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Product Code: 151617
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sofobuvir 400mg tablets 

Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults .

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)

Mechanism of Action:

Sovaldi (sofosbuvir) s an inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication. Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analog triphosphate (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator.

Uses :

Sovaldi (Sofosbuvir) is used for treating chronic hepatitis C. It is classified as a nucleotide analog polymerase inhibitor and its mode of action is preventing the virus from spreading by inhibiting the synthesis of RNA. It has been hailed as a breakthrough in the treatment of Hep C due to reports of patients being cured after treatment. In a recent medical study, 89 per cent of patients affected by hepatitis C genotype 1 (the most commonly occurring form of the virus) were successfully cured when given this medicine in combination with ribivarin and peginterferon alfa.

This medicine inhibits the hepatitis C virus (HCV) nucleotide analog NS5B polymerase, which is the name given to the enzyme required by the virus to replicate itself and spread throughout the body. When taken by mouth, it is quickly converted into the active metabolite, allowing it to target the virus. Following this, it acts in the liver and binds to the viral RNA, which prevents the virus from copying itself and infecting other liver cells. Because of this, the hep C virus cells are no longer able to multiply in the body. This helps to bring the infection under control and the subsequent reduction in HCV inside the body may stop further damage to the liver.

It is generally used in combination with other antiviral drugs to boost the immune system`s ability to fight off the infection. Some patients may also be cured of their condition. Patients affected by all 4 genotypes of the virus (1,2, 3 and 4) can be treated with this medicine. It has also been given to patients who are waiting to undergo a liver transplant, to prevent the recurrence of HCV, or to treat patients who are infected with both HCV and HIV-1. It is not used to treat an infection caused by HIV, however.

Dosage and Administration :

Sovaldi (Sofosbuvir) comes in the form of 400mg tablets. Daily dosage and the length of treatment must be individualized, and will be decided upon by the physician in charge of treatment. Physicians generally direct patients to take one tablet (400mg) per day either with or without food. Adults affected by HCV genotype 1 or 4 are sometimes told to take it for 12 weeks, alongside ribavirin and peg-interferon alfa (the required dosage for other medicines will be calculated by the physician).

Genotype 2 is normally treated along with ribavirin, and physicians usually tell the patient to continue treatment for a 12 week period. Hepatitis C genotype 3 is also treated in combination with ribavirin, however physicians normally advise the patient to use it for 24 weeks. It is important to note that the exact dosage could differ based on each patient`s individual circumstances, and that it is essential that all instructions given by the physician in charge of treatment be strictly followed. Close medical supervision will also be required for the entire duration of treatment, and after treatment has finished.

Side effects :

When sofosbuvir is taken with peg-interferon and/or ribavirin, the most common side effects are:

depression 

  • difficulty sleeping
  • dry skin, itchy skin or rash
  • fatigue
  • headache
  • irritability
  • low blood platelets (thrombocytopenia)
  • low red blood cells and iron in blood (anemia)
  • low white blood cells (neutropenia)
  • nausea
  • If any of the following side effects occur while taking sofosbuvir, check with your doctor immediately:

    More common:
  • chills
  • fever
  • lower back or side pain
  • pale skin
  • ulcers, sores, or white spots in the mouth
  • unusual tiredness or weakness
  • Pregnancy :
  • Animal studies with this drug have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy. Monotherapy is not recommended. Pregnancy must be avoided in female patients and female partners of male patients during combination therapy. Females of reproductive potential and their male partners should not receive ribavirin unless they are using at least 2 reliable forms of effective contraception during therapy and for at least 6 months after therapy. A negative pregnancy test should be obtained immediately before the start of therapy and monthly pregnancy testing is recommended during and for 6 months after therapy. AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage. AU TGA pregnancy category X: Drugs which have such a high risk of causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of pregnancy. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

    Use of a ribavirin-containing regimen is contraindicated in pregnant women and in the male partners of women who are pregnant. Sofosbuvir should be used during pregnancy only if the benefit outweighs the risk to the fetus; as a precaution, some experts prefer to avoid use during pregnancy. For regimens containing ribavirin or peginterferon alfa: -AU TGA pregnancy category: X For sofosbuvir: -AU TGA pregnancy category: B1 -US FDA pregnancy category: B

  • Before using sofosbuvir:

    Some medical conditions may interact with sofosbuvir. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

    if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have liver problems other than HCV (eg, cirrhosis), HIV infection, or anemia
  • if you have kidney problems or you are on dialysis
  • if you have had a liver transplant
  • if you are taking amiodarone. The risk of slow heartbeat may be increased, especially if you are taking a beta blocker (eg, metoprolol), have heart problems, or have severe liver disease
  • Some MEDICINES MAY INTERACT with sofosbuvir. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Carbamazepine, hydantoins (eg, phenytoin), oxcarbazepine, phenobarbital, rifamycins (eg, rifampin), St. John's wort, or tipranavir because they may decrease sofosbuvir's effectiveness
  • This may not be a complete list of all interactions that may occur. Ask your health care provider if sofosbuvir may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

  • Cautions : 

    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
    • Drug - drug interaction
    • 1-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
    • 2-ombitasvir/paritaprevir/ritonavir will increase the level or effect of sofosbuvir by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Paritaprevir and ritonavir inhibit P-gp. Caution if coadministered with P-gp substrates.
    • 3-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 
  • 4-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
  • 5- daclatasvir will increase 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

  • 6-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.

     

 

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