Patient Medication Information: uses, side effects, how to take - Rukobia
What is RUKOBIA used for?
- RUKOBIA is used to treat HIV (human immunodeficiency virus) infection in adults who have had difficulty in controlling their HIV with many other antiretroviral medicines.
- It is used in patients who have HIV that is resistant to many antiretroviral medicines.
- RUKOBIA is used in combination with other antiretroviral medicines.
How does RUKOBIA work?
RUKOBIA belongs to a group of anti-retroviral medicines called attachment inhibitors (AIs). It works by binding to the virus and then blocking HIV from attaching to and infecting your blood cells.
RUKOBIA helps to reduce the amount of virus in your body and keep it at a low level. This helps maintain the number of CD4+ cell count in your blood. CD4+ cells are a type of white blood cells that are important in helping your body to fight infection. RUKOBIA does not cure HIV infection.
What are the ingredients in RUKOBIA?
Medicinal ingredients: 600 mg fostemsavir (as fostemsavir tromethamine).
Non-medicinal ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide.
RUKOBIA comes in the following dosage forms:
As an extended-release tablet containing 600 mg fostemsavir.
Do not use RUKOBIA if:
- You are allergic to fostemsavir or to any ingredient in RUKOBIA (listed above).
You are taking any of these medicines:
- carbamazepine, or phenytoin, known as anticonvulsants used to treat epilepsy and prevent seizures.
- rifampin used to treat some bacterial infections such as tuberculosis.
- mitotane used to treat several types of cancer.
- enzalutamide used to treat prostate cancer.
- products that contain St John’s wort (Hypericum perforatum) which is a herbal product used to treat depression.
These medicines are not recommended with RUKOBIA:
- elbasvir/grazoprevir used to treat hepatitis C infection.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take RUKOBIA. Talk about any health conditions or problems you may have, including if you:
- Have or have had a heart problem, including a heart rhythm problem called QTc prolongation (irregular heartbeat).
- Have or have had liver problems including hepatitis B or C infection. Your healthcare professional may need to do tests to check your liver enzymes before and during treatment with RUKOBIA.
Other warnings you should know about:
Pregnancy:
Tell your healthcare professional if you are pregnant or planning to become pregnant. You should not take RUKOBIA if you are pregnant or planning on becoming pregnant. It is not known if RUKOBIA can harm your unborn baby. Tell your healthcare professional if you become pregnant while you are taking RUKOBIA.
Pregnancy Registry:
There is a pregnancy registry for women who take antiretroviral medicines while they are pregnant. The purpose of this registry is to collect information about the health of you and your baby. If you do become pregnant while taking RUKOBIA, talk to your healthcare professional about taking part in this registry.
Breastfeeding:
You should not breastfeed if you are taking RUKOBIA. This is because RUKOBIA may pass into breast milk. You should also not breastfeed a baby if you are infected with HIV. This is because you can pass HIV to your baby. If you breastfeed a baby they can get HIV from you.
Immune Reconstitution Inflammatory Syndrome (disorder involving changes to your immune system) and Autoimmune Disorders:
Changes in your immune system can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Autoimmune disorders (when the immune system attacks healthy body tissue) may also occur after you start taking medicines for HIV infection. Examples of this include: Grave's disease (which affects the thyroid gland), Guillain-Barré syndrome (which affects the nervous system), or polymyositis (which affects the muscles). Autoimmune disorders may occur many months after the start of treatment. See “Serious side effects and what to do about them”.
QTc prolongation (Heart rhythm problem):
RUKOBIA may cause a heart rhythm problem called QTc prolongation. QTc prolongation causes an irregular heartbeat. If you are elderly, you may be at a greater risk for developing this heart problem with RUKOBIA. See “Serious side effects and what to do about them”.
Changes in liver function:
Tell your healthcare professional if you have hepatitis B or C infection. You are more likely to have negative changes to liver function test results while you are taking RUKOBIA. Your healthcare professional will check your liver enzymes before and during your treatment with RUKOBIA. If you stop your hepatitis B treatment your hepatitis B infection may become active again. Always take all hepatitis B or C medicines prescribed to you while you are receiving RUKOBIA. See “Serious side effects and what to do about them”.
Other complications:
Patients receiving RUKOBIA may develop complications of HIV, including infection. While taking RUKOBIA, you should remain under the close supervision of a healthcare professional who is experienced in the treatment of HIV.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with RUKOBIA:
- Medicines used to treat heart conditions such as amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine, or sotalol.
- Medicines known as statins such as rosuvastatin, atorvastatin, pitavastatin, simvastatin or Fluvastatin, used to lower cholesterol levels.
- Ethinyl estradiol, used for birth control or hormone replacement therapy.
How to take RUKOBIA:
- Always take RUKOBIA exactly as your healthcare professional has told you to.
- Swallow RUKOBIA tablets whole.
Take with or without food.
- Do not break, crush or chew RUKOBIA tablets before swallowing.
- RUKOBIA tablets may have a slight odor like vinegar. This is normal.
- Check with your healthcare professional if you're not sure how to take RUKOBIA.
Usual dose:
The usual dose of RUKOBIA is one tablet taken twice a day.
Overdose:
| If you think you, or a person you are caring for, have taken too much RUKOBIA, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
|---|
Missed Dose:
If you miss a dose, take RUKOBIA as soon as you remember. Never take a double dose to make up for a missed dose.
What are possible side effects from using RUKOBIA?
These are not all the possible side effects you may have when taking RUKOBIA. If you experience any side effects not listed here, tell your healthcare professional.
Side effects of RUKOBIA include:
- nausea
- diarrhea
- headache
- rash
- dizziness
- abdominal pain
- vomiting
- feeling sleepy
- feeling weak
- tingling, numbness, weakness in hands and/or feet
- indigestion
- lack of energy
- difficulty sleeping
- muscle ache or pain
- itching
- taste disturbance
- changes in laboratory results that could mean muscle injury
- changes in laboratory results that could mean kidney injury
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| COMMON | |||
| Immune Reconstitution Inflammatory Syndrome and Autoimmune Disorders: fever, redness, rash or swelling, fatigue, joint or muscle pain, numbness or weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, chest pain or rapid heart rate, yellowing of the eyes and skin. | X | ||
| FREQUENCY NOT KNOWN | |||
| QTc prolongation (Heart rhythm problems): dizziness, feeling lightheaded, changes in heartbeat, fainting (loss of consciousness). | X | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|---|---|
| Only if severe | In all cases | |
| Changes in liver function: yellowing of the skin and the whites of the eyes, dark or tea coloured urine, pale coloured stools/ bowel movements, nausea, vomiting, loss of appetite, pain, aching or tenderness on right side below the rib, bilirubin increase (substance produced by liver), increase of liver enzymes (transaminases). | ||
| X | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Store RUKOBIA at 15 °C to 25 °C.
Keep out of reach and sight of children.
If you want more information about RUKOBIA:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.viivhealthcare.ca, or by calling 1-877-393-8448.
Last Revised MAR 27, 2024
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