Prospect: information for the patient

Rukobia 600mg prolonged-release tablets

fostemsavir

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.

Rukobia contains fostemsavir and is a type of antiretroviral medication for HIV known asa fusion inhibitor(FI). It acts by binding to the virus and preventing it from adhering to blood cells.

Rukobia is used in combination with other antiretroviral medications (combination therapy), to treat HIV infection in adults with limited treatment options (other antiretroviral medications are not sufficiently effective or are not suitable).

Rukobia does not cure HIV infection; it reduces the amount of virus in the body and keeps it at a low level. Since HIV reduces the number of CD4 cells in the body, keeping HIV at a low level also increases the CD4 cell count in the blood. CD4 cells are a type of white blood cell that are important in helping the body fight infections.

Do not take Rukobia

• if you areallergic to fostemsaviror any of the other ingredients in this medicine (listed in section6)
• if you are taking any of the following medicines:
• • carbamazepineorphenytoin(used to treatepilepsyand prevent seizures)
  • mitotane(used to treat various types ofcancer)
  • enzalutamide(used to treatprostate cancer)
  • rifampicin(used to treat somebacterial infections, such astuberculosis)
  • products containingSt. John's Wort(Hypericum perforatum) (a herbal product used to treatdepression).

• If you think this applies to you, do not take Rukobiauntil you have talked to your doctor.

Warnings and precautions

Be aware of these situations

Some people taking medicines to treat HIV infection develop other conditions, which can be serious. These include:

• symptoms of infection and inflammation
• joint pain, stiffness, and bone problems.

You need to know what important signs and symptoms to watch for while taking Rukobia.

• See section4 of this leaflet.

Before taking Rukobia, your doctor needs to know

• if you have or have had aheart problem, or if you notice any unusual changes in your heartbeat (such as a racing or slow heartbeat). Rukobia can affect your heart rhythm.
• if you have or have had aliver disease, including hepatitis B or C.

• Consult your doctorif this applies to you. You may need additional check-ups, including blood tests, while taking your medication.

You will need regular blood tests

While taking Rukobia, your doctor will ask you to have regular blood tests to measure the amount of HIV in your blood and to detect any side effects. There is more information about these side effects in section4of this leaflet.

Keep in regular contact with your doctor

Rukobia helps control your disease, but it does not cure HIV infection. You must keep taking it every day to prevent your disease from getting worse. Because Rukobia does not cure HIV infection, you may still develop other infections and diseases related to HIV infection.

• Keep in contact with your doctor, and do not stop taking Rukobiawithout first talking to your doctor.

Children and adolescents

Rukobia is not recommended for people under 18years old, as it has not been studied in this age group.

Other medicines and Rukobia

Inform your doctor or pharmacistif you are taking, have taken recently, or may need to take any other medicine.

Rukobia should not be taken with some medicines

Do not take Rukobia if you are taking any of the following medicines:

• carbamazepine, orphenytoin, to treatepilepsyand prevent seizures
• mitotane, to treat various types ofcancer
• enzalutamide, to treatprostate cancer
• rifampicin, to treatbacterial infections, such astuberculosis
• products containingSt. John's Wort(Hypericum perforatum) (a herbal product to treatdepression).

This medicine is not recommended with Rukobia:

• elbasvir/grazoprevir, to treathepatitis C infection.

• Inform your doctor or pharmacistif you are being treated with this medicine.

Some medicines may affect how Rukobia works

Or increase the risk of side effects. Rukobia may also affect how other medicines work.

Inform your doctorif you are taking any of the following medicines:

• amiodarone, disopyramide, ibutilide, procainamide, quinidine, or sotalol, used to treatheart conditions
• statins(atorvastatin, fluvastatin, pitavastatin, rosuvastatin, or simvastatin), used tolower cholesterol levels
• ethinylestradiol, used forcontraception
• tenofovir alafenamide, used as anantiviral.

• Inform your doctor or pharmacistif you are taking any of these. Your doctor may decide to adjust your dose or consider additional check-ups.

Pregnancy

If you arepregnantor think you may bepregnant, or if you are planning to becomepregnant, do not take Rukobiawithout first talking to your doctor.

Breastfeeding

It is not recommendedthat women with HIV breastfeed, as HIV infection can be transmitted to the baby through breast milk.

The safety of Rukobia's components during breastfeeding is unknown

If you are breastfeeding or plan to breastfeed,you should talk to your doctor as soon as possible

Driving and operating machinery

Rukobia may make you feel dizzy and/or have other side effects that make you less alert.

?Do not drive or operate machinery unless you are sure it will not affect you.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

• The recommended doseof Rukobia is a 600mg tablet, taken twice a day.
• The Rukobia tablet must be swallowed whole,with a little liquid.Do not chew, crush, or break the tablets– if you do, there is a risk that the medication will be released into your body too quickly.
• Rukobia can be takenwith or without food.

If you take more Rukobia than you should

If you exceed the number of Rukobia tablets,contact your doctor or pharmacist.If possible, show them the Rukobia box.

If you forget to take Rukobia

Take it as soon as you remember. However, if it is almost time for your next dose, omit the missed dose and return to your regular schedule.Do not take a double doseto make up for the missed dose. If you are unsure of what to do,consult your doctor or pharmacist.

If you interrupt treatment with Rukobia

Do not stop treatment with Rukobia without first consulting your doctor.

To control your HIV infection and prevent your disease from worsening, take Rukobia for the time your doctor recommends. Do not interrupt treatment unless your doctor tells you to.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.Therefore, it is very important that you inform your doctor about any changes in your health.

Common symptoms of infection and inflammation are frequent(they can affect up to 1 in 10 people)

People with advanced HIV (AIDS) infection have a weakened immune system, and are more prone to developing severe infections (opportunistic infections). When they start treatment, the immune system is strengthened, so the body begins to fight these infections.

Side effects of infection and inflammation may develop due to:

• old and hidden infections that reappear as the body fights them
• or the immune system mistakenly attacking healthy body tissue (autoimmune disorders).

Autoimmune disorder symptoms may appear many months after starting treatment for HIV infection.

These symptoms may include:

• Muscle weaknessand/ormuscle pain
• Joint painorswellingof the joints
• Weaknessthat begins in the hands and feet and ascends to the body trunk
• Palpitationsorshakiness
• Excessive restlessness and movement(hyperactivity).

If you experience any symptoms of infection and inflammationor if you notice any of the above symptoms:

• Inform your doctor immediately. Do not take other medications for the infection without consulting your doctor first.

Very common side effects(they can affect more than 1 in 10 people):

• Nausea
• Diarrhea
• Unpleasantness (vomiting)
• Abdominal pain (abdominal pain)
• Headache
• Rash.

• Consult your doctorif you experience any of these side effects.

Common side effects(they can affect up to 1 in 10 people):

• Indigestion (indigestion)
• Lack of energy (fatigue)
• Alteration of heart rhythm observed on theelectrocardiogram(prolonged QT interval)
• Muscle pain (mialgia)
• Sensation of drowsiness
• Dizziness
• Alteration of taste (disgeusia)
• Gas
• Difficulty sleeping (insomnia)
• Itching (pruritus).

• Consult your doctorif you experience any of these side effects.

Some side effects may only be observed in blood tests and may not appear immediately after starting Rukobia treatment.

Common side effects that may appear in blood tests are:

• Increased levels of enzymes produced in muscles (creatine phosphokinase; an indicator of muscle damage)
• Increased levels of creatinine, an indicator of kidney function
• Increased levels of enzymes produced in the liver (transaminases, an indicator of liver damage).

Other side effects that may appear in blood tests

In some people, other side effects have occurred, but their exact frequency is unknown:

• Increasedbilirubin(a substance produced in the liver) in blood.

Joint pain, stiffness, and bone problems

Some people taking combined HIV-1 treatment developosteonecrosis. In this condition, parts of the bone tissue die due to reduced blood supply to the bones. People may be more prone to this condition:

• If they have been taking combined treatment for a long time
• If they are also taking anti-inflammatory medications called corticosteroids
• If they drink alcohol
• If their immune system is severely weakened
• If they are overweight.

The signs of osteonecrosis include:

• Joint stiffness
• Pain and discomfort in the joints (especially in the hip, knee, or shoulder)
• Difficulty moving.

If you notice any of these symptoms:

• Inform your doctor.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and bottle after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Rukobia

• The active ingredient is fostemsavir. Each tablet contains fostemsavir tromethamine equivalent to 600mg of fostemsavir.
• The other components are hydroxypropylcellulose, hypromellose, anhydrous colloidal silica, magnesium stearate, poly(vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), and red iron oxide (E172).

Appearance of the product and contents of the pack

The prolonged-release tablets of Rukobia 600mg are beige, oval, biconvex, approximately 19mm long, 10mm wide, and 8 mm thick, coated with a film, and marked with the code‘SV1V7’ on one side.

Each pack contains one or three bottles, each containing 60prolonged-release tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

ViiV Healthcare BV

Van Asch van Wijckstraat 55H

3811 LP Amersfoort

Netherlands

Responsible for manufacturing

GlaxoSmithKline Manufacturing S.P.A

Strada Provinciale Asolana, 90

San Polo di Torrile

Parma, 43056

Italy

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:09/2023.

Other sources of information

More detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.