Abiraterone

Name: Abiraterone

Abiraterone side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using abiraterone and call your doctor at once if you have:

  • swelling in your ankles or feet, pain in your legs;

  • pain or burning when you urinate;

  • dangerously high blood pressure--severe headache, blurred vision, pounding in your neck or ears, nosebleed, anxiety, severe chest pain, shortness of breath;

  • high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss;

  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • low potassium--confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling; or

  • signs of low adrenal gland hormones--worsening tiredness or muscle weakness, feeling light-headed, nausea, vomiting, loss of appetite, diarrhea, and weight loss.

Common side effects may include:

  • vomiting, diarrhea, painful or difficult urination;

  • swelling;

  • feeling weak, feeling very hot;

  • joint pain or swelling;

  • bruising; or

  • cough, feeling short of breath.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before Using abiraterone

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For abiraterone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to abiraterone or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Abiraterone is not indicated for use in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of abiraterone in the elderly.

Pregnancy

Pregnancy Category Explanation
All Trimesters X Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking abiraterone, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using abiraterone with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Dabrafenib
  • Selexipag

Using abiraterone with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Repaglinide

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of abiraterone. Make sure you tell your doctor if you have any other medical problems, especially:

  • Adrenal or pituitary problems, history of or
  • Heart attack, recent or
  • Heart failure or
  • Heart or blood vessel disease, history of or
  • Heart rhythm problems (eg, ventricular arrhythmia) or
  • Hypertension (high blood pressure) or
  • Hypokalemia (low potassium in the blood)—Use with caution. May make these conditions worse.
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of abiraterone

Take abiraterone only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

abiraterone comes with a patient information leaflet. Read the information carefully and make sure you understand it before taking abiraterone. If you have any questions, ask your doctor.

Swallow the tablets whole with water. Do not break, crush, or chew it.

It is best to take abiraterone on an empty stomach. Do not eat 2 hours before or 1 hour after taking abiraterone.

Dosing

The dose of abiraterone will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of abiraterone. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For castration-resistant prostate cancer:
      • Adults—1000 milligrams (mg) (two 500-mg tablets or four 250-mg tablets) once a day, taken together with 5 mg oral prednisone two times a day.
      • Children—Use is not recommended.

Missed Dose

If you miss a dose of abiraterone, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you missed a dose of abiraterone, take your normal dose on the following day. If more than one daily dose is missed, call your doctor.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

What special precautions should I follow?

Before taking abiraterone,

  • tell your doctor and pharmacist if you are allergic to abiraterone, any other medications, or any of the ingredients in abiraterone tablets. Ask your pharmacist for a list of the ingredients.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: certain antifungals such as itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend); clarithromycin (Biaxin, in Prevpac); HIV protease inhibitors including atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Fortovase, Invirase); certain medications for seizures such as carbamazepine (Carbatrol, Epitol, Tegretol), phenobarbital (Luminal), and phenytoin (Dilantin, Phenytek); nefazodone; rifabutin (Mycobutin); rifampin (Rifadin, in Rifamate, in Rifater, Rimactane); rifapentine (Priftin); telithromycin (Ketek); and thioridazine. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with abiraterone, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
  • tell your doctor if you have an infection or are experiencing unusual stress, have had a recent heart attack, or if you have or have ever had adrenal or pituitary gland problems, an irregular heartbeat, high blood pressure, a low level of potassium in your blood, or heart or liver disease.
  • you should know that abiraterone is only for use in men. Women should not take this medication, especially if they are or may become pregnant or are breast-feeding. If taken by pregnant women, abiraterone may harm the fetus. Women who are, could become, or may be pregnant should not touch abiraterone tablets without protective gloves. If a pregnant woman takes or touches abiraterone tablets, she should call her doctor immediately.you should know that men must use a condom if having sex with a pregnant woman during treatment and for 1 week after finishing treatment with abiraterone. If you are having sex with someone who may become pregnant, you must use a condom and another form of birth control during your treatment and for 1 week after finishing treatment. Talk to your doctor about the types of birth control that are right for you.

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your blood pressure should be checked regularly. Your doctor will order certain lab tests to check your body's response to abiraterone.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Inform MD

Before taking abiraterone, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

  • have heart problems
  • have liver problems
  • have a history of adrenal and/or pituitary problems
  • have any other medical conditions
  • plan to become pregnant.
  • are breastfeeding or plan to breastfeed. 

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Abiraterone can interact with many other medicines.

 

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

-Mild Liver Dysfunction (Child-Pugh A): No adjustment recommended.
-Moderate Liver Dysfunction (Child-Pugh B): 250 mg orally once a day.
-Severe Liver Dysfunction (Child-Pugh C): Do not use.

Development of Hepatotoxicity (ALT and/or AST greater than 5 x ULN or total bilirubin greater than 3 x ULN) During Treatment:
-Interrupt treatment, then restart at a reduced dose of 750 mg orally once a day following return of liver function tests to the patient's baseline or to ALT and AST 2.5 x ULN or less and total bilirubin 1.5 x ULN or less.
-If hepatotoxicity recurs at 750 mg/day, then restart at a reduced dose of 500 mg orally once a day following return of liver function tests to the patient's baseline or to ALT and AST 2.5 x ULN or less and total bilirubin 1.5 x ULN or less.
-Discontinue treatment if hepatotoxicity recurs at 500 mg/day.

Development of Severe Hepatotoxicity (ALT or AST 20 x ULN) During Treatment:
-Permanently discontinue treatment.

Abiraterone Breastfeeding Warnings

This drug is not indicated for use in women. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: The effects in the nursing infant are unknown.

Dosage Forms and Strengths

Abiraterone acetate 250 mg tablets are white to off-white, oval-shaped tablets debossed with AA250 on one side.

Contraindications

Pregnancy

Abiraterone acetate can cause fetal harm when administered to a pregnant woman. Abiraterone acetate is not indicated for use in women. Abiraterone acetate is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus and the potential risk for pregnancy loss [see Use in Specific Populations (8.1)].

How Supplied/Storage and Handling

Abiraterone acetate 250 mg tablets are white to off-white, oval tablets debossed with AA250 on one side. Abiraterone acetate 250 mg tablets are available in high-density polyethylene bottles of 120 tablets.

NDC Number 57894-155-12

Storage and Handling

Store at 20°C to 25°C (68°F to 77°F); excursions permitted in the range from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Keep out of reach of children.

Based on its mechanism of action, Abiraterone acetate may harm a developing fetus. Women who are pregnant or women who may be pregnant should not handle Abiraterone acetate without protection, e.g., gloves [see Use in Specific Populations (8.1)].

(web3)