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Cabazitaxel

Pronunciation

(ca baz i TAKS el)

Index Terms

  • RPR-116258A
  • XRP6258

Dosage Forms

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

Solution, Intravenous:

Jevtana: 60 mg/1.5 mL (1.5 mL) [contains alcohol, usp, polysorbate 80]

Brand Names: U.S.

  • Jevtana

Pharmacologic Category

  • Antineoplastic Agent, Antimicrotubular
  • Antineoplastic Agent, Taxane Derivative

Pharmacology

Cabazitaxel is a taxane derivative which is a microtubule inhibitor; it binds to tubulin promoting assembly into microtubules and inhibiting disassembly which stabilizes microtubules. This inhibits microtubule depolymerization and cell division, arresting the cell cycle and inhibiting tumor proliferation. Unlike other taxanes, cabazitaxel has a poor affinity for multidrug resistance (MDR) proteins, therefore conferring activity in resistant tumors.

Distribution

Vdss: 4,864 L; has greater CNS penetration than other taxanes

Metabolism

Extensively hepatic; primarily via CYP3A4 and 3A5; also via CYP2C8 (minor)

Excretion

Feces (76% as metabolites); Urine (~4%)

Half-Life Elimination

Terminal: 95 hours

Protein Binding

89% to 92%; primarily to serum albumin and lipoproteins

Special Populations: Hepatic Function Impairment

Clearance was decreased 39% in patients with severe hepatic impairment (total bilirubin >3 times ULN) as compared to patients with mild impairment (total bilirubin >1 to ≤1.5 times ULN and AST >1.5 times ULN).

Use: Labeled Indications

Prostate cancer, metastatic: Treatment of hormone-refractory metastatic prostate cancer (in combination with prednisone) in patients previously treated with a docetaxel-containing regimen

Contraindications

Severe hypersensitivity to cabazitaxel or any component of the formulation, or to other medications formulated with polysorbate 80; neutrophil count ≤1,500/mm3; severe hepatic impairment (total bilirubin >3 times ULN)

Canadian labeling: Additional contraindications (not in US labeling): Hepatic impairment (bilirubin ≥ULN or AST and/or ALT ≥1.5 times ULN); concomitant vaccination with yellow fever vaccine

Dosage

Note: Premedicate at least 30 minutes prior to each dose of cabazitaxel with an antihistamine (eg, diphenhydramine IV 25 mg or equivalent), a corticosteroid (eg, dexamethasone 8 mg IV or equivalent), and an H2 antagonist (eg, ranitidine 50 mg IV or equivalent). Per the manufacturer, antiemetic prophylaxis (oral or IV) is also recommended.

Prostate cancer, metastatic: Adults: IV: 25 mg/m2 once every 3 weeks (in combination with prednisone)

Dosage adjustment for concomitant use with strong CYP3A inhibitors: Concomitant use with strong CYP3A inhibitors (eg, ketoconazole, itraconazole, clarithromycin, protease inhibitors, nefazodone, telithromycin, voriconazole) may increase cabazitaxel plasma concentrations; avoid concurrent use. If concomitant use cannot be avoided, consider reducing cabazitaxel dose by 25%.

Dosage adjustment for toxicity:

Hematologic toxicity:

Neutropenia ≥grade 3 for >1 week despite WBC growth factors: Delay treatment until ANC >1,500/mm3 and then reduce dose to 20 mg/m2 with continued WBC growth factor secondary prophylaxis

Neutropenic fever or neutropenic infection: Delay treatment until improvement/resolution and ANC >1,500/mm3 and then reduce dose to 20 mg/m2 with continued WBC growth factor secondary prophylaxis

Persistent hematologic toxicity (despite dosage reduction): Discontinue treatment

Nonhematologic toxicity:

Severe hypersensitivity: Discontinue immediately

Diarrhea ≥grade 3 or persistent despite appropriate medication, fluids, and electrolyte replacement: Delay treatment until improves or resolves and then reduce dose to 20 mg/m2

Persistent diarrhea (despite dosage reduction): Discontinue treatment

Peripheral neuropathy (grade 2): Delay treatment until improves or resolves and then reduce dose to 20 mg/m2

Persistent peripheral neuropathy (despite dosage reduction) or ≥grade 3 peripheral neuropathy: Discontinue treatment

Dosage adjustment in renal impairment:

Mild to moderate renal impairment (CrCl ≥30 mL/minute): No dosage adjustment necessary.

Severe renal impairment (CrCl <30 mL/minute) or end-stage renal disease (ESRD): Use with caution; monitor closely.

Dosage adjustment in hepatic impairment:

US labeling:

Mild impairment (total bilirubin >1 to ≤1.5 times ULN or AST ≥1.5 times ULN): Reduce dose to 20 mg/m2

Moderate impairment (total bilirubin >1.5 to ≤3 times ULN with any AST): Reduce dose to 15 mg/m2 (based on tolerability; efficacy of this dose is not known).

Severe impairment (total bilirubin >3 times ULN): Use is contraindicated

Canadian labeling: Hepatic impairment (bilirubin ≥1 times ULN or AST and/or ALT ≥1.5 times ULN): Use is contraindicated

Dosing in obesity: ASCO Guidelines for appropriate chemotherapy dosing in obese adults with cancer: Utilize patient’s actual body weight (full weight) for calculation of body surface area- or weight-based dosing, particularly when the intent of therapy is curative; manage regimen-related toxicities in the same manner as for nonobese patients; if a dose reduction is utilized due to toxicity, consider resumption of full weight-based dosing with subsequent cycles, especially if cause of toxicity (eg, hepatic or renal impairment) is resolved (Griggs 2012).

Reconstitution

Hazardous agent; use appropriate precautions for handling and disposal (NIOSH 2014 [group 1]). Do not prepare or administer in PVC-containing infusion containers or polyurethane infusion sets. Cabazitaxel and diluent vials contain overfill. Preparation requires 2 steps. Slowly inject the entire contents of the provided diluent vial into the cabazitaxel 60 mg/1.5 mL vial, directing the diluent down the vial wall. Mix gently by inverting the vial for at least 45 seconds; do not shake. Allow vial to sit so that foam dissipates and solution appears homogeneous. This results in an intermediate reconstituted concentration of 10 mg/mL. The US labeling recommends to further dilute within 30 minutes into a 250 mL D5W or NS non-PVC infusion container to final concentration of 0.1 to 0.26 mg/mL (total doses >65 mg will require a larger infusion volume; final concentration should not exceed 0.26 mg/mL). The Canadian labeling recommends further dilution of the reconstituted vial occur within 60 minutes. Gently invert container to mix. Do not use infusion solutions if crystals or precipitate appear; discard if this occurs. Infusion should be completed within 8 hours if stored at room temperature. For infusion solutions stored under refrigeration, the US labeling recommends that the infusion be completed within 24 hours. The Canadian labeling recommends that the infusion be completed within 48 hours.

Administration

IV: Infuse over 1 hour using a 0.22-micron inline filter. Do not use polyurethane-containing infusion sets for administration. Allow to reach room temperature prior to infusion. Premedicate with an antihistamine, a corticosteroid, and an H2 antagonist at least 30 minutes prior to infusion. Observe closely during infusion (for hypersensitivity). Per the manufacturer, antiemetic prophylaxis (oral or IV) is also recommended.

Hazardous agent; use appropriate precautions for handling and disposal (NIOSH 2014 [group 1]).

Dietary Considerations

Avoid grapefruit juice.

Compatibility

Stable in D5W, NS

Storage

Store intact vials at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Do not refrigerate. Do not prepare or administer in PVC-containing infusion containers or polyurethane infusion sets. The US labeling indicates the initial reconstituted solution (at 10 mg/mL) is stable for 30 minutes in the vial and that solutions for infusion are stable for up to 8 hours at room temperature (includes the 1 hour infusion) or 24 hours refrigerated (includes the 1 hour infusion). The Canadian labeling indicates the initial reconstituted solution (at 10 mg/mL) is stable for 1 hour in the vial and that solutions for infusion are stable for up to 8 hours at room temperature (includes the 1 hour infusion) or 48 hours refrigerated (includes the 1 hour infusion).

Drug Interactions

Antineoplastic Agents (Anthracycline, Systemic): Taxane Derivatives may enhance the adverse/toxic effect of Antineoplastic Agents (Anthracycline, Systemic). Taxane Derivatives may increase the serum concentration of Antineoplastic Agents (Anthracycline, Systemic). Taxane Derivatives may also increase the formation of toxic anthracycline metabolites in heart tissue. Consider therapy modification

Aprepitant: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

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

Bosentan: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

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

Conivaptan: May increase the serum concentration of CYP3A4 Substrates. Avoid combination

CYP3A4 Inducers (Moderate): May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

CYP3A4 Inducers (Strong): May increase the metabolism of CYP3A4 Substrates. Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Consider therapy modification

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

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Cabazitaxel. Management: Concurrent use of cabazitaxel with strong inhibitors of CYP3A4 should be avoided when possible. If such a combination must be used, consider a 25% reduction in the cabazitaxel dose. Consider therapy modification

Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates. 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. Monitor therapy

Deferasirox: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Avoid combination

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

DOXOrubicin (Conventional): Taxane Derivatives may decrease the metabolism of DOXOrubicin (Conventional). Management: Consider using docetaxel instead of paclitaxel as a way to avoid this potential interaction, and monitor closely for toxic effects of doxorubicin. Administer doxorubicin prior to paclitaxel when used concomitantly. Consider therapy modification

Echinacea: May diminish the therapeutic effect of Immunosuppressants. Consider therapy modification

Enzalutamide: May decrease the serum concentration of CYP3A4 Substrates. 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

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

Fosaprepitant: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

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

Idelalisib: May increase the serum concentration of CYP3A4 Substrates. Avoid combination

Ivacaftor: May increase the serum concentration of CYP3A4 Substrates. 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

Luliconazole: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Mifepristone: May increase the serum concentration of CYP3A4 Substrates. 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. Management: Doses of CYP3A4 substrates may need to be adjusted substantially when used in patients being treated with mitotane. Consider therapy modification

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

Netupitant: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Osimertinib: May increase the serum concentration of CYP3A4 Substrates. Osimertinib may decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Palbociclib: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

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

Platinum Derivatives: May enhance the myelosuppressive effect of Taxane Derivatives. Administer Taxane derivative before Platinum derivative when given as sequential infusions to limit toxicity. Consider therapy modification

Roflumilast: May enhance the immunosuppressive effect of Immunosuppressants. Consider therapy modification

Siltuximab: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Simeprevir: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Monitor therapy

St Johns Wort: May decrease the serum concentration of CYP3A4 Substrates. Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Consider therapy modification

Stiripentol: May increase the serum concentration of CYP3A4 Substrates. 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

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

Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates. 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. Avoid combination

Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Monitor therapy

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. Avoid combination

Adverse Reactions

Note: Adverse reactions reported for combination therapy with prednisone.

>10%:

Central nervous system: Fatigue (37%), fever (12%)

Gastrointestinal: Diarrhea (47%; grades 3/4: 6%), nausea (34%), vomiting (22%), constipation (20%), abdominal pain (17%), anorexia (16%), taste alteration (11%)

Hematologic: Anemia (98%; grades 3/4: 11%), leukopenia (96%; grades 3/4: 69%), neutropenia (94%; grades 3/4: 82%; nadir: 12 days [range: 4-17 days]), thrombocytopenia (48%; grades 3/4: 4%)

Neuromuscular & skeletal: Weakness (20%), back pain (16%), peripheral neuropathy (13%; grades 3/4: <1%), arthralgia (11%)

Renal: Hematuria (17%)

Respiratory: Dyspnea (12%), cough (11%)

1% to 10%:

Cardiovascular: Peripheral edema (9%), arrhythmia (5%), hypotension (5%)

Central nervous system: Dizziness (8%), headache (8%), pain (5%)

Dermatologic: Alopecia (10%)

Endocrine & metabolic: Dehydration (5%)

Gastrointestinal: Dyspepsia (10%), weight loss (9%), mucosal inflammation (6%)

Genitourinary: Urinary tract infection (8%), dysuria (7%)

Hematologic: Neutropenic fever (grades 3/4: 7%)

Hepatic: ALT increased (grades 3/4: ≤1%), AST increased (grades 3/4: ≤1%), bilirubin increased (grades 3/4: ≤1%)

Neuromuscular & skeletal: Muscle spasm (7%)

<1% (Limited to important or life-threatening): Colitis, electrolyte imbalance, enterocolitis, gastritis, gastrointestinal hemorrhage, gastrointestinal perforation, hypersensitivity (eg, rash, erythema, hypotension, bronchospasm), intestinal obstruction, neutropenic enterocolitis, renal failure, sepsis, septic shock

ALERT: U.S. Boxed Warning

Neutropenia:

Neutropenic deaths have been reported. In order to monitor the occurrence of neutropenia, frequently perform blood cell counts on all patients receiving cabazitaxel. Cabazitaxel is contraindicated in patients with neutrophil counts of 1,500 cells/mm3 or less.

Hypersensitivity reactions:

Severe hypersensitivity reactions can occur and may include generalized rash/erythema, hypotension, and bronchospasm. Severe hypersensitivity reactions require immediate discontinuation of the cabazitaxel infusion and administration of appropriate therapy. Patients should receive premedication. Cabazitaxel is contraindicated in patients who have a history of severe hypersensitivity reactions to cabazitaxel or to other drugs formulated with polysorbate 80.

Warnings/Precautions

Concerns related to adverse effects:

• Bone marrow suppression: [US Boxed Warning]: Deaths due to neutropenia have been reported. Cabazitaxel is contraindicated in patients with neutrophil count ≤1,500/mm3. Monitor blood counts frequently. Neutropenia, anemia, thrombocytopenia, and/or pancytopenia may occur with use; grade 3 and 4 neutropenia was observed in over 80% of patients treated with cabazitaxel in a clinical trial. Dose reductions are recommended following neutropenic fever or prolonged neutropenia. Administration of WBC growth factors may reduce the risk of complications due to neutropenia. Consider primary WBC growth factor prophylaxis in high-risk patients (eg, >65 years of age, poor performance status, history of neutropenic fever, extensive prior radiation, poor nutrition status, other serious comorbidities); secondary prophylaxis and therapeutic WBC growth factors should be considered in all patients with increased risk for neutropenic complications. Use cautiously in patients with hemoglobin <10 g/dL. Monitor complete blood counts weekly during cycle 1 and prior to subsequent treatment cycles, or as clinically indicated.

• Gastrointestinal toxicity: Nausea, vomiting and diarrhea may occur. Diarrhea may be severe and may result in dehydration and electrolyte imbalance; fatalities have been reported. Per the manufacturer, antiemetic prophylaxis is recommended. Antidiarrheal medication and fluid and electrolyte replacement may be necessary. Diarrhea ≥ grade 3 may require treatment delay and or dosage reduction. Gastrointestinal hemorrhage and perforation, enterocolitis, neutropenic enterocolitis, and ileus (some fatal) have also been observed. Use with caution in patients at risk of developing gastrointestinal complications (eg, elderly patients, those with neutropenia or a prior history of pelvic radiation, adhesions, GI ulceration or bleeding, concomitant use of steroids, NSAIDs, antiplatelet or anticoagulant medications). Evaluate promptly if symptoms such as abdominal pain and tenderness, fever, persistent constipation, and diarrhea (with or without neutropenia) occur. May require treatment interruption and/or therapy discontinuation.

• Hypersensitivity reactions: [US Boxed Warning]: Severe hypersensitivity reactions, including generalized rash, erythema, hypotension, and bronchospasm may occur. Immediate discontinuation is required if hypersensitivity is severe; administer appropriate supportive medications. Premedicate with an IV antihistamine, corticosteroid, and H2 antagonist prior to infusion. Use in patients with history of severe hypersensitivity to cabazitaxel or other medications formulated with polysorbate 80 is contraindicated. Observe closely during infusion, especially during the first and second infusions; reaction may occur within minutes. Do not rechallenge after severe hypersensitivity reactions.

• Renal failure: Renal failure (including rare fatalities) has been reported from clinical trials; generally associated with dehydration, sepsis, or obstructive uropathy. Use with caution in patients with severe renal impairment (CrCl <30 mL/minute) and end-stage renal disease.

Disease-related concerns:

• Hepatic impairment: Use is contraindicated in patients with severe hepatic impairment (total bilirubin >3 times ULN). Dose reduction is necessary in patients with mild impairment (total bilirubin >1 to ≤1.5 times ULN or AST >1.5 times ULN) and moderate impairment (total bilirubin >1.5 to ≤3 times ULN); use with caution and monitor closely. Due to extensive hepatic metabolism, cabazitaxel exposure is increased in patients with hepatic impairment.

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.

Dosage form specific issues:

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer’s labeling.

Special populations:

• Elderly: Patients ≥65 years of age are more likely to experience certain adverse reactions, including grade 3 and 4 neutropenia and neutropenic fever. Fatigue, asthenia, pyrexia, dizziness, urinary tract infection, and dehydration also occurred more frequently in elderly patients compared to younger patients. Death due to causes other than disease progression (within 30 days of the last cabazitaxel dose) was higher in elderly patients versus younger patients.

Other warnings/precautions:

• Preparation for administration: Failure to properly reconstitute the concentrated vial of cabazitaxel with the correct amount of diluent may lead to higher dosage being administered and increased risk of toxicity. Follow manufacturer instructions carefully.

Special handling:

• Hazardous agent: Use appropriate precautions for handling and disposal (NIOSH 2014 [group 1]).

Monitoring Parameters

CBC with differential and platelets (weekly during first cycle, then prior to each treatment cycle and as clinically indicated); hepatic/renal function. Monitor for hypersensitivity reactions (especially during the first and second infusions). Monitor for signs/symptoms of gastrointestinal disorders (eg, nausea, vomiting, diarrhea, gastrointestinal hemorrhage and perforation, ileus, colitis, abdominal pain/tenderness)

Pregnancy Risk Factor

D

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies. Cabazitaxel is not indicated for use in women. May cause fetal harm if administered during pregnancy. Pregnant women should avoid exposure to cabazitaxel.

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 headache, nausea, vomiting, back pain, lack of appetite, back pain, joint pain, alopecia, or change in taste. Have patient report immediately to prescriber signs of infection, signs of fluid and electrolyte problems (mood changes, confusion, muscle pain or weakness, abnormal heartbeat, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or nausea or vomiting), signs of bleeding (vomiting 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 bleeding that is very bad or that will not stop), signs of severe cerebrovascular disease (change in strength on one side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight), signs of DVT (edema, warmth, numbness, change in color, or pain in the extremities), signs of kidney problems (urinary retention, blood in urine, change in amount of urine passed, weight gain), severe dizziness, passing out, arrhythmia, severe abdominal pain, severe constipation, severe diarrhea, or loss of strength and energy (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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