Myvelpa 400mg/100mg Mylan medicine for chronic hepatitis C (28 tablets)

Dosage form Box of 28 tablets
Specifications Sofosbuvir, velpatasvir

Ingredient

Composition information	Content
Sofosbuvir	400mg
Velpatasvir	100mg

Uses

Indications

Myvelpa 400mg/100mg medicine is indicated in the following cases:

Treatment of chronic hepatitis C virus in adults. Sofosbuvir is the precursor of nucleotid after experiencing intracellular metabolism that will form a triphosphate form similar to the pharmaceutical Uridine activity (GS - 461203), which can be integrated into the RNA of HCV with polymerase NS5B and plays a chain ending role. In a biochemical test, GS - 461203 inhibit the polymerase activity of NS5B recombinant from the HCV 1B, 2A, 3A and 4A genotypes with a 50% inhibitor (IC50) that ranges from 0.7 to 2.6µm. GS - 461203 (active metabolites of Sofosbuvir) does not inhibit DNA and RNA polymerase as well as non -inhibition of RNA polymerase in the mitochondria.

Velpatasvir is a HCV inhibitor targeting NS5A HCV protein, essential for both RNA copying and assembling HCV viruses. In In Vitro studies, select antagonists and cross -resistance to show that Velpatasvir's main mechanism of operation is targeting NS5A.

antiviral activity

The concentration of Sofosbuvir and Velpatasvir against re -edged units with adequate lengths or Chimeric reproduction units that encrypt NS5B and NS5A from strains in the laboratory are presented in Table 4. EC50 value of SofosbiVir and Velpatasvir against clinical independants are presented in Table 5.

Table 1: Activities of Sofosbuvir and Velpatasvir against reprinting units with full length or chimeric in the laboratory

Genetic reproduction units Sofosbuvir
EC50, N.MA

Velpatasvir
EC50, N.MA LA 14 0.006C 3a 50 4 5A 15b 0.021 - 0.054D

The average value from many experiments of the same publishing unit in the laboratory.

A stable 1B reprint unit with NS5B from the 2B, 5A or 6A genotype used for testing.

Data obtained from many edition units with adequate lengths or Chimeric NS5A reprinting units carrying NS5A genes with full length containing L31 or M31 polymorphic.

Data obtained from Chimeric NS5A reprint unit with NS5A containing Amino Acid 9 - 184.

Table 2: Activities of Sofosbuvir and Velpatasvir against temporary reprinting units containing NS5A or NS5B from clinical isolation

Genotype reprinting unit EC50, Nm The number of clinical isolation lines concentration
Velpatasvir EC50, NM The number of clinical isolation lines

67 62 (29 - 128) (0.011 - 0.078)

1b 29 102 (45 - 170) 34

0.012 (0.005 - 0.500)

0.011 (0.006 - 0.364)

na 16 181) 38 0.005 (0.002-1.871) na 10 0.007 (0.004 - 0.011) Na

42 0.005 (0.001 - 0.019) Na 15 0.024 (0.005 - 0.433)

The presence of 40% of serum does not work on Sofosbuvir's hepatitis C antiviral activity but works to reduce Velpatasvir's anti -viral antiviral activity by 13 times, against the reprint units of genotypes of genotypes 1A.

The combination of Sofosbuvir with Velpatasvir shows no antagonistic effect in reducing the RNA HCV concentration in reprinted cells.

drug resistance

In cell culture

The HCV reprinting units reduce sensitivity to Sofosbuvir selected by cell culture with multi -genotype including 1B, 2A, 2B, 3A, 4A, 5A and 6A. Reducing sensitivity to Sofosbuvir is related to the replacement of S282T NS5B on all research genotypes. The formation of S282T replacement mutations in the reprinting units of 8 genotypes reduces sensitivity to Sofosbuvir 2 - 18 times and reduces the reprints of virus 89% to 99% to the corresponding wild strain.

In biochemical tests, NS5B Polymerase is recombinant from phenotypes 1B, 2A, 3A and 4A, which replaces S282T, showing reduced sensitivity to GS - 461203 compared to the corresponding wild strains, increasing average inhibitor concentration (IC50) from 8.5 to 24 times.

In the In vitro selection of the HCV reprinting unit reduces the sensitivity of Velpatasvir, which is performed in cell culture for multiple genotypes including 1A, 1B, 2A, 3A, 4A, 5A and 6A. The variable selected in NS5A antagonists related to positions 24, 28, 30, 31, 32, 58, 92 and 93. The antagonist related to the variant selected in 2 or more genotypes are F28S, L31I/V and Y93H.

The direct gene mutation area of NS5A antagonists shows that the replacement is reduced by more than 100 times the sensitivity of Velpatasvir is M28G, A92K and Y93H/N/N/R/W in genotype 1A, A92K in genotypes 1B, C92T and Y93H/N in genotypes 2B, Y93H in genotypes 3, and L31V and P32A/L/Q/R in genotype 6. Tested in genotypes 2A, 4A or 5A lead to a decrease of more than 100 times for the sensitivity to Velpatasvir. The combination of these variants shows more sensitivity to Velpatasvir rather than an antiviral drug.

pharmacokinetic

absorption

Sofosbuvir pharmacokinetic properties, the main metabolites GS - 331007 and Velpatasvir have been assessed in 1011 healthy people and people with chronic hepatitis C. After drinking, Sofosbuvir is quickly absorbed and the peak concentration in plasma is reached after 1 hour. The average peak concentration in GS - 331007 is observed after 3 hours of medication. The average peak concentration in the plasma of Velpatasvir is observed after 3 hours of medication.

Sofosbuvir/Velpatasvir tablets can be used not related to food.

Distribution

Sofosbuvir's bloody ratio in the blood of Sofosbuvir is approximately 61 - 65% and the cohesion with plasma proteins does not depend on the dose of 1 mg/ml to 20 mg/ml. The cohesion of GS - 331007 with plasma is very few.

The link between velpatasvir and plasma proteins in the blood> 99% and the cohesion with plasma protein does not depend on the dose in the dose of 0.09μg/ml to 1.8μg/ml.

Metabolism

Sofosbuvir is widely metabolized in the liver to form the metabolites with the same pharmacological activity similar to Nucleosid Triphosphate GS - 461203. The transformation into the active substance is related to the continuous hydrolysis of the Carboxyl moiety Carboxyl moieter catalyzed by a human Cathepsin A (CATA) or Carboxy Lolesterase 1 (CES1) (CES1) "Histidine triad nucleotide-binding protein 1" (Hint1), followed by phosphorylation by the path of pyrimidine nucleotide biosynthesis.

The process of Dephosphorylation is the result in the formation of nucleosid GS-331007 metabolites but it is impossible to re-effectively re-phosphorylation and loss of anti-HCV in vitro. Sofosbuvir and GS-33 1,007 are not substrates or UGT1A1 inhibitors or enzymes CYP3A4, CYP1A2, CYP2B6, CYP2B6, CYP2C8, CYP2C9, CYP2C19 and CYP2D6.

After taking a single dose of 400mg [14C] - Sofosbuvir, GS - 331007 accounts for approximately> 90% of the drug.

Velpatasvir is a substrate of CYP2B6, CYP2C8, and CYP3A4 is slowly rotated. After a single dose of 100mg [14C] - Velpatasvir, most (> 98%) radioactive in plasma is the mother medicine. Velpatasvir monohydroxylated and desmethylated are metabolic products in plasma. Velpatasvir does not change and is excreted in stool.

Elimination

After a single dose of 400mg [14C] - Sofosbuvir, the average level of excretion is greater than 92%, including about 80% excreted in urine, 14% excreted in feces and 2.5% excreted in the form of breathing gas. The main ingredient of the drug eliminated in urine is GS - 331007 (78%), while 3.5% are eliminated as Sofosbuvir. This data indicates that the main elimination line for GS - 331007 is excreted active in the kidneys. The average last phase selling time of Sofosbuvir and GS - 331007 is 0.5 and 25 hours respectively.

After a single dose of 100 mg [14C] - Velpatasvir, the average level of reabsorption of radioactive [14C] is 95%, including approximately 94% and 0.4% equivalent through feces and urine, Velpatasvir is not metabolized will eliminate in large parts with a concentration of up to 77% of the amount of drug, monitored by monohydroxylated velpatasvir (5.9%). Desmethylated Velpatasvir (3.0%). These data show that Velpatasvir is excreted in biliary tract. Velpatasvir waste time in Sofosbuvir/Velpatasvir tablets is approximately 15 hours.

Before taking Myvelpa 400mg/100mg Mylan medicine for chronic hepatitis C (28 tablets)

How to use

Oral drugs.

Patients taking whole tablets with or without food. Because the drug has a bitter taste, should not chew or crush the medicine.

Dosage

Treatment with Velpatasvir/Sofosbuvir tablets should be started and monitored by experienced physicians in the treatment of hepatitis c.

The recommended dose of Velpatasvir/Sofosbuvir is 1 capsule/day, with or without food.

Table 3: Treatment and treatment time for all genotypes of hepatitis C

Patient group A

Treatment time It is possible to meet with ribavirin in patients with cirrhosis and genotype 3. H1V co -infected and patients with hepatitis C virus after grafting.

When using a combination of ribavirin, it is necessary to see more instruction sheets of Ribavirin for more details.

The recommended dose if using Ribavirin is divided into 2 times/day, and used with food presented in Table 4.

Table 4: Instructions for using Ribavirin when used in combination with Velpatasvir/Sofosbuvir in patient cirrhosis. 1,200mg/day in severe patients> 75kg

Patients with cirrhosis CPT C before liver transplantation.
Patient CPT B or C after liver transplantation. Dosage should be reduced for patients without tolerance based on Haemoglobin concentration. 75kg).

If you need to change the dose of ribavirin, refer to the user manual of drugs containing ribavirin. If vomiting occurs within 3 hours after using the drug, the patient should be instructed to take an extra Velpatasvir/Sofosbuvir tablet. If vomiting occurs 3 hours after taking the drug, no more medication.

If you forget to take Velpatasvir/Sofosbuvir within 18 hours from the time of taking the usual medication, the patient needs to be compensated as soon as possible and continue to take the next dose as usual. If it is too 18 hours, do not drink and wait until the next dose. It is recommended that patients do not take double the dose to compensate for the drug.

Treatment of patients who failed to treat the regimen containing NS5A.

Can consider using velpatasvir/sofosbuvir combined ribavirin for 24 weeks.

Elderly

No dose adjustment in the elderly.

Patients with renal function

For patients with mild and moderate renal function, the dose of Velpatasvir/Sofosbuvir. There is no study to consider the safety and effectiveness of Velpatasvir/Sofosbuvir in patients with severe renal impairment [EGFR]

Patients with liver function impaired

No need to adjust the dose of Velpatasvir/Sofosbuvir in patients with mild, medium or severe liver failure (CPT A, B or C). The safety and effectiveness of Velpatasvir/Sofosbuvir has been evaluated in cirrhosis patients with CPT B but has not been evaluated in cirrhosis patients with CPT C.

Pediatric patients

Safety and effectiveness of Velpatasvir/Sofosbuvir in children and minors under 18 years of age has not been set up. There is no data in this age group.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose? In research in healthy volunteers, there is no unwanted effect to be observed at the above -mentioned dose levels, unwanted effects with frequency and severity are similar to unwanted effects observed in patients using placebo. It is not clear the effect of the drug when using high doses.

It is unclear whether specific antidote for the case of overdose of Sofosbuvir/Velpatasvir. If an overdose occurs, it is necessary to solve the toxicity for the patient. For overdose treatment of Sofosbuvir/Velpatasvir, patients need to be supported with general medical support including maintaining life as well as monitoring the patient's clinical status. Hematopsy can effectively remove the main metabolites of Sofosbuvir, GS - 331007 with a rate of 53%. Duodian hemolysis is not valid in the elimination of Velpatasvir due to Velpatasvir with high plasma protein mounting ratio.

What to do when forgetting 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

When using myvelpa 400mg/100mg medicine, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Nervous system: headache.

DA: rash. all body: tired.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Myvelpa medicine 400mg/100mg contraindicated in the following cases:

Hypersensitivity to the main active ingredient or any ingredient of the drug.

For patients who are using P - Glycoprotein induction drugs and CYP induction drugs.

When used simultaneously with drugs that cause P - Glycoprotein or Cytochrome P450 (CYP), (Rifampicin, Rifabutin, St. John’s World [Hypericum Perforatum], Carbamazepin, Phenobarbital and Phenytoin) can reduce Sofosbirbir and Sofosbir and Sofosbirin and Sofosbirin and Sofosbidine concentration and plasma concentration Velpatasvir and leads to reduced effectiveness of the drug.

Precautions when using

Unsonized use of Velpatasvir/Sofosbuvir with other pharmaceuticals containing Sofosbuvir.

Slow heart rate and heavy heart block: Observed some cases of serious heart rate slow or heart block when using Sofosbuvir in combination with other direct antiviral drugs (DAA) or when used with amiodaron and other heart -slow drugs. This activity mechanism has not been established.

Data on simultaneous use with Amiodaron through Sofosbuvir clinical development studies with other direct antiviral drugs (DAAS) is limited. However, due to the seriousness of this reaction and may be fatal, it is advisable to avoid using amiodaron in patients treated with Velpatasvir/Sofosbuvir tablets, except for non -tolerated or contraindicated diseases with other medications for arrhythmia.

In case the patient is required to use Amiodaron, the patient should be carefully monitored when starting to use Velpatasvir/Sofosbuvir. Patients with high risk of heartbeat should be monitored continuously at medical facilities for 48 hours.

Because Amiodaron has a long selling time, the patient should be monitored for amiodaron treatment for several months and when starting to use Velpatasvir/Sofosbuvir.

All patients using Velpatasvir/Sofosbuvir combined with Amiodaron or other drugs that can slow heart rate should be warned of heartbrate symptoms, cardiac blocks and need emergency medical support when detecting these conditions.

Patients have failed with the treatment regimen containing NS5A

There is no clinical data to prove the effectiveness of Velpatasvir/Sofosbuvir in the treatment of patients who have failed with the treatment regimen containing other NS5A inhibitors. However, based on the knowledge of the micro -micro -variants of NS5A observed in patients who have treated failures with other NS5A inhibitors, and based on the results of Velpatasvir/Sofosbuvir in patients involved in Astral research without using NS5A inhibitors with super -level microfinosa various models of NS5A level Velpatasvir/Sofosbuvir in collaboration with Ribavirin for 24 weeks in patients who failed with the treatment regimen containing NS5A inhibitors with a high clinical risk and no other replacement treatment regimen.

kidney failure

For patients with mild and moderate renal function, the dose of Velpatasvir/Sofosbuvir. There is no research to evaluate the effectiveness and safety of Velpatasvir/Sofosbuvir in patients with severe renal impairment [EGFR]

Patients who are using drugs P - GP and CYP are average

Medications containing P - Glycoprotein or increasing cytochrome P450 (CYP) (Rifampicin, Rifabutin, St. John's World Hypericum Perforatum, Carbamazepine, Phenobarbital and Phenytoin) when used can reduce the blood soip of Sofosbirvir and Velpatasvir and reduce the effectiveness of the drug. So do not use Sofosbuvir/Velpatasvir with the above drugs.

Use in combination with HIV treatment regimens

Sofosbuvir/Velpatasvir can increase the effect of tenofovir, especially when used with H1V treatment regimen with Tenofovir Disoproxil Fumarate and pharmacological stimulus (Ritonavir or CoBicistat). The safety of Tenofovir Disoproxil Fumarate when used with these drugs has not been determined. The risks and benefits of Sofosbuvir/Velpatasvir should be considered with a combination dose containing Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate or Tenofovir Disoproxil Fumarate in combination with Protease inhibitors (for example: Atazanavir or DarunAr) Especially in patients with high kidney failure.

Patients use Sofosbuvir/Velpatasvir with drugs with Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate or Tenofovir Disoproxil Fumarate in combination with protease inhibitors that need to be observed to identify Tenofovir's side effects. Refer to the product details of Tenofovir Disoproxil Fumarate, Emtricitabine/Tenofovir Disoproxil Fumarate or Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate for more details of observation of kidney function.

Patients with co -infections of HCV and HBV (hepatitis b)

Cases of regeneration of hepatitis B virus (HBV), some fatal, have been reported during or after treatment with antiviral drugs directly acting. HBV screening should be performed in all patients before starting treatment. Patients with HBV/HCV infection are at risk of HBV regeneration, so they need to be monitored and managed under the current clinical instructions.

Patients with cirrhosis CPT C

The efficiency and safety of Sofosbuvir/Velpatasvir has not been tested in patients with cirrhosis CPT C.

Patients with liver transplant

Efficiency and safety of Sofosbuvir/Velpatasvir in the treatment of hepatitis C infection in patients with liver transplantation. The dosage treatment is indicated by the doctor after reviewing the risks and benefits in this.

Colonel components

Sofosbuvir/Veltapasvir contains lactose monohydrate. Patients with Galatose -intolerant genetic disorders, Lapp Lactase deficiency or poor absorbing glucose - Galatose should not use this drug.

The ability to drive and operate machinery

Sofosbuvir/Velpatasvir is not or negligible to the ability to drive and operate machinery.

Pregnancy

There are very little data on the use of Sofosbuvir, Velpatasvir or Sofosbuvir/Velpatasvir (total of less than 300 cases) in pregnant women.

Sofosbuvir

Animal studies do not show that drugs may affect direct or indirect fertility. Studies determine the dose in mice equivalent to the dose of human treatment.

velpatasvir

Animal studies show that drugs are associated with reducing fertility. Therefore, this risk should be prevented and does not use Sofobuvir/Velpatasvir in pregnant women.

Breastfeeding period

Not yet identified Sofosbuvir and the metabolites of Sofosbuvir or Velpatasvir is secreted by breast milk or not.

Animal dynamic dynamics shows Velpatasvir and the metabolites of Sofosbuvir are secreted according to breast milk.

Therefore can not eliminate risks to newborns. Breastfeeding women should not use Sofosbuvir/Velpatasvir.

Medicinal interaction

Because Sofosbuvir/Veltapasvir has Sofosbuvir and Velpatasvir, drugs interacting with each separate ingredient may also have interaction with Sofosbuvir/Velpatasvir tablets.

Sofosbuvir/Veltapasvir capabilities affect other medications

Velpatasvir is an inhibitor of components such as P-GP drug transport agent, anti-cancer protein (BCRP), Polypeptide transporting anion (OATP) 1B1 and 1B3. If shared with Sofosbuvir/Veltapasvir with drugs whose substrate of these factors may increase the impact of the drugs. Table 5 lists interactive medications of P - GP (Digoxin), BCRP (Rosuvastatin), and OATP (Pravastatin).

Other pharmaceuticals can interact with Sofosbuvir/Velpatasvir

Sofosbuvir and Velpatasvir are the substrate of transport proteins P - GP and BCRP. Velpatasvir is also the substance of OATP1B. In Vitro, Velpatasvir is partially metabolized by CYP2B6, CYP2C8, CYP3A4. The pharmaceuticals increasing the activity of P-GP or CYP2B6, CYP2C8, CYP3A4 (such as Rifampicin, Rifabutin, St. John’s Wort, Carbamazepine, Phenobarbital and Phenytoin) can reduce the plasma concentration of Sofosbuvir or VelpatasVir and reduce the efficiency of the efficiency of the effect Sofosbuvir/Velpatavir.

So the use of Sofosbuvir/Velpatasvir with the above drugs is contraindicated. Increasing medications of P - GP or CYP (such as Oxcarbazepine, Modafinil or Efavirenz) may reduce the plasma concentration of Sofosbuvir or Velpatasvir reducing the effectiveness of the drug. Do not use the above drugs with Sofosbuvir/Velpatasvir. Using p - GP or BRCP inhibitors may increase the plasma concentration of Sofusbuvir or Velpatavir.

Oatp, CYP2B6, CYP2C8 inhibitors. CYP3A4 can increase the plasma concentration of Velpatasvir. The interactions on P - GP, BCRP, OATP, CYP450 are predicted without significantly clinical effects, can use Sofosbuvir/Velpatasvir with P -PG inhibitors, BCRP, OATP and CYP.

Patients are treated with vitamin K antagonists

Because the liver function can change during treatment with Sofosbuvir/Velpatasvir, it is close to closely monitoring the international normalized index values (INR).

Interaction between Sofosbuvir/Velpatasvir and other drugs

Table 5 lists important or possible drug interactions (the 90% confidence range of the average change ratio is in "⭤", on "⭡", or under "⭣" the interaction level is not important). Interactions are listed based on studies with Sofosbuvir/Velpatasvir or separate Velpatasvir or Sotbsbuvir, or predicted may occur with Sofosbir/Velpatasvir. This table does not include all possible reactions.

Table 5: Interaction between Sofosbuvir/Velpatasvir and other drugs

Pharmaceuticals arranged in groups/ interactive mechanisms

affect the indicators of the drug.

Active

cmax auc cmin Velpatasvir decreases if the pH increases. The drugs that increase the pH in the stomach may reduce the concentration of Velpatasvir. ⭤Sofosbuvir
⭤velpatasvir

Time/day)/Sofosbuvir/velpatasvir (dose 400/100mg)
Famotidine is shared with Sofosbuvir/Velpatasvird
cimetidinee
nizatidinee
ranitidinee

⭤0.80
(0.70,
0.91)

⭤0.81
(0.71,0.91)

can take H2 receptor inhibitors with Sofosbuvir/Velpatasvir at the same dose not higher than Famotidine 40mg 2 times/day. Famotidine
(dose 40mg 1 time/day)/Sofosbuvir/Velpatasvir (400/100mg 1 time/day) C
Famotidine uses 12 before taking
sofosbuvir/velpatasvir
(increase the stomach pH)

⭤0.77
(0.68,
0.87) ⭤ 0.80
(0.73, 0.88) day)/Sofosbuvir/Velpatasvir (400/100mg 1 time/day when fasting) C
Omeprazole is used at the same time with Sofosbuvir/Velpatasvird

lansoprazolee rabeprazoleee pantoprazolee esomeprazolee
(increase pH)

Sofosbuvir

velpatasvir ⭤ 0.66
(0.55,
0.78)

⭤ 0.63
(0.50,
0.78)

⭤ 0.64
(0.52, 0.79) should not be used together with
with pump inhibitors
proton. If it is required to use PPI only oral the equivalent dose of omeprazole
20mg and take 4 hours after using
sofosbuvir/velpalasvir with
Food NO) C
Omeprazole used 4 hours after Sofosbuvir/Velpatasvird
(Increasing the stomach pH) 0.78) ⭤0.74
(0.63, 0.86) Sofosbuvir is only used if there is no other medication instead. It is necessary to observe the patient carefully if used with Sofosbuvir/Velpatasvir

Digoxin only tested with
predicted:
Sofosbuvir

If using Digoxin in general with Sofosbuvir/Velpatasvir, patients should be warned and observed the concentration of strict digoxin
predict:
velpatasvir

anticoagulant drugs

Perform blood clotting function to identify patients with high hemorrhage risks.

Guess:
Sofosbuvir
dvelpatasvir

Sofosbuvir/Velpatasvir is contraindicated with carbamazepine, phenobarbital phenytoin, and other powerful P-GP and CYP induction drugs. CYP) Unresponded interaction. Sofosbuvir/Velpatasvir. Do not share these drugs. ⭤ 0.23
(0.19,
0.29)

⭤0.28
(0.24, 0.32)

Rifampicin (600mg 1 time/day)/Sofosbuvir (400mg 1/day) D
(increase operations of P-GP and CYPS) Rifampicin (600mg 1 time/day)/Velpatasvir (100mg 1 time/day)
(P-GP and CYPS induction) Results:
velpatasvir

⭤0.29
(0.23,
0.37) P-GP and CYP activity medications like rifabutin. Do not share the above drugs. The level of influence (AUC and CMAX) of Tenofovir increases about 40 - 80% in patients using HIV treatment regimen with Sofosbuvir/Velpatasvir and Tenofobvir Disoproxil Fumarate/Emtricitabine. Carefully close the signs of increasing the influence of tenofovir. Refer to the product details summary of products with tenofovir disoproxil fumarate for details on how to observe kidney function. times/day) c, d Efavirenz

Do not use Sofosbuvir/Velpatasvir with regimens with efavirenz.

sofosbuvir ⭤1.2
(1.1, 1.7)

(0.39, 0.57) ⭤0.43
(0.36,
0.52)

time/day) c’D Rilpivirine

sofosbuvir

Atazanavir combines ritonavir (300/100mg 1 time/day) +
emtricitabine/tenofovir disoproxil fumarate (200/300mg 1 time/day)/Sofosbuvir/Velpatasvir (400/100mg 1 time/day) Atazanavir ⭤1.4 (1.2.
1.6) Fumarate.
ritonavir
⭤1.3 (1.5,
1.4) Velpatasvir ⭤1.6
(1.4, 1.7)
⭤2.4 (2.2,
2.6) Emtricitabine/Tenofovir Disoproxil Fumarate (200/300mg 1 time/day)/Sofosbuvir/Velpatasvir (400/100mg 1 time/day) C’D Darunavir
ritonavir

velpatasvir ⭤0.76
(0.65,
0.89) Disoproxil Fumarate (200/300mg 1
/day)/Sofosbuvir/Velpatasvir (400/100 mg 1 time/day) C, D
lopinavir
ritonavir

velpatasvir 0.70
(0.59,
0.83)

⭤1.6 (1.4,
1.9)
raltegravir (400mg 2 times/day) +
emtricitabine/tenofovir disoproxil fumarate
(200/300 mg 1 time/day)/Sofosbuvir/Velpatasvir (400/100mg once/day) C '
raltegravir ⭤0.79
(0.42, 1.5)

No need to change the dose of Sofosbuvir/Velpatasvir Raltegravir or
emtricitabine/tenofovir
Fumarate.

sofosbuvir Emtricitabine/Tenofovir Alafenamide Fumarate
(150/150/200/10mg 1 time/day)/Sofosbuvir/Velpatasvir (400/100mg 1 time/day)

Elvitegravir 1.5) ⭤1.5 (1.4,
1.7) ⭤1.6 (1.4,
1.8) dolutegravir
sofosbuvir
John's World
(P-GP and CYP induction)
Interactive interactions have not been tested.
Predict:
Sofosbuvir
velpatasvir

rosuvastatin

only testing interactive with velpatasvir
predicted:
Sofosbuvir
Sofosbuvir/Velpatasvir. Result:
rosuvastatin
⭤2.6
(2.3, 2.9)

Result:
pravastatin ⭤1-3
(1.1,1.5) ⭤1.4 (1.2,
1.5) If using these drugs in general with Sofosbuvir/Velpatasvir, you need to observe side effects and change the dose if necessary.
r-
methadone

s-methadone Methadone only test interactive with Sofosbuvir. time/day) ciclosporin Sofosbuvir ⭤2.5
(1.9, 3.5) ⭤4.5 (3.3.
6.3) time/day)
ciclosporin
⭤0.88
(0.78, 1.0) tacrolimus ⭤0.73
(0.59,
0.90)
⭤1.1 (0.84,
1.4)
sofosbuvir ⭤0.97
(0.65,
1.4) ⭤1.1 (0.81,
1.6) Guess:
dvelpatasvir time/day) d
~~Norelgestro Min~~

No need to change the dose of birth control pills.

ethinyl estradiol (100mg 1 time/day)

Storage

Store no more than 30 ° C, stored in the original packaging.

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The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.