Doravirine oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulation of doravirine.
Drugs List
Therapeutic Indications
Uses
HIV infection-combined with other antiretrovirals
Indicated in combination with other antiretroviral medicinal products for the treatment of adults, and adolescents aged 12 years and older weighing at least 35kg infected with HIV-1 without past or present evidence of resistance to non-nucleoside reverse transcriptase inhibitors.
Dosage
Adults
100mg once daily, to be taken with or without food.
Children
Children aged 12-18 years weighing 35kg or above
(See Dosage; Adult)
Children aged 12-18 years weighing less than 35kg
Contraindicated.
Children aged less than 12 years
Contraindicated.
Additional Dosage Information
Missed dose
If a dose is missed within 12 hours of the time usually taken, the patient should take the missed dose as soon as possible and then resume normal dosing schedule.
If a dose is missed by more than 12 hours, the patient should not take the missed dose and instead take the next dose at the regular scheduled time.
Combination with rifabutin
If doravirine is taken in combination with rifabutin, 100mg of doravirine should be taken twice daily (approximately 12 hours apart).
Contraindications
Children under 12 years
Children weighing less than 35kg
Breastfeeding
Galactosaemia
Precautions and Warnings
Glucose-galactose malabsorption syndrome
Lactose intolerance
Pregnancy
Severe hepatic impairment
Treatment does not prevent risk of transmission of HIV
Advise ability to drive/operate machinery may be affected by side effects
HIV therapy: 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
Contains lactose
Autoimmune disorders can occur many months after initiation of treatment
Inflammatory symptoms should be evaluated and treated appropriately
Risk of developing opportunistic infections
Advise patient not to take St John's wort concurrently
Pregnancy and Lactation
Pregnancy
Use doravirine with caution during pregnancy.
The manufacturer recommends to avoid the use of doravirine during pregnancy as a precautionary measure, and to monitor maternal-foetal outcomes in any patients exposed to doravirine during pregnancy. Encouraging physicians to register patients to the Antiretroviral Pregnancy Registry.
At the time of writing there is limited published information regarding the use of doravirine during pregnancy. Animal studies with doravirine do not indicate direct or indirect harmful effects with respects to reproductive toxicity.
Lactation
Doravirine is contraindicated during breastfeeding.
The manufacturer does not recommend the use of doravirine during breastfeeding, and that mothers should be instructed to not breastfeed due to the potential HIV-1 transmission and potential adverse reactions in the infant.
It is unknown if doravirine is excreted into breast milk. There is limited published information regarding the use of doravirine during breastfeeding.
Effects on exposed infants are unknown.
Side Effects
Abdominal discomfort
Abdominal distension
Abdominal pain
Abnormal faeces
Acute kidney injury
Adjustment disorder
Aggression
Alanine aminotransferase increased
Allergic dermatitis
Anxiety
Arthralgia
Aspartate aminotransferase increased
Asthenia
Attention disturbances
Changes in mood
Chest pain
Chills
Confusion
Constipation
Creatine phosphokinase increased
Depression
Diarrhoea
Dizziness
Dream abnormalities
Dyspepsia
Dyspnoea
Elevated amylase levels
Elevated serum lipase
Fatigue
Flatulence
Gastro-intestinal motility disturbances
Haemoglobin decrease
Hallucinations
Headache
Hepatocellular damage
Hypertension
Hypertonia
Hypomagnesaemia
Hypophosphataemia
Immune Reactivation/Reconstitution Syndrome
Impaired memory
Insomnia
Irritability
Malaise
Musculoskeletal pain
Myalgia
Nausea
Nephrolithiasis
Nightmares
Pain
Paraesthesia
Pruritus
Pustular rash
Rash
Rectal tenesmus
Renal calculus
Renal disorders
Rosacea
Sleep disturbances
Sleep walking
Soft faeces
Somnolence
Suicidal tendencies
Thirst
Tonsillar hypertrophy
Vomiting
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: July 2022
Reference Sources
Summary of Product Characteristics: Pifeltro 100mg film-coated tablets. Merck Sharp & Dohme (UK) Limited. Revised May 2022.
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