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.
Contents of the pack
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.
Do not take Rukobia
Warnings and precautions
Situations to look out for
Some people taking medicines for HIV infection develop other conditions, which can be serious. These include:
You need to know about the important signs and symptoms to look out for while taking Rukobia.
Beforetaking Rukobia, your doctor must know
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.
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:
This medicine is not recommended with Rukobia:
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:
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.
Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
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.
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:
Symptoms of autoimmune disorders may appear many months after you start taking medicines for your HIV infection.
These symptoms can include:
If you have any symptoms of infection or inflammationor if you notice any of the above symptoms:
Very common side effects(may affect more than 1 in 10 people):
Common side effects(may affect up to 1 in 10 people):
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:
Other side effects that may appear in blood tests
In some people, other side effects have occurred, but their exact frequency is unknown:
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:
Signs of osteonecrosis include:
If you notice any of these symptoms:
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.
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.
Rukobia Composition
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:
Belgium/Belgique/Belgien ViiV Healthcare srl/bv Tel: + 32 (0) 10 85 65 00 | Lithuania ViiV Healthcare BV Tel: + 370 80000334 |
Bulgaria ViiV Healthcare BV Tel: + 359 2 80018205 | Luxembourg/Luxemburg ViiV Healthcare srl/bv Belgium/Belgien Tel: + 32 (0) 10 85 65 00 |
Czech Republic GlaxoSmithKline, s.r.o. Tel: + 420 222 001 111 cz.info@gsk.com | Hungary ViiV Healthcare BV Tel: + 36 80088309 |
Denmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 dk-info@gsk.com | Malta ViiV Healthcare BV Tel: + 356 80065004 |
Germany ViiV Healthcare GmbH Tel.: + 49 (0)89 203 0038-10 viiv.med.info@viivhealthcare.com | Netherlands ViiV Healthcare BV Tel: + 31 (0)33 2081199 |
Estonia ViiV Healthcare BV Tel: + 372 8002640 | Norway GlaxoSmithKline AS Tlf: + 47 22 70 20 00 |
Greece GlaxoSmithKline Μονοπρ?σωπη A.E.B.E. Tel: + 30 210 68 82 100 | Austria GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 at.info@gsk.com |
Spain Laboratorios ViiV Healthcare, S.L. Tel: + 34 900 923 501 es-ci@viivhealthcare.com | Poland GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9000 |
France ViiV Healthcare SAS Tél.: + 33 (0)1 39 17 69 69 Infomed@viivhealthcare.com | Portugal VIIVHIV HEALTHCARE, UNIPESSOAL, LDA Tel: + 351 21 094 08 01 viiv.fi.pt@viivhealthcare.com |
Croatia ViiV Healthcare BV Tel: + 385 800787089 | Romania ViiV Healthcare BV Tel: + 40800672524 |
Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955000 | Slovenia ViiV Healthcare BV Tel: + 386 80688869 |
Iceland Vistor hf. Tel: +354 535 7000 | Slovak Republic ViiV Healthcare BV Tel: + 421 800500589 |
Italy ViiV Healthcare S.r.l Tel: + 39 (0)45 9212611 | Finland GlaxoSmithKline Oy Tel: + 358 (0)10 30 30 30 Finland.tuoteinfo@gsk.com |
Cyprus ViiV Healthcare BV Tel: + 357 80070017 | Sweden GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00 info.produkt@gsk.com |
Latvia ViiV Healthcare BV Tel: + 371 80205045 | United Kingdom(Northern Ireland) ViiV Healthcare BV Tel: + 44 (0)800 221441 customercontactuk@gsk.com |
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.