sofosbuvir (Rx)

Brand and Other Names:Sovaldi
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 400mg

Chronic Hepatitis C Virus (HCV) Infection

Indicated as a component of a combination antiviral regimen for HCV mono-infection and HCV/HIV-1 coinfection

Treatment regimen and duration are dependent on both viral genotype and patient population

Genotype 1 or 4: 400 mg PO qDay plus ribavirin and peginterferon alfa for 12 weeks; may consider sofosbuvir plus ribavirin for 24 weeks in genotype 1 patients ineligible to receive peg-interferon-based regimen

Genotype 2: 400 mg PO qDay plus ribavirin for 12 weeks

Genotype 3: 400 mg PO qDay plus ribavirin for 24 weeks

Patients with hepatocellular carcinoma awaiting liver transplantation

  • For prevention of post-transplant HCV reinfection
  • 400 mg PO qDay plus ribavirin for up to 48 weeks or until the time of liver transplantation, whichever occurs first

Ribavirin dosage regimen with sofosbuvir (genotypes 1, 2, 3, and 4)

  • Take with food
  • <75 kg : 500 mg PO BID
  • ≥75 kg: 600 mg PO BID
  • Renal impairment (CrCl ≤50 mL/min): Reduce dose (see prescribing information)

Peginterferon alfa regimen with sofosbuvir (genotype 1 or 4)

  • Peginterferon alfa 2a: 180 mcg SC weekly
  • Peginterferon alfa 2b: 1.5 mcg/kg/week SC; not to exceed 150 mcg/week
  • Renal impairment (CrCl ≤50 mL/min): Reduce dose (see prescribing information)

Dosage Modification

Reduction of sofosbuvir dose not recommended

Discontinue sofosbuvir therapy if the agents used in combination are discontinued

Genotypes 1 and 4

  • Serious adverse reactions potentially related to peginterferon alfa and/or ribavirin: Should reduce or discontinue dose of peginterferon alfa and/or ribavirin following the recommendations of their respective prescribing information

Genotypes 2 and 3

  • Serious adverse reaction potentially related to ribavirin: Modify or discontinue ribavirin dose
  • Hemoglobin <10 g/dL without cardiac disease: Reduce ribavirin dose to 600 mg/day PO divided BID with food
  • Hemoglobin <8.5 g/dL without cardiac disease: Discontinue ribavirin
  • Cardiac disease and hemoglobin decreased ≥2 g/dL during 4 week period: Reduce ribavirin dose to 600 mg/day PO divided BID with food
  • Cardiac disease and hemoglobin <12 g/dL despite 4 weeks at reduced dose: Discontinue ribavirin
  • After discontinuing the dose may attempt to restart ribavirin at 600 mg PO divided bid and further increase it to 800 mg PO divided bid; increasing the dose to 1000-1200 mg/day not recommended

Renal impairment

  • Mild or moderate: No adjustments required
  • Severe (eGFR <30 mL/min/1.73 m²) or ESRD: No dosage recommendation can be given owing to higher exposures (up to 20-fold) of the predominant sofosbuvir metabolite

Hepatic impairment

  • Mild, moderate, or severe (Child-Pugh Classes A, B or C): No dose adjustments required
  • Decompensated cirrhosis: Not established

Dosing Considerations

Efficacy has been established in combination with peginterferon alfa and ribavirin in HCV genotypes 1, 2, 3, and 4 infected subjects including hepatocellular carcinoma meeting Milan criteria (awaiting liver transplantation) and those with HCV/HIV-1 coinfection

Must not be used as monotherapy; if peginterferon alfa or ribavirin is discontinued for any reason, sofosbuvir must also be discontinued

Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with HCV direct acting antivirals (DDAs)

Dosage Forms & Strengths

tablet

  • 400mg

oral pellets

  • 150mg per packet
  • 200mg per packet

Chronic Hepatitis C Virus (HCV) Infection

Indicated for genotypes 2 or 3 infection in patients (≥3 yr) without cirrhosis or with compensated cirrhosis; use in combination with ribavirin

<3 years: Safety and efficacy not established

≥3 years

  • <17 kg: 150 mg (oral pellets) PO qDay
  • 17 to <35kg: 200 mg (tablet or oral pellets) PO qDay
  • ≥35 kg: 400 mg (tablet or oral pellets) PO qDay

Treatment duration

  • The following regimens apply to HCV treatment-naïve and treatment experienced without cirrhosis or with compensated cirrhosis (Child-Pugh A)
  • The following regimens also apply to HCV/HIV-1 coinfection
  • Genotype 2: 12 weeks plus ribavirin
  • Genotype 3: 24 weeks plus ribavirin
  • Ribavirin dosing
    • <47 kg: 15 mg/kg/day PO (divided dose AM and PM)  

    • 47-49 kg: 600 mg/day PO (ie, 200 mg AM, 400 mg PM)

    • 50-65 kg: 800 mg/day PO (ie, 400 mg AM, 400 mg PM)

    • 66-80 kg: 1000 mg/day PO (ie, 400 mg AM, 600 mg PM)

    • >80 kg: 1200 mg/day PO (ie, 600 mg AM, 600 mg PM)

Dosage Modifications

Renal impairment

  • Mild or moderate: No adjustments required
  • Severe (eGFR <30 mL/min/1.73 m²) or ESRD: No dosage recommendation can be given owing to higher exposures (up to 20-fold) of the predominant sofosbuvir metabolite

Dosing Considerations

Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with HCV direct acting antivirals (DDAs)

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Interactions

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            Contraindicated (0)

              Serious - Use Alternative (16)

              • amiodarone

                sofosbuvir increases toxicity of amiodarone by unknown mechanism. Avoid or Use Alternate Drug. Postmarketing reports describe bradycardia resulting in death or pacemaker insertion when amiodarone was coadministered with sofosbuvir in combination with another direct acting antiviral. Patients also taking beta blockers (7 of 9 of the postmarketing reports), or those with underlying cardiac comorbidities and/or advanced liver disease may be at increased risk for symptomatic bradycardia with coadministration of amiodarone. If coadministration is required, cardiac monitoring in an inpatient setting for the first 48 hr of coadministration is recommended, after which outpatient or self-monitoring of the heart rate should occur on a daily basis through at least the first 2 weeks of treatment.

              • carbamazepine

                carbamazepine will decrease the level or effect of sofosbuvir by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. P-gp inducers decrease sofosbuvir levels, and therefore decrease conversion to sofosbuvir's active metabolite (GS-331007) responsible for 90% of pharmacologic effect

              • eliglustat

                eliglustat increases levels of sofosbuvir by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Monitor therapeutic drug concentrations, as indicated, or consider reducing the dosage of the P-gp substrate and titrate to clinical effect.

              • erdafitinib

                erdafitinib will increase the level or effect of sofosbuvir by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If coadministration unavoidable, separate administration by at least 6 hr before or after administration of P-gp substrates with narrow therapeutic index.

              • fosphenytoin

                fosphenytoin will decrease the level or effect of sofosbuvir by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. P-gp inducers decrease sofosbuvir levels, and therefore decrease conversion to sofosbuvir's active metabolite (GS-331007) responsible for 90% of pharmacologic effect

              • lasmiditan

                lasmiditan increases levels of sofosbuvir by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • oxcarbazepine

                oxcarbazepine will decrease the level or effect of sofosbuvir by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. P-gp inducers decrease sofosbuvir levels, and therefore decrease conversion to sofosbuvir's active metabolite (GS-331007) responsible for 90% of pharmacologic effect

              • phenobarbital

                phenobarbital will decrease the level or effect of sofosbuvir by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. P-gp inducers decrease sofosbuvir levels, and therefore decrease conversion to sofosbuvir's active metabolite (GS-331007) responsible for 90% of pharmacologic effect

              • phenytoin

                phenytoin will decrease the level or effect of sofosbuvir by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. P-gp inducers decrease sofosbuvir levels, and therefore decrease conversion to sofosbuvir's active metabolite (GS-331007) responsible for 90% of pharmacologic effect

              • rifabutin

                rifabutin will decrease the level or effect of sofosbuvir by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. P-gp inducers decrease sofosbuvir levels, and therefore decrease conversion to sofosbuvir's active metabolite (GS-331007) responsible for 90% of pharmacologic effect

              • rifampin

                rifampin will decrease the level or effect of sofosbuvir by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. P-gp inducers decrease sofosbuvir levels, and therefore decrease conversion to sofosbuvir's active metabolite (GS-331007) responsible for 90% of pharmacologic effect

              • rifapentine

                rifapentine will decrease the level or effect of sofosbuvir by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. P-gp inducers decrease sofosbuvir levels, and therefore decrease conversion to sofosbuvir's active metabolite (GS-331007) responsible for 90% of pharmacologic effect

              • sotorasib

                sotorasib will decrease the level or effect of sofosbuvir by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If use is unavoidable, refer to the prescribing information of the P-gp substrate for dosage modifications.

              • St John's Wort

                St John's Wort will decrease the level or effect of sofosbuvir by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. P-gp inducers decrease sofosbuvir levels, and therefore decrease conversion to sofosbuvir's active metabolite (GS-331007) responsible for 90% of pharmacologic effect

              • tepotinib

                tepotinib will increase the level or effect of sofosbuvir by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If concomitant use unavoidable, reduce the P-gp substrate dosage if recommended in its approved product labeling.

              • tipranavir

                tipranavir will decrease the level or effect of sofosbuvir by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. P-gp inducers decrease sofosbuvir levels, and therefore decrease conversion to sofosbuvir's active metabolite (GS-331007) responsible for 90% of pharmacologic effect

              Monitor Closely (18)

              • acalabrutinib

                acalabrutinib increases levels of sofosbuvir by Other (see comment). Use Caution/Monitor. Comment: Acalabrutinib may increase exposure to coadministered BCRP substrates by inhibition of intestinal BCRP.

              • apalutamide

                apalutamide will decrease the level or effect of sofosbuvir by increasing elimination. Use Caution/Monitor. Apalutamide weakly induces BCRP and may decrease systemic exposure of drugs that are BCRP substrates.

              • berotralstat

                berotralstat will increase the level or effect of sofosbuvir by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor or titrate P-gp substrate dose if coadministered.

              • darolutamide

                darolutamide will increase the level or effect of sofosbuvir by Other (see comment). Modify Therapy/Monitor Closely. Darolutamide is a BCRP inhibitor. Avoid coadministration with BCRP inhibitors. If use is unavoidable, closely monitor for adverse reactions and consider dose reduction of BCRP substrate drug (refer BCRP substrate prescribing information).

              • elagolix

                elagolix will increase the level or effect of sofosbuvir by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • elvitegravir/cobicistat/emtricitabine/tenofovir DF

                sofosbuvir will increase the level or effect of elvitegravir/cobicistat/emtricitabine/tenofovir DF by unspecified interaction mechanism. Use Caution/Monitor.

              • fostemsavir

                fostemsavir will increase the level or effect of sofosbuvir by Other (see comment). Modify Therapy/Monitor Closely. Fostemsavir inhibits BCRP transporters. If possible, avoid coadministration or modify dose of BCRP substrate coadministered with fostemsavir.

              • istradefylline

                istradefylline will increase the level or effect of sofosbuvir by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of P-gp substrates in clinical trials. Consider dose reduction of sensitive P-gp substrates.

              • lonafarnib

                lonafarnib will increase the level or effect of sofosbuvir by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Lonafarnib is a weak P-gp inhibitor. Monitor for adverse reactions if coadministered with P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicities. Reduce P-gp substrate dose if needed.

              • regorafenib

                regorafenib will increase the level or effect of sofosbuvir by Other (see comment). Modify Therapy/Monitor Closely. Regorafenib likely inhibits BCRP (ABCG2) transport. Coadministration with a BCRP substrate may increase systemic exposure to the substrate and related toxicity.

              • safinamide

                safinamide will increase the level or effect of sofosbuvir by Other (see comment). Use Caution/Monitor. Safinamide and its major metabolite may inhibit intestinal BCRP. Monitor BCRP substrates for increased pharmacologic or adverse effects.

              • sarecycline

                sarecycline will increase the level or effect of sofosbuvir by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor for toxicities of P-gp substrates that may require dosage reduction when coadministered with P-gp inhibitors.

              • stiripentol

                stiripentol will increase the level or effect of sofosbuvir by Other (see comment). Modify Therapy/Monitor Closely. Stiripentol is a BCRP transport inhibitor. Consider dosage reduction for BCRP substrates if adverse effects are experienced when coadministered.

              • tafamidis

                tafamidis will increase the level or effect of sofosbuvir by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.

              • tafamidis meglumine

                tafamidis meglumine will increase the level or effect of sofosbuvir by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.

              • tenofovir DF

                sofosbuvir will increase the level or effect of tenofovir DF by unspecified interaction mechanism. Use Caution/Monitor.

              • tucatinib

                tucatinib will increase the level or effect of sofosbuvir by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Consider reducing the dosage of P-gp substrates, where minimal concentration changes may lead to serious or life-threatening toxicities.

              • warfarin

                sofosbuvir increases toxicity of warfarin by anticoagulation. Use Caution/Monitor. Fluctuations in INR values may occur in patients receiving warfarin concomitant with HCV treatment; frequent monitoring of INR values recommended during treatment and post-treatment follow-up.

              Minor (0)

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                Adverse Effects

                >10%

                Sofosbuvir plus ribavarin (12 weeks)

                • Fatigue (38%)
                • Headache (24%)
                • Nausea (22%)
                • Insomnia (15%)
                • Pruritus (11%)

                Sofosbuvir plus ribavarin (24 weeks)

                • Fatigue (30%)
                • Headache (30%)
                • Nausea (13%)
                • Insomnia (16%)
                • Pruritus (27%)
                • Asthenia (21%)
                • Diarrhea (12%)

                Sofosbuvir plus ribavarin plus peg-interferon (12 weeks)

                • Fatigue (59%)
                • Headache (36%)
                • Nausea (34%)
                • Insomnia (25%)
                • Pruritus (17%)
                • Anemia (21%)
                • Rash (18%)
                • Decreased appetite (18%)
                • Chills (17%)
                • Influenza-like illness (16%)
                • Pyrexia (18%)
                • Diarrhea (12%)
                • Neutropenia (17%)
                • Myalgia (14%)
                • Irritability (13%)

                Sofosbuvir plus ribavarin plus peg-interferon (24 weeks)

                • Fatigue (55%)
                • Headache (44%)
                • Nausea (29%)
                • Insomnia (29%)
                • Pruritus (17%)
                • Anemia (12%)
                • Rash (18%)
                • Decreased appetite (18%)
                • Chills (18%)
                • Influenza-like illness (18%)
                • Pyrexia (14%)
                • Diarrhea (17%)
                • Neutropenia (12%)
                • Myalgia (16%)
                • Irritability (16%)

                1-10%

                Sofosbuvir plus ribavarin (12 weeks)

                • Anemia (10%)
                • Asthenia (6%)
                • Rash (8%)
                • Decreased appetite (6%)
                • Chills (2%)
                • Influenza-like sickness (3%)
                • Pyrexia (4%)
                • Diarrhea (9%)
                • Myalgia (6%)
                • Irritability (10%)

                Sofosbuvir plus ribavarin (24 weeks)

                • Anemia (6%)
                • Rash (9%)
                • Decreased appetite (6%)
                • Chills (2%)
                • Influenza-like sickness (6%)
                • Pyrexia (4%)
                • Myalgia (9%)
                • Irritability (10%)

                <1%

                Neutropenia

                Pancytopenia

                Severe depression (particularly in patients with pre-existing psychiatric illness)

                Postmarketing Reports

                Bradycardia

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                Warnings

                Black Box Warnings

                Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with HCV direct acting antivirals (DDAs)

                HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with DDAs and were not receiving HBV antiviral therapy

                Some cases have resulted in fulminant hepatitis, hepatic failure, and death

                Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up

                Initiate appropriate patient management for HBV infection as clinically indicated

                Contraindications

                Contraindications applicable to combination therapy

                Combination with ribavirin

                • Hypersensitivity
                • Pregnancy or planning pregnancy, including men whose female partners are pregnant/planning to get pregnant
                • CrCl <50 mL/min
                • Pancreatitis
                • Hemoglobinopathies (eg, thalassemia major, sickle cell anemia)
                • Coadministration with didanosine
                • Autoimmune hepatitis, decompensated liver disease (Child-Pugh class B, C)
                • Use in neonates, infants (contains benzyl alcohol)

                Combination with peg-interferon alfa

                • Autoimmune hepatitis, decompensated liver disease (Child-Pugh class B, C)
                • Use in neonates, infants (contains benzyl alcohol)

                Cautions

                Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV DDAs, and who were not receiving HBV antiviral therapy; HBV reactivation is characterized as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA level (see Black Box Warnings and Dosing Considerations)

                Drugs that are potent P-gp inducers in the intestine (eg, rifampin, St. John’s wort) may significantly decrease sofosbuvir plasma concentrations

                Serious symptomatic bradycardia may occur in coadministration with amiodarone in combination with another direct acting antiviral (DAA), particularly in patients also receiving beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease; coadministration is not recommended, if no alternative exists, inpatient cardiac monitoring is recommended for the first 48 hr and then daily home monitoring for at least the first 2 weeks

                Must NOT be used as monotherapy

                Use with other drugs containing sofosbuvir not recommended

                Combination with ribavirin

                • Ribavirin may cause birth defects and fetal death; avoid pregnancy in female patients and female partners of male patients; patients must have a negative pregnancy test prior to therapy; use 2 or more forms of contraception, 1 of these forms of contraception can be a combined oral contraceptive product containing at least 1 mg of norethindrone (lower doses of norethindrone and other forms of hormonal contraception have not been studied or are contraindicated)
                • Risk of hemolytic anemia
                • Anemia associated with treatment may result in worsening of cardiac disease
                • Potential carcinogen effects
                • Ocular disorders reported when ribavirin is used in combination therapy with alpha interferons (eg, decrease or loss of vision, retinopathy including macular edema, retinal artery or vein, thrombosis, retinal hemorrhages; cotton wool spots, optic neuritis, papilledema, serous retinal detachment)
                • Study in boys showed growth rate inhibited (ie, height percentile decreases) with peginterferon alfa-2b plus ribavirin
                • Pancytopenia and bone marrow suppression reported when coadministered with pegylated interferon and azathioprine

                Combination with peg-interferon alfa

                • Discontinue STAT if progressive ALT increases despite dose reduction or accompanied with increased bilirubin or signs of hepatic decompensation
                • Caution in renal impairment
                • Risk of suicidal ideation and psychoses; discontinued if severe depression occurs
                • Safety and efficacy not been established in patients with liver and other transplantations; as with other alpha interferons, liver and renal graft rejections have been reported
                • May cause myelosuppression; discontinue therapy (at least temporarily) if platelet count <25,000/mm³ or ANC <500/mm³
                • Will likely experience flu-like symptoms in early part of treatment
                • May cause development of exacerbation of several pathologic conditions
                • Reduce/discontinue if moderate/severe depression, see Manufacturer's package insert
                • In hepatic impairment, reduce/discontinue as suggested by Manufacturer's package insert

                Drug interaction overview

                • Frequent monitoring of relevant laboratory parameters (eg, International Normalized Ratio [INR] in patients taking warfarin, blood glucose levels in diabetic patients) or drug concentrations of concomitant medications such as cytochrome P450 substrates with a narrow therapeutic index (eg, certain immunosuppressants) is recommended to ensure safe and effective use; dose adjustments of concomitant medications may be necessary
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                Pregnancy & Lactation

                Pregnancy

                If therapy administered with ribavirin or peginterferon alfa and ribavirin, the combination regimen is contraindicated in pregnant women and in men whose female partners are pregnant; refer to ribavirin and/or peginterferon alfa prescribing information for more information on ribavirin-and peginterferon alfa-associated risks of use during pregnancy

                No adequate human data available to establish whether or not drug poses a risk to pregnancy outcomes

                Animal data

                • In animal reproduction studies, no evidence of adverse developmental outcomes observed with sofosbuvir at exposures greater than those in humans at recommended human dose (RHD); during organogenesis in the rat and rabbit, systemic exposures (AUC) to predominant circulating metabolite of sofosbuvir (GS-331007) were ≥5 (rats) and 12 (rabbits) times the exposure in humans at the RHD; in the rat pre/postnatal development study, maternal systemic exposure (AUC) to GS-331007 was ≥6 times exposure in humans at RHD

                Lactation

                Not known whether sofosbuvir or metabolites are present in human breast milk, affect human milk production or have effects on breastfed infant; the predominant circulating metabolite of sofosbuvir (GS-331007) was the primary component observed in the milk of lactating rats, without effect on nursing pups

                The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or from underlying maternal condition

                If drug is administered with ribavirin, the nursing mother’s information for ribavirin also applies to this combination regimen; refer to ribavirin prescribing information for more information on use during lactation

                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.

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                Pharmacology

                Mechanism of Action

                Nucleotide prodrug that undergoes metabolism to the active uridine analog triphosphate, an inhibitor of HCV NS5B RNA-dependent polymerase; its inhibition in turn suppresses viral replication

                Pharmacokinetics

                Absorption

                • Peak plasma time: 0.5-2 hr (sofosbuvir); 2-4 hr (metabolite GS-331007)
                • AUC when coadministered with ribavirin (with or without peg-interferon): 828 ng•hr/mL (sofosbuvir); 6790 ng•hr/mL (metabolite GS-331007)

                Distribution

                • Plasma bound: 61-65% (sofosbuvir); minimal for metabolite GS-331007

                Metabolism

                • Liver
                • Substrate: P-gp transporter and breast cancer resistance protein (substrate for sofosbuvir but not metabolite GS-331007)

                Elimination

                • Excretion: Urine (78% metabolite GS-331007; 3.5% sofosbuvir)
                • Half-life: 0.4hr (sofosbuvir); 27 hr (metabolite GS-331007)

                Pharmacogenomics

                Available data on genotype 5 or 6 HCV infection insufficient for dosing recommendations

                Genotype 2 or 3: Sustained virologic response (SVR): The response to the addition of peg-interferon alfa to the sofosbuvir/ribavirin combination therapy was not significantly different, in clinical trials, compared to the sofosbuvir/ribavirin combination alone

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                Administration

                Oral Preparation (Oral Pellets)

                Do not chew pellets

                If pellets are administered with food, sprinkle on ≥1 spoonfuls of nonacidic soft food (eg, pudding, chocolate syrup, mashed potato, ice cream) at or below room temperature

                Take pellets within 30 min of gently mixing with food and swallow entire contents without chewing to avoid a bitter aftertaste

                Oral Administration

                Take with or without food

                Storage

                Tablets: Store <30ºC; dispense in original bottle

                Oral pellet packets: Store <30°C; do not use if packet seal has broken or damaged

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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                Sovaldi oral
                -
                400 mg tablet
                Sovaldi oral
                -
                200 mg tablet

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                Patient Education
                sofosbuvir oral

                SOFOSBUVIR - ORAL

                (soe-FOS-bue-vir)

                COMMON BRAND NAME(S): Sovaldi

                WARNING: Although this medication helps many people with hepatitis C, it may cause people who also have another liver problem called hepatitis B to get worse. Before starting this medication, tell your doctor if you have ever had hepatitis B. Tell your doctor right away if you have new or worsening symptoms of liver disease, such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, dark urine or yellowing eyes/skin.

                USES: Sofosbuvir is used with other antiviral medications (such as ribavirin, peginterferon, daclatasvir) to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. It works by reducing the amount of hepatitis C virus in your body, which may help your liver recover. Chronic hepatitis C infection can cause serious liver problems such as scarring (cirrhosis), or liver cancer.Sofosbuvir in combination with other antiviral medications reduces the amount of hepatitis C virus in the body and helps the body's immune system fight the infection. It is not known if this treatment can prevent you from passing the virus to others. Do not share needles, and practice "safer sex" (including the use of latex condoms) to lower the risk of passing the virus to others.Sofosbuvir must be used in combination treatment to have the best effect. Do not use sofosbuvir alone to treat hepatitis C.

                HOW TO USE: Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start taking sofosbuvir and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Also read the drug information for your other antiviral medication(s).Take this medication by mouth with or without food as directed by your doctor, usually once daily. The dosage is based on your medical condition and response to treatment. In children, the dosage is also based on weight.If you are using the pellet form of this medication, gently shake the packet before use. To take this medication without food, open the packet and pour the pellets directly into your mouth. Swallow the pellets without chewing. You may drink water after swallowing the pellets if needed. Repeat these steps if your dose is for more than one packet. If you are taking this medication with food, open the packet(s) and pour the pellets into a small bowl with one or more spoonfuls of non-acidic soft food (such as pudding, mashed potato, ice cream). The soft food should be at or below room temperature. After gently mixing, take all of the mixture without chewing within 30 minutes.This medication works best when the amount of drug in your body is kept at a constant level. Take this drug at evenly spaced intervals. To help you remember, take it at the same time each day.Continue to take sofosbuvir and your other antiviral medication(s) for the full length of time prescribed, even if your symptoms disappear after a short time. Stopping any of the drugs too early may result in a return of the infection.

                SIDE EFFECTS: See also Warning section.Tiredness, headache, nausea, diarrhea, itchy skin, difficulty sleeping, or irritability may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: signs of low red blood cell count (such as unusual tiredness, rapid breathing, pale skin, shortness of breath, fast heartbeat).A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

                PRECAUTIONS: Before taking sofosbuvir, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, other liver problems (such as hepatitis B), diabetes.If you have diabetes, your blood sugar may be lower with hepatitis C treatment. This can increase your risk of low blood sugar, so your doctor may adjust your diabetes treatment plan. Tell your doctor right away if you have symptoms of low blood sugar such as sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, sofosbuvir should be used only when clearly needed. Sofosbuvir, in combination with ribavirin or peginterferon, must not be used during pregnancy by either the pregnant woman or her male partner. The combination may harm an unborn baby. Two reliable forms of birth control (such as condoms, birth control pills) must be used whenever at least one sexual partner is using these medicines together, and for six months after stopping treatment. If you or your partner becomes pregnant, or if you think you or your partner may be pregnant, tell your doctor right away.It is unknown if this medication passes into breast milk. Breast-feeding while using sofosbuvir, in combination with ribavirin or peginterferon, is not recommended. Consult your doctor before breast-feeding.

                DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.A product that may interact with this drug is: amiodarone.Other medications can affect the removal of sofosbuvir from your body, which may affect how sofosbuvir works. Examples include rifamycins (such as rifampin, rifabutin), St. John's wort, tipranavir/ritonavir, drugs used to treat seizures (such as carbamazepine, phenobarbital, phenytoin, primidone), among others.Do not take this medication with other products that contain sofosbuvir.

                OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

                NOTES: Do not share this medication with others.Lab tests (such as liver function, tests for hepatitis B and C) should be done before you start using this medication, while you are using it, and after completing treatment. Keep all medical and lab appointments.If you are using this medication with ribavirin, it is recommended that female patients or female partners of male patients take a pregnancy test before starting this medication. A pregnancy test should also be taken every month while using this medication and for 6 months after treatment ends to make sure no pregnancy occurs.

                MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

                STORAGE: Store at room temperature away from light and moisture. Store the tablets in the original container. Keep the pellets in the packets and do not open the packets until ready for use. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

                Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

                IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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                FormularyPatient Discounts

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                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
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                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.