Treating a certain type of prostate cancer that has spread to other parts of the body. It is used along with another medicine (prednisone). It may also be used for other conditions as determined by your doctor.
Abitate is an androgen biosynthesis inhibitor. It works by decreasing levels of certain hormones produced by the testes. This helps to prevent the growth of certain tumors that need these hormones to grow.
Abitate indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Abitate is indicated with prednisone or prednisolone for the treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated; the treatment of metastatic castration resistant prostate cancer in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.
How should I use Abitate?
Use Abitate as directed by your doctor. Check the label on the medicine for exact dosing instructions.
An extra patient leaflet is available with Abitate. Talk to your pharmacist if you have questions about this information.
Take Abitate by mouth on an empty stomach at least 1 hour before or 2 hours after eating. Do NOT take it with food. The amount of Abitate in your body may be increased if you take it with food. This may increase the risk of side effects.
Swallow Abitate whole with water. Do not break, crush, or chew before swallowing.
If you miss a dose of Abitate, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you miss more than 1 dose, contact your doctor.
Ask your health care provider any questions you may have about how to use Abitate.
Uses of Abitate in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Abitate is used in adult men to treat prostate cancer that has spread to other parts of the body. Abitate is usually prescribed with another medicine called prednisone or prednisolone to lower chances of getting high blood pressure, fluid retention, or having reduced levels of a chemical (potassium) in blood.
Abitate description
Abitate is a derivative of steroidal progesterone and is an innovative drug that offers clinical benefit to patients with hormone refractory prostate cancer. Abitate is administered as an acetate salt prodrug because it has a higher bioavailability and less susceptible to hydrolysis than Abitate itself. FDA approved on April 28, 2011.
Abitate dosage
Usual Adult Dose for Prostate Cancer
1,000 mg orally once a day on an empty stomach (in combination with prednisone 5 mg orally 2 times a day)
Comments: No food should be consumed for at least 2 hours before the dose and for at least 1 hour after the dose of this drug.
Use: Treatment of metastatic castration-resistant prostate cancer
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.
Dose Adjustments
Concomitant Use of Strong CYP450 3A4 Inducer:
-Avoid concomitant use if possible.
-If concomitant use is necessary, increase the dosing frequency of this drug to 2 times a day during the co-administration period.
-Return to the previous dosing frequency once the strong CYP450 3A4 inducer is discontinued.
Concomitant Use of CYP450 2D6 Substrates with Narrow Therapeutic Index:
-Avoid concomitant use if possible.
-If concomitant use is necessary, consider a dose reduction of the CYP450 2D6 substrate during the co-administration period.
Precautions
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration Advice:
-This drug should be swallowed whole with water.
-Drug tablets should not be crushed or chewed.
-Pregnant women should not handle this drug without protection (e.g., gloves).
-In the event of a missed dose, the missed dose should be skipped and treatment should be resumed the following day with the usual daily dose.
General:
-Patients already receiving a gonadotropin-releasing hormone (GnRH) agonist should continue to take that drug during Abitate treatment.
Interactions With Other Drugs: Potential for Other Drugs To Affect Abitate Exposures: In a clinical pharmacokinetic interaction study of healthy subjects pre-treated with a strong CYP3A4 inducer (rifampicin 600 mg daily for 6 days) followed by a single dose of Abitate 1,000 mg, the mean plasma AUC∞ of Abitate was decreased by 55%. Strong inducers of CYP3A4 (eg, phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarbital) during treatment with Abitate are to be avoided or used with careful evaluation of clinical efficacy.
In a separate clinical pharmacokinetic interaction study of healthy subjects, co-administration of ketoconazole, a strong inhibitor of CYP3A4, had no clinically meaningful effect on the pharmacokinetics of Abitate.
Potential of Abitate to Affect Exposures to Other Drugs: Abitate is an inhibitor of the hepatic drug-metabolizing enzymes CYP2D6 and CYP2C8. In the clinical study to determine the effects of Abitate (plus prednisone) on a single dose of the CYP2D6 substrate dextromethorphan, the systemic exposure (AUC) of dextromethorphan was increased by approximately 200%. The AUC24 for dextrorphan, the active metabolite of dextromethorphan, increased approximately 33%.
Caution is advised when Abitate is administered with drugs activated by or metabolized by CYP2D6, particularly with drugs that have a narrow therapeutic index. Dose reduction of narrow therapeutic index drugs metabolized by CYP2D6 should be considered.
In the same study to determine the effects of Abitate (plus prednisone) on a single dose of the CYP1A2 substrate theophylline, no increase in systemic exposure of theophylline was observed.
In a CYP2C8 drug-drug interaction trial in healthy subjects, the AUC of pioglitazone was increased by 46% and the AUCs for M-III and M-IV, the active metabolites of pioglitazone, each decreased by 10%, when pioglitazone was given together with a single dose of Abitate 1,000 mg. Although these results indicate that no clinically meaningful increases in exposure are expected when Abitate is combined with drugs that are predominantly eliminated by CYP2C8, patients should be monitored for signs of toxicity related to a CYP2C8 substrate with a narrow therapeutic index if used concomitantly with Abitate.
Effect of Food on Abitate: Administration of Abitate with food significantly increases the absorption of Abitate. The efficacy and safety of Abitate given with food has not been established. Abitate must not be taken with food.
In addition to its needed effects, some unwanted effects may be caused by Abitate. In the event that any of these side effects do occur, they may require medical attention.
Major Side Effects
You should check with your doctor immediately if any of these side effects occur when taking Abitate:
More common:
Bladder pain
bloating or swelling of the face, arms, hands, lower legs, or feet
bloody or cloudy urine
blurred vision
bone fracture
chest pain or discomfort
convulsions
decreased urine
difficult, burning, or painful urination
dizziness
dry mouth
fainting
fast, pounding, or irregular heartbeat or pulse
feeling of warmth
frequent urge to urinate
headache
increased need to urinate
increased thirst
increased urge to urinate during the night
lightheadedness, dizziness, or fainting
loss of appetite
lower back or side pain
mood changes
muscle pain or cramps
nausea or vomiting
nervousness
numbness or tingling in the hands, feet, or lips
pain or swelling in the arms or legs without any injury
passing urine more often
pounding in the ears
rapid weight gain
redness of the face, neck, arms, and occasionally, upper chest
shortness of breath
slow heartbeat
sudden sweating
swelling
swelling with pits or depressions on the skin
unusual tiredness or weakness
unusual weight gain or loss
waking to urinate at night
Less common:
Abdominal or stomach pain or tenderness
arm, back, or jaw pain
chest tightness or heaviness
clay colored stools
cool, sweaty skin
dark urine
decreased appetite
decreased urine output
difficulty with breathing
dilated neck veins
extreme fatigue
fever
headache
irregular breathing
itching skin
rash
sweating
swelling of the face, fingers, feet, or lower legs
weakness
weight gain
wheezing
yellow eyes or skin
Rare
Darkening of the skin
diarrhea
mental depression
Minor Side Effects
Some of the side effects that can occur with Abitate may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:
Use in pregnancy: Women who are or may potentially be pregnant.
There are no human data on the use of Abitate in pregnancy and Abitate is not for use in women of childbearing potential. Maternal use of a CYP17 inhibitor is expected to produce changes in hormone levels that could affect development of the fetus.
It is not known if Abitate or its metabolites are present in semen. A condom is required if the patient is engaged in sexual activity with a pregnant woman. If the patient is engaged in sex with a woman of childbearing potential, a condom is required along with another effective contraceptive method.
To avoid inadvertent exposure, women who are pregnant or women who may be pregnant should not handle Abitate without protection eg, gloves.
Use in lactation: Abitate is not for use in women.
It is not known if either Abitate or its metabolites are excreted in human breast milk.
DTP/NCI. "Abiraterone: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Abitate are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Abitate. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
User reports
Consumer reported useful
No survey data has been collected yet
1 consumer reported price estimates
Was the price you paid to purchase the drug reasonable? Did you feel it was expensive? The below mentioned numbers have been reported by ndrugs.com website users about whether the Abitate drug is expensive or inexpensive. There is a mixed opinion among users. The rating about the cost of the drug depends on factors like which brand drug the patient purchased, how effective it was for the price paid, the country or place the drug is marketed, and the economic condition of the patient. The users who feel the drug is expensive can look for an alternative brand drug or a generic drug to save the cost.
Users
%
Expensive
1
100.0%
Consumer reported time for results
No survey data has been collected yet
3 consumers reported age
Users
%
46-60
2
66.7%
> 60
1
33.3%
Consumer reviews
There are no reviews yet. Be the first to write one!
