Cobicistat

Cobicistat is a prescription medication used to increase the effectiveness of drugs that treat human immunodeficiency virus (HIV) infection.

Cobicistat belongs to a group of drugs called enzyme inhibitors. These work by stopping the body’s natural enzymes that metabolize drugs. Therefore, drugs that are metabolized by these enzymes are able to stay in the body for a longer period of time and have a greater effect.

This medication comes in tablet form and is taken once a day, with food.

Common side effects of cobicistat include yellowing of the skin or eyes and nausea.

Cobicistat is a prescription medication used to increase the effectiveness of drugs that treat human immunodeficiency virus (HIV) infection.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Cobicistat may be found in some form under the following brand names:

• Tybost

Serious side effects have been reported with cobicistat. See the “Cobicistat Precautions” section.

Common side effects of cobicistat include the following:

• yellowing of the skin or eyes
• nausea

This is not a complete list of cobicistat side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• hormone-based contraceptives (birth control pills or other hormone-based contraceptives not taken by mouth, such as patches or rings)
• medicines for indigestion, heartburn, or ulcers
• medicines to treat depression
• medicines to treat cancer
• medicines to prevent organ transplant rejection
• medicines to treat high blood pressure
• medicines that treat erectile dystfunction, including avanafil (Stendra), sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra, Staxyn)
• medicines used to treat pain and addiction to narcotic pain medicines
• medicines used to treat seizures
• more than 1 HIV-1 protease inhibitor or an HIV-1 protease inhibitor and elvitegravir (Vitekta)
• protease inhibitor medicines, other than atazanavir (Reyataz) or darunavir (Prezista)
• other medicines that contain cobicistat (Stribild)
• amiodarone (Cordarone, Pacerone)
• atorvastatin (Lipitor, Caduet)
• boceprevir (Victrelis)
• bosentan (Tracleear)
• budesonide (Entocort, Pulmicort Flexhaler, Pulmicort Respules, Rhinocort, Symbicort, Uceris)
• buspirone
• clarithromycin (Biaxin, Prevpac)
• colchicine (Colcrys)
• dexamethasone
• diazepam (Valium)
• digoxin (Lanoxin)
• disopyramide (Norpace)
• erythromycin (Benzamycin)
• efavirenz (Atripla, Sustiva)
• etravirine (Intelence)
• flecainide (Tambocor)
• fluticasone (FLovent, Flonase, Flovent Diskus, Flovent HFA, Veramyst)
• itraconazole (Sporanox)
• ketoconazole (Nizoral)
• maraviroc (Selzentry)
• mexiletine
• nevirapine (Viramune, Viramine XR)
• a medicine that contains perphenazine
• propafenone (Rythmol)
• quinidine (Neudexta)
• rifabutin (Mycobutin)
• risperidone (Risperdal, Rsiperdal Consta)
• ritonavir (Norvir) or medicines that contain ritonavir such as lopinavir/ritonavir (Kaletra)
• rivaroxaban (Xarelto)
• rosuvastatin (Crestor)
• salmeterol (Serevent, Advair Diskus, Advair HFA)
• simeprevir (Olysio)
• tadalafil (Adcirca), for the treatment of pulmonary arterial hypertension
• telithromycin (Ketek)
• telaprevir (Incivek)
• thioridazine
• timolol
• voriconazole (Vfend)
• warfarin (Coumadin, Jantoven)

This is not a complete list of cobicistat drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with cobicistat including the following:

• Renal impairment. Renal function should be assessed before and during treatment with cobicistat, and patients who experience changes in renal function should be monitored closely.

Do not take cobicistat if you:

• are allergic to cobicistat or to any of its ingredients
• take the following drugs:
  • alfuzosin (Uroxatral)
  • dronedarone (Multaq)
  • rifampin (Rifadin)
  • irinotecan (Camptosar)
  • ergot derivatives: dihydroergotamine (Migranal), ergotamine, and methylergonovine (Methergine)
  • cisapride (not available in the United States)
  • St. John’s wort
  • lovastatin (Altoprev, Mevacor)
  • simvastatin (Zocor)
  • pimozide (Orap)
  • nevirapine (Viramune)
  • sildenafil (as Revatio for the treatment of pulmonary hypertension)
  • indinavir (Crixivan)
  • triazolam (Halcion)
  • orally administered midazolam (Versed)

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of cobicistat, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking cobicistat, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to cobicistat or to any of its ingredients
• have kidney problems
• have liver problems
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X – are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Cobicistat falls into category B. There are no well-done studies that have been done in humans with cobicistat. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if cobicistat crosses into human milk. The Centers for Disease Control and Prevention recommend that HIV-infected mothers not breastfeed their infants, to avoid risking postnatal transmission of HIV. Because of both the potential for HIV transmission and the potential for serious adverse reactions in nursing infants, HIV-infected mothers should not breastfeed.

Take cobicistat exactly as prescribed.

This medication comes in tablet form and is taken once a day, with food.

If you miss a dose of cobicistat with atazanavir or cobicistat with darunavir and you remember within 12 hours, take the missed dose of cobicistat with atazanavir or darunavir right away. The next dose of cobicistat with atazanavir or darunavir should be taken together as usual. If you miss a dose of cobicistat with atazanavir or cobicistat with darunavir and it has been more than 12 hours, wait and take the next dose at the usual time. If a dose of cobicistat with atazanavir or darunavir is skipped, do not double the next dose of cobicistat with atazanavir or darunavir.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The recommended dose cobicistat is 150 mg orally once daily. Cobicistat should always be administered at the same time as atazanavir or darunavir or another anti-retroviral agent for the treatment of human immunodeficiency virus.

If you take too much cobicistat, call your healthcare provider or local Poison Control Center or seek emergency medical attention right away.

If cobicistat is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store cobicistat at room temperature in the original container.
• Keep container tightly closed.
• Keep this and all medicines out of the reach of children.