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Symtuza

Generic Name: Cobicistat (also known as darunavir), Emtricitabine, and Tenofovir
Drug class: antiviral combinations

What is Symtuza?

Symtuza is a combination of cobicistat, darunavir, emtricitabine, and tenofovir alafenamide. Cobicistat inhibits enzymes that are responsible for the breakdown of certain antiviral medications in your liver. Cobicistat reduces the action of enzymes in your liver that break down certain antiviral medications. Darunavir, emtricitabine, and tenofovir are antiviral medicines that stop the human immunodeficiency virus (HIV) from multiplying within your body. HIV can lead to acquired immunodeficiency (AIDS).

Symtuza, an antiviral medication, is used to treat the acquired immunodeficiency syndrome (AIDS), which can be caused by the human immunodeficiency virus (HIV). Symtuza can be used by adults and children who weigh at least 88 pounds. This medication is not a cure or treatment for HIV/AIDS.

Symtuza can be prescribed to people who have not been treated before with HIV medication. Symtuza can also be used as a replacement for other HIV medications among adults with a suppressed viral load. Your doctor will decide which medication is right for you.

Warnings

Inform your physician of all of the medications you are currently taking. Symtuza should not be combined with certain drugs. Symtuza may cause liver damage. Contact your doctor immediately if you experience upper abdominal pain, nausea, dark urine, or yellowing skin or eyes.

If you experience a severe reaction to Symtuza, stop taking it and contact your doctor immediately. This includes a fever, redness or burning in your eyes, sores on your mouth, or a rash that spreads and results in blisters and peeling. After stopping Symtuza, you may experience an increase in symptoms or a worsening of your hepatitis. You may require frequent liver function testing for several months.

Similar/related drugs

Biktarvy, Descovy, Truvada, Tenofovir, Atripla, Complera, and Epzicom

Before you take this drug

Symtuza should not be taken with certain drugs. If you use:

  • Alfuzosin;
  • Cisapride;
  • Colchicine
  • Elbasvir and grazoprevir
  • Lovastatin or simvastatin;
  • Pimozide, lurasidone;
  • Rifampin;
  • Sildenafil is used to treat pulmonary arterial hypertension.
  • John's Wort;
  • Triazolam or oral midazolam;
  • Heart medication: dronedarone, ivabradine, ranolazine;
  • Ergot medicines: dihydroergotamine, ergotamine, methylergonovine;
  • Seizure medicine: carbamazepine, phenytoin, and phenobarbital.

Tell your doctor about any of the following to ensure that Symtuza will be safe for you:

  • Hepatitis B and C (especially cirrhosis)
  • Kidney disease
  • Diabetes;
  • An allergy to sulfa medications;
  • A bleeding disorder, such as hemophilia.

You could develop lactic acidosis. This is a dangerous accumulation of lactic acids in your blood. Consult your doctor to determine your risk. Symtuza might not work as effectively if taken during pregnancy. Ask your doctor about another antiviral medication to take during pregnancy if you are planning to become pregnant. Use all medications to control your infection while pregnant in order to prevent HIV from affecting a newborn. Your name could appear on a registry of antiviral pregnant women.

Ask your doctor if you don't plan to become pregnant if you want to avoid pregnancy. When combined with hormonal birth controls (pills or injections, skin patches, implants, diaphragms, etc.), Symtuza may increase some side effects. Breastfeeding is not recommended for women with HIV. Breast milk can transmit the virus to your child.

How to take Symtuza?

Follow your doctor's instructions and take Symtuza only as directed. Read and follow all instructions on the prescription label. Take Symtuza along with your food. You can break a Symtuza tablet in half if you are unable to swallow it whole. Both halves should be taken immediately. Medical tests will be required frequently.

All HIV medications should be taken as prescribed. You should not stop taking medication or change the dose without consulting your doctor. By skipping doses, you could cause your virus to become resistant to the medication. Continue to be under the doctor's care. Store away from heat and moisture at room temperature. Keep the tablets and the moisture-absorbing preservative in the original containers. You may get hepatitis after stopping Symtuza. While using Symtuza and for several months afterwards, you may need to have liver function tests.

Details on dosage

Adult dose of Symtuza as per usual for HIV infection:

Take 1 tablet once daily, orally.
Comments:
This drug is not recommended for use during pregnancy because of the lower levels of exposure to darunavir or cobicistat in the second and third trisomies.
This drug should not begin treatment for women who are pregnant. Patients who become pregnant while on this drug's therapy should switch to an alternate regimen.
Use: As an effective treatment regimen to eradicate HIV-1 infection in patients without prior antiretroviral treatment history or with viral suppression (HIV-1 RNA less than 50 copies/ml on an effective regimen for at least 6 months without known substitutions associated with resistance to darunavir or tenofovir.

The usual pediatric dose of Symtuza to treat HIV infection is:

A minimum of 40 kg: Take 1 tablet once daily.
Comments:
This drug is not recommended for use during pregnancy because of the lower levels of exposure to darunavir or cobicistat in the second and third trisomies.
This drug should not begin treatment for women who are pregnant. Patients who become pregnant while on this drug's therapy should switch to an alternate regimen.
Use: As a complete regimen to treat HIV-1 infection in patients who have never taken antiretrovirals before or those virologically suppressed (HIV-1 RNA less than 50 copies/ml) on stable antiretroviral regimens for at least 6 months who do not harbor mutations associated with resistance to darunavir or tenofovir.

What happens if I miss the dose?

If you are almost due for your next dose, skip the missed one. Never take two doses of the same medicine at once. Refill your prescription before you run out.

What happens if I overdose?

Call 1-800-222-1222 for poison help or seek immediate medical attention.

What should be avoided?

Symtuza does not stop the spread of your illness. Share razors and toothbrushes. Consult your doctor about how to avoid HIV transmission while sexing. It is not safe to share syringes or needles for drugs or medicines.

Side effects of Symtuza

If you experience any of the following symptoms: signs or symptoms of an allergic reaction to Symtuza: (hives; difficulty breathing; swelling on your face or in your throat); or a severe reaction to the skin (fever, burning eyes, skin pain, blistering or peeling skin, or a red or purple rash).

If you experience:

  • Increased thirst leads to increased urination.
  • Kidney problems: swelling, urinating more, feeling tired, or short of breath
  • Lactic acidosis: unusual muscle pains, difficulty breathing, stomach pains, vomiting, irregular pulse rate, dizziness, or feeling cold or tired.
  • Liver disease: nausea (upper stomach pain), loss of appetite, dark-colored urine, clay-colored stools, jaundice (yellowing skin or eyes).

Symtuza may affect your immune system, even weeks or months later. Tell your doctor about:

  • Signs that a new infection is present: fever, sweating at night, swollen lymph nodes, colds, sores. Cough, wheezing. Diarrhea. Loss of weight.
  • If you have difficulty speaking or swallowing, have problems with balance, eye movements, or weakness, or feel prickly, then it could be a sign of a problem.
  • Impotence, menstrual changes, swelling of the neck or throat (enlarged thyroid)

Side effects of Symtuza include:

  • Nausea, upset stomach, diarrhea, gas;
  • Headache, feeling tired,

There may be other side effects. For medical advice on side effects, call your doctor. The FDA can be contacted at 1-800-FDA-1088 to report side effects.

Interaction with other drug

It is sometimes not safe to take certain medications at the same time. Some drugs may affect the blood levels of the drugs that you are taking, causing side effects or making them less effective.

Cobicistat (and other drugs) can have interactions with darunavir, cobicistat (and other drugs), emtricitabine, and tenofovir. Some drugs shouldn't be taken at the same time. Inform your doctor of all the medicines you take. Included are prescription and over-the-counter medicines, vitamins, and herbal products. This list does not include all possible interactions.

DRUG STATUS

Availability

Prescription only

Pregnancy & Lactation

CSA Schedule*
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