Rukobia

Package leaflet: Information for the patient

Rukobia 600 mg prolonged-release tablets

fostemsavir
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Rukobia is and what it is used for

Rukobia contains fostemsavir and is a type of HIV medicine (antiretroviral) known as an
attachment inhibitor. It works by binding to the virus, thereby blocking its entry into blood cells.
Rukobia is used in combination with other antiretroviral medicines (combination therapy) to treat
HIV infection in adults who have limited treatment options (other antiretroviral medicines 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 low
levels. Since HIV reduces the number of CD4 cells in the body, maintaining low levels of HIV also helps
increase the number of CD4 cells in the blood. CD4 cells are a type of white blood cell that play an
important role in helping the body fight infection.

2. What you need to know before taking Rukobia

Do not take Rukobia

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

➔ If you think any of these conditions apply to you, do not take Rukobia until you have
consulted your doctor.
Warnings and precautions
Conditions requiring caution
Some people who take medicines for HIV infection develop other conditions, which
can be serious. These include:

• infections and inflammations
• joint pain, stiffness and bone problems
  You should be aware of important signs and symptoms so that you can recognize them while taking Rukobia. ➔ See Section 4 of this leaflet.

Before taking Rukobia, your doctor must know

• if you have or have had a heart problem, or if you notice any unusual changes in your heartbeat (such as beating too fast or too slow). Rukobia can affect heart rhythm.
• if you have or have had liver disease, including hepatitis B or hepatitis C. ➔ Talk to your doctor if this applies to you. You may need additional monitoring, including blood tests, while taking this medicine.

You will need regular blood tests
Throughout the time you are taking Rukobia, your doctor will schedule regular blood tests to
measure the amount of HIV in your blood and to monitor for side effects. More information
about these side effects is provided in Section 4 of this leaflet.
Stay in regular contact with your doctor
Rukobia helps control your condition but does not cure HIV infection. You must take it every day to
prevent the disease from worsening. Since Rukobia does not cure HIV infection, you may still develop other HIV-related infections and illnesses.
➔ Stay in contact with your doctor, and do not stop taking Rukobia without medical advice.
Children and adolescents
Rukobia is not recommended for people under 18 years of age because it has not been studied in this
age group.
Other medicines and Rukobia
Tell your doctor or pharmacist if you are taking, have recently taken, or might start taking any other medicines.
Rukobia must not be taken with certain other medicines
Do not take Rukobia if you are taking any of the following medicines:

• carbamazepine or phenytoin, to treat epilepsy and prevent seizures
• mitotane, to treat various types of cancer
• enzalutamide, to treat prostate cancer
• rifampicin, to treat certain bacterial infections such as tuberculosis
• products containing St John’s wort (Hypericum perforatum) (a herbal remedy for depression)

This medicine is not recommended with Rukobia:

• elbasvir/grazoprevir, used to treat hepatitis C virus infection. ➔ Inform your doctor or pharmacist if you are being treated with this medicine.

Some medicines may affect the activity of Rukobia
Or may increase the likelihood of you experiencing side effects. Rukobia may also
affect the activity of other medicines.
Tell your doctor if you are taking any of the following medicines:

• amiodarone, disopyramide, ibutilide, procainamide, quinidine or sotalol, used to treat heart conditions
• statins (atorvastatin, fluvastatin, pitavastatin, rosuvastatin or simvastatin), used to lower cholesterol levels
• ethinylestradiol, used as a contraceptive
• tenofovir alafenamide, used as an antiviral ➔ Inform your doctor or pharmacist if you are taking any of these medicines. Your doctor may decide you need additional monitoring.

Pregnancy
If you are pregnant, think you might be pregnant, or are planning to become pregnant, do not
take Rukobia without first consulting your doctor. Your doctor will assess the benefit to you and the risk to your unborn child of taking Rukobia during pregnancy.
Breast-feeding
Breast-feeding is not recommended for women who are HIV-positive because HIV infection can be
transmitted to the baby through breast milk.
It is not known whether the components of Rukobia pass into breast milk and could harm the baby.
If you are breast-feeding or are considering breast-feeding, you must discuss this with your doctor as soon as possible.
Driving and using machines
Rukobia may cause dizziness and other side effects that may reduce your attention.
Do not drive or operate machinery if you are not sure that your level of alertness is not impaired.

3. How to take Rukobia

Take Rukobia exactly as your doctor has told you. If you are unsure, consult your
doctor or pharmacist.

• The recommended dose of Rukobia is one 600 mg tablet, taken twice daily.
• Rukobia must be swallowed whole with liquid. Do not chew, crush, or split the tablets – doing so may cause the medicine to be released into the body too quickly.
• You may take Rukobia with or without food.

If you take more Rukobia than you should
If you take too many Rukobia tablets, contact your doctor or pharmacist immediately. If possible, show them
the Rukobia packaging.
If you forget to take Rukobia
Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the
missed dose and return to your regular dosing schedule. Do not take a double dose to make up for a
missed dose. If you are unsure what to do, consult your doctor or pharmacist.
If you stop taking Rukobia
Do not stop taking Rukobia without consulting your doctor.
To control HIV infection and prevent the disease from worsening, take Rukobia for the entire duration
prescribed by your doctor. Do not discontinue treatment unless instructed by your doctor.
If you have further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Therefore, it is very important to discuss with your doctor any changes in your health status.
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). After starting treatment, the immune system becomes stronger and begins to fight these infections.
Symptoms of infection and inflammation may therefore develop due to:

• re-emergence of previous "silent" infections as the body starts fighting them
• the immune system mistakenly attacking healthy body tissues (autoimmune disorders). Symptoms of autoimmune disorders may develop many months after starting treatment for HIV infection.

Symptoms may include:

• muscle weakness and/or pain
• pain or swelling of the joints
• weakness starting in the hands and feet and spreading towards the trunk of the body
• palpitations or tremor
• agitation and excessive movement (hyperactivity)
  If you experience any symptoms of infection or inflammation or notice any of the symptoms listed above: ➔ inform your doctor immediately. Do not take any other medicines for infection without consulting your doctor.

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

• nausea
• diarrhoea
• vomiting
• stomach ache (abdominal pain)
• headache
• rash ➔ Consult your doctor if you experience these side effects.

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

• difficulty digesting (dyspepsia)
• lack of energy (fatigue)
• heart rhythm disturbances observed on electrocardiogram (ECG) (prolongation of the QT interval)
• muscle pain (myalgia)
• feeling of tiredness (somnolence)
• dizziness
• taste disturbances (dysgeusia)
• flatulence
• difficulty sleeping (insomnia)
• itching ➔ Consult your doctor if you experience these side effects.

Some side effects may only be detected through blood tests and may not appear immediately after taking Rukobia.
Common side effects detectable by blood tests include:

• increased levels of enzymes produced in the muscles (creatine phosphokinase, a marker of muscle damage)
• increased creatinine, a marker of kidney function
• increased levels of enzymes produced by the liver (transaminases, a marker of liver damage).

Other side effects detectable by blood tests
Other side effects have occurred in some people, but their exact frequency is unknown:

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

Joint pain, stiffness and bone problems
Some people taking combination therapy for HIV infection develop a condition called osteonecrosis. As a result of this condition, part of the bone tissue dies due to reduced blood supply to the bones. The risk of developing this condition may be higher in people who:

• have been on combination therapy for a long time
• are also taking anti-inflammatory medicines called corticosteroids
• consume alcoholic beverages
• have a very weak immune system
• are overweight.

Signs of osteonecrosis include:

• stiffness in the joints
• pain and discomfort in the joints (especially the hip, knee or shoulder)
• difficulty moving
  If you notice any of these symptoms: ➔ inform your doctor.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Rukobia

Keep this medicine out of the sight and reach of children.
Do not use Rukobia after the expiry date stated on the packaging, which is indicated after "Exp." on the box and bottle.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6 Contents of the pack and other information

What Rukobia contains

• The active substance is fostemsavir. Each tablet contains fostemsavir trometamol equivalent to 600 mg of fostemsavir.
• The other ingredients are hydroxypropyl cellulose, hypromellose, anhydrous colloidal silica, magnesium stearate, polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172).

Description of Rukobia and contents of the pack
The 600 mg prolonged-release tablets of Rukobia are beige, biconvex, oval tablets approximately 19 mm long, 10 mm wide and 8 mm thick, with the code 'SV 1V7' engraved on one side.
Each pack contains one or three bottles, each containing 60 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
ViiV Healthcare BV
Van Asch van Wijckstraat 55H
3811 LP Amersfoort
The Netherlands

Manufacturer
GlaxoSmithKline Manufacturing S.p.A
Strada Provinciale Asolana, 90
San Polo di Torrile
Parma, 43056
Italy

For further information on this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
ViiV Healthcare srl/bv ViiV Healthcare BV
Tél/Tel: + 32 (0) 10 85 65 00 Tel: + 370 80000334

България Luxembourg/Luxemburg
ViiV Healthcare BV ViiV Healthcare srl/bv
Teл.: + 359 80018205 Belgique/Belgien
Tél/Tel: + 32 (0) 10 85 65 00

Česká republika Magyarország
GlaxoSmithKline, s.r.o. ViiV Healthcare BV
Tel: + 420 222 001 111 Tel.: + 36 80088309
[email protected]

Danmark Malta
GlaxoSmithKline Pharma A/S ViiV Healthcare BV
Tlf: + 45 36 35 91 00 Tel: + 356 80065004
[email protected]

Deutschland Nederland
ViiV Healthcare GmbH ViiV Healthcare BV
Tel.: + 49 (0)89 203 0038-10 Tel: + 31 (0)33 2081199
[email protected]

Eesti Norge
ViiV Healthcare BV GlaxoSmithKline AS
Tel: + 372 8002640 Tlf: + 47 22 70 20 00

Ελλάδα Österreich
GlaxoSmithKline Μονοπρόσωπη A.E.B.E. GlaxoSmithKline Pharma GmbH
Τηλ: + 30 210 68 82 100 Tel: + 43 (0)1 97075 0
[email protected]

España Polska
Laboratorios ViiV Healthcare, S.L. GSK Services Sp. z o.o.
Tel: + 34 900 923 501 Tel.: + 48 (0)22 576 9000
[email protected]

France Portugal
ViiV Healthcare SAS VIIVHIV HEALTHCARE, UNIPESSOAL, LDA
Tél.: + 33 (0)1 39 17 69 69 Tel: + 351 21 094 08 01
[email protected] [email protected]

Hrvatska România
ViiV Healthcare BV ViiV Healthcare BV
Tel: + 385 800787089 Tel: + 40 800672524

Ireland Slovenija
GlaxoSmithKline (Ireland) Limited ViiV Healthcare BV
Tel: + 353 (0)1 4955000 Tel: + 386 80688869

Ísland Slovenská republika
Vistor ehf. ViiV Healthcare BV
Sími: +354 535 7000 Tel: + 421 800500589

Italia Suomi/Finland
ViiV Healthcare S.r.l GlaxoSmithKline Oy
Tel: + 39 (0)45 7741600 Puh/Tel: + 358 (0)10 30 30 30

Κύπρος Sverige
ViiV Healthcare BV GlaxoSmithKline AB
Τηλ: + 357 80070017 Tel: + 46 (0)8 638 93 00
[email protected]

Latvija
ViiV Healthcare BV
Tel: + 371 80205045

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