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Lorlatinib

Medically reviewed by Drugs.com. Last updated on Jun 10, 2019.

Pronunciation

(lor LA ti nib)

Index Terms

  • PF-06463922

Dosage Forms

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

Tablet, Oral:

Lorbrena: 25 mg, 100 mg

Brand Names: U.S.

  • Lorbrena

Pharmacologic Category

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

Pharmacology

Lorlatinib is a reversible potent third generation tyrosine kinase inhibitor that targets ALK and ROS1; it is highly selective, overcomes known ALK resistance mutations, and penetrates the blood brain barrier (Shaw 2017). Lorlatinib has antitumor activity against multiple mutant forms of the ALK enzyme, including some mutations detected in tumors at the time of disease progression on crizotinib and other ALK inhibitors. Antitumor activity of lorlatinib is dose-dependent and correlates with inhibition of ALK phosphorylation. Lorlatinib also exhibits activity against TYK1, FER, FPS, TRKA, TRKB, TRKC, FAK, FAK2, and ACK.

Absorption

Rapid (Shaw 2017)

Distribution

Vss: 305 L

Metabolism

Primarily via CYP3A4 and UGT1A4, with minor contribution from CYP2C8, CYP2C19, CYP3A5, and UGT1A3

Excretion

Urine: 48% (<1% as unchanged drug); feces: 41% (~9% as unchanged drug)

Time to Peak

1.2 hours (range: 0.5 to 4 hours) following a single dose; 2 hours (range: 0.5 to 23 hours) at steady state

Half-Life Elimination

24 hours

Protein Binding

66%; to plasma proteins

Use: Labeled Indications

Non-small cell lung cancer, metastatic: Treatment of anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) in patients whose disease has progressed on crizotinib and at least 1 other ALK inhibitor for metastatic disease; or progressed on alectinib as the first ALK inhibitor therapy for metastatic disease; or progressed on ceritinib as the first ALK inhibitor therapy for metastatic disease.

Contraindications

Concomitant use of strong CYP3A inducers

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

Dosing: Adult

Non-small cell lung cancer, metastatic (ALK-positive): Oral: 100 mg once daily; continue until disease progression or unacceptable toxicity (Shaw 2017).

Dosage adjustment for CYP3A inhibitors/inducers:

Moderate or strong CYP3A inducers: Lorlatinib is contraindicated in patients taking strong CYP3A inducers; the strong CYP3A inducer must be discontinued for 3 plasma half-lives (of the strong CYP3A inducer) prior to initiating lorlatinib. Avoid concomitant use of lorlatinib with moderate CYP3A inducers.

Strong CYP3A inhibitors: Avoid concomitant use of lorlatinib with strong CYP3A inhibitors; if concomitant use with a strong CYP3A inhibitor cannot be avoided, reduce the lorlatinib starting dose from 100 mg once daily to 75 mg once daily. In patients who have had a lorlatinib dose reduction to 75 mg once daily (due to adverse reactions) and who initiate a strong CYP3A inhibitor, reduce the lorlatinib dose to 50 mg once daily. When the strong CYP3A inhibitor is discontinued, increase the lorlatinib dose (after 3 plasma half-lives of the strong CYP3A inhibitor have elapsed) to the dose that was used prior to initiation of the strong CYP3A inhibitor.

Missed doses: If a dose is missed, administer the missed dose unless it is due within 4 hours. Do not administer 2 doses to make up for a missed dose. If vomiting occurs, do not administer an additional dose; continue with the next scheduled dose.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Adjustment for Toxicity

Recommended dosage reduction levels:

Usual initial dose: 100 mg once daily

First dose reduction level: 75 mg once daily

Second dose reduction level: 50 mg once daily

Discontinue permanently if unable to tolerate 50 mg once daily.

Cardiovascular toxicity (atrioventricular [AV] block):

Second degree AV block: Withhold lorlatinib until PR interval is <200 msec and then resume lorlatinib at a reduced dose.

First occurrence of complete AV block: Withhold lorlatinib until either pacemaker is placed or PR interval is <200 msec. If a pacemaker is placed, resume lorlatinib at the same dose. If no pacemaker is placed, resume lorlatinib at a reduced dose.

Recurrent complete AV block: Place pacemaker or permanently discontinue lorlatinib.

CNS toxicity:

Grade 1: Continue lorlatinib at the same dose or withhold until recovery to baseline. Resume lorlatinib at the same dose or at a reduced dose.

Grade 2 or 3: Withhold dose until resolved to grade 0 or 1, then resume lorlatinib at a reduced dose.

Grade 4: Permanently discontinue lorlatinib.

Hyperlipidemia: Grade 4 hypercholesterolemia or grade 4 hypertriglyceridemia: Withhold lorlatinib until recovery of hypercholesterolemia and/or hypertriglyceridemia to ≤ grade 2 and then resume lorlatinib at the same dose. If severe hypercholesterolemia and/or hypertriglyceridemia recurs, resume lorlatinib at a reduced dose. Hyperlipidemia may require initiation (or increased doses) of lipid-lowering agents.

Pulmonary toxicity: Treatment-related interstitial lung disease (ILD)/pneumonitis, any grade: Permanently discontinue lorlatinib.

Other toxicities:

Grade 1 or 2: Continue lorlatinib at the same dose or at a reduced dose.

Grade 3 or 4: Withhold lorlatinib until symptoms resolve to ≤ grade 2 or baseline, then resume lorlatinib at a reduced dose.

Administration

Oral: Administer with or without food at the same time each day. Swallow intact tablets whole; do not crush or split; do not ingest tablets that are broken, cracked or otherwise not intact.

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

Abemaciclib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Abemaciclib. Avoid combination

Antihepaciviral Combination Products: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Antihepaciviral Combination Products. Avoid combination

Asunaprevir: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Asunaprevir. Avoid combination

Axitinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Axitinib. Avoid combination

Bedaquiline: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Bedaquiline. Avoid combination

Bosutinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Bosutinib. Avoid combination

Brigatinib: 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

Clarithromycin: CYP3A4 Inducers (Moderate) may increase serum concentrations of the active metabolite(s) of Clarithromycin. CYP3A4 Inducers (Moderate) may decrease the serum concentration of Clarithromycin. Management: Consider alternative antimicrobial therapy for patients receiving a CYP3A inducer. Drugs that enhance the metabolism of clarithromycin into 14-hydroxyclarithromycin may alter the clinical activity of clarithromycin and impair its efficacy. Consider therapy modification

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

CloZAPine: CYP3A4 Inducers (Moderate) may decrease the serum concentration of CloZAPine. Monitor therapy

Cobimetinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Cobimetinib. Avoid combination

Codeine: CYP3A4 Inducers (Moderate) may decrease serum concentrations of the active metabolite(s) of Codeine. Monitor therapy

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

CYP3A4 Inducers (Moderate): May enhance the hepatotoxic effect of Lorlatinib. CYP3A4 Inducers (Moderate) may decrease the serum concentration of Lorlatinib. Management: Avoid use of lorlatinib with moderate CYP3A4 inducers. If such a combination must be used, monitor AST, ALT, and bilirubin within 48 hours of starting the combination and at least three times within the first week of combined use. Consider therapy modification

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

CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Lorlatinib. Management: Avoid use of lorlatinib with strong CYP3A4 inhibitors. If the combination cannot be avoided, reduce the lorlatinib dose from 100 mg once daily to 75 mg once daily, or from 75 mg once daily to 50 mg once daily. Consider therapy modification

CYP3A4 Substrates (High risk with Inducers): Lorlatinib may decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Avoid concurrent use of lorlatinib with any CYP3A4 substrates for which a minimal decrease in serum concentrations of the CYP3A4 substrate could lead to therapeutic failure and serious clinical consequences. 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

Daclatasvir: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Daclatasvir. Management: Increase the daclatasvir dose to 90 mg once daily if used with a moderate CYP3A4 inducer. Consider therapy modification

Dasabuvir: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Dasabuvir. Avoid combination

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

Deflazacort: CYP3A4 Inducers (Moderate) may decrease serum concentrations of the active metabolite(s) of Deflazacort. Avoid combination

Elbasvir: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Elbasvir. Avoid combination

Encorafenib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Encorafenib. Avoid combination

Entrectinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Entrectinib. Avoid combination

Erdafitinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Erdafitinib. Management: Dose modifications of erdafitinib may be required. See full monograph for details. Consider therapy modification

Estriol (Systemic): CYP3A4 Inducers (Moderate) may decrease the serum concentration of Estriol (Systemic). Monitor therapy

Estriol (Topical): CYP3A4 Inducers (Moderate) may decrease the serum concentration of Estriol (Topical). Monitor therapy

Fedratinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Fedratinib. Avoid combination

FentaNYL: CYP3A4 Inducers (Moderate) may decrease the serum concentration of FentaNYL. Monitor therapy

Flibanserin: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Flibanserin. Avoid combination

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

Glecaprevir and Pibrentasvir: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Glecaprevir and Pibrentasvir. Monitor therapy

Grazoprevir: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Grazoprevir. Avoid combination

GuanFACINE: CYP3A4 Inducers (Moderate) may decrease the serum concentration of GuanFACINE. Management: Increase the guanfacine dose by up to double when initiating guanfacine in a patient taking a moderate CYP3A4 inducer. Increase guanfacine dose gradually over 1 to 2 weeks if initiating a moderate CYP3A4 inducer in a patient already taking guanfacine. Consider therapy modification

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

Ifosfamide: CYP3A4 Inducers (Moderate) may decrease serum concentrations of the active metabolite(s) of Ifosfamide. CYP3A4 Inducers (Moderate) may increase serum concentrations of the active metabolite(s) of Ifosfamide. Monitor therapy

Lefamulin: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Lefamulin. Management: Avoid concomitant use of lefamulin with moderate CYP3A4 inducers unless the benefits outweigh the risks. Consider therapy modification

Lefamulin (Intravenous): CYP3A4 Inducers (Moderate) may decrease the serum concentration of Lefamulin (Intravenous). Management: Avoid concomitant use of lefamulin (intravenous) with moderate CYP3A4 inducers unless the benefits outweigh the risks. Consider therapy modification

Lurasidone: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Lurasidone. Management: Monitor for decreased lurasidone effects if combined with moderate CYP3A4 inducers and consider increasing the lurasidone dose if coadministered with a moderate CYP3A4 inducer for 7 or more days. Consider therapy modification

Meperidine: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Meperidine. Management: Consider increasing meperidine dose if concomitant use with moderate CYP3A4 inducers is required. Monitor for signs and symptoms of opioid withdrawal. Consider therapy modification

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

Neratinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Neratinib. Avoid combination

Nisoldipine: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Nisoldipine. Avoid combination

Olaparib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Olaparib. Avoid combination

Palbociclib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Palbociclib. Management: The US label does not provide specific recommendations concerning use with moderate CYP3A4 inducers, but the Canadian label recommends avoiding use of moderate CYP3A4 inducers. Consider therapy modification

Perampanel: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Perampanel. Management: Increase the perampanel starting dose to 4 mg/day when perampanel is used concurrently with moderate and strong CYP3A4 inducers. Consider therapy modification

Pimavanserin: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Pimavanserin. Avoid combination

Pitolisant: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Pitolisant. Monitor therapy

Pretomanid: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Pretomanid. Avoid combination

Ranolazine: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Ranolazine. Avoid combination

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: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Simeprevir. Avoid combination

Sonidegib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Sonidegib. 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

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

Velpatasvir: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Velpatasvir. Avoid combination

Venetoclax: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Venetoclax. Avoid combination

Adverse Reactions

>10%:

Cardiovascular: Edema (57%)

Central nervous system: Peripheral neuropathy (47%; grade 3/4: 3%), cognitive dysfunction (27% to 29%), fatigue (26%), mood disorder (23% to 24%), headache (18%), dizziness (16%), speech disturbance (12% to 14%), sleep disorder (10%)

Dermatologic: Skin rash (14%)

Endocrine & metabolic: Hypercholesterolemia (96%), hypertriglyceridemia (90%), hyperglycemia (52%), hypoalbuminemia (33%), weight gain (24%), increased amylase (22%), hyperkalemia (21%), hypomagnesemia (21%), hypophosphatemia (21%)

Gastrointestinal: Increased serum lipase (24%), diarrhea (22%), nausea (18%), constipation (15%), vomiting (12%)

Hematologic & oncologic: Anemia (52%; grade 3/4: 5%), thrombocytopenia (23%; grade 3/4: <1%), lymphocytopenia (22%; grades 3/4: 3%)

Hepatic: Increased serum aspartate aminotransferase (37%), increased serum alanine aminotransferase (28%), increased serum alkaline phosphatase (24%)

Neuromuscular & skeletal: Arthralgia (23%), myalgia (17%), back pain (13%), limb pain (13%)

Ophthalmic: Visual disturbance (15%)

Respiratory: Dyspnea (27%), cough (18%), upper respiratory tract infection (12%)

Miscellaneous: Fever (12%)

1% to 10%:

Cardiovascular: Atrioventricular block (1%)

Central nervous system: Hallucination (7%), seizure (3%), mental status changes (2%)

Respiratory: Pneumonia (3%), interstitial pulmonary disease (≤2%), pneumonitis (≤2%), respiratory failure (1%)

Warnings/Precautions

Concerns related to adverse effects:

• Bone marrow suppression: Anemia (usually mild) commonly occurred with lorlatinib. Mild thrombocytopenia and lymphopenia also occurred.

• Cardiovascular effects: PR interval prolongation and atrioventricular (AV) block may rarely occur in patients receiving lorlatinib, including grade 3 events. Some patients required pacemaker placement. Monitor ECG prior to initiating lorlatinib treatment and periodically thereafter. Withhold treatment and resume at a reduced dose (if no pacemaker placement) or at the same dose in patients who undergo pacemaker placement. Permanently discontinue for recurrence in patients without a pacemaker.

• CNS effects: CNS effects (including seizures, hallucinations, cognitive function, mood [including suicidal ideation], speech, mental status, and sleep changes) may occur in patients receiving lorlatinib. Overall, CNS effects occurred in just over half of patients receiving lorlatinib. Cognitive effects occurred in nearly one-third patients who received lorlatinib (at any dose) in one study; a small percentage of these events were severe (grade 3 or 4). Mood effects occurred in nearly one-fourth of patients; severe events occurred rarely. Speech effects, hallucinations, and mental status changes have also been reported, including rare severe events. Seizures have been observed, sometimes in conjunction with other neurologic findings. Changes in sleep have also been reported. The median time to initial onset of any CNS effect was 1.2 months (range: 1 day to 1.7 years). Depending on the severity, CNS adverse events may require treatment interruption, dose reduction, and/or permanent discontinuation.

• Hepatotoxicity: Severe hepatotoxicity occurred in a majority of healthy subjects who received a lorlatinib dose in combination with multiple daily doses of rifampin (a strong CYP3A inducer). Grade 3 and 4 ALT or AST elevations occurred commonly; grade 2 elevations also were reported. ALT or AST elevations occurred within 3 days and returned to within normal limits after a median of 15 days (range: 7 to 34 days); for subjects with grade 2 ALT or AST elevation, the median time to recovery was 7 days and for subjects with grade 3 or 4 ALT or AST elevations, the median time to recovery was 18 days. Lorlatinib use is contraindicated in patients taking strong CYP3A inducers. Discontinue strong CYP3A inducers for 3 plasma half-lives (of the strong CYP3A inducer) prior to initiating lorlatinib treatment. Avoid concomitant use of lorlatinib with moderate CYP3A inducers; if concomitant use of moderate CYP3A inducers cannot be avoided, monitor AST, ALT, and bilirubin 48 hours after initiating lorlatinib and at least 3 times during the first week after lorlatinib initiation. Depending upon the relative importance of each drug, discontinue lorlatinib or the CYP3A inducer for persistent grade 2 or higher hepatotoxicity.

• Hyperlipidemia: Serum cholesterol and triglycerides increases may occur in patients receiving lorlatinib. Grade 3 or 4 total cholesterol and triglyceride elevations have been reported. The median time to onset (for both hypercholesterolemia and hypertriglyceridemia) was 15 days. A majority of patients with hypercholesterolemia and hypertriglyceridemia required initiation of lipid-lowering medications, usually at ~21 days after lorlatinib initiation. Monitor serum cholesterol and triglycerides prior to initiating lorlatinib, at 1 and 2 months after lorlatinib initiation, and periodically thereafter. Initiate lipid-lowering agents (or increase the dose) in patients with hyperlipidemia. Depending on the severity, hyperlipidemia may require lorlatinib treatment interruption and/or dose reduction.

• Pulmonary toxicity: While rare, severe or life-threatening pulmonary adverse reactions consistent with interstitial lung disease (ILD)/pneumonitis may occur with lorlatinib, including grades 3 and 4 events. Promptly evaluate new or worsening respiratory symptoms indicative of ILD/pneumonitis (eg, dyspnea, cough, fever). Immediately withhold lorlatinib if ILD/pneumonitis is suspected; discontinue permanently for lorlatinib-related ILD/pneumonitis of any severity.

Concurrent drug therapy issues:

• Drug-drug 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:

• ALK positivity: Lorlatinib is approved for use in patients with metastatic non-small cell lung cancer (NSCLC) who test positive for the abnormal anaplastic lymphoma kinase (ALK) gene. Information on approved tests for detection of ALK gene rearrangements may be found at https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm301431.htm.

Monitoring Parameters

ALK positivity; serum cholesterol and triglycerides (prior to initiating lorlatinib, at 1 and 2 months after lorlatinib initiation, and periodically thereafter); AST, ALT, and bilirubin (48 hours after initiating lorlatinib and at least 3 times during the first week after initiation [if concomitant use of moderate CYP3A inducers cannot be avoided]); pregnancy test (prior to treatment in females of reproductive potential). Monitor ECG (prior to lorlatinib initiation and periodically thereafter). Monitor for signs/symptoms of CNS adverse events and interstitial lung disease/pneumonitis. Monitor adherence.

Pregnancy Considerations

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

Evaluate pregnancy status in females of reproductive potential prior to initiating therapy. Females of reproductive potential should avoid pregnancy and use an effective nonhormonal method of contraception during treatment and for at least 6 months after the final lorlatinib dose. Male patients with female partners of reproductive potential should use effective contraception during treatment and for at least 3 months after the last lorlatinib dose.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience weight gain, muscle pain, joint pain, diarrhea, nausea, vomiting, constipation, back pain, painful extremities, or common cold symptoms. Have patient report immediately to prescriber signs of high blood sugar (confusion, fatigue, increased thirst, increased hunger, polyuria, flushing, fast breathing, or breath that smells like fruit), signs of electrolyte problems (mood changes, confusion, muscle pain or weakness, abnormal heartbeat, seizures, lack of appetite, or severe nausea or vomiting), seizures, difficulty speaking, burning or numbness feeling, change in balance, muscle weakness, memory impairment, difficulty focusing, severe fatigue, bradycardia, abnormal heartbeat, dizziness, passing out, edema, severe loss of strength and energy, bruising, bleeding, chills, pharyngitis, anxiety, nightmares, insomnia, vision changes, confusion, agitation, restlessness, hallucination, severe headache, signs of depression (thoughts of suicide, anxiety, emotional instability, or confusion), or signs of a severe pulmonary disorder (lung or breathing problems like difficulty breathing, shortness of breath, or a cough that is new or worse) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Further information

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

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