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Siponimod

Medically reviewed by Drugs.com. Last updated on Jul 11, 2020.

Pronunciation

(si PON i mod)

Dosage Forms

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

Tablet, Oral, as fumarate:

Mayzent: 0.25 mg, 2 mg [contains soybean lecithin]

Tablet Therapy Pack, Oral, as fumarate:

Mayzent Starter Pack: 0.25 mg (12 ea) [contains soybean lecithin]

Brand Names: U.S.

  • Mayzent
  • Mayzent Starter Pack

Pharmacologic Category

  • Sphingosine 1-Phosphate (S1P) Receptor Modulator

Pharmacology

Siponimod, a sphingosine-1-phosphate (S1P) receptor modulator, binds to sphingosine 1-phosphate receptors 1 and 5. Siponimod blocks the lymphocytes' ability to emerge from lymph nodes; therefore, the amount of lymphocytes available to the CNS is decreased, which reduces central inflammation (Behrangi 2019).

Absorption

Extensive.

Distribution

Vd: 124 L.

Metabolism

Extensively metabolized, mainly via CYP2C9 (79.3%), followed by CYP3A4 (18.5%) to inactive metabolites, M3 and M17.

Excretion

Biliary/fecal (as inactive metabolites).

Time to Peak

~4 hours (range 3 to 8 hours).

Half-Life Elimination

~30 hours.

Protein Binding

>99.9%.

Use: Labeled Indications

Multiple sclerosis: Treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Contraindications

CYP2C9*3/*3 genotype; recent (in the past 6 months) myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or Class III or IV heart failure; Mobitz type II second-degree, third-degree atrioventricular block, or sick sinus syndrome, unless patient has a functioning pacemaker.

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to siponimod, peanut, soya, or any component of the formulation; patients at increased risk for opportunistic infections, including those who are immunocompromised due to treatment (eg, antineoplastic, immunosuppressive or immunomodulating therapies, total lymphoid irradiation, bone marrow transplantation) or disease (eg, immunodeficiency syndrome); severe active infections including bacterial, fungal, or viral infections (eg, hepatitis, tuberculosis); known active malignancy (excluding basal cell carcinoma); pregnancy and women in childbearing years not using effective contraception.

Dosing: Adult

Note: Before initiating siponimod, determine CYP2C9 genotype and dose accordingly. First-dose 6-hour monitoring is recommended for patients with certain preexisting cardiac conditions, including sinus bradycardia (HR <55 bpm), first- or second-degree (Mobitz type 1) AV block, or a history of MI or heart failure. For these patients, administer the first dose and doses following therapy interruption (≥4 days) in a setting in which resources to appropriately manage symptomatic bradycardia and other conduction abnormalities are available.

Multiple sclerosis: Oral:

CYP2C9 Genotype *1/*1, *1/*2, or *2/*2:

Initial: 0.25 mg once daily on Days 1 and 2, then 0.5 mg once daily on Day 3, then 0.75 mg once daily on Day 4, then 1.25 mg once daily on Day 5.

Maintenance: 2 mg once daily, beginning on Day 6.

CYP2C9 Genotype *1/*3 or *2/*3:

Initial: 0.25 mg once daily on Days 1 and 2, then 0.5 mg once daily on Day 3, then 0.75 mg once daily on Day 4.

Maintenance: 1 mg once daily, beginning on Day 5.

Missed dose: If a dose is missed for more than 24 hours during the initial titration regimen, reinitiate with Day 1 of the titration regimen. If treatment with siponimod is interrupted for 4 or more consecutive daily doses after completion of initial titration, reinitiate treatment with Day 1 of the titration regimen, including first-dose monitoring when appropriate.

Dosing: Geriatric

Refer to adult dosing.

Administration

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

Storage

Store unopened containers in a refrigerator between 2°C to 8°C (36°F to 46°F); may be stored at 20°C to 25°C (68°F to 77°F) for ≤3 months after dispensing to the patient.

Store opened containers as follows:

Starter Pack/Blister Card: 20°C to 25°C (68°F to 77°F) for ≤3 months after opening the blister; do not refrigerate. Store in original container.

Bottles: 20°C to 25°C (68°F to 77°F) for ≤3 months after opening the bottles; do not refrigerate.

Drug Interactions

Alpelisib: May decrease the serum concentration of CYP2C9 Substrates (High risk with Inducers). Monitor therapy

Baricitinib: Immunosuppressants may enhance the immunosuppressive effect of Baricitinib. Management: Use of baricitinib in combination with potent immunosuppressants such as azathioprine or cyclosporine is not recommended. Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted. Consider therapy modification

BCG (Intravesical): Immunosuppressants may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

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

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

CarBAMazepine: May decrease the serum concentration of Siponimod. Avoid combination

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

Cladribine: May enhance the immunosuppressive effect of Immunosuppressants. Avoid combination

Coccidioides immitis Skin Test: Immunosuppressants may diminish the diagnostic effect of Coccidioides immitis Skin Test. Monitor therapy

CYP2C9 Inhibitors (Moderate): May increase the serum concentration of Siponimod. Monitor therapy

Denosumab: May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased. Monitor therapy

Echinacea: May diminish the therapeutic effect of Immunosuppressants. Management: Consider avoiding Echinacea in patients receiving therapeutic immunosuppressants. If coadministered, monitor for reduced efficacy of the immunosuppressant during concomitant use. Consider therapy modification

Enzalutamide: May decrease the serum concentration of Siponimod. Avoid combination

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

Fingolimod: Immunosuppressants may enhance the immunosuppressive effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and other immunosuppressants when possible. If combined, monitor patients closely for additive immunosuppressant effects (eg, infections). Consider therapy modification

Fluconazole: May increase the serum concentration of Siponimod. Avoid combination

Haloperidol: QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of Haloperidol. Monitor therapy

Immunosuppressants: May enhance the immunosuppressive effect of Siponimod. Monitor therapy

Inebilizumab: May enhance the immunosuppressive effect of Immunosuppressants. Monitor therapy

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

Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Consider therapy modification

Lumacaftor and Ivacaftor: May decrease the serum concentration of CYP2C9 Substrates (High Risk with Inhibitors or Inducers). Lumacaftor and Ivacaftor may increase the serum concentration of CYP2C9 Substrates (High Risk with Inhibitors or Inducers). Monitor therapy

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

MiFEPRIStone: May increase the serum concentration of Siponimod. Avoid combination

Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Avoid combination

Nivolumab: Immunosuppressants may diminish the therapeutic effect of Nivolumab. Management: Avoid use of immunosuppressants (including systemic corticosteroids) prior to initiation of nivolumab. Use of immunosuppressants after administration of nivolumab (eg, for immune-related toxicity) is unlikely to affect nivolumab efficacy. Consider therapy modification

Ocrelizumab: May enhance the immunosuppressive effect of Immunosuppressants. Monitor therapy

Pidotimod: Immunosuppressants may diminish the therapeutic effect of Pidotimod. Monitor therapy

Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Monitor therapy

RifAMPin: May decrease the serum concentration of Siponimod. Avoid combination

Rifapentine: May decrease the serum concentration of CYP2C9 Substrates (High risk with Inducers). Monitor therapy

Roflumilast: May enhance the immunosuppressive effect of Immunosuppressants. Management: Consider avoiding concomitant use of roflumilast and immunosuppressants as recommended by the Canadian product monograph. Inhaled or short-term corticosteroids are unlikely to be problematic. 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

Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Management: Evaluate patients to see if it is medically appropriate to reduce or discontinue therapy with immunosuppressants prior to initiating sipuleucel-T therapy. Consider therapy modification

Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

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

Tertomotide: Immunosuppressants may diminish the therapeutic effect of Tertomotide. Monitor therapy

Tofacitinib: Immunosuppressants may enhance the immunosuppressive effect of Tofacitinib. Management: Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted, and this warning seems particularly focused on more potent immunosuppressants. Consider therapy modification

Upadacitinib: Immunosuppressants may enhance the immunosuppressive effect of Upadacitinib. Management: Concomitant use of upadacitinib with potent immunosuppressants is not recommended. Drugs listed as exceptions to this monograph are discussed in separate drug interaction monographs. Avoid combination

Vaccines (Inactivated): Siponimod may diminish the therapeutic effect of Vaccines (Inactivated). Management: Avoid administration of vaccines (inactivated) during treatment with siponimod and for 1 month after discontinuation due to potential decreased vaccine efficacy. Consider therapy modification

Vaccines (Live): Immunosuppressants may enhance the adverse/toxic effect of Vaccines (Live). Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live organism vaccines with immunosuppressants; live-attenuated vaccines should not be given for at least 3 months after immunosuppressants. Exceptions: Smallpox and Monkeypox Vaccine (Live). Avoid combination

Vaccines (Live): Siponimod may enhance the adverse/toxic effect of Vaccines (Live). Siponimod may diminish the thrombocytopenic effect of Vaccines (Live). Management: Avoid administration of vaccine (live) during treatment with siponimod and for 1 month after discontinuation due to potential decreased vaccine efficacy and increased infection risk. Consider therapy modification

Adverse Reactions

>10%:

Cardiovascular: Hypertension (13%)

Central nervous system: Headache (15%), falling (11%)

Hepatic: Increased serum transaminases (≤11%)

1% to 10%:

Cardiovascular: Peripheral edema (8%), bradycardia (4% to 6%), first degree atrioventricular block (5%), second degree atrioventricular block (<2%)

Central nervous system: Dizziness (7%), seizure (2% to <5%)

Gastrointestinal: Nausea (7%), diarrhea (6%)

Hematologic & oncologic: Lymphocytopenia (<5%)

Hepatic: Increased serum bilirubin (≤10%), increased serum alanine aminotransferase (6%), increased serum aspartate aminotransferase (1%)

Infection: Herpes virus infection (5%), herpes zoster infection (<5%)

Neuromuscular & skeletal: Limb pain (6%), asthenia (<5%), tremor (<5%)

Ophthalmic: Macular edema (2% to <5%)

Respiratory: Reduced forced expiratory volume (<5%)

Frequency not defined:

Dermatologic: Facial swelling

Infection: Infection

<1%, postmarketing, and/or case reports: Malignant melanoma, meningitis (cryptococcal), testicular neoplasm (seminoma), varicella zoster infection (meningitis)

Warnings/Precautions

Concerns related to adverse effects:

• Atrioventricular conduction delays: Initiation has been associated with transient and asymptomatic AV conduction delays, including first-degree atrioventricular (AV) block (most cases) and second-degree AV block, usually Mobitz type I. The conduction abnormalities typically occur concomitantly with bradycardia, resolve within 24 hours of treatment initiation, and do not require discontinuation of siponimod or treatment with atropine. No second-degree AV blocks of Mobitz type II or higher degree were observed, and most conduction abnormalities occurred at doses >2 mg or in situations when the siponimod dose was not titrated.

• Bradycardia: Initiation results in transient decreases in heart rate; gradual titration will minimize this effect. Following the first titration dose, heart rate may decrease as soon as 1 hour postdose, with the maximal decrease usually occurring ~3 to 4 hours postdose. Although postdose bradycardia will likely continue to occur during the dose titration period, it will not be as pronounced as day 1. Heart rate begins to increase after day 6 of therapy and typically returns to baseline after 10 days of therapy. Most patients are asymptomatic; however, dizziness and fatigue may occur; symptoms usually resolve within 24 hours.

• Hepatic effects: Elevated liver enzymes may occur; most elevations occurred within 6 months of treatment initiation. Obtain baseline liver enzymes and bilirubin in all patients prior to therapy initiation (within 6 months); monitor liver enzymes in patients who develop symptoms of hepatic dysfunction (eg, nausea, vomiting, abdominal pain, fatigue, anorexia, jaundice, dark urine). Discontinue treatment with confirmation of liver injury; transaminases tend to return to normal within 1 month of discontinuation.

• Hypertension: Increased blood pressure may occur ~1 month after initiation of therapy; monitor blood pressure throughout treatment.

• Infections: Dose-dependent reduction of peripheral lymphocyte counts may increase risk of infections; life-threatening and rare fatal infections have occurred. Review CBC before treatment initiation. Delay treatment initiation in patients with severe active infections. Peripheral lymphocyte counts may also be lowered for 3 to 4 weeks after treatment discontinuation; therefore, continue to monitor for signs of infection during this period. Consider suspension of treatment if a serious infection develops. Rare cases of cryptococcal meningitis have occurred with siponimod; disseminated cryptococcal infections have been reported with another sphingosine 1-phosphate receptor modulator. In patients with signs and symptoms of cryptococcal infection, treatment with siponimod should be interrupted until cryptococcal infection has been ruled out. Herpes viral infections, including reactivation of varicella zoster virus (VZV) infection, have also occurred.

• Macular edema: Macular edema has been reported, typically within the first 4 months of treatment. Patients may present with blurred vision, decreased visual acuity, or without symptoms. Patients with a history of diabetes mellitus or uveitis are at increased risk; use with caution. Perform ophthalmologic exams (including the fundus and macula) at baseline and if vision changes; more frequent examination is warranted in patients with diabetes or a history of uveitis.

• Malignancy: Cases of lymphoma and skin cancer have been reported with another sphingosine 1-phosphate receptor modulator (Manouchehri 2018; Robinson 2016).

• Neurotoxicity: Posterior reversible encephalopathy syndrome (PRES) has been observed with another sphingosine 1-phosphate receptor modulator. Monitor for signs/symptoms of PRES (eg, behavioral changes, cognitive deficits, cortical visual disturbances, any other neurological cortical symptom/sign, or symptoms/signs suggestive of increased intracranial pressure); symptoms are usually reversible, but may evolve into ischemic stroke or cerebral hemorrhage. Delayed diagnosis and treatment may result in permanent neurological sequelae. Discontinue use if PRES is suspected.

• Progressive multifocal leukoencephalopathy: Cases of progressive multifocal leukoencephalopathy (PML) due to the John Cunningham (JC) virus have been reported with another sphingosine 1-phosphate receptor modulator and have been associated with specific risk factors, including immune compromise and immunosuppressant polypharmacy. Symptoms progress over days to weeks and may include progressive weakness on one side of the body or clumsiness of limbs, vision disturbances, and mental status changes. At the first sign or symptom suggestive of PML, perform a diagnostic evaluation and withhold therapy. MRI findings may be apparent before patients are symptomatic. Monitoring with brain MRI for signs that may be consistent with PML may be beneficial and allow for an early diagnosis of PML.

• QT prolongation: May cause QT prolongation; patients with a prolonged QT interval (>500 msec) at baseline or during the first 6 hours of treatment initiation, at an increased risk of QT prolongation, or on concomitant QT-prolonging drugs may require continuous overnight ECG monitoring in a medical facility after the initial dose.

• Respiratory effects: Reductions of forced expiratory volume in the first second of expiration (FEV1) are dose dependent and may occur within the first 3 months of therapy. It is unknown whether these changes are reversible with drug discontinuation. If clinically necessary, spirometric evaluation of respiratory function should be performed during therapy.

Disease-related concerns:

• Cardiovascular disease: For patients with sinus bradycardia (HR <55 bpm), first- or second-degree (Mobitz type 1) AV block, or a history of MI or heart failure (HF), initiation must occur in a setting with resources and personnel capable of appropriately managing symptomatic bradycardia. Patients may also require overnight monitoring during treatment initiation if they have prolonged QTc interval at baseline or at 6-hour postdose, ECG, additional risks for QT prolongation, concurrent therapy with QT prolonging agents with a known risk of torsades de pointes or drugs that slow heart rate or AV conduction, or some preexisting heart and cerebrovascular conditions. Consult with a cardiologist before initiating siponimod in patients with QTc >500 msec, arrhythmias requiring treatment with Class Ia or Class III antiarrhythmic drugs, ischemic heart disease, HF, history of cardiac arrest or MI, cerebrovascular disease, uncontrolled hypertension, history of second degree Mobitz type II or higher AV block, sick-sinus syndrome, or sino-atrial heart block.

• Hepatic impairment: Use with caution and closely monitor patients with significant hepatic disease; may be at increased risk of increased liver enzymes.

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:

• Discontinuation of therapy: Cases of rebound syndrome (clinical and radiological signs of severe exacerbation beyond what was expected) have been reported with discontinuation of another sphingosine 1-phosphate receptor modulator. Monitor for development of severe increase in disability following discontinuation and begin appropriate treatment as needed. Due to residual pharmacodynamic effects following treatment discontinuation (eg, decreased peripheral lymphocyte counts), use caution for 3 to 4 weeks after the last dose of therapy.

• Immunizations: Testing for antibodies to varicella zoster virus (VZV) is recommended prior to initiation of treatment if history of chickenpox or VZV vaccination status is unknown. Complete full course of immunization for antibody-negative patients with varicella vaccine at least 4 weeks prior to initiating treatment. Avoid immunization with live attenuated vaccines during and for 4 weeks after treatment. Vaccines may not be as effective if administered during therapy; discontinuation of treatment 1 week before and 4 weeks following a planned vaccination is recommended.

Monitoring Parameters

All patients:

CBC including lymphocyte counts (baseline [within 6 months or after discontinuation of previous therapy])

Hepatic monitoring: Baseline bilirubin and transaminase levels in all patients prior to therapy initiation (within 6 months); monitor transaminases in patients who develop symptoms of hepatic dysfunction.

ECG (baseline); ophthalmologic exam of fundus, including macula (at baseline and if vision changes, more frequent in patients with diabetes or a history of uveitis), respiratory function (FEV1) if clinically indicated, VZV antibodies (prior to starting treatment in patients with no health care professional-confirmed history of chickenpox or without documented previous full series VZV vaccination), blood pressure, signs and symptoms of infection (during treatment and at least 3 to 4 weeks after discontinuation), signs/symptoms of progressive multifocal leukoencephalopathy, and/or posterior reversible encephalopathy syndrome; monitor for suspicious skin lesions; severe increase in disability following discontinuation of therapy.

Additional required monitoring for patients with sinus bradycardia (HR <55 bpm), first- or second-degree (Mobitz type 1) AV block, or a history of MI or heart failure:

First-dose 6-hour monitoring: Monitor patient for 6 hours following the first dose for signs and symptoms of bradycardia; assess heart rate and blood pressure measurements every 1 hour. Repeat ECG after initial 6-hour dose observation period. After the initial 6-hour monitoring, continue to monitor (until resolution) if 6-hour postdose heart rate is <45 bpm, 6-hour postdose heart rate is lowest postbaseline measurement, or 6-hour postdose ECG shows new-onset second-degree or higher AV block. Start continuous ECG monitoring if postdose symptomatic bradycardia, bradyarrhythmia, or conduction-related symptoms occur or if 6-hour postdose ECG shows new-onset second degree or higher AV block or QTc ≥500 msec. Monitor until symptom resolution if no pharmacologic treatment is necessary. Monitor overnight with continuous ECG in a medical facility and repeat observation period for second dose if pharmacologic intervention is necessary.

Patients may also require overnight monitoring during treatment initiation if they have prolonged QTc interval at baseline or at 6-hour postdose ECG, additional risks for QT prolongation, concurrent therapy with QT prolonging agents with a known risk of torsades de pointes, concurrent therapy with drugs that slow heart rate or AV conduction, or some preexisting heart and cerebrovascular conditions.

Initial monitoring procedures (ECG, heart rate, blood pressure) must be repeated for:

- treatment interruption of 24 hours during the initial titration regimen, or

- treatment interruption of ≥4 consecutive days during the maintenance period

Reproductive Considerations

Females of reproductive potential should use effective contraception during therapy and for 10 days after the last siponimod dose.

Pregnancy Considerations

Based on the mechanism of action and data from animal reproduction studies, in utero exposure to siponimod may cause fetal harm. Disease modifying therapies are generally not initiated during pregnancy (AAN [Rae-Grant 2018]).

Patient Education

What is this drug used for?

• It is used to treat MS (multiple sclerosis).

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

• Diarrhea

• Painful extremities

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:

• Infection

• Meningitis like headache with fever, stiff neck, nausea, confusion, or sensitivity to light.

• Liver problems like dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin.

• Severe headache

• Dizziness

• Passing out

• Vision changes

• Shortness of breath

• Trouble breathing

• Swelling in the arms or legs

• Posterior reversible encephalopathy syndrome like confusion, not alert, vision changes, seizures, or severe headache.

• Progressive multifocal leukoencephalopathy like confusion, depression, trouble with memory, behavioral changes, change in strength on one side is greater than the other, trouble speaking, change in balance, or vision changes.

• 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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