Rukobia is a brand-name extended-release oral tablet. It’s prescribed for HIV in certain situations. Rukobia contains the active ingredient fostemsavir and belongs to the antiretroviral drug class.
Drug details
You’ll find key information about Rukobia below.
- Drug class: HIV-1 gp120-directed attachment inhibitor, which is a type of antiretroviral drug
- Drug form: extended-release* oral tablet
- Generic available? no
- Prescription required? yes
- Controlled substance? no
- Year of FDA approval: 2020
* “Extended release” means the drug is slowly released into your body over a long period of time.
Rukobia is available only as a brand-name medication. It’s not currently available in generic form.
A generic drug is an exact copy of the active ingredient in a brand-name medication. Generics usually cost less than brand-name drugs.
The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.
Drug form and strength
Rukobia comes as an extended-release (ER) oral tablet. (“ER” means the drug is slowly released into your body over a long period of time.) It’s available in one strength of 600 milligrams (mg).
Dosage for HIV
Rukobia is prescribed to treat HIV in certain adults. It’s taken in combination with other antiretroviral drugs for HIV. For details, see the “Rukobia uses” section.
The typical dosage of Rukobia is 1 tablet (600 mg) taken twice per day.
About taking Rukobia
Below you’ll find information about key dosage issues.
- When to take: You should take Rukobia twice daily, around the same time each day. Doing so helps keep a steady level of the drug in your body so that Rukobia works effectively.
- If you miss a dose: It’s important that you don’t miss a dose of Rukobia. A missed dose can allow HIV to become resistant to the drug, which means Rukobia may be less effective. If you do miss a dose, take it as soon as you remember. However, if it’s almost time for your next dose, skip your missed dose and take your next dose at its usual time. If you aren’t sure whether to take your missed dose or skip it, talk with your doctor or pharmacist.
- Taking Rukobia with food: You can take Rukobia with food or without it.
- Crushing, splitting, or chewing Rukobia: You’ll swallow Rukobia tablets whole. The tablets should not be crushed, split, or chewed. If you have trouble swallowing tablets, talk with your doctor or pharmacist. You can also refer to this article for tips.
- Length of use: Rukobia is meant to be used as a long-term treatment. If you and your doctor determine that Rukobia is safe and effective for you, you’ll likely take it long term.
- Length of time to work: Rukobia starts working right after you take your first dose of the drug. Doctors use HIV tests to help monitor how well the drug is working. In clinical trials, most people had an undetectable amount of HIV in their blood after 24 weeks of Rukobia treatment.
Overdose
Do not take more Rukobia than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.
What to do in case you take too much Rukobia
If you think you’ve taken too much of this drug, call your doctor. You can also call America’s Poison Centers at 800-222-1222 or use its online tool. However, if your symptoms are severe, call 911 or your local emergency number or go to the nearest emergency room right away.
Rukobia can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Rukobia. These lists do not include all possible side effects.
For more information about the possible side effects of Rukobia, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.
Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Rukobia, you can do so through MedWatch.
Mild side effects
Below is a partial list of mild side effects of Rukobia. To learn about other mild side effects, talk with your doctor or pharmacist or view Rukobia’s prescribing information.
Mild side effects of Rukobia can include:
- abdominal pain
- fatigue
- diarrhea
- headache
- indigestion
- nausea or vomiting
- skin rash
- sleep changes such as insomnia, sleepiness, and abnormal dreams
Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.
Serious side effects
Serious side effects from Rukobia aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or you think you’re having a medical emergency.
Serious side effects and their symptoms can include:
- immune reconstitution syndrome (a condition that can develop if your immune system becomes overactive), which may lead to infection and can cause symptoms such as:
- fatigue
- fever or chills
- swollen lymph nodes
- long QT syndrome (a type of irregular heart rhythm), which may include symptoms such as:
- fainting
- gasping during sleep
- heart palpitations
- changes in liver function tests, which may be a sign of liver damage and can cause symptoms such as:
- abdominal pain
- dark urine
- jaundice
ALLERGIC REACTIONFor some people, Rukobia can cause an allergic reaction. But this side effect wasn’t reported in the drug’s clinical trials.
In general, symptoms of allergic reaction can be mild or serious.
Ways to manage
For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.
For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Rukobia, your doctor may recommend taking a different medication instead.
The Food and Drug Administration (FDA) approves prescription drugs such as Rukobia to treat certain conditions.
Rukobia for HIV
Rukobia is approved to treat HIV-1 (the most common type of HIV) in certain adults.
Specifically, Rukobia can be prescribed for adults who meet all of the following criteria:
- They have taken several HIV medications in the past.
- They have HIV that is resistant (no longer sensitive) to several HIV medications.
- They are currently taking HIV medications that are not managing the virus because the medications have stopped working, because they cause intolerable side effects, or for other reasons.
For this purpose, Rukobia is prescribed with other antiretroviral drugs for HIV. Examples of other drugs that may be used with Rukobia include dolutegravir (Tivicay, Tivicay PD) and darunavir (Prezista).
You can learn more about HIV by visiting our HIV hub.
Rukobia and children
Rukobia is not FDA approved for use in children. It is not known for sure whether the drug is safe or effective for children.
Rukobia can interact with several other medications and certain supplements. The drug is not known to interact with any foods.
Before taking Rukobia, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you take. Sharing this information can help you avoid potential interactions.
Interactions with medications and supplements
Below is a list of medications and supplements that can interact with Rukobia. This list does not contain all drugs that may interact with Rukobia. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.
Medications that can interact with Rukobia | • birth control pills, such as ethinyl estradiol/levonorgestrel (Seasonale, Seasonique, others) and drospirenone/ethinyl estradiol (Kariva, Yaz, others) • statins, such as rosuvastatin (Crestor) and simvastatin (FloLipid, Zocor) • certain antiseizure drugs, such as phenytoin (Dilantin, Phenytek) and carbamazepine (Carbatrol, Equetro, others) • certain hepatitis C drugs, such as sofosbuvir/velpatasvir/voxilaprevir (Vosevi) and elbasvir/grazoprevir (Zepatier) • enzalutamide (Xtandi) • mitotane (Lysodren) • rifampin (Rifadin, Rimactane) |
---|---|
Supplements that can interact with Rukobia | St. John’s wort |
Alcohol interaction
Alcohol is not known to interact with Rukobia. However, your doctor may advise you to limit alcohol consumption while taking the drug.
This is because consuming large amounts of alcohol over a long period of time can lead to liver damage. And Rukobia may cause changes in liver function tests, which could be a sign of liver damage. Drinking large amounts of alcohol while taking the drug could increase this risk.
If you have questions about how much alcohol is safe to drink while taking Rukobia, talk with your doctor or pharmacist.
As with all medications, the cost of Rukobia can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.
Drug coupons: You can visit Optum Perks for price estimates of Rukobia. These estimates are based on the use of Optum Perks coupons. (Note: Optum Perks coupons cannot be used with any insurance copays or benefits.)
Financial and insurance assistance: If you need financial support to pay for Rukobia or if you need help understanding your insurance coverage, help is available.
A savings program called ViiV Connect is available for Rukobia. For more information and to find out whether you’re eligible for support, call 844-588-3288 or visit the program website. To learn more about the Rukobia copay card, visit this website.
To learn more about saving money on prescriptions, check out this article.
Generic version: Rukobia is not available in a generic form. A generic drug is an exact copy of the active ingredient in a brand-name medication. Generics tend to cost less than brand-name drugs.
If you can become pregnant, consider the following information about pregnancy and breastfeeding.
Rukobia and pregnancy
It’s not known whether Rukobia should be taken during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before taking this medication.
If you take Rukobia during pregnancy, consider enrolling in the drug’s pregnancy registry. This registry collects information about Rukobia’s safety when taken during pregnancy. You can learn more at the pregnancy registry website or by calling 800-258-4263.
Rukobia and breastfeeding
It may not be safe to take Rukobia while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before taking this medication. Your doctor may recommend other ways to feed a child.
Rukobia is prescribed to treat HIV in certain adults. (For details, see the “Rukobia uses” section.) HIV is a virus that attacks cells in the immune system and weakens the body’s ability to fight infections.
The goal of HIV treatment is to reduce the viral load (amount of HIV in the blood) to a level that is undetectable on HIV tests. Having a low viral load can help protect the immune system and prevent HIV transmission to others.
Rukobia is a type of antiretroviral drug. Its mechanism of action (how it works) is to attach to a protein on HIV that the virus uses to enter immune system cells. By blocking this protein, Rukobia helps prevent HIV from entering new cells and helps stop the virus from spreading in the body.
To learn more about how Rukobia works, talk with your doctor or pharmacist.
This drug comes with several precautions.
Before taking Rukobia, discuss your health history with your doctor. Rukobia may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:
- certain heart problems, such as long QT syndrome
- hepatitis B virus or hepatitis C virus
- previous allergic reaction to this or a similar drug
- pregnancy
- breastfeeding
Note: For more information about the potential negative effects of Rukobia, see the “Rukobia side effects” section.
Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.