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MyHep ALL

MyHep ALL Special Precautions

sofosbuvir + velpatasvir

Manufacturer:

Mylan Healthcare

Distributor:

Antah Pharma
Full Prescribing Info
Special Precautions
Sofosbuvir and Velpatasvir Film Coated Tablets 400 mg/100 mg should not be administered concurrently with other medicinal products containing sofosbuvir.
Severe bradycardia and heart block:
Cases of severe bradycardia and heart block have been observed when sofosbuvir-containing regimens are used in combination with amiodarone with or without other medicinal products that lower heart rate. The mechanism is not established.
The concomitant use of amiodarone was limited through the clinical development of sofosbuvir. Cases are potentially life threatening, therefore amiodarone should only be used in patients on Sofosbuvir and Velpatasvir Film Coated Tablets 400 mg/100 mg when other alternative anti-arrhythmic treatments are not tolerated or are contraindicated.
Should concomitant use of amiodarone be considered necessary, it is recommended that patients are closely monitored when initiating Sofosbuvir and Velpatasvir Film Coated Tablets 400 mg/100 mg. Patients who are identified as being at high risk of bradyarrhythmia should be continuously monitored for 48 hours in an appropriate clinical setting.
Due to the long half-life of amiodarone, appropriate monitoring should also be carried out for patients who have discontinued amiodarone within the past few months and are to be initiated on Sofosbuvir and Velpatasvir Film Coated Tablets 400 mg/100 mg.
All patients receiving Sofosbuvir and Velpatasvir Film Coated Tablets 400 mg/100 mg in combination with amiodarone with or without other medicinal products that lower heart rate should also be warned of the symptoms of bradycardia and heart block and should be advised to seek medical advice urgently should they experience them.
Patients who have previously failed therapy with an NS5A-containing regimen: There are no clinical data to support the efficacy of sofosbuvir/velpatasvir for the treatment of patients who have failed treatment with a regimen containing another NS5A inhibitor. However, on the basis of NS5A resistance associated variants (RAVs) typically seen in patients who have failed therapy with other NS5A inhibitor containing regimens, the in vitro pharmacology of velpatasvir, and the outcomes of sofosbuvir/velpatasvir treatment in NS5A-naïve patients with baseline NS5A RAVs enrolled into the ASTRAL-studies, treatment with Sofosbuvir and Velpatasvir Film Coated Tablets 400 mg/100 mg + RBV for 24 weeks can be considered for patients who have failed therapy on an NS5A-containing regimen and who are deemed at high risk for clinical disease progression and who do not have alternative treatment options.
Use with moderate P-gp inducers or moderate CYP inducers: Medicinal products that are moderate P-gp or moderate CYP inducers (e.g. oxcarbazepine, modafinil or efavirenz) may decrease sofosbuvir or velpatasvir plasma concentrations leading to reduced therapeutic effect of Sofosbuvir and Velpatasvir Film Coated Tablets 400 mg/100 mg. Co-administration of such medicinal products with Sofosbuvir and Velpatasvir Film Coated Tablets 400 mg/100 mg is not recommended (see Interactions).
Use with certain HIV antiretroviral regimens: Sofosbuvir and Velpatasvir Film Coated Tablets 400 mg/100 mg has been shown to increase tenofovir exposure, especially when used together with an HIV regimen containing tenofovir disoproxil fumarate and a pharmacokinetic enhancer (ritonavir or cobicistat). The safety of tenofovir disoproxil fumarate in the setting of Sofosbuvir and Velpatasvir Film Coated Tablets 400 mg/100 mg and a pharmacokinetic enhancer has not been established. The potential risks and benefits associated with co-administration of Sofosbuvir and Velpatasvir Film Coated Tablets 400 mg/100 mg with the fixed-dose combination tablet containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or tenofovir disoproxil fumarate given in conjunction with a boosted HIV protease inhibitor (e.g. atazanavir or darunavir) should be considered, particularly in patients at increased risk of renal dysfunction. Patients receiving Sofosbuvir and Velpatasvir Film Coated Tablets 400 mg/100 mg concomitantly with elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or with tenofovir disoproxil fumarate and a boosted HIV protease inhibitor should be monitored for tenofovir-associated adverse reactions. Refer to tenofovir disoproxil fumarate, emtricitabine/tenofovir disoproxil fumarate, or elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate Summary of Product Characteristics for recommendations on renal monitoring.
Use in diabetic patients: Diabetics may experience improved glucose control, potentially resulting in symptomatic hypoglycaemia, after initiating HCV direct-acting antiviral treatment. Glucose levels of diabetic patients initiating direct-acting antiviral therapy should be closely monitored, particularly within the first 3 months, and their diabetic medication modified when necessary. The physician in charge of the diabetic care of the patient should be informed when direct-acting antiviral therapy is initiated.
HCV/HBV (hepatitis B virus) co-infection: Cases of hepatitis B virus (HBV) reactivation, some of them fatal, have been reported during or after treatment with direct-acting antiviral agents. HBV screening should be performed in all patients before initiation of treatment. HBV/HCV co-infected patients are at risk of HBV reactivation, and should therefore be monitored and managed according to current clinical guidelines.
CPT Class C cirrhosis: Safety and efficacy of Sofosbuvir and Velpatasvir Film Coated Tablets 400 mg/100 mg has not been assessed in patients with CPT Class C cirrhosis (see Adverse Reactions and Pharmacology: Pharmacodynamics under Actions).
Liver transplant patients: The safety and efficacy of Sofosbuvir and Velpatasvir Film Coated Tablets 400 mg/100 mg in the treatment of HCV infection in patients who are post-liver transplant have not been assessed. Treatment with Sofosbuvir and Velpatasvir Film Coated Tablets 400 mg/100 mg in accordance with the recommended posology (see Posology under Dosage & Administration) should be guided by an assessment of the potential benefits and risks for the individual patient.
Renal impairment: Safety data are limited in patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2) and ESRD requiring haemodialysis. Sofosbuvir and Velpatasvir Film Coated Tablets 400 mg/100 mg can be used in these patients with no dose adjustment when no other relevant treatment options are available (see Pharmacology: Pharmacokinetics and Pharmacodynamics under Actions). When Sofosbuvir and Velpatasvir Film Coated Tablets 400 mg/100 mg is used in combination with ribavirin refer also to the Package Insert for ribavirin for patients with creatinine clearance < 50 mL/min (see Pharmacology: Pharmacodynamics under Actions).
Effects on ability to drive and use machines: Sofosbuvir and Velpatasvir tablet has no or negligible influence on the ability to drive and use machines.
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