Fostemsavir oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulation of fostemsavir.
Drugs List
Therapeutic Indications
Uses
HIV infection in adults- in combination with other antiretrovirals
Fostemsavir, in combination with other antiretrovirals, is indicated for the treatment of adults with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.
Dosage
Fostemsavir should be prescribed by physicians experienced in the management of HIV infection.
Adults
600mg twice daily.
Additional Dosage Information
Missed doses
If a patient misses a dose of fostemsavir, the patient should take the missed dose as soon as the patient remembers, unless it is almost time for the next dose. In this case, the missed dose should be skipped and the next dose should be taken according to the dosing schedule. The patient should not take a double dose.
Contraindications
Children under 18 years
Breastfeeding
Long QT syndrome
Pregnancy
Torsade de pointes
Precautions and Warnings
Family history of long QT syndrome
Electrolyte imbalance
Hepatitis B
Hepatitis C
History of torsade de pointes
Correct electrolyte disorders before treatment
Treatment does not prevent risk of transmission of HIV
Advise ability to drive/operate machinery may be affected by side effects
Treatment should be initiated by doctor experienced in HIV management
Autoimmune disorders can occur many months after initiation of treatment
Consider monitoring ECG in patients at risk of QT prolongation
Monitor ECG in patients at risk of QT prolongation
Monitor serum electrolytes
Advise patient to seek medical advice if joint aches or pain occur
Inflammatory symptoms should be evaluated and treated appropriately
May develop immune reactivation syndrome
Risk of developing opportunistic infections
Advise patient not to take St John's wort concurrently
Typically, immune reactivation syndrome reactions have been observed within the first few weeks or months of initiation of the antiretroviral treatment. For example, cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia. Autoimmune disorders (such as Graves' disease, autoimmune hepatitis, polymyositis and Guillain-Barre syndrome) have also been observed, however, the reported time to onset is more variable and these reactions can occur many months after initiation of treatment.
In patients with hepatitis B and/or C co-infection, monitoring of liver chemistries are recommended. Patients with chronic hepatitis B or C treated with combination antiretroviral therapy are at an increased risk of severe and potentially fatal hepatic adverse reactions. In the case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
Pregnancy and Lactation
Pregnancy
Fostemsavir is contraindicated during pregnancy.
The manufacturer recommends that it is preferable to avoid the use of fostemsavir during pregnancy. At the time of writing there is limited data regarding the use of fostemsavir during pregnancy. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity, however, fostemsavir and/or its metabolites have been known to cross the placenta in some species. Human data is limited and as such a potential risk cannot be ruled out.
Lactation
Fostemsavir is contraindicated during breastfeeding.
The manufacturer recommends that HIV infected women do not breastfeed their infants under any circumstances in order to avoid transmission of HIV. It is unknown whether fostemsavir/temsavir are excreted in human milk. Animal data have shown excretion of fostemsavir into breast milk however presence in human breast milk is unknown. Effects on exposed infants are unknown.
Side Effects
Abdominal pain
Autoimmune disorders
Autoimmune hepatitis
Creatine phosphokinase increased
Diarrhoea
Dizziness
Dysgeusia
Dyspepsia
Fatigue
Flatulence
Graves' disease
Guillain-Barre syndrome
Headache
Immune Reactivation/Reconstitution Syndrome
Increase in serum transaminases
Insomnia
Myalgia
Nausea
Opportunistic infections
Osteonecrosis
Polymyositis
Prolongation of QT interval
Pruritus
Rash
Serum creatinine increased
Somnolence
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: December 2021
Reference Sources
Summary of Product Characteristics: Rukobia 600mg prolonged-release tablets. ViiV Healthcare UK Limited. Revised September 2021.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 21 December 2021
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.