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Rukobia 600mg Extended-Release Tablet
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Indications & Clinical Uses
- Rukobia 600 mg (fostemsavir, given as the tromethamine salt) is a gp120 attachment inhibitor, a class of antiretroviral distinct from other HIV medicines such as protease inhibitors, integrase inhibitors or the CCR5 antagonist maraviroc (Selzentry); it works by blocking HIV from attaching to and entering CD4 T-cells.
- Rukobia, in combination with other antiretrovirals, is approved for adults with multidrug-resistant HIV-1 infection who are heavily treatment-experienced and failing their current regimen because of resistance, intolerance or safety concerns, when no other suppressive regimen can be constructed.
- It is not intended for patients who are not treatment-experienced or whose HIV is not multidrug-resistant.
- Rukobia is an oral extended-release tablet, self-administered at home; unlike some other HIV medicines for resistant infection such as ibalizumab (Trogarzo), which is given by intravenous infusion, Rukobia does not require clinic visits for dosing.
Side Effects
- Common side effects may include diarrhoea, headache, nausea, rash, abdominal pain and vomiting, each affecting more than 1 in 10 people in clinical trials.
- Rukobia has NO boxed warning.
- A recognised reaction after starting Rukobia and other antiretrovirals is immune reconstitution inflammatory syndrome, where the recovering immune system reacts to a previously hidden infection, causing new or worsening symptoms in the weeks to months after starting treatment; report any new fever, swollen glands or unusual symptoms during this period.
- Heart rhythm changes (QT interval prolongation) have been seen at high doses, so caution and, where relevant, ECG monitoring are advised in people with existing heart rhythm problems or those taking other QT-prolonging medicines.
- People with hepatitis B or C co-infection should have regular liver blood tests during treatment.
Precautions & Warnings
- Rukobia is contraindicated with strong CYP3A inducers, including carbamazepine, phenytoin, rifampicin, mitotane, enzalutamide and St John's wort, because these can cause a large drop in fostemsavir levels and loss of viral control.
- Caution is advised in people with a history of heart rhythm problems, a prolonged QT interval, or who take other medicines that affect heart rhythm.
- Liver blood tests are recommended in patients with hepatitis B or C co-infection.
- Rukobia has not been established as safe in pregnancy or breastfeeding, and the extended-release tablets must be swallowed whole, never split, crushed or chewed, because doing so changes how the drug is released.
- Rukobia must always be used together with other active antiretroviral medicines, never as a single agent, to reduce the risk of resistance developing.
- Store the tablets at 20°C to 25°C, with excursions permitted to 15°C to 30°C.
Avoid Interactions
- Strong CYP3A inducers such as carbamazepine, phenytoin, rifampicin, mitotane, enzalutamide and St John's wort are contraindicated with Rukobia, because they substantially lower fostemsavir levels and can lead to loss of virologic control and resistance.
- No dose adjustment of Rukobia is needed with CYP3A inhibitors, but Rukobia itself can raise levels of certain other drugs, including some statins, where a lower statin dose may be needed - tell the prescriber about any cholesterol medicine being taken.
- Other medicines that prolong the QT interval should be used cautiously alongside Rukobia because of a possible additive effect on heart rhythm.
- Rukobia must always be combined with other active antiretroviral agents.
- Tell the HIV care team and pharmacist about every prescription, over-the-counter medicine, herbal product and supplement being taken before starting or changing treatment.
References
Frequently Asked Questions
Rukobia (fostemsavir) is an HIV attachment inhibitor used, together with other antiretrovirals, for adults with multidrug-resistant HIV-1 who are heavily treatment-experienced and failing their current regimen. It's reserved for people who cannot build a fully suppressive regimen from other available HIV medicines.
Take one Rukobia 600 mg extended-release tablet by mouth twice daily, with or without food, always alongside other antiretroviral medicines. Swallow the tablet whole - never split, crush or chew it, since this changes how the drug is released into your body.
The most common side effects of Rukobia are diarrhoea, headache, nausea, rash and abdominal pain. After starting, your immune system may react to a hidden infection (immune reconstitution syndrome) - report any new fever or swollen glands. Rukobia can also affect heart rhythm at high exposure.
Avoid rifampicin, carbamazepine, phenytoin, enzalutamide, mitotane and St John's wort - these are contraindicated with Rukobia because they sharply lower its levels and risk treatment failure. Tell your HIV team about any heart rhythm medicines or statins, and never take Rukobia as your only HIV medicine.
If you miss a dose of Rukobia, take it as soon as you remember, then take your next dose at the usual time - do not double up. Missing doses of HIV medicines can allow the virus to become resistant, so try to take Rukobia consistently, twice daily.
Safety in pregnancy has not been firmly established for Rukobia, so tell your HIV care team if you are pregnant, planning pregnancy, or breastfeeding, so they can weigh the benefits and risks. Continue other prescribed antiretrovirals as directed and discuss any change in treatment first.
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