Drugs List

Therapeutic Indications

Uses

Non-resistant HIV in adults - viral load <100,000 HIV-1 RNA copies/mL

Treatment of Human Immunodeficiency Virus 1 (HIV-1) infected patients without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine, and with a viral load of less than or equal to 100,000 HIV-1 RNA copies/mL.

As with other antiretroviral medicinal products, genotypic resistance testing and/or historical resistance data should guide the use of emtricitabine with rilpivirine and tenofovir alafenamide.

Contraindications

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

Precautions and Warnings

Adolescents
Glucose-galactose malabsorption syndrome
Haemodialysis
Hepatitis B
Hepatitis C
Lactose intolerance
Moderate hepatic impairment
Pregnancy

Treatment does not prevent risk of transmission of HIV
Advise ability to drive/operate machinery may be affected by side effects
Avoid H2 antagonists 12hrs before or 4hrs after dose
Perform viral resistance testing before initiating therapy
Treatment should be initiated by doctor experienced in HIV management
Contains lactose
Advise patient to take with or after food
Autoimmune disorders can occur many months after initiation of treatment
Blood lipid and glucose levels may increase requiring treatment
On discontinuation, may cause recurrence of hepatitis B
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
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 self medicate with antacids or acid suppressants
Advise patient not to take St John's wort concurrently
Male & female: Ensure adequate contraception during treatment
Take another dose if vomiting occurs within 4 hours

Patients with hepatic impairment or chronic hepatitis B or C who are treated with combination antiretroviral therapy should be closely monitored during treatment. Patients with hepatitis B should be monitored for several months after stopping treatment. Patients with hepatic impairment have an increased risk of hepatic function abnormalities during treatment. Patients with chronic hepatitis B or C who are treated with combination antiretroviral therapy have an increased risk of developing severe and potentially fatal hepatic adverse effects. The product literature relating to concurrent treatments for hepatitis B or C should be consulted. Treatment discontinuation in patients with HIV and hepatitis B may be associated with severe acute exacerbations of hepatitis. If hepatic function deteriorates in patients with hepatic impairment, consider interrupting or discontinuing treatment.

Blood lipid and glucose levels may increase during antiretroviral therapy. This may be linked to disease control and lifestyle. Refer to established HIV treatment guidelines for monitoring and manage lipid and glucose level disorders as appropriate.

Treatment regimens containing nucleoside or nucleotide analogues have been reported to cause mitochondrial dysfunction in HIV-negative infants exposed in utero and/or postnatally. 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.

Pregnancy and Lactation

Pregnancy

Use emtricitabine with rilpivirine and tenofovir alafenamide with caution during pregnancy.

The manufacturer suggests avoiding use of emtricitabine with rilpivirine and tenofovir alafenamide during pregnancy as a precaution.

At the time of writing there is limited published information regarding the use of emtricitabine with rilpivirine and tenofovir alafenamide during pregnancy.

Data from over 1,000 exposed outcomes in pregnant women indicate no malformations or foetal/neonatal toxicity is associated with emtricitabine. Studies with rilpivirine in pregnant women have shown reduced exposure of the drug, and a subsequent increase in the risk of virological failure. Viral load should be closely monitored in these patients. Animal studies with emtricitabine with rilpivirine and tenofovir alafenamide do not indicate direct or indirect harmful effects with respect to reproductive toxicity.

Lactation

Emtricitabine with rilpivirine and tenofovir alafenamide is contraindicated during breastfeeding.

The manufacturer does not recommend the use of emtricitabine with rilpivirine and tenofovir alafenamide during breastfeeding.

It is recommended that HIV infected women should not breastfeed due to the risk of passing on the infection to the infant.

Emtricitabine is excreted in breast milk. It is unknown whether rilpivirine or tenofovir alafenamide are excreted into breast milk.

Side Effects

Abdominal discomfort
Abdominal pain
Alterations in pancreatic enzymes
Anaemia
Angioedema
Arthralgia
Autoimmune disorders
Autoimmune hepatitis
Decrease in glomerular filtration rate
Decreased appetite
Depressed mood
Depression
Diarrhoea
Dizziness
Dream abnormalities
Dry mouth
Dyspepsia
Elevated serum LDL cholesterol
Elevated serum lipase
Elevated triglyceride levels
Fatigue
Flatulence
Graves' disease
Haemoglobin decrease
Headache
Immune Reactivation/Reconstitution Syndrome
Increase in serum ALT/AST
Increase in serum glucose
Increase in total cholesterol
Inflammatory reactions
Insomnia
Nausea
Osteonecrosis
Pruritus
Rash
Reduced platelet count
Reduction in serum cortisol levels
Rise in blood lipids
Serum bilirubin increased
Serum creatinine increased
Severe skin reactions
Skin reactions
Sleep disorders
Somnolence
Urticaria
Vomiting
Weight gain
White blood cell count decreased

Presentation

Oral formulations of emtricitabine with rilpivirine and tenofovir alafenamide.

Drugs List

Therapeutic Indications

Uses

Non-resistant HIV in adults - viral load <100,000 HIV-1 RNA copies/mL

Treatment of Human Immunodeficiency Virus 1 (HIV-1) infected patients without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine, and with a viral load of less than or equal to 100,000 HIV-1 RNA copies/mL.

As with other antiretroviral medicinal products, genotypic resistance testing and/or historical resistance data should guide the use of emtricitabine with rilpivirine and tenofovir alafenamide.

Dosage

Adults

Children

Patients with Renal Impairment

Additional Dosage Information

Contraindications

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

Precautions and Warnings

Adolescents
Glucose-galactose malabsorption syndrome
Haemodialysis
Hepatitis B
Hepatitis C
Lactose intolerance
Moderate hepatic impairment
Pregnancy

Treatment does not prevent risk of transmission of HIV
Advise ability to drive/operate machinery may be affected by side effects
Avoid H2 antagonists 12hrs before or 4hrs after dose
Perform viral resistance testing before initiating therapy
Treatment should be initiated by doctor experienced in HIV management
Contains lactose
Advise patient to take with or after food
Autoimmune disorders can occur many months after initiation of treatment
Blood lipid and glucose levels may increase requiring treatment
On discontinuation, may cause recurrence of hepatitis B
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
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 self medicate with antacids or acid suppressants
Advise patient not to take St John's wort concurrently
Male & female: Ensure adequate contraception during treatment
Take another dose if vomiting occurs within 4 hours

Patients with hepatic impairment or chronic hepatitis B or C who are treated with combination antiretroviral therapy should be closely monitored during treatment. Patients with hepatitis B should be monitored for several months after stopping treatment. Patients with hepatic impairment have an increased risk of hepatic function abnormalities during treatment. Patients with chronic hepatitis B or C who are treated with combination antiretroviral therapy have an increased risk of developing severe and potentially fatal hepatic adverse effects. The product literature relating to concurrent treatments for hepatitis B or C should be consulted. Treatment discontinuation in patients with HIV and hepatitis B may be associated with severe acute exacerbations of hepatitis. If hepatic function deteriorates in patients with hepatic impairment, consider interrupting or discontinuing treatment.

Blood lipid and glucose levels may increase during antiretroviral therapy. This may be linked to disease control and lifestyle. Refer to established HIV treatment guidelines for monitoring and manage lipid and glucose level disorders as appropriate.

Treatment regimens containing nucleoside or nucleotide analogues have been reported to cause mitochondrial dysfunction in HIV-negative infants exposed in utero and/or postnatally. 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.

Pregnancy and Lactation

Pregnancy

Use emtricitabine with rilpivirine and tenofovir alafenamide with caution during pregnancy.

The manufacturer suggests avoiding use of emtricitabine with rilpivirine and tenofovir alafenamide during pregnancy as a precaution.

At the time of writing there is limited published information regarding the use of emtricitabine with rilpivirine and tenofovir alafenamide during pregnancy.

Data from over 1,000 exposed outcomes in pregnant women indicate no malformations or foetal/neonatal toxicity is associated with emtricitabine. Studies with rilpivirine in pregnant women have shown reduced exposure of the drug, and a subsequent increase in the risk of virological failure. Viral load should be closely monitored in these patients. Animal studies with emtricitabine with rilpivirine and tenofovir alafenamide do not indicate direct or indirect harmful effects with respect to reproductive toxicity.

Lactation

Emtricitabine with rilpivirine and tenofovir alafenamide is contraindicated during breastfeeding.

The manufacturer does not recommend the use of emtricitabine with rilpivirine and tenofovir alafenamide during breastfeeding.

It is recommended that HIV infected women should not breastfeed due to the risk of passing on the infection to the infant.

Emtricitabine is excreted in breast milk. It is unknown whether rilpivirine or tenofovir alafenamide are excreted into breast milk.

Side Effects

Abdominal discomfort
Abdominal pain
Alterations in pancreatic enzymes
Anaemia
Angioedema
Arthralgia
Autoimmune disorders
Autoimmune hepatitis
Decrease in glomerular filtration rate
Decreased appetite
Depressed mood
Depression
Diarrhoea
Dizziness
Dream abnormalities
Dry mouth
Dyspepsia
Elevated serum LDL cholesterol
Elevated serum lipase
Elevated triglyceride levels
Fatigue
Flatulence
Graves' disease
Haemoglobin decrease
Headache
Immune Reactivation/Reconstitution Syndrome
Increase in serum ALT/AST
Increase in serum glucose
Increase in total cholesterol
Inflammatory reactions
Insomnia
Nausea
Osteonecrosis
Pruritus
Rash
Reduced platelet count
Reduction in serum cortisol levels
Rise in blood lipids
Serum bilirubin increased
Serum creatinine increased
Severe skin reactions
Skin reactions
Sleep disorders
Somnolence
Urticaria
Vomiting
Weight gain
White blood cell count decreased

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: September 2019

Reference Sources

Summary of Product Characteristics: Odefsey 200mg/25mg/25mg film-coated tablets. Revised June 2019.