Patient leaflet - Yeytuo 300 mg film-coated tablets
1. What Yeytuo is and what it is used for
Yeytuo contains the active substance lenacapavir. It is a long acting antiretroviral medicine known as a capsid inhibitor. Lenacapavir, the active substance in Yeytuo, binds to proteins of the HIV-1 virus’s outer layer, disrupting its ability to multiply and spread.
Yeytuo is used to help prevent HIV-1 infection in adults and adolescents weighing at least 35 kg who are at an increased risk of getting HIV-1. This is called pre-exposure prophylaxis (PrEP). It should be used in combination with safer sex practices.
Your doctor will advise you to take Yeytuo tablets when you are given Yeytuo injections for the first time.
If you are being given Yeytuo injections, but you plan to miss your scheduled Yeytuo injections, you can take Yeytuo tablets instead, until you can receive the injections again (see section 3).
2. What you need to know before you take Yeytuo
Do not take Yeytuo
- If you are allergic to lenacapavir or any of the other ingredients of this medicine (listed in section 6).
- If you do not know if you have HIV. You must get tested to make sure that you do not already have HIV before you start treatment with Yeytuo. Yeytuo can only prevent HIV if you don’t already have it.
If you are taking any of these medicines:
- rifampicin, used to treat some bacterial infections such as tuberculosis
- carbamazepine, phenytoin, used to prevent seizures ■ St. John’s wort (Hypericum perforatum), a herbal remedy used for depression and anxiety
➥Do not take Yeytuo and tell your doctor or nurse
immediately if you think any of these apply to you.
Warnings and precautions
Just taking Yeytuo may not stop you from getting HIV. Take extra measures to help prevent HIV while you are receiving Yeytuo
- Always practice safer sex. Use condoms to reduce contact with semen, vaginal fluids, or blood. ■ Do not share or re-use needles or other injection or drug equipment.
- Get tested for other sexually transmitted infections such as syphilis and gonorrhoea. These infections make it easier for HIV to infect you.
- Get tested for HIV when your doctor or nurse tells you. You must get tested before starting Yeytuo and before every injection to make sure that you stay HIV negative while receiving this medicine.
- Keep all your appointments to get your Yeytuo injections on time. Talk to your doctor or nurse if you are thinking about stopping injections: stopping may increase your risk of getting HIV. If you do stop, or miss your scheduled injections, you may need to take other medicines or precautions to reduce your risk of getting HIV and possibly developing viral resistance.
Tell your doctor or nurse straight away if you think you were infected with HIV. They may want to do more tests to make sure you still do not have HIV.
If you get a flu-like illness, it could mean you have recently been infected with HIV. These may be signs of HIV infection:
- tiredness
- fever
- joint or muscle aches
- headache
- vomiting or diarrhoea
- rash
- night sweats
- enlarged lymph nodes in the neck or groin.
➥Tell your doctor or nurse about any flu-like illness,
either in the month before starting Yeytuo, or at any time while taking Yeytuo.
Talk to your doctor or nurse if you have any more questions about how to prevent getting HIV.
Children and adolescents
Do not give this medicine to anyone weighing less than 35 kg because it has not been studied in these individuals.
Other medicines and Yeytuo
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines. Yeytuo may interact with other medicines. This may keep Yeytuo or other medicines from working properly, or may make side effects worse. In some cases, your doctor or nurse may need to adjust your dose or check your blood levels.
Medicines that must never be taken with Yeytuo:
- rifampicin, used to treat some bacterial infections, such as tuberculosis
- carbamazepine, phenytoin, used to prevent seizures
- St. John’s wort (Hypericum perforatum), a herbal remedy used for depression and anxiety
➥If you are taking any of these medicines, do not take
Yeytuo and tell your doctor or nurse immediately.
Talk to your doctor or nurse in particular if you are taking:
medicines used to treat some bacterial infections, such as tuberculosis, containing:
- rifabutin or rifapentine
anticonvulsants used to treat epilepsy and prevent seizures, containing:
- oxcarbazepine or phenobarbital
- medicines used to treat migraine, containing: ■ dihydroergotamine or ergotamine
medicines used to treat impotence and pulmonary hypertension, containing:
- sildenafil or tadalafil
- medicine used to treat impotence, containing: ■ vardenafil
corticosteroids (also known as ‘steroids’) taken orally or given by injection used to treat allergies, inflammatory bowel diseases, and other illnesses involving inflammation in your body, containing:
- dexamethasone or hydrocortisone/cortisone
- medicines used to lower cholesterol, containing: ■ lovastatin or simvastatin
- antiarrhythmics used to treat heart problems, containing: ■ digoxin
- medicines used to help you sleep, containing: ■ midazolam or triazolam.
anticoagulants used to prevent and treat blood clots, containing:
- rivaroxaban, dabigatran or edoxaban
➥Tell your doctor or nurse if you are taking any of
these medicines or if you start taking any of these medicines while receiving Yeytuo. Do not stop any treatment without contacting your doctor or nurse.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, nurse or pharmacist for advice before taking this medicine.
If you are breast-feeding, or thinking about breast-feeding, you should discuss it with your doctor or nurse.
Driving and using machines
Yeytuo is not expected to have any effect on your ability to drive or use machines.
Yeytuo contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. How to take Yeytuo
You must have a negative HIV test before starting Yeytuo and before every injection.
You will take tablets by mouth and your doctor or nurse will give you injections under the skin (subcutaneously) when you start Yeytuo. After that you will have injections every 6 months.
Day 1:
Two tablets taken by mouth. These can be taken with or without food.
- Two injections given by your doctor or nurse. The two injections will be given at the same time at least 5 centimetres apart from each other and may be given into your abdomen (tummy) or thigh.
Day 2:
- Two tablets taken by mouth, as above.
Every 6 months:
- Two injections given by your doctor or nurse, as above.
If you have difficulty swallowing the tablet whole, you can split it in half. Take both halves of the tablet one after the other to get the full dose. Do not store the split tablet.
It is important that you attend your planned appointments every 6 months (26 weeks) to receive your injections of Yeytuo. This will continue to help protect you from getting HIV.
- Schedule your appointment with your doctor or nurse to make sure you will receive your next injections on time.
- You must receive your next injections within 28 weeks of your last injection.
If you take more Yeytuo than you should
Contact your doctor, nurse or pharmacist immediately for advice. If you take more than the recommended dose of Yeytuo, you may be at higher risk of side effects (see section 4, Possible side effects).
It is important not to miss a dose of Yeytuo tablets.
If you forget to take your tablets, contact your doctor, nurse or pharmacist immediately.
If you vomit within 3 hours after taking Yeytuo tablets, contact your doctor or nurse immediately and take another two tablets. If you vomit more than 3 hours after taking Yeytuo you do not need to take more tablets until your next scheduled tablets or injection.
If you miss a Yeytuo injection appointment
- If you think you will not be able to attend an appointment for your injections, contact your doctor or nurse as soon as possible to discuss your options. If you need to miss a scheduled injection appointment, there is the option to temporarily take Yeytuo tablets instead.
Using Yeytuo tablets if you have to miss an injection appointment
- Take one tablet by mouth, every 7 days until your injections resume. Tablets can be taken with or without food.
- It is important to continue Yeytuo as your doctor or nurse recommends.
Do not stop taking Yeytuo
Do not stop taking Yeytuo without talking to your doctor or nurse. Take Yeytuo for as long as your doctor recommends. Don’t stop unless your doctor advises you to. Missing Yeytuo injections or tablets increases your risk of getting HIV.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme,
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Yeytuo
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and bottle label after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special temperature storage conditions. Store in the original package in order to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Yeytuo® 300 mg
film-coated tablets
Yeytuo® 300 mg
film-coated tablets
6. Contents of the pack and other information
What Yeytuo contains
The active substance is lenacapavir. Each tablet contains lenacapavir sodium equivalent to 300 mg lenacapavir.
The other ingredients are
Tablet core
Mannitol (E421), microcrystalline cellulose (E460), croscarmellose sodium (E468), copovidone, magnesium stearate (E572), poloxamer
(see section 2, Yeytuo contains sodium).
Film-coating
Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), iron oxide yellow (E172), iron oxide black (E172), iron oxide red (E172).
What Yeytuo looks like and contents of the pack
Yeytuo film-coated tablets are beige, capsule-shaped, film-coated tablets, debossed with “GSI” on one side of the tablet and “62L” on the other side of the tablet. Yeytuo comes in a bottle of 4 tablets. Each bottle contains a silica gel desiccant that must be kept in the bottle to help protect your tablets. The silica gel desiccant is contained in a separate packet and should not be swallowed.
Marketing Authorisation Holder
Gilead Sciences Ltd
280 High Holborn
London
WC1V 7EE
United Kingdom
Manufacturer
Gilead Sciences Ireland UC
IDA Business & Technology Park
Carrigtohill
County Cork
Ireland
For any information about this medicine,
please contact the local representative of the Marketing Authorisation Holder:
Gilead Sciences Ltd
Tel: + 44 (0) 8000 113 700