Dosing & Uses
Dosage Forms & Strengths
tablet
- 5mg
- 10mg
Acute Coronary Syndrome
Reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome (ACS) managed by means of percutaneous coronary intervention (PCI) who have either (a) unstable angina or non-ST-elevation MI (NSTEMI) or (b) ST-elevation MI (STEMI) when managed with primary or delayed PCI
60 mg PO once as loading dose, then 10 mg/day PO in combination with aspirin 81-325 mg/day; if patient <60 kg, consider 5 mg/day PO because of potentially increased bleeding risk (efficacy and safety not established)
Dosing Modifications
Renal impairment
- No dosage adjustment necessary
- End-stage renal disease: Limited experience; these patients are generally at higher risk of bleeding
Hepatic impairment
- Mild-to-moderate (Child-Pugh Class A or B): No dosage adjustment necessary
- Severe (Child-Pugh Class C): Not studied
Dosing in low weight patients
- Patients (<60 kg) had an increased exposure to active metabolite of prasugrel and an increased risk of bleeding on a 10-mg daily maintenance dose
- Consider lowering the maintenance dose to 5-mg in patients <60 kg
Sickle Cell Disease (Orphan)
Orphan designation for treatment of sickle cell disease
Sponsor
- Eli Lilly; Lilly Corporate Center; Indianapolis, IN 46285
Not recommended
Acute Coronary Syndrome
<75 years
- 60 mg PO once as loading dose, then 10 mg/day PO in combination with aspirin 81-325 mg/day
- Weight <60 kg: consider 5 mg/day because of potentially increased bleeding risk (efficacy and safety not established)
≥75 years
- Generally not recommended, because of increased risk of fatal and intracranial bleeding and uncertain benefit, except in high-risk patients (diabetes or prior MI), for whom effect appears to be greater and use may be considered
Interactions
Interaction Checker
No Results
Contraindicated
Serious
Significant - Monitor Closely
Minor
Contraindicated (1)
- abrocitinib
abrocitinib and prasugrel both increase anticoagulation. Contraindicated. Antiplatelet drugs, except for low-dose aspirin (=81 mg qDay), during the first 3 months of treatment are contraindicated.
Serious (10)
- apixaban
prasugrel and apixaban both increase anticoagulation. Avoid or Use Alternate Drug.
- cangrelor
cangrelor decreases effects of prasugrel by receptor binding competition. Avoid or Use Alternate Drug. The expected antiplatelet effect of a 60 mg loading dose of prasugrel was blocked when prasugrel was administered during a cangrelor infusion. Therefore, prasugrel should not be administered until cangrelor infusion is discontinued.
- caplacizumab
caplacizumab, prasugrel. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug.
- codeine
codeine will decrease the level or effect of prasugrel by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Co-administration of opioid agonists delay and reduce absorption of prasugrel and its active metabolite presumably by slowing gastric emptying; consider the use of a parenteral anti-platelet agent in acute coronary syndrome patients requiring co-administration of opioid agonists
- heparin
heparin, prasugrel. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Enhanced risk of hemorrhage.
- hydromorphone
hydromorphone will decrease the level or effect of prasugrel by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Co-administration of opioid agonists delay and reduce absorption of prasugrel and its active metabolite presumably by slowing gastric emptying; consider the use of a parenteral anti-platelet agent in acute coronary syndrome patients requiring co-administration of opioid agonists
- morphine
morphine will decrease the level or effect of prasugrel by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Coadministration of opioid agonists delay and reduce the absorption of prasugrel?s active metabolite presumably because of slowed gastric emptying. Consider using a parenteral antiplatelet agent in acute coronary syndrome patients requiring coadministration of morphine or other opioid agonists. Risks associated with other opioids are unknown.
- oxycodone
oxycodone will decrease the level or effect of prasugrel by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Co-administration of opioid agonists delay and reduce absorption of prasugrel and its active metabolite presumably by slowing gastric emptying; consider the use of a parenteral anti-platelet agent in acute coronary syndrome patients requiring co-administration of opioid agonists
- oxymorphone
oxymorphone will decrease the level or effect of prasugrel by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Co-administration of opioid agonists delay and reduce absorption of prasugrel and its active metabolite presumably by slowing gastric emptying; consider the use of a parenteral anti-platelet agent in acute coronary syndrome patients requiring co-administration of opioid agonists
- protamine
protamine, prasugrel. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Enhanced risk of hemorrhage.
Monitor Closely (61)
- acalabrutinib
acalabrutinib increases effects of prasugrel by anticoagulation. Modify Therapy/Monitor Closely. Coadministration of acalabrutinib with antiplatelets or anticoagulants may further increase risk of hemorrhage. Monitor for signs of bleeding and consider the benefit-risk of withholding acalabrutinib for 3-7 days presurgery and postsurgery depending upon the type of surgery and the risk of bleeding.
- antithrombin alfa
antithrombin alfa, prasugrel. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Enhanced risk of hemorrhage.
- antithrombin III
antithrombin III, prasugrel. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Enhanced risk of hemorrhage.
- argatroban
argatroban, prasugrel. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Enhanced risk of hemorrhage.
- aspirin
aspirin, prasugrel. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. The need for simultaneous use of low-dose aspirin and anticoagulant or antiplatelet agents are common for patients with cardiovascular disease; monitor closely.
- aspirin rectal
aspirin rectal, prasugrel. pharmacodynamic synergism. Use Caution/Monitor. The need for simultaneous use of low-dose aspirin and anticoagulant or antiplatelet agents are common for patients with cardiovascular disease; monitor closely.
- aspirin/citric acid/sodium bicarbonate
aspirin/citric acid/sodium bicarbonate, prasugrel. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. The need for simultaneous use of low-dose aspirin and anticoagulant or antiplatelet agents are common for patients with cardiovascular disease; monitor closely.
- azficel-T
azficel-T, prasugrel. Other (see comment). Use Caution/Monitor. Comment: Coadministration with anticoagulants or antiplatelets may increase bruising or bleeding at biopsy and/or injection sites; concomitant use not recommended. Decisions regarding continued use or cessation of anticoagulants or antiplatelets should be made by a physician.
- betrixaban
prasugrel, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- bivalirudin
bivalirudin, prasugrel. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Enhanced risk of hemorrhage.
- celecoxib
celecoxib, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.
- choline magnesium trisalicylate
choline magnesium trisalicylate, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.
- citalopram
citalopram increases effects of prasugrel by pharmacodynamic synergism. Use Caution/Monitor. Combination may increase risk of bleeding.
- dabigatran
dabigatran, prasugrel. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.
- dalteparin
dalteparin, prasugrel. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Enhanced risk of hemorrhage.
- deferasirox
deferasirox, prasugrel. Other (see comment). Use Caution/Monitor. Comment: Gastric ulceration and GI bleeding have been reported in patients taking deferasirox, use caution when coadministering with other drugs known to increase the risk of peptic ulcers or gastric hemorrhage including anticoagulants.
- defibrotide
defibrotide increases effects of prasugrel by Other (see comment). Use Caution/Monitor. Comment: Defibrotide may enhance effects of platelet inhibitors.
- diclofenac
diclofenac, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.
- diflunisal
diflunisal, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.
- edoxaban
edoxaban, prasugrel. Either increases toxicity of the other by anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding. The need for simultaneous use of platelet aggregation inhibitors with anticoagulants is common for patients with cardiovascular disease, but may result in increased bleeding; monitor closely. Promptly evaluate any signs or symptoms of blood loss.
- enoxaparin
enoxaparin, prasugrel. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Enhanced risk of hemorrhage.
- etodolac
etodolac, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.
- fenoprofen
fenoprofen, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.
- fentanyl
fentanyl will decrease the level or effect of prasugrel by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Coadministration of opioid agonists delay and reduce the absorption of prasugrel?s active metabolite presumably because of slowed gastric emptying. Consider using a parenteral antiplatelet agent in acute coronary syndrome patients requiring coadministration of morphine or other opioid agonists. Risks associated with other opioids are unknown.
- fish oil
fish oil, prasugrel. Other (see comment). Use Caution/Monitor. Comment: Patients taking fish oil and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding. .
- fish oil triglycerides
fish oil triglycerides will increase the level or effect of prasugrel by anticoagulation. Use Caution/Monitor. Prolonged bleeding reported in patients taking antiplatelet agents or anticoagulants and oral omega-3 fatty acids. Periodically monitor bleeding time in patients receiving fish oil triglycerides and concomitant antiplatelet agents or anticoagulants.
- flurbiprofen
flurbiprofen, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.
- fondaparinux
fondaparinux, prasugrel. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Enhanced risk of hemorrhage.
- green tea
green tea increases effects of prasugrel by pharmacodynamic synergism. Use Caution/Monitor. (Theoretical interaction). Combination may increase risk of bleeding.
- ibrutinib
ibrutinib will increase the level or effect of prasugrel by anticoagulation. Use Caution/Monitor. Ibrutinib may increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies and monitor for signs of bleeding.
- ibuprofen
ibuprofen, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.
- ibuprofen IV
ibuprofen IV, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.
- ibuprofen/famotidine
ibuprofen/famotidine, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.
- icosapent
icosapent, prasugrel. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Icosapent may prolong bleeding time; monitor periodically if coadministered with other drugs that affect bleeding.
- imatinib
imatinib, prasugrel. Either increases toxicity of the other by Other (see comment). Modify Therapy/Monitor Closely. Comment: Imatinib may cause thrombocytopenia; bleeding risk increased when imatinib is coadministered with anticoagulants, NSAIDs, platelet inhibitors, and thrombolytic agents.
- indomethacin
indomethacin, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.
- ketoprofen
ketoprofen, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.
- ketorolac
ketorolac, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.
- ketorolac intranasal
ketorolac intranasal, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.
- meclofenamate
meclofenamate, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.
- mefenamic acid
mefenamic acid, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.
- melatonin
melatonin increases effects of prasugrel by anticoagulation. Use Caution/Monitor. Melatonin may decrease prothrombin time.
- meloxicam
meloxicam, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.
- nabumetone
nabumetone, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.
- naproxen
naproxen, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.
- omega 3 carboxylic acids
omega 3 carboxylic acids, prasugrel. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.
- omega 3 fatty acids
omega 3 fatty acids, prasugrel. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3-fatty acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding. .
- oxaprozin
oxaprozin, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.
- piracetam
piracetam increases effects of prasugrel by pharmacodynamic synergism. Use Caution/Monitor.
- piroxicam
piroxicam, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.
- porfimer
prasugrel decreases effects of porfimer by pharmacodynamic antagonism. Use Caution/Monitor.
- rivaroxaban
rivaroxaban, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Avoid concurrent use of rivaroxaban with other anticoagulants due to increased bleeding risk other than during therapeutic transition periods where patients should be observed closely. Monitor for signs/symptoms of blood loss.
- salsalate
salsalate, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.
- selumetinib
prasugrel and selumetinib both increase anticoagulation. Modify Therapy/Monitor Closely. An increased risk of bleeding may occur in patients taking a vitamin-K antagonist or an antiplatelet agent with selumetinib. Monitor for bleeding and INR or PT in patients coadministered a vitamin-K antagonist or an antiplatelet agent with selumetinib.
- sodium zirconium cyclosilicate
sodium zirconium cyclosilicate will decrease the level or effect of prasugrel by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.
- sulindac
sulindac, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.
- ticagrelor
ticagrelor, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Increased risk of bleeding during concomitant use of medications that increase potential for bleeding.
- tolmetin
tolmetin, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.
- vorapaxar
prasugrel, vorapaxar. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Coadministration of anticoagulants, antiplatelets, or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.
- vortioxetine
prasugrel increases effects of vortioxetine by anticoagulation. Use Caution/Monitor.
- warfarin
prasugrel, warfarin. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Drugs with antiplatelet properties may increase anticoagulation effect of warfarin.
Minor (5)
- devil's claw
devil's claw, prasugrel. pharmacodynamic synergism. Minor/Significance Unknown. May prolong bleeding time. Conflicting evidence. Use with caution.
- ginger
ginger, prasugrel. pharmacodynamic synergism. Minor/Significance Unknown. May prolong bleeding time. Conflicting evidence. Use with caution.
- ginkgo biloba
ginkgo biloba, prasugrel. pharmacodynamic synergism. Minor/Significance Unknown. May prolong bleeding time. Conflicting evidence.ÿ Use with caution.
- horse chestnut seed
horse chestnut seed, prasugrel. pharmacodynamic synergism. Minor/Significance Unknown. May prolong bleeding time. Theoretical. Use with caution.
- verteporfin
prasugrel decreases effects of verteporfin by pharmacodynamic antagonism. Minor/Significance Unknown.
Adverse Effects
1-10%
Hypertension (7.5%)
Hypercholesterolemia/hyperlipidemia (7%)
Headache (5.5%)
Back pain (5%)
Dyspnea (4.9%)
Nausea (4.6%)
Dizziness (4.1%)
Cough (3.9%)
Hypotension (3.9%)
Fatigue (3.7%)
Noncardiac chest pain (3.1%)
Atrial fibrillation (2.9%)
Bradycardia (2.9%)
Leukopenia (<4 x 10^9 WBC/L) (2.8%)
Rash (2.8%)
Pyrexia (2.7%)
Peripheral edema (2.7%)
Pain in extremity (2.6%)
Diarrhea (2.3%)
<1%
Thrombotic thrombocytopenic purpura
Abnormal hepatic function
Angioedema
Hematoma
Hemolysis
Hemorrhage
Abnormal liver function
Postmarketing Reports
Blood and lymphatic system disorders: Thrombocytopenia, thrombotic thrombocytopenic purpura (TTP)
Immune system disorders: Hypersensitivity reactions (eg, anaphylaxis)
Warnings
Black Box Warnings
Potential for significant, sometimes fatal, bleeding
- Prasugrel can cause significant, sometimes fatal, bleeding
- Do not use in patients with active pathological bleeding or a history of transient ischemic attack or stroke
- In patients ≥75 years of age, use is generally not recommended, owing to increased risk of fatal and intracranial bleeding and uncertain benefit, except in high-risk situations (eg, diabetes or prior MI)
- Do not start in patients likely to undergo urgent coronary artery bypass graft surgery (CABG); when possible, discontinue prasugrel at least 7 days prior to any surgery
- If possible, manage bleeding without discontinuing (risk of subsequent cardiovascular events is increased if prasugrel stopped, particularly in first few weeks after ACS)
- Suspect bleeding in any patient who is hypotensive and has recently undergone invasive or surgical procedures
Additional risk factors for bleeding
- Weight <60 kg increases risk of bleeding
- Propensity to bleed (eg, recent trauma, recent surgery, recent or recurrent GI bleeding, active peptic ulcer disease, severe hepatic impairment, or moderate-to-severe renal impairment)
- Concomitant use of other drugs that increase bleeding risk
Contraindications
Hypersensitivity
Active pathologic bleeding (eg, peptic ulcer, intracranial hemorrhage)
Prior TIA or stroke
Cautions
Hypersensitivity with angioedema reported
Bleeding diathesis
Thrombocytopenic purpura occurring within 2 weeks of initiation of therapy reported
Discontinue treatment for active bleeding, elective surgery, stroke, or TIA; premature discontinuation of any antiplatelet medication conveys an increased risk of stent thrombosis, myocardial infarction, and death; patients who require premature discontinuation of a thienopyridine will be at increased risk for cardiac events; avoid lapses in therapy, and if thienopyridines must be temporarily discontinued because of an adverse event(s), restart as soon as possible
Risk increases in patients receiving drug who undergo CABG
Premature discontinuation increases risk of stent thrombosis, MI, and death
See Black Box Warnings
Drug interactions overview
- Coadministration with warfarin or nonsteroidal anti-inflammatory drugs (NSAIDs) (used chronically) increases the risk of bleeding
- Coadministration of opioid agonists delay and reduce the absorption of prasugrel’s active metabolite presumably because of slowed gastric emptying
Pregnancy & Lactation
Pregnancy
There are no data with prasugrel use in pregnant women to inform a drug-associated risk
Due to the mechanism of action, and the associated identified risk of bleeding, consider the benefits and possible risks to the fetus when prescribing prasugrel to a pregnant woman
Lactation
There is no information regarding the presence of prasugrel in human milk, the effects on the breastfed infant, or the effects on milk production
Metabolites of prasugrel were found in rat milk
Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for prasugrel and any potential adverse effects on the breastfed child from prasugrel or from the underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
A prodrug, a thienopyridine that inhibits platelet activation and aggregation through irreversible binding of active metabolite to adenosine phosphate (ADP) platelet receptors (specifically, P2Y12 receptor)
Absorption
Bioavailability: >78%
Peak plasma time: 30 min
Absorption: >79%
With high fat, high calorie meal, peak plasma concentration decreased by 49% and peak plasma time increased from 0.5-1.5 hr
Distribution
Protein bound: 98% (active metabolite)
Vd: 44-68 L (active metabolite)
Metabolism
Rapidly hydrolyzed in intestine to active metabolite via CYP3A4 and CYP2B6
Elimination
Half-life: 7 hr (range, 2-15 hr)
Clearance: 112-166 L/hr
Excretion: Urine (68%), feces (27%)
Administration
Oral Administration
Take with or without food
Storage
Tablets: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F); dispense and keep product in original container; keep container closed and do not remove desiccant from bottle
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Effient oral - | 10 mg tablet |  | |
| Effient oral - | 5 mg tablet |  |
Copyright © 2010 First DataBank, Inc.
Formulary
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