Tenofovir Disoproxil Fumarate/ Emtricitabine

Registered South African indications:

• HIV-1  infection

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Moderate to severe uncontrolled renal failure
• Creatinine clearance <60ml/min when used for pre-exposure prophylaxis (PrEP)
• Creatinine clearance <50ml/min when used for treatment of HIV-1
• Should not be used for PrEP in individuals with unknown or positive HIV-1 status
• Should not be used for PrEP in individuals not fully committed to full treatment compliance
• Pregnancy
• Lactation

Cautions

• Mild renal impairment
• Hepatic impairment
• Elderly
• Risk factors for renal disease
• Severe acute exacerbations of hepatitis B
• HIV sexual transmission
• HIV-1 harbouring the K65R mutation
• Co-infected with hepatitis B virus or hepatitis C virus 
• Osteoporosis 
• High risk for fractures
• Galactose intolerance 
• Lapp lactase deficiency
• Glucose-galactose malabsorption

Forms avail. in SA and covered in this monograph: tab

HIV and hepatitis B co-infection
Pre-exposure prophylaxis

Tenofovir disoproxil fumarate/ Emtricitabine
300/200 (mg)

• Oral (tab): 1 tab, dly

See additional prescribing points for information on missed dose and vomiting

Forms avail. in SA and covered in this monograph: tab

HIV infection

Tenofovir disoproxil fumarate,/ Emtricitabine
300/200 (mg)

Weight less than 35kg

• Not indicated for use

Weight greater than 35kg

• See adult dosage

See additional prescribing points for information on missed dose and vomiting

Consult HIV/infectious disease specialists prior to any decisions related to ARV regimen termination/switch

Pregnancy

• Contraindicated

Breastfeeding

• Contraindicated

Renal Impairment

• Mild: Caution; no dose adjustment recommended
• Moderate to severe uncontrolled renal failure: Contraindicated
• CrCl<60ml/min when used for pre-exposure prophylaxis (PrEP): Contraindicated
• CrCI<50ml/min when used for treatment of HIV-1: Contraindicated

Hepatic Impairment

• Caution; no dose adjustment recommended

Elderly

• Caution; no dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Insomnia
• Abnormal dreams
• Dizziness
• Headache
• Asthenia

Gastrointestinal Disorders

• Diarrhoea
• Nausea and vomiting
• Elevated amylase
• Elevated pancreatic amylase
• Abdominal pain
• Dyspepsia
• Abdominal distension
• Flatulence
• Pancreatitis

Hepatobiliary Disorders

• Elevated serum aspartate aminotransferase (AST) 
• Elevated serum alanine aminotransferase (ALT)
• Hyperbilirubinaemia
• Increased transaminases
• Hepatic steatosis
• Hepatitis

Genitourinary Disorders

• Increased creatinine
• Proteinuria
• Proximal renal tubulopathy
• Renal failure 
• Acute tubular necrosis
• Nephritis
• Nephrogenic diabetes insipidus

Endocrine and Metabolic Disorders

• Hypophosphataemia
• Hyperglycaemia
• Hypertriglyceridaemia
• Hypokalaemia
• Lactic acidosis

Musculoskeletal Disorders

• Elevated creatine kinase
• Rhabdomyolysis
• Muscular weakness
• Osteomalacia 
• Myopathy

Skin and Subcutaneous Tissue Disorders

• Rash
• Vesiculobullous rash
• Pustular rash
• Maculopapular rash
• Pruritus
• Urticaria
• Skin discolouration
• Angioedema

Immune, Blood and Lymphatic System Disorders

• Neutropenia
• Anaemia
• Allergic reaction

• Didanosine
• Nephrotoxic agents
• Lopinavir/ritonavir
• Atazanavir
• Non-steroidal anti-inflammatory drugs
• Emtricitabine
• Tenofovir disoproxil
• Tenofovir alafenamide
• Cytidine analogues
• Ledipasvir/sofosbuvir

• Renal function

Missed dose

If a dose is missed <12hrs of the time it is usually taken, a second dose should be taken as soon as possible and the normal dosing schedule should be resumed. 

If a dose is missed by >12hrs and it is almost time for the next dose, the missed dose should not be taken and the usual dosing schedule should be resumed.

Vomiting

If vomiting occurs <1hr, another tablet should be taken. 

If vomiting occurs >1hr after taking, a second dose should not be taken.

Tenofovir disoproxil fumarate
Tenofovir disoproxil fumarate, a prodrug, is converted to tenofovir. Tenofovir is a nucleotide reverse transcriptase inhibitor (nRTIs). It is an analogue of the naturally occurring deoxynucleotides required to synthesize the viral DNA. Tenofovir inhibits HIV-1 reverse transcriptase and the HBV polymerase by direct binding competition with the natural deoxyribonucleotide substrate and, after incorporation into DNA, by DNA chain termination. 

Emtricitabine
Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI), it's an analogue of cytidine. It inhibits reverse transcriptase, the enzyme that copies HIV RNA into new viral DNA. 

Tenofovir disoproxil fumarate/ Emtricitabine

Tablet 300mg/200mg

• Adco Emtevir (Adcock)
• Didivir (Cipla Medpro)
• Emcovir (Emcure)
• Emten (Emcure)
• Emtewin (Zentiva) (Discontinued: 13/07/2018)
• Emtroc (Macleods)
• Hetemcit (Hetero)
• Temecit (Adcock)
• Tencitab (Pharmacare)
• Tenemcom (Specpharm)
• Tenemine (Mylan)
• Tenobine (Adcock)
• Tremdex (Macleods)
• Truvada (Pharmacare)
• Tyricten (Novagen)