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Cinacalcet

Medically reviewed by Drugs.com. Last updated on Jul 13, 2020.

Pronunciation

(sin a KAL cet)

Index Terms

  • AMG 073
  • Cinacalcet Hydrochloride

Dosage Forms

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

Tablet, Oral:

Sensipar: 30 mg, 60 mg, 90 mg

Generic: 30 mg, 60 mg, 90 mg

Brand Names: U.S.

  • Sensipar

Pharmacologic Category

  • Calcimimetic

Pharmacology

Increases the sensitivity of the calcium-sensing receptor on the parathyroid gland thereby, concomitantly lowering parathyroid hormone (PTH), serum calcium, and serum phosphorus levels, preventing progressive bone disease and adverse events associated with mineral metabolism disorders.

Distribution

Vd: ~1,000 L

Metabolism

Hepatic (extensive) via CYP3A4, 2D6, 1A2; forms inactive metabolites

Excretion

Urine ~80% (as metabolites); feces ~15%

Time to Peak

~2 to 6 hours; increased with food

Half-Life Elimination

Terminal: 30 to 40 hours; moderate hepatic impairment: 65 hours; severe hepatic impairment: 84 hours

Protein Binding

~93% to 97%

Special Populations: Hepatic Function Impairment

In patients with moderate or severe hepatic impairment, the AUCs were 2.4 and 4.2 times higher, respectively, than in healthy subjects; the half-life is increased to 65 hours and 84 hours in patients with moderate and severe hepatic impairment, respectively.

Use: Labeled Indications

Hyperparathyroidism, primary: Treatment of hypercalcemia in adults with primary hyperparathyroidism for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy.

Hyperparathyroidism, secondary: Treatment of secondary hyperparathyroidism in adults with chronic kidney disease (CKD) on dialysis.

Parathyroid carcinoma: Treatment of hypercalcemia in adults with parathyroid carcinoma.

Contraindications

Serum calcium less than the lower limit of normal range

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to any component of the formulation

Dosing: Adult

Hyperparathyroidism, primary: Oral: Initial: 30 mg twice daily; increase dose incrementally every 2 to 4 weeks (to 60 mg twice daily, 90 mg twice daily, and 90 mg 3 or 4 times daily) as necessary to normalize serum calcium levels.

Hyperparathyroidism, secondary: Oral: Initial: 30 mg once daily; increase dose incrementally every 2 to 4 weeks (to 60 mg once daily, 90 mg once daily, 120 mg once daily, and 180 mg once daily) as necessary to maintain intact parathyroid hormone (iPTH) level between 150 to 300 pg/mL. May be used alone or in combination with vitamin D and/or phosphate binders.

Conversion from etelcalcetide: Discontinue etelcalcetide for at least 4 weeks prior to initiating cinacalcet.

Parathyroid carcinoma: Oral: Initial: 30 mg twice daily; increase dose incrementally every 2 to 4 weeks (to 60 mg twice daily, 90 mg twice daily, and 90 mg 3 to 4 times daily) as necessary to normalize serum calcium levels.

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: Pediatric

Hyperparathyroidism, secondary: Note: Should only be used when standard therapies have proven ineffective. Ensure calcium is in normal range before initiating therapy and monitor closely throughout treatment. Dosing based on patient's dry weight.

Children ≥3 years and Adolescents: Limited data available, optimal dosage not established in pediatric patients: Oral:

Weight-directed dosing: Initial: ≤0.2 mg/kg/dose once daily; may titrate every 4 weeks to reach target range of intact parathyroid hormone (iPTH) of 100 to 300 pg/mL. Maximum daily dose: 180 mg/day or 2.5 mg/kg/dose (whichever is lower) (Warady 2019; Mimpara prescribing information [European Union] 2018). Dosing based on a randomized, double-blind study (n=43) with an open-label phase (n=12) with secondary hyperparathyroidism on hemodialysis or peritoneal dialysis. Cinacalcet was started at ≤0.2 mg/kg/day in 22 patients (mean age: 13.3 ± 3.6 years) and titrated every 4 weeks to goal iPTH. For the efficacy endpoint phase, the mean weight adjusted dose was 1.54 mg/kg/day which corresponded to 50.4 mg/day. iPTH was decreased by ≥30% in 54% of patients receiving cinacalcet compared to 19% with placebo. Serum calcium was significantly reduced in patients receiving cinacalcet compared to placebo and severe hypocalcemia (<7.5 mg/dL) occurred in 3 patients, including 1 death where treatment-related cause could not be ruled out (corrected calcium was 5.3 mg/dL). This study was placed on hold following the reported death and ultimately terminated after 14 months. Despite the limited number of patients enrolled due to study termination, efficacy was still demonstrated (Warady 2019). Note: Cinacalcet use in children <3 years and infants as young as 8 months has been described; however, variable dosing strategies were used or only single doses were administered (Muscheites 2008; Platt 2010; Sohn 2019).

Weight-band (fixed) dosing (Mimpara prescribing information [European Union] 2018):

Weight Band

Initial Dose

Suggested Adjustment Doses

≥10 to <12.5 kg

1 mg once daily

1 mg, 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg

≥12.5 to <25 kg

2.5 mg once daily

2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 30 mg

≥25 to <36 kg

5 mg once daily

5 mg, 10 mg, 15 mg, 30 mg, 60 mg

≥36 to <50 kg

5 mg once daily

5 mg, 10 mg, 15 mg, 30 mg, 60 mg, 90 mg

≥50 to <75 kg

10 mg once daily

10 mg, 15 mg, 30 mg, 60 mg, 90 mg, 120 mg

≥75 kg

15 mg once daily

15 mg, 30 mg, 60 mg, 90 mg, 120 mg, 180 mg

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

Dosing adjustment for toxicity:

Dosage adjustment for hypocalcemia (Mimpara prescribing information [European Union] 2018): Children ≥3 years and Adolescents:

Corrected serum calcium at or below age-specific lower limit or symptoms of hypocalcemia (regardless of calcium concentration): Temporarily discontinue cinacalcet and administer calcium supplements, calcium-containing phosphate binders, and/or vitamin D to raise calcium.

Corrected serum calcium above age-specific lower limit and resolution of hypocalcemia symptoms: Re-initiate cinacalcet at a lower dose. If treatment is stopped for ≥14 days, restart at initial dose.

Dose adjustment based on iPTH (Mimpara prescribing information [European Union] 2018): Children ≥3 years and Adolescents:

If iPTH is ≥100 to <150 pg/mL: Reduce dose.

If iPTH <100 pg/mL: Discontinue cinacalcet until iPTH is >150 pg/mL; restart at lower dose; if treatment has been stopped for >14 days, restart at initial dose.

Dosing: Adjustment for Toxicity

Dosage adjustment for hypocalcemia:

If iPTH <150 pg/mL: Reduce dose or discontinue cinacalcet and/or vitamin D.

Hyperparathyroidism, secondary:

If serum calcium >7.5 mg/dL but <8.4 mg/dL or if hypocalcemia symptoms occur: Use calcium-containing phosphate binders and/or vitamin D to raise calcium levels.

If serum calcium <7.5 mg/dL or if hypocalcemia symptoms persist and the dose of vitamin D cannot be increased: Withhold cinacalcet until serum calcium ≥8 mg/dL and/or symptoms of hypocalcemia resolve. Reinitiate cinacalcet at the next lowest dose.

Extemporaneously Prepared

5 mg/mL Oral Suspension

A 5 mg/mL oral suspension may be made with tablets and either a 1:1 mixture of Ora-Sweet and Ora-Plus or a 1:1 mixture of Ora-Sweet SF and Ora-Plus. Crush five 30 mg tablets in a glass mortar and reduce to a fine powder. Add 15 mL of Ora-Plus in parts and triturate into a smooth suspension. Transfer to a calibrated 2 oz amber bottle. Rinse mortar with Ora-Sweet or Ora-Sweet SF and add to bottle for a final volume of 30 mL and shake suspension. Label “shake well”. Stable for 64 days refrigerated or at room temperature (Thomson 2018).

Thomson K, Hutchinson DJ, Chablani L. Stability of extemporaneously prepared cinacalcet oral suspensions. Am J Health Syst Pharm. 2018;75(9):e236-e240. doi: 10.2146/ajhp170072.29691267

Administration

Administer with food or shortly after a meal. Do not chew, crush, or divide tablet; administer whole.

Storage

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 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

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 Inhibitors (Strong): May increase the serum concentration of Cinacalcet. Monitor therapy

Denosumab: May enhance the hypocalcemic effect of Calcimimetic Agents. 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

Etelcalcetide: Cinacalcet may enhance the hypocalcemic effect of Etelcalcetide. Avoid combination

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

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

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

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

Siponimod: Calcimimetic Agents may increase the serum concentration of Siponimod. Management: Coadministration of siponimod with drugs which are both moderate inhibitors of CYP2C9 and moderate or strong inhibitors of CYP3A4 is not recommended. Consider therapy modification

Tacrolimus (Systemic): Cinacalcet may decrease the serum concentration of Tacrolimus (Systemic). 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

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

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

>10%:

Cardiovascular: Hypotension (12%)

Endocrine & metabolic: Hypocalcemia (<8.4 mg/dL: 6% to 75%; <7.5 mg/dL: 29% to 33%), hypoparathyroidism (intact parathyroid hormone <100 pg/mL: ≤11%)

Gastrointestinal: Nausea (29% to 31%), vomiting (26% to 27%), diarrhea (21%), abdominal pain (11%)

Nervous system: Headache (12%)

Neuromuscular & skeletal: Muscle spasm (11% to 18%), myalgia (15%), back pain (12%)

Respiratory: Dyspnea (13%), cough (12%)

1% to 10%:

Cardiovascular: Hypertension (7%)

Endocrine & metabolic: Hyperkalemia (8%)

Gastrointestinal: Upper abdominal pain (8%), dyspepsia (7%), anorexia (6%), decreased appetite (6%), constipation (5%)

Hypersensitivity: Hypersensitivity reaction (9%)

Nervous system: Dizziness (7% to 10%), noncardiac chest pain (6%), seizure (≤3%)

Neuromuscular & skeletal: Asthenia (5% to 7%)

Respiratory: Upper respiratory tract infection (8%)

Frequency not defined: Hematologic & oncologic: Upper gastrointestinal hemorrhage

<1%, postmarketing, and/or case reports: Adynamic bone disease, angioedema, calcium pyrophosphate deposition disease, cardiac arrhythmia, cardiac failure, gastrointestinal hemorrhage, prolonged QT interval on ECG (secondary to hypocalcemia), skin rash, urticaria, ventricular arrhythmia (secondary to hypocalcemia)

Warnings/Precautions

Concerns related to adverse effects:

• Adynamic bone disease: May develop if intact parathyroid hormone (iPTH) levels are suppressed <100 pg/mL; reduce dose or discontinue use of cinacalcet and/or vitamin D if iPTH levels decrease below 150 pg/mL.

• Cardiovascular effects: QT prolongation and ventricular arrhythmia secondary to hypocalcemia may occur. Patients with congenital long QT syndrome, history of QT interval prolongation, family history of long QT syndrome or sudden cardiac death, and other conditions that predispose to QT interval prolongation and ventricular arrhythmia may be at increased risk. Closely monitor corrected serum calcium and QT interval. Cases of idiosyncratic hypotension, worsening of heart failure, and/or arrhythmia have been reported in patients with impaired cardiovascular function; may correlate with decreased serum calcium.

• GI effects: GI bleeding, mostly upper GI bleeding, have been reported (exact cause unknown); patients with risk factors for upper GI bleeding (eg, gastritis, esophagitis, ulcers, severe vomiting) may be at increased risk. Monitor for worsening of common GI adverse reactions of nausea and vomiting and for signs and symptoms of GI bleeding and ulcerations during therapy.

• Hypocalcemia: Life-threatening and fatal events associated with hypocalcemia have occurred. Monitor serum calcium and for symptoms of hypocalcemia (eg, muscle spasms, myalgia, paresthesia, seizure, tetany). Use with caution in patients receiving concomitant therapies known to lower serum calcium concentrations. May require treatment interruption, dose reduction, or initiation (or dose increases) of calcium-based phosphate binder and/or vitamin D to raise serum calcium depending on calcium levels or symptoms of hypocalcemia. Do not initiate therapy if the corrected serum calcium is less than the lower limit of normal; corrected serum calcium must be at or above the lower limit of normal prior to initiation, dose increase, or reinitiation.

Disease-related concerns:

• Hepatic impairment: Use with caution in patients with moderate-to-severe hepatic impairment (Child-Pugh classes B and C); cinacalcet exposure and half-life are increased; monitor serum calcium, serum phosphorus and iPTH closely.

• Seizure disorder: Use with caution in patients with a history of seizure disorder; seizure threshold is lowered by significant serum calcium reductions. Monitor calcium levels closely.

Other warnings/precautions:

• Appropriate use: Not indicated for chronic kidney disease (CKD) patients not receiving dialysis. In the US, the long-term safety and efficacy of cinacalcet has not been evaluated in CKD patients with hyperparathyroidism not requiring dialysis. Although possibly related to lower baseline calcium levels, clinical studies have shown an increased incidence of hypocalcemia (<8.4 mg/dL) in patients not requiring dialysis.

Monitoring Parameters

Monitor for signs/symptoms of hypocalcemia. Monitor serum calcium and iPTH concentrations closely in patients on concurrent CYP3A4 inhibitors or with seizure disorders; monitor serum calcium, iPTH, and serum phosphorous concentrations closely in patients with hepatic moderate to severe hepatic impairment.

Hyperparathyroidism, secondary: Serum calcium and phosphorus levels prior to initiation and within a week of initiation and frequently during dose titration; iPTH should be measured 1 to 4 weeks after initiation or dosage adjustment (wait at least 12 hours after dose before drawing iPTH levels). After the maintenance dose is established, obtain serum calcium levels monthly.

Parathyroid carcinoma and hyperparathyroidism, primary: Serum calcium levels prior to initiation and within a week of initiation or dosage adjustment; once maintenance dose is established, obtain serum calcium every 2 months.

Pregnancy Considerations

Information related to the use of cinacalcet in pregnant women is limited (Edling 2014; Horjus 2009; Nadarasa 2014; Rey 2016; Vera 2016).

Patient Education

What is this drug used for?

• It is used to treat high parathyroid hormone levels in certain patients.

• It is used to treat high calcium levels in patients with parathyroid disease.

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:

• Nausea

• Vomiting

• Constipation

• Abdominal pain

• Diarrhea

• Back pain

• Cough

• Common cold symptoms

• Lack of appetite

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:

• Low calcium like muscle cramps or spasms, numbness and tingling, or seizures.

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

• Dehydration like dry skin, dry mouth, dry eyes, increased thirst, fast heartbeat, dizziness, fast breathing, or confusion.

• Heart problems like cough or shortness of breath that is new or worse, swelling of the ankles or legs, abnormal heartbeat, weight gain of more than five pounds in 24 hours, dizziness, or passing out.

• Bowel bleeding like black, tarry, or bloody stools; vomiting blood; severe abdominal pain; severe nausea; or vomiting.

• Chest pain

• Depression

• Joint pain

• Severe headache

• Severe dizziness

• Passing out

• Vision changes

• Bone pain

• Severe loss of strength and energy

• 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.

Further information

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