Sunlenca 464 mg solution for injection

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient

Sunlenca 464 mg injection solution

lenacapavir

This medicinal product is subject to additional monitoring, which will allow for faster detection of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is included at the end of section 4.

Read this entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Sunlenca is and what it is used for
2. What you need to know before you are given Sunlenca
3. How Sunlenca is administered
4. Possible side effects
5. How to store Sunlenca
6. Contents of the pack and other information

1. What Sunlenca is and what it is used for

Sunlenca contains the active substance lenacapavir. It is an antiretroviral medicine known as a capsid inhibitor.

Sunlenca is a long-acting medicine and is used in combination with other antiretroviral medicines to treat human immunodeficiency virus type 1 (HIV), the virus that causes acquired immunodeficiency syndrome (AIDS).

It is used to treat HIV infection in adults with limited treatment options (for example, when other antiretroviral medicines are not effective enough or are not suitable).

Treatment with Sunlenca in combination with other antiretrovirals reduces the amount of HIV in the body. This improves the function of the immune system (the body's natural defenses) and reduces the risk of developing HIV-related illnesses.

2. What you need to know before Sunlenca is administered to you

Do not receive Sunlenca

• If you are allergic to lenacapavir or to any of the other ingredients of this medicine (listed in section 6).
• If you are taking any of the following medicines:
  • rifampicin, used to treat certain bacterial infections such as tuberculosis
  • carbamazepine, phenytoin, used to prevent seizures
  • St. John’s wort (Hypericum perforatum), a herbal medicine used for depression and anxiety

? If you think this applies to you, do not receive Sunlenca and inform your doctor immediately.

Warnings and precautions

Talk to your doctor before using Sunlenca

• Consult your doctor or pharmacist if you have or have ever had severe liver disease or if tests have shown liver problems. Your doctor will carefully assess whether or not to treat you with Sunlenca.

While using Sunlenca

Once you start using Sunlenca, be alert for:

• Signs of inflammation or infection.

?If you notice any of these symptoms, inform your doctor immediately. For more information, see section 4, Possible side effects.

Regular appointments are important

It is important that you attend your scheduled appointments to receive your Sunlenca injection to control HIV infection and prevent your condition from worsening. Talk to your doctor if you are considering stopping treatment. If there is a delay in administering your injection or if you stop receiving Sunlenca, you will need to take other medicines to treat HIV infection and reduce the risk of developing viral resistance.

Children and adolescents

Do not administer this medicine to children under 18 years of age. The use of Sunlenca has not yet been studied in patients under 18 years of age, so it is unknown how safe and effective the medicine is in this age group.

Other medicines and Sunlenca

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Sunlenca may interact with other medicines. This may prevent Sunlenca or other medicines from working properly or may worsen side effects. In some cases, your doctor may need to adjust your dose or monitor your blood levels.

Medicines that must never be taken with Sunlenca:

• rifampicin, used to treat certain bacterial infections such as tuberculosis
• carbamazepine, phenytoin, used to prevent seizures
• St. John’s wort (Hypericum perforatum), a herbal medicine used for depression and anxiety

?.If you are taking any of these medicines, do not receive injectable Sunlenca and inform your doctor immediately.

Talk to your doctor especially if you are taking:

• antibiotics containing:
  • rifabutin
• antiepileptic medicines used to treat epilepsy and prevent seizures (convulsions), containing:
  • oxcarbazepine or phenobarbital
• medicines used to treat HIV, containing:
  • atazanavir/cobicistat, efavirenz, nevirapine, tipranavir/ritonavir or etravirine
• medicines used to treat migraine headache, containing:
  • dihydroergotamine or ergotamine
• medicines used to treat erectile dysfunction and pulmonary hypertension, containing:
  • sildenafil or tadalafil
• medicines used to treat erectile dysfunction, containing:
  • vardenafil
• corticosteroids (also known as “steroids”) taken orally or by injection, used to treat allergies, inflammatory bowel diseases, and other conditions involving inflammation in the 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

?Inform your doctor if you are taking any of these medicines or if you start taking any of these medicines during treatment with Sunlenca. Do not stop your treatment without consulting your doctor.

Sunlenca is a long-acting medicine. You should know that if you decide to discontinue or switch your treatment to another after consulting your doctor, low concentrations of lenacapavir (the active substance in Sunlenca) may remain in your body for several months after your last injection. The presence of these residual low concentrations is not expected to affect other antiretroviral medicines you may take later to treat HIV infection. However, the presence of low concentrations of lenacapavir in your body may affect other medicines you take within the 9 months following your last Sunlenca injection. Ask your doctor whether these medicines are safe for you after stopping treatment with Sunlenca.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

As a precautionary measure, you should avoid using Sunlenca during pregnancy unless your doctor advises otherwise.

Women with HIV infection are advised not to breastfeed their infants, as HIV-1 infection can be transmitted to the baby through breast milk. If you are breastfeeding or plan to breastfeed, talk to your doctor as soon as possible.

Driving and use of machines

Sunlenca is not expected to affect your ability to drive or operate machinery.

Sunlenca contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per injection; essentially “sodium-free”.

3. How Sunlenca is administered

Sunlenca is used in combination with other antiretroviral medicines to treat HIV infection. Your doctor will advise you which other medicines you should take to treat HIV infection and when to take them.

Treatment with Sunlenca starts with taking oral tablets, followed by injections administered by your doctor or nurse, as described below.

Talk to your doctor before taking the tablets. Your doctor will inform you when to start taking the tablets and when your appointment for the first injections will be scheduled.

Day 1 of treatment:

• Two tablets taken orally. These can be taken with or without food.

Day 2 of treatment:

• Two tablets taken orally. These can be taken with or without food.

Day 8 of treatment:

• One tablet taken orally. This can be taken with or without food.

Day 15 of treatment:

• Two injections into the abdomen (the stomach area) administered at the same time by your doctor or nurse.

Every 6 months:

• Two injections into the abdomen administered at the same time by your doctor or nurse.

If you are given more injectable Sunlenca than you should

Your doctor or nurse will administer this medicine, so it is unlikely that you will be given too much. Inform your doctor or nurse if you are concerned.

If you miss an injection of Sunlenca

• It is important that you attend your scheduled appointments every 6 months to receive your Sunlenca injections. This will help control your HIV infection and prevent your condition from worsening.
• If you think you will be unable to attend your appointment for the injections, contact your doctor as soon as possible to discuss your treatment options.

Refer to the Sunlenca tablet package leaflet if you forget to take or vomit the tablets.

If you stop treatment with Sunlenca

Do not stop treatment with Sunlenca without speaking to your doctor. Continue treatment with Sunlenca injections as long as your doctor recommends. Stopping Sunlenca may seriously affect the effectiveness of future HIV treatments.

Talk to your doctor if you wish to stop treatment with Sunlenca injections.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Possible serious side effects: tell a doctor immediately

• Any sign of inflammation or infection. In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (infections that occur in people with a weakened immune system), signs and symptoms of inflammation from previous infections may occur shortly after starting anti-HIV treatment. These symptoms are believed to result from an improved immune response, enabling the body to fight infections that may have been present without obvious symptoms.

• Autoimmune disorders may also occur, in which the immune system attacks healthy body tissues, after you start taking medicines for HIV infection. Autoimmune disorders may occur many months after starting treatment. Be alert for any symptoms of infection or other symptoms such as:

  • muscle weakness
  • weakness beginning in the hands and feet and moving towards the trunk
  • palpitations, tremor, or hyperactivity

? If you notice any of these symptoms or any symptoms of inflammation or infection, tell your doctor immediately.

Very common side effects

(may affect more than 1 in 10 people)

• Reactions at the Sunlenca injection site.

Symptoms may include:

• pain and discomfort
• a lump or hardened mass
• inflammatory reaction such as redness, itching, and swelling

Common side effects

(may affect up to 1 in 10 people)

• Nausea

Reporting of side effects

If you experience any type of side effect, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sunlenca

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 label of the vial and on the carton after {EXP}. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature. Store in the original packaging to protect from light.

6. Contents of the pack and other information

Composition of Sunlenca

The active substance is lenacapavir. Each single-dose vial contains 463.5 mg of lenacapavir.

The other components are

Macrogol (E1521), water for injections.

Appearance of Sunlenca and contents of the pack

Sunlenca injectable solution is a clear, yellow to brown solution, free from visible particles. Sunlenca is supplied in two glass vials containing 1.5 ml of injectable solution each. These vials are included in an administration kit which also contains 2 vial access devices (a device that will allow your doctor or nurse to withdraw Sunlenca from the vial), 2 disposable syringes, and 2 injection needles.

Marketing Authorization Holder

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Manufacturer

Gilead Sciences Ireland UC

IDA Business & Technology Park

Carrigtohill

County Cork

Ireland

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

This information is intended for healthcare professionals only:

Instructions for use – Sunlenca 464 mg injection solution

The kit contains

All components are for single use only.

Two 1.5 ml injections are required for a complete dose. The vial access device must be used.

Check that:

• The vial contains a yellow to brown solution, free from particles
• The contents are undamaged
• The medicine has not expired