600 mg prolonged-release tablets are
fostemsavir
What Rukobia is and what it is used for
Rukobia contains fostemsavir and is a type of HIV medicine (antiretroviral medicine) called a binding inhibitor. Rukobia works by binding to HIV and thus preventing it from entering 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 but it does reduce the amount of virus in the body and keeps it at a low level. Because HIV reduces the number of CD4 cells in the body, a low level of HIV means that the number of CD4 cells in the blood increases. CD4 cells are a type of white blood cell that is important for the body’s ability to fight infections.
What you need to know before taking Rukobia
Do not take Rukobia
- if you are allergic to fostemsavir or any of the other ingredients of this medicine (listed in section 6).
- if you are taking any of these medicines:
- carbamazepine or phenytoin (used to treat epilepsy and prevent seizures)
- mitotane (for the treatment of several forms of cancer )
- enzalutamide (for the treatment of prostate cancer )
- rifampicin (for the treatment of certain bacterial infections, such as tuberculosis )
- medicines containing St. John’s wort ( Hypericum perforatum ) (a traditional herbal medicine used for mild depression and mild anxiety ).
- If you think any of these apply to you, do not take Rukobia until you have talked to your doctor.
Warnings and cautions
Symptoms you need to be aware of
Some people who take medicines for HIV infection get other symptoms, which can be serious. These are:
- infection and inflammation _
- joint pain, stiffness, and skeletal problems.
You need to know the important signs and symptoms to be aware of while taking Rukobia.
- See section 4 of this leaflet.
Before taking Rukobia, your doctor needs to know
- if you have or have had heart problems, or if you notice any abnormal changes in the heartbeat (eg too fast or too slow heartbeat). Rukobia can affect the 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 extra checks, including blood tests, while you are taking the medicine.
You will need to submit blood samples regularly
As long as you are taking Rukobia, your doctor will arrange for regular blood tests to measure the amount of HIV in your blood and to check if you have any side effects. You will find more information about such side effects in section 4 of this leaflet.
Keep in regular contact with your doctor
Rukobia helps to keep the HIV infection under control, but it does not cure the disease. You need to keep taking it every day to prevent the disease from getting worse. Because Rukobia does not cure HIV infection, you can still develop infections and diseases associated with HIV infection.
- Keep in touch with your doctor and do not stop taking Rukobia unless your doctor advises you to do so.
Protect others
HIV infection is spread through sexual contact with someone who is infected or by transmission via infected blood (eg if you use the same injection needles). Although effective antiretroviral therapy reduces the risk, you can still transmit HIV infection while taking this medicine. Discuss with your doctor what steps you need to take to avoid infecting others.
Children and young people
Rukobia is not recommended for patients under 18 years of age as it has not been studied in this age group.
Other medicines and Rukobia
Tell your doctor or pharmacist if you have recently taken, or might take any other medicines.
Rukobia must not be taken with certain other medicines
Do not take Rukobia if you are taking any of these medicines:
- carbamazepine or phenytoin for the treatment of epilepsy and the prevention of seizures
- mitotane for the treatment of several forms of cancer
- enzalutamide for the treatment of prostate cancer
- rifampicin for the treatment of certain bacterial infections, e.g. tuberculosis
- products containing St. John’s wort ( Hypericum perforatum ) (a traditional herbal medicine used for mild depression and mild anxiety ).
The following medicines are not recommended with Rukobia:
- elbasvir/grazoprevir, for the treatment of hepatitis C infection.
- Tell your doctor or pharmacist if you are being treated with any of these medicines.
Some medicines may affect the effect of Rukobia
or may increase the risk of side effects. Rukobia can also affect the effects of certain other medicines.
Tell your doctor if you are taking any of the medicines listed below:
- amiodarone, disopyramide, ibutilide, procainamide, quinidine, or sotalol, used to treat heart problems
- statins (atorvastatin, fluvastatin, pitavastatin, rosuvastatin, or simvastatin ), which are used to lower cholesterol levels
- ethinyl estradiol, which is used in contraception
- tenofoviralafenamide, which is used as antiviral medicine.
- Tell your doctor or pharmacist if you are taking any of these medicines. Your doctor may decide that your dose needs to be changed or that you need to have more check-ups.
Pregnancy and breastfeeding
Pregnancy
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking Rukobia. Your doctor will discuss with you the benefits and risks for your baby if you are taking Rukobia during pregnancy.
Breast-feeding
Women who are HIV -positive should not breastfeed because the HIV infection can be transmitted to the baby via breast milk.
It is not known whether the ingredients in Rukobia can pass into breast milk.
- If you are breastfeeding or planning to breastfeed, talk to a doctor immediately.
Driving and using machines
Rukobia makes you dizzy and has other side effects that diminish your attention.
Do not drive or use machines unless you are sure that the medicine has no such effect on you.
How to take Rukobia
Always take Rukobia exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
- The usual dose of Rukobia is a 600 mg tablet twice daily.
- The Rukobia tablets should be swallowed whole with a little liquid. Do not chew, crush or split the tablets – if you do, there is a risk that the drug will be released too quickly in the body.
- You can take Rukobia with or without food.
If you take more Rukobia than you should
If you have taken too many Rukobia tablets, contact your doctor or pharmacist. Show them the package with Rukobia if possible.
If you forget to take Rukobia
Take it as soon as you remember. However, if it is time for your next dose, skip the missed dose and return to your regular schedule. Do not take a double dose to make up for a forgotten dose. 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 a doctor.
Take Rukobia for as long as your doctor recommends keeping your HIV infection under control and preventing the disease from getting worse. Do not stop unless your doctor tells you to.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. It is therefore very important that you talk to 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 weak immune system and are more likely to get serious infections ( opportunistic infections ). When they start treatment, the immune system becomes stronger and the body begins to fight infection.
Symptoms of infection and inflammation may develop, caused by:
- that old, hidden infections flare up again when the body fights them
- that the immune system accidentally attacks healthy tissue ( autoimmune diseases ).
The symptoms of autoimmune diseases can develop several months after you start taking medicines for your HIV infection.
The symptoms can be:
- muscle weakness and/or muscle pain
- joint pain or joint swelling
- weakness that begins in the hands and feet and moves upwards towards the torso
- palpitations or tremors _ _ _ _ _ _
- excessive restlessness and excessive movements ( hyperactivity ).
If you get symptoms of an infection or inflammation, or if you notice any of the symptoms mentioned above:
Tell your doctor immediately. Do not take other medicines for infection without talking to a doctor.
Very common side effects (may affect more than 1 in 10 people ):
- nausea
- diarrhea
- vomiting
- abdominal pain ( abdominal pain )
- headache
- rash.
- Talk to your doctor if you get any side effects.
Common side effects (may affect up to 1 in 10 people ):
- indigestion ( dyspepsia )
- lack of energy
- cardiac arrhythmia is seen on ECG ( prolonged QT interval )
- muscle aches ( myalgia )
- drowsiness ( somnolence )
- dizziness
- altered sense of taste ( dysgeusia )
- intestinal gases
- difficulty sleeping ( insomnia )
- itching ( pruritus ).
- Talk to your doctor if you get any side effects.
Some side effects may only be seen in blood tests and may not occur immediately after you start taking Rukobia.
Common side effects that can show up in blood tests are:
- the increased amount of enzymes produced in the muscles (creatine phosphokinase, a sign of muscle damage)
- elevated creatinine, an indicator of how well the kidneys are working
- the increased amount of enzymes produced in the liver (increased transaminases, a sign of liver damage).
Other side effects that can show up in blood tests are:
Other side effects have occurred in some people but it is not known how common they are:
- the increased amount of bilirubin (a substance produced by the liver) in the blood
Joint pain, stiffness, and skeletal problems
Some people who take combination drugs for HIV suffer from a condition called osteonecrosis. Osteonecrosis means that parts of the skeletal tissue die because the blood supply to the skeleton decreases.
The risk of suffering from this increases in people who:
- treated for a long time with combination drugs
- also, take anti-inflammatory drugs in the form of corticosteroids
- drinking alcohol
- has a very weak immune system
- are overweight.
Signs of osteonecrosis are:
- stiffness in the joints
- aches and pains (especially in hips, knees, or shoulders)
- difficulty moving.
If you get any of these symptoms:
- Tell your doctor.
How to store Rukobia
Keep out of sight and reach of children.
Do not take Rukobia after the expiry date which is stated on the carton and jar after “EXP”.
No special storage instructions.
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.
Contents of the packaging and other information
Content declaration
- The active substance is fostemsavir. One tablet contains fostemsavir tromethamine equivalent to 600 mg fostemsavir.
- The other ingredients are hydroxypropylcellulose, hypromellose, colloidal anhydrous silica, magnesium stearate, poly (vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide, red iron oxide (E172).
What the medicine looks like and the contents of the pack
Rukobia 600 mg prolonged-release tablets are beige, oval, biconvex tablets, approximately 19 mm long, 10 mm wide, and 8 mm thick, film-coated, and marked with the code “SV 1V7” on one side.
Each pack consists of one or three cans containing 60 prolonged-release tablets each.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
ViiV Healthcare BV
Van Asch van Wijckstraat 55H
3811 LP Amersfoort
Netherlands
Manufacturer
GlaxoSmithKline Manufacturing SPA
Strada Provinciale Atlanta, 90
San Polo di Torrile
Parma, 43056
Italy
For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:
| Belgium / Belgique / BelgienViiV Healthcare srl / bvTel: + 32 (0) 10 85 65 00 | LithuaniaViiV Healthcare BVTel: + 370 80000334 |
| BulgariaViiV Healthcare BVTel: + 359 80018205 | Luxembourg / LuxemburgViiV Healthcare srl / bvBelgium / BelgiumTel: + 32 (0) 10 85 65 00 |
| Czech RepublicGlaxoSmithKline, sroTel: + 420 222 001 111cz.info@gsk.com | HungaryHealthcare BVTel .: + 36 80088309 |
| DenmarkGlaxoSmithKline Pharma A / STel: + 45 36 35 91 00dk-info@gsk.com | MaltaHealthcare BVTel: + 356 80065004 |
| GermanyViiV Healthcare GmbHTel .: + 49 (0) 89 203 0038-10 viiv.med.info@viivhealthcare.com | The NetherlandsViiV Healthcare BV Tel: + 31 (0) 33 2081199 |
| EestiViiV Healthcare BVTel: + 372 8002640estonia@gsk.com | NorwayGlaxoSmithKline ASTel: + 47 22 70 20 00 |
| GreeceGlaxoSmithKline Aονοπρόσωπη AEBE:Ηλ: + 30 210 68 82 100 | AustriaGlaxoSmithKline Pharma GmbHTel: + 43 (0) 1 97075 0at.info@gsk.com |
| SpainLaboratorios ViiV Healthcare, SL Tel: + 34 900 923 501es-ci@viivhealthcare.com | PolandGSK Services Sp. z ooTel .: + 48 (0) 22 576 9000 |
| FranceViiV Healthcare SASTel .: + 33 (0) 1 39 17 69 69 Infomed@viivhealthcare.com | PortugalVIIVHIV HEALTHCARE, UNIPESSOAL, LDATel: + 351 21 094 08 01 viiv.fi.pt@viivhealthcare.com |
| CroatiaViiV Healthcare BVTel: + 385 800787089 | RomaniaViiV Healthcare BVTel: + 40800672524 |
| IrelandGlaxoSmithKline (Ireland) LimitedTel: + 353 (0) 1 4955000 | SloveniaViiV Healthcare BVTel: + 386 80688869 |
| IcelandVistor hf.Phone: +354 535 7000 | Slovak RepublicViiV Healthcare BVTel: + 421 800500589 |
| ItalyViiV Healthcare Srl Tel: + 39 (0) 45 7741600 | Finland / FinlandGlaxoSmithKline OyPuh / Tel: + 358 (0) 10 30 30 30Finland.tuoteinfo@gsk.com |
| ΚύπροςViiV Healthcare BV:Ηλ: + 357 80070017 | SwedenGlaxoSmithKline ABTel: + 46 (0) 8 638 93 00info.produkt@gsk.com |
| LatviaViiV Healthcare BVTel: + 371 80205045 | United Kingdom(Northern Ireland)ViiV Healthcare BVTel: + 44 (0) 800 221441customercontactuk@gsk.com |