Ledifos, Hetero, Hepatitis Drugs, Sofosbuvir and Ledipasvir

 

LEDIFOS

Drug profile:

Ledifos tablets are anti-viral agent.

Ledifos   which have procured by a patient only with a prescription

Ledifos tablets fixed-dose combination contains sofosbuvir and ledipasvir

Trade name: Ledifos

Active components: sofosbuvir & ledipasvir

Strength of the components: 400mg & 90mg respectively

Mfg: Hetero healthcare

Package: 28 tablets in a container

Category: Anti-cancer agent.

Ledifos Prescribing Information:

Ledifos is a very effective drug, involves in the treatment of chronic hepatitis C viral infection

Ledifos  tablets  is a single dose medicine, used alone or in combination with other anti-viral medicines in a chronic condition.

Ledifos, used by the patients having a valid prescription.

Ledifos Mechanism of Action:

Ledifos has two eminent compounds like;

Sofosbuvir & ledipasvir

Ledifos is directly acting anti-viral drug, exhibits its activity by inhibiting the viral replication.

Ledipasvir: exhibits its action by Ledifos tablets  intercedes with NS5A activity which is important for viral multiply, secretion, and colony of HCV virions. Due to the effect of ledipasvir, NS5A inhibitor causes eradicate viral growth.

Sofosbuvir: Generally it is anti-hepaciviral associated Ledifos tablets with NS5B polymerase inhibitor. This polymerase enzyme is responsible for viral proliferation, by interfering with these enzymes causes stoppage of viral reproduction acts as a chain terminator.

Absorption:

The absorption of Ledifos occurs rapidly, the peak plasma concentration of sofosbuvir 0.8 to 1 hour, ledipasvir is 4 to 4.5 hours; and GS-331007 3.5 to 4 hours.

Distribution:

Ledifos should be administered with or without food; the human plasma protein bound of ledipasvir occurs as >99.8%; sofosbuvir 61 to 65%.

The metabolite of sofosbuvir GS-331007 has minimal plasma protein bounding capability.

Ledifos

Metabolism:

Ledifos tablets  contains ledipasvir which is not metabolized hepatically and is excreted through feces as an unchanged form.Sofosbuvir metabolized to pharmacologically active form GS-461203.

Elimination:

Ledifos Excretion occurs through feces and urine

Sofosbuvir:

Urine: 80%, feces: 14%, exhaled air: 3.5%

Ledipasvir:

99% in feces & 1% in urine as an unchanged.

When to take Ledifos tablets:

Ledifos tablets should be taken as a once a day, with or without a meal.

Ledifos is used either alone or with a combination.

Ledifos is a prescription medicine; care should be taken to avoid the self-medication problems.

Dosage Regimens

In pediatric:

Used for HCV infection:

Duration of therapy:

Genotype IV, V or VI:

Therapy naïve and experienced without cirrhosis or with compensated cirrhosis:

Ledifos followed for 12 weeks as a single dose.

Genotype I:

Therapy naïve with compensated cirrhosis or without cirrhosis:

Ledifos recommended for 12 weeks as a single dose.

Therapy-experienced without cirrhosis:

Ledifos has taken orally as a single dose for 12 weeks.

Therapy naïve and experienced without cirrhosis or with compensated cirrhosis:

Ledifos took for 24 weeks as a single dose.

Ledifos is majorly indicated in pediatric patients with the age of 12 or older or weight of 35kg.

<12 years or <35kg: the safety and efficacy have not been established.

≥12 years or ≥35kg: one tablet to be taken as a single dose.

In adults:

The recommended dose of Ledifos tablets in adults are;
One tablet 90mg/400mg to be taken as a single dose.

Patients acquired without cirrhosis or with compensated cirrhosis:

Ledifos should be taken as a single dose orally for 12 weeks.

Therapy-experienced without cirrhosis:

Ledifos should be taken as once a day for 12 weeks.

Therapy-experienced with compensated cirrhosis:

Ledifos should be taken as a single dose for 24 weeks alone or in combination with ribavirin.

In decompensated cirrhosis:

Ledifos combined with weight-based ribavirin followed for 12 weeks

Ribavirin dosage regimen:

<75kg: 1000mg per day

≥75kg: 1200mg per day.

In Genotype I or IV:

Spontaneous therapy and therapy competent without cirrhosis or Ledifos tablets  with compensated cirrhosis:

Ledifos with ribavirin taken for 12 weeks as a single dose.

In genotype IV, V or VI:

Therapy-experienced and therapy naïve without cirrhosis or with compensated cirrhosis:

Ledifos should be taken as a single dose for 12 weeks.

Dosage adjustment:

In renal and hepatic impairment patients, mild or moderate conditions, on dosage adjustments required

In decompensated condition, safety and Ledifos tablets efficacy has not been established.

Ledifos Called side effects:

Adverse effects in Ledifos cirrhosis condition;

Asthenia, headache, fatigue, Myalgia, dyspnea, dizziness and irritability

Elevation of Ledifos tablets bilirubin levels

Elevation of lipase level

Elevation of creatine kinase levels

In cardiac: bradycardia,  Ledifos cardiac arrest

Skin: angioedema and rashes

Serious Ledifos tablets  bradycardia occurs

While combining with ribavirin, related problems occurs

Common side effects;

Headache

Fatigue

Nausea

Diarrhea

Insomnia

Drug Interaction:

Ledifos concomitant with other drugs likes;
Ledifos tablets   With antacids: like proton pump inhibitors, H2 receptor antagonist causes reduce effect of concentration of ledipasvir

Ledifos with HMG CoA reductase: increase the effect of concentration of these lipid mimic drugs

Ledifos tablets  b  With amiodarone: serious bradycardia occurs

Ledifos   With digoxin: increase the effect of concentration of digoxin

Ledifos tablets  With anti-convulsants: reduce the effect of concentration of Sofosbuvir and ledipasvir

Ledipasvir: Drug transporter P-gp inhibitors and breast cancer resistance protein inhibitor, while concomitant withSofosbuvir and ledipasvir may causes increase the intestinal absorption of these substrates

Ledifos With anti-mycobacterials: reduce the effect of concentration of Sofosbuvir and ledipasvir.

Food -Drug Interactions:

Food-drug interaction in Ledifos tablets; food does not interfere with the activity of Ledifos

Herbal product like st. Johns wort combined with Ledifos     may cause loss of effect of concentration of Ledifos.

Possible Contraindications:

Ledifos tablets are contraindicated;

Renal and hepatic impairment patients

While combining Ledifos  with ribavirin contraindicated to pregnancy conditions

Hypersensitivity reactions occur.

Safety Measures:

Exposed to adverse Ledifos  effects due to concomitant with ribavirin.

Risk of the reaction of HBV infection to HCV/HBV co-infected patients.

The possibility of symptomatic Ledifos tablets  bradycardia occurs during combination with ribavirin.

Risk of loss of therapeutic effect because of combination with P-gp inducers.

Care was taken  Ledifos in hepatic and renal impairment patients.

Pregnancy and Lactation:

Ledifos with ribavirin pregnancy category: X

Ribavirin causes fetal death

Ledifos tablets  pregnancy category: B1

Ledifos is safe to use in case of monotherapy (used alone)

Breastfeeding is not recommended for the patients who are getting ribavirin.

Storage and Handling:

Ledifos tablets container should be stored at room temperature below 30oC
Ledifos Container should be keep away from moisture, heat and light.

Missed Dose:

If patient fail to take the dose Ledifos, must consult with medical practitioner and administered the missed dose as soon as possible within the time. Ledifos tablets are prescription use, before taking the tablet patient must advise by a physician for avoiding self-medication.

Otherwise, the missed dose should be skipped and maintain the regular dosing schedule.

Do not take Ledifos  an overdose.

Overdosage:

The maximum dose of Ledifos (Sofosbuvir and ledipasvir) was 1200mg and 120mg twice daily for 10days.
No special antidote is recommended for overdosage of ledipasvir and Sofosbuvir
Hemodialysis is suitable Ledifos tablets   for elimination of ledipasvir hence; ledipasvir is largely bound to plasma protein and also helps to expel the dominant circulating metabolite of Sofosbuvir GS-331007 with a range of 53%
If overdosage of both  Ledifos drugs, patients should be examined for confirmation of toxicity
Other precaution: in case of overdosage, Ledifos tablets  contact poison information center as soon as possible

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