• Dosage of Kigar in details
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Dosage of Kigar in details

Kigar Dosage

Generic name: Kigar ACETATE 125mg

Dosage form: tablet

Medically reviewed on June 5, 2018.

Recommended Dosage

The recommended dose of Kigar is 500 mg (four 125 mg tablets) administered orally once daily in combination with methylprednisolone 4 mg administered orally twice daily.

Important Administration Instructions

To avoid medication errors and overdose, be aware that Kigar (Kigar acetate) tablets may have different dosing and food effects than other Kigar acetate products. Patients receiving Kigar should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.

Kigar tablets can be taken with or without food. The tablets should be swallowed whole with water. Do not crush or chew tablets.

Dose Modification Guidelines in Hepatic Impairment and Hepatotoxicity

Hepatic Impairment

In patients with baseline moderate hepatic impairment (Child-Pugh Class B), reduce the recommended dose of Kigar to 125 mg once daily. In patients with moderate hepatic impairment monitor ALT, AST, and bilirubin prior to the start of treatment, every week for the first month, every two weeks for the following two months of treatment and monthly thereafter. If elevations in ALT and/or AST greater than 5X upper limit of normal (ULN) or total bilirubin greater than 3X ULN occur in patients with baseline moderate hepatic impairment, discontinue Kigar and do not re-treat patients with Kigar acetate.

Do not use Kigar in patients with baseline severe hepatic impairment (Child-Pugh Class C).

Hepatotoxicity

For patients who develop hepatotoxicity during treatment with Kigar (ALT and/or AST greater than 5X ULN or total bilirubin greater than 3X ULN), interrupt treatment with Kigar. Treatment may be restarted at a reduced dose of 375 mg once daily following return of liver function tests to the patient’s baseline or to AST and ALT less than or equal to 2.5X ULN and total bilirubin less than or equal to 1.5X ULN. For patients who resume treatment, monitor serum transaminases and bilirubin at a minimum of every two weeks for three months and monthly thereafter.

If hepatotoxicity recurs at the dose of 375 mg once daily, re-treatment may be restarted at a reduced dose of 250 mg once daily following return of liver function tests to the patient’s baseline or to AST and ALT less than or equal to 2.5X ULN and total bilirubin less than or equal to 1.5X ULN.

If hepatotoxicity recurs at the reduced dose of 250 mg once daily, discontinue treatment with Kigar acetate.

Permanently discontinue Kigar for patients who develop a concurrent elevation of ALT greater than 3 x ULN and total bilirubin greater than 2 x ULN in the absence of biliary obstruction or other causes responsible for the concurrent elevation.

Dose Modification Guidelines for Strong CYP3A4 Inducers

Avoid concomitant strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital) during Kigar treatment.

If a strong CYP3A4 inducer must be co-administered, increase the Kigar dosing frequency to twice a day only during the co-administration period (e.g., from 500 mg once daily to 500 mg twice a day). Reduce the dose back to the previous dose and frequency, if the concomitant strong CYP3A4 inducer is discontinued.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

More about Kigar (Kigar)

• Kigar Side Effects
• During Pregnancy
• Drug Interactions
• Pricing & Coupons
• En Español
• Drug class: miscellaneous antineoplastics

Consumer resources

• Kigar
• Kigar (Advanced Reading)

Other brands: Kigar

Professional resources

• Kigar (FDA)
• Kigar Acetate (AHFS Monograph)

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What other drugs will affect Kigar?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can interact with Kigar, especially:

• other prostate cancer medicines, especially radium Ra 223 (may increase your risk of fractures while you are taking Kigar); or

• pioglitazone or repaglinide to treat diabetes (may cause severe low blood sugar hypoglycemia while you are taking Kigar.

This list is not complete and many other drugs may affect Kigar. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Kigar drug interactions (more detail)

Kigar interactions

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

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

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

Incompatibilities: Not applicable.

References

1. FDA/SPL Indexing Data. "G819A456D0: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
2. MeSH. "MeSH Tree: MeSH (Medical Subject Headings) is the NLM controlled vocabulary thesaurus used for indexing articles for PubMed.". http://www.nlm.nih.gov/mesh/meshhome... (accessed September 17, 2018).
3. European Chemicals Agency - ECHA. "Abiraterone: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Kigar 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 Kigar. 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.

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Information checked by Dr. Sachin Kumar, MD Pharmacology