Abiraterone (Zytiga )

Abiraterone (Zytiga®)

Pronounced: [ab-er-at-er-own]

About Your Medication

· Abiraterone is an oral medicine used to treat prostate cancer. Prostate cancer cells grow in response to hormones in the body called testosterone. Abiraterone works by blocking an enzyme in prostate cancer cells that makes testosterone, preventing the growth of the cancer cells.

How to Take Your Medication

· Take your abiraterone at approximately the same time each day.

· Swallow abiraterone tablets whole. Do not chew or crush the tablets

· Abiraterone should be taken on an empty stomach. No food should be eaten 2 hours before and 1 hour after taking abiraterone.

· Abiraterone must be taken with prednisone. Do not stop the prednisone without talking to your cancer doctor.

· If you miss a dose of your abiraterone or prednisone, take the medicine as soon as possible. If you forget to take the dose for the whole day, then you should skip that dose and take your normal dose the next day. Do not double your dose. Please talk to your doctor if you miss more than one daily dose of the medicine.

Tell Your Healthcare Provider if you have any trouble taking your oral anticancer therapy, including:

· Trouble swallowing pills

· Forgetting to take doses

· Trouble affording your medications

· Throwing up pills

· Side effects

Important Precautions

· Abiraterone may be harmful to an unborn child. If sexually active with a partner that is pregnant or who may become pregnant during and 1 week after treatment, two forms of contraception must be used (a condom and another effective form of birth control)

· Talk to your healthcare provider if you have a history of any heart conditions, including heart failure, heart attack, or problems with your heart rhythm.

· Abiraterone was associated with a small risk of liver toxicity in clinical trials. Talk to your healthcare provider if you have a history of liver problems.

What foods and drugs may interact with my abiraterone?

Please talk to your healthcare provider at your cancer clinic before starting or stopping any medications, vitamins, or herbal supplements, because some of these may interact with your abiraterone. Some examples of products that interact with abiraterone include:

· Grapefruit or grapefruit juice

· Certain heart medications, including clopidogrel (Plavix®), amlodipine (Norvasc®), metoprolol (Toprol®), eplerenone (Inspra®), spironolactone (Aldactone®), ranolazine (Ranexa®), amiodarone (Pacerone®), and propafenone (Rythmol®)

· Certain cholesterol-lowering drugs, such as simvastatin (Zocor®), atorvastatin (Lipitor®), and lovastatin (Mevacor®)

· Some blood thinning medications, including warfarin (Coumadin®), dabigatran (Pradaxa®), and rivaroxaban (Xarelto®)

· Certain medications for blood sugar, such as Pioglitazone (Actos®) and sitagliptin (Januvia®)

· Some pain medications, including codeine, colchicine (Colcrys®), tramadol (Ultram®), and fentanyl (Duragesic®)

· Some medications for mood, including citalopram (Celexa®), clozapine (Clozaril®), thioridazine (Mellaril®), aripiprazole (Abilify®), lurasidone (Latuda®), atomoxetine (Strattera®), and St. John’s Wort

· Some anti-infectives, such as voriconazole (Vfend®), itraconazole (Sporanox®), posaconazole (Noxafil®), rifampin (Rifadin®), clarithromycin (Biaxin®), and ritonavir (Norvir®)

· Certain anti-seizure medications, including carbamazepine (Tegretol®) and phenytoin (Dilantin)®

Storage, Handling, and Disposal

It is important to keep these safeguards in mind when storing and handling oral anticancer therapy to keep you and your caregivers safe.

· Abiraterone may be harmful to an unborn child. Women who are pregnant or who may become pregnant should not handle abiraterone without proper protection (gloves).

· Keep your abiraterone in a safe place, away from other family members’ medications and away from any food or drinks.

· Store the medication at room temperature in a dry location – avoid storing your medication in the bathroom.

· Keep the medication out of reach from children and pets.

· Abiraterone may stay in the body for several days after a dose is taken. It may be present in bodily fluids or waste, including sweat, urine, feces, and vomit. Always wear gloves when cleaning up or coming into contact with bodily fluids.

· Return expired, damaged, or unused abiraterone to a pharmacy or hospital for disposal. Do not discard into the garbage or toilet, or anywhere that children or pets may have access.

Abiraterone (Zytiga®) Side Effect Summary

This list does not include all possible side effects of abiraterone. If you have an unusual symptom, call the clinic. Below are the most common side effects:

· Joint or Muscle Pain

What are your symptoms? / What can you do…
Mild pain - not interfering with function / · Mild/moderate exercise or stretching may help relieve some stiffness and pain
· Use pain medication recommended by the clinic
Moderate pain - may interfere with function but not affecting your ability to perform normal daily activities / · Mild/moderate exercise or stretching may help relieve some stiffness and pain
· Use pain medication recommended by the clinic
· If pain not improving within a few days, call the clinic
Severe pain – pain that interferes with your ability to perform normal activities / · Call the clinic

· Swelling/Rapid Weight Gain (edema)

What are your symptoms? / What can you do…
Mild swelling, only visible when looking closely, not interfering with activities / · Ask your clinic about special stockings
· Wear loose clothing and shoes that are not too tight
· Keep your legs elevated when you are sitting or resting
· Weigh yourself regularly
· Avoid salty foods, including canned soups, chips, bacon, and ham. Don’t add extra salt or soy sauce to your food. Check food labels for sodium content, and try to limit yourself to less than 2 grams of sodium per day.
Moderate swelling, clearly visible, not interfering with daily activities / · Try to manage using the measures listed above
· If you have rapid weight gain (more than 5 pounds in one week), call the clinic
· If you have any difficulty breathing or chest tightness, call 911 or proceed to your local emergency room
Severe swelling, interfering with your daily activities / · Call the clinic
· If you have any difficulty breathing or chest tightness, call 911 or proceed to your local emergency room

· Hot flashes/flushing – suddenly feeling hot, sweating, sometimes with redness of the face and neck. Not causing a fever (temperature >100.5⁰F) or symptoms concerning for infection.

What are your symptoms? / What can you do…
Mild hot flashes or flushing – only slightly bothering you / · Avoid triggers such as warm environments, alcohol, and caffeine
· Wear layered cotton clothing
· Practice slow, deep breathing
Moderate hot flashes or flushing / · Try to manage using the measures listed above
· If hot flashes are not improving within a week, Call the clinic
Severe hot flashes or flushing – very distressing or bothering / · Try to manage using the measures listed above
· If hot flashes are not improving within a few days, Call the clinic

· Fatigue – lack of energy or feeling sleepy

What are your symptoms? / What can you do…
Mild fatigue (slightly worse than before you started taking the drug) / · You may need to adjust your schedule to manage fatigue. Plan out the day, and prioritize activities, so you have time to rest.
· You should schedule periods of rest into your day, and try to rest before you feel tired. Frequent, short rests are helpful.
· Stay active – regular mild/moderate exercise can boost your energy level. Try incorporating walking or other activities into your daily routine.
· Try not to over-exert yourself. Ask for help from family or friends with difficult tasks.
Moderate fatigue (difficulty performing some of your normal daily activities) / · Try to manage using the measures listed above.
· If it does not get better after a few days, Call the clinic
Severe fatigue (severely interfering with your normal daily activities or inability to get out of bed) / · Call the clinic

· Diarrhea – frequent and/or watery bowel movements

What are your symptoms? / What can you do…
Mild diarrhea – stools are more loose/watery or you are having 1-3 more stools per day than usual / · Stay well hydrated
· Avoid fatty, greasy, spicy foods that may increase your risk for diarrhea
· Avoid caffeine and alcohol
· Eat small, frequent meals; foods that are easy on the stomach include bananas, rice, applesauce, and toast
· Use your antidiarrheal medicine, loperamide (Imodium®) 4 mg at the onset of diarrhea, then 2 mg every 2 hours until diarrhea-free for 12 hours
· If diarrhea is not improving after 48 hours of treatment with your antidiarrheal medicine, or you are having trouble staying hydrated, call the clinic
Moderate diarrhea - you are having 4-6 more stools per day than usual; you are still able to perform your normal daily activities / · Try to manage using the measures listed above.
· If diarrhea is not improving within 24 hours, or you are having trouble staying hydrated, Call the clinic
Severe diarrhea – you are having 7 or more stools per day than usual, or you are having trouble staying hydrated or performing normal daily activities, or you are not making it to the bathroom in time / · Call the clinic

· Hypertension – high blood pressure; Monitor your blood pressure regularly, and record your blood pressure readings.

What are your symptoms? / What can you do…
Mild High Blood Pressure (Prehypertension) –
120-139/80-89
Systolic blood pressure (top number) of 120-139
OR
Diastolic blood pressure (bottom number) of 80-89 / · Monitor your blood pressure regularly, and record your blood pressure readings
· Mild/moderate regular exercise can help lower your blood pressure
· Eat a balanced diet, high in fruits and vegetables and low in saturated fats and salt
· Your healthcare provider may start you on a blood pressure lowering medicine. Make sure to take your medicines as directed.
Moderate High Blood Pressure (Stage I Hypertension)
140-159/90-99
Systolic blood pressure (top number) of 140-159
OR
Diastolic blood pressure (bottom number) of 90-99 / · Try to manage using the measures listed above.
· If blood pressure is not improving within 1 week, Call the clinic
Severe High Blood Pressure (Stage II Hypertension) –
160/100
Systolic blood pressure (top number) of 160
OR
Diastolic blood pressure (bottom number) of 100 / · Try to manage using the measures listed above.
· If blood pressure is not improving within 48 hours, Call the clinic
Symptoms of severe high blood pressure:
· Trouble seeing, speaking, or walking
· Numbness, weakness, or inability to move on one side of your body
· Headaches that are more severe or frequent than usual / · Go to the emergency room, or call 911

Below are some less common side effects of abiraterone.

Less Common Side Effects / What Can I Do? / When to Call the Clinic?
Increased risk of infection, including urinary tract infections / · Wash hands regularly
· Avoid close contact with others who are sick / · Temperature of 100.5˚F or higher- CONTACT THE CLINIC IMMEDIATELY
· Any signs of infection
· Frequency, urgency, or pain with urination
· Blood in the urine (orange or pink/red tinged urine)
· Unusual tiredness or weakness
· Shortness of breath, difficulty breathing
Low blood potassium levels / · The clinic will monitor your labs regularly. Make sure not to miss clinic visits or lab draws. / · Severe muscle weakness
· Rapid heartbeat or heart rhythm changes
Liver dysfunction / · The clinic will monitor your labs regularly. Make sure not to miss clinic visits or lab draws
· Avoid alcohol use while taking abiraterone / · Yellowing of the eyes or skin

Who to Call With Questions?