Patient Information on Velasof (Sofosbuvir and Velpatasvir) Tablets

Read this patient information before you start taking velasof, and each time you get a refill, there may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

What is Velasof ?

Velasof is a prescription medicine used to treat adults with chronic (lasting for a long time) Hepatitis C Virus (HCV), genotype 1, 2, 3, 4, 5 or 6 infection,

  • Without cirrhosis or with compensated cirrhosis
  • With advanced cirrhosis (decompensated) in combination with ribavirin
  • Velasof is a film-coated tablet that contains the two medicines, namely, sofosbuvir (400 mg) and velpatasvir (100 mg)

What are the ingredients in velasof ?

Velasof contains active ingredients like sofosbuvir (400 mg) and velpatasvir (100 mg).

The film-coated tablet contains colors like indigo carmine aluminum lake, brilliant blue FCF aluminum lake & titanium dioxide IP.

How should I take sofosbuvir and velpatasvir ?

The recommended dosage of velasof is one tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily with or without food. The treatment regimen and duration in patients with genotypes 1, 2, 3, 4, 5 or 6 HCV infection is mentioned in the below table.

Patient Population Recommended Treatment Regimen
Patients without cirrhosis and patients with compensated cirrhosis (Child-Pugh A) Velpatasvir/Sofosbuvir for 12 weeks
Patients with decompensated cirrhosis (Child-Pugh B and C) Velpatasvir/Sofosbuvir+ribavirin for 12 weeks

What are the contraindications ?

The combination of sofosbuvir and velpatasvir along with ribavirin combination regimen is contraindicated in patients for whom ribavirin is contraindicated. Males and females who take sofosbuvir and velpatasvir combination with ribavirin should also read the ribavirin medication guide for important pregnancy, contraception and infertility information.

What are the possible side effects of sofosbuvir and velpatasvir ?

Slow Heart Rate (Bradycardia): Sofosbuvir and velpatasvir combination treatment may result in slowing of heart rate along with amiodarone, a medicine used to treat certain heart problems. Cardiac arrest is seen in patients when sofosbuvir is coadministered along with amiodarone. Patients with bradycardia must seek medical evaluation immediately. The other possible symptoms include,

  • Fainting
  • Dizziness
  • Restlessness
  • Weakness
  • Excessive tiredness
  • Shortness of breath
  • Chest pain
  • Confusion

What should you tell your healthcare provider before taking sofosbuvir and velpatasvir ?

Pregnancy

  • In case of pregnant women, it is not known if sofosbuvir and velpatasvir combination will harm your unborn baby
  • Females who take sofosbuvir and velpatasvir combination along with ribavirin should avoid becoming pregnant during treatment and for 6 months after stopping treatment
  • Call/Consult your doctor if you think you may be pregnant or become pregnant during treatment with sofosbuvir and velpatasvir combination along with ribavirin

During breast-feeding,

  • It is not known if sofosbuvir and velpatasvir combination passes through breast milk
  • Talk to your doctor about the best way to feed your baby if you take sofosbuvir and velpatasvir combination

Children

  • It is not known if sofosbuvir and velpatasvir combination is safe and effective in children

What has to be done for sofosbuvir and velpatasvir overdosing ?

The subject should be monitored for verification of toxicity, besides that, supportive measures should be taken. Hemodialysis can be effective in removing the sofosbuvir metabolites whereas it is unlikely for velpatasvir.

How to store and handle sofosbuvir and velpatasvir ?

  • Store sofosbuvir and velpatasvir combination at a temperature not exceeding 30ÂșC
  • Keep sofosbuvir and velpatasvir combination in a container that is tightly closed
  • Do not use if seal over bottle opening is broken or missing

Keep sofosbuvir and velpatasvir combination and all medicines out of reach of children.

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CORPORATE OFFICE
Hetero Healthcare Limited
S.no: 80-84, Melange Towers, Patrika Nagar, Madhapur, Hyderabad.


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MARKETING OFFICE
Hetero Healthcare Limited
A/B: 201/202. Dipti Classic, 32/34. W.T. Suren Road, Andheri (East). Mumbai-400093

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