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Epoprostenol

Pronunciation

(e poe PROST en ole)

Index Terms

  • Epoprostenol Sodium
  • Epoprostenol Sodium (Arginine)
  • PGI2
  • PGX
  • Prostacyclin

Dosage Forms

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

Solution Reconstituted, Intravenous:

Flolan: 0.5 mg (1 ea); 1.5 mg (1 ea)

Veletri: 0.5 mg (1 ea); 1.5 mg (1 ea)

Generic: 0.5 mg (1 ea); 1.5 mg (1 ea)

Brand Names: U.S.

  • Flolan
  • Veletri

Pharmacologic Category

  • Prostacyclin
  • Prostaglandin
  • Vasodilator

Pharmacology

Epoprostenol is also known as prostacyclin and PGI2. It is a strong vasodilator of all vascular beds. In addition, it is a potent endogenous inhibitor of platelet aggregation. The reduction in platelet aggregation results from epoprostenol's activation of intracellular adenylate cyclase and the resultant increase in cyclic adenosine monophosphate concentrations within the platelets. Additionally, it is capable of decreasing thrombogenesis and platelet clumping in the lungs by inhibiting platelet aggregation.

Metabolism

Rapidly hydrolyzed; subject to some enzymatic degradation; forms two active metabolites (6-keto-prostaglandin F1α and 6,15-diketo-13,14-dihydro-prostaglandin F1α) with minimal activity and 14 inactive metabolites

Excretion

Urine (84%); feces (4%)

Half-Life Elimination

~6 minutes

Use: Labeled Indications

Pulmonary arterial hypertension: Treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in patients with NYHA Class III or IV symptoms to improve exercise capacity. Note: According to treatment guidelines from the Fifth World Symposium on Pulmonary Hypertension (WSPH), continuous IV epoprostenol is recommended as first-line therapy in PAH patients with WHO-FC IV symptoms (WSPH [Gailè 2013]).

Use: Unlabeled

Acute vasodilator testing in pulmonary arterial hypertension (PAH)

Inhalation: Flolan; Intraoperative treatment of pulmonary hypertension in patients undergoing cardiac surgery with cardiopulmonary bypass; post-cardiothoracic surgery pulmonary hypertension, right ventricular dysfunction, or refractory hypoxemia

Contraindications

US labeling:

Hypersensitivity to epoprostenol, to structurally-related compounds; or any component of the formulation; chronic use in patients with heart failure due to severe left ventricular systolic dysfunction

Veletri: Additional contraindications: Chronic use in patients who develop pulmonary edema during dose initiation

Canadian labeling: Hypersensitivity to epoprostenol, to structurally-related compounds; or any component of the formulation; chronic use in patients with heart failure due to severe left ventricular systolic dysfunction; chronic use in patients who develop pulmonary edema during dose initiation

Dosing: Adult

Pulmonary arterial hypertension (PAH): IV: Initial: 2 ng/kg/minute; a lower initial dose may be used if patient is intolerant of starting dose. Increase dose in increments of 1 to 2 ng/kg/minute at intervals of ≥15 minutes until dose-limiting side effects (eg, flushing, jaw pain, headache, hypotension, nausea) are noted or response to epoprostenol plateaus. Usual optimal dose (monotherapy): 25 to 40 ng/kg/minute (McLaughlin 2009); significant patient variability in optimal dose exists. Maximum dose with chronic therapy has not been defined; however, doses as high as 195 ng/kg/minute have been described in children (Rosenzweig 1999).

Dose adjustment during chronic phase of treatment:

If PAH symptoms persist or recur following improvement, increase dose in 1 to 2 ng/kg/minute increments at intervals of ≥15 minutes. May also increase dose at intervals of 24 to 48 hours or longer (eg, every 1 to 2 weeks). Note: The need for increased doses should be expected with chronic use; incremental increases occur more frequently during the first few months after the drug is initiated.

In case of dose-limiting pharmacologic events (eg, hypotension, severe nausea, vomiting), decrease dose in 2 ng/kg/minute decrements at intervals of ≥15 minutes until dose-limiting effects resolve. Avoid abrupt withdrawal or sudden large dose reductions. Note: Adverse event may resolve without dosage adjustment.

Lung transplant: In patients receiving lung transplants, epoprostenol may be tapered after sequential lung transplantation once the allografts have been reperfused. If cardiopulmonary bypass utilized, epoprostenol may be tapered after pump perfusion has been initiated.

Acute vasodilator testing in patients with PAH (off-label use) (McLaughlin 2009): Note: Acute vasodilator testing should only be done in patients who might be considered candidates for calcium channel blocker therapy.

IV: Initial: 2 ng/kg/minute; increase dose in increments of 2 ng/kg/minute every 10 to 15 minutes; dosing range during testing: 2 to 10 ng/kg/minute

Intraoperative pulmonary hypertension during cardiac surgery with cardiopulmonary bypass (CPB) (off-label use): Inhalation (off-label route): Note: Institution-specific protocols vary.

Administration after induction of anesthesia before incision: Flolan: 60 mcg (4 mL of 15,000 ng/mL concentration) via jet nebulizer; effect persists for ~25 minutes (Hache 2003)

or

Intraoperative administration: Nebulization via ventilator circuit: Flolan: Using a 15,000 ng/mL concentration and an oxygen flow of 8 L/minute, begin administration via jet nebulizer 5 minutes prior to weaning from CPB; discontinue at least 60 minutes after CPB weaned (Fattouch 2006)

Post-cardiothoracic surgery pulmonary hypertension, right ventricular dysfunction, or refractory hypoxemia (off-label use) (DeWet 2004): Flolan: Inhalation (off-label route): Note: May need to change ventilator filter every 2 hours due to glycine buffer diluent; may cause ventilator valve malfunction. Tidal volume delivered by ventilator may require adjustment.

Nebulization via ventilator circuit: Flolan: Using a 20,000 ng/mL concentration, prime nebulizer chamber with 15 mL; administer remainder at a constant rate of 8 mL/hour; delivers ~38 ng/kg/minute (based on a 70 kg patient); set oxygen flow at 2 to 3 L/minute; wean as tolerated. Note: Although not achieved with this regimen, in general, doses >50 ng/kg/minute do not provide additional benefit and may increase the risk of hypotension.

or

Nebulization via facemask with Venturi attachment: Flolan: Using a 20,000 ng/mL concentration, prime nebulizer chamber with 15 mL; set oxygen flow at 2 to 3 L/minute; 8 mL/hour will be nebulized; wean as tolerated.

Weaning procedure: Reduce dose by 50% every 2 to 4 hours (ie, 20,000 ng/mL to 10,000 ng/mL to 5,000 ng/mL) until a concentration of 2,500 ng/mL is reached; carefully discontinue once patient remains stable on this concentration for at least 4 hours.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Pulmonary arterial hypertension (PAH): Children (off-label use) and Adolescents (off-label use): Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling.

Reconstitution

Preparation of Epoprostenol Infusion

To make solution with concentration:

Flolan

Instructions

Veletri or Caripul

Instructions

Note: Flolan may only be prepared with sterile diluent provided.

Note: Veletri or Caripul may only be prepared with sterile water for injection (SWFI) or NS.

3000 ng/mL

Dissolve one 0.5 mg vial with 5 mL supplied diluent, withdraw 3 mL, and add to a sufficient volume of supplied diluent to make a total of 100 mL.

Dissolve one 0.5 mg vial with 5 mL of SWFI or NS, withdraw 3 mL, and add to a sufficient volume of the identical diluent to make a total of 100 mL.

5000 ng/mL

Dissolve one 0.5 mg vial with 5 mL supplied diluent, withdraw entire vial contents, and add to a sufficient volume of supplied diluent to make a total of 100 mL.

Dissolve one 0.5 mg vial with 5 mL of SWFI or NS, withdraw entire vial contents, and add to a sufficient volume of the identical diluent to make a total of 100 mL.

10,000 ng/mL

Dissolve two 0.5 mg vials each with 5 mL supplied diluent, withdraw entire vial contents, and add to a sufficient volume of supplied diluent to make a total of 100 mL.

Dissolve two 0.5 mg vials each with 5 mL of SWFI or NS, withdraw entire vial contents, and add to a sufficient volume of the identical diluent to make a total of 100 mL.

15,000 ng/mL

Dissolve one 1.5 mg vial with 5 mL supplied diluent, withdraw entire vial contents, and add to a sufficient volume of supplied diluent to make a total of 100 mL.

Dissolve one 1.5 mg vial with 5 mL of SWFI or NS, withdraw entire vial contents, and add to a sufficient volume of the identical diluent to make a total of 100 mL.

20,000 ng/mL

Dissolve two 0.5 mg vials each with 5 mL supplied diluent, withdraw entire vial contents, and add to a sufficient volume of supplied diluent to make a total of 50 mL (DeWet, 2004).

30,000 ng/mL

Dissolve two 1.5 mg vials each with 5 mL of SWFI or NS, withdraw entire vial contents, and add to a sufficient volume of the identical diluent to make a total of 100 mL.

Table has been converted to the following text.

Preparation of Epoprostenol Infusion

Note: Flolan may only be prepared with sterile diluent provided. Veletri or Caripul may only be prepared with sterile water for injection (SWFI) or NS.

To make solution with the following concentrations:

3000 ng/mL:

Flolan: Dissolve one 0.5 mg vial with 5 mL supplied diluent, withdraw 3 mL, and add to a sufficient volume of supplied diluent to make a total of 100 mL.

Veletri, Caripul: Dissolve one 0.5 mg vial with 5 mL of SWFI or NS, withdraw 3 mL, and add to a sufficient volume of the identical diluent to make a total of 100 mL.

5000 ng/mL:

Flolan: Dissolve one 0.5 mg vial with 5 mL supplied diluent, withdraw entire vial contents, and add to a sufficient volume of supplied diluent to make a total of 100 mL.

Veletri, Caripul: Dissolve one 0.5 mg vial with 5 mL of SWFI or NS, withdraw entire vial contents, and add to a sufficient volume of the identical diluent to make a total of 100 mL.

10,000 ng/mL:

Flolan: Dissolve two 0.5 mg vials each with 5 mL supplied diluent, withdraw entire vial contents, and add to a sufficient volume of supplied diluent to make a total of 100 mL.

Veletri, Caripul: Dissolve two 0.5 mg vials each with 5 mL of SWFI or NS, withdraw entire vial contents, and add to a sufficient volume of the identical diluent to make a total of 100 mL.

15,000 ng/mL:

Flolan: Dissolve one 1.5 mg vial with 5 mL supplied diluent, withdraw entire vial contents, and add to a sufficient volume of supplied diluent to make a total of 100 mL.

Veletri, Caripul: Dissolve one 1.5 mg vial with 5 mL of SWFI or NS, withdraw entire vial contents, and add to a sufficient volume of the identical diluent to make a total of 100 mL.

20,000 ng/mL: Flolan: Dissolve two 0.5 mg vials each with 5 mL supplied diluent, withdraw entire vial contents, and add to a sufficient volume of supplied diluent to make a total of 50 mL (DeWet, 2004).

30,000 ng/mL: Veletri, Caripul: Dissolve two 1.5 mg vials each with 5 mL of SWFI or NS, withdraw entire vial contents, and add to a sufficient volume of the identical diluent to make a total of 100 mL.

Administration

IV: For IV use via an infusion pump. Use infusion sets with an in-line 0.22 micron filter. When administered on an ongoing basis, must be infused through a central venous catheter. Peripheral infusion may be used temporarily until central line is established. Do not administer as a bolus injection. Avoid abrupt withdrawal (including interruptions in delivery) or sudden large reductions in dosing. The ambulatory infusion pump should be small and lightweight, be able to adjust infusion rates in 2 ng/kg/minute increments, have occlusion, end of infusion, and low battery alarms, have ± 6% accuracy of the programmed rate, and have positive continuous or pulsatile pressure with intervals ≤3 minutes between pulses. The reservoir should be made of polyvinyl chloride, polypropylene, or glass. Immediate access to back up pump, infusion sets and medication is essential to prevent treatment interruptions. Consult manufacturer’s labeling for infusion rate example calculations.

Inhalation (off-label route):

Intraoperative administration: Administer via jet nebulizer connected to the inspiratory limb of the ventilator near the endotracheal tube with a bypass oxygen flow of 8 L/minute to achieve administration of a high proportion of small particles (Fattouch 2006; Hache 2003).

Post-cardiothoracic surgery: May also be administered via jet nebulizer connected to the inspiratory limb of the ventilator near the endotracheal tube or via face mask with a Venturi attachment for aerosolization with a bypass oxygen flow of 2 to 3 L/minute (De Wet 2004). Note: Glycine buffer diluent may cause ventilator valve malfunction; it has been recommended that filters be changed on the ventilator every 2 hours; may also use a ventilator heating coil (De Wet 2004).

Compatibility

Flolan: Only prepare with sterile diluent provided. Veletri or Caripul [Canadian product]: Only prepare with SWFI or NS. Per manufacturer, do not mix or administer with any other drugs or solutions prior to or during administration.

Storage

Flolan: Prior to use, store intact vials and diluent at 15°C to 25°C (59°F to 77°F); do not freeze. Protect from light. Following reconstitution, solution must be stored at 2°C to 8°C (36°F to 46°F) if not used immediately; do not freeze. Protect from light. Storage and administration limits for reconstituted solution are dependent on type of diluent use during reconstitution:

Sterile diluent for Flolan: When used at 15°C to 25°C (59°F to 77°F), reconstituted solutions are stable for up to 8 hours following reconstitution or removal from refrigerator. May also be stored for up to 40 hours at 2°C to 8°C (36°F to 46°F) before use. When used with a cold pack, reconstituted solutions are stable for up to 24 hours; may also be stored at 2°C to 8°C (36°F to 46°F) before use as long as the total time of refrigerated storage and infusion does not exceed 48 hours. Change cold packs every 12 hours. The Canadian labeling recommends changing cold pouches every 8 hours if room temperature approaches 30°C (86°F)

pH 12 sterile diluent for Flolan: Freshly prepared reconstituted solutions or reconstituted solutions that have been stored at 2°C to 8°C (36°F to 46°F) for no longer than 8 days can be administered up to 72 hours at up to 25°C (77°F); 48 hours at up to 30°C (86°F); 24 hours at up to 35°C (95°F); 12 hours at up to 40°C (104°F).

Veletri: Prior to use, store intact vials at 20°C to 25°C (68°F to 77°F); do not freeze. Protect from light. Reconstituted vials must be further diluted prior to use.

Caripul [Canadian product]: Prior to use, store intact vials at 15°C to 30°C (59°F to 86°F); do not freeze. Reconstituted vials must be further diluted prior to use.

Reconstituted solutions of Veletri or Caripul immediately diluted with NS to a final concentration within a drug delivery reservoir may be administered immediately or stored at 2°C to 8°C (36°F to 46°F) for up to 8 days; do not freeze. Protect from light.

If administered immediately, the following maximum durations of administration at room temperature (25°C [77°F]) according to solution concentration are recommended:

U.S. labeling (Veletri):

3000 to <15,000 ng/mL: 48 hours

15,000 to <60,000 ng/mL: 48 hours

≥60,000 ng/mL: 72 hours

Canadian labeling (Caripul):

3000 to <15,000 ng/mL: 48 hours

≥15,000: 48 hours

If stored at 2°C to 8°C (36°F to 46°F) for up to 8 days, the following maximum durations of administration at room temperature (25°C [77°F]) according to solution concentration are recommended:

3000 to <15,000 ng/mL: 24 hours

15,000 to <60,000 ng/mL: 48 hours

≥60,000 ng/mL: 48 hours

Short excursions at 40°C (104°F) are permitted as follows:

Solution concentration <15,000 ng/mL: Up to 2 hours

Solution concentration 15,000 to <60,000 ng/mL: Up to 4 hours

Solution concentration ≥60,000 ng/mL: Up to 8 hours

The following maximum durations of administration at temperatures >25°C to 40°C (>77°F up to 104°F) administered either immediately or after up to 8 days storage at 2°C to 8°C (36°F to 46°F) according to solution concentration are recommended:

Use at temperature >25°C to 30°C (>77°F up to 86°F):

U.S. labeling (Veletri):

<60,000 ng/mL: 24 hours

≥60,000 ng/mL: 48 hours

Canadian labeling (Caripul): All concentrations: 24 hours

Use at temperature up to 40°C (104°F):

U.S. labeling (Veletri): ≥60,000 ng/mL: 24 hours (immediately administered after preparation)

Drug Interactions

Agents with Antiplatelet Properties (e.g., P2Y12 inhibitors, NSAIDs, SSRIs, etc.): Prostacyclin Analogues may enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Alfuzosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When amifostine is used at chemotherapy doses, blood pressure lowering medications should be withheld for 24 hours prior to amifostine administration. If blood pressure lowering therapy cannot be withheld, amifostine should not be administered. Consider therapy modification

Anticoagulants: Prostacyclin Analogues may enhance the adverse/toxic effect of Anticoagulants. Specifically, the antiplatelet effects of these agents may lead to an increased risk of bleeding with the combination. Monitor therapy

Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may enhance the hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]). Monitor therapy

Barbiturates: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Blood Pressure Lowering Agents: Prostacyclin Analogues may enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Blood Pressure Lowering Agents: May enhance the hypotensive effect of Hypotension-Associated Agents. Monitor therapy

Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Digoxin: Epoprostenol may increase the serum concentration of Digoxin. Monitor therapy

DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Monitor therapy

Herbs (Hypotensive Properties): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect of Hypotension-Associated Agents. Monitor therapy

Levodopa: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa. Monitor therapy

Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Naftopidil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nicergoline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. Monitor therapy

Obinutuzumab: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Consider therapy modification

Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Thrombolytic Agents: May enhance the adverse/toxic effect of Prostacyclin Analogues. Specifically, the antiplatelet effects of prostacyclin analogues may lead to an increased risk of bleeding when combined with thrombolytic agents. Monitor therapy

Adverse Reactions

Note: Adverse events reported during dose initiation and escalation include flushing (58%), headache (49%), nausea/vomiting (32%), hypotension (16%), anxiety/nervousness/agitation (11%), chest pain (11%); dizziness, abdominal pain, bradycardia, musculoskeletal pain, dyspnea, back pain, diaphoresis, dyspepsia, hypoesthesia/paresthesia, and tachycardia are also reported. Although some adverse reactions may be related to the underlying disease state, abdominal pain, anxiety/nervousness/agitation, arthralgia, bleeding, bradycardia, diarrhea, diaphoresis, flu-like syndrome, flushing, headache, hypotension, jaw pain, nausea, pain, pulmonary edema, rash, tachycardia, thrombocytopenia, and vomiting are clearly contributed to epoprostenol. The following adverse events have been reported during chronic administration for idiopathic or heritable PAH:

>10%:

Cardiovascular: Tachycardia (35% to 43%), flushing (23% to 42%), hypotension (13%)

Central nervous system: Dizziness (83%), headache (46% to 83%), chills (25%), fever (25%), flu-like syndrome (25%), sepsis (25%), anxiety (21%), nervousness (21%), tremor (21%), agitation (11%)

Dermatologic: Dermal ulcer (39%), eczema (25%), skin rash (25%), urticaria (25%)

Gastrointestinal: Nausea (≤67%), vomiting (≤67%), anorexia (66%), diarrhea (37% to 50%)

Local: Injection site reactions: Infection (18%), pain (11%)

Neuromuscular & skeletal: Arthralgia (≤84%), neck pain (≤84%), pain (≤84%), jaw pain (54% to 75%), myalgia (44%), musculoskeletal pain (35%), hyperesthesia (≤12%), hypoesthesia (≤12%), paresthesia (≤12%)

<1%, postmarketing, and/or case reports: Abdominal pain, anemia, ascites, dyspnea, fatigue, hemorrhage, hepatic failure, hyperthyroidism, pancytopenia, pulmonary edema, pulmonary embolism, splenomegaly, thrombocytopenia

Warnings/Precautions

Concerns related to adverse effects:

• Pulmonary edema: Some patients with PAH have developed pulmonary edema during dosing adjustment and acute vasodilator testing (an off-label use), which may be associated with concomitant heart failure (LV systolic dysfunction with significantly elevated left heart filling pressures) or pulmonary veno-occlusive disease/pulmonary capillary hemangiomatosis. If pulmonary edema develops during therapy initiation, discontinue and do not readminister.

• Rebound pulmonary hypertension: Avoid abrupt interruptions or large sudden reductions in dosage; may result in rebound pulmonary hypertension (eg, dyspnea, dizziness, asthenia). A fatal case occurred following interruption. Immediate access to medication or pump and infusion sets is essential to prevent treatment interruptions.

• Vasodilation: Epoprostenol is a potent pulmonary and systemic vasodilator and can cause hypotension and other reactions such as flushing, nausea, vomiting, dizziness, and headache. Monitor blood pressure and symptoms regularly during initiation and after dose change.

Disease-related concerns:

• Conditions that increase bleeding risk: Epoprostenol is a potent inhibitor of platelet aggregation. Use with caution in patients with other risk factors for bleeding.

Other warnings/precautions:

• Appropriate Use: Initiation or transition to epoprostenol requires specialized cardiopulmonary monitoring in a critical care setting where clinicians are experienced in advanced management of pulmonary arterial hypertension. To reduce the risk of thromboembolism during chronic use, anticoagulants should be coadministered unless contraindicated.

• Infection: Chronic continuous IV infusion of epoprostenol via a chronic indwelling central venous catheter (CVC) has been associated with local infections and serious blood stream infections.

Monitoring Parameters

Monitor for improvements in pulmonary function, decreased exertional dyspnea, fatigue, syncope and chest pain, blood pressure, pulmonary vascular resistance, pulmonary arterial pressure and quality of life. Following establishment of a new chronic infusion rate, measure standing and supine blood pressure for several hours. In addition, the pump device and catheters should be monitored frequently to avoid “system” related failure. Monitor arterial pressure; assess all vital functions. Hypoxia, flushing, and tachycardia may indicate overdose.

Pregnancy Risk Factor

B

Pregnancy Considerations

Adverse events have not been observed in animal reproduction studies. Women with PAH are encouraged to avoid pregnancy (McLaughlin 2009).

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 anxiety, back pain, diarrhea, flushing, lack of appetite, jaw pain, bone pain, muscle pain, joint pain, nausea, vomiting, or flu-like symptoms. Have patient report immediately to prescriber signs of infection, 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), shortness of breath, severe dizziness, passing out, severe headache, dark urine, angina, tachycardia, bradycardia, arrhythmia, pale skin, tremors, severe loss of strength and energy, burning or numbness feeling, abdominal edema, skin sores, or injection site redness, edema, or severe irritation (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 health care 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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