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Fixvel
Beacon Pharmaceuticals PLC
Generic: Sofosbuvir + Velpatasvir
Safety Advices
বাংলা
English
CONSULT YOUR DOCTOR
It is not known whether it is safe to consume alcohol with Fixvel. Please consult your doctor.
SAFE IF PRESCRIBED
Fixvel is generally considered safe to use during pregnancy. Animal studies have shown low or no adverse effects to the developing baby; however, there are limited human studies.
SAFE IF PRESCRIBED
Fixvel is probably safe to use during breastfeeding. Limited human data suggests that the drug does not represent any significant risk to the baby.
UNSAFE
Fixvel may cause side effects which could affect your ability to drive.
Fixvel, when taken together with other medicines for the treatment of hepatitis c infection, may produce dizziness, blurred vision and this may affect your ability to drive.
CAUTION
Fixvel should be used with caution in patients with severe kidney disease. Dose adjustment of Fixvel may be needed. Please consult your doctor.
Limited information is available on the use of Fixvel in these patients. No dose adjustment is recommended in patients with mild to moderate kidney disease.
SAFE IF PRESCRIBED
Fixvel is safe to use in patients with liver disease. No dose adjustment of Fixvel is recommended.
However, inform your doctor if you have any kidney disease as regular monitoring of liver function tests may be advised in some patients while taking this medicine.
Medicine Overview of Fixvel 400mg+100mg Tablet
Introduction
Fixvel is a combination of two antiviral medicines. This prescription medicine is used in the treatment of chronic hepatitis C virus (HCV) infection. It fights against the viruses to resolve the infection. Fixvel should be taken in the prescribed dose and duration. It can be taken with or without food, but take it at the same time daily. It is advised not to consume more than the recommended dose. It is important to inform your doctor if you have any health conditions such as liver or kidney disease. It is harmful to consume alcohol along with this medicine, so it...
... Show moreUses of Fixvel
- Chronic hepatitis C virus (HCV) infection
Side effects of Fixvel
Common
- Headache
- Tiredness
How to use Fixvel
Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Fixvel may be taken with or without food, but it is better to take it at a fixed time.
How Fixvel works
Fixvel is a combination of two antiviral medicines: Sofosbuvir and Velpatasvir. They work by lowering the amount of hepatitis C virus in the body and removing the virus from the blood over a period of time.
Quick Tips
- Fixvel is used for the treatment of chronic hepatitis C virus (HCV) infection.
- Take it with food, preferably at the same time everyday.
- You will usually need to take this medicine every day for either 12 or 24 weeks.
- Skipping doses increases the risk of treatment failure. Make sure that you take all your doses at the correct time.
- It may cause fatigue, dizziness, and blurred vision. Don't drive or do anything requiring concentration until you know how it affects you.
- Fixvel may cause headaches. Drink plenty of water and take a suitable painkiller. Inform your doctor if it does not go away.
- Your doctor may monitor your liver function and the amount of hepatitis C virus in your body regularly.
- Do not stop taking this medicine without your doctor’s advice.
Brief Description
Indication
Chronic Hepatitis C
Administration
May be taken with or without food
Adult Dose
Oral
Adult
Chronic Hepatitis C
Indicated for adults with chronic hepatitis C virus (HCV) infection genotypes 1, 2, 3, 4, 5, and 6
1 tablet (400 mg sofosbuvir/ 100 mg velpatasvir) qDay
Patients without cirrhosis or with compensated cirrhosis (Child-Pugh A): Sofosbuvir/velpatasvir for 12 weeks
Patients with decompensated cirrhosis (Child-Pugh B or C): Sofosbuvir/velpatasvir plus weight-based ribavirin with food for 12 weeks
Hepatic impairment
Mild, moderate, or severe (Child-Pugh A, B, or C): No dosage adjustment required
Child Dose
Safety and efficacy not established
Renal Dose
Renal impairment
Severe renal impairment (eGFR <30mL/min/1.73 m²) or ESRD: No dosage recommendation can be give owing to higher exposures (up to 20-fold) of the predominant sofosbuvir metabolite
Contraindication
Hypersensitivity.
Mode of Action
Sofosbuvir: Inhibitor of HCV NS5B RNA-dependent polymerase; its inhibition, in turn, suppresses viral replication
Velpatasvir: Pangenotypic HCV NS5A inhibitor; the NS5A protein is required for viral replication
Precaution
Direct-acting antivirals (DDAs) may reactivate hepatitis B virus (HBV) in patients who have a current or previous HBV infection while being treated for hepatitis C virus In a few cases, HBV reactivation in patients treated with DAA medicines resulted in serious liver problems or death Patients should be screened for evidence of current or prior HBV infection before starting treatment with DAAs, and monitored for HBV flare-ups or reactivation during DAA treatment and posttreatment follow-up Serious symptomatic bradycardia may occur if sofosbuvir is coadministered with amiodarone in combination with another direct-acting antiviral (eg, daclatasvir, simeprevir) Lactation: Unknown if sofosbuvir, velpatasvir,...
... Show moreSide Effect
>10%
Without cirrhosis or with compensated cirrhosis
Headache (22%),Fatigue (15%)
With decompensated cirrhosis
Fatigue (32%),Anemia (26%),Hemoglobin 3 x ULN (3%),Rash (2%),Depression (1%),Increased creatinine kinase >10 x ULN (1%)
With decompensated cirrhosis
Diarrhea (10%)
Hemoglobin <3.5 g/dL (7%),Rash (5%),Increased creatinine kinase ≥10 x ULN (2%)
Interaction
Coadministration with drugs that increase gastric pH are expected to decrease velpatasvir serum concentration
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