Tenofovir DF

Tenofovir DF is a prescription medication used for the treatment of HIV and hepatitis infection.

• Tenofovir DF is available under the following different brand names: Viread

Adult and pediatric dosage

Tablet

• 150mg
• 200mg
• 250mg
• 300mg

Powder, oral

• 40mg/g of powder (i.e., 1 scoopful) 

HIV Infection 

Adult dosage

• 300 mg orally every day 

Pediatric dosage

• Children below 2 years: Safety and efficacy not established
• Children above 2 years and weighing above10 kg: 8 mg/kg orally every day; not to exceed 300 mg/day  

Oral powder

• Children weighing 10 to 11 kg: 80 mg (2 scoops) orally every day
• Children weighing 12 to 13 kg: 100 mg (2.5 scoops) orally every day
• Children weighing 14 to 16 kg: 120 mg (3 scoops) orally every day 
• Children weighing 17 to 18 kg: 140 mg (3.5 scoops) orally every day
• Children weighing 19 to 21 kg: 160 mg (4 scoops) orally every day
• Children weighing 22 to 23 kg: 180 mg (4.5 scoops) orally every day
• Children weighing 24 to 26 kg: 200 mg (5 scoops) orally every day
• Children weighing 27 to 28 kg: 220 mg (5.5 scoops) orally every day
• Children weighing 29 to 31 kg: 240 mg (6 scoops) orally every day
• Children weighing 32 to 33 kg: 260 mg (6.5 scoops) orally every day
• Children weighing 34 to 35 kg: 280 mg (7 scoops) orally every day 
• Children weighing above 35 kg: 300 mg (7.5 scoops) orally every day

Tablet

• Children weighing 17 to 21 kg: 150 mg orally every day
• Children weighing 22 to 27 kg: 200 mg orally every day
• Children weighing 28 to 34 kg: 250 mg orally every day
• Children weighing above 35 kg: 300 mg orally every day

Hepatitis B infection

Adult dosage

• 300 mg orally every day 

Pediatric dosage

• Children below 2 years: Safety and efficacy not established
• Children above 2 years and weighing above10 kg: 8 mg/kg orally every day; not to exceed 300 mg/day  

Oral powder

• Children weighing 10 to 11 kg: 80 mg (2 scoops) orally every day
• Children weighing 12 to 13 kg: 100 mg (2.5 scoops) orally every day
• Children weighing 14 to 16 kg: 120 mg (3 scoops) orally every day 
• Children weighing 17 to 18 kg: 140 mg (3.5 scoops) orally every day
• Children weighing 19 to 21 kg: 160 mg (4 scoops) orally every day
• Children weighing 22 to 23 kg: 180 mg (4.5 scoops) orally every day
• Children weighing 24 to 26 kg: 200 mg (5 scoops) orally every day
• Children weighing 27 to 28 kg: 220 mg (5.5 scoops) orally every day
• Children weighing 29 to 31 kg: 240 mg (6 scoops) orally every day
• Children weighing 32 to 33 kg: 260 mg (6.5 scoops) orally every day
• Children weighing 34 to 35 kg: 280 mg (7 scoops) orally every day 
• Children weighing above 35 kg: 300 mg (7.5 scoops) orally every day

Tablet

• Children weighing 17 to 21 kg: 150 mg orally every day
• Children weighing 22 to 27 kg: 200 mg orally every day
• Children weighing 28 to 34 kg: 250 mg orally every day
• Children weighing above 35 kg: 300 mg orally every day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Tenofovir DF include:

• nausea
• rash
• diarrhea
• headache
• pain
• depression
• weakness
• fever
• itching
• vomiting
• stomach-area pain
• dizziness
• sleeping problems

Serious side effects of Tenofovir DF include:

• new or worse kidney problems, including kidney failure,
• changes in the immune system,
• bone problems,
• excess lactic acid in the blood
• severe liver problems 

Rare side effects of Tenofovir DF include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Tenofovir DF has severe interactions with the following drugs:
  • elvitegravir/cobicistat/emtricitabine/tenofovir DF
  • streptozocin
• Tenofovir DF has serious interactions with the following drugs:
  • adefovir
  • bacitracin
  • cabotegravir
  • cyclosporine
  • dabigatran
  • edoxaban
  • lasmiditan
  • letermovir
  • nintedanib
  • sotorasib
  • tepotinib
• Tenofovir DF has moderate interactions with at least 113 other drugs.
• Tenofovir DF has minor interactions with the following drugs:
  • black cohosh
  • paromomycin

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Tenofovir DF?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Tenofovir DF?”

Cautions

• May cause redistribution/accumulation of body fat that may result in the cushingoid appearance
• Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including TDF, alone or in combination with other antiretrovirals; treatment should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in absence of marked transaminase elevations)
• Exacerbation of hepatitis B
  • All patients should be tested for the presence of chronic hepatitis B virus (HBV) before or when initiating therapy
  • Discontinuation of anti-HBV therapy may be associated with severe acute exacerbations of hepatitis B; patients infected with HBV who discontinue therapy should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment
  • If appropriate, resumption of anti-hepatitis B therapy may be warranted, especially in patients with advanced liver disease or cirrhosis; posttreatment exacerbation of hepatitis may lead to hepatic decompensation and liver failure
• Renal toxicity
  • Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), reported with therapy
  • Before initiation and during therapy, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus
  • Dosing interval adjustment and close monitoring of renal function recommended in all patients with creatinine clearance below 50 mL/min; no safety or efficacy data are available in patients with renal impairment who received therapy using these dosing guidelines; potential benefit of therapy should be assessed against the potential risk of renal toxicity
  • Therapy should be avoided with concurrent or recent use of a nephrotoxic agent (e.g., high-dose or multiple non-steroidal anti-inflammatory drugs [NSAIDs])
  • Cases of acute renal failure after initiation of high-dose or multiple NSAIDs were reported in HIV-infected patients with risk factors for renal dysfunction who appeared stable on TDF
  • Some patients required hospitalization and renal replacement therapy; alternatives to NSAIDs should be considered, if needed, in patients at risk for renal dysfunction
  • Persistent or worsening bone pain, pain in extremities, fractures, and/or muscular pain or weakness may be manifestations of proximal renal tubulopathy and should prompt an evaluation of renal function in patients at risk of renal dysfunction
• Patients coinfected with HIV-1 and HBV
  • Due to the risk of development of HIV-1 resistance, the drug should only be used in HIV-1 and HBV coinfected patients as part of an appropriate antiretroviral combination regimen
  • HIV-1 antibody testing should be offered to all HBV-infected patients before initiating therapy; it is also recommended that all patients with HIV-1 be tested for the presence of chronic hepatitis B before initiating therapy
• Immune reconstitution syndrome
  • The syndrome has been reported in HIV-1 infected patients treated with combination antiretroviral therapy
  • During the initial phase of combination antiretroviral treatment, HIV-1 infected patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia [PCP], or tuberculosis), which may necessitate further evaluation and treatment
  • Autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) have been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable and can occur many months after initiation of treatment
• Bone loss and mineralization defects
  • In HIV-1 infected adults, the drug has been associated with slightly greater decreases in bone mineral density (BMD) and increases in biochemical markers of bone metabolism, suggesting increased bone turnover
  • Serum parathyroid hormone levels and 1,25 Vitamin D levels have also been reported to be higher in subjects receiving therapy
  • The effects of therapy-associated changes in BMD and biochemical markers on long-term bone health and future fracture risk in adults and pediatric subjects 2 years and older are unknown
  • The long-term effect of the lower spine and total body BMD on skeletal growth in pediatric patients, and in particular, the effects of long-duration exposure in younger children are unknown
  • Although the effect of supplementation with calcium and vitamin D has not been studied, such supplementation may be beneficial; assessment of BMD should be considered for adult and pediatric patients who have a history of pathologic bone fracture or other risk factors for osteoporosis or bone loss
  • If bone abnormalities are suspected, appropriate consultation should be obtained; mineralization defects cases of osteomalacia associated with proximal renal tubulopathy manifested as bone pain or pain in extremities and which may contribute to fractures have been reported in association with therapy
  • Arthralgia and muscle pain or weakness have also been reported in cases of proximal renal tubulopathy
  • Hypophosphatemia and osteomalacia secondary to proximal renal tubulopathy should be considered in patients at risk of renal dysfunction who present with persistent or worsening bone or muscle symptoms while receiving TDF-containing products 

Pregnancy and Lactation

• Antiretroviral Pregnancy Registry (APR) monitors pregnancy outcomes in women exposed to tenofovir DF during pregnancy; encourage patients to register at 1-800-258-4263
• Human data
  • Available prospective reported data from the APR shows no increase in the overall risk of major birth defects with first-trimester exposure for tenofovir DF compared with the US rate for major birth defects
  • Data from 3 controlled clinical trials in 327 pregnant women with chronic HBV infection did not observe an increased risk of adverse pregnancy-related outcomes with tenofovir DF use during the third trimester 
• Lactation
  • Based on published data, tenofovir shown to be present in human breast milk
  • Unknown if tenofovir DF affects milk production or has effects on the breastfed child
  • HIV-infected mothers: Breastfeeding in HIV-1 infected mothers is not recommended owing to the potential for HIV-1 transmission
  • HBV-infected mothers: The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for the drug and any potential adverse effects on the breastfed infant from the drug or the underlying maternal condition
  • In a study of 50 HIV-uninfected, breastfeeding women on a tenofovir-containing regimen initiated between 1 and 24 weeks postpartum (median 13 weeks), the drug was undetectable in the plasma of most infants after 7 days of treatment in mothers