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Aktif madde: sofosbuvir
Marka(lar): Şövaldi, Sofosbuvir Generic

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What is Sofosbuvir

Sofosbuvir is an inhibitor of the RNA-dependent RNA polymerase of HCV NS5B, an enzyme important for viral replication, and acts in opposition to all genotypes of the hepatitis C virus. It’s a nucleotide prodrug: throughout intracellular metabolism within the liver it’s transformed into the pharmacologically lively uridine analogue triphosphate. That is included into HCV RNA by NS5B polymerase, resulting in chain termination. The lively metabolite doesn’t inhibit human DNA and RNA polymerases and isn’t an inhibitor of mitochondrial RNA polymerase.

Sofosbuvir Drug Recommendation

Prevention of hepatitis C an infection consists of observing non-medicinal measures. There isn’t any drug prophylaxis. Remedy of persistent hepatitis C an infection, as preliminary remedy or after failure of earlier therapy, consists of a mix of direct-acting antiviral medicine. The selection of therapy routine relies upon, amongst different issues, on the HCV genotype and the diploma of pre-existing fibrosis within the liver. 

Belirteçler: Remedy of persistent hepatitis C (CHC) in adults and kids over 12 years of age, together with different medicinal merchandise.

Bu İlacı Kullanmadan Önce Doktorunuzla Neleri Konuşmalısınız?

  1. Hamile olmak
    • teratogenez: In people, inadequate knowledge. In animals, no proof of harmfulness. Nevertheless, Sofosbuvir is utilized in mixture with different medicinal merchandise (together with in selective instances ribavirin and/or peginterferon α).
    • Öneri: The use of sofosbuvir alone or together with peginterferon α shouldn’t be really useful. Together with (different) direct-acting brokers in opposition to:
      • hepatitis C:  Seek the advice of the medicinal product textual content of the respective agent.
      • Mixture with ribavirin: The usage of ribavirin is contra-indicated throughout being pregnant because of the important teratogenic and embryogenic results of ribavirin.
    • Farklı: Together with ribavirin, strict contraceptive measures apply, together with for a interval after the tip of therapy.

  2. emzirme
    • Transition to breast milk: Unknown. An antagonistic impact on the toddler can’t be excluded.
    • Öneri: The usage of this medicinal product together with ribavirin or breast-feeding is contraindicated. Breast-feeding is discouraged together with peginterferon α (alone); if utilizing (different) direct-acting brokers in opposition to hepatitis C, seek the advice of the related drugs textual content. In case of maternal HIV an infection, breast-feeding is discouraged because of the threat of HIV transmission.

Sofosbuvir Drug Interactions

Sofosbuvir is a substrate for P-glycoprotein (Pgp) and breast most cancers resistance protein (BCRP). On account of a decreased therapeutic impact, co-medication with potent inducers of Pgp or BCRP equivalent to:

  • rifampisin
  • karbamazepin
  • fenitoin
  • fenobarbital
  • Sarı Kantaron

The impact of an inducer might persist for no less than 2 weeks after its discontinuation. Co-medication with moderate-strength Pgp inducers equivalent to modafinil, oxcarbazepine and rifabutin shouldn’t be really useful. Co-medication with amiodarone is strongly discouraged because of the incidence of extreme (life-threatening) bradycardia and AV blockade.

When utilizing vitamin Okay antagonists, intently monitor the INR in reference to any change in liver operate that will happen throughout therapy. Additionally, the pharmacokinetics of different medicinal merchandise metabolized by the liver might change in relation to the clearance of HCV. Due to this fact, concomitant use of ciclosporin or tacrolimus requires shut monitoring and probably dose adjustment of those brokers; nevertheless, no dose adjustment is required on the begin of co-administration.

It could be obligatory to regulate the dosage of blood glucose regulators, attributable to an enhancement in blood glucose management. Nevertheless, Sofosbuvir might be co-administered with medicine that inhibit Pgp or BCRP and with a number of antiviral medicine in opposition to HIV.

Sofosbuvir Dosage

Remedy of persistent hepatitis C

  • Yetişkinler (yaşlı dahil)
    • Together with different medicines: 400 mg 1×/day. A discount of the dose shouldn’t be really useful.
    • The period of remedy with sofosbuvir + ribavirin is:
      • 12 weeks (CHC genotype 2),
      • 24 weeks (CHC genotype 3)
      • for genotypes 1, 4, 5 or 6, use this routine (24 weeks) solely in sufferers who’re ineligible or illiberal to peginterferon α) or till liver transplantation (in sufferers with CHC awaiting liver transplantation).
    • The therapy period for remedy with sofosbuvir + ribavirin + peginterferon α is:
      • 12 weeks (CHC genotype 1, 3, 4, 5 or 6).
    • In all of the above instances the place the therapy period is 12 weeks, therapy could also be prolonged past 12 weeks to a most of 24 weeks, particularly within the presence of a number of threat elements for a decrease response to interferon-based therapy.
    • After receiving a liver transplant, the therapy period is 24 weeks with a preliminary dose of ribavirin of 400 mg divided into 2 doses per day. If nicely tolerated, the dose of ribavirin needs to be step by step elevated to 1000 mg (< 75 kg physique weight) or 1200 mg (≥ 75 kg). If the preliminary dose shouldn’t be nicely tolerated, scale back the dose based on haemoglobin ranges. In scientific trials, if nicely tolerated, the dose was elevated after 2 and after 4 weeks, then no prior to as soon as each 4 weeks.

  • Kids 12 years and older
    • Together with different medicines: 400 mg 1×/day. A discount of the dose shouldn’t be really useful.
    • The therapy period for remedy with sofosbuvir + ribavirin is:
      • 12 weeks (CHC genotype 2)
      • 24 weeks (CHC genotype 3)
    • In genotype 2, the place the therapy period is 12 weeks, therapy past 12 weeks could also be prolonged as much as a most of 24 weeks, particularly within the presence of a number of threat elements for a decrease response to interferon-based therapy.
    • The dose of ribavirin in youngsters relies on physique weight:
      • < 47 kg: 15 mg/kg/day;
      • 47-49 kg: 600 mg/day;
      • 50-65 kg: 800 mg/day;
      • 66-80 kg: 1000 mg/day;
      • > 81 kg: 1200 mg/day

In case of great antagonistic reactions: dose discount of sofosbuvir shouldn’t be really useful. The official product data CBG/EMA lists normally phrases when the dose of which different medicinal product needs to be decreased and intimately data regarding ribavirin. Dosage data for the opposite medicinal merchandise might be discovered within the related medicinal product texts.

Co-infection with HIV: The really useful dosages described right here additionally apply to sufferers with HIV co-infection.

Impaired liver operate: No dose adjustment is critical in gentle to extreme hepatic impairment

Decreased renal operate: In gentle or reasonable renal impairment, no dose adjustment is required. There are comparatively few knowledge concerning the use in extreme renal impairment (eGFR < 30 ml/min/1.73m²) or in terminal renal illness on haemodialysis. Sofosbuvir could also be utilized in these sufferers with out dose adjustment if no different related therapy choices can be found.

In case of kusma inside 2 hours after tablet-taking, take an additional pill. If > 2 hours have handed, no further dose is critical.

Unutulan doz: Take as quickly as doable if seen inside 18 hours after the standard time of administration. If > 18 hours have handed, don’t repeat the missed dose.

Administration: Take the pill complete (due to the bitter style of the lively substance) and with meals (for higher absorption).

Sofosbuvir Precautions

Hepatitis B co-infection: Verify for hepatitis B virus (HBV) co-infection earlier than beginning therapy, as instances of HBV reactivation, together with some with deadly consequence, have been reported after therapy with direct-acting antivirals (DAAs). If co-infection is detected, test fastidiously and deal with based on present therapy tips.

Life-threatening bradycardia and AV blockade have been reported with using sofosbuvir and amiodarone. Bradycardia often happens inside hours or days of use however can last as long as roughly 2 weeks after initiation of HCV therapy. Due to this fact, the mix of sofosbuvir and amiodarone ought to ideally be prevented; apply solely when different antiarrhythmic brokers should not tolerated or contraindicated. If the mix is critical, when beginning sofosbuvir monitor the affected person repeatedly for no less than 48 hours in an applicable scientific setting. Thereafter, monitor day by day, for no less than the primary 2 weeks of therapy, in an outpatient setting, or instruct the affected person to take action. As amiodarone has an especially lengthy half-life (20-100 days), additionally do these observations in a affected person who has stopped amiodarone previously months and is now beginning sofosbuvir. Instruct the affected person utilizing this mix to contact us instantly if signs of bradycardia or coronary heart block happen.

Diabetics: an enchancment in blood glucose regulation might happen after initiation of therapy, probably resulting in symptomatic hypoglycaemia; monitor blood glucose ranges intently, particularly throughout the first 3 months, and modify the (dose of) blood glucose management merchandise if obligatory.

Analysis knowledge and expertise: The scientific trials with sofosbuvir have primarily been carried out together with ribavirin or with ribavirin + peginterferon α. As well as, a lot of mixture preparations with sofosbuvir have come onto the market:

  • ledipasvir/sofosbuvir
  • sofosbuvir/velpatasvir
  • sofosbuvir/velpatasvir/voxilaprevir

Due to this fact, these are presently the really useful mixtures. There are comparatively few security knowledge concerning use in sufferers with severely impaired renal operate (eGFR < 30 ml/min/1.73m²) or terminal renal illness (ESRD) requiring haemodialysis. The efficacy and security of sofosbuvir haven’t been established in:

  • youngsters beneath 12 years of age;
  • youngsters with liver cirrhosis;
  • youngsters with genotype 1, 4, 5 or 6.

Sofosbuvir Side Effects

Bir ilaç, gerekli etkilerinin yanı sıra bazı istenmeyen etkilere de neden olabilir. Bu yan etkilerin tümü ortaya çıkmasa da, ortaya çıkarsa tıbbi müdahaleye ihtiyaç duyabilirler. Aşağıdaki yan etkilerden herhangi biri meydana gelirse derhal doktorunuza danışın:

    • yorgunluk
    • sinirlilik
    • uykusuzluk hastalığı
    • baş ağrısı
    • Mide bulantısı
    • Elevated bilirubin in blood
    • Decreased haemoglobin
    • focus dysfunction
    • Çaresizlik
    • Dyspepsia, constipation.
    • dispne
    • öksürük
    • Muscle ache, joint ache, again ache, muscle spasms
    • Fever, asthenia
    • Nasopharyngitis
    • Dry pores and skin, itching, alopecia
    • Anemi.

Listelenmeyen diğer yan etkiler de bazı hastalarda ortaya çıkabilir. Başka bir etki fark ederseniz, sağlık uzmanınıza danışın.


Information concerning psychotic disorders, included within the review of Sofosbuvir, is used for the informative features exclusively as well as should not be thought-about to alternative to licensed healthcare or referral of the well being treatment distributor.


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Sıkça Sorulan Sorular

  • What is Sofosbuvir?

    Sofosbuvir is a standout amongst the most well known and dependable medicines of the hepatitis C. The rate of the treatment with Sofosbuvir can shift from 40-99% of the sicknesses in regards to the earnestness of the disease.

  • Bir dozu kaçırırsanız ne yapmalısınız?

    If you miss a dose of Sofosbuvir, take it as quickly as potential. However, whether it is virtually time to your subsequent dose, skip the missed dose and return to your common dosing schedule. Do not double doses.

  • What if u take too much Sofosbuvir?

    Doz aşımı meydana gelirse, doktorunuzu adlandırın veya size en yakın hastaneyi arayın. Acil tıbbi bakım almış olabilirsiniz. Ayrıca yerel hastanenizdeki zehir yönetimiyle de iletişime geçebilirsiniz.

  • How to store Sofosbuvir?

    Store Sofosbuvir at 77 degrees F (25 degrees C). Store away from heat, moisture, and light. 

  • What Should I Avoid While Taking Sofosbuvir?

    Belirgin uyuşukluk oluşabilir Alkollü içeceklerden kaçının alkol, sakinleştirici ve sakinleştiriciler uyuşukluğu artırabilir Özellikle çocuklarda motorlu taşıt veya makine kullanırken dikkatli olun 

  • What are the side effects of Sofosbuvir?

    The most common side effects includes feeling tired, cerebral pain, queasiness, inconvenience dozing, rash, dizziness and sickliness.

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