Consumer Information for: ANDROCUR DEPOT

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

ANDROCUR and ANDROCUR DEPOT is used to reduce pain in the treatment of patients with advanced prostate cancer.

What it does

ANDROCUR and ANDROCUR DEPOT contain the medicinal ingredient cyproterone acetate. It is an antiandrogen therapy. It blocks the actions of male sex hormones (androgens). Androgens promote the growth of prostate cancer.

When it should not be used

  • are allergic (hypersensitive) to cyproterone acetate or any of the other ingredients of ANDROCUR and ANDROCUR DEPOT;
  • have a liver disease or reduced liver function;
  • have Dubin-Johnson syndrome or Rotor syndrome. Both syndromes result in an increase in bilirubin (red blood cell pigment);
  • have or have had liver tumors that are not due to the spread of prostate cancer;
  • have or ever had a benign brain tumor (meningioma);
  • have wasting diseases (diseases involving an unintended loss of weight or muscle) that are not related to prostate cancer;
  • suffer from severe chronic depression;
  • have conditions that increase your risk for developing blood clots (thromboembolic process).
What the medicinal ingredient is

ANDROCUR

Medicinal ingredients: Cyproterone acetate.

ANDROCUR DEPOT

Medicinal ingredients: Cyproterone acetate.

What the non-medicinal ingredients are

ANDROCUR

Non-medicinal ingredients: colloidal anhydrous silica, lactose monohydrate, magnesium stearate, maize starch and povidone 25.

ANDROCUR DEPOT

Non-medicinal ingredients: benzyl benzoate in castor oil solution.

What dosage form it comes in

ANDROCUR Tablet: Each tablet contains 50 mg cyproterone acetate ANDROCUR DEPOT Solution: Each 3 mL ampoule contains 100 mg/mL cyproterone acetate

Warnings and precautions

Serious Warnings and Precautions

ANDROCUR and ANDROCUR DEPOT should be prescribed and managed by a doctor experienced with the treatment of prostate cancer. Treatment with ANDROCUR and ANDROCUR DEPOT may cause: Liver damage and liver failure

  • have a breathing problem. Shortness of breath has been reported in patients taking 300 mg a day of ANDROCUR.
  • have heart disease;
  • have blood clots. Blood clots have been reported in patients taking ANDROCUR and ANDROCUR DEPOT. Tell your doctor if any of the following apply to you, as you may be at an increased risk of getting a blood clot. If you have:
    • a history of blood clots, strokes or heart attacks
    • cancer
    • abnormal red blood cells (sickle-cell anaemia)
    • Severe diabetes that affects your blood circulation
  • have liver problem. Severe and fatal liver problems have been reported with ANDROCUR and ANDROCUR DEPOT. Your doctor may conduct regular liver tests before and during treatment to monitor the condition of your liver. Your doctor might decide to end your treatment if necessary;
  • have or have had a history of depression;
  • have diabetes. Your doctor may need to adjust your antidiabetic medication as taking ANDROCUR and ANDROCUR DEPOT can alter the sugar levels in your blood. Your doctor will check your blood sugars before you begin and during treatment. Strict supervision is required if you are diabetic during your treatment.
  • have anemia. Your doctor will monitor your red-blood cell count during treatment. Anaemia has been reported rarely during long term treatment with ANDROCUR and ANDROCUR DEPOT;
  • have a history of benign brain tumors (meningiomas).

Other warnings you should know about:
ANDROCUR and ANDROCUR DEPOT is not for use in:

  • women
  • children under the age of 18
  • males who have not reached the end of puberty. Using it may have a negative effect on growth and hormonal functions.

Alcohol use: Consuming alcohol while taking ANDROCUR and ANDROCUR DEPOT may impact the effect of the drug. It is recommended that you avoid the use of alcohol while on treatment.

Use with orchiectomy or GnRH agonist drugs

Your life expectancy may be reduced if you are taking ANDROCUR and ANDROCUR DEPOT for a long period of time if you:

  • had an orchiectomy (removal of testicles) or;
  • are taking a GnRH agonist (one class of drug that acts against male sex hormones).
Long term treatment in patients with advanced prostate cancer may reduce the life expectancy by 5 years when compared to using surgical castration treatment only.

Driving and using machines:

You may feel tired and weak during treatment. Before you do tasks that require special attention, wait until you know how your body responds to ANDROCUR and ANDROCUR DEPOT.

Pulmonary oil microembolism and post-injection reactions

ANDROCUR DEPOT needs to be injected very slowly into the muscle to prevent:
  • pulmonary oil microembolism (when oily solution gets into the lung). Pulmonary microembolism can cause symptoms such as coughing, shortness of breath and chest pain. And;
  • vasovagal reactions (post-injection reactions). Vasovagal reactions can cause symptoms such as discomfort, bleeding, dizziness, tingling or pricking sensation, or fainting.
Liver tumours (benign and malignant)

Using medicines such as ANDROCUR has very rarely been linked to the development of:
  • benign (non-malignant) liver tumours and;
  • some forms of liver cancer (malignant liver tumours).
Benign brain tumours (meningiomas)

You may develop meningioma if you take ANDROCUR for a long duration. Meningioma has been rarely reported in patients with prostate cancer that are taking ANDROCUR for a shorter duration. Your risk increases especially when you use it for a longer duration (several years) or for a shorter duration with high doses (25mg per day and above). If you are diagnosed with meningioma, your doctor will stop your treatment.

Antiandrogen Withdrawal Syndrome

Taking ANDROCUR and ANDROCUR DEPOT may increase the risk of the prostate cancer growing, rather than prevent it. Your doctor will stop your treatment immediately and monitor your condition for 6-8 weeks before deciding to proceed with other prostate cancer therapies.

Swelling of breast tissue in males

You may experience swelling of your breasts while on treatment. Your doctor may reduce your dosage or terminate your treatment once assessing your condition.

Adrenal glands

Your adrenal glands may become supressed during treatment with ANDROCUR and ANDROCUR DEPOT. Your doctor will check the function of your adrenal glands periodically.

Sperm count:

Your sperm count and the amount of ejaculation is reduced when taking 50 mg to 300 mg of ANDROCUR a day. Your sperm count and ejaculation will usually return to normal after stopping your treatment. Skin

Treatment with ANDROCUR and ANDROCUR DEPOT may cause the following skin problems:
  • Dry skin
  • Patchy body hair loss
Interactions with this medication
  • Statins (medicines for reducing blood fats)
  • Ketoconazole, itraconazole, clotrimazole (for fungal infections)
  • Ritonavir (for viral infections)
  • Rifampicin (for tuberculosis)
  • Phenytoin (for epilepsy)
  • St. John’s Wort (herbal remedy for depression)
Proper use of this medication

  • Take exactly as your doctor tells you to take it. Do NOT take more of it than prescribed. Check with your doctor if you are not sure.
  • Do not reduce your dose or stop taking your medicine unless your doctor tells you to.

Usual adult dose:

ANDROCUR Tablet

The recommended starting and maintenance daily dose: 200 mg to 300 mg (4 to 6 tablets)taken in two or three divided doses. Each dose should be taken with liquid after meals. The maximum daily dose: 300 mg.

Recommended daily dose after orchiectomy (removal of testicles): 100-200 mg (2 to 4 tablets).

ANDROCUR DEPOT Injection

The recommended starting and maintenance dose: 300 mg (3 mL) once a week. ANDROCUR DEPOT is to be given slowly into a muscle (intramuscular).

Recommended dose after orchiectomy (removal of testicles): 300 mg (3 mL) once every two weeks.

Overdose:

If you think you, or a person you are caring for, have taken too much ANDROCUR or ANDROCUR DEPOT, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Missed Dose

ANDROCUR Tablet

If you missed a dose of ANDROCUR tablet, 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.

ANDROCUR DEPOT Injection

Have a new appointment with your doctor in order to make up for the forgotten injection. You should not get a double dose.

Side effects and what to do about them

These are not all the possible side effects you may feel when taking ANDROCUR. If you experience any side effects not listed here, contact your healthcare professional.

Very frequent side effects:

  • Swelling of the breast, breast soreness (gynecomastia)

Other side effects:

  • Constipation or diarrhea (loose stools)
  • Depression
  • Dizziness
  • Fever or chills
  • Frequent urination
  • Hair loss or unusual increase in hair growth
  • Headache
  • Hot flashes
  • Indigestion
  • Nausea
  • Shortness of breath
  • Skin rash, blisters
  • Skin discoloration
  • Tiredness and weakness
  • Unusual swelling of the arms, hands, legs, feet and ankles, face
  • Vomiting
  • Vision change
  • Weight gainor weight loss
Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
VERY COMMON
Inability to achieve or maintain and erection ✔    
Reduced sexual drive ✔    
Reversible inhibition of sperm production ✔    
RARE
Liver toxicity, liver inflammation (hepatitis), liver disease, liver failure: generally feeling unwell, fever, nausea, vomiting, loss of appetite, itching all over the body, yellowing of the skin or eyes, light colored bowel movements, dark urine     ✔
Blood clots: swelling of the calf or leg (blood clots in the leg), chest pain and being short of breath (blood clots in the lung), suddenly feeling weak, loss of coordination, slurred speech (a stroke or blood clots in the brain), temporary blindness (blood clots in the eye)     ✔
Life-threatening internal bleeding (intra-abdominal hemorrhage): unusual upper abdominal pains which do not disappear within a short time     ✔
UNKNOWN
Osteoporosis (thin, fragile bones): broken bones, pain, back pain that gets worse when standing or walking   ✔  
Pulmonary oil microembolism (oily solution gets into the lung): cough, shortness of breath, or chest pain   ✔  
General post injection reactions (vasovagal reactions): malaise, increased sweating, dizziness, “pins and needles” sensation or fainting   ✔  
Hypotension (low blood pressure): dizziness, fainting, light-headedness, blurred vision, nausea, vomiting, fatigue (may occur when you go from lying or sitting to standing up)   ✔  
Benign brain tumors: dull and constant headaches, seizures, sensory deficits (hearing or vision problems, loss of coordination or spatial orientation), cognitive dysfunction (difficulty concentrating, mood or personality problems), and increased intracranial pressure (presents as nausea, headache, papilledema)   ✔  
Galactorrhea (production of breast milk): nipple discharge in one or both breasts, headaches, vision problems   ✔  
Benign (not cancer) breast lump: pain, swelling and/or tenderness in the breast, skin irritation, nipple pain, feeling of a lump through the skin or nipple, redness or scaling on the nipple, and nipple pain or retraction   ✔  
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     ✔
Allergic reaction: hypersensitivity, itchiness, rash, swelling, difficulty breathing     ✔
Asthma: difficulty breathing and coughing, chest tightness, wheezing or whistling sound when breathing     ✔
Pancreatitis (inflammation of the pancreas): upper abdominal pain, fever, rapid heartbeat, nausea, vomiting, tenderness when touching the abdomen   ✔  
Anemia (decreased number of red blood cells): fatigue, loss of energy, irregular heartbeats, pale complexion, shortness of breath, weakness   ✔  
Diabetes or increase in blood sugar: with symptoms such as excessive thirst, excessive urination, excessive eating, unexplained weight loss, poor wound healing, infections   ✔  
Thrombocytopenia (low blood platelets): bruising or bleeding for longer than usual if you hurt yourself, fatigue and weakness   ✔  

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

How to store

Do not take ANDROCUR after the expiry date which is stated on the pack.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicine no longer required. These measures will help to protect the environment.
Keep out of reach and sight of children.

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.

More information

If you want more information about ANDROCUR:

This leaflet was prepared by
Bayer Inc.
2920 Matheson Blvd East,
Mississauga, Ontario
L4W 5R6
Canada Last Revised: May 13, 2021
©2021, Bayer Inc.
® TM see www.bayer.ca/tm-mc.

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