Pentostatin

Dosage Forms

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

Solution Reconstituted, Intravenous:

Nipent: 10 mg (1 ea)

Pharmacology

Mechanism of Action

Pentostatin is a purine antimetabolite that inhibits adenosine deaminase, preventing the deamination of adenosine to inosine. Accumulation of deoxyadenosine (dAdo) and deoxyadenosine 5′-triphosphate (dATP) results in a reduction of purine metabolism which blocks DNA synthesis and leads to cell death.

Pharmacokinetics/Pharmacodynamics

Distribution

V_d: IV: 20 L/m² (Lathia 2002).

Excretion

Urine (~90%).

Clearance: Adults: 68 mL/minute/m² (mean).

Half-Life Elimination

Terminal: 5.7 hours; Renal impairment (CrCl <50 mL/minute): 18 hours (range: 11 to 23 hours [Lathia 2002]).

Protein Binding

~4%.

Use: Labeled Indications

Hairy cell leukemia: Treatment (as a single agent) of untreated and interferon alfa-refractory hairy cell leukemia in patients with active disease (clinically significant anemia, neutropenia, thrombocytopenia, or disease-related symptoms).

Use: Off Label

Chronic lymphocytic leukemiab

Data from 2 studies (one in previously treated and one in previously untreated patients) support the use of pentostatin (in combination with cyclophosphamide and rituximab) for the treatment of chronic lymphocytic leukemia Kay 2007, Lamanna 2006.

Cutaneous T-cell lymphomas, mycosis fungoides/Sezary syndromeb

Data from a phase II study in a limited number of patients with T-cell malignancies support the use of pentostatin in the treatment of the cutaneous T-cell lymphomas mycosis fungoides and Sezary syndrome Ho 1999.

Graft-versus-host disease, acute (treatment)b

Data from a phase II study of pentostatin (in combination with corticosteroids) as initial therapy for acute graft-versus-host disease (GVHD) and from a phase I study in steroid-refractory acute GVHD support the use of pentostatin in the management of acute GVHD Alousi 2009, Bolanos-Meade 2005.

Graft-versus-host disease, chronic, steroid-refractory (treatment)byes

Data from 2 phase II studies in steroid-refractory chronic GVHD support the use of pentostatin in the management of chronic GVHD Jacobsohn 2007, Jacobsohn 2009.

Based on the American Society for Blood and Marrow Transplant consensus conference on clinical practice in chronic GVHD: second-line treatment of chronic graft-versus-host disease, pentostatin is an option for second-line management of steroid-refractory chronic GVHD, although the best results have been in children with chronic GVHD.

T-cell large granular lymphocytic leukemiac

Data from a limited number of patients in 3 retrospective studies support the use of pentostatin (either as a single agent or in combination with alemtuzumab) for the treatment of T-cell large granular lymphocytic leukemia Aribi 2007, Fortune 2010, Osuji 2006.

T-cell prolymphocytic leukemia, refractoryb

Data from a small phase II study in patients with T-cell malignancies support the use of pentostatin (in combination with alemtuzumab) in the treatment of refractory T-cell prolymphocytic leukemia Ravandi 2009. In addition, data from a retrospective study of patients with T-cell malignancies support the use of pentostatin in the treatment of the T-cell prolymphocytic leukemia Mercieca 1994.

Contraindications

Hypersensitivity to pentostatin or any component of the formulation

Dosage and Administration

Dosing: Adult

Chronic lymphocytic leukemia (off-label use): IV:

Previously treated: 4 mg/m² once every 3 weeks (in combination with cyclophosphamide and rituximab) for 6 cycles (Lamanna 2006).

Previously untreated: 2 mg/m² once every 3 weeks (in combination with cyclophosphamide and rituximab) for 6 cycles (Kay 2007).

Cutaneous T-cell lymphoma, mycosis fungoides/Sezary syndrome (off-label use): IV: 4 mg/m² once weekly for 3 weeks, then 4 mg/m² once every 2 weeks for 6 weeks, then 4 mg/m² once a month for a maximum of 6 months (Ho 1999).

Graft-versus-host-disease (off-label use): IV:

Acute graft-versus-host disease, steroid-refractory:

Initial therapy: 1.5 mg/m² days 1 to 3 and days 15 to 17 (in combination with corticosteroids) (Alousi 2009).

Steroid-refractory disease: 1.5 mg/m² daily for 3 days; may repeat after 2 weeks if needed (Bolanos-Meade 2005).

Chronic graft-versus-host disease, steroid-refractory: IV: 4 mg/m² once every 2 weeks; discontinue after 6 months for sustained objective response, or continue every 2 to 4 weeks for up to 12 months if still improving (Jacobsohn 2007; Jacobsohn 2009) or 4 mg/m² once every 2 weeks for 3 months (Wolff 2011).

Hairy cell leukemia (previously untreated or refractory): IV: 4 mg/m² once every 2 weeks. Note: The optimal duration has not been determined; in the absence of unacceptable toxicity, may continue until complete response is achieved or until 2 doses after complete response. Discontinue after 12 months if the best response achieved is a partial response or after 6 months if partial or complete response is not achieved. Consensus guidelines suggest pentostatin may be continued until hematologic parameters have normalized and splenomegaly is no longer present on physical exam (Grever 2017).

T-cell large granular lymphocytic leukemia (off-label use; based on limited data): IV: 4 mg/m² once every 1 to 2 weeks until maximum response is achieved (Osuji 2006) or 4 to 5 mg/m² every 2 weeks for 8 courses (Fortune 2010) or 4 mg/m² once a week (in combination with alemtuzumab) (Aribi 2007).

T-cell prolymphocytic leukemia, refractory (off-label use): IV: 4 mg/m² once weekly for 4 weeks, then 4 mg/m² every 2 weeks until optimum response is achieved (Mercieca 1994) or 4 mg/m² once weekly for 4 weeks, then 4 mg/m² every 2 weeks (in combination with alemtuzumab) until complete or best response or up to a total of 14 doses (Ravandi 2009).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Chronic graft-versus-host disease (GVHD), steroid-refractory: Limited data available: Infant, Children, and Adolescents: IV: Initial: 4 mg/m² once every 2 weeks; after 6 months of therapy, discontinue for sustained objective response, or continue same dose every 2 to 4 weeks for up to 12 months if still improving (Jacobsohn 2007; Jacobsohn 2009) or 4 mg/m² once every 2 weeks for 3 months (Wolff 2011)

Dosing adjustment for toxicity:

Infants, Children, and Adolescents (Jacobsohn 2007; Jacobsohn 2009; Wolff 2011):

ANC 500 to 1,000/mm³: Reduce dose by 25%

ANC <500/mm³, platelets <20,000/mm³, or neutropenic fever: Reduce dose by 50%

Infection, severe: Interrupt treatment until infection is controlled

Rash: Severe rashes may require treatment interruption or discontinuation based on experience in adult patients

Other severe adverse reactions: Withhold treatment or discontinue based on experience in adult patients

Dosing: Adjustment for Toxicity

Acute graft-versus-host disease (off-label use):

ANC <500/mm³: Withhold treatment until ANC recovery (Alousi 2009).

ANC 500 to <1,000/mm³: Reduce dose by 50% (Alousi 2009).

Chronic graft-versus-host disease (off-label use):

ANC <500/mm³, platelets <20,000/mm³, or neutropenic fever: Reduce dose by 50% (Jacobsohn 2007; Jacobsohn 2009; Wolff 2011).

ANC 500 to 1,000/mm³: Reduce dose by 25% (Jacobsohn 2007; Wolff 2011).

Hairy cell leukemia:

ANC <200/mm³ (with baseline ANC >500/mm³): Temporarily interrupt treatment until ANC returns to pre-dose levels.

CNS toxicity: Withhold treatment or discontinue.

Infection, active: Interrupt treatment until infection is controlled.

Rash: Severe rashes may require treatment interruption or discontinuation.

Other severe adverse reactions: Withhold treatment or discontinue.

Dosing: Obesity

American Society of Clinical Oncology guidelines for appropriate chemotherapy dosing in obese adults with cancer (excludes leukemias): Utilize patient's actual body weight (full weight) for calculation of BSA- 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).

American Society for Blood and Marrow Transplantation practice guideline committee position statement on chemotherapy dosing in obesity: Utilize actual body weight (full weight) for calculation of BSA in pentostatin dosing for hematopoietic stem cell transplant conditioning regimens in adults (Bubalo 2014).

Reconstitution

Reconstitute each 10 mg vial with 5 mL SWFI to a concentration of 2 mg/mL. The solution may be further diluted in 25 to 50 mL NS or D5W for infusion. When diluted for infusion in D5W or NS at concentrations of 0.18 to 0.33 mg/mL, pentostatin is compatible with polyvinyl chloride-containing infusion bags and infusion sets.

Administration

IV: Administer IV over 20 to 30 minutes or as a bolus infusion. Hydrate with 500 to 1,000 mL fluid prior to infusion and 500 mL after infusion.

Storage

Store intact vials at 2°C to 8°C (36°F to 46°F). Reconstituted vials and solutions diluted for infusion (in D5W or NS) may be stored at room temperature and should be used within 8 hours.

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

Cladribine: Agents that Undergo Intracellular Phosphorylation may diminish the therapeutic effect of Cladribine. 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

Cyclophosphamide: Pentostatin may enhance the cardiotoxic effect of Cyclophosphamide. 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. 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

Fludarabine: May enhance the adverse/toxic effect of Pentostatin. Pentostatin may enhance the adverse/toxic effect of Fludarabine. Pulmonary toxicity is of specific concern. Avoid combination

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

Lenograstim: Antineoplastic Agents may diminish the therapeutic effect of Lenograstim. Management: Avoid the use of lenograstim 24 hours before until 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Consider therapy modification

Lipegfilgrastim: Antineoplastic Agents may diminish the therapeutic effect of Lipegfilgrastim. Management: Avoid concomitant use of lipegfilgrastim and myelosuppressive cytotoxic chemotherapy. Lipegfilgrastim should be administered at least 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. 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

Nelarabine: Pentostatin may diminish the antineoplastic effect of Nelarabine. Conversion of nelarabine, a pro-drug, to its active form may be inhibited by pentostatin. Avoid combination

Nivolumab: Immunosuppressants may diminish the therapeutic effect of Nivolumab. Consider therapy modification

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

Palifermin: May enhance the adverse/toxic effect of Antineoplastic Agents. Specifically, the duration and severity of oral mucositis may be increased. Management: Do not administer palifermin within 24 hours before, during infusion of, or within 24 hours after administration of myelotoxic chemotherapy. Consider therapy modification

Pegademase Bovine: Pentostatin may diminish the therapeutic effect of Pegademase Bovine. Pegademase Bovine may diminish the therapeutic effect of Pentostatin. 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. 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

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

Upadacitinib: Immunosuppressants may enhance the immunosuppressive effect of Upadacitinib. 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 (29% to 42%), pain (8% to 20%), chills (11% to 19%), headache (13% to 17%), central nervous system toxicity (1% to 11%)

Dermatologic: Skin rash (26% to 43%), pruritus (10% to 21%), skin changes (4% to 17%)

Gastrointestinal: Nausea (≤63%), vomiting (≤63%), diarrhea (15% to 17%), anorexia (13% to 16%), abdominal pain (4% to 16%), stomatitis (5% to 12%)

Hematologic & oncologic: Leukopenia (22% to 60%), anemia (8% to 35%), thrombocytopenia (6% to 32%)

Hepatic: Increased serum transaminases (2% to 19%)

Hypersensitivity: Hypersensitivity reaction (2% to 11%)

Infection: Infection (7% to 38%)

Neuromuscular & skeletal: Myalgia (11% to 19%), asthenia (10% to 12%)

Respiratory: Cough (17% to 20%), upper respiratory tract infection (13% to 16%), rhinitis (10% to 11%), dyspnea (8% to 11%)

Miscellaneous: Fever (42% to 46%)

1% to 10%:

Cardiovascular: Chest pain (3% to 10%), facial edema (3% to 10%), hypotension (3% to 10%), peripheral edema (3% to 10%), angina pectoris (<3%), atrioventricular block (<3%), bradycardia (<3%), cardiac arrhythmia (<3%), cardiac failure (<3%), deep vein thrombophlebitis (<3%), hypertension (<3%), pericardial effusion (<3%), phlebitis (<3%), pulmonary embolism (<3%), sinoatrial arrest (<3%), syncope (<3%), tachycardia (<3%), vasculitis (<3%), ventricular premature contractions (<3%)

Central nervous system: Anxiety (3% to 10%), confusion (3% to 10%), depression (3% to 10%), dizziness (3% to 10%), drowsiness (3% to 10%), insomnia (3% to 10%), nervousness (3% to 10%), paresthesia (3% to 10%), abnormal dreams (<3%), abnormality in thinking (<3%), amnesia (<3%), ataxia (<3%), dysarthria (<3%), emotional lability (<3%), encephalitis (<3%), hallucination (<3%), hangover effect (<3%), hostility (<3%), meningism (<3%), neuralgia (<3%), neuritis (<3%), neuropathy (<3%), neurosis (<3%), paralysis (<3%), seizure (<3%), twitching (<3%), vertigo (<3%)

Dermatologic: Diaphoresis (8% to 10%), urticaria (3% to 10%), xeroderma (3% to 10%), cellulitis (6%), furunculosis (4%), acne vulgaris (<3%), alopecia (<3%), eczema (<3%), skin photosensitivity (<3%)

Endocrine & metabolic: Amenorrhea (<3%), decreased libido (<3%), hypercalcemia (<3%), hyponatremia (<3%), gout (<3%), loss of libido (<3%)

Gastrointestinal: Dyspepsia (3% to 10%), flatulence (3% to 10%), gingivitis (3% to 10%), constipation (<3%), dysgeusia (<3%), dysphagia (<3%), glossitis (<3%), intestinal obstruction (<3%), oral candidiasis (2%)

Genitourinary: Urinary tract infection (3%), impotence (<3%), lump in breast (<3%)

Hematologic & oncologic: Agranulocytosis (3% to 10%), hemorrhage (3% to 10%), acute leukemia (<3%), aplastic anemia (<3%), hemolytic anemia (<3%), neoplasm (<3%), petechial rash (<3%)

Infection: Herpes zoster infection (8%), viral infection (8%), bacterial infection (5%), herpes simplex infection (4%), sepsis (3%), abscess (2%)

Neuromuscular & skeletal: Arthralgia (3% to 6%), arthritis (<3%), hyperkinetic muscle activity (<3%), osteomyelitis (1%)

Ophthalmic: Conjunctivitis (4%), amblyopia (<3%), disease of the lacrimal apparatus (<3%), nonreactive pupils (<3%), photophobia (<3%), retinopathy (<3%), visual disturbance (<3%), watery eyes (<3%), xerophthalmia (<3%)

Otic: Deafness (<3%), labyrinthitis (<3%), otalgia (<3%), tinnitus (<3%)

Renal: Increased serum creatinine (3% to 10%), nephrolithiasis (<3%), renal disease (<3%), renal failure syndrome (<3%), renal function abnormality (<3%), renal insufficiency (<3%)

Respiratory: Pharyngitis (8% to 10%), sinusitis (6%), pneumonia (5%), asthma (3% to 10%), bronchitis (3%), bronchospasm (<3%), flu-like symptoms (<3%), laryngeal edema (<3%)

<1%: Fungal skin infection, uveitis, vision loss

Frequency not defined:

Hematologic & oncologic: Bone marrow depression, neutropenia

Hepatic: Hepatotoxicity

Renal: Nephrotoxicity

Respiratory: Pulmonary toxicity

Postmarketing: Acute respiratory failure, autoimmune thrombocytopenia, exfoliative dermatitis, febrile neutropenia, hemolytic-uremic syndrome, pulmonary edema, thrombotic thrombocytopenic purpura

Warnings/Precautions

Concerns related to adverse effects:

• Bone marrow suppression: Myelosuppression may occur, primarily in the early treatment courses. Neutropenia may worsen during initial courses for the treatment of hairy cell leukemia. If severe neutropenia persists beyond early cycles, evaluate for disease status (including bone marrow examination). Monitor blood counts during treatment (more frequently in the initial cycles).
• CNS toxicity: [US Boxed Warning]: Severe CNS toxicities have occurred with doses higher than recommended; do not exceed the recommended dose. Withhold treatment or discontinue for CNS toxicity.
• Dermatologic toxicity: Severe rashes may occur and may worsen with therapy continuation; may require treatment interruption or discontinuation.
• Hepatotoxicity: [US Boxed Warning]: Severe liver toxicities have occurred with doses higher than recommended; do not exceed the recommended dose. May cause elevations (usually reversible) in liver function tests.
• Pulmonary toxicity: [US Boxed Warning]: Severe pulmonary toxicities have occurred with doses higher than recommended; do not exceed the recommended dose. Concomitant use with fludarabine has resulted in serious or fatal pulmonary toxicity; the use of pentostatin in combination with fludarabine is not recommended.
• Renal toxicity: [US Boxed Warning]: Severe renal toxicities have occurred with doses higher than recommended; do not exceed the recommended dose. Serum creatinine elevations occurring at recommended doses are usually minor and reversible. Withhold treatment for elevated serum creatinine and determine creatinine clearance. May require dosage adjustment or therapy discontinuation.

Disease-related concerns:

• Infections: Preexisting infections may worsen with pentostatin treatment; if possible, infections should be resolved prior to pentostatin treatment initiation. Temporarily withhold pentostatin for active infection during therapy. Guidelines from the Hairy Cell Leukemia Society suggest that pentostatin has been used in patients with an active infection (Grever 2017). Use in patients with infections only if the potential benefit justifies the potential risk.
• Renal impairment: Use with caution in patients with renal dysfunction (CrCl <60 mL/minute); the terminal half-life is prolonged; may require dosage adjustment.

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. Concurrent use with fludarabine has resulted in severe or fatal pulmonary toxicity and is not recommended. Fatal pulmonary edema and hypotension have been reported in patients treated with pentostatin in combination with carmustine, etoposide, or high-dose cyclophosphamide as part of a myeloablative regimen for bone marrow transplant.

Other warnings/precautions:

• Experienced physician: [US Boxed Warning]: Pentostatin should be administered under the supervision of an experienced cancer chemotherapy physician.

Monitoring Parameters

CBC with differential and platelet count (prior to each dose; more frequently during initial cycles), peripheral blood smears (periodically for hairy cells and to assess treatment response), liver function, serum uric acid, renal function (serum creatinine and/or CrCl at baseline, and serum creatinine prior to each dose), bone marrow evaluation, signs/symptoms of pulmonary, CNS, and dermatologic toxicity.

Pregnancy

Pregnancy Considerations

Based on the mechanism of action and on findings from animal reproduction studies, in utero exposure to pentostatin may cause fetal harm. Females of reproductive potential should avoid becoming pregnant during treatment.

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 nausea, vomiting, headache, diarrhea, abdominal pain, lack of appetite, runny nose, itching, mouth sores, mouth irritation, common cold symptoms, muscle pain, joint pain, or sweating a lot. Have patient report immediately to prescriber signs of infection, signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin), signs of kidney problems (unable to pass urine, blood in the urine, change in amount of urine passed, or weight gain), signs of a severe pulmonary disorder (lung or breathing problems like difficulty breathing, shortness of breath, or a cough that is new or worse), mood changes, confusion, numbness or tingling of feet or hands, chest pain, neck stiffness, sensitivity to bright lights, severe muscle weakness, fatigue, chest pain, depression, anxiety, dizziness, passing out, bruising, bleeding, severe loss of strength and energy, or swelling of arms of legs (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.