Drugs List

Therapeutic Indications

Uses

HIV infection - combination therapy

Contraindications

Children under 12 years
Weight below 35kg
Breastfeeding
Renal impairment - creatinine clearance below 30 ml/minute

Precautions and Warnings

Hepatic impairment
Hepatitis
Hepatitis B
Hepatitis C
Pregnancy

Monitor HBV levels during and after treatment in patients with co-infection
Treatment does not prevent risk of transmission of HIV
Advise ability to drive/operate machinery may be affected by side effects
Must be used in combination with other antiretrovirals
Perform viral resistance testing before initiating therapy
Treatment should be initiated by doctor experienced in HIV management
Autoimmune disorders can occur many months after initiation of treatment
Blood lipid and glucose levels may increase requiring treatment
Monitor hepatic function frequently in patients with hepatic impairment
Advise patient to seek medical advice if joint aches or pain occur
Advise patient to seek medical advice if movement becomes difficult
Inflammatory symptoms should be evaluated and treated appropriately
May cause weight gain
Neonate exposed in utero: Risk of mitochondrial dysfunction
Risk of developing opportunistic infections
Discontinue if creatinine clearance below 30ml/minute
Discontinue if hepatic function deteriorates in pts with hepatic impairment
Advise patient not to take St John's wort concurrently
Take another dose if vomiting occurs within one hour

Patients co-infected with hepatitis B or C treated with antiretroviral therapy are at an increased risk of severe and potentially fatal adverse reactions. Discontinuation of therapy in patients co-infected with hepatitis B may be associated with severe acute exacerbations of hepatitis. Closely monitor these patients with both clinical and laboratory follow-up for several months after stopping treatment if therapy with elvitegravir with tenofovir alafenamide is discontinued.

Treatment regimens containing nucleoside or nucleotide analogues have been reported to cause mitochondrial dysfunction in HIV-negative infants exposed in utero and/or post-natally. Adverse reactions such as haematological (anaemia, neutropenia), metabolic (hyperlactataemia, hyperlipasemia) and neurological (hypertonia, convulsions, abnormal behaviour) have been reported. Consider in children exposed to nucleoside or nucleotide analogues in utero (including HIV-negative infants) and who present with neurological symptoms or severe clinical findings of unknown cause.

Avoid emtricitabine with tenofovir alafenamide in patients with HIV patients with K65R mutation.

Pregnancy and Lactation

Pregnancy

Use emtricitabine with tenofovir alafenamide with caution during pregnancy.

The manufacturer advises emtricitabine with tenofovir alafenamide should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus. Animal studies indicate no risk of teratogenic or developmental effects. Human data is limited and as such a potential risk cannot be ruled out.

Lactation

Emtricitabine with tenofovir alafenamide is contraindicated during breastfeeding.

Use of emtricitabine with tenofovir alafenamide when breastfeeding is contraindicated by the manufacturer. The presence of emtricitabine with tenofovir alafenamide in human breast milk and the effects on exposed infants are unknown.

Side Effects

Abdominal pain
Anaemia
Angioedema
Arthralgia
Autoimmune disorders
Autoimmune hepatitis
Blood lipid changes
Diarrhoea
Dizziness
Dream abnormalities
Dyspepsia
Fatigue
Flatulence
Graves' disease
Headache
Increase in serum glucose
Inflammatory reactions
Nausea
Osteonecrosis
Pruritus
Rash
Vomiting
Weight gain

Presentation

Oral formulations of emtricitabine and tenofovir alafenamide.

Drugs List

Therapeutic Indications

Uses

HIV infection - combination therapy

Dosage

Adults

Children

Additional Dosage Information

Contraindications

Children under 12 years
Weight below 35kg
Breastfeeding
Renal impairment - creatinine clearance below 30 ml/minute

Precautions and Warnings

Hepatic impairment
Hepatitis
Hepatitis B
Hepatitis C
Pregnancy

Monitor HBV levels during and after treatment in patients with co-infection
Treatment does not prevent risk of transmission of HIV
Advise ability to drive/operate machinery may be affected by side effects
Must be used in combination with other antiretrovirals
Perform viral resistance testing before initiating therapy
Treatment should be initiated by doctor experienced in HIV management
Autoimmune disorders can occur many months after initiation of treatment
Blood lipid and glucose levels may increase requiring treatment
Monitor hepatic function frequently in patients with hepatic impairment
Advise patient to seek medical advice if joint aches or pain occur
Advise patient to seek medical advice if movement becomes difficult
Inflammatory symptoms should be evaluated and treated appropriately
May cause weight gain
Neonate exposed in utero: Risk of mitochondrial dysfunction
Risk of developing opportunistic infections
Discontinue if creatinine clearance below 30ml/minute
Discontinue if hepatic function deteriorates in pts with hepatic impairment
Advise patient not to take St John's wort concurrently
Take another dose if vomiting occurs within one hour

Patients co-infected with hepatitis B or C treated with antiretroviral therapy are at an increased risk of severe and potentially fatal adverse reactions. Discontinuation of therapy in patients co-infected with hepatitis B may be associated with severe acute exacerbations of hepatitis. Closely monitor these patients with both clinical and laboratory follow-up for several months after stopping treatment if therapy with elvitegravir with tenofovir alafenamide is discontinued.

Treatment regimens containing nucleoside or nucleotide analogues have been reported to cause mitochondrial dysfunction in HIV-negative infants exposed in utero and/or post-natally. Adverse reactions such as haematological (anaemia, neutropenia), metabolic (hyperlactataemia, hyperlipasemia) and neurological (hypertonia, convulsions, abnormal behaviour) have been reported. Consider in children exposed to nucleoside or nucleotide analogues in utero (including HIV-negative infants) and who present with neurological symptoms or severe clinical findings of unknown cause.

Avoid emtricitabine with tenofovir alafenamide in patients with HIV patients with K65R mutation.

Pregnancy and Lactation

Pregnancy

Use emtricitabine with tenofovir alafenamide with caution during pregnancy.

The manufacturer advises emtricitabine with tenofovir alafenamide should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus. Animal studies indicate no risk of teratogenic or developmental effects. Human data is limited and as such a potential risk cannot be ruled out.

Lactation

Emtricitabine with tenofovir alafenamide is contraindicated during breastfeeding.

Use of emtricitabine with tenofovir alafenamide when breastfeeding is contraindicated by the manufacturer. The presence of emtricitabine with tenofovir alafenamide in human breast milk and the effects on exposed infants are unknown.

Side Effects

Abdominal pain
Anaemia
Angioedema
Arthralgia
Autoimmune disorders
Autoimmune hepatitis
Blood lipid changes
Diarrhoea
Dizziness
Dream abnormalities
Dyspepsia
Fatigue
Flatulence
Graves' disease
Headache
Increase in serum glucose
Inflammatory reactions
Nausea
Osteonecrosis
Pruritus
Rash
Vomiting
Weight gain

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: February 2020

Reference Sources

Summary of Product Characteristics: Descovy 200mg/10mg film coated tablets. Gilead Sciences Ltd. Revised June 2019.
Summary of Product Characteristics: Descovy 200mg/25mg film coated tablets. Gilead Sciences Ltd. Revised June 2019.