Vocabria 200 mg Suspension

VOCABRIA injections are used to treat HIV (human immunodeficiency virus) infection in adults. VOCABRIA contains the active ingredient cabotegravir, which belongs to a group of antiretroviral medicines called integrase inhibitors (INIs). VOCABRIA does not cure HIV infection; it keeps the amount of virus in your body at a low level. This helps maintain the number of CD4+ cells in your blood. CD4+ cells are a type of white blood cells that are important in helping your body to fight infection. VOCABRIA injection is always given, in combination with another anti-retroviral medicine called rilpivirine injection to treat HIV infection. To control your HIV infection, and to stop your illness from getting worse, you must keep taking all your medicines, unless your doctor tells you to stop taking any.

You must not receive VOCABRIA injection:

• if you are allergic (hypersensitive) to cabotegravir or to any of the other ingredients of VOCABRIA (listed in section 6)
• if you are taking any of these medicines:
  • rifampicin or rifapentine (to treat some bacterial infections such as tuberculosis)
  • phenytoin, phenobarbitone, carbamazepine or oxcarbazepine (also known as anticonvulsants used to treat epilepsy and prevent seizures)

Do not have a VOCABRIA Injection with any of these medicines. Tell your doctor if you are taking any of the above medicines.

Warnings and precautions:

Take special care with VOCABRIA injection: VOCABRIA injection can cause serious side effects. You must look out for certain symptoms while you are using VOCABRIA injection.

Do not share medicines prescribed for you with any other person. Your doctor will schedule regular appointments according to the dosing schedule he will put you on. Check with your doctor if you are not sure. You are not expected to administer the injection to yourself. It will be given to you by your doctor or his nurse, in the muscle of your buttock (intramuscular injection). As VOCABRIA injection must always be given with another HIV medicine (rilpivirine), you should also read the instructions for rilpivirine injection carefully. The leaflet is supplied in the rilpivirine injection carton. You will be given VOCABRIA injection as a single injection, either once every month or once every 2 months, together with another injectable medicine called rilpivirine. Your doctor will advise you of your dosing schedule.

VOCABRIA can have side effects. Not all side effects reported for VOCABRIA are included is leaflet. Should your general health worsen or if you experience any untoward effects while taking VOCABRIA, please consult your healthcare provider for advice. When you are being treated for HIV, it can be hard to tell whether a symptom is a side effect of VOCABRIA or other medicines you are taking, or an effect of the HIV disease itself. So, it is very important to talk to your doctor about any changes in your health.

Conditions you need to look out for:

Allergic reactions: If any of the following happens, tell your doctor immediately or go to the casualty department at your nearest hospital:

• skin rash
• a high temperature (fever)
• lack of energy (fatigue)
• swelling sometimes of the face or mouth (angioedema), causing difficulty in breathing
• muscle or joint aches.

These are all very serious side effects. If you have them, you may have had a serious reaction to VOCABRIA Injection.

Keep out of reach of children. Unopened packs: Store at or below 30 ºC. Do not freeze. Open packs: Once the suspension has been drawn into the syringe, the injection should be administered as soon as possible, but may be stored for up to 2 hours at room temperature. If 2 hours are exceeded, the medication, syringe and needle must be discarded. Do not use after the expiry date on the label or carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).