight gain. | √ | ||
| Bleeding problem: blood in the stool, urine or eye, vomiting blood, coughing up blood, purple spotted rash | √ | ||
| Bone fracture (broken bone): area around break will be painful and swollen, bulge or bump at site of break, broken bone may push through skin | √ | ||
| Heart failure (heart does not pump blood as well as it should): shortness of breath, fatigue and weakness, swelling in ankles, legs and feet, cough, fluid retention, lack of appetite, nausea, rapid or irregular heartbeat, reduced ability to exercise | √ | ||
| Lung Problems (including pneumonia, lung disease and lung cancer): chest pain when you breath or cough, confusion, cough which may produce phlegm, fatigue, fever, sweating and shaking chills, nausea, vomiting or diarrhea, shortness of breath, wheezing, chest tightness | √ | ||
| Myocardial infarction (heart attack): pressure or squeezing pain in the chest, jaw, left arm, between the shoulder blades or upper abdomen, shortness of breath, dizziness, fatigue, light- | √ | ||
| Serious side effects and what to do about them | |||
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| headedness, clammy skin, sweating, indigestion, anxiety, feeling faint and possible irregular heartbeat. | |||
| QT prolongation (a heart rhythm condition): dizziness, palpitations, fainting or near fainting, seizures, rapid, slow or irregular heartbeat, chest pain | √ | ||
| Urinary tract infection (infection in urinary system including kidneys, ureters, bladder and urethra): Pain or burning sensation while urinating, frequent urination, blood in urine, pain in the pelvis, strong smelling urine, cloudy urine | √ | ||
| UNKNOWN | |||
| Allergic Reaction: difficulty swallowing or breathing, hives or rash, swelling of the face, lips, tongue, hands, feet or throat, swelling of the digestive tract causing diarrhea, nausea or vomiting | √ | ||
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:
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. |
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Storage:
•
- Store ORGOVYX between 15°C to 30°C.
•
- Keep the bottle tightly closed after you first open it.
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The ORGOVYX bottle contains a desiccant to help keep your medicine dry (protect it from
moisture). Do not remove the desiccant from the bottle.
•
- Do not flush unused tablets down the toilet.
•
Return unused tablets to the pharmacy or dispose of them in a safe way according to local
requirements. These measures will help protect the environment.
•
- Keep ORGOVYX out of the reach and sight of children.
If you want more information about ORGOVYX:
•
- Talk to your healthcare professional.
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Find this document plus the full product monograph, prepared for health professionals by visiting
the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drugproducts/drug-productdatabase.html); the manufacturer’s website
(https://knighttx.com), by emailing medinfo@knighttx.com, or by calling 1-844-483-5636.