Sofokem
Sofokem Uses, Dosage, Side Effects, Food Interaction and all others data.
Sofokem is an inhibitor of the hepatitis C virus (HCV) NS5B ribonucleic acid (RNA)-dependent RNA polymerase, which is essential for viral replication. Sofokem 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.
Sofokem 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 | Sofokem |
| Availability | Prescription only |
| Generic | Sofosbuvir |
| Sofosbuvir Other Names | Sofosbuvir |
| Related Drugs | Epclusa, Harvoni, Sovaldi, Vosevi, Mavyret, ribavirin |
| 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 | |
| Available Country | India |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Sofokem is used for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen. Sofokem 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.
Sofokem 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 Sofokem works
Sofokem 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, Sofokem 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
Sofokem 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: Sofokem + Peginterferon alfa + Ribavirin for 12 weeks
- Genotype 2: Sofokem + Ribavirin for 12 weeks
- Genotype 3: Sofokem + Ribavirin for 24 weeks
Sofokem 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 Sofokem in combination with ribavirin were fatigue and headache.
The most common adverse events for Sofokem, peginterferon alfa and Ribavirin combination therapy were fatigue, headache, nausea, insomnia and anemia.
The following ADRs occured in <1% of subjects receiving Sofokem 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
Sofokem, 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 Sofokem 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 Sofokem 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.
Sofokem 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
Sofokem 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
Sofokem has a terminal half life of 0.4 hours .
Clearance
The clearance of sofosbuvir has yet to be determined .
Elimination Route
Sofokem 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. Sofokem 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 Sofokem is warranted in geriatric patients.
Acute Overdose
The highest dose of Sofokem is a single dose of Sofokem 1200 mg. No specific antidote is available for overdose treatment. Treatment of overdose with Sofokem 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 Sofokem
Sofokem contains Sofosbuvir see full prescribing information from innovator Sofokem Monograph, Sofokem MSDS, Sofokem FDA label
FAQ
What is Sofokem used for?
Sofokem 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 Sofokem?
Sofokem 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 Sofokem?
Common side effects of Sofokem 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 Sofokem safe during pregnancy?
Sofokem appears to have a favourable pharmacokinetic profile and animal studies indicate that it may be safe during pregnancy. Thus, Sofokem used in Ribavirin-free regimens, may become the drug of choice for women of childbearing age affected by HCV infection.
Is Sofokem safe during breastfeeding?
Breastfeeding is not recommended during use of this drug. According to some authorities,Use is not recommended.Sofokem has not been studied in nursing mothers receiving treatment for hepatitis C virus infection.
Can I drink alcohol with Sofokem?
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 Sofokem?
If Sofokem is taken in combination with peginterferon alfa and ribavirin, it is usually taken for 12 weeks. If Sofokem is taken in combination with ribavirin alone, it is usually taken for 12 or 24 weeks.
When is the best time to take Sofokem?
Take your dose at about the same time each day. Take it with a small amount of food.
Does Sofokem cure hep C?
Sofokem 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 Sofokem?
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 Sofokem?
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 Sofokem a nucleotide?
Sofokem is a new nucleotide analogue NS5B polymerase inhibitor indicated for the treatment of chronic HCV.
What is the mechanism of Sofokem?
The drug is a direct-acting antiviral agent and interferes with the HCV lifecycle, restraining the viral replication.Sofokem contains oral nucleotide analogue inhibitor of the hepatitis C virus (HCV) polymerase.
Is Sofokem an antibiotic?
Sofokem is an antiviral medicine that is used to treat chronic hepatitis C in adults and children who are at least 3 years old. Sofokem must be given in combination with other antiviral medications .
Can Sofokem cause liver damage?
Sofokem may cause serious liver injury, even death, mostly in patients with underlying advanced liver disease.
How much Sofokem can I take in a day?
The recommended dose of Sofokem is one 400 mg tablet, taken orally, once daily with or without food.Sofokem is always taken with other antiviral medicines.
Can I take overdose of Sofokem?
If you take too much Sofokem, call your healthcare provider or go to the nearest hospital emergency room right away.
