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Brigatinib

Medically reviewed by Drugs.com. Last updated on Jul 30, 2020.

Pronunciation

(bri GA ti nib)

Index Terms

  • AP26113

Dosage Forms

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

Tablet, Oral:

Alunbrig: 30 mg, 90 mg, 180 mg

Tablet Therapy Pack, Oral:

Alunbrig: 90 mg (7s) & 180 mg (23s) (30 ea)

Brand Names: U.S.

  • Alunbrig

Pharmacologic Category

  • Antineoplastic Agent, Anaplastic Lymphoma Kinase Inhibitor
  • Antineoplastic Agent, Tyrosine Kinase Inhibitor

Pharmacology

Brigatinib is a broad spectrum multikinase inhibitor with activity against anaplastic lymphoma kinase (ALK), ROS1, insulin-like growth factor-1 receptor (IGF-1R), and FLT-3, as well as EGFR deletion and point mutations. ALK autophosphorylation and ALK-mediated phosphorylation of downstream signaling proteins STAT3, AKT, ERK1/2, and S6 are inhibited by brigatinib. In vitro, brigatinib also inhibited proliferation of cell lines expressing EML4-ALK and NPM-ALK fusion proteins. Brigatinib has activity against cells expressing EML4-ALK and 17 mutant forms associated with ALK inhibitor resistance, as well as EGFR-Del (E746-A750), ROS1-L2026M, FLT3-F691L, and FLT3-D835Y. Clinically, brigatinib showed anti-tumor activity against EML4-ALK mutant forms (including G1202R and L1196M) which were identified in NSCLC cells in patients who progressed on crizotinib.

Distribution

307 L.

Metabolism

Primarily hepatic via CYP2C8 and CYP3A4; N-demethylation and cysteine conjugation are the two major metabolic pathways.

Excretion

Feces (65%; 41% as unchanged drug); urine (25%; 86% as unchanged drug).

Time to Peak

1 to 4 hours.

Half-Life Elimination

25 hours.

Protein Binding

91% bound to plasma proteins (not concentration dependent).

Special Populations: Renal Function Impairment

Following a single brigatinib 90 mg dose, systemic exposure (AUC0-inf) of unbound brigatinib was 86% higher in subjects with severe renal impairment (CrCl 15 to 29 mL/minute) compared with subjects with normal renal function.

Special Populations: Hepatic Function Impairment

Following a single brigatinib 90 mg dose, systemic exposure (AUC0-inf) of unbound brigatinib was 37% higher in subjects with severe hepatic impairment (Child-Pugh class C) compared with subjects with normal hepatic function.

Use: Labeled Indications

Non-small cell lung cancer, metastatic: Treatment of anaplastic lymphoma kinase (ALK)-positive (as detected by an approved test) metastatic non-small cell lung cancer (NSCLC) in adults.

Contraindications

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

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

Dosing: Adult

Note: Select patients for the treatment of metastatic non-small cell lung cancer based on the presence of anaplastic lymphoma kinase (ALK) positivity in tumor specimens.

Non-small cell lung cancer, metastatic (ALK-positive): Oral: 90 mg once daily for 7 days; if tolerated, then increase dose to 180 mg once daily; continue until disease progression or unacceptable toxicity (Camidge 2018; Kim 2017). Note: If therapy is interrupted for ≥14 days due to reasons other than adverse reactions, resume treatment at 90 mg once daily for 7 days before escalating dose to the previously tolerated dose.

Missed dose: If a dose is missed or vomited, do not administer an additional dose; administer the next dose at the regularly scheduled time.

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: Once the brigatinib dose is reduced for adverse reactions, do not subsequently escalate the dose.

Recommended Brigatinib Dosage Adjustment Levels

Dosage

Dosage reduction

First

Second

Third

90 mg once daily

60 mg once daily

Permanently discontinue brigatinib

180 mg once daily

120 mg once daily

90 mg once daily

60 mg once daily. Permanently discontinue brigatinib if unable to tolerate the 60 mg once daily dose.

Cardiac toxicity:

Hypertension:

Grade 3 (systolic blood pressure [SBP] ≥160 mm Hg or diastolic blood pressure [DBP] ≥100 mm Hg, medical intervention indicated, >1 antihypertensive medication necessary, or more intensive therapy than previously used): Interrupt brigatinib until hypertension recovers to ≤ grade 1 (SBP <140 mm Hg and DBP <90 mm Hg), then resume at the same dose. If grade 3 hypertension recurs, interrupt brigatinib until recovery to ≤ grade 1 and resume at the next lower dose or permanently discontinue brigatinib.

Grade 4 (life-threatening, urgent intervention required): Interrupt brigatinib until recovery to ≤ grade 1, then resume at the next lower dose or permanently discontinue. If grade 4 hypertension recurs, permanently discontinue brigatinib.

Bradycardia (heart rate <60 bpm):

Symptomatic bradycardia: Interrupt brigatinib until recovery to asymptomatic bradycardia or to a resting heart rate of ≥60 bpm. If a concomitant bradycardia-inducing medication is identified and discontinued (or dose-adjusted), upon recovery to asymptomatic bradycardia or to a resting heart rate of ≥60 bpm, resume brigatinib at the same dose. If no concomitant medication is identified (or cannot be discontinued or dose-adjusted), upon recovery to asymptomatic bradycardia or to a resting heart rate of ≥60 bpm, resume brigatinib at the next lower dose.

Life-threatening bradycardia (urgent intervention required): Permanently discontinue brigatinib if no contributing concomitant medication is identified. If contributing concomitant medication is present and discontinued (or dose-adjusted), upon recovery to asymptomatic bradycardia or to a resting heart rate of ≥60 bpm, resume brigatinib at the next lower dose (with frequent monitoring). If life-threatening bradycardia recurs, permanently discontinue brigatinib.

CPK elevation:

Grade 3 or 4 (CPK >5 times ULN with ≥ grade 2 muscle pain or weakness): Interrupt brigatinib therapy until recovery to ≤ grade 1 (≤2.5 times ULN) or to baseline, then resume at the same dose. If grade 3 or 4 CPK elevation recurs, interrupt brigatinib therapy until recovery to ≤ grade 1 (≤2.5 times ULN) or to baseline, then resume at the next lower dose.

Hyperglycemia: Grade 3 or 4 (glucose ≥250 mg/dL or 13.9 mmol/L): Interrupt brigatinib therapy if adequate hyperglycemic control cannot be achieved with optimal medical management. Once hyperglycemic control is achieved, resume at the next lower dose or permanently discontinue brigatinib.

Lipase/amylase elevation:

Grade 3 (>2 times ULN): Interrupt brigatinib until recovery to ≤ grade 1 (≤1.5 times ULN) or to baseline, then resume at the same dose. If grade 3 lipase/amylase elevation recurs, interrupt brigatinib therapy until recovery to ≤ grade 1 (≤1.5 times ULN) or to baseline, then resume at the next lower dose.

Grade 4 (>5 times ULN): Interrupt brigatinib therapy until recovery to ≤ grade 1 (≤1.5 times ULN) or to baseline, then resume at the next lower dose.

Ocular toxicity:

Grade 2 or 3 visual disturbance: Interrupt brigatinib therapy until recovery to grade 1 or baseline, then resume at the next lower dose.

Grade 4 visual disturbance: Permanently discontinue brigatinib.

Pulmonary toxicity (interstitial lung disease [ILD]/pneumonitis):

Grade 1: If new pulmonary symptoms develop during the first 7 days of therapy, interrupt brigatinib until recovery to baseline, then resume treatment at the same dose; do not escalate to 180 mg once daily if ILD/pneumonitis is suspected. If new pulmonary symptoms occur after the first 7 days of therapy, interrupt brigatinib until recovery to baseline, then resume at the same dose. If ILD/pneumonitis recurs, permanently discontinue brigatinib.

Grade 2: If new pulmonary symptoms develop during the first 7 days of therapy, interrupt brigatinib until recovery to baseline, then resume treatment at the next lower dose; do not escalate to 180 mg once daily if ILD/pneumonitis is suspected. If new pulmonary symptoms occur after the first 7 days of therapy, interrupt brigatinib until recovery to baseline. If ILD/pneumonitis is suspected, resume at the next lower dose; otherwise, resume at the same dose. If ILD/pneumonitis recurs, permanently discontinue brigatinib.

Grade 3 or 4: Permanently discontinue brigatinib for ILD/pneumonitis.

Other toxicities:

Grade 3: Interrupt brigatinib therapy until recovery to baseline, then resume at the same dose. If grade 3 toxicity recurs, interrupt brigatinib until recovery to baseline and then resume at the next lower dose or discontinue.

Grade 4: Interrupt brigatinib therapy until recovery to baseline and resume at the next lower dose. If grade 4 toxicity recurs, permanently discontinue brigatinib.

Administration

Oral: Administer with or without food. Swallow tablets whole; do not crush or chew.

Dietary Considerations

Avoid grapefruit and grapefruit juice.

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

Abametapir: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy

Antihypertensive Agents: Brigatinib may diminish the antihypertensive effect of Antihypertensive Agents. Brigatinib may enhance the bradycardic effect of Antihypertensive Agents. Monitor therapy

Bradycardia-Causing Agents: May enhance the bradycardic effect of other Bradycardia-Causing Agents. Monitor therapy

Ceritinib: Bradycardia-Causing Agents may enhance the bradycardic effect of Ceritinib. Management: If this combination cannot be avoided, monitor patients for evidence of symptomatic bradycardia, and closely monitor blood pressure and heart rate during therapy. Exceptions are discussed in separate monographs. Consider therapy modification

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Conivaptan: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

CYP3A4 Inducers (Moderate): May decrease the serum concentration of Brigatinib. Management: Avoid concurrent use of brigatinib with moderate CYP3A4 inducers when possible. If combined, increase the daily dose of brigatinib in 30 mg increments after 7 days of treatment with the current brigatinib dose, up to maximum of twice the dose. Consider therapy modification

CYP3A4 Inducers (Strong): May decrease the serum concentration of Brigatinib. Avoid combination

CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Brigatinib. Management: Avoid concurrent use of brigatinib with moderate CYP3A4 inhibitors when possible. If such a combination cannot be avoided, reduce the dose of brigatinib by approximately 40% (ie, from 180 mg to 120 mg, from 120 mg to 90 mg, or from 90 mg to 60 mg). Consider therapy modification

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Brigatinib. Management: Avoid concurrent use of brigatinib with strong CYP3A4 inhibitors when possible. If combination cannot be avoided, reduce the brigatinib dose by approximately 50%, rounding to the nearest tablet strength (ie, from 180 mg to 90 mg, or from 90 mg to 60 mg). Consider therapy modification

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

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

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

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

Estrogen Derivatives (Contraceptive): Brigatinib may decrease the serum concentration of Estrogen Derivatives (Contraceptive). Management: Females of childbearing potential should use an alternative, non-hormonal contraceptive during brigatinib therapy and for at least 4 months after the final brigatinib dose. Consider therapy modification

Fexinidazole [INT]: Bradycardia-Causing Agents may enhance the arrhythmogenic effect of Fexinidazole [INT]. Avoid combination

Fosaprepitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Grapefruit Juice: May increase the serum concentration of Brigatinib. Avoid combination

Idelalisib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Ivabradine: Bradycardia-Causing Agents may enhance the bradycardic effect of Ivabradine. Monitor therapy

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

Lacosamide: Bradycardia-Causing Agents may enhance the AV-blocking effect of Lacosamide. Monitor therapy

Larotrectinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Midodrine: May enhance the bradycardic effect of Bradycardia-Causing Agents. Monitor therapy

MiFEPRIStone: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Minimize doses of CYP3A4 substrates, and monitor for increased concentrations/toxicity, during and 2 weeks following treatment with mifepristone. Avoid cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus. Consider therapy modification

Palbociclib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Progestins (Contraceptive): Brigatinib may decrease the serum concentration of Progestins (Contraceptive). Management: Females of childbearing potential should use an alternative, non-hormonal contraceptive during brigatinib therapy and for at least 4 months after the final brigatinib dose. Consider therapy modification

Ruxolitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Management: Ruxolitinib Canadian product labeling recommends avoiding use with bradycardia-causing agents to the extent possible. 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

Simeprevir: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Siponimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Siponimod. Management: Avoid coadministration of siponimod with drugs that may cause bradycardia. Consider therapy modification

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

St John's Wort: May decrease the serum concentration of Brigatinib. Avoid combination

Stiripentol: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Use of stiripentol with CYP3A4 substrates that are considered to have a narrow therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any CYP3A4 substrate used with stiripentol requires closer monitoring. Consider therapy modification

Terlipressin: May enhance the bradycardic effect of Bradycardia-Causing Agents. Monitor therapy

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

Tofacitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Monitor therapy

Adverse Reactions

>10%:

Cardiovascular: Bradycardia (8% to 12%), edema (18%, including angioedema), hypertension (21% to 32%)

Dermatologic: Pruritus (20%), skin rash (24% to 40%; including palmar-plantar erythrodysesthesia)

Endocrine & metabolic: Decreased serum albumin (15%), decreased serum calcium (15%), decreased serum phosphate (23% to 41%), decreased serum magnesium (21%), hyperglycemia (49% to 56%; including exacerbations), hypokalemia (19%), hyponatremia (20%), increased amylase (39% to 52%), increased serum calcium (22%), increased serum cholesterol (13%), increased serum potassium (24%)

Gastrointestinal: Abdominal pain (10% to 24%), constipation (15% to 18%), decreased appetite (9% to 15%), diarrhea (38% to 53%), increased serum lipase (45% to 59%), nausea (30% to 40%), stomatitis (13%; grades 3/4: <1%), vomiting (21% to 23%)

Hematologic & oncologic: Anemia (40%; grades 3/4: <1%), decreased neutrophils (12%), lymphocytopenia (27% to 42%; grades 3/4: 5% to 9%), prolonged partial thromboplastin time (20%; grades 3/4: <1%)

Hepatic: Increased serum alanine aminotransferase (40% to 52%), increased serum alkaline phosphatase (29% to 36%), increased serum aspartate aminotransferase (65% to 72%)

Nervous system: Dizziness (15%), fatigue (32% to 36%), headache (22% to 27%), insomnia (7%), peripheral neuropathy (including hyperesthesia, hypoesthesia, neuralgia, paresthesia, polyneuropathy: 11% to 13%, grades 3/4: 2%)

Neuromuscular & skeletal: Arthralgia (14%), back pain (15% to 21%), increased creatine phosphokinase in blood specimen (48% to 81%), limb pain (4% to 5%), muscle spasm (17%), myalgia (15% to 28%, including muscle twitching, musculoskeletal pain)

Renal: Increased serum creatinine (25%)

Respiratory: Cough (34% to 35%), dyspnea (21% to 25%; severe dyspnea: 2%), pneumonia (10% to 15%), upper respiratory tract infection (12%)

Miscellaneous: Fever (6% to 15%), high fever (3%)

1% to 10%:

Cardiovascular: Pulmonary embolism (2%)

Dermatologic: Xeroderma (5%)

Gastrointestinal: Dysgeusia (3%), dyspepsia (8%)

Genitourinary: Urinary tract infection (6%)

Hematologic & oncologic: Decreased platelet count (10%)

Nervous system: Pain (3%)

Neuromuscular & skeletal: Asthenia (severe: 2%), muscle rigidity (1%)

Ophthalmic: Visual disturbance (7% to 10%; including blurred vision, cataract, diplopia, glaucoma, macular edema, papilledema, reduced visual acuity, vitreous detachment)

Respiratory: Hypoxia (3%), interstitial pulmonary disease (≤9%), nasopharyngitis (8%), pneumonitis (≤9%)

<1%: Gastrointestinal: Gastroesophageal reflux disease

Warnings/Precautions

Concerns related to adverse effects:

• Cardiac effects: Hypertension was reported commonly in patients receiving brigatinib (including grade 3 hypertension). Blood pressure should be controlled prior to initiating brigatinib therapy. Monitor blood pressure after 2 weeks and at least monthly subsequently. Hypertension may require brigatinib therapy interruption, dose reduction, and/or permanent discontinuation; may also require antihypertensive therapy. Bradycardia has also occurred with brigatinib therapy; monitor heart rate (more frequently if on concomitant bradycardia-inducing medication). Symptomatic bradycardia may require therapy interruption or dose reduction. Permanently discontinue for life-threatening bradycardia that is not associated with a concomitant medication. Use caution when administering brigatinib in combination with antihypertensive medications that cause bradycardia.

• CPK elevation: CPK elevations have been reported in up to ~80% of patients receiving brigatinib (including grade 3 or 4 elevations). A higher incidence was associated with the 180 mg/day dose (compared to 90 mg/day). Monitor CPK levels during treatment; advise patients to report unexplained muscle pain, tenderness, or weakness. Elevated CPK levels may require therapy interruption and/or dose reduction.

• GI toxicity: Pancreatic enzyme elevations (lipase and amylase) have been reported, including grade 3 or 4 elevations. A higher incidence was associated with the 180 mg/day dose (compared to 90 mg/day). Monitor amylase/lipase during treatment; may require therapy interruption and/or dose reduction. Nausea, vomiting, diarrhea, constipation, and abdominal pain have also been observed with brigatinib therapy.

• Hyperglycemia: More than half of patients receiving brigatinib experienced new or worsening hyperglycemia, including grade 3 toxicity. Some patients with diabetes or glucose intolerance (at baseline) required insulin therapy while receiving brigatinib. Monitor fasting serum glucose at baseline and periodically during treatment. Initiate or optimize antihyperglycemic therapy; if adequate serum glucose control cannot be achieved with optimal medical management, interrupt brigatinib until metabolic control is achieved. Dose reduction or permanent discontinuation may be necessary.

• Ocular toxicity: Visual disturbances such as blurred vision, diplopia, photophobia, photopsia, and reduced visual acuity have been reported. Grade 3 macular edema and cataract also occurred (rare). Advise patients to report visual symptoms. Interrupt brigatinib therapy and obtain an ophthalmologic evaluation in patients with new or worsening ≥ grade 2 visual symptoms. Visual disturbances may require dose reduction or permanent discontinuation.

• Pulmonary toxicity: Severe, life-threatening, and fatal cases of pulmonary toxicity consistent with interstitial lung disease (ILD)/pneumonitis have been reported. ILD/pneumonitis generally occurred within 8 to 9 days of brigatinib initiation (with a median onset of 2 days in one clinical trial) and occurred at both dose levels. Monitor for new or worsening pulmonary symptoms (eg, dyspnea, cough), particularly in the first week of therapy. Interrupt brigatinib in any patient with new or worsening respiratory symptoms; promptly evaluate for ILD/pneumonitis or other potential cause of toxicity (eg, pulmonary embolism, tumor progression, or infectious etiology). Pulmonary toxicity may require treatment interruption, dose reduction, and/or permanent discontinuation.

Concurrent drug therapy issues:

• Drug-drug/drug-food interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Other warnings/precautions:

• Anaplastic lymphoma kinase testing: Select patients for the treatment of metastatic non-small cell lung cancer based on the presence of anaplastic lymphoma kinase (ALK) positivity in tumor specimens. Information on approved tests for the detection of ALK rearrangements may be found at http://www.fda.gov/companiondiagnostics.

Monitoring Parameters

Anaplastic lymphoma kinase (ALK) positivity; monitor CPK and amylase/lipase levels periodically throughout therapy; fasting serum glucose at baseline and periodically thereafter; monitor heart rate and blood pressure (after 2 weeks and at least monthly thereafter); evaluate pregnancy status in females of reproductive potential prior to therapy initiation. Monitor for signs/symptoms of interstitial lung disease (ILD)/pneumonitis (new or worsening pulmonary symptoms), muscular symptoms of CPK elevations, and visual disturbances (obtain ophthalmologic evaluation in patients with new or worsening ≥ grade 2 visual symptoms). Monitor adherence.

Reproductive Considerations

Evaluate pregnancy status in females of reproductive potential prior to therapy initiation. Females of reproductive potential should use an effective nonhormonal contraceptive during therapy and for at least 4 months after the last brigatinib dose. Males with female partners of reproductive potential should use effective contraception during therapy and for at least 3 months after the last dose.

Pregnancy Considerations

Based on the mechanism of action and adverse events observed in animal reproduction studies, brigatinib may be expected to cause fetal harm if used during pregnancy.

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:

• Nausea

• Vomiting

• Diarrhea

• Constipation

• Abdominal pain

• Lack of appetite

• Mouth irritation

• Mouth sores

• Feeling dizzy, tired, or weak

• Headache

• Back pain

• Joint pain

• Painful extremities

• Trouble sleeping

• Common cold symptoms

• Nose irritation

• Throat irritation

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

• Pancreatitis like severe abdominal pain, severe back pain, severe nausea, or vomiting

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

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

• High blood pressure like severe headache or dizziness, passing out, or vision changes

• Sore throat

• Chills

• Swelling

• Vision changes

• Slow heartbeat

• Chest pain

• Double vision

• Sensitivity to light

• Muscle pain

• Muscle weakness

• Muscle spasms

• Burning or numbness feeling

• 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.