Zybirra Uses

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What is Zybirra?

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.

Zybirra 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.

Zybirra 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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Zybirra 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 Zybirra?

Use Zybirra as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Zybirra.

Uses of Zybirra 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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Zybirra is used in adult men to treat prostate cancer that has spread to other parts of the body. Zybirra 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.

Zybirra description

Zybirra is a derivative of steroidal progesterone and is an innovative drug that offers clinical benefit to patients with hormone refractory prostate cancer. Zybirra is administered as an acetate salt prodrug because it has a higher bioavailability and less susceptible to hydrolysis than Zybirra itself. FDA approved on April 28, 2011.

Zybirra 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 Zybirra treatment.

Monitoring:

-Cardiovascular: Cardiac function

-Endocrine: Blood pressure, serum potassium, fluid retention, signs/symptoms of adrenocortical insufficiency

-Hepatic: ALT, AST, bilirubin

-Metabolic: Blood sugar (in diabetic patients)

Zybirra interactions

See also:
What other drugs will affect Zybirra?

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Interactions With Other Drugs: Potential for Other Drugs To Affect Zybirra 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 Zybirra 1,000 mg, the mean plasma AUC of Zybirra was decreased by 55%. Strong inducers of CYP3A4 (eg, phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarbital) during treatment with Zybirra 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 Zybirra.

Potential of Zybirra to Affect Exposures to Other Drugs: Zybirra is an inhibitor of the hepatic drug-metabolizing enzymes CYP2D6 and CYP2C8. In the clinical study to determine the effects of Zybirra (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 Zybirra 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 Zybirra (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 Zybirra 1,000 mg. Although these results indicate that no clinically meaningful increases in exposure are expected when Zybirra 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 Zybirra.

Effect of Food on Zybirra: Administration of Zybirra with food significantly increases the absorption of Zybirra. The efficacy and safety of Zybirra given with food has not been established. Zybirra must not be taken with food.

Incompatibilities: Not applicable.

Zybirra side effects

See also:
What are the possible side effects of Zybirra?

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Applies to Zybirra: oral tablet

In addition to its needed effects, some unwanted effects may be caused by Zybirra. 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 Zybirra:

More common:

Less common: Rare

Minor Side Effects

Some of the side effects that can occur with Zybirra 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:

More common:

Zybirra contraindications

See also:
What is the most important information I should know about Zybirra?

Use in pregnancy: Women who are or may potentially be pregnant.

There are no human data on the use of Zybirra in pregnancy and Zybirra 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 Zybirra 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 Zybirra without protection eg, gloves.

Use in lactation: Zybirra is not for use in women.

It is not known if either Zybirra or its metabolites are excreted in human breast milk.

Active ingredient matches for Zybirra:

Abiraterone Acetate


Unit description / dosage (Manufacturer)Price, USD
ZYBIRRA 250MG TABLET 1 packet / 120 tablets each (Zydus Cadila)$ 1284.96

List of Zybirra substitutes (brand and generic names):

Abatitor 250mg Tablet (Torrent Pharmaceuticals Ltd)$ 5.28
ABIONE 250MG TABLET 1 packet / 120 tablets each (Intas Pharmaceuticals Ltd)$ 1571.43
ABIRATAS 250MG TABLET 1 packet / 120 tablets each (Intas Pharmaceuticals Ltd)$ 1496.60
ABRETONE 250MG TABLET 1 packet / 120 tablets each (Cadila Pharmaceuticals Ltd)$ 1511.71
ABRETONE 250MG TABLET 1 packet / 60 tablets each (Cadila Pharmaceuticals Ltd)$ 786.10
Abretone 250mg Tablet (Cadila Pharmaceuticals Ltd)$ 12.60
ABSTET 250MG TABLET 1 packet / 120 tablets each (Biocon)$ 1170.63
ABSTET 250MG TABLET 1 packet / 60 tablets each (Biocon)$ 623.58
ABSTET 250MG TABLET 1 strip / 30 tablets each (Biocon)$ 466.67
ARBITUS TABLET 1 packet / 120 tablets each (Dr Reddy's Laboratories Ltd)$ 603.24
Arbitus 250mg Tablet (Dr Reddy's Laboratories Ltd)$ 5.03
SAMTICA 250MG TABLET 1 packet / 120 tablets each (Samarth Life Sciences Pvt Ltd)$ 992.06
XBIRA 250 MG TABLET 1 packet / 120 tablets each (Cipla)$ 1349.21
XBIRA tab 250 mg x 120's (Cipla)
Xbira 250mg Tablet (Cipla)$ 3.69
ZELGOR 250 MG TABLET 1 packet / 120 tablets each (Ranbaxy Laboratories Ltd)$ 468.25
Zelgor 250mg Tablet (Sun Pharmaceutical Industries Ltd)$ 2.38
ZYTIPROST 250MG TABLET 1 strip / 30 tablets each (Alkem Laboratories Ltd)$ 544.22

References

  1. PubChem. "Abiraterone". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  2. DrugBank. "Abiraterone". http://www.drugbank.ca/drugs/DB05812 (accessed September 17, 2018).
  3. 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).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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