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Overview: Rukobia (fostemsavir) is used to treat resistant forms of HIV in people who have already tried many other medicines. It works by helping stop the spread of HIV in your body. The most common side effect is nausea. Do not start or stop any prescribed or over-the-counter (OTC) medicine without talking with your health care provider.

Uses

What is Rukobia used for?

Rukobia (fostemsavir) is used with other medicines to treat HIV. Rukobia is usually reserved for people with treatment-resistant HIV who have already tried many other medicines.

Rukobia may also be used for other conditions as determined by your health care provider.

How does Rukobia work (mechanism of action)?

Rukobia helps stop the spread of HIV in your body. The medicine binds to a protein on the surface of HIV. By binding to this protein, Ruxobia prevents HIV from binding to certain immune cells. Thus, HIV cannot infect these immune cells, which helps protect and preserve the immune system.

How is Rukobia supplied (dosage forms)?

Brands and other names

  • Rukobia

Dosage forms and strengths

  • 600 mg extended-release oral tablets

How should I store Rukobia?

Rukobia should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Side Effects

What are the most common side effects of Rukobia?

The most common side effect of Rukobia is nausea. Tell your health care provider if you have nausea that is severe or bothersome.

There may be other side effects of Rukobia that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Rukobia?

While less common, the most serious side effects of Rukobia are described below, along with what to do if they happen.

Severe Allergic Reactions. Rukobia may cause allergic reactions, which can be serious. Stop taking Rukobia and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Immune System Changes. When you start Rukobia, your immune system might get stronger and start fighting infections that have been hiding inside your body for a long time. The type of symptoms you may have will depend on the infection. Tell your health care provider right away if you notice any of the following new symptoms of infection.

  • Fever, sweats, chills, or muscle aches
  • Swollen lymph nodes
  • Vision problems
  • Confusion, problems talking, or headache
  • Skin problems such as a painful rash or warts
  • Cough or coughing up blood
  • Weakness or coordination problems

Heart Rhythm Changes. Rukobia may cause a rare, dangerous heart rhythm problem called QT prolongation and torsade de pointes. Some people have a higher risk of this, including people who are older, have other people in their family who have had these conditions, have low potassium or magnesium levels, or who take medicines that can prolong the QT interval. Tell your health care provider right away if you faint, get dizzy or lightheaded, or have changes in your heart rate or rhythm, such as a fast or skipping heartbeat.

Warnings & Precautions

Who should not use Rukobia?

Allergies to Ingredients. People who are allergic to any of the following should not take Rukobia.

  • Fostemsavir
  • Rukobia
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in the specific Rukobia products they stock.

Drug Interactions. Rukobia should not be taken while you are using certain other medicines. Before taking Rukobia, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.  See the Interactions section for more details.

What should I know about Rukobia before using it?

Do not take Rukobia unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Rukobia with other people, even if they have the same condition as you. It may harm them.

Rukobia tablets should be swallowed whole. Do not chew, crush, or split them.

It is normal for the Rukobia tablets to smell a little like vinegar.

Keep Rukobia out of the reach of children.

While Rukobia can help keep the HIV infection under control, it does not cure it. Rukobia does not help protect against or prevent the spread of sexually transmitted infections (STIs), like herpes, gonorrhea, or chlamydia.

What should I tell my health care provider before using Rukobia?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Rukobia is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Liver problems, including hepatitis B or C
  • Long QT syndrome, also known as QT prolongation
  • Heart disease

Pregnancy. It is not known if or how Rukobia could affect pregnancy or harm an unborn baby. Tell your health care provider if you are pregnant or plan to become pregnant. Your health care provider will advise you if you should take Rukobia while you are pregnant or trying to get pregnant. If you become pregnant while taking Rukobia, you can register for the Antiretroviral Pregnancy Registry by visiting www.apregistry.com. This registry collects safety information about the use of antiretroviral medicines during pregnancy.

Breastfeeding. It is not known if Rukobia passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will advise you if you should take Rukobia while breastfeeding. There may be risks with breastfeeding while taking Rukobia and having HIV.

How can I get more information about Rukobia?

For more information about Rukobia, you can visit the manufacturer’s website www.rukobia.com or call them at 877‑844‑8872.

Interactions

Does Rukobia interact with foods or drinks?

There are no known interactions between Rukobia and foods or drinks.

It is unknown if drinking alcohol will affect Rukobia.

Does Rukobia interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Rukobia.

  • A birth control pill that contains an estrogen
  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
  • Enzalutamide (Xtandi), which is a medicine used to treat prostate cancer
  • Carbamazepine (Carbatrol, Tegretol, and others), which is a medicine commonly used to treat seizures or nerve pain
  • Phenytoin (Dilantin, Phenytek, and others), which is a medicine to control seizures
  • Mitotane (Lysodren), which is a medicine used to treat cancer of the adrenal glands
  • St. John’s wort, which is a supplement that may be used to treat depression
  • A statin, such as atorvastatin (Lipitor and others) or rosuvastatin (Crestor), which is a medicine to lower cholesterol
  • Any medicine that can cause QT prolongation, which is a potentially dangerous heart rhythm problem

Many other medicines may alter the blood levels of Rukobia. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Rukobia. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Rukobia?

If you or someone else has used too much Rukobia, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Rukobia?

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.

Missing doses of Rukobia can cause it not to work as well over time. So it is very important not to miss or skip doses.