Sofoxen Tablet 400 mg
Sofoxen Tablet 400 mg Uses, Dosage, Side Effects, Food Interaction and all others data.
Sofoxen Tablet 400 mg is an inhibitor of the hepatitis C virus (HCV) NS5B ribonucleic acid (RNA)-dependent RNA polymerase, which is essential for viral replication. Sofoxen Tablet 400 mg 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. In a biochemical assay, GS-461203 inhibited the polymerase activity of the recombinant NS5B from HCV genotype 1b, 2a, 3a and 4a with a 50% inhibitory concentration (IC50) value ranging from 0.7-2.6 micrometer. GS-461203 (the active metabolite of sofosbuvir) is not an inhibitor of human deoxyribonucleic acid (DNA) and RNA polymerases, nor an inhibitor of mitochondrial RNA polymerase.
Sofoxen Tablet 400 mg acts against HCV and is categorized as a direct-acting antiviral agent (DAA).
At a dose 3 times the recommended dose, sofosbuvir does not prolong QTc to any clinically relevant extent .
| Trade Name | Sofoxen Tablet 400 mg |
| Availability | Prescription only |
| Generic | Sofosbuvir |
| Sofosbuvir Other Names | Sofosbuvir |
| Related Drugs | Epclusa, Harvoni, Sovaldi, Vosevi, Mavyret, ribavirin |
| Weight | 400 mg |
| Type | Tablet |
| Formula | C22H29FN3O9P |
| Weight | Average: 529.458 Monoisotopic: 529.162544687 |
| Protein binding | Sofosbuvir is approximately 61-65% bound to human plasma proteins . |
| Groups | Approved |
| Therapeutic Class | Hepatic viral infections (Hepatitis C) |
| Manufacturer | Everest Pharmaceuticals Ltd. |
| Available Country | Bangladesh |
| Last Updated: | October 19, 2023 at 6:27 am |
Uses
Sofoxen Tablet 400 mg is used for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen. Sofoxen Tablet 400 mg efficacy has been established in subjects with MCV genotype 1, 2, 3 or 4 infection, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplantation) and those with HCV/HIV-1 co-infection.
Sofoxen Tablet 400 mg is also used to associated treatment for these conditions: Chronic Hepatitis C Genotype 1, Chronic hepatitis C genotype 2, Chronic hepatitis C genotype 3, Chronic hepatitis C genotype 4, Chronic hepatitis C genotype 5, Genotype 6 chronic hepatitis C infection
How Sofoxen Tablet 400 mg works
Sofoxen Tablet 400 mg is nucleotide analog inhibitor, which specifically inhibits HCV NS5B (non-structural protein 5B) RNA-dependent RNA polymerase. Following intracellular metabolism to form the pharmacologically active uridine analog triphosphate (GS-461203), sofosbuvir incorporates into HCV RNA by the NS5B polymerase and acts as a chain terminator . More specifically, Sofoxen Tablet 400 mg prevents HCV viral replication by binding to the two Mg2+ ions present in HCV NS5B polymerase's GDD active site motif and preventing further replication of HCV genetic material .
Dosage
Sofoxen Tablet 400 mg dosage
One 400 mg tablet taken once daily with or without food. Should be used in combination with Ribavirin or in combination with Pegylated Interferon and Ribavirin for the treatment of CHC.
Recommended combination therapy: (HCV Mono-infected and HCV/HIV-1 Co-infected)-
- Genotype 1 or 4: Sofoxen Tablet 400 mg + Peginterferon alfa + Ribavirin for 12 weeks
- Genotype 2: Sofoxen Tablet 400 mg + Ribavirin for 12 weeks
- Genotype 3: Sofoxen Tablet 400 mg + Ribavirin for 24 weeks
Sofoxen Tablet 400 mg in combination with Ribavirin for 24 weeks can be considered for CHC patients with genotype 1 infection who are Interferon ineligible
Should be used in combination with Ribavirin for treatment of CHC in patients with hepatocellular carcinoma awaiting liver transplantation for up to 48 weeks or until liver transplantation whichever occurs first
A dose recommendation cannot be made for patients with severe renal impairment or end stage renal disease
Side Effects
The most common adverse events observed with Sofoxen Tablet 400 mg in combination with ribavirin were fatigue and headache.
The most common adverse events for Sofoxen Tablet 400 mg, peginterferon alfa and Ribavirin combination therapy were fatigue, headache, nausea, insomnia and anemia.
The following ADRs occured in <1% of subjects receiving Sofoxen Tablet 400 mg in combination regimen.
Hematologic effects: pancytopenia (particularly in subjects receiving concomitant Pegylated Interferon).
Psychiatric disorders: severe depression (particularly in subjects with pre-existing history of psychiatric illness), including suicidal ideation and suicide.
Toxicity
Sofoxen Tablet 400 mg, as a single agent, has very mild toxicity. The most common adverse reactions are headache and fatigue. The FDA Label currently warns of a risk of symptomatic bradycardia when Epclusa is used in combination with amiodarone .
Precaution
Bradycardia with amiodarone co-administration: Serious symptomatic bradycardia may occur in patients taking amiodarone and Sofoxen Tablet 400 mg 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. Co-administration of amiodarone with Sofoxen Tablet 400 mg in combination with another DAA is not recommended. In patients without alternative, viable treatment options, cardiac monitoring is recommended.
Interaction
Reduced therapeutic effect with drugs that are potent P-gp inducers in the intestine (eg rifampicin, St. John's wort, carbamazepine & phenytoin), modafinil, phenobarb/ oxcarbazepine, rifabutin/ rifapentine. P-gp &/or BCRP inhibitors. May result in serious symptomatic bradycardia when co-administered with amiodarone in combination with another direct acting antiviral.
Food Interaction
- Take with or without food.
Sofoxen Tablet 400 mg Drug Interaction
Moderate: insulin glargineUnknown: aspirin, fexofenadine, aspirin, calcium / vitamin d, Allergy , heparin, esomeprazole, multivitamin with minerals, acetaminophen, peginterferon alfa-2a, peginterferon alfa-2b, tacrolimus, vitamin a topical, bioflavonoids, sotalol, valproic acid, thiamine, cyanocobalamin, cholecalciferol
Sofoxen Tablet 400 mg Disease Interaction
Major: immunosuppressionModerate: hepatic impairment, renal impairment
Volume of Distribution
The volume of distribution for sofosbuvir has yet to be determined .
Elimination Route
When given orally, sofosbuvir reaches its maximum plasma concentration in about 0.5 to 2 hours with a maximal concentration (Cmax) of 567 ng/mL .
Half Life
Sofoxen Tablet 400 mg has a terminal half life of 0.4 hours .
Clearance
The clearance of sofosbuvir has yet to be determined .
Elimination Route
Sofoxen Tablet 400 mg is eliminated by three routes: urine ( 80%), feces (14%), and respiration (2.5%); however, elimination through the kidneys is the major route .
Pregnancy & Breastfeeding use
Pregnancy Category- B. Ribavirin may cause birth defects and fetal death and animal studies have shown interferons have abortifacient effects; avoid pregnancy in female patients and female partners of male patients. Patients must have a negative pregnancy test prior to initiating therapy, use at least 2 effective methods of contraception and have monthly pregnancy tests.
Lactation: Unknown if distributed in human breast milk; take into account the importance of therapy to the mother when administered combination with ribavirin and/or peg-interferon alfa; because of the potential for adverse reaction, breastfeeding is not recommended
Contraindication
When Sofosbivur is used in combination with Ribavirin or Peginterferon alfa/ Ribavirin, the contraindications applicable to those agents are applicable to combination therapies. Sofoxen Tablet 400 mg combination treatment with Ribavirin or Peginterferon alfa/Ribavirin is contraindicated in women who are pregnant or may become pregnant and men whose female partners are pregnant, because of the risks for birth defects and fetal death associated with Ribavirin.
Special Warning
Geriatric Use: No dose adjustment of Sofoxen Tablet 400 mg is warranted in geriatric patients.
Acute Overdose
The highest dose of Sofoxen Tablet 400 mg is a single dose of Sofoxen Tablet 400 mg 1200 mg. No specific antidote is available for overdose treatment. Treatment of overdose with Sofoxen Tablet 400 mg consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.
Storage Condition
Keep out of the reach of children. Keep in a cool & dry place. Protect from light.
Innovators Monograph
You find simplified version here Sofoxen Tablet 400 mg
Sofoxen Tablet 400 mg contains Sofosbuvir see full prescribing information from innovator Sofoxen Tablet 400 mg Monograph, Sofoxen Tablet 400 mg MSDS, Sofoxen Tablet 400 mg FDA label
FAQ
What is Sofoxen Tablet 400 mg used for?
Sofoxen Tablet 400 mg is used along with ribavirin and sometimes another medication (peginterferon alfa) to treat certain types of chronic hepatitis C (an ongoing viral infection that damages the liver) in adults.
How safe is Sofoxen Tablet 400 mg?
Sofoxen Tablet 400 mg based treatment is safe and effective in patients with chronic hepatitis C infection and end stage renal disease, a case series.
What are the common side effects of Sofoxen Tablet 400 mg?
Common side effects of Sofoxen Tablet 400 mg are include:
- fatigue,
- headache,
- nausea,
- insomnia,
- itching,
- anemia,
- weakness,
- rash,
- decreased appetite,
- chills,
- flu-like illness,
- fever,
- diarrhea,
- joint pain,
- irritability,
- low white blood cell count (neutropenia), and
- low blood cell count (pancytopenia).
Is Sofoxen Tablet 400 mg safe during pregnancy?
Sofoxen Tablet 400 mg appears to have a favourable pharmacokinetic profile and animal studies indicate that it may be safe during pregnancy. Thus, Sofoxen Tablet 400 mg used in Ribavirin-free regimens, may become the drug of choice for women of childbearing age affected by HCV infection.
Is Sofoxen Tablet 400 mg safe during breastfeeding?
Breastfeeding is not recommended during use of this drug. According to some authorities,Use is not recommended.Sofoxen Tablet 400 mg has not been studied in nursing mothers receiving treatment for hepatitis C virus infection.
Can I drink alcohol with Sofoxen Tablet 400 mg?
Drinking alcohol is not strictly contraindicated with Epclusa treatment, it should be avoided. However, one beer every now and then is unlikely to affect the outcome of treatment. Alcohol may increase the risk of side effects with Epclusa, such as nausea, diarrhea, fatigue, and headache.
How long do I take Sofoxen Tablet 400 mg?
If Sofoxen Tablet 400 mg is taken in combination with peginterferon alfa and ribavirin, it is usually taken for 12 weeks. If Sofoxen Tablet 400 mg is taken in combination with ribavirin alone, it is usually taken for 12 or 24 weeks.
When is the best time to take Sofoxen Tablet 400 mg?
Take your dose at about the same time each day. Take it with a small amount of food.
Does Sofoxen Tablet 400 mg cure hep C?
Sofoxen Tablet 400 mg is effective for treating infection with HCV genotype 1,2,3, or 4, and in clinical trials, 50% to 90% of individuals treated with the drug cleared the hepatitis C virus from their blood.
How to use Sofoxen Tablet 400 mg?
Take this medication by mouth with or without food as directed by your doctor, usually once daily. Children's dosage is based on age and weight.If you have any questions, ask your doctor or pharmacist.
What happen if I miss dose of Sofoxen Tablet 400 mg?
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.
Is Sofoxen Tablet 400 mg a nucleotide?
Sofoxen Tablet 400 mg is a new nucleotide analogue NS5B polymerase inhibitor indicated for the treatment of chronic HCV.
What is the mechanism of Sofoxen Tablet 400 mg?
The drug is a direct-acting antiviral agent and interferes with the HCV lifecycle, restraining the viral replication.Sofoxen Tablet 400 mg contains oral nucleotide analogue inhibitor of the hepatitis C virus (HCV) polymerase.
Is Sofoxen Tablet 400 mg an antibiotic?
Sofoxen Tablet 400 mg is an antiviral medicine that is used to treat chronic hepatitis C in adults and children who are at least 3 years old. Sofoxen Tablet 400 mg must be given in combination with other antiviral medications .
Can Sofoxen Tablet 400 mg cause liver damage?
Sofoxen Tablet 400 mg may cause serious liver injury, even death, mostly in patients with underlying advanced liver disease.
How much Sofoxen Tablet 400 mg can I take in a day?
The recommended dose of Sofoxen Tablet 400 mg is one 400 mg tablet, taken orally, once daily with or without food.Sofoxen Tablet 400 mg is always taken with other antiviral medicines.
Can I take overdose of Sofoxen Tablet 400 mg?
If you take too much Sofoxen Tablet 400 mg, call your healthcare provider or go to the nearest hospital emergency room right away.
