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Maraviroc

Pronunciation

(mah RAV er rock)

Index Terms

  • UK-427,857

Dosage Forms

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

Solution, Oral:

Selzentry: 20 mg/mL (230 mL) [contains sodium benzoate; strawberry flavor]

Tablet, Oral:

Selzentry: 25 mg, 75 mg, 150 mg, 300 mg [contains fd&c blue #2 aluminum lake, soybean lecithin]

Brand Names: U.S.

  • Selzentry

Pharmacologic Category

  • Antiretroviral, CCR5 Antagonist (Anti-HIV)

Pharmacology

Maraviroc, a CCR5 antagonist, selectively and reversibly binds to the chemokine (C-C motif receptor 5 [CCR5]) coreceptors located on human CD4 cells. CCR5 antagonism prevents interaction between the human CCR5 coreceptor and the gp120 subunit of the viral envelope glycoprotein, thereby inhibiting gp120 conformational change required for CCR5-tropic HIV-1 fusion with the CD4 cell and subsequent cell entry.

Distribution

Vd: ~194 L

Metabolism

Hepatic, via CYP3A to inactive metabolites

Excretion

Urine (~20%, 8% as unchanged drug); feces (76%, 25% as unchanged drug)

Time to Peak

Plasma: 0.5 to 4 hours

Half-Life Elimination

14 to 18 hours

Protein Binding

~76%

Special Populations: Renal Function Impairment

In a single 300 mg dose study in patients with severe renal impairment (CrCl <30 mL/minute) and ESRD, Cmax and AUC were 2.4- and 3.2-fold higher, respectively, for patients with severe renal impairment, and 1.7- and 2-fold higher, respectively, for ESRD patients.

Use: Labeled Indications

HIV-1 infection: Treatment of only CCR5-tropic HIV-1 infection in patients 2 years and older and weighing ≥10 kg, in combination with other antiretroviral agents

Contraindications

Patients with severe renal impairment (CrCl <30 mL/minute) or end-stage renal disease (ESRD) who are taking concomitant potent CYP3A inhibitors or inducers

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

Dosing: Adult

HIV-1 infection, treatment: Oral: 300 mg twice daily; dose recommended when maraviroc administered concomitantly with other medications that are not potent CYP3A inhibitors or inducers, including tipranavir/ritonavir, nevirapine, raltegravir, all NRTIs and enfuvirtide.

Dosage adjustment for concomitant CYP3A inhibitors/inducers:

CYP3A inhibitors (with or without a potent CYP3A inducer): 150 mg twice daily; dose recommended when maraviroc administered concomitantly with potent CYP3A inhibitors including (but not limited to) protease inhibitors (excluding tipranavir/ritonavir), delavirdine, elvitegravir/ritonavir, ketoconazole, itraconazole, clarithromycin, nefazodone, telithromycin, and boceprevir.

CYP3A inducers (without a potent CYP3A inhibitor): 600 mg twice daily; dose recommended when maraviroc administered concomitantly with potent CYP3A inducers including (but not limited to) efavirenz, etravirine, rifampin, carbamazepine, phenobarbital, and phenytoin

Dosing: Pediatric

HIV-1 infection: Children ≥2 years and ≥10 kg and Adolescents: Oral:

Weight <30 kg: Not recommended

Weight ≥30 kg: 300 mg twice daily; dose recommended when maraviroc administered concomitantly with other medications that are not potent CYP3A inhibitors or inducers, including tipranavir/ritonavir, nevirapine, raltegravir, all NRTIs and enfuvirtide.

Dosage adjustment for concomitant CYP3A inhibitors/inducers:

CYP3A inhibitors (with or without a potent CYP3A inducer):

10 to <20 kg: 50 mg twice daily

20 to <30 kg: 75 mg twice daily (tablets) or 80 mg twice daily (oral solution)

30 to <40 kg: 100 mg twice daily

≥40 kg: 150 mg twice daily

CYP3A inducers (without a potent CYP3A inhibitor): Not recommended

Dosing: Renal Impairment

Adults:

CrCl ≥30 mL/minute: No dosage adjustment necessary

CrCl <30 mL/minute:

Concomitant potent CYP3A inhibitors (with or without a potent CYP3A inducer) or concomitant potent CYP3A inducer (without a potent CYP3A inhibitor): Use is contraindicated

Other concomitant medications (eg, tipranavir/ritonavir, nevirapine, raltegravir, all NRTIs, enfuvirtide, and other medications that are not potent CYP3A inhibitors or inducers): No dosage adjustment necessary, unless postural hypotension occurs; then, reduce dose to 150 mg twice daily

ESRD requiring intermittent hemodialysis (IHD): Note: Hemodialysis has minimal effect on clearance

Concomitant potent CYP3A inhibitors (with or without a potent CYP3A inducer) or concomitant potent CYP3A inducer (without a potent CYP3A inhibitor): Use is contraindicated

Other concomitant medications (eg, tipranavir/ritonavir, nevirapine, raltegravir, all NRTIs, enfuvirtide, and other medications that are not potent CYP3A inhibitors or inducers): No dosage adjustment necessary, unless postural hypotension occurs; then, reduce dose to 150 mg twice daily.

Children ≥ 2 years and Adolescents:

Mild or moderate impairment: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Severe impairment and receiving potent CYP3A inhibitors: Use is contraindicated.

End-stage renal disease (ESRD) on intermittent hemodialysis and receiving potent CYP3A inhibitors: Use is contraindicated.

Dosing: Hepatic Impairment

Mild to moderate impairment: There are no dosage adjustments provided in the manufacturer's labeling; however, maraviroc concentrations are increased in mild to moderate impairment; use caution.

Moderate impairment (with concomitant potent CYP3A inhibitor): There are no dosage adjustments provided in the manufacturer's labeling; however, maraviroc concentrations are increased moderate impairment; use caution and monitor closely for adverse events.

Severe impairment: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Administration

Administer without regards to meals.

Storage

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

Drug Interactions

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

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

CYP3A4 Inducers (Strong): May decrease the serum concentration of Maraviroc. Management: Increase maraviroc adult dose to 600 mg twice daily when used with strong CYP3A4 inducers. This does not apply to patients also receiving strong CYP3A4 inhibitors. Do not use maraviroc with strong CYP3A4 inducers in patients with CrCl less than 30 mL/min. Consider therapy modification

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 Maraviroc. Management: Reduce the adult dose of maraviroc to 150 mg twice daily when used with a strong CYP3A4 inhibitor. Do not use maraviroc with strong CYP3A4 inhibitors in patients with Clcr less than 30 mL/min. 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

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

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

Efavirenz: May decrease the serum concentration of Maraviroc. Of note, this effect only applies in the absence of a strong CYP3A4 inhibitor Management: Increase maraviroc adult dose to 600 mg twice daily if used with efavirenz. This does not apply to patients also receiving strong CYP3A4 inhibitors. This combination is contraindicated in patients with CrCl less than 30 mL/min. Consider therapy modification

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

Etravirine: May decrease the serum concentration of Maraviroc. Of note, this effect only applies in the absence of a strong CYP3A4 inhibitor Management: Increase maraviroc adult dose to 600 mg twice daily if used with etravirine. This does not apply to patients also receiving strong CYP3A4 inhibitors. This combination is contraindicated in patients with CrCl less than 30 mL/min. Consider therapy modification

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

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

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

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

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

Orlistat: May decrease the serum concentration of Antiretroviral Agents. Monitor therapy

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

Pitolisant: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Combined use of pitolisant with a CYP3A4 substrate that has a narrow therapeutic index should be avoided. Other CYP3A4 substrates should be monitored more closely when used with pitolisant. Consider therapy modification

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

St John's Wort: May decrease the serum concentration of Maraviroc. 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

Adverse Reactions

Includes data from both treatment-naive and treatment-experienced patients. Unless otherwise noted, frequency of adverse events is as reported in adults receiving combination antiretroviral therapy.

>10%:

Dermatologic: Skin rash (11%)

Gastrointestinal: Vomiting (children and adolescents: 12%; may be more common with oral solution)

Infection: Infection (55%)

Respiratory: Upper respiratory tract infection (23% to 32%), cough (14%)

Miscellaneous: Fever (13%)

1% to 10%:

Cardiovascular: Hypertension (3%), cardiac failure (<2%), cerebrovascular accident (<2%), coronary artery disease (<2%), coronary occlusion (<2%), endocarditis (<2%), myocardial infarction (<2%), portal vein thrombosis (<2%), septic shock (<2%), unstable angina pectoris (<2%)

Central nervous system: Dizziness (9%; children and adolescents: 3%; including postural dizziness), insomnia (8%), paresthesia (≤5%), dysesthesia (≤5%), anxiety (4%), impaired consciousness (4%), depression (4%), peripheral neuropathy (4%), malaise (≤4%), pain (≤4%), sensory disturbance (3% to 4%; includes body temperature perception disorder), memory impairment (3%), epilepsy (<2%), loss of consciousness (<2%), meningitis (<2%; includes viral), facial paralysis (<2%), seizure (<2%)

Dermatologic: Nail disease (6%; nail and nail bed disorder [excluding infection and infestation]), sweat gland disease (5%; apocrine and eccrine gland disorders), folliculitis (4%), pruritus (4%), tinea (4%), acne vulgaris (3%), alopecia (2%), erythema (2%), condyloma acuminatum (2%)

Endocrine & metabolic: Lipodystrophy (3% to 4%)

Gastrointestinal: Abdominal distension (≤10%), bloating (≤10%), flatulence (≤10%), decreased gastrointestinal motility (9%), change in appetite (8%), constipation (6%; may be more common with oral solution), abdominal pain (children and adolescents: 4%; may be more common with oral solution), diarrhea (children and adolescents: 4%; may be more common with oral solution), nausea (children and adolescents: 4%; may be more common with oral solution), carcinoma in situ of esophagus (<2%), colitis (Clostridium difficile-associated: <2%)

Genitourinary: Genitourinary complaint (urinary tract/bladder symptoms, 3% to 5%), ejaculatory disorder (≤3%), erectile dysfunction (≤3%)

Hematologic & oncologic: Anemia (8%), neutropenia (4% to 6%), benign skin neoplasm (3%), basal cell carcinoma (<2%), bone marrow depression (<2%), Bowen disease (<2%), carcinoma (nasopharyngeal: <2%), hypoplastic anemia (<2%), liver metastases (<2%), malignant lymphoma (including diffuse large B-cell and anaplastic large cell lymphomas T- and null-cell types), malignant neoplasm (anal: <2%), malignant neoplasm of bile duct (cholangiocarcinoma; <2%), malignant neoplasm of tongue (<2%; malignant stage unspecified), neoplasm (<2%; includes abdominal and unspecified malignant endocrine neoplasm), squamous cell carcinoma (<2%), squamous cell carcinoma of skin (<2%)

Hepatic: Increased serum AST (>5 x ULN: 5%), cholestatic jaundice (<2%), hepatic cirrhosis (<2%), hepatic failure (<2%), jaundice (<2%)

Infection: Herpes virus infection (7% to 8%), bacterial infection (6%), herpes zoster (≤5%), varicella zoster infection (≤5%), meningococcal infection (3%) viral infection (3%), influenza (2%), bacterial infection (treponema <2%)

Neuromuscular & skeletal: Arthropathy (6% to 7%), myalgia (3%), increased creatine phosphokinase (<2%), myositis (<2%; may be infective), osteonecrosis (<2%), rhabdomyolysis (<2%), tremor (<2%; excluding congenital)

Ophthalmic: Conjunctivitis (2%), eye disease (2%; includes infection and inflammation), hemianopia (<2%), visual field defect (<2%)

Otic: Otitis media (2%)

Respiratory: Bronchitis (7% to 13%), upper respiratory complaint (6% to 9%), sinusitis (7%), irregular breathing (4%), nasal congestion (≤4%), rhinitis (≤4%), lower respiratory tract infection (≤3%), pulmonary infection (≤3%), paranasal sinus disease (3%), pneumonia (<2%)

Frequency not defined:

Hepatic: Hepatitis, hepatotoxicity

Immunologic: Immune reconstitution syndrome

<1%, postmarketing, and/or case reports: DRESS syndrome, ischemic heart disease, Stevens-Johnson syndrome, toxic epidermal necrolysis

ALERT: U.S. Boxed Warning

Hepatotoxicity:

Hepatotoxicity has been reported with maraviroc use. Severe rash or evidence of a systemic allergic reaction (eg, eosinophilia, elevated immunoglobulin E [IgE], fever) prior to the development of hepatotoxicity may occur. Immediately evaluate patients with signs or symptoms of hepatitis or allergic reactions following use of maraviroc.

Warnings/Precautions

Concerns related to adverse effects:

• CNS effects: May cause dizziness. If this occurs, patients should avoid driving or operating machinery.

• Hepatotoxicity: [US Boxed Warning]: Possible drug-induced hepatotoxicity with allergic type features has been reported; hepatotoxicity may be preceded by severe rash or other signs of systemic allergic reactions (eg, pruritic rash, eosinophilia, fever, and/or increased IgE, excluding rash alone or Stevens-Johnson syndrome (HHS [adult], 2015) and/or hepatic adverse events (transaminase increases or signs/symptoms of hepatitis); some cases have been life-threatening; immediately evaluate patients with signs and symptoms of allergic reaction or hepatitis (with or without allergy symptoms). Use with caution in patients with pre-existing hepatic dysfunction or coinfection with HBV and/or HCV, however symptoms have occurred in the absence of pre-existing hepatic conditions. Monitor hepatic function at baseline and as clinically indicated during treatment. Consider discontinuation in any patient with possible hepatitis or with elevated transaminases combined with systemic allergic events. Rechallenge with maraviroc is not recommended (HHS [pediatric] 2016).

• Immune reconstitution syndrome: Patients may develop immune reconstitution syndrome resulting in the occurrence of an inflammatory response to an indolent or residual opportunistic infection during initial HIV treatment or activation of autoimmune disorders (eg, Graves’ disease, polymyositis, Guillain-Barré syndrome) later in therapy; further evaluation and treatment may be required.

• Infections: Monitor closely for signs/symptoms of developing infections; use associated with a small increase of certain upper respiratory tract infections and herpes virus infections during clinical trials.

• Malignancy: May affect immune surveillance and lead to an increased risk of malignancy due to pharmacologic mechanism of action. No increase in malignancy has been observed. Long term follow up needed to assess this risk.

• Postural hypotension: Symptomatic postural hypotension has occurred; use caution in patients at risk due to concomitant medication or history of condition. An increased risk of postural hypotension may occur in patients with severe renal insufficiency or in those with ESRD. Patients with severe renal dysfunction or ESRD who experience postural hypotension should have dose reduced.

• Skin and hypersensitivity reactions: Severe and life-threatening skin and hypersensitivity reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis and drug rash with eosinophilia with systemic symptoms (DRESS), have been reported with use, predominately in patients also receiving concomitant agents associated with these reactions. Rash and constitutional findings (eg, fever, muscle aches, conjunctivitis, oral lesions), with or without organ dysfunction (including hepatic failure), have also accompanied these reports. Discontinue maraviroc and any other suspected agent immediately if symptoms or signs of hypersensitivity occur. Monitor liver function tests and clinical status as appropriate.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with cardiovascular disease, or in patients with a history of or current cardiac risk factors for postural hypotension, or receiving concomitant medication known to lower blood pressure. Patients who have cardiovascular comorbidities could be at risk for cardiac adverse events prompted by postural hypotension. During trials, a small increase in cardiovascular events (myocardial ischemia and/or infarction) occurred in treated patients compared to placebo, although a contributory relationship relative to therapy is unknown. Of note, patients experiencing events generally had cardiac disease/risk factors prior to therapy.

• Hepatic impairment: Use caution in patients with HBV and/or HCV coinfection or with mild-to-moderate hepatic impairment; maraviroc concentrations are increased. Maraviroc concentrations are further increased in patients with moderate hepatic impairment receiving concomitant potent CYP3A inhibitors; monitor closely for adverse events. Use in patients with severe hepatic impairment has not been studied.

• Renal impairment: Renal impairment may increase maraviroc concentrations. Use with caution in patients with mild-to-moderate renal impairment. An increased risk of postural hypotension may occur in patients with severe renal impairment or in those with ESRD. Patients with severe renal dysfunction or ESRD who experience postural hypotension should have dose reduced. Use in patients with severe renal impairment or ESRD who are receiving potent CYP3A inhibitors or inducers is contraindicated.

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:

• Appropriate use: Prior to therapy, coreceptor tropism testing should be performed for presence of CCR5-tropic only virus HIV-1 infection. Therapy not recommended for use in patients with CXCR4- or dual/mixed tropic HIV-1 infection; efficacy not demonstrated in this population. In studies with treatment-naive patients, virologic failure and emergent lamivudine resistance was more common in maraviroc-treated patients compared to patients receiving efavirenz.

Monitoring Parameters

Viral load, CD4 count, transaminases and bilirubin (prior to initiation and periodically during treatment); signs/symptoms of infection, rash, severe skin reactions, hepatitis and/or allergic reaction; postural hypotension; tropism testing (prior to initiation)

Pregnancy Considerations

Maraviroc has moderate transfer across the human placenta. Data collected by the antiretroviral pregnancy registry are insufficient to evaluate human teratogenic risk. Maternal antiretroviral therapy may increase the risk of preterm delivery, although available information is conflicting possibly due to variability of maternal factors (disease severity; initiation of therapy); however, maternal antiretroviral medication should not be withheld due to concerns of preterm birth. Information related to stillbirth, low birth weight, and small for gestational age infants is limited. Long-term follow-up is recommended for all infants exposed to antiretroviral medications; children who develop significant organ system abnormalities of unknown etiology (particularly of the CNS or heart) should be evaluated for potential mitochondrial dysfunction.

Combination antiretroviral therapy (cART) therapy is recommended for all HIV-infected pregnant women to keep the viral load below the limit of detection and reduce the risk of perinatal transmission. When HIV is diagnosed during pregnancy in a woman who has never received antiretroviral therapy, cART should begin as soon as possible after diagnosis. The Health and Human Services (HHS) Perinatal HIV Guidelines note there are insufficient data to recommend use of maraviroc as initial therapy in antiretroviral-naive pregnant women. Dose adjustments are not needed in pregnancy. In general, women who become pregnant on a stable cART regimen may continue that regimen if viral suppression is effective, appropriate drug exposure can be achieved, contraindications for use in pregnancy are not present, and the regimen is well tolerated. Monitoring during pregnancy is more frequent than in non-pregnant adults; cART should be continued postpartum.

For HIV-infected couples planning a pregnancy, maximum viral suppression with cART is recommended prior to conception for the HIV-infected partner(s) and expert consultation is recommended; modification of therapy (if needed) and optimization of the woman’s health should be done prior to conception. HIV-infected women not planning a pregnancy may use any available type of contraception, considering possible drug interactions and contraindications of the specific method. In addition, consistent use of condoms is also recommended (even during pregnancy) to prevent transmission of HIV or other sexually transmitted diseases.

Health care providers are encouraged to enroll pregnant women exposed to antiretroviral medications as early in pregnancy as possible in the Antiretroviral Pregnancy Registry (1-800-258-4263 or www.APRegistry.com). Health care providers caring for HIV-infected women and their infants may contact the National Perinatal HIV Hotline (888-448-8765) for clinical consultation (HHS [perinatal] 2016).

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 constipation, diarrhea, rhinorrhea, common cold symptoms, heartburn, bloating, abdominal pain, flatulence, or insomnia. Have patient report immediately to prescriber signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of infection, severe dizziness, passing out, burning or numbness feeling, angina, urinary retention, change in amount of urine passed, joint pain, muscle pain, severe loss of strength and energy, swollen glands, or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) (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 healthcare 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.

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