Drug Database: Fostemsavir

What is fostemsavir?What is fostemsavir?

What is fostemsavir?

Fostemsavir (brand name: Rukobia) is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV in adults for whom other HIV medicines have not worked and who meet certain requirements, as determined by a health care provider. Fostemsavir is always used in combination with other HIV medicines.

For more information on the use of fostemsavir in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents With HIV.

HIV medicines cannot cure HIV, but using HIV medicines as directed by a health care provider helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission. If you are using HIV medicines, do not cut down on, skip, or stop using them unless your health care provider tells you to. For more information about using your HIV medicines as prescribed and ways to overcome barriers to medication adherence, please read the HIVinfo fact sheet on HIV Treatment Adherence.

What should I tell my health care provider before taking fostemsavir?What should I tell my health care provider before taking fostemsavir?

What should I tell my health care provider before taking fostemsavir?

Before taking fostemsavir, tell your health care provider:

• If you are allergic to fostemsavir or any other medicines.
• If you have ever had a heart problem, including QTc prolongation, which is a heart disorder that causes irregular heartbeats.
• If you have ever had liver problems, including hepatitis B virus infection (HBV) or hepatitis C virus infection (HCV).
• If you have any other medical conditions.
• If you are pregnant or plan to become pregnant. Talk to your health care provider about the risks and benefits of taking fostemsavir during pregnancy. For more information on the use of fostemsavir during pregnancy, please refer to the Recommendations for the Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States.
• If you are breastfeeding or plan to breastfeed. For mothers with HIV in the United States, the Guideline recommends speaking with your health care provider to discuss options for feeding your baby. Mothers with suppressed viral load have a less than 1% chance of transmitting HIV to their baby via their own milk. Although most medicines are safe to use while breastfeeding, some medicines should be avoided. Always let your health care provider know about all the medicines and supplements you are using before you start breastfeeding.
• If you are using hormone-based birth control (such as pills, injections, vaginal rings, implants, contraceptive patches, or birth control pills), especially if you are taking birth control pills that contain ethinyl estradiol. Your health care provider can help you decide how to adjust your birth control while you are taking fostemsavir. For more information about using birth control and HIV medicines at the same time, view the HIVinfo HIV and Birth Control infographic.
• About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take (particularly St. John’s wort).

How should I take fostemsavir?How should I take fostemsavir?

How should I take fostemsavir?

Fostemsavir comes as an extended-release tablet that contains 600 mg of fostemsavir.

Take fostemsavir according to your health care provider’s instructions. Do not miss a dose of fostemsavir, and do not change your dose or stop taking fostemsavir without first talking with your health care provider. While taking fostemsavir, it is important to keep all your appointments with your health care provider.

Take fostemsavir by mouth with or without food. Swallow fostemsavir tablets whole. Do not chew, crush, or split the tablets before swallowing.

Fostemsavir tablets may have a slight odor (like vinegar), which is normal.

Always take fostemsavir in combination with other HIV medicines.

If you have taken too much fostemsavir, contact your health care provider or local poison control center (1-800-222-1222 or online) right away, or go to the nearest hospital emergency room.

For more information on how to take fostemsavir, see the FDA drug label.

What should I do if I forget a dose?What should I do if I forget a dose?

What should I do if I forget a dose?

If you miss a dose of fostemsavir, take the missed dose as soon as you remember it. But if it is almost time for your next dose, skip the missed dose and just take your next dose at the regular time. Do not take two doses at the same time to make up for a missed dose.

What side effects can fostemsavir cause?What side effects can fostemsavir cause?

What side effects can fostemsavir cause?

Fostemsavir may cause side effects. Many side effects from HIV medicines, such as fostemsavir, are temporary or manageable. See the HIVinfo fact sheet on HIV Medicines and Side Effects for more information. Some side effects of fostemsavir can be serious, as described below.

• Changes in your immune system (called immune reconstitution inflammatory syndrome or IRIS). IRIS is a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. As the immune system gets stronger, it may have an increased response to a previously hidden infection.
• Heart rhythm problems. Fostemsavir may cause a heart rhythm problem called QTc prolongation. Your risk for developing this problem may be greater if you are elderly or if you take certain other medicines with fostemsavir. Contact your health care provider right away if you have any of the following symptoms: dizziness; lightheadedness; changes in your heartbeat; or fainting.
• Changes in liver function blood test results. Some people with HIV who take fostemsavir and who also have hepatitis B virus infection (HBV) or hepatitis C virus infection (HCV) may have an increased risk of developing new or worsening changes in liver function blood tests during treatment with fostemsavir. Your HBV may become active again if you stop taking HBV medicines. Your health care provider may do blood tests to check your liver function during treatment with fostemsavir, especially if you have HBV. Take any HBV or HCV medicines as prescribed by your health care provider.

Tell your health care provider if you have any side effects that bother you or that do not go away.

These are not all the possible side effects of fostemsavir. To learn more about possible side effects of fostemsavir, read the drug label or package insert or talk to your health care provider or pharmacist.

You can report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online.

What medicines can interact with fostemsavir?What medicines can interact with fostemsavir?

What medicines can interact with fostemsavir?

HIV medicines may interact with other medicines and supplements. Before starting fostemsavir, tell your health care provider about all the prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products (including St. John's wort) you are taking or plan to take. Taking fostemsavir together with certain medicines or products may cause serious side effects.

For a list of medicines that may interact with fostemsavir, see the drug label or ask your health care provider or pharmacist. You can also look up potential interactions between your HIV medicines and other drugs using the HIV Drug Interaction Checker online.

How should fostemsavir be stored?How should fostemsavir be stored?

How should fostemsavir be stored?

• Store fostemsavir at room temperature, 68°F to 77°F (20°C to 25°C).
• Keep fostemsavir in the container that it came in and keep the container tightly closed.
• Do not use fostemsavir if the original seal over the container opening is broken or missing.
• Throw away fostemsavir that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
• Keep fostemsavir and all medicines out of reach of children.

Where can I find more information about fostemsavir?Where can I find more information about fostemsavir?

Where can I find more information about fostemsavir?

• For more information on the use of fostemsavir in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living With HIV.
• This Patient Version drug summary is based on the following FDA label(s): Tablet (film-coated, extended-release). The Patient Package Insert includes information for people taking fostemsavir.
• The American Hospital Formulary Service (AHFS) Patient Medication Information for fostemsavir available from MedlinePlus.
• Fostemsavir-related research studies, from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests.)
• A list of FDA-approved HIV medicines, from HIVinfo.