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Selinexor

Medically reviewed by Drugs.com. Last updated on Aug 21, 2020.

Pronunciation

(SEL i NEX or)

Index Terms

  • KPT-330
  • SINE KPT-330

Dosage Forms

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

Tablet Therapy Pack, Oral:

Xpovio (100 MG Once Weekly): 20 mg (5 ea, 20 ea)

Xpovio (40 MG Once Weekly): 20 mg (2 ea, 8 ea)

Xpovio (40 MG Twice Weekly): 20 mg (4 ea, 16 ea)

Xpovio (60 MG Once Weekly): 20 mg (3 ea, 12 ea)

Xpovio (60 MG Twice Weekly): 20 mg (6 ea, 24 ea)

Xpovio (80 MG Once Weekly): 20 mg (4 ea, 16 ea)

Xpovio (80 MG Twice Weekly): 20 mg (8 ea, 32 ea)

Brand Names: U.S.

  • Xpovio (100 MG Once Weekly)
  • Xpovio (40 MG Once Weekly)
  • Xpovio (40 MG Twice Weekly)
  • Xpovio (60 MG Once Weekly)
  • Xpovio (60 MG Twice Weekly)
  • Xpovio (80 MG Once Weekly)
  • Xpovio (80 MG Twice Weekly)

Pharmacologic Category

  • Antineoplastic Agent, Nuclear Export Inhibitor

Pharmacology

Selinexor reversibly inhibits nuclear export of tumor suppressor proteins, growth regulators, and mRNAs of oncogenic proteins via blockage of exportin 1. Inhibition of exportin 1 results in accumulation of tumor suppressor proteins (in the nucleus), oncoproteins reduction, cell cycle arrest, and cancer cell apoptosis.

Distribution

Vd: 133 L.

Metabolism

Hepatic via CYP3A4, multiple UDP-glucuronosyltransferases, and glutathione S-transferases

Excretion

Clearance: 18.6 L/hour.

Time to Peak

Within 4 hours

Half-Life Elimination

6 to 8 hours

Protein Binding

95%

Use: Labeled Indications

Diffuse large B-cell lymphoma, relapsed or refractory: Treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, in adults after at least 2 lines of systemic therapy.

Multiple myeloma, relapsed or refractory: Treatment of relapsed or refractory multiple myeloma (in combination with dexamethasone) in adults who have received at least 4 prior therapies and whose disease is refractory to at least 2 proteasome inhibitors, at least 2 immunomodulatory agents, and an anti-CD38 monoclonal antibody.

Contraindications

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

Dosing: Adult

Note: Selinexor is associated with a moderate emetic potential; antiemetics are recommended to prevent nausea and vomiting.

Diffuse large B-cell lymphoma (relapsed or refractory): Oral: 60 mg/dose twice weekly on days 1 and 3 each week; continue until disease progression or unacceptable toxicity. Total selinexor dose per week: 120 mg.

Multiple myeloma (relapsed or refractory): Oral: 80 mg/dose twice weekly on days 1 and 3 each week (in combination with dexamethasone); continue until disease progression or unacceptable toxicity (Chari 2019). Total selinexor dose per week: 160 mg.

Missed doses: If a selinexor dose is missed or delayed, administer the next dose at the next regularly scheduled time. If a dose is vomited, administer the next dose at the next regularly scheduled day (do not repeat the dose).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Adjustment for Toxicity

Recommended Selinexor Dosage Reduction Levels
­

Multiple myeloma

Diffuse large B-cell lymphoma

Recommended starting dose

80 mg on days 1 and 3 (total weekly selinexor dose is 160 mg)

60 mg on days 1 and 3 (total weekly selinexor dose is 120 mg)

1st dose reduction

100 mg once weekly

40 mg on days 1 and 3 (total weekly selinexor dose is 80 mg)

2nd dose reduction

80 mg once weekly

60 mg once weekly

3rd dose reduction

60 mg once weekly

40 mg once weekly

4th dose reduction

Permanently discontinue selinexor

Permanently discontinue selinexor

Hematologic toxicity:

Diffuse large B-cell lymphoma:

Thrombocytopenia:

Platelets 50,000/mm3 to <75,000/mm3 (any occurrence): Withhold one selinexor dose. Restart selinexor at the same dose level.

Platelets 25,000/mm3 to <50,000/mm3 without bleeding (1st occurrence): Interrupt selinexor treatment and monitor until platelets return to ≥50,000/mm3 and then restart selinexor with the dose reduced by 1 dose level.

Platelets 25,000/mm3 to <50,000/mm3 with concurrent bleeding (any occurrence): Interrupt selinexor treatment and monitor until platelets return to ≥50,000/mm3 and bleeding has resolved, then restart selinexor with the dose reduced by 1 dose level. Administer platelet transfusions per clinical guideline recommendations.

Platelets <25,000/mm3 (any occurrence): Interrupt selinexor treatment and monitor until platelets return to ≥50,000/mm3 and then restart selinexor with the dose reduced by 1 dose level. Administer platelet transfusions per clinical guideline recommendations.

Neutropenia:

ANC 500/mm3 to <1,000/mm3 without fever (1st occurrence): Interrupt selinexor treatment and monitor until ANC returns to ≥1,000/mm3 and then restart selinexor at the same dose level.

ANC 500/mm3 to <1,000/mm3 without fever (recurrence): Interrupt selinexor treatment and monitor until ANC returns to ≥1,000/mm3 and then restart selinexor with the dose reduced by 1 dose level. Administer growth factor support per clinical guidelines.

ANC <500/mm3 or neutropenic fever (any occurrence): Interrupt selinexor treatment and monitor until ANC returns to ≥1,000/mm3 and then restart selinexor with the dose reduced by 1 dose level. Administer growth factor support per clinical guidelines.

Anemia (any occurrence):

Hemoglobin <8 g/dL: Reduce selinexor dose by 1 dose level. Administer blood transfusions per clinical guideline recommendations.

Life-threatening anemia: Interrupt selinexor treatment and monitor until hemoglobin returns to ≥8 g/dL and then restart selinexor with the dose reduced by 1 dose level. Administer blood transfusions per clinical guideline recommendations.

Multiple myeloma:

Thrombocytopenia (any occurrence):

Platelets 25,000/mm3 to <75,000/mm3: Reduce selinexor dose by 1 dose level.

Platelets 25,000/mm3 to <75,000/mm3 with concurrent bleeding: Interrupt selinexor treatment. After bleeding has resolved, restart selinexor with the dose reduced by 1 dose level. Administer platelet transfusions per clinical guideline recommendations.

Platelets <25,000/mm3: Interrupt selinexor treatment and monitor until platelets return to ≥50,000/mm3 and then restart selinexor with the dose reduced by 1 dose level.

Neutropenia (any occurrence):

ANC 500/mm3 to 1,000/mm3: Reduce selinexor dose by 1 dose level.

ANC <500/mm3 or neutropenic fever: Interrupt selinexor treatment and monitor until ANC returns to ≥1,000/mm3 and then restart selinexor with the dose reduced by 1 dose level.

Anemia (any occurrence):

Hemoglobin <8 g/dL: Reduce selinexor dose by 1 dose level. Administer blood transfusion per clinical guideline recommendations.

Life-threatening anemia: Interrupt selinexor treatment and monitor until hemoglobin returns to ≥8 g/dL and then restart selinexor with the dose reduced by 1 dose level. Administer blood transfusion per clinical guideline recommendations.

Nonhematologic toxicity (diffuse large B-cell lymphoma and multiple myeloma):

Fatigue, grade 2 lasting >7 days or grade 3 (any occurrence): Interrupt selinexor treatment and monitor until fatigue returns to grade 1 or baseline and then restart selinexor with the dose reduced by 1 dose level.

Hyponatremia, sodium level ≤130 mmol/L (any occurrence): Interrupt selinexor treatment and provide appropriate supportive care. Monitor until sodium levels return to >130 mmol/L and restart selinexor with the dose reduced by 1 dose level.

GI toxicity:

Diarrhea:

Grade 2 (increase of 4 to 6 stools/day over baseline), first occurrence: Maintain selinexor dose and initiate supportive care.

Grade 2 (increase of 4 to 6 stools/day over baseline), second and subsequent occurrences: Reduce selinexor dose by 1 dose level and initiate supportive care.

Grade 3 or higher (increase of ≥7 stools/day over baseline; hospitalization indicated), any occurrence: Interrupt selinexor treatment and initiate supportive care. Monitor until diarrhea resolves to ≤ grade 2 and restart selinexor with the dose reduced by 1 dose level.

Nausea and vomiting (any occurrence):

Grade 1 or 2 nausea (oral intake decreased without significant weight loss, dehydration, or malnutrition) or grade 1 or 2 vomiting (≤5 episodes/day): Maintain selinexor dose and initiate additional antinausea medications.

Grade 3 nausea (inadequate oral caloric or fluid intake) or ≥ grade 3 vomiting (≥6 episodes per day): Interrupt selinexor treatment and monitor until nausea or vomiting has resolved to ≤ grade 2 or baseline and restart selinexor with the dose reduced by 1 dose level. Also initiate additional antinausea medications.

Weight loss and anorexia (any occurrence): Weight loss of 10% to <20% or anorexia associated with significant weight loss or malnutrition: Interrupt selinexor treatment and initiate supportive care. Monitor until weight returns to >90% of baseline weight and restart selinexor with the dose reduced by 1 dose level.

Ocular toxicity:

Grade 2 (excluding cataract), any occurrence: Interrupt selinexor treatment and perform ophthalmologic evaluation. Provide supportive care. Monitor until ocular symptoms resolve to grade 1 or baseline and restart selinexor with the dose reduced by 1 dose level.

Grade 3 or higher, any occurrence: Permanently discontinue selinexor and perform ophthalmologic evaluation.

Cataract ≥ grade 2, any occurrence: Perform ophthalmologic evaluation. Reduce selinexor by 1 dose level. Monitor for progression. Hold selinexor for 24 hours prior to and 72 hours after surgery.

Other nonhematologic toxicities: Grade 3 or 4 (any occurrence): Interrupt selinexor treatment and monitor until resolved to ≤ grade 2 and restart selinexor with the dose reduced by 1 dose level.

Administration

Oral: Administer at approximately the same time of day on the scheduled day(s) of the week. Swallow whole with water; do not break, chew, crush, or divide tablets.

Selinexor is associated with a moderate emetic potential; antiemetics are recommended prior to and during treatment to prevent nausea and vomiting. Maintain adequate hydration and caloric intake throughout treatment; consider IV hydration in patients at risk of dehydration.

Storage

Store at or below 30°C (86°F).

Drug Interactions

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

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

Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Monitor therapy

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

Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Avoid combination

CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Monitor therapy

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

Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Consider therapy modification

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

Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Avoid combination

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

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

Inebilizumab: May enhance the immunosuppressive effect of Immunosuppressants. 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

Mesalamine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Monitor therapy

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

Ozanimod: Immunosuppressants may enhance the immunosuppressive effect of Ozanimod. Monitor therapy

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

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

Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. 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

Siponimod: Immunosuppressants may enhance the immunosuppressive effect of Siponimod. 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

Smallpox and Monkeypox Vaccine (Live): Immunosuppressants may diminish the therapeutic effect of Smallpox and Monkeypox Vaccine (Live). Monitor therapy

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

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): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. 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

Adverse Reactions

>10%:

Central nervous system: Fatigue (73%), neurological signs and symptoms (≤30%), mental status changes (16%), dizziness (15%), insomnia (15%)

Endocrine & metabolic: Weight loss (47%), hyponatremia (39%), hyperglycemia (15%), dehydration (14%), hypokalemia (12%)

Gastrointestinal: Nausea (72%), decreased appetite (53%), diarrhea (44%), vomiting (41%), constipation (25%), dysgeusia (11%)

Hematologic & oncologic: Thrombocytopenia (74%; grades ≥3: 61%), anemia (59%; grades ≥3: 40%), neutropenia (34%; grades ≥3: 21%), leukopenia (28%; grades ≥3: 11%), lymphocytopenia (15%; grades ≥3: 10%)

Infection: Infection (52%)

Renal: Increased serum creatinine (14%)

Respiratory: Dyspnea (24%), upper respiratory tract infection (21%), cough (16%), pneumonia (13%), epistaxis (12%)

Miscellaneous: Fever (16%)

1% to 10%:

Central nervous system: Headache (10%)

Infection: Sepsis (6%)

Ophthalmic: Blurred vision (10%)

Frequency not defined:

Central nervous system: Confusion, delirium, impaired consciousness

Cardiovascular: Syncope

Hematologic & oncologic: Hemorrhage

Warnings/Precautions

Concerns related to adverse effects:

• Bone marrow suppression: Selinexor may cause life-threatening thrombocytopenia (potentially leading to hemorrhage); grade 3 and 4 events occurred in ~50% to 60% of patients. The median time to onset (first event) was 22 to 28 days; the median time to onset of ≥ grade 3 thrombocytopenia in patients with diffuse large B-cell lymphoma (DLBCL) was 33 days. Bleeding has occurred in patients with thrombocytopenia, including clinically significant bleeding and (rare) fatal hemorrhage. Selinexor is also associated with neutropenia, including grade 3 and 4 events; neutropenia may potentially increase the risk of infection. The median time to onset (first neutropenic event) was 25 days in multiple myeloma patients; the median time to first onset of ≥ grade 3 neutropenia was 32 days in DLBCL patients. Neutropenic fever has also been reported. Monitor CBC (including WBC with differential and platelets) at baseline and throughout treatment (monitor more frequently during the first 3 treatment months). May require platelet transfusion (and/or other treatments) as clinically indicated. Monitor for signs/symptoms of bleeding or concomitant infection and evaluate promptly. Based on the severity, hematologic toxicity may require treatment interruption, dose reduction, and/or permanent discontinuation. Consider supportive measures including antimicrobials for signs of infection and WBC growth factors. Anemia and lymphopenia may also occur.

• GI toxicity: GI toxicities have occurred in patients treated with selinexor; may be severe. Selinexor is associated with a moderate emetic potential. Nausea and vomiting were commonly reported; grade 3 nausea and vomiting have occurred. The median time to nausea onset (first event) was 3 days; the median time to the first vomiting event was 5 to 7 days. Provide prophylactic 5-HT3 antagonists and/or other antinausea agents prior to and during selinexor treatment; additional antinausea medications may be required as clinically indicated. Nausea or vomiting may require treatment interruption, dose reduction, and/or discontinuation. Administer IV fluids to prevent dehydration and electrolyte replacement as clinically indicated. Diarrhea has been reported, including grade 3 diarrhea; the median time to diarrhea onset was 12 to 15 days. Diarrhea may be managed with dose modifications and/or standard antidiarrheal agents; administer IV fluids to prevent dehydration and electrolyte replacement as clinically indicated. Anorexia was reported in over one-third to one-half of patients receiving selinexor, with grade 3 anorexia occurring in some patients. The median time to onset of anorexia was 8 days in patients with multiple myeloma. Weight loss was reported in nearly one-third to one-half of patients receiving selinexor, with grade 3 weight loss occurring rarely. In patients with multiple myeloma, the median time to weight loss onset was 15 days. Monitor weight, nutritional status, and volume status at baseline and throughout treatment (monitor more frequently during the first 3 treatment months). Manage anorexia and weight loss with dose modifications, fluids, electrolyte replacement, and/or nutritional support.

• Hyponatremia: Selinexor may cause hyponatremia, including grades 3 and 4 hyponatremia, which may be severe or life-threatening. The median time to onset of the first event was 8 days in patients with multiple myeloma. In some cases, hyponatremia occurred in those experiencing nausea, vomiting, diarrhea, dehydration, and anorexia. Monitor sodium level at baseline and throughout treatment (monitor more frequently during the first 2 treatment months). Correct sodium levels for concurrent hyperglycemia (serum glucose >150 mg/dL) and high serum paraprotein levels. Assess hydration status and manage hyponatremia with IV saline and/or salt tablets per clinical guidelines, including dietary review. Based on the severity, hyponatremia may require treatment interruption, dose reduction, and/or permanent discontinuation.

• Infection: Serious and potentially fatal infections may occur; infection (any grade) occurred in approximately half of patients treated with selinexor. Infections included upper or lower respiratory tract infection (including pneumonia) and sepsis. Grade 3 or higher infections were reported in one-fourth of patients; some were fatal. The most commonly reported grade 3 or higher infections were pneumonia and sepsis. In patients with multiple myeloma, the median time to onset was 54 days (for pneumonia) and 42 days (for sepsis); the median time to onset of ≥ grade 3 infection in patients with DLBCL was 42 days. Most infections were not associated with ≥ grade 3 neutropenia; atypical infections such as fungal pneumonia and herpesvirus were reported. Monitor for signs/symptoms of infection; evaluate and manage promptly.

• Neurotoxicity: Selinexor may cause life-threatening neurotoxicity. Neurologic toxicities (including dizziness, syncope, decreased consciousness, cognitive disorders, somnolence, hallucination, and mental status changes [including delirium and confusion]) have occurred in patients who received selinexor. Grade 3 and 4 events have been reported. The median time to the first event was 15 to 28 days. In patients with DLBCL, ~70% of patients recovered with a median time to recovery of 14 days. Optimize hydration status, hemoglobin level, and concomitant medications to avoid exacerbation of dizziness or mental status changes. Avoid driving or operating heavy or dangerous machinery until neurotoxicity fully resolves; institute fall precautions as appropriate.

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.

Special populations:

• Elderly: Patients ≥75 years of age with multiple myeloma experienced a higher incidence of serious adverse reactions, fatal adverse events, and a higher incidence of treatment discontinuation (due to adverse events) when compared to younger patients.

Monitoring Parameters

Monitor CBC with differential and standard blood chemistries at baseline and as clinically indicated during treatment (monitor more frequently during the first 3 treatment months); evaluate pregnancy status (in females of reproductive potential) prior to treatment initiation. Assess body weight, nutritional status, and hydration/volume status at baseline and as clinically indicated during treatment (monitor more frequently during the first 3 treatment months). Monitor for signs/symptoms of bleeding, infection, neurotoxicity, ocular toxicity, and GI toxicity. Monitor adherence.

Reproductive Considerations

Evaluate pregnancy status prior to use in females of reproductive potential. Females of reproductive potential should use effective contraception during treatment and for 1 week after the last selinexor dose. Males with a female partner of reproductive potential should also use effective contraception during treatment and for 1 week after the last selinexor dose.

Pregnancy Considerations

Based on the mechanism of action and data from animal reproduction studies, in utero exposure to selinexor may cause fetal harm.

Patient Education

What is this drug used for?

• It is used to treat multiple myeloma.

• It is used to treat a type of lymphoma.

• It may be given to you for other reasons. Talk with the doctor.

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:

• Feeling tired or weak

• Constipation

• Stomach pain

• Common cold symptoms

• Trouble sleeping

• Change in taste

• Headache

• Diarrhea

• Loss of appetite

• Upset stomach

• Throwing up

• Weight loss

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:

• Bleeding like throwing up blood or vomit that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a reason or that get bigger; or any severe or persistent bleeding

• Dehydration like dry skin, dry mouth, dry eyes, increased thirst, fast heartbeat, dizziness, fast breathing, or confusion

• Infection

• Electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up

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

• Nerve problems like abnormal burning, numbness, or tingling feeling; dizziness or passing out; hallucinations (seeing or hearing things that are not there); new or worse behavior or mood changes; feeling less alert; confused; or very sleepy

• Shortness of breath

• Blurred vision

• Vision changes

• Falls

• Swelling

• 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.