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Dacomitinib

Medically reviewed by Drugs.com. Last updated on Jun 24, 2020.

Pronunciation

(DAK oh MI ti nib)

Index Terms

  • PF-00299804
  • PF-00299804-03
  • Vizimpro

Dosage Forms

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

Tablet, Oral:

Vizimpro: 15 mg, 30 mg, 45 mg [contains fd&c blue #2 aluminum lake]

Brand Names: U.S.

  • Vizimpro

Pharmacologic Category

  • Antineoplastic Agent, Epidermal Growth Factor Receptor (EGFR) Inhibitor
  • Antineoplastic Agent, Tyrosine Kinase Inhibitor

Pharmacology

Dacomitinib is an irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor which has activity against EGFR/HER1, HER2, and HER4, as well as some EGFR-activating mutations (exon 19 deletion or exon 21 L858R substitution mutation). Dacomitinib also has activity against DDR1, EPHA6, LCK, DDR2, and MNK1 (in vitro).

Distribution

Vss: 1,889 L

Metabolism

Hepatic, primarily via oxidation and glutathione conjugation; CYP2D6 is involved in the formation of O-desmethyl dacomitinib (active), and CYP3A4 contributes to the formation of minor oxidative metabolites

Excretion

Feces: 79% (20% as parent drug); Urine: 3% (<1% as parent drug)

Time to Peak

~6 hours (range: 2 to 24 hours)

Half-Life Elimination

70 hours

Protein Binding

~98%

Special Populations: Hepatic Function Impairment

In a single-dose 30 mg study, dacomitinib AUCinf and Cmax were decreased by 15% and 20%, respectively, in patients with moderate hepatic impairment as compared to subjects with normal hepatic function.

Use: Labeled Indications

Non-small cell lung cancer, metastatic: First-line treatment of metastatic non-small cell lung cancer (NSCLC) in patients with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an approved test.

Contraindications

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

Canadian labeling: Hypersensitivity to dacomitinib or any component of the formulation.

Dosing: Adult

Note: Prior to treatment, confirm tumor epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.

Non-small cell lung cancer, metastatic, first-line (EGFR exon 19 deletion- or exon 21 L858R substitution mutation-positive): Oral: 45 mg once daily until disease progression or unacceptable toxicity (Wu 2017)

Missed doses: If a dose is missed or vomited, do not make up the missed/vomited dose; administer the next dose as scheduled.

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

Note: Recommended dose reductions for adverse reactions:

Initial/usual dose: 45 mg once daily

First dose reduction: 30 mg once daily

Second dose reduction: 15 mg once daily

Dermatologic toxicity:

Grade 2: Temporarily interrupt dacomitinib therapy for persistent grade 2 reactions; upon recovery to ≤ grade 1, resume dacomitinib at the same dose. If grade 2 dermatologic toxicity recurs, withhold until recovery to ≤ grade 1, then resume therapy at a reduced dose.

Grade 3 or 4: Temporarily interrupt dacomitinib therapy until recovery to ≤ grade 1, then resume therapy at a reduced dose.

Gastrointestinal toxicity:

Diarrhea, grade 2: Temporarily interrupt dacomitinib therapy until recovery to ≤ grade 1, then resume dacomitinib at the same dose. If grade 2 diarrhea recurs, withhold until recovery to ≤ grade 1, then resume therapy at a reduced dose.

Diarrhea, grade 3 or 4: Temporarily interrupt dacomitinib therapy until recovery to ≤ grade 1, then resume therapy at a reduced dose.

Pulmonary toxicity: Interstitial lung disease (any grade): Permanently discontinue.

Other toxicities: Grade 3 or 4 adverse reaction: Temporarily interrupt dacomitinib therapy until recovery to ≤ grade 2, then resume therapy at a reduced dose.

Administration

Oral: Administer at the same time each day with or without food. Avoid the concomitant use of proton pump inhibitors with dacomitinib. If using an H2 blocker or antacid, administer dacomitinib at least 6 hours before or 10 hours after the H2 blocker or antacid.

Storage

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

Drug Interactions

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

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

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

Amphetamines: CYP2D6 Inhibitors (Strong) may increase the serum concentration of Amphetamines. Management: Monitor for amphetamine toxicities (including serotonin syndrome) if used with a strong 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 (Strong) may increase the serum concentration of ARIPiprazole. Management: Aripiprazole dose reductions are required for indications other than major depressive disorder. Dose reductions vary based on formulation, initial starting dose, and the additional use of CYP3A4 inhibitors. See full interaction monograph for details. Consider therapy modification

ARIPiprazole Lauroxil: CYP2D6 Inhibitors (Strong) may increase serum concentrations of the active metabolite(s) of ARIPiprazole Lauroxil. Management: Decrease aripiprazole lauroxil dose to next lower strength if used with strong CYP2D6 inhibitors for over 14 days. No dose adjustment needed if using the lowest dose (441 mg) or if a CYP2D6 PM. Max dose is 441 mg if also taking strong CYP3A4 inhibitors. Consider therapy modification

AtoMOXetine: CYP2D6 Inhibitors (Strong) may increase the serum concentration of AtoMOXetine. Management: Initiate atomoxetine at a reduced dose (patients who weigh up to 70 kg: 0.5 mg/kg/day; adults or patients who weigh 70 kg or more: 40 mg/day) in patients receiving a strong CYP2D6 inhibitor. Increase to usual target dose after 4 weeks if needed. Consider therapy modification

Benzhydrocodone: CYP2D6 Inhibitors (Strong) may decrease serum concentrations of the active metabolite(s) of Benzhydrocodone. Monitor therapy

Brexpiprazole: CYP2D6 Inhibitors (Strong) may increase the serum concentration of Brexpiprazole. Management: Reduce brexpiprazole dose to 50% of usual with strong CYP2D6 inhibitors, reduce to 25% of usual if used with both a strong CYP2D6 inhibitor and a strong or moderate CYP3A4 inhibitor; these recommendations do not apply if treating major depressive disorder Consider therapy modification

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

Chlorpheniramine: CYP2D6 Inhibitors (Strong) may increase the serum concentration of Chlorpheniramine. Monitor therapy

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

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

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

Dapoxetine: CYP2D6 Inhibitors (Strong) may increase the serum concentration of Dapoxetine. Monitor therapy

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

Deutetrabenazine: CYP2D6 Inhibitors (Strong) may increase serum concentrations of the active metabolite(s) of Deutetrabenazine. Management: The total daily dose of deutetrabenazine should not exceed 36 mg, and the maximum single dose of deutetrabenazine should not exceed 18 mg, with concurrent use of a strong CYP2D6 inhibitor. Consider therapy modification

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

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

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

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

DULoxetine: CYP2D6 Inhibitors (Strong) may increase the serum concentration of DULoxetine. Monitor therapy

Eliglustat: CYP2D6 Inhibitors (Strong) 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

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

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

FLUoxetine: CYP2D6 Inhibitors (Strong) may increase the serum concentration of FLUoxetine. Monitor therapy

FluPHENAZine: CYP2D6 Inhibitors (Strong) may increase the serum concentration of FluPHENAZine. Monitor therapy

FluvoxaMINE: CYP2D6 Inhibitors (Strong) may increase the serum concentration of FluvoxaMINE. Monitor therapy

Galantamine: CYP2D6 Inhibitors (Strong) may increase the serum concentration of Galantamine. Monitor therapy

Gefitinib: CYP2D6 Inhibitors (Strong) may increase the serum concentration of Gefitinib. Monitor therapy

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

Histamine H2 Receptor Antagonists: May decrease the serum concentration of Dacomitinib. Management: Administer dacomitinib at least 6 hours before or 10 hours after an histamine H2-receptor antagonist (H2RA). Consider therapy modification

HYDROcodone: CYP2D6 Inhibitors (Strong) may decrease serum concentrations of the active metabolite(s) of HYDROcodone. Specifically, concentrations of hydromorphone may be decreased. Monitor therapy

Iloperidone: CYP2D6 Inhibitors (Strong) may increase serum concentrations of the active metabolite(s) of Iloperidone. Specifically, concentrations of the metabolite P88 may be increased. CYP2D6 Inhibitors (Strong) may decrease serum concentrations of the active metabolite(s) of Iloperidone. Specifically, concentrations of the metabolite P95 may be decreased. CYP2D6 Inhibitors (Strong) may increase the serum concentration of Iloperidone. Management: Reduce iloperidone dose by half when administered with a strong CYP2D6 inhibitor and monitor for increased iloperidone toxicities, including QTc interval prolongation and arrhythmias. Consider therapy modification

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

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

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

Lofexidine: CYP2D6 Inhibitors (Strong) may increase the serum concentration of Lofexidine. Monitor therapy

Maprotiline: CYP2D6 Inhibitors (Strong) may increase the serum concentration of Maprotiline. Monitor therapy

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

Metoclopramide: CYP2D6 Inhibitors (Strong) may increase the serum concentration of Metoclopramide. Management: For gastroparesis: reduce metoclopramide dose to 5mg 4 times/day and limit to 20mg/day; nasal spray not recommended. For GERD: reduce metoclopramide dose to 5mg 4 times/day or to 10mg 3 times/day and limit to 30mg/day. Monitor for EPS when combined. Consider therapy modification

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

Mexiletine: CYP2D6 Inhibitors (Strong) may increase the serum concentration of Mexiletine. Monitor therapy

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

Nicergoline: CYP2D6 Inhibitors (Strong) may increase serum concentrations of the active metabolite(s) of Nicergoline. Specifically, concentrations of the MMDL metabolite may be increased. CYP2D6 Inhibitors (Strong) may decrease serum concentrations of the active metabolite(s) of Nicergoline. Specifically, concentrations of the MDL metabolite may be decreased. Monitor therapy

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

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

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

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

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

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

Pimozide: CYP2D6 Inhibitors (Strong) may increase the serum concentration of Pimozide. Avoid combination

Pitolisant: CYP2D6 Inhibitors (Strong) may increase the serum concentration of Pitolisant. Management: Reduce the pitolisant dose by 50% if a strong CYP2D6 inhibitor is initiated. For patients receiving strong CYP2D6 inhibitors, initiate pitolisant at 8.9 mg once daily and increase after 7 days to a maximum of 17.8 mg once daily. Consider therapy modification

Primaquine: CYP2D6 Inhibitors (Strong) may diminish the therapeutic effect of Primaquine. CYP2D6 Inhibitors (Strong) may decrease serum concentrations of the active metabolite(s) of Primaquine. Monitor therapy

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

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

Proton Pump Inhibitors: May decrease the serum concentration of Dacomitinib. Management: Avoid concurrent use of dacomitinib with proton pump inhibitors. Antacids may be used. Histamine H2-receptor antagonists (HR2A) may be used if dacomitinib is given at least 6 hours before or 10 hours after the H2RA. Avoid combination

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

RisperiDONE: CYP2D6 Inhibitors (Strong) may increase the serum concentration of RisperiDONE. Management: Careful monitoring for risperidone toxicities and possible dose adjustment are recommended when combined with strong CYP2D6 inhibitors. See full interaction monograph for details. Consider therapy modification

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

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

Tetrabenazine: CYP2D6 Inhibitors (Strong) may increase the serum concentration of Tetrabenazine. Specifically, concentrations of the active alpha- and beta-dihydrotetrabenazine metabolites may be increased. Management: Limit the tetrabenazine dose to 50 mg per day (25 mg per single dose) in patients taking strong CYP2D6 inhibitors. Consider therapy modification

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

Timolol (Ophthalmic): CYP2D6 Inhibitors (Strong) may increase the serum concentration of Timolol (Ophthalmic). Monitor therapy

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

Tolterodine: CYP2D6 Inhibitors (Strong) may increase the serum concentration of Tolterodine. Monitor therapy

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

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

Tropisetron: CYP2D6 Inhibitors (Strong) may increase the serum concentration of Tropisetron. Monitor therapy

Valbenazine: CYP2D6 Inhibitors (Strong) may increase serum concentrations of the active metabolite(s) of Valbenazine. Management: Reduce valbenazine dose to 40 mg once daily when combined with a strong CYP2D6 inhibitor. Monitor for increased valbenazine effects/toxicities. Consider therapy modification

Vortioxetine: CYP2D6 Inhibitors (Strong) may increase the serum concentration of Vortioxetine. Management: The vortioxetine dose should be reduced by 50% when used together with a strong CYP2D6 inhibitor. Following cessation of the strong CYP2D6 inhibitor, the vortioxetine dose should be returned to the normal level. Consider therapy modification

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

Adverse Reactions

>10%:

Cardiovascular: Chest pain (10%)

Central nervous system: Insomnia (11%)

Dermatologic: Skin rash (69% to 78%), paronychia (64%), xeroderma (30%), alopecia (23%), pruritus (21%), palmar-plantar erythrodysesthesia (15%), dermatitis (11%)

Endocrine & metabolic: Hypoalbuminemia (44%), hyperglycemia (36%), hypocalcemia (33%), hypokalemia (29%), hyponatremia (26%), weight loss (26%), hypomagnesemia (22%)

Gastrointestinal: Diarrhea (87%), stomatitis (45%; grades 3/4: 4%), decreased appetite (31%), nausea (19%), constipation (13%), oral mucosa ulcer (12%)

Hematologic & oncologic: Anemia (44%; grades 3/4: <1%), lymphocytopenia (42%; grades 3/4: 6%)

Hepatic: Increased serum alanine aminotransferase (40%), increased serum aspartate aminotransferase (35%), increased serum alkaline phosphatase (22%), hyperbilirubinemia (16%)

Neuromuscular & skeletal: Limb pain (14%), asthenia (13%), musculoskeletal pain (12%)

Ophthalmic: Conjunctivitis (19%)

Renal: Increased creatinine clearance (24%)

Respiratory: Cough (21%), nasal signs and symptoms (19%), dyspnea (13%), upper respiratory tract infection (12%)

1% to 10%:

Central nervous system: Fatigue (9%)

Dermatologic: Skin fissure (9%), exfoliation of skin (4% to 7%), hypertrichosis (1%)

Endocrine & metabolic: Dehydration (1%)

Gastrointestinal: Vomiting (9%), dysgeusia (7%)

Ophthalmic: Keratitis (2%)

Respiratory: Interstitial pulmonary disease (3%)

<1%, postmarketing, and/or case reports: Pneumonitis

Warnings/Precautions

Concerns related to adverse effects:

• Dermatologic toxicity: Rash and exfoliative skin reactions have occurred with dacomitinib, including grade 3 or 4 events. Rash has been observed in over three-quarters of patients treated with dacomitinib. Sun exposure may increase the incidence and severity of dermatologic toxicity; limit sun exposure and utilize sunscreen when beginning dacomitinib treatment. Initiate moisturizers at the time of dacomitinib treatment initiation. Temporarily interrupt dacomitinib for persistent grade 2 or any grade 3 or 4 dermatologic toxicity until recovery to ≤ grade 1; may resume therapy at the same or reduced dose (depending on the severity of the reaction). Initiate topical antibiotics and topical steroids for grade 1 rash; administer oral antibiotics for grade 2 or higher dermatologic toxicity. Dry skin and nail disorders have been commonly reported with dacomitinib.

• Gastrointestinal toxicity: Severe and fatal diarrhea has occurred in patients treated with dacomitinib. Diarrhea was reported in the majority of patients; grade 3 or 4 events have been reported. Temporarily interrupt dacomitinib for grade 2 or higher diarrhea, then resume at the same or reduced dose (depending on severity) once diarrhea has resolved to grade 1 or less. Promptly initiate antidiarrheal treatment (eg, loperamide or diphenoxylate and atropine). Mucositis/stomatitis has been observed with dacomitinib.

• Pulmonary toxicity: Interstitial lung disease (ILD), including severe and fatal ILD/pneumonitis, has been reported with dacomitinib. Monitor for pulmonary symptoms suggestive of ILD/pneumonitis. Temporarily interrupt dacomitinib and promptly evaluate for ILD in patients with worsening respiratory symptoms (such as dyspnea, cough, and fever). Permanently discontinue dacomitinib if ILD is confirmed.

Concurrent drug therapy issues:

• Drugs that affect gastric pH: Avoid the concomitant use of proton pump inhibitors with dacomitinib. If using an H2 blocker or antacids, administer dacomitinib at least 6 hours before or 10 hours after the H2 blocker or antacid.

Special populations:

• Elderly: Patients ≥65 years of age may experience a higher incidence of grade 3 and 4 adverse events, more frequent dose interruptions, and more frequent treatment discontinuations.

Other warnings/precautions:

• Appropriate use: Confirm the presence of epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations in tumor specimen prior to therapy initiation. Information on diagnostic tests approved for detection of EGFR mutations may be found at www.fda.gov/companiondiagnostics.

Monitoring Parameters

Prior to treatment, confirm epidermal growth factor receptor exon 19 deletion or exon 21 L858R substitution mutation status; pregnancy test (in females of reproductive potential) prior to therapy initiation. Monitor for signs/symptoms of interstitial lung disease/pneumonitis (eg, dyspnea, cough, fever), diarrhea, and dermatologic toxicity. Monitor adherence.

Reproductive Considerations

Verify pregnancy status in females of reproductive potential prior to initiating dacomitinib. Females of reproductive potential should use effective contraception during therapy and for at least 17 days after the last dacomitinib dose.

Pregnancy Considerations

Based on data from animal reproduction studies and the mechanism of action, dacomitinib use during pregnancy may cause fetal harm.

Patient Education

What is this drug used for?

• It is used to treat lung cancer.

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:

• Hair loss

• Nail changes

• Mouth irritation

• Mouth sores

• Lack of appetite

• Weight loss

• Dry skin

• Nausea

• Vomiting

• Constipation

• Common cold symptoms

• Eye irritations

• Painful extremities

• Muscle pain

• Trouble sleeping

• Change in taste

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:

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

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

• Severe diarrhea

• Persistent diarrhea

• Skin reaction

• Redness or irritation of palms or soles of feet

• Chest pain

• Severe loss of strength and energy

• Lung problems like shortness of breath or other trouble breathing, cough that is new or worse

• 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.

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