Lenacapavir Gilead contains the active substance lenacapavir. It is a long acting antiretroviral medicine known as a capsid inhibitor. Lenacapavir Gilead is in combination with safer practices to prevent HIV-1 infection in adults and adolescents weighing at least 35 kg. This is called pre-exposure prophylaxis (PrEP). Your doctor will advise you to take Lenacapavir Gilead tablets when you are given Lenacapavir Gilead injections for the first time. If you are being given Lenacapavir Gilead injections, but you plan to miss your scheduled Lenacapavir Gilead injections, you can take Lenacapavir Gilead tablets instead, until you can receive the injections again (see section 3).
1. What Lenacapavir Gilead is and what it is used for
2. What you need to know before you take Lenacapavir Gilead
Do not take Lenacapavir Gilead:
- If you are allergic to lenacapavir or any of the other ingredients of Lenacapavir Gilead (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. Lenacapavir Gilead can only prevent HIV if you don’t already have it.
- If you are taking any of these medicines:
- carbamazepine, phenytoin, used to prevent seizures
- St. John’s wort (Hypericum perforatum), a herbal remedy used for depression and anxiety
→ Do not take Lenacapavir Gilead and tell your doctor or nurse immediately if you think any of these apply to you.
3. How to take Lenacapavir Gilead
You must have a negative HIV test before taking Lenacapavir Gilead. You will take tablets by mouth and your doctor or nurse will give you injections under the skin (subcutaneously) when you start Lenacapavir Gilead. 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 upper buttocks.
Day 2:
- Two tablets taken by mouth, as above.
Every 6 months:
- Two injections given by your doctor or nurse, as above. It is important to keep your scheduled appointments every 6 months (26 weeks) to receive your injections of Lenacapavir Gilead. This will continue to help prevent 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.
4. Possible side effects
Lenacapavir Gilead can have side effects. Should your general health worsen or if you experience any untoward effects while taking Lenacapavir Gilead, please consult your healthcare provider for advice. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
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 to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Lenacapavir Gilead
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. Store below 30 °C. 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.