Is Fostemsavir approved by the FDA?
Yes, fostemsavir, marketed under the brand name Rukobia, is FDA approved. The U.S. Food and Drug Administration (FDA) approved Rukobia on July 2, 2020, for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection.
What is Fostemsavir?
Fostemsavir is an extended-release oral tablet that belongs to the miscellaneous antivirals drug class. It is used in combination with other antiviral drugs to treat human immunodeficiency virus (HIV), which can lead to acquired immunodeficiency syndrome (AIDS). Fostemsavir works by preventing HIV from multiplying in the body, but it is not a cure for HIV or AIDS.
Indications for Use
Fostemsavir is indicated for use in combination with other antiretroviral agents in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection who are failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.
Dosage and Administration
The usual adult dose for HIV infection is 600 mg taken orally twice a day. Fostemsavir can be taken with or without food, and the tablet should be swallowed whole without crushing, chewing, or breaking it.
Important Warnings and Precautions
Serious Side Effects:
- Fast or pounding heartbeats
- Fluttering in the chest
- Shortness of breath
- Sudden dizziness
Immune System Effects: Fostemsavir can affect the immune system and may cause side effects even weeks or months after taking it. These can include:
- Signs of a new infection such as fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss
- Trouble speaking or swallowing
- Problems with balance or eye movement
- Weakness or prickly feeling
- Swelling in the neck or throat (enlarged thyroid)
- Menstrual changes or impotence
Common Side Effects:
- Nausea
Liver Problems: Using fostemsavir can cause new or worsening liver problems, especially in patients with hepatitis B or C. Frequent liver function tests may be required while using fostemsavir and for several months after stopping the medication.
Drug Interactions
Fostemsavir can interact with many other drugs, causing dangerous effects. It is particularly important to avoid using fostemsavir with:
- Carbamazepine
- Enzalutamide
- Mitotane
- Phenytoin
- Rifampin
- St. John's wort
Additionally, fostemsavir can cause a serious heart problem, and the risk may be higher if used with certain other medications. Always inform your doctor about all other medications you are taking, including prescription and over-the-counter medicines, vitamins, and herbal products.
Conclusion
Fostemsavir (Rukobia) is an FDA-approved medication for the treatment of HIV-1 in adults with multidrug-resistant HIV-1 infection. Approved on July 2, 2020, it offers a treatment option for patients who have not responded to other HIV medications. As with any medication, it is essential to use fostemsavir under the guidance of a healthcare provider and to be aware of potential side effects and drug interactions.
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