Product Information for the Patient

Tybost 150 mg Film-Coated Tablets

cobicistat

Read this entire product information carefully before starting to take this medicine, as it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

Tybost contains the active ingredient cobicistat.

Tybost is used to treat human immunodeficiency virus 1 (HIV-1) infection, the virus that causes acquired immunodeficiency syndrome (AIDS). It is used in adults and adolescents 12 years of age or older who are infected with HIV:

• who weigh at least 35 kg (when administered concomitantly with atazanavir 300 mg) or
• who weigh at least 40 kg (when administered concomitantly with darunavir 800 mg).

Tybost acts as abooster(potentiator) ofatazanavir or darunavir(both protease inhibitors) to help improve their effect (see section 3 of this leaflet).

Tybost does not directly treat HIV infection, but rather potentiates the levels of atazanavir and darunavirin the blood. It does this by delaying the degradation of atazanavir and darunavir, which will makethem remain in the body for a longer time.

Do not take Tybost

• If you are allergic to cobicistator any of the other ingredients in this medicine(listed in section 6 of this leaflet).

• If you are taking medicines that contain any of the following active ingredients:
• • alfuzosin,used to treat an enlarged prostate
  • amiodarone, quinidine,used to correct irregular heartbeats
  • dabigatran,used to prevent and treat blood clots
  • carbamazepine, phenobarbital, phenytoin,used to prevent seizures
  • rifampicin,used to prevent and treat tuberculosis and other infections
  • dihydroergotamine, ergometrine, ergotamine,used to treat migraines
  • St. John's Wort,Hypericum perforatum, a herbal remedy used to treatdepression and anxiety

• If you are in any of these circumstances, do not take Tybost and consult your doctor immediately.

Warnings and precautions

You must remain under your doctor's supervision while taking Tybost.

You can still transmit HIVwhile taking this medicine, although effective antiretroviral treatment reduces the risk. Consult your doctor about what precautions are necessary to avoid infecting others. This medicine is not a cure for HIV infection. You may develop infections or other diseases associated with HIV infection. You should stay in regular contact with your doctor.

Consult your doctor before starting to take Tybost:

• If you are taking another protease inhibitor.Tybost, taken with atazanavir or darunavir,should not be used with another antiviral that requires boosting.

• Consult your doctor or pharmacist if you have or have had kidney disease or if tests have shown kidney problems.Your doctor will carefully weigh whetheryou should be treated with Tybost.

• Consult your doctor or pharmacist if you have or have had severe liver disease or if tests have shown liver problems.Your doctor will carefully weigh whetheryou should be treated with Tybost.

Children and adolescents

Do not administer this medicine to childrenunder 12 years of age or weighing less than 35 kg(or 40 kg), as explained in section 3 of this leaflet. Tybost has not yet been studied in children under 12 years of age or weighing less than 35 kg.

Other medicines and Tybost

Inform your doctor or pharmacist if you are taking, have taken recently or may take any other medicine.Tybost may interact with other substances. As a result,the blood levels of Tybost or other medicines may be affected. This may prevent your medicines from working properly or worsen their possible side effects. In some cases, your doctor may need to adjust the dose or check the blood concentrations of the medicine.

There are medicines that should never be taken with Tybost.

These medicines are specified in the section “Do not take Tybost-If you are taking medicines that contain any of the following active ingredients”.

Medicines used to treat HIV infection:

You should not take Tybost with other medicines that contain:

• ritonavir
• cobicistat

Inform your doctor if you are taking:

• another protease inhibitor
• efavirenz
• etravirine
• nevirapine
• maraviroc

• Inform your doctorif you are taking any of these medicines for HIV infection.

Other types of medicines:

• ketoconazole, itraconazole, voriconazole, posaconazoleandfluconazole,medicines usedto treat fungal infections

• clarithromycin and rifabutin,medicines used to treat bacterial infections,including tuberculosis
• dasatinib, nilotinib, vinblastineandvincristine,medicines used to treat cancer
• corticosteroids,includingbetamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone. These medicines are used to treat allergies, asthma,inflammatory diseases of the intestines, eye, joint, and muscle inflammation, and other inflammatory diseases. If alternatives cannot be used, only use after a clinical evaluation and with close monitoring by your doctor to evaluate the adverse effects of corticosteroids.

• metformin,medicine used to treat type 2 diabetes
• oral or implanted hormonal contraceptivesused to prevent pregnancy
• amlodipine, digoxin, diltiazem, disopyramide, felodipine, flecainide, lidocaine, metoprolol, mexiletine, nicardipine, nifedipine, propafenone, timololandverapamil,medicines used to treat heart problems

• bosentan,a medicine used to treat pulmonary arterial hypertension
• apixaban, edoxaban, rivaroxabanandwarfarin,medicines used to prevent andtreat blood clots

• salmeterol,a medicine used to treat asthma
• atorvastatin, fluvastatin, pitavastatin, pravastatinandrosuvastatin,medicinesused to lower cholesterol
• sildenafilandvardenafil,medicines used to treat erectile dysfunction, andtadalafil, amedicine used to treat erectile dysfunction and pulmonary arterial hypertension
• trazodone,a medicine used to treat depression
• ciclosporin, sirolimusandtacrolimus,medicines used to control the body's immune response after a transplant
• buspirone, chlorazepate, diazepam, estazolam, flurazepam, perphenazine, risperidone, thioridazine, zolpidem,medicines used to treat nervous system disorders

• colchicine,a medicine used to treat gout

• Inform your doctorif you are taking any of these medicines.

• Inform your doctor if you are taking these or any other medicine.Do not stop yourtreatment without contacting your doctor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

• Inform your doctor immediately if you are pregnant, think you may be pregnant, or intend to become pregnant.Pregnant women should nottake Tybost with atazanavir or darunavir. The levels of these medicines in the blood may decrease during pregnancy, making them less effective.

• Do not breastfeed your child during treatment with Tybost.We do not know if the active ingredientof this medicine passes into breast milk. If you are an HIV-positive woman, it is recommended that you do not breastfeed to avoid passing the virus to the baby through breast milk.

Driving and operating machinery

Some patients have reported dizziness when taking Tybost with atazanavir or darunavir. If you experience dizziness while taking Tybost, do not drive or operate tools or machinery.

Tybost contains yellow-orange aluminium lake FCF (E110).

Inform your doctor if you are allergic to yellow-orange aluminium lake FCF (E110).Tybost contains yellow-orange aluminium lake FCF, which may cause allergic reactions.

Follow exactly the administration instructions for this medication as indicated by your doctor.

In case of doubt, consult your doctor or pharmacist again.

Recommended dose for adults:

• One tablet per day by mouth, with food.Do not chew, crush, or divide the tablet.
• Tybost should be taken with atazanavir (300 mg) or darunavir (800 mg).

Recommended dose for adolescents 12 years of age or less:

• One tablet per day by mouth, with food.Do not chew, crush, or divide the tablet.
• Adolescents taking Tybost with atazanavir (300 mg) must weigh at least 77 lbs.
• Adolescents taking Tybost with darunavir (800 mg) must weigh at least 88 lbs.

Take the recommended dose as prescribed by your doctor.This is to ensure that your medication is completely effective. Do not change the dose unless your doctor tells you to.

If you take more Tybost than you should

If you accidentally take more than the recommended dose of Tybost, you may be at a higher risk of experiencing adverse effects with this medication (see section 4 of this leaflet).

Consult your doctor or go to the nearest emergency service immediately. Bring the tablet container with you so that you can easily describe what you have taken.

If you forget to take Tybost

It is essential that you do not forget a dose of Tybost.

If you forget to take a dose and realize:

• Within 12 hoursafter the time you normally take Tybost, you must take the tablet as soon as possible. Take the tablet always with food. Then, take the next dose as usual, in combination with atazanavir or darunavir.

• 12 hours or moreafter the time you normally take Tybost, do not take the missed dose. Wait and take the next dose, with food, at the usual time.

Do not interrupt treatment with Tybost

Do not interrupt treatment with Tybost without first speaking with your doctor.Interrupting Tybost and atazanavir or darunavir may reduce the success of future treatments prescribed by your doctor.

Always keep enough Tybost so that you do not run out.When you see that you have littleamount of Tybost left, go to your doctor or pharmacist to get more.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. When treating HIV infection, it is not always possible to distinguish whether some unwanted effects are due to Tybost or other medicines being taken at the same time or the disease caused by HIV itself. Taking Tybost with atazanavir may cause the following side effects.

Very common side effects

(may affect more than 1 in 10 people)

• feeling sick (nausea)
• yellowing of the skin, eyes, and/or both (jaundice)

Common side effects

(may affect up to 1 in 10 people)

• high blood sugar levels (hyperglycemia)
• increased appetite, altered sense of taste, dry mouth
• headache, dizziness
• vomiting, diarrhea, stomach pain, digestive problems that cause pain after eating (indigestion), feeling bloated, gas (flatulence)
• high levels of bilirubin in the blood (hyperbilirubinemia)
• skin rash
• difficulty sleeping, abnormal dreams, drowsiness, fatigue (fatigue)

Uncommon side effects

(may affect up to 1 in 100 people)

• blood in the urine (hematuria)
• protein in the urine (proteinuria)
• sensation of depression
• itching
• muscle pain, weakness
• kidney stones
• fever
• sleep disorder

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.Also, you canreport them directly through thenational notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

For more information on the side effects of atazanavir or darunavir, consult the leaflets for these medicines.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the bottle and on the packaging after {CAD}. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Tybost

The active ingredient iscobicistat. Each film-coated tablet contains 150 mg ofcobicistat.

The other components are

Core tablet:

Sodium croscarmellose, magnesium stearate, microcrystalline cellulose, silicon dioxide.

Film coating:

Yellow-orange aluminium lake FCF (E110), macrogol 3350 (E1521), partially hydrolysed polyvinyl alcohol (E1203), talc (E553B), titanium dioxide (E171), iron oxide yellow (E172) (see section 2 of this leaflet).

Appearance of the product and contents of the pack

Tybost film-coated tablets are orange, round, biconvex, marked on one face with “GSI” and smooth on the other face of the tablet.

Tybost is presented in bottles of 30 tablets (with a sachet or tube of silica gel that must be kept in the bottle to help protect the tablets). The silica gel desiccant is in a separate sachet or tube and must not be swallowed.

This medicinal product is available in packs of 1 bottle of 30 film-coated tablets and of 90 (3 bottles of 30) film-coated tablets. Only some pack sizes may be marketed.

Marketing Authorisation Holder

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Responsible for manufacturing

Gilead Sciences Ireland UC

IDA Business & Technology Park

Carrigtohill

County Cork

Ireland

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Date of the last revision of this leaflet:{MM/AAAA}.

Further information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu