Aluminum hydroxide 320 mg/5 mL gel oral suspension

640 mg 5-6 times/d after meals and at bedtime x 2 weeks

NA

Constipation, hypophosphatemia, anemia, osteomalacia

Increases pH which affects absorption of weak acids (digoxin, phenytoin, isoniazid)

Decreases bioavailability of drugs via adsorption (e.g., tetracyclines, fluoroquinolones)

Increases urinary pH, which inhibits excretion of bases (quinidine, amphetamines) and enhances excretion of acidic drugs (salicylates)

Take 1-3 hours after meals

Maintain proper hydration

Magnesium hydroxide

311 mg chewable tablet;

1200 mg/5 mL oral suspension

5-15 mL (2-4 tabs) up to QID

NA

Cathartic colon (chronic abuse), rectal bleeding, tartrazine (FD&C Yellow) sensitivity

Take with full glass of water

Do not use longer than 1 week

Do not use if experiencing abdominal pain, nausea, vomiting

Calcium carbonate 200, 500, 600, 650, 750, 1000, 1250 mg tablets/capsules/chewable tablets; 1250 mg/5 mL oral suspension

500 mg, 2-4 tablets PRN

NA

Tartrazine (FD&C Yellow) sensitivity, GI tract irritation, hypercalcemia, renal calculi

Take with or after meals for best absorption

Take with full glass of water

Avoid excessive use in pregnancy

Bismuth subsalicylate 262 mg caplet/chewable tablet; 262 mg/15 mL, 525 mg/15 mL oral suspension

Bismuth subcitrate potassium

(Pylera)^b

Gas/indigestion/ heartburn/nausea: 2 tablets or 30 mL (524 mg) every 30 min to 1 h, PRN (maximum 8 doses/d)

H. pylori

525 mg QID

H. pylori

3 capsules with each meal and at bedtime

Nausea and vomiting, fever, tinnitus, fecal impaction

Coadministration with anticoagulants may increase the risk of bleeding

May decrease absorption of tetracyclines

Causes gray-black stool

Potentially toxic if breastfeeding

Cimetidine (Tagamet HB)
200, 300, 400, 800 mg tablet; 300 mg/5 mL oral solution^e

200-400 mg/d

GERD, erosive

1600 mg/d, divided as BID or QID, x 12 weeks

Duodenal ulcer

800 mg QHS or

300 mg QID with meals and QHS or

400 mg BID x 8 weeks

400 mg QHS (maintenance)

Benign Gastric ulcer

800 mg QHS or

300 mg QID with meals and QHS x 8 weeks

Headache, gynecomastia

Major CYP inhibitor; increases serum levels and delays elimination of drugs metabolized by CYP, including drugs with narrow therapeutic windows (warfarin, theophylline, phenytoin)

OTC – do not take maximum dose for more than 2 weeks

Do not use with other acid reducers

Famotidine (Pepcid, Pepcid AC)
10, 20, 40 mg tablet; 40 mg/5 mL powder for oral suspension^e

10-20 mg/d

GERD

20 mg BID x 6 weeks

Duodenal ulcer

40 mg QHS or 20 mg BID x 4 to 8 weeks

20 mg QHS

(maintenance)

Benign Gastric ulcer

40 mg QHS

Headache, dizziness, constipation, diarrhea

No CYP activity

Additive effect with other QT-prolonging drugs

Decreases levels of many drugs via increased gastric pH causing reduced effectiveness (cyclosporine, cefditoren, cefpodoxime, itraconazole, certain ARTs, tyrosine kinase inhibitors)

Nizatidine (Axid; Axid AR)
75 mg tablet;

150, 300 mg capsule;

15 mg/mL oral solution

75 mg/d

GERD

150 mg BID

Duodenal ulcer

300 mg QHS x 4 weeks

(150 mg BID alternative)

150 mg QHS (maintenance)

Benign Gastric ulcer

300 mg given either as 150 mg BID or 300 mg QHS

Dizziness, headache

No CYP activity

Absorption decreased by aluminum- and magnesium-containing antacids

Ranitidine (Zantac)

150, 300 mg capsule; 75, 150, 300 mg tablet;

15 mg/mL, 75 mg/5 mL, 150 mg/10 mL oral syrup^e

75 mg/d

GERD

150 mg BID x 6 weeks

Duodenal/benign gastric ulcer

150 mg BID initial, 150 mg QHS (maintenance)

Rare

No clinical CYP activity

Omeprazole

(Prilosec)

10, 20, 40 mg delayed-release capsule;

2 mg/mL oral suspension; 20 mg delayed-release tablet

20 mg/d

GERD

20 mg/d x 4 weeks

Duodenal ulcer ±

H. pylori

20 mg/d x 4-8 weeks

Gastric ulcer

40 mg/d x 4-8 weeks

Headache, nausea, vomiting, diarrhea, abdominal pain, flatulence

Antiplatelets: All PPIs have the potential to inhibit conversion of clopidogrel to its active metabolite via CYP 2C19. However, there is no good evidence showing meaningful differences in clinical outcomes.^2,5

Reduced efficacy of drugs that depend on gastric pH, (e.g., ketoconazole, ampicillin, iron salts, digoxin, cyanocobalamin)

Drug-lab interaction: false-positive for THC in urine drug test

Can use with antacids

If diarrhea does not improve, rule-out CDI

Take before meals: omeprazole, esomeprazole, lansoprazole

Take without regard to meals: dexlansoprazole, pantoprazole, rabeprazole

Can open and sprinkle over applesauce: dexlansoprazole, esomeprazole, lansoprazole, rabeprazole

Chronic use of PPIs and/or H2RAs can cause decreased absorption of vitamin B12, especially with high doses and in elderly patients. Hypomagnesemia is also possible, but rare.

Pregnancy category B (omeprazole category C); all safe in pregnancy per ACG guideline

Omeprazole/sodium bicarbonate

(Zegerid; Zegerid OTC)

Oral capsule/packet, omeprazole
20, 40 mg/bicarbonate 1100, 1680 mg

20 mg/1100 mg/d

GERD & duodenal ulcer

20 mg/d x 4-8 weeks

H. pylori duodenal ulcer

20 mg/d

Gastric ulcer

40 mg/d x 4-8 weeks

Lansoprazole

(Prevacid)

15, 30 mg delayed-release capsule;

15, 30 mg delayed-release orally disintegrating tablet;

3 mg/mL suspension

15 mg/d

GERD

15 mg/d x 8 weeks

Duodenal ulcer

15 mg/d x 4 weeks

15 mg/d

(maintenance)

H. pylori duodenal ulcer

30 mg/d

Gastric ulcer

30 mg/d x 8 weeks

NSAID-induced gastric ulcer

30 mg/d x 8 weeks (healing)

15 mg/d x 12 weeks (risk reduction)

Abdominal pain, nausea, diarrhea, constipation

Esomeprazole

(Nexium; Nexium 24 HR)
20, 40 mg delayed-release oral capsule; 2.5, 5, 10, 20, 40 mg delayed-release powder for oral suspension; 49.3 mg delayed release capsule^e

20 mg/d

GERD

20 mg/d x 4-8 weeks

H. pylori eradication

40 mg/d x 10 days

NSAID-induced gastric ulcer

20-40 mg/d up to 6 months (risk reduction)

Headache, flatulence, nausea, diarrhea, abdominal pain, dizziness, vertigo, dry mouth

Pantoprazole

(Protonix)
20, 40 mg delayed release tablet^e

40 mg packet

Rx only

GERD (erosive)

40 mg/d x 8-16 weeks

Headache, dizziness, diarrhea, vomiting, arthralgia

Rabeprazole (Aciphex)
20 mg delayed-release tablet

5 and 10 mg capsule sprinkle

Rx only

GERD

20 mg/d x 4-8 weeks

Duodenal ulcer

20 mg/d after morning meal x 4 weeks

H. pylori

20 mg BID with meals x 7 days

Pain, pharyngitis, flatulence, constipation, infection

Dexlansoprazole (Dexilant)
30, 60 mg delayed-release capsule

Rx only

GERD

30 mg/d x 4 weeks

Ulcer healing

30-60 mg/d

Ulcer maintenance

30 mg/d

Nausea, vomiting, diarrhea, flatulence, upper respiratory tract infection

Amoxicillin (Moxatag, various generics)
Tablet, capsule, chewable tablet, powder for oral suspension, extended-release tablet (Moxatag only)

Rx only

1 g BID

All: hypersensitivity reactions, GI, CNS, dermatologic effects

Superinfection possible

CDAD possible with all but tetracycline

QT prolongation possible with levofloxacin and clarithromycin

Teeth discoloration may occur in children if mother takes tetracycline during last half of pregnancy, or if taken by infants and children up to 8 years of age

Boxed warning for levofloxacin: tendinitis/tendon rupture and exacerbation of myasthenia gravis

Decreases effect of live vaccine and oral contraceptives

Causes increased methotrexate levels

Pregnancy category B

Do not swallow chewable tablets whole

Store oral suspension at room temperature or refrigerated for 14 days

Clarithromycin (Biaxin)
Tablet, extended-release tablet, powder for oral suspension

500 mg BID

Major CYP3A4 substrate

Weak CYP1A2 inhibitor

Strong CYP3A4 inhibitor

Inhibits P-glycoprotein

Contraindicated with multiple drugs, including QT prolonging drugs

Pregnancy category C

Do not refrigerate reconstituted solution

Levofloxacin (Levaquin)
Tablet, oral solution, ophthalmic solution^e

500 mg QD or BID

Additive effect with QT-prolonging drugs

Decreases effect of live vaccine

Decreased absorption of levofloxacin with concomitant use of antacids

Pregnancy category C

Tetracycline,

Oral capsule

500 mg QID

Decreases effect of live vaccines, oral contraceptives

Impaired absorption if given with drugs that adsorb tetracycline

Contraindicated in second and third trimesters

Metronidazole (Flagyl)
Oral capsule, oral tablet, topical cream/gel/lotion, vaginal gel^e

500 mg BID

250 mg QID

Peripheral neuropathy, vaginal candidiasis, GI discomfort

Boxed warning of possible carcinogenesis

Disulfiram reaction with ethanol

Potentiates anticoagulant effect of warfarin

Human data suggest low risk in pregnancy

Avoid alcohol during and for 3 days after therapy

Contraindicated when breastfeeding

Bismuth subsalicylate^g

Refer to antacids section above.

Sucralfate (Carafate)
Oral suspension, tablet

Rx only

Duodenal Ulcer

1 g QID empty stomach

1 g BID (maintenance dose)

Constipation

Bezoars have been reported

Decreased absorption of many drugs

Pregnancy category B

Misoprostol (Cytotec)
Oral tablet

Ulcer healing

200 mcg QID

Diarrhea

Boxed warning: abortifacient, contraindicated in women of child-bearing potential

Oxytocin,

antacids

Abortifacient and teratogen: follow safe handling procedures

Table 9. Guideline-Recommended Drugs for Ulcerative Colitis and Crohn's Disease^4,11-14*

Drug

Formulation

Induction

Maintenance

Common side effects

Drug interactions

Comments

Sulfasalazine (Azulfidine, Azulfidine EN)

Oral tablet, 500 mg

Delayed release tablet (EN), 500 mg

UC: 4-6 g/d, divided

CD: 3-6 g/d, divided

UC: 2-4 g/d

CD: none

Anorexia, gastric pain, headache, nausea, vomiting, reversible oligospermia

Sulfapyridine intolerance results in nausea, vomiting, headache, anorexia

Decreases folate absorption in diet

Minimal hepatic metabolism; extensively metabolized by intestinal tract

Potentiates effect of heparin, LMWH, MTX (hepatotoxicity), prilocaine (methemoglobinemia), Varicella-containing vaccines (Reye's Syndrome)

Decreases concentration of digoxin

Warnings

Irreversible neuromuscular and CNS changes, blood dyscrasias, renal damage, hepatotoxicity, serious infections (e.g., pneumonia and sepsis), serious skin reactions, crystalluria, G6PD deficiency at risk for hemolytic anemia, porphyria, oligospermia, hypersensitivity reactions

Mesalamine (Canasa)

Rectal suppository, 1 g

UC: 1 g/d

UC: 500 mg/d or BID

Headache, abdominal pain, flatulence, diarrhea, nausea

Inhibits TMPT, which can increase toxicity of AZA and 6-MP

Do not administer antacids, PPIs, H2RAs with formulations with pH-sensitive coatings (Asacol, Lialda, Apriso), which cause early dissolution of coating

Warnings

Worsening of symptoms may occur, including acute intolerance syndrome

Cases of pericarditis, pancolitis, and sulfite sensitivity have been reported

Monitor renal function if pre-existing renal condition

Nephrotoxicity, pancreatitis, hepatotoxicity, and infertility in men have been reported in postmarketing setting

Mesalamine (Rowasa)

Rectal enema, 4 g/60 mL

UC: 1-4 g/d

UC: 2-4 g/d to every third day

Mesalamine (Asacol)

Delayed release tablet, 400 mg

UC: 800 mg TID

UC: 3.2 g/d

Mesalamine (Asacol HD)

Delayed release tablet, 800 mg

UC: 1600 mg TID

UC: Use beyond 6 weeks not evaluated

Mesalamine (Apriso)

24 hour extended release capsule, 0.375 g

None

UC: 1.5 g/d

Mesalamine (Lialda)

Delayed release tablet, 1.2 g

UC: 2.4 g or 4.8 g/d

UC: 2.4 g/d

Mesalamine (Pentasa)

Extended release capsule, 250 mg, 500 mg

UC: 1 g QID

UC: 1 g QID

Mesalamine (Delzicol)

Delayed release capsule, 400 mg

UC: 800 mg TID

UC: 1.6 g/d, divided

Olsalazine (Dipentum)

Oral capsule, 250 mg

UC: 1.5-3 g/d in 2 divided doses

UC: 1 g/d

Diarrhea, rash, abdominal pain, headache

Increased PT with warfarin

Warnings

Dose-related diarrhea, exacerbation of symptoms, renal tubular damage, carcinogenesis

Balsalazide (Colazal, Giazo)

Oral capsule, 750 mg (Colazal), 1.1 g (Giazo)

UC: 6.75 g/d in 3 divided doses

UC: 3-6 g/d

Headache, abdominal pain, diarrhea, nausea, arthralgia, respiratory tract infection, vomiting

Same as mesalamine

Therapeutically active form is mesalamine

Warnings

Renal toxicity and hypersensitivity reactions, exacerbation of UC, pyloric stenosis, hepatic function impairment

Hydrocortisone rectal topical (Colocort, Cortenema, Cortifoam)

Rectal enema, 100 mg/mL

10% foam, 90 mg (Cortifoam)

UC: Enema: 1 enema QHS x 21 days

Foam: 1 applicator full once or twice daily x 2-3 weeks, then every second day thereafter

Not recommended for chronic use

Burning, itching, irritation, dryness, allergic contact dermatitis, secondary infection

Lack of antibody response or neurological complications with vaccination

Warnings

Rectal wall damage possible with improper administration technique, signs of infection may be masked, ocular effects, BP elevation, electrolyte abnormalities, viral infections, reactivation of TB, psychiatric effects, secondary adrenal insufficiency

Budesonide

(Enterocort EC, Uceris)

24 hour extended release capsule, 3 mg (Entocort EC)

Extended release tablet, 9 mg (Uceris)

CD & UC: 9 mg/d

Not recommended for chronic use

Prednisone

oral

UC & CD: 40-60 mg/d

Not recommended for chronic use

Azathioprine (Imuran, Azasan)

Oral tablet, 50 mg, 75 mg, 100 mg

UC: 2-3 mg/kg/d

UC: 1.5-2.5 mg/kg/d

CD: 2-2.5 mg/kg/d

Myelosuppression, nausea, vomiting, diarrhea, hepatotoxicity, rash, pulmonary edema, pancreatitis, hypersensitivity

Increases effect of warfarin

XO inhibitors (allopurinol, febuxostat) may inhibit metabolism of AZA and 6-MP, leading to bone marrow suppression; dose reduction of AZA/6-MP may be necessary

Coadministration with ACEi or TMP/SMX may cause severe leukopenia

Hazardous agent handling precautions

Boxed warning

Malignancy (non-melanoma skin cancer and lymphoma), serious infection, hematologic effects, GI hypersensitivity, caution in renal/hepatic insufficiency

Mercaptopurine (Purinethol)

Oral tablet, 50 mg

UC: 1.5 mg/kg/d

UC: 1.5 mg/kg/d

CD: 1.5 mg/kg/d

Adalimumab (Humira)

10 mg/0.2 mL SC

20 mg/0.4 mL SC

40 mg/0.8 mL SC

CD: 160 mg wk 0, 80 mg wk 2

CD: 40 mg every wk or every other wk

Injection site reactions

Enhances neutropenic effect of other immunosuppressants

Enhances toxic effect of live vaccines

Diminishes therapeutic effect of inactivated vaccines

Boxed warnings

Increased risk of serious infections, including active TB, invasive fungal infections, and opportunistic infections

Malignancy

Warnings

CNS demyelinating disease

Pancytopenia

Worsening of CHF

Hypersensitivity

Autoimmunity

Certolizumab (Cimzia)

200 mg/mL SC kit

CD: 400 mg

CD: 400 mg every 4 weeks

URI, rash, UTI

Infliximab (Remicade)

100 mg reconstituted IV solution

CD & UC: 5 mg/kg IV at wk 0, 2, 6

CD & UC : 5 mg/kg IV every 8 weeks

Infusion reactions (dyspnea, flushing, headache, rash)

Natalizumab (Tysabri)

300 mg/15 mL injection solution

CD: 300 mg IV every 4 weeks

CD: 300 mg IV every 4 weeks

Headache, fatigue, URI, nausea

Boxed warning

Increased risk of opportunistic viral infection of brain, progressive multifocal leukoencephalopathy, leading to potential death or severe disability

REMS

TOUCH program, both patient and prescriber must be enrolled prior to dispensing

Warnings

Herpes encephalitis/

meningitis

Hepatotoxicity

Immunogenicity

Hypersensitivity

PEG IFN alfa-2a (Pegasys)

180 mcg SC once weekly

Renal impairment

Contraindicated in hepatic decompensation (Child-Pugh B or C)

Reduce dose for adverse reactions

Hypertension, neuropsychiatric reactions, bone marrow suppression, autoimmune exacerbation, ocular effects, cerebrovascular events, hepatitis B exacerbations, pulmonary effects, pancreatitis, fertility impairment, flu-like symptoms

Combinations with NRTIs may cause hematologic toxicity

Increased methadone and theophylline levels

Baseline:

Standard hematological and biochemical laboratory tests, including CrCl, and an eye examination

Pregnancy screening

Electrocardiograms for patients with preexisting cardiac disease

During therapy:

Hematological/biochemical tests

TSH

Evidence of psychiatric symptoms

Signs/symptoms of toxicity

Administer in abdomen or thigh

Do not shake

Do not leave outside of refrigerator for

>24 hours

Protect from light

Pregnancy category C

Entecavir (Baraclude)

0.5 mg once daily^b

1 mg once daily^c

Dose adjustment when CrCl <50 mL/min

Dizziness, fatigue, headache, nausea, ALT elevation associated with VL reduction

Boxed warning

Severe acute exacerbation of HBV may occur if entecavir discontinued

Treatment for HIV/HBV coinfection not recommended due to resistance

Lactic acidosis and hepatomegaly have been reported

Increased levels of entecavir if coadministered with drugs competing for renal tubular secretion, or drugs that reduce renal function

Hepatic function, periodically

Adverse reactions when administered with drugs affecting renal function

Take on an empty stomach 2 hours after a meal and 2 hours before the next meal

Pregnancy category C

Tenofovir (Viread)

300 mg once daily

Dose adjustment when CrCl <50 mL/min

Fanconi syndrome,

osteomalacia, decreased bone density, renal insufficiency

Boxed warning

Severe acute exacerbation of HBV may occur if tenofovir discontinued

Lactic acidosis and hepatomegaly have been reported

Weak CYP1A2 inhibitor

P-glycoprotein inducer

HIV status

Bone density

Urine SCr, glucose, protein

LFTs

Take with or without food

Pregnancy category B

Lamivudine (Epivir)

100 mg once daily

Dose adjustment when CrCl <50 mL/min

Well-tolerated;

reports of myopathy, peripheral neuropathy

Boxed warning

Severe acute exacerbation of HBV may occur if lamivudine discontinued

Lamivudine-containing products have lower dose for HBV than HIV

Lactic acidosis and hepatomegaly have been reported

Pancreatitis

Enhances effect/toxicity of emtricitabine and ganciclovir/valganciclovir

Enhances hepatotoxicity of ribavirin

Decreases excretion of trimethoprim

Hematologic labs

Signs/symptoms of pancreatitis

Amylase, bilirubin, LFTs

Take without regard to meals

Pregnancy category C

Adefovir (Hepsera)

10 mg once daily

Extend dosing interval when CrCl <50 mL/min

Boxed warning

Severe acute exacerbation of HBV may occur if adefovir discontinued

HIV resistance may develop in patients with HBV/HIV coinfection not being treated for HIV

Lactic acidosis and hepatomegaly have been reported

Nephrotoxicity may occur in patients with underlying renal dysfunction

Fanconi syndrome

Nephrogenic diabetes insipidus

Increased concentration if coadministered with nephrotoxic drugs or drugs that competitively inhibit renal tubular secretion

Renal and hepatic function

Take with or without food

Pregnancy category C

Telbivudine (Tyzeka)

600 mg once daily

Dose adjustment when CrCl <50 mL/min and in elderly patients

Myopathy, peripheral neuropathy

Boxed warning

Severe acute exacerbation of HBV may occur if telbivudine discontinued

Lactic acidosis and hepatomegaly have been reported

Potential additive effect of myopathy if given with other drugs known to cause myopathy

Increased neuropathy with PEG IFN alfa-2a

Hepatic and renal function

Unexplained muscle weakness and tenderness

Take with or without food

Pregnancy category B

Daclatasvir (Daklinza)

60 mg once daily

Strong CYP3A inhibitors: reduce dose to 30 mg once daily

Moderate CYP3A inducers: increase dose to 90 mg once daily

Bradycardia, fatigue, headache, diarrhea, nausea

Substrate of CYP3A4, P-glycoprotein

Liver enzymes and serum creatinine at baseline and periodically when indicated thereafter

Do not use as monotherapy; use only in combination with sofosbuvir

Approved for use in genotype 3 infection; duration of therapy 12 weeks

Administer with or without food

Elbasvir; grazoprevir (Zepatier)

1 tablet once daily

None

ALT elevations; changes have been mostly asymptomatic and resolved with ongoing or completed therapy

Many potential drug interactions with this agent; refer to product labeling for specific information

Hepatic function: monitor at baseline, treatment week 8, and week 12 (if treatment duration is 16 weeks) and as clinically indicated

May need to test for viral resistance

HCV RNA at baseline, weeks 4, 8, and 12, during follow-up, and when clinically indicated

May be used in combination with ribavirin in some patients

Approved for use in genotype 1 and 4 infection with or without cirrhosis; duration of therapy 12 or 16 weeks

Administer without regard to meals

Contraindicated in moderate or severe hepatic impairment

Ledipasvir; sofosbuvir

(Harvoni)

1 tablet once daily

None

Fatigue, headache, insomnia, diarrhea, nausea, increased lipase

Bilirubin, liver enzymes, and serum creatinine at baseline and periodically when indicated

HCV RNA at baseline, during treatment, at the end of treatment, during follow-up, and when clinically indicated

May be used with ribavirin in some patients

Approved for use in genotype 1, 4, 5 or 6 infection; duration of therapy 8, 12, or 24 weeks

Administer with or without food

Ombitasvir; paritaprevir; ritonavir

(Technivie)

2 tablets every morning

None

Weakness, fatigue, insomnia, allergic skin reaction, pruritus, nausea, hepatic effects

Baseline hepatic function tests and for the first 4 weeks of therapy, then periodically during therapy

HCV RNA at baseline and at the end of treatment, during follow-up, and when clinically indicated

May be used in combination with ribavirin

Approved for use in genotype 4 infection; duration of therapy 12 weeks

Contraindicated in moderate to severe hepatic impairment

Concurrent use of ethinyl estradiol-containing products is contraindicated; these products may be restarted approximately 2 weeks following completion of HCV therapy

Administer with a meal

Ombitasvir; paritaprevir; ritonavir; dasabuvir

(Viekira Pak)

2 tablets every morning of Technivie

1 tablet twice daily of dasabuvir

None

Fatigue, headache, insomnia, pruritus, diarrhea, nausea, decreased hemoglobin, muscle spasm, weakness, cough, hepatic effects

Baseline hepatic function tests and for the first 4 weeks of therapy, then periodically during therapy

HCV RNA at baseline and at the end of treatment, during follow-up, and when clinically indicated

May be used in combination with ribavirin

Approved for use in genotype 1 infection; duration of therapy 12 or 24 weeks

Contraindicated in moderate to severe hepatic impairment

Concurrent use of ethinyl estradiol-containing products is contraindicated; these products may be restarted approximately 2 weeks following completion of HCV therapy

Administer with a meal

Sofosbuvir (Sovaldi)

400 mg once daily

Dose reduction is not recommended

Chills, fatigue, headache, insomnia, irritability, pruritis, skin rash, diarrhea, nausea, decreased appetite, decreased neutrophils, thrombocytopenia,, anemia, fever, myalgia, flu-like symptoms

P-glycoprotein substrate

Bilirubin, liver enzymes, and serum creatinine at baseline and periodically when indicated

HCV RNA at baseline, during treatment, at the end of treatment, during follow-up and when indicated

Pretreatment and monthly pregnancy tests

Use only in combination with ribavirin or in combination with pegylated interferon and ribavirin

Approved for use in genotype 1, 2, 3, or 4 infection and in patients with hepatocellular carcinoma patients awaiting transplantation; duration of therapy 12, 24, or 48 weeks

Administer with or without food

Teratogenic

Simeprevir (Olysio)

150 mg once daily

None

Dizziness, fatigue, headache, insomnia, pruritus, skin rash, diarrhea, nausea, myalgia, dyspnea, photosensitivity, hepatic effects

Sulfa allergy – contains a sulfonamide moiety; no increased incidence of rash has been reported

CYP3A4 substrate, inducers/inhibitors may significantly affect serum drug levels

Mildly inhibits CYP1A2, P-glycoprotein

Bilirubin and liver enzymes at baseline and periodically when indicated

HCV RNA at baseline, weeks 4, 12, and 24, end of treatment, during follow-up and when clinically indicated

Viral resistance screening

Monotherapy is not recommended; administer with other agents for hepatitis C; dose reduction or interruption is not recommended

Approved for use in genotype 1 or 4 infection; duration of therapy 12, 24 or 48 weeks

Contraindicated in moderate or severe hepatic impairment

Patients of East Asian ancestry exhibit higher simeprevir exposures

Administer with food; swallow whole