Sovaldi Tablets / Film-coated
Sofosbuvir
400mg
GILEAD SCIENCES INTERNATIONAL LTD.
| Pack size | 28's HDPE Bottle |
|---|---|
| Dispensing mode | POM |
| Source | UK |
| Agent | QUADRI PHARMACEUTICALS STORE L.L.C. |
| Retail Price | 74500.50 AED |
Indications
Sovaldi Tablets / Film-coated is used for:
Chronic Hepatitis C, Patients with hepatocellular carcinoma awaiting liver transplantation
Adult Dose
Oral
Chronic Hepatitis C
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 : Sofosbuvir + Peginterferon alfa + Ribavirin for 12 weeks
Genotype 2: Sofosbuvir + Ribavirin for 12 weeks
Genotype 3: Sofosbuvir + Ribavirin for 24 weeks
- Sofosbuvir 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
Child Dose
Safety and efficacy not established
Renal Dose
Administration
Should be taken with food.
Contra Indications
When Sofosbivur is used in combination with Ribavirin or Peginterferon alfa/Ribavirin, the contraindications applicable to those agents are applicable to combination therapies. Sofosbuvir 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.
Precautions
Pregnancy: 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
Pregnancy-Lactation
Pregnancy Category: B; Category X when used in combination with ribavirin or peginterferon alfa/ribavirin
Sofosbuvir is coadministered with ribavirin and peginterferon alfa; extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients while taking this combination
Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin; and therefore ribavirin is contraindicated
Women of childbearing potential and their male partners should not receive ribavirin or peginterferon alfa/ribavarin unless they are using effective contraception (2 reliable forms) during treatment with ribavirin and for 6 months after treatment; routine monthly pregnancy tests must be performed during this time
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
Interactions
Reduced therapeutic effect w/ 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 w/ amiodarone in combination w/ another direct acting antiviral.
Adverse Effects
Side effects of Sofosbuvir :
>10%
Sofosbuvir plus ribavarin (12 weeks)
Fatigue (38%), Headache (24%), Nausea (22%), Insomnia (15%), Pruritus (11%), Sofosbuvir plus ribavarin (24 weeks), Fatigue (30%), Headache (30%), Nausea (13%), Insomnia (16%), Pruritus (27%), Asthenia (21%), Diarrhea (12%)
Sofosbuvir plus ribavarin plus peg-interferon (12 weeks)
Fatigue (59%), Headache (36%), Nausea (34%), Insomnia (25%), Pruritus (17%), Anemia (21%), Rash (18%), Decreased appetite (18%), Chills (17%), Influenza-like illness (16%), Pyrexia (18%), Diarrhea (12%), Neutropenia (17%), Myalgia (14%), Irritability (13%)
Sofosbuvir plus ribavarin plus peg-interferon (24 weeks)
Fatigue (55%), Headache (44%), Nausea (29%), Insomnia (29%), Pruritus (17%), Anemia (12%), Rash (18%), Decreased appetite (18%), Chills (18%), Influenza-like illness (18%), Pyrexia (14%), Diarrhea (17%), Neutropenia (12%), Myalgia (16%), Irritability (16%)
1-10%
Sofosbuvir plus ribavarin (12 weeks)
Anemia (10%), Asthenia (6%), Rash (8%), Decreased appetite (6%), Chills (2%), Influenza-like sickness (3%), Pyrexia (4%), Diarrhea (9%), Myalgia (6%), Irritability (10%)
Sofosbuvir plus ribavarin (24 weeks)
Anemia (6%), Rash (9%), Decreased appetite (6%), Chills (2%), Influenza-like sickness (6%), Pyrexia (4%), Myalgia (9%), Irritability (10%)
<1%
Neutropenia, Pancytopenia, Severe depression (particularly in patients with pre-existing psychiatric illness)
Mechanism of Action
Nucleotide prodrug that undergoes metabolism to the active uridine analog triphosphate, an inhibitor of HCV NS5B RNA-dependent polymerase; its inhibition in turn suppresses viral replication .
Note
Sovaldi 400mg Tablets / Film-coated manufactured by GILEAD SCIENCES INTERNATIONAL LTD. . Its generic name is Sofosbuvir. Sovaldi is availble in United Arab Emirates.
Farmaco UAE drug index information on Sovaldi Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.