Tibsovo (ivosidenib)

What is Tibsovo?

Tibsovo is a brand-name prescription drug. It’s FDA-approved to treat acute myeloid leukemia (AML) in certain situations. AML is a type of cancer that affects white blood cells.

Tibsovo is for use in adults who either:

• Are age 75 years or older and have been newly diagnosed with AML. Also, they can’t be able to undergo intensive chemotherapy due to other medical conditions.
• Have relapsed or refractory AML.*

In addition, the AML must have a gene mutation (abnormal change) called IDH1. That’s short for isocitrate dehydrogenase 1.

For more information about AML and how Tibsovo is used to treat it, see the “Tibsovo uses” section below.

* AML is relapsed if it comes back after you’ve been in remission (a period of time when you don’t have any signs of cancer). AML is refractory if your condition continues to worsen with your current treatment.

Drug details

Tibsovo contains the active drug ivosidenib. It’s in a class of drugs known as IDH1 inhibitors. (A drug class is a group of medications that work in a similar way.)

Tibsovo comes as a tablet that you swallow. Tibsovo tablets are available in one strength: 250 milligrams (mg). You’ll likely take Tibsovo once per day.

FDA approval

Tibsovo is the first drug approved by the Food and Drug Administration (FDA) to treat AML in people with an IDH1 gene mutation. Tibsovo is also the first medication in its drug class (IDH1 inhibitors).

In 2018, Tibsovo was approved by the FDA and granted orphan drug status.

Orphan drugs are researched and developed to treat rare conditions that lack effective treatment options. The FDA places a high priority on reviewing the safety and effectiveness of orphan drugs. If the FDA approves an orphan drug, the medication becomes available more quickly than usual. The orphan drug program is a way to accelerate the drug approval process, making medications accessible to those in need.

Effectiveness

For information about the effectiveness of Tibsovo, see the “Tibsovo uses” section below.

Tibsovo generic

Tibsovo 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 drug in a brand-name medication. Generics usually cost less than brand-name drugs.

Tibsovo side effects

Tibsovo can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Tibsovo. These lists do not include all possible side effects.

For more information about the possible side effects of Tibsovo, talk with your doctor or pharmacist. They can give you tips on how to deal with 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 Tibsovo, you can do so through MedWatch.

Mild side effects

Mild side effects* of Tibsovo can include:

• fatigue† (lack of energy)
• joint pain
• diarrhea
• edema (swelling caused by fluid collection, usually in the lower legs)
• nausea
• shortness of breath
• mouth sores
• rash
• cough
• decreased appetite
• muscle pain
• constipation
• fever
• mild changes in lab tests, including:
  • increased levels of white blood cells
  • decreased levels of hemoglobin (a protein in red blood cells that carry oxygen)
  • decreased levels of electrolytes
  • changes in liver or kidney function tests

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Tibsovo. To learn about other mild side effects, talk with your doctor or pharmacist, or view Tibsovo’s medication guide.
† For more information about this side effect, see “Side effect details” below.

Serious side effects

Serious side effects from Tibsovo 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:

• Severe changes in lab tests, including:*
  • increased levels of white blood cells
  • decreased levels of hemoglobin (a protein in red blood cells that carry oxygen)
  • decreased levels of electrolytes
  • changes in liver or kidney function tests
• Guillain-Barré syndrome (a disease that affects your nervous system). Symptoms can include:
  • weakness or a prickling or burning sensation in your legs, arms, or upper body
  • pain and numbness on one or both sides of your body
  • changes in your sense of taste, touch, vision, or hearing
  • trouble breathing
• Changes in heart rhythm.†
• Differentiation syndrome (a serious condition that affects your blood cells).†‡
• Allergic reaction.†

* Symptoms may vary depending on what’s being measured. To learn more, talk with your doctor.
† For more information about this side effect, see “Side effect details” below.
‡ Tibsovo has a boxed warning for this side effect. This is the most serious warning from the Food and Drug Administration (FDA).

Side effect details

Here’s some detail on certain side effects this drug may cause.

Changes in heart rhythm

Tibsovo may cause a serious change in heart rhythm called QT prolongation in some people. QT prolongation is a type of abnormal heart rhythm. This side effect was seen in clinical studies of the drug.

Your risk for developing QT prolongation may be higher if you either:

• already have a heart condition such as congestive heart failure
• are taking certain medications that interact* with Tibsovo

Symptoms of QT prolongation can include dizziness, lightheadedness, and fainting. If you experience these symptoms while using Tibsovo, talk with your doctor right away. They may want to perform tests to check your heart rhythm. If your results show heart rhythm changes, your doctor may have you stop taking Tibsovo.

If you have questions or concerns about this side effect, talk with your doctor.

*For more information about drug interactions with Tibsovo, see the “Tibsovo interactions” section below.

Fatigue

In a clinical study, fatigue (lack of energy) was one of the most common side effects that occurred in people taking Tibsovo.

In some people, fatigue may occur even if they get adequate sleep. But this side effect may ease or go away after a few weeks of taking Tibsovo. To find out more about how often this side effect occurred in clinical trials, see the drug’s prescribing information.

Fatigue is commonly described as feeling physically or mentally exhausted. If you feel this way after starting Tibsovo treatment, the following tips may help:

• Be sure to get adequate sleep. Aim for 7 to 8 hours each night.
• Try to exercise regularly, such as going for a daily walk.
• Listen to your body and rest or nap when needed.
• Make sure to drink plenty of water.
• Don’t overload your schedule or set unrealistic expectations for your day.

If you develop fatigue that’s concerning to you, talk with your doctor. They may be able to suggest treatments to help.

Differentiation syndrome

Treatment with Tibsovo can increase your risk for differentiation syndrome (DS). This is a serious condition that affects your blood cells. In fact, Tibsovo has a boxed warning for DS. Boxed warnings are the most serious type of FDA warnings. They alert doctors and patients about drug effects that may be dangerous.

DS is a common* side effect that can occur within 1 day or up to 3 months after starting Tibsovo treatment. If DS isn’t treated, it can lead to organ failure or, in some cases, death. It’s important to get immediate medical care if you develop symptoms such as:

• fever
• trouble breathing or cough
• rash
• unexplained weight gain that occurs quickly, such as over a few days or a week
• swelling in your arms, hands, legs, or feet
• feeling lightheaded

If you develop DS, you may receive medications such as hydroxyurea (Hydrea, Droxia) or a corticosteroid, such as dexamethasone (Decadron). Depending on your condition, your doctor may have you stay in the hospital for monitoring until your symptoms improve. They may also have you stop taking Tibsovo.

If you have questions or concerns about DS, talk with your doctor.

* To find out more details about how often this side effect occurred in clinical trials, see the drug’s prescribing information.

Allergic reaction

In a clinical study, no allergic reactions were reported in people who took Tibsovo. But as with most drugs, it’s possible for some people to have an allergic reaction after taking Tibsovo.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing (warmth or redness/deepening of skin color for a brief time)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your tongue, mouth, or throat
• trouble breathing

Call your doctor right away if you have an allergic reaction to Tibsovo, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Tibsovo cost

As with all medications, the cost of Tibsovo can vary.

The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Keep in mind that you may be able to get a 90-day supply of Tibsovo. If approved by your insurance company, getting a 90-day supply of the drug could reduce your number of trips to the pharmacy and help lower the cost. If you’re interested in this option, check with your doctor or your insurance company.

It’s important to note that you’ll have to get Tibsovo at a specialty pharmacy. This type of pharmacy is authorized to carry specialty medications. These are drugs that may be expensive or may require help from healthcare professionals to be used safely and effectively.

Before approving coverage for Tibsovo, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure whether you’ll need to get prior authorization for Tibsovo, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Tibsovo, or if you need help understanding your insurance coverage, help is available.

Agios Pharmaceuticals, Inc., the manufacturer of Tibsovo, offers myAgios Patient Support Services. These services can help determine if a financial assistance program can aid you. For more information and to find out if you’re eligible, call 844-409-1141 or visit the website.

Mail-order pharmacies

Tibsovo may be available through a mail-order pharmacy. Using this service may help lower the drug’s cost and allow you to get your medication without leaving home.

If recommended by your doctor, you may be able to receive a 90-day supply of Tibsovo, so there’s less concern about running out of the medication. If you’re interested in this option, check with your doctor and your insurance company. Some Medicare plans may help cover the cost of mail-order medications.

If you don’t have insurance, you can ask your doctor or pharmacist about online pharmacy options.

Generic version

Tibsovo isn’t available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.

Tibsovo dosage

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 forms and strengths

Tibsovo comes as a tablet that you swallow. This medication is available in one strength: 250 milligrams (mg).

Dosage for acute myeloid leukemia

Tibsovo is used to treat acute myeloid leukemia (AML) in certain adults.* The recommended dosage of Tibsovo for this use is 500 mg once daily. This is two 250-mg tablets.

You’ll likely follow this Tibsovo dosing schedule for at least 6 months, unless:

• your AML gets worse, or
• you develop serious side effects that Tibsovo can’t manage

* For details about Tibsovo’s uses, see the “Tibsovo uses” section below.

What if I miss a dose?

If you miss a dose of Tibsovo, take the dose as soon as possible but at least 12 hours before your next scheduled dose. Then take your next dose at your usual time the following day. You shouldn’t take more than one dose within 12 hours.

For example, if you usually take Tibsovo at 7 a.m. and miss your dose, you can take the missed dose no later than 7 p.m. The next day, you can take your regularly scheduled dose of Tibsovo at 7 a.m. If it was after 7 p.m. that you remember you missed a dose, you should skip the dose and take your next regular dose at 7 a.m. the next day. If you have questions about missed doses, talk with your doctor.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or timer on your phone or downloading a reminder app. A kitchen timer can work, too.

Will I need to use this drug long term?

Tibsovo is meant to be used as a long-term treatment. If you and your doctor determine that Tibsovo is safe for you, and your AML doesn’t get worse, then you’ll take this drug for at least 6 months.

Common questions about Tibsovo

Here are answers to some frequently asked questions about Tibsovo.

Can Tibsovo be used to treat a type of liver cancer called cholangiocarcinoma?

Tibsovo isn’t approved to treat a type of liver cancer called cholangiocarcinoma. But it’s possible that the drug may be used off-label. Off-label drug use means using a drug for a purpose other than what it’s been approved for by the Food and Drug Administration (FDA). The FDA is reviewing Tibsovo for the treatment of cholangiocarcinoma.

Tibsovo is currently FDA-approved to treat acute myeloid leukemia (AML) in adults with an IDH1 gene mutation (abnormal change). This gene mutation is also found in other types of cancer, including cholangiocarcinoma.

Currently, the FDA is looking at whether to approve Tibsovo to treat cholangiocarcinoma in people with an IDH1 gene mutation. Clinical studies, such as this one, have shown that Tibsovo could be an effective treatment option for cholangiocarcinoma.

In the study, people with cholangiocarcinoma took Tibsovo or a placebo. (A placebo is a treatment that contains no active drug.) Researchers found that progression-free survival improved more significantly in people who took Tibsovo than in people who took a placebo.

“Progression-free survival” refers to the length of time a person continues to live with a condition, but the condition doesn’t get worse. In a clinical trial, measuring progression-free survival is one way to test the effectiveness of a new treatment.

If you’re interested in Tibsovo treatment for cholangiocarcinoma, talk with your doctor.

Is Tibsovo chemotherapy?

Tibsovo is used to treat a type of cancer called acute myeloid leukemia (AML). However, it’s not a chemotherapy drug.

With cancer, certain cells in your body grow and multiply in an uncontrolled way. Chemotherapy drugs work to treat cancer by stopping cells from multiplying. However, this may also damage healthy cells, which often leads to undesirable side effects.

Tibsovo, on the other hand, is a type of drug called an IDH1 inhibitor. This is a kind of targeted cancer treatment. Targeted treatments seek out cells with specific targets, such as gene mutations, and attach to the cells. (A gene mutation is an abnormal change.)

Tibsovo targets certain cells that have a specific gene mutation known as IDH1. Once Tibsovo attaches to its target, the drug inhibits (blocks) certain activities of the mutated cells.

To learn more about how Tibsovo works to treat AML, see the “How Tibsovo works” section below.

Is Tibsovo approved to treat a kind of brain cancer known as a glioma?

No, Tibsovo is currently FDA-approved to treat only acute myeloid leukemia (AML) in certain adults.* (AML is a type of cancer.) But it’s possible that Tibsovo may be used off-label to treat glioma, a form of brain cancer. Off-label drug use means using a drug for a purpose other than what it’s been approved for by the FDA.

Clinical trials are currently studying whether Tibsovo could be an effective treatment for cancers other than AML, including glioma. In one small clinical study, people with advanced glioma who received Tibsovo treatment experienced reduced tumor growth.

If you’re interested in Tibsovo treatment for glioma, talk with your doctor.

* For details about Tibsovo’s uses, see the “Tibsovo uses” section below.

How Tibsovo works

Acute myeloid leukemia (AML) is a type of cancer that affects your blood cells. These cells are produced in your bone marrow, which is the tissue inside bones. There, blood cells normally mature into white blood cells, red blood cells, or platelets (blood cells that help your blood clot).

With AML, immature blood cells aren’t able to mature. Instead, they form nonfunctional myeloid cells (also known as blasts). These blasts accumulate in your bone marrow and blood. Too many blasts overcrowd your normal blood cells. This prevents them from working properly, especially your white blood cells. (White blood cells are part of your immune system and help fight off infection.)

Tibsovo is used to treat AML in adults with a certain gene mutation (abnormal change) known as IDH1. That’s short for isocitrate dehydrogenase 1.

Tibsovo is the first in a class of drugs known as IDH1 inhibitors. A drug class is a group of medications that have a similar mechanism of action (the way a drug works).

Tibsovo is a type of treatment called targeted therapy. These treatments seek out specific targets, such as cells with gene mutations. Tibsovo targets certain cells in your body that have the IDH1 mutation. Once this drug attaches to its target, Tibsovo inhibits (blocks) some activities of the mutated cells.

The end result of this targeted action is that immature blood cells can develop normally into fully functional blood cells. The goal of AML treatment is to reduce or eliminate the presence of blasts in your blood.

How long does it take to work?

Clinical studies of Tibsovo looked at how soon after taking the drug people had blood levels that were partially or fully back to normal. This was known as a “response.” Researchers found the following:

• In people with newly diagnosed AML who had a response to Tibsovo, the response occurred within 6 months. In half of the people who had a response, it occurred by 2.8 months.
• In people with relapsed or refractory AML* who had a response to Tibsovo, the response occurred within 6 months. In half of the people who had a response, it occurred by 2 months.

If you have questions about how soon Tibsovo may work for you, talk with your doctor.

* With relapsed AML, the cancer comes back after a person has been in remission (a period of time when they don’t have any signs of cancer). AML is refractory if the cancer continues to worsen with current treatment.

Tibsovo uses

The Food and Drug Administration (FDA) approves prescription drugs such as Tibsovo to treat certain conditions. Tibsovo may also be used off-label for other conditions. Off-label drug use means using a drug for a purpose other than what it’s been approved for by the FDA.

Tibsovo for acute myeloid leukemia

Tibsovo is FDA-approved to treat acute myeloid leukemia (AML) in adults who either:

• Are age 75 years or older and have been newly diagnosed with AML. Also, they can’t be able to undergo intensive chemotherapy due to other medical conditions.
• Have relapsed or refractory AML. With relapsed AML, the cancer comes back after a person has been in remission (a period of time when they don’t have any signs of cancer). AML is refractory if the cancer continues to worsen with current treatment.

In addition, the AML must have a gene mutation (abnormal change) called IDH1. That’s short for isocitrate dehydrogenase 1. If you have AML, your doctor will have you take a blood test or provide a bone marrow sample to see if you have the IDH1 mutation.

Acute myeloid leukemia explained

AML is a type of cancer of the blood cells. It occurs most often in older adults.

Inside your bones, your bone marrow makes different types of blood cells:

• red blood cells to carry oxygen
• platelets to help prevent or stop bleeding
• white blood cells to help fight off infection

All blood cells start as nonfunctioning, immature cells. As they mature, they develop into one of the three types of blood cells described above.

Myeloid cells (also known as blasts) are immature cells that normally mature into white blood cells. However, AML prevents blasts from maturing into healthy white blood cells.

Instead, too many blasts accumulate in your bone marrow and blood. This leaves little space for your healthy blood cells to function the way they normally would. When blasts overcrowd your healthy blood cells, symptoms of AML begin to appear. AML symptoms often start suddenly and may include:

• fatigue (lack of energy)
• fever
• flu-like symptoms
• increased sweating
• frequent infections
• anemia (decreased red blood cell count)
• unexplained bleeding, such as gum or nose bleeding
• small red spots under the skin or other bruising
• loss of appetite, which can lead to weight loss
• abdominal (belly) pain

Diagnosis and treatment

AML is usually diagnosed with genetic testing or by testing a sample of your bone marrow. If 20% or more of your bone marrow consists of blasts or if your genetic test is positive, your doctor will diagnose you with AML.

Treatment options for AML include:

• chemotherapy
• targeted therapy, such as Tibsovo
• radiation therapy
• bone marrow transplant

The goal of AML treatment is to reduce the level of blasts in your bone marrow to less than 5%.

Effectiveness for acute myeloid leukemia

In clinical studies, Tibsovo was effective for treating certain types of AML in adults. For details on how Tibsovo performed in this study, visit the manufacturer’s website or see the drug’s prescribing information.

In addition, Tibsovo is a recommended treatment option in the National Comprehensive Cancer Network’s guidelines for AML in certain adults.

Tibsovo and children

Tibsovo isn’t FDA-approved for use in children with AML.

A clinical trial is currently studying the use of Tibsovo in children who have cancer with an IDH1 gene mutation. The age range for eligible study participants is 12 months to 21 years.

Tibsovo and alcohol

Tibsovo doesn’t interact with alcohol.

However, alcohol may worsen certain side effects from Tibsovo, such as nausea and diarrhea. (For more information about side effects, see the “Tibsovo side effects” section above.)

If you drink alcohol, talk with your doctor about how much is safe for you to consume while you’re taking Tibsovo.

Tibsovo interactions

Tibsovo can interact with several other medications. It can also interact with certain supplements as well as certain foods.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase the number of side effects or make them more severe.

Tibsovo and other medications

Below is a list of medications that can interact with Tibsovo. But this list doesn’t contain all drugs that may interact with Tibsovo.

Before taking Tibsovo, 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 use. Sharing this information can help you avoid potential interactions.

Types of drugs that can interact with Tibsovo include the following.

Drugs that could be less effective than usual when taken with Tibsovo. Tibsovo may interact with some medications by reducing their levels and effects in your body. This can prevent the other drugs from being effective. Examples of medications that could be less effective than usual when taken with Tibsovo can include:

• certain antifungals, such as itraconazole, fluconazole (Diflucan), and ketoconazole (Nizoral)
• hormonal forms of birth control, such as certain birth control pills, the patch, or the vaginal ring (NuvaRing).

Drugs that may cause QT prolongation. Tibsovo may cause a heart rhythm change called QT prolongation. Other medications can also cause this serious side effect. Taking Tibsovo with other drugs that can cause heart rhythm changes may significantly raise your risk of developing QT prolongation. Examples of these medications can include:

• certain anti-arrhythmic drugs, such as flecainide (Tambocor)
• certain antifungals,* such as itraconazole, fluconazole (Diflucan), and ketoconazole (Nizoral)
• fluoroquinolone antibiotics, such as levofloxacin (Levaquin)
• certain antinausea medications, such as ondansetron (Zofran) and palonosetron (Aloxi)

If you have questions or concerns about drug interactions that may affect you, talk with your doctor or pharmacist.

* Certain antifungals (itraconazole, ketoconazole) can also interact with Tibsovo by significantly increasing the level of Tibsovo in your body. This further raises your risk for serious side effects. For more information about side effects, see the “Tibsovo side effects” section above.

Tibsovo and herbs and supplements

There aren’t any herbs or supplements that have been specifically reported to interact with Tibsovo. However, Tibsovo is known to interact with medications that are metabolized (broken down) by certain enzymes. These enzymes can also be affected by certain herbs and supplements. So, you should still check with your doctor or pharmacist before using any of these products while taking Tibsovo.

Tibsovo and foods

You can take Tibsovo tablets with or without food. But if you choose to take Tibsovo with food, it shouldn’t be with high fat foods. This is because taking Tibsovo with high-fat foods can increase the level of the drug in your body. Too much Tibsovo in your system could raise your risk for mild or serious side effects.* It’s important that your meal or snack doesn’t contain more than 1,000 calories or 58 grams of fat.

You should check food labels if you aren’t sure of their fat or calorie content. Some examples of foods to limit or avoid when taking a dose of Tibsovo include bacon, butter, eggs, and whole milk.

You should also avoid eating grapefruit and drinking grapefruit juice while taking Tibsovo. The fruit and its juice can block the activity of an enzyme that helps break down Tibsovo. So if you consume grapefruit or grapefruit juice, the level of Tibsovo in your body could rise. This could increase your risk for serious side effects, such as heart rhythm changes.

If you have any questions about eating certain foods with Tibsovo, talk with your doctor or pharmacist.

* For more about side effects, see the “Tibsovo side effects” section above.

Tibsovo and lab tests

Whether Tibsovo can interact with lab tests isn’t known. But the drug may change certain blood levels that lab tests may check. To learn more, see the “Tibsovo side effects” section above.

How to take Tibsovo

You should take Tibsovo according to your doctor’s or healthcare provider’s instructions.

Tibsovo comes as a tablet that you swallow.

When to take

You should take your dose of Tibsovo once a day. It’s best to take your dose around the same time every day. This helps keep a consistent level of the drug in your body so it can work effectively.

Keep in mind that Tibsovo tablets are available in one strength: 250 milligrams (mg). The usual dosage of Tibsovo is 500 mg once daily. So you’ll need to swallow two 250-mg tablets for each dose. You shouldn’t space the two tablets apart. Once per day, you should take them together or swallow one tablet right after the other.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or timer on your phone or downloading a reminder app. A kitchen timer can work, too.

Taking Tibsovo with food

You can take Tibsovo tablets with or without food, but the food shouldn’t be high in fat. You also shouldn’t eat grapefruit or drink grapefruit juice with Tibsovo. For details, see “Tibsovo and foods” in the “Tibsovo interactions” section above.

Can Tibsovo be crushed, split, or chewed?

No, you shouldn’t crush, split, or chew Tibsovo tablets. You should swallow them whole.

Tibsovo and pregnancy

You shouldn’t take Tibsovo while pregnant. If you do, the drug may cause harm to the developing fetus.

Tibsovo use during pregnancy hasn’t been studied in humans. But the drug did cause harm when it was given to pregnant animals in studies. Although animal studies don’t always predict what will happen in humans, to be safe, you shouldn’t use Tibsovo if you’re pregnant.

If you’re pregnant or have plans to become pregnant, talk with your doctor. They can help determine whether other treatments may be right for you.

Tibsovo and fertility

Tibsovo may cause fertility problems in females and males. (“Fertility” is the ability to become pregnant or cause someone to become pregnant.) This means that Tibsovo treatment may affect your ability to have a biological child.

If you’re concerned about fertility problems with Tibsovo treatment, talk with your doctor.

Note: Sex and gender exist on spectrums. Use of the terms “male” and “female” in this article refers to sex assigned at birth.

Tibsovo and birth control

Tibsovo isn’t safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about effective birth control options while you’re using Tibsovo.

For more information about taking Tibsovo during pregnancy, see the “Tibsovo and pregnancy” section above.

For females using Tibsovo

If you can become pregnant, you should use an effective form of birth control during Tibsovo treatment. And you should continue using birth control for at least 1 month after your last dose.

It’s important to note that Tibsovo may make some hormonal birth control less effective than usual. Talk with your doctor about which contraceptives are best to use with Tibsovo.

To learn more about Tibsovo and hormonal birth control, see the “Tibsovo interactions” section above.

For males using Tibsovo

If you have a partner who can become pregnant, you should use an effective form of birth control while taking Tibsovo,. And you should continue using birth control for at least 1 month after your last dose.

During this time, your doctor may recommend that both you and your partner use birth control. To learn which contraceptive options are best, talk with your doctor.

Note: Sex and gender exist on spectrums. Use of the terms “male” and “female” in this article refers to sex assigned at birth.

Tibsovo and breastfeeding

You shouldn’t breastfeed while taking Tibsovo and for at least 1 month after your treatment ends.

It’s not known if Tibsovo is safe to take while breastfeeding. But if the drug passes into breast milk, the risks of harmful side effects in a breastfed child are too high.

If you’re breastfeeding or planning to breastfeed, talk with your doctor. They can recommend healthy ways to feed your child and help determine if other treatments may be right for you.

Tibsovo precautions

This drug comes with several precautions.

FDA warning: Differentiation syndrome

This drug has a boxed warning. This is the most serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.

Taking Tibsovo can increase your risk for differentiation syndrome (DS). This is a serious condition that affects your blood cells. If DS isn’t treated, it can lead to organ failure or, in some cases, death. It’s important to get immediate medical care if you develop symptoms such as:

• fever
• trouble breathing or cough
• rash
• unexplained weight gain that occurs quickly, such as over a few days or a week
• swelling in your arms, hands, legs, or feet
• feeling lightheaded

If you develop DS, you may receive medications such as hydroxyurea (Hydrea, Droxia) or a corticosteroid, such as dexamethasone (Decadron). Depending on your condition, your doctor may have you stay in the hospital for monitoring until your symptoms ease. They may also have you stop taking Tibsovo. For more information, see “Side effect specifics” in the “Tibsovo side effects” section above.

Other precautions

Before taking Tibsovo, talk with your doctor about your health history. Tibsovo may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

• Conditions that affect heart rhythm. Tibsovo may increase the risk of serious heart rhythm changes known as QT prolongation. If you have a history of certain heart disorders, talk with your doctor. This is because taking Tibsovo may worsen your condition. Some examples of these disorders include QT prolongation, congestive heart failure, or problems with electrolytes. Your doctor may need to monitor you more frequently than usual during treatment or recommend a safer option for you.
• Dialysis or advanced kidney disease. If you’re on dialysis or have advanced kidney disease, it isn’t known how Tibsovo will affect you. People with these factors weren’t included in clinical studies of the drug. Talk with your doctor to review Tibsovo’s risks and potential benefits before starting treatment.
• Cirrhosis or severe liver disease. If you have cirrhosis or other severe liver disease, it isn’t known if Tibsovo is safe for you. This drug wasn’t studied in people who have these conditions. Talk with your doctor to discuss the risks and potential benefits of Tibsovo before starting treatment.
• Allergic reaction. If you’ve had an allergic reaction to Tibsovo or any of its ingredients, you shouldn’t take Tibsovo. Ask your doctor what other medications are better options for you.
• Pregnancy. Tibsovo isn’t safe to take during pregnancy. For more information, see the “Tibsovo and pregnancy” section above.
• Breastfeeding. You shouldn’t breastfeed while taking Tibsovo and for at least 1 month after your treatment ends. For more information, see the “Tibsovo and breastfeeding” section above.

Note: For more information about the potential negative effects of Tibsovo, see the “Tibsovo side effects” section above.

Tibsovo overdose

Do not take more Tibsovo than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.

If you vomit after taking a dose of Tibsovo, do not take an additional dose. Instead, wait to take your next scheduled dose of Tibsovo the next day at your usual time. You shouldn’t take more than one dose of Tibsovo within a 12-hour period.

If it seems that you’re vomiting frequently after taking Tibsovo, talk with your doctor. Because vomiting isn’t a reported side effect of Tibsovo, they may want to order tests or examine you. This could help your doctor find the underlying cause of this symptom.

What to do in case you take too much Tibsovo

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers, at 800-222-1222, or use their online tool. But if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.