Tenovi Tablet (Tenofovir Disoproxil Fumarate)

Adult dosage

Adults For the treatment of HIV-1 or chronic hepatitis B, take 1 tablet once daily (equivalent to tenofovir disoproxil 245mg). It may be taken with or without food. The optimal duration of treatment for chronic hepatitis B is unknown. Patients with renal impairment Drug exposure was significantly increased when this medicine was administered to patients with moderate to severe renal impairment. Therefore, in patients with baseline creatinine clearance <50mL/min, adjust the dosing interval of this medicine according to Table 1. These dosing interval adjustment guidelines are based on a model of single-dose pharmacokinetic data in patients with varying degrees of renal impairment, including patients with end-stage renal disease requiring hemodialysis, who were not infected with HIV or HBV. The safety and efficacy of these dosing interval adjustment guidelines have not been clinically evaluated in patients with moderate or severe renal impairment; therefore, renal function and clinical response to treatment should be closely monitored in these patients (see Warnings 3). No adjustment of the dosing interval is necessary in patients with mild renal impairment (creatinine clearance 50-80mL/min), but calculated creatinine clearance and serum phosphate should be monitored regularly (see Warnings 3). Table 1. Adjustment of dosing intervals according to creatinine clearance Creatinine clearance (mL/min)a ≥50: Take 1 tablet every 24 hours Creatinine clearance (mL/min)a 30-49: Take 1 tablet every 48 hours Creatinine clearance (mL/min)a 10-29: Take 1 tablet every 72-96 hours Patients on hemodialysis: Take 1 tablet every 7 days or approximately 12 hours after dialysisb a. Calculated using ideal (lean) body weight. b. Generally, administer once weekly, assuming 3 hemodialysis sessions of approximately 4 hours each per week. This medicine should be administered after dialysis is completed. The pharmacokinetics of tenofovir have not been evaluated in patients with creatinine clearance below 10mL/min who are not receiving hemodialysis; therefore, no dosing recommendations are available for these patients.

Children's dosage

Pediatric patients aged 12 years or older (35kg or more): For the treatment of HIV-1 or chronic hepatitis B, take 1 tablet once daily (equivalent to tenofovir disoproxil 245mg). It may be taken with or without food. Pediatric patients with chronic hepatitis B weighing less than 35kg: Safety and efficacy have not been established. Pediatric patients with renal impairment: There are no data to support a dose recommendation.

This drug should be used with caution in patients with severely impaired liver function as the risk of lactic acidosis and liver fat accumulation may increase. Discontinuing treatment abruptly can worsen hepatitis, so liver status should be continuously monitored even after stopping the medication. Due to renal excretion, patients with compromised kidney function may experience increased drug concentrations putting strain on the kidneys, therefore kidney function should be checked regularly. Co-administration with certain medications may worsen side effects, so it is essential to consult a physician or pharmacist. Patients co-infected with HIV and Hepatitis B should not use this drug alone and should receive appropriate combination therapy. Bone density may decrease, so patients at risk of fractures should regularly check bone health and may benefit from supplements if necessary. Body fat distribution may change, and recovery of the immune system may lead to inflammatory responses or autoimmune diseases, so any unusual symptoms should be reported immediately. In the early stages of treatment, there may be insufficient viral suppression, so treatment progress should be closely monitored. Patients with allergies or genetic issues such as lactose intolerance should not take this medication. Use during pregnancy should only occur if absolutely necessary, and breastfeeding mothers should avoid breastfeeding as the drug can be passed on to the baby. Safety and effectiveness in children under 12 years have not been established, so it is not recommended for this age group. Elderly patients or those with severely impaired kidney function require careful dosage adjustments and monitoring. In the event of an overdose, immediate medical attention should be sought, and some drugs may be eliminated through blood dialysis. This medicine should be stored out of reach of children and kept in its original container for safety.

Severe hepatic enlargement with hyperlipidemia, exacerbation of hepatitis, acute renal failure, Fanconi syndrome, renal impairment, decreased bone density, fractures, osteomalacia, proximal renal tubular disorder, central obesity, posterior neck fat expansion, peripheral wasting syndrome, facial wasting syndrome, breast enlargement, Cushing-like syndrome, immune reconstitution syndrome, autoimmune diseases, early virological failure, rash, diarrhea, headache, pain, depression, asthenia, nausea, dizziness, dyspepsia, vomiting, arthralgia, myalgia, insomnia, anxiety disorder, pneumonia, fever, abdominal pain, back pain, fatigue, sinusitis, upper respiratory infection, nasopharyngitis, nausea, abdominal bloating, loss of appetite, sweating, weight loss, pneumonia, allergic reactions, hypokalemia, hypophosphatemia, dyspnea, pancreatitis, increased amylase, hepatic steatosis, hepatitis, increased liver enzymes, rhabdomyolysis, muscle weakness, myopathy, acute tubular necrosis, interstitial nephritis, nephrogenic diabetes insipidus, increased creatinine, proteinuria, polyuria, asthenia, dyspepsia, constipation, gastroesophageal reflux disease, ascites, abdominal bloating, urinary tract infection, gastroenteritis, herpes zoster, septic shock, worsening condition, increased ALT, increased AST, hepatocellular carcinoma, metastatic brain tumors, osteoporosis, flank pain, spinal pain, sensory impairment, cerebral infarction, diabetic neuropathy, metabolic encephalopathy, seizures, cholelithiasis, liver cirrhosis, alcoholic sclerosis, hepatic insufficiency, liver fibrosis, hand fractures, febrile neutropenia, leukopenia, deep vein thrombosis, corneal degeneration, graft-vs-host disease, hair loss, erythema multiforme, sialadenitis, nail ingrowth, urticaria, fibromyalgia, herniated disc, osteoarthritis, limb pain, trigger finger, dementia, confusion, sleep disorders, bladder dysfunction, urinary calculi, dysuria, renal cysts, ureterolithiasis, anemia, splenomegaly, thrombocytopenia, decreased appetite, eating disorders, cough, rhinitis, upper respiratory cough syndrome, hypertension, conjunctival hemorrhage, ocular movement disorders, conjunctival hyperemia, benign prostatic hyperplasia

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. The storage temperature should be kept between 1 to 30 degrees Celsius. This will help maintain the efficacy and safety of the medication for a long time.

Appearance

Pale blue almond-shaped film-coated tablet

Package unit

30 tablets/bottle