Patient Medication Information: uses, side effects, how to take - Mylan-Cyproterone / Ethinylestradiol
ABOUT THIS MEDICATION
What the medication is used for:
VOTRIENT is used in the treatment of:
Metastatic kidney cancer (when cancer cells have spread from the kidney to other parts of the body).
Selective subtypes of advanced soft tissue sarcoma in patients who have received prior chemotherapy. Soft tissue sarcoma is a type of cancer that occurs in muscles, blood vessels or other tissues that support, surround and protect the organs.
VOTRIENT is shown to slow tumour growth, however, it is not known whether VOTRIENT prolongs overall survival or improves the quality of life of patients.
What it does:
VOTRIENT prevents the activity of a special group of proteins which are known to be involved in the growth and spread of cancer cells.
When it should not be used:
VOTRIENT must not be used if you are allergic to pazopanib hydrochloride, or any of the other ingredients in VOTRIENT (see What the important nonmedicinal ingredients are).
VOTRIENT must not be used in children under two years of age.
What the medicinal ingredient is:
The active ingredient is pazopanib hydrochloride.
What the important nonmedicinal ingredients are:
The other ingredients are hypromellose, macrogol 400, magnesium stearate, microcrystalline cellulose, povidone (K30), polysorbate 80, sodium starch glycollate, titanium dioxide (E171), iron oxide black (E172) and iron oxide yellow (E172).
What dosage forms it comes in:
VOTRIENT is available as tablets. Each film coated tablet contains either 200 mg or 400 mg* of pazopanib hydrochloride. The 200 mg tablets of VOTRIENT are modified capsule shaped, grey, film coated with GS JT debossed on one side and are available in bottles of 120 tablets.
The 400 mg* tablets are modified capsule shaped, yellow, film coated with GS UHL debossed on one side and are available in bottles of 30 tablets or 60 tablets.
*VOTRIENT 400 mg tablets not available in Canada
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
VOTRIENT should be prescribed and managed by a doctor experienced in the use of cancer drugs. VOTRIENT is not recommended for patients with moderate or severe liver impairment (reduced function). Serious side effects with the use of VOTRIENT may include the following:
|
Safety and efficacy of VOTRIENT have not been established in children less than 18 years of age. VOTRIENT must not be used in children under two years of age.
BEFORE you use VOTRIENT talk to your doctor or pharmacist:
- if you have or had heart disease, heart failure or heart attack
- if you have or have had a heart rhythm disorder such as irregular heartbeat, prolongation of the QT interval or any risk factors for Torsade de Pointes (dangerous rapid fluttering of the heart) such as diabetes, low potassium, magnesium or calcium levels, or a history of low heart rate, fainting, or loss of consciousness
- if you have high blood pressure and its complications, including separation of the layers of the arterial wall (Artery Dissection)
- if you have liver disease
- if you have problems with bleeding
- if you have gastrointestinal problems
- if you have or had a blood clot in a vein or in a lung
- if you have had prior collapse of a lung
- if you have a kidney problem
- if you have thyroid problems
- if you are going to have a surgical or dental procedure, or if you have had either recently
While you are taking VOTRIENT your doctor will take blood samples to check for any liver problems. You should report any signs or symptoms of liver injury including jaundice (yellowing of whites of eyes or skin), unusual darkening of the urine, anorexia (loss of appetite), nausea, fatigue, right upper abdominal discomfort and vomiting. Your doctor will also take urine samples to check for any kidney problems. You will also have your blood pressure checked. Your doctor will periodically record your electrocardiogram (ECG) to check your heart’s electrical conduction.
Your doctor will also check on any recent surgical or dental procedures to see if you are healing properly.
Use a reliable method of contraception to avoid becoming pregnant while you’re taking VOTRIENT and for up to 8 weeks after you stop treatment with VOTRIENT. If you are pregnant or think you could be, talk to your doctor about the risks and benefits to you and your baby while taking VOTRIENT. Your doctor may recommend that you don't take VOTRIENT while you are pregnant.
Male patients (including those who have had vasectomies) with sexual partners who are pregnant, possibly pregnant, or who could become pregnant should use condoms during sexual intercourse while taking VOTRIENT and for at least 2 weeks after the last dose of drug.
Breastfeeding is not recommended during treatment with VOTRIENT. Ask your doctor for advice.
INTERACTIONS WITH THIS MEDICATION
Tell your doctor or pharmacist if you are taking, or have recently taken any other medicines including any medicines you bought without a prescription. This includes herbal medicines.
Some medicines may affect the way VOTRIENT works or VOTRIENT may affect how other medicines work. These include:
- clarithromycin, ketoconazole, itraconazole, telithromycin, voriconazole (used to treat infections)
- atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (used to treat HIV)
- dextromethorphan (used in cough medicines)
- simvastatin and possibly other statins (used to treat high cholesterol levels)
- medicines that reduce stomach acid (e.g. esomeprazole, ranitidine, magnesium hydroxide)
Also, the following list includes some, but not all, of the drugs that may interact with VOTRIENT to affect the electrical activity of your heart:
- antiarrhythmics (drugs that stabilize the heart rhythm function, such as quinidine, procainamide, amiodarone, sotalol, etc.)
- antidepressants (mood disorder drugs)
- antipsychotics (drugs used to stabilize thinking and behaviour)
- opioids (e.g. methadone)
- macrolide antibiotics (such as erythromycin, clarithromycin)
- fluoroquinolone antibiotics (such as moxifloxacin, levofloxacin, ciprofloxacin)
- antifungals (such as fluconazole, voriconazole)
- antimalarials (e.g. quinine)
- antinauseants (e.g. granisetron, ondansetron, dolasetron)
- anti-asthmatics (e.g. salmeterol, formoterol)
- tacrolimus (used after organ transplant to prevent rejection)
- certain anticancer treatments (e.g. sunitinib, nilotinib, lapatinib, sorafenib, vorinostat)
VOTRIENT is affected by food intake (see PROPER USE OF THIS MEDICATION). You should not drink grapefruit juice or eat grapefruit while you are being treated with
VOTRIENT as this may increase the chance of side effects.
PROPER USE OF THIS MEDICATION
Always take VOTRIENT exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Usual dose:
The usual dose is 800 mg VOTRIENT, taken once a day.
Do not take more than 800 mg VOTRIENT a day.
Swallow the tablets whole with water, one after the other, at about the same time each day. Do not break or crush the tablets as it affects the way the medicine is absorbed and may increase the chance of side effects.
It is important that you take VOTRIENT either at least one hour before or at least two hours after food.
Depending on your response to treatment, your doctor may recommend adjusting your dose or temporarily stopping your treatment.
Overdose:
| If you have accidentally taken more VOTRIENT tablets than you should, contact your doctor, or poison control centre, or go to the emergency room of the nearest hospital even if there are no symptoms. |
Missed Dose:
If you forget to take VOTRIENT, do not take a double dose to make up for a missed dose. Take the next dose at the scheduled time.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, VOTRIENT can cause side effects including:
- feeling or being sick (nausea or vomiting)
- loss of appetite
- stomach pain or discomfort
- weight loss
- problems with taste
- sore mouth, mouth ulcers or sores
indigestion
- flatulence
- headache
- loss of strength
- lack of energy
- weakness
- difficulty sleeping
- dizziness
- changes in hair colour
- skin rash
- unusual hair loss or thinning
- loss of skin pigment
- dry skin
- nail disorder
- unusual prickling or crawling sensations on the skin
- excessive sweating
- hoarseness
- nosebleeds
- cough
- shortness of breath
- swelling of hands, ankles or feet
- muscle pain
- muscle spasms
- pain in the bones, muscles, ligaments, joints and tendons
- slow heart rate
- tumour pain
- increase in some substances (enzymes) produced by the liver
- under-active thyroid gland
- chills
- urinary tract infection
- blood in the urine
- painful urination
- infections, with or without changes in white blood cells (cells that fight infection)
VOTRIENT can cause abnormal blood and urine test results. Your doctor will decide when to perform blood and urine tests and will interpret the results.
If you get side effects, tell your doctor or pharmacist if any of the side effects listed becomes severe or troublesome, or if you notice any side effects not listed in this leaflet.
| 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 pharma cist | |
| Only if severe | In all cases | ||
| Very common | |||
| Palmar-plantar erythrodysaesthesia syndrome (skin reaction also known as hand-foot syndrome): pain, tingling, swelling or redness, thick calluses and blisters on the palms of the hands or soles of the feet | ✓ | ||
| Chest pain | ✓ | ||
| Common | |||
| QT-prolongation (changes in the heart’s electrical conduction): irregular heartbeat, fainting, loss of consciousness, seizures | ✓ | ||
| Myocardial infarction (heart attack, the supply of blood to the heart is suddenly blocked): pressure, tightness, pain, or a squeezing or aching sensation in chest or arms | ✓ | ||
| Pneumothorax (sudden collapse of a lung): sudden chest pain and shortness of breath | ✓ | ||
| Diarrhea: severe, 3 or more loose or liquid bowel movements in a day; may be accompanied by fever | ✓ | ||
| Liver problems and/or liver failure: yellowing of the skin and eyeballs (jaundice), dark urine, pain in your right abdomen, abdominal swelling, nausea, vomiting, a general sense of feeling unwell (malaise), disorientation or confusion or sleepiness | ✓ | ||
| 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 pharma cist |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| Hypertension (increased blood pressure): can be sudden and severe, may be life-threatening; headache, stronger and possibly faster heartbeat | ✓ | ||
| Transient ischemic attack (mini-stroke, temporary reduction in blood supply to the brain): numbness or weakness on one side of the body, difficulty speaking, dizziness, loss of balance. Symptoms can last from a few minutes to several hours. | ✓ | ||
| Angina (reduction of blood supply to the heart): discomfort in the shoulder, arm, back, throat, jaw or teeth; pain or pressure in the chest | ✓ | ||
| Deep vein thrombosis or pulmonary embolism (blood clots in the veins of the arms, legs or lungs): chest pain, shortness of breath, leg pain, swelling of the legs/feet | ✓ | ||
| Heart failure (decreased amount of blood pumped out of the heart): shortness of breath, fatigue, swollen feet and ankles | ✓ | ||
| Hemorrhage (severe bleeding from the esophagus, stomach, intestine or anus): vomiting blood, passing blood with or in the stools or black stools | ✓ | ||
| Uncommon | |||
| Pulmonary haemorrhage (severe | ✓ | ||
| 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 pharma cist |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| bleeding in lung): coughing up blood | |||
| Cerebral haemorrhage (severe bleeding in brain): a sudden severe headache, seizures, weakness in an arm or leg, lethargy, changes in vision, difficulty speaking or understanding speech, loss of coordination, loss of balance, loss of consciousness | ✓ | ||
| Torsade de Pointes (a dangerous rapid fluttering of the heart): heart palpitations, dizziness, nausea, cold sweats, chest pain, shortness of breath, rapid pulse or low blood pressure | ✓ | ||
Heart problems including irregular heartbeat: dizziness, palpitations, cold sweats, chest pain, shortness of breath, rapid pulse or low blood pressure | ✓ | ||
| Stroke (poor blood flow to the brain): sudden numbness or weakness of your arm, leg or face, especially if only on one side of the body; difficulty speaking sudden difficulty in walking or loss of balance or coordination | ✓ | ||
| Thrombotic microangiopathy [TMA], including thrombotic thrombocytopenic purpura [TTP] and hemolytic uremic | ✓ | ||
| 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 pharma cist |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| syndrome [HUS] (blood clots accompanied by a decrease in red blood cells and cells involved in clotting): bruising under the skin, bleeding of the nose or gums, less urine, blood in the urine | |||
| Gastrointestinal perforation (hole in digestive tract): abdominal pain or tenderness, bloating or a feeling of fullness (distention) in abdomen | ✓ | ||
| Fistula (abnormal connection between parts of the digestive tract): diarrhea, rectal bleeding, weight loss, dehydration | ✓ | ||
| Pancreatitis (inflammation of the pancreas): abdominal pain that lasts and gets worse when you lie down, nausea, vomiting | ✓ | ||
| Retinal detachment or tear (separation or tear of the lining of the back part of the eye): trouble seeing, blurry or impaired vision | ✓ | ||
| Very rare | |||
| Artery dissection (sudden severe pain in the back, chest or abdomen) | ✓ | ||
| Artery aneurysm (a bulge in the wall of any artery including in the chest, arms, legs, heart, and brain): symptoms will differ by the site. They can be cough, coughing up blood, strong pain high in your neck or in your back when you didn’t hurt | ✓ | ||
| 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 pharma cist |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| yourself, problems swallowing, hoarse voice, unusual pulsing in your chest or abdomen | |||
| Unknown Frequency | |||
| Interstitial lung disease (a form of lung scarring or inflammation, can have a fatal outcome in some cases): cough, shortness of breath, difficulty breathing, fever | ✓ | ||
| Posterior Reversible Encephalopathy Syndrome or Reversible Posterior Leukoencephalopathy Syndrome (reversible swelling in the rear part of the brain): headaches, seizures, loss of speech or vision, high blood pressure, abnormal drowsiness, confusion, seizure | ✓ | ||
This is not a complete list of side effects. For any unexpected effects while taking VOTRIENT, contact your doctor or pharmacist.
HOW TO STORE IT
Keep out of the reach and sight of children. Do not use VOTRIENT after the expiry date.
Store between 15ºC - 30ºC.
If you have any unwanted tablets do not put them in waste water or household rubbish. Ask your pharmacist how to dispose of tablets you do not need. This will help to protect the environment.
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
This document plus the full product monograph, prepared for health professionals can be found at:
http://www.novartis.ca or by contacting the sponsor,
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.
Dorval, Quebec
H9S 1A9
1-800-363-8883
Last revised: July 31, 2019
VOTRIENT is a registered trademark