RUKOBIA 600 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Rukobia 600mg prolonged-release tablets

fostemsavir

This medicine is subject to additional monitoring, which will help to quickly identify new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on how to report side effects.

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Rukobia and what is it used for
2. What you need to know before you take Rukobia
3. How to take Rukobia
4. Possible side effects
5. Storage of Rukobia
6. Contents of the pack and other information

1. What is Rukobia and what is it used for

Rukobia contains fostemsavir and is a type of antiretroviral medicine for HIV known as an attachment inhibitor(AI). It works by attaching to the virus and preventing it from attaching to blood cells.

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

Rukobia does not cure HIV infection; it reduces the amount of virus in your 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 for helping your body fight infections.

2. What you need to know before you take Rukobia

Do not take Rukobia

• if you are allergic to fostemsaviror any of the other ingredients of this medicine (listed in section 6)
• if you are taking any of these medicines:
• • carbamazepineor phenytoin(used to treat epilepsyand prevent seizures (fits))
  • mitotane(used to treat various types of cancer)
  • enzalutamide(used to treat prostate cancer)
  • rifampicin(used to treat some bacterial infectionssuch as tuberculosis)
  • products containing St. John's Wort(Hypericum perforatum) (a herbal product used to treat depression).

• If you think any of these apply to you, do not take Rukobiauntil you have talked to your doctor.

Warnings and precautions

Situations to look out for

Some people taking medicines for 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 about the important signs and symptoms to look out for while taking Rukobia.

• See section 4 of this leaflet.

Beforetaking Rukobia, your doctor must know

• if you have or have had a heart problem, or if you notice any unusual change in your heartbeat (such as beats that are too fast or too slow). Rukobia may affect your heart rhythm.
• if you have or have had a liver disease, including hepatitis B or C.

• Tell your doctorif this applies to you. You may need extra check-ups, including blood tests, while taking your medicine.

You will needregular 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 side effects. There is more information about these side effects in section4of this leaflet.

Keep inregular contact with your doctor

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

• Stay intouch with your doctor and do not stop taking Rukobiawithout talking to your doctor first.

Children and adolescents

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

Other medicines and Rukobia

Tell your doctor or pharmacistif you are taking, have recently taken or might take any other medicines.

Rukobia must not be taken with some medicines

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

• carbamazepine, or phenytoin, for treating epilepsyand preventing seizures
• mitotane, for treating various types of cancer
• enzalutamide, for treating prostate cancer
• rifampicin, for treating some bacterial infectionssuch as tuberculosis
• products containing St. John's Wort(Hypericum perforatum) (a herbal product for treating depression).

This medicine is not recommended with Rukobia:

• elbasvir/grazoprevir, for treating hepatitis C infection.

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

Some medicines may affect how Rukobia works

Or increase the chance of you having side effects. Rukobia may also affect how other medicines work.

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

• amiodarone, disopyramide, ibutilide, procainamide, quinidine or sotalol, used for treating heart conditions
• statins(atorvastatin, fluvastatin, pitavastatin, rosuvastatin or simvastatin), used for lowering cholesterol levels
• ethinylestradiol, used for birth control
• tenofovir alafenamide, used as an antiviral.

• Tell your doctor or pharmacistif you are taking any of these. Your doctor may decide to adjust your dose or consider that you need extra check-ups.

Pregnancy

If you are pregnantor think you may be pregnant, or are planning to have a baby, do not take Rukobiawithout talking to your doctor. Your doctorwill discuss with you the benefits and risks of taking Rukobia during pregnancy.

Breast-feeding

It is not recommendedthat HIV-infected women breast-feed their babies because HIV infection can be passed to the baby through breast milk.

It is not knownif the components of Rukobia can pass into breast milk and harm your baby. If you are breast-feeding or think you may want to breast-feed, talk to your doctor as soon as possible

Driving and using machines

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

? Do not drive or use machines unless you are sure that you are not affected.

3. How to take Rukobia

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

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

If you take more Rukobia than you should

If you take more Rukobia than you should, contact your doctor or pharmacist. If possible, show them the Rukobia pack.

If you forget to take Rukobia

Take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose and go back to your regular schedule. Do not take a double doseto make up for missed doses. If you are not sure what to do, ask your doctor or pharmacist.

If you stop taking Rukobia

Do not stop taking Rukobia without talking to your doctor first.

To control your HIV infection and prevent it getting worse, take Rukobia for as long as your doctor recommends. Do not stop treatment unless your doctor tells you to.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. It is very important that you tell your doctor about any changes in your health.

Symptoms of infection and inflammation are common(may affect up to 1 in 10 people)

People with advanced HIV infection (AIDS) have a weakened immune system and are more likely to develop serious infections (opportunistic infections). When they start treatment, their immune system becomes stronger, so the body starts fighting these infections.

Symptoms of infection and inflammation can develop due to:

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

Symptoms of autoimmune disorders may appear many months after you start taking medicines for your HIV infection.

These symptoms can include:

• muscle weaknessand/or muscle pain
• painor swellingof the joints
• weaknessthat starts in the hands and feet and moves up towards the trunk of the body
• palpitationsor tremors
• excessive restlessness and movement(hyperactivity).

If you have any symptoms of infection or inflammationor if you notice any of the above symptoms:

• Tell your doctor immediately. Do not take other medicines for the infection without talking to your doctor first.

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

• nausea
• diarrhea
• feeling sick (vomiting)
• stomach pain (abdominal pain)
• headache
• rash.

• Tell your doctorif you get any of these side effects.

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

• indigestion (dyspepsia)
• lack of energy (fatigue)
• abnormal heart rhythm observed in the electrocardiogram(prolonged QT interval)
• muscle pain (myalgia)
• feeling sleepy
• dizziness
• altered sense of taste (dysgeusia)
• wind
• difficulty sleeping (insomnia)
• itching (pruritus).

• Tell your doctorif you get any of these side effects.

Some side effects may only be seen in blood tests and may not appear immediately after you start taking Rukobia.

Common side effects that may appear in blood tests are:

• increased levels of muscle enzymes (creatine phosphokinase; an indicator of muscle damage)
• increased levels of creatinine, an indicator of kidney function
• increased levels of liver enzymes (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:

• increased bilirubin(a substance produced in the liver) in the blood.

Pain in the joints, stiffness, and bone problems

Some people taking combination therapy for HIV-1 develop osteonecrosis. In this condition, parts of the bone tissue die due to reduced blood supply to the bones. People may be more likely to get this condition:

• if they have been taking combination therapy for a long time
• if they are also taking anti-inflammatory medicines called corticosteroids
• if they drink alcohol
• if their immune system is very weakened
• if they are overweight.

Signs of osteonecrosis include:

• joint stiffness
• joint pain or pain in the bones (especially in the hip, knee, or shoulder)
• difficulty moving.

If you notice any of these symptoms:

• Tell your doctor.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rukobia

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 blister after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Package Contents and Additional Information

Rukobia Composition

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

Product Appearance and Package Contents

Rukobia 600 mg prolonged-release tablets are beige, oval, biconvex, approximately 19 mm in length, 10 mm in width, and 8 mm in thickness, film-coated, and marked with the code 'SV 1V7' on one face.

Each package contains one or three bottles, each with 60 prolonged-release tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

ViiV Healthcare BV

Van Asch van Wijckstraat 55H

3811 LP Amersfoort

Netherlands

Manufacturer

GlaxoSmithKline Manufacturing S.P.A

Strada Provinciale Asolana, 90

San Polo di Torrile

Parma, 43056

Italy

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:09/2023.

Other Sources of Information

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