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Abiraterone Acetate

Medically reviewed by Drugs.com. Last updated on June 20, 2020.

Pronunciation

(a bir A ter one AS e tate)

Index Terms

  • Abiraterone
  • Abiraterone Acetate Fine Particle (Yonsa)
  • Abiraterone Acetate Micronized (Yonsa)
  • Abiraterone Acetate Originator (Zytiga)
  • CB7630

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Yonsa: 125 mg

Zytiga: 250 mg, 500 mg

Generic: 250 mg

Brand Names: U.S.

  • Yonsa
  • Zytiga

Pharmacologic Category

  • Antiandrogen
  • Antineoplastic Agent, Antiandrogen

Pharmacology

Abiraterone selectively and irreversibly inhibits CYP17 (17 alpha-hydroxylase/C17,20-lyase), an enzyme required for androgen biosynthesis which is expressed in testicular, adrenal, and prostatic tumor tissues. Inhibits the formation of the testosterone precursors dehydroepiandrosterone (DHEA) and androstenedione.

Distribution

Vdss: 19,669 ± 13,358 L

Metabolism

Abiraterone acetate is hydrolyzed to the active metabolite abiraterone; further metabolized to inactive metabolites abiraterone sulphate and N-oxide abiraterone sulphate via CYP3A4 and SULT2A1

Excretion

Feces (~88%); urine (~5%)

Time to Peak

2 hours (Acharya 2012)

Half-Life Elimination

14.4 to 16.5 hours (Acharya 2012)

Protein Binding

>99%; to albumin and alpha1-acid glycoprotein

Special Populations: Hepatic Function Impairment

After a single oral 1,000 mg dose (Zytiga), systemic exposure increased ~1.1- and 3.6-fold in subjects with mild and moderate hepatic impairment, respectively. The mean half-life was prolonged to ~18 hours and ~19 hours in subjects with mild and moderate impairment, respectively. Systemic exposure of abiraterone increased by 7- fold and the fraction of free drug increased by 2-fold in subjects with severe baseline hepatic impairment. Mean protein binding was found to be lower in patients with severe hepatic impairment.

Use: Labeled Indications

Prostate cancer, metastatic:

Treatment of metastatic, castration-resistant prostate cancer (in combination with prednisone [Zytiga] or methylprednisolone [Yonsa])

Treatment of metastatic, high-risk castration-sensitive prostate cancer (in combination with prednisone [Zytiga])

Contraindications

There are no contraindications listed in the manufacturer's US labeling.

Canadian labeling: Hypersensitivity to abiraterone acetate or any component of the formulation or container; females who are or may become pregnant.

Dosing: Adult

Note: Patients receiving abiraterone should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently (or have had a bilateral orchiectomy). Abiraterone acetate is available in different tablet formulations; use caution when selecting dosage form as dosing and food effects vary between products. The formulations are NOT interchangeable; do not substitute between formulations.

Prostate cancer, metastatic, castration-resistant: Oral:

Zytiga: 1,000 mg once daily (in combination with prednisone 5 mg twice daily) (de Bono 2011; Ryan 2015)

Yonsa (micronized formulation): 500 mg once daily (in combination with methylprednisolone 4 mg twice daily)

Prostate cancer, metastatic, high-risk, castration-sensitive: Oral: Zytiga: 1,000 mg once daily (in combination with prednisone 5 mg once daily) (Fizazi 2017)

or (off-label combination; Zytiga) 1,000 mg once daily (in combination with prednisolone 5 mg once daily) (James 2017)

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Adjustment for Toxicity

Hepatotoxicity: Refer to Dosing: Hepatic Impairment.

Administration

Note: Abiraterone acetate is available in different tablet formulations; use caution when selecting dosage form as dosing and food effects vary between products. The formulations are NOT interchangeable; do not substitute between formulations.

Oral: Administer abiraterone (Zytiga) orally on an empty stomach, at least 1 hour before and 2 hours after food. No food should be consumed for at least 2 hours before or for at least 1 hour after the abiraterone (Zytiga) dose. Abiraterone micronized (Yonsa) may be administered without regard to food. Swallow tablets whole with water. Do not crush or chew.

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F).

Drug Interactions

Ajmaline: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Ajmaline. Monitor therapy

Amitriptyline: CYP2D6 Inhibitors (Moderate) may increase serum concentrations of the active metabolite(s) of Amitriptyline. CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Amitriptyline. Monitor therapy

Amoxapine: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Amoxapine. Monitor therapy

Amphetamines: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Amphetamines. Management: Monitor for amphetamine toxicities (including serotonin syndrome) if used with a moderate CYP2D6 inhibitor. Initiate amphetamine therapy at lower doses, monitor frequently, and adjust doses as needed. Discontinue amphetamines if serotoinin syndrome occurs Monitor therapy

ARIPiprazole: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of ARIPiprazole. Management: Monitor for increased aripiprazole pharmacologic effects. Aripiprazole dose adjustments may or may not be required based on concomitant therapy, indication, or dosage form. Consult full interaction monograph for specific recommendations. Monitor therapy

ARIPiprazole Lauroxil: CYP2D6 Inhibitors (Moderate) may increase serum concentrations of the active metabolite(s) of ARIPiprazole Lauroxil. Monitor therapy

AtoMOXetine: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of AtoMOXetine. Monitor therapy

Brexpiprazole: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Brexpiprazole. Management: If brexpiprazole is to be used together with both a moderate CYP2D6 inhibitor and a strong or moderate CYP3A4 inhibitor, the brexpiprazole dose should be reduced to 25% of the usual dose when treating indications other than major depressive disorder. Monitor therapy

Carvedilol: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Carvedilol. Monitor therapy

Choline C 11: Antiandrogens may diminish the therapeutic effect of Choline C 11. Monitor therapy

ClomiPRAMINE: CYP2D6 Inhibitors (Moderate) may increase serum concentrations of the active metabolite(s) of ClomiPRAMINE. CYP2D6 Inhibitors (Moderate) may increase the serum concentration of ClomiPRAMINE. Monitor therapy

CloZAPine: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of CloZAPine. Monitor therapy

Codeine: CYP2D6 Inhibitors (Moderate) may diminish the therapeutic effect of Codeine. These CYP2D6 inhibitors may prevent the metabolic conversion of codeine to its active metabolite morphine. Monitor therapy

CYP3A4 Inducers (Moderate): May decrease the serum concentration of Abiraterone Acetate. Monitor therapy

CYP3A4 Inducers (Strong): May decrease the serum concentration of Abiraterone Acetate. Management: Avoid whenever possible. If such a combination cannot be avoided, increase abiraterone acetate dosing frequency from once daily to twice daily during concomitant use. Consider therapy modification

Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Seek alternatives to concomitant therapy when possible. If concomitant therapy cannot be avoided, monitor for reduced clinical effects of the CYP3A4 substrate. Consider therapy modification

Deferasirox: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Desipramine: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Desipramine. Monitor therapy

Deutetrabenazine: CYP2D6 Inhibitors (Moderate) may increase serum concentrations of the active metabolite(s) of Deutetrabenazine. Monitor therapy

Dextromethorphan: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Dextromethorphan. Monitor therapy

Doxepin (Systemic): CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Doxepin (Systemic). Monitor therapy

Doxepin (Topical): CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Doxepin (Topical). Monitor therapy

DOXOrubicin (Conventional): CYP2D6 Inhibitors (Moderate) may increase the serum concentration of DOXOrubicin (Conventional). Avoid combination

Eliglustat: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Eliglustat. Management: Eliglustat dose is 84 mg daily with CYP2D6 inhibitors. Use is contraindicated (COI) when also combined with strong CYP3A4 inhibitors. When also combined with a moderate CYP3A4 inhibitor, use is COI in CYP2D6 EMs or IMs and should be avoided in CYP2D6 PMs. Consider therapy modification

Enzalutamide: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Concurrent use of enzalutamide with CYP3A4 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP3A4 substrate should be performed with caution and close monitoring. Consider therapy modification

Erdafitinib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Flecainide: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Flecainide. Monitor therapy

Haloperidol: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Haloperidol. Monitor therapy

Iloperidone: CYP2D6 Inhibitors (Moderate) may decrease serum concentrations of the active metabolite(s) of Iloperidone. Specifically, concentrations of the metabolite P95 may be decreased. CYP2D6 Inhibitors (Moderate) may increase serum concentrations of the active metabolite(s) of Iloperidone. Specifically, concentrations of the metabolite P88 may be increased. CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Iloperidone. Monitor therapy

Imipramine: CYP2D6 Inhibitors (Moderate) may increase serum concentrations of the active metabolite(s) of Imipramine. Concentrations of desipramine may be increased. CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Imipramine. Monitor therapy

Indium 111 Capromab Pendetide: Antiandrogens may diminish the diagnostic effect of Indium 111 Capromab Pendetide. Avoid combination

Indoramin: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Indoramin. Monitor therapy

Ivosidenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Lofepramine: CYP2D6 Inhibitors (Moderate) may increase serum concentrations of the active metabolite(s) of Lofepramine. The active metabolite of lofepramine is desipramine. Monitor therapy

Mequitazine: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Mequitazine. Avoid combination

Metoclopramide: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Metoclopramide. Monitor therapy

Metoprolol: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Metoprolol. Monitor therapy

Mitotane: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Doses of CYP3A4 substrates may need to be adjusted substantially when used in patients being treated with mitotane. Consider therapy modification

Nebivolol: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Nebivolol. Monitor therapy

Nortriptyline: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Nortriptyline. Monitor therapy

Oliceridine: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Oliceridine. Monitor therapy

Olmutinib: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Olmutinib. Monitor therapy

PARoxetine: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of PARoxetine. Monitor therapy

Perhexiline: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Perhexiline. Monitor therapy

Perphenazine: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Perphenazine. Monitor therapy

Pimozide: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Pimozide. Monitor therapy

Pitolisant: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Pitolisant. Monitor therapy

Propafenone: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Propafenone. Monitor therapy

Propranolol: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Propranolol. Monitor therapy

Protriptyline: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Protriptyline. Monitor therapy

Radium Ra 223 Dichloride: May enhance the adverse/toxic effect of Abiraterone Acetate. Specifically, the risk for fractures and death may be increased. Avoid combination

Repaglinide: CYP2C8 Inhibitors (Weak) may increase the serum concentration of Repaglinide. Monitor therapy

Rifabutin: May decrease the serum concentration of Abiraterone Acetate. Monitor therapy

Rifapentine: May decrease the serum concentration of Abiraterone Acetate. Monitor therapy

RisperiDONE: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of RisperiDONE. Monitor therapy

Sarilumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Siltuximab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Solriamfetol: May enhance the hypertensive effect of Hypertension-Associated Agents. Monitor therapy

Spironolactone: May diminish the therapeutic effect of Abiraterone Acetate. Monitor therapy

Tamoxifen: CYP2D6 Inhibitors (Moderate) may decrease serum concentrations of the active metabolite(s) of Tamoxifen. Specifically, CYP2D6 inhibitors may decrease the metabolic formation of highly potent active metabolites. Management: Consider alternatives to the use of moderate CYP2D6 inhibitors with tamoxifen when possible, as the combination may be associated with reduced clinical effectiveness of tamoxifen. Consider therapy modification

Tamsulosin: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Tamsulosin. Monitor therapy

Tetrabenazine: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Tetrabenazine. Specifically, concentrations of the active alpha- and beta-dihydrotetrabenazine metabolites may be increased. Monitor therapy

Thiazolidinediones: Abiraterone Acetate may enhance the hyperglycemic effect of Thiazolidinediones. Monitor therapy

Thioridazine: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Thioridazine. Avoid combination

Timolol (Systemic): CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Timolol (Systemic). Monitor therapy

Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

TraMADol: CYP2D6 Inhibitors (Moderate) may decrease serum concentrations of the active metabolite(s) of TraMADol. CYP2D6 Inhibitors (Moderate) may increase the serum concentration of TraMADol. Monitor therapy

Trimipramine: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Trimipramine. Monitor therapy

Valbenazine: CYP2D6 Inhibitors (Moderate) may increase serum concentrations of the active metabolite(s) of Valbenazine. Monitor therapy

Vortioxetine: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Vortioxetine. Monitor therapy

Zuclopenthixol: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Zuclopenthixol. Monitor therapy

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported for use in combination with a corticosteroid.

>10%:

Cardiovascular: Edema (25% to 27%), hypertension (9% to 37%)

Endocrine & metabolic: Hot flash (15% to 22%), hyperglycemia (57%), hypernatremia (33%), hypertriglyceridemia (63%), hypokalemia (17% to 30%), hypophosphatemia (24%)

Gastrointestinal: Constipation (23%), diarrhea (18% to 22%), dyspepsia (6% to 11%)

Genitourinary: Urinary tract infection (7% to 12%)

Hematologic & oncologic: Bruise (13%), lymphocytopenia (20% to 38%; grades 3/4: 4% to 9%)

Hepatic: Increased serum alanine aminotransferase (11% to 46%), increased serum aspartate aminotransferase (15% to 37%), increased serum bilirubin (7% to 16%)

Nervous system: Fatigue (39%), insomnia (14%)

Neuromuscular & skeletal: Arthralgia, joint swelling, myalgia (26%)

Respiratory: Cough (7% to 17%), dyspnea (12%), nasopharyngitis (11%), upper respiratory infection (5% to 13%)

1% to 10%:

Cardiovascular: Cardiac arrhythmia (7%), cardiac failure (2%), chest discomfort, chest pain

Dermatologic: Skin rash (8%)

Genitourinary: Groin pain (7%), hematuria (10%), nocturia (6%), urinary frequency (7%)

Nervous system: Falling (6%), headache (8%)

Neuromuscular & skeletal: Bone fracture (6%)

Miscellaneous: Fever (9%)

<1%: Endocrine & metabolic: Adrenocortical insufficiency

Postmarketing:

Hepatic: Acute hepatic failure, fulminant hepatitis

Hypersensitivity: Anaphylaxis

Neuromuscular & skeletal: Myopathy, rhabdomyolysis

Respiratory: Pneumonia

Warnings/Precautions

Concerns related to adverse effects:

• Adrenocortical insufficiency: Concurrent infection, stress, or interruption of daily corticosteroids is associated with reports of adrenocortical insufficiency. Monitor closely for signs and symptoms of adrenocorticoid insufficiency, which could be masked by adverse events associated with mineralocorticoid excess. Diagnostic testing for adrenal insufficiency may be clinically indicated. Increased corticosteroid doses may be required before, during, and after stress.

• Hepatotoxicity: Severe hepatotoxicity (eg, fulminant hepatitis, acute liver failure, and death) has been reported. Significant increases in liver enzymes (including grade 3 and 4 events) have also been observed (higher likelihood in patients with baseline elevations), generally occurring in the first 3 months of treatment. May require dosage reduction, treatment interruption, and/or discontinuation. ALT, AST, and bilirubin should be monitored prior to treatment, every 2 weeks for 3 months and monthly thereafter; patients with hepatic impairment, elevations in liver function tests, or experiencing hepatotoxicity require more frequent monitoring (see dosage adjustment for hepatic impairment and monitoring parameters). Evaluate liver function promptly with signs or symptoms of hepatotoxicity. The safety of retreatment after significant elevations (ALT or AST ≥20 times the ULN and/or total bilirubin ≥10 times ULN) has not been evaluated.

• Mineralocorticoid excess: Increased mineralocorticoids due to CYP17 inhibition may result in hypertension, hypokalemia, and fluid retention (including grade 3 and 4 events). Monitor at least monthly for hypertension, hypokalemia, and fluid retention (if necessary, control blood pressure and correct hypokalemia prior to and during treatment). Concomitant administration with corticosteroids reduces the incidence and severity of these adverse events.

Disease-related concerns:

• Cardiovascular disease: May cause hypertension, hypokalemia, and fluid retention. Control hypertension and correct hypokalemia prior to and during treatment. QT prolongation and torsades de pointes have been observed rarely (postmarketing reports) in patients who developed hypokalemia during abiraterone administration. Monitor patients with cardiovascular disease closely, particularly those with heart failure, recent MI, or ventricular arrhythmia. Patients with left ventricular ejection fraction (LVEF) <50% or NYHA class II, III, or IV heart failure were excluded from clinical trials. Monitor at least monthly for hypertension, hypokalemia, and fluid retention.

• Diabetes: Use with caution in patients with diabetes; severe hypoglycemia has been reported, particularly in patients receiving concomitant therapy with thiazolidinediones (eg, pioglitazone) or repaglinide. Monitor blood glucose during and after discontinuation of abiraterone therapy; antidiabetic medication dosage adjustments may be needed.

• Hepatic impairment: Do not use in patients with preexisting severe hepatic impairment (Child-Pugh class C); dosage reduction is recommended in patients with baseline moderate impairment.

Concurrent drug therapy issues:

• Radium Ra 223 dichloride: Due to an increased risk of fractures and mortality, the use of abiraterone plus a corticosteroid in combination with radium Ra 223 dichloride is not recommended.

Dosage form specific issues:

• Tablet formulations: Abiraterone acetate is available in different tablet formulations (the conventional formulation [Zytiga] and a micronized [fine particle] formulation [Yonsa]); use caution when selecting dosage form as dosing and food effects vary between products. The formulations are NOT interchangeable; do not substitute between formulations.

Other warnings/precautions:

• Food: Abiraterone (Zytiga) must be administered on an empty stomach (administer at least 1 hour before and 2 hours after any food); abiraterone AUC (exposure) may be increased up to 10-fold if administered with a meal. Abiraterone micronized (Yonsa) may be administered without regard to food.

Monitoring Parameters

ALT, AST, and bilirubin prior to treatment, every 2 weeks for 3 months and monthly thereafter; if baseline moderate hepatic impairment (Child-Pugh class B), monitor ALT, AST, and bilirubin prior to treatment, weekly for the first month, every 2 weeks for 2 months then monthly thereafter. If hepatotoxicity develops during treatment (and only after therapy is interrupted and liver function tests have returned to safe levels), monitor ALT, AST, and bilirubin every 2 weeks for 3 months and monthly thereafter. Monitoring of testosterone levels is not necessary. Serum potassium (prior to treatment and at least monthly).

Monitor for signs and symptoms of adrenocorticoid insufficiency; if clinically indicated, consider appropriate diagnostics to confirm adrenal insufficiency. Monitor blood pressure and for fluid retention (prior to treatment and at least monthly). Monitor adherence.

Reproductive Considerations

Male patients with female partners of reproductive potential should use effective contraception during treatment and for 3 weeks after the last abiraterone dose.

Abiraterone is available in uncoated and film-coated tablets and in micronized tablets; the manufacturer recommends females who may become pregnant wear gloves if handling uncoated tablets, micronized tablets, or tablets that are broken, crushed, or damaged. NIOSH recommends single gloving for administration of hazardous intact oral tablets (NIOSH 2016).

Pregnancy Considerations

Based on the mechanism of action and adverse effects observed in animal reproduction studies, abiraterone may cause fetal harm or fetal loss if administered during pregnancy. Abiraterone is not indicated for use in females.

Abiraterone is available in uncoated and film-coated tablets and in micronized tablets; the manufacturer recommends females who are pregnant wear gloves if handling uncoated tablets, micronized tablets, or tablets that are broken, crushed, or damaged. NIOSH recommends single gloving for administration of hazardous intact oral tablets (NIOSH 2016).

Patient Education

What is this drug used for?

• It is used to treat prostate cancer.

• It may be given for other reasons. Talk with the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Flushing

• Muscle pain

• Joint pain

• Joint swelling

• Heartburn

• Cough

• Diarrhea

• Constipation

• Common cold symptoms

• Stuffy nose

• Sore throat

• Trouble sleeping

• Nausea

• Vomiting

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Electrolyte problems like mood changes, confusion, muscle pain or weakness, abnormal heartbeat, seizures, lack of appetite, or severe nausea or vomiting

• Liver problems like dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin.

• Adrenal gland problems like severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss

• Urinary tract infection like blood in the urine, burning or painful urination, passing a lot of urine, fever, lower abdominal pain, or pelvic pain

• High blood sugar like confusion, fatigue, increased thirst, increased hunger, passing a lot of urine, flushing, fast breathing, or breath that smells like fruit

• Severe headache

• Severe dizziness

• Passing out

• Vision changes

• Abnormal heartbeat

• Fast heartbeat

• Trouble breathing

• Weight gain

• Swelling

• Bone pain

• Severe loss of strength and energy

• Bruising

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Frequently asked questions

Further information

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