May 11, 2022

Cost, operation, dosage, side effects, etc.

Trodelvy can cause mild or serious side effects. The following lists contain some of the main side effects that can occur when taking Trodelvy. These lists do not include all possible side effects.

For more information about the possible side effects of Trodelvy, talk to your doctor or pharmacist. They can give you advice on how to deal with side effects that may be worrying or bothersome.

To note: The Food and Drug Administration (FDA) tracks the side effects of drugs it has approved. If you would like to inform the FDA of a side effect you have had with Trodelvy, you can do so via MedWatch.

Mild side effects

Mild side effects * of Trodelvy may include:

Most of these side effects can go away within days or weeks. But if they get worse or don’t go away, talk to your doctor or pharmacist.

* This is a partial list of the mild side effects of Trodelvy. To find out more about other mild side effects, talk to your doctor or pharmacist, or consult Trodelvy prescribing information.
** For more information about this side effect, see “Side effect details” below.

Serious side effects

Serious side effects of Trodelvy can occur. But even so, most people are able to continue taking the medicine.

Serious side effects can happen regardless of the condition Trodelvy is used to treat. However, in clinical tests, serious side effects were more common in people with bladder cancer than in people with breast cancer. Additionally, people with bladder cancer were more likely to stop taking Trodelvy due to serious side effects.

It is not uncommon for doctors to temporarily stop treatment with Trodelvy until the serious side effects disappear.

Call your doctor immediately if you experience serious side effects. Call 911 or your local emergency number if your symptoms are life-threatening or if you think you have a medical emergency.

Serious side effects and their symptoms can include:

  • Acute (sudden) kidney damage. Symptoms may include:
  • Anemia (low level of red blood cells). Symptoms may include:
  • Blood clots. Symptoms affecting the clot area may include:
    • pain, tenderness, or heat
  • Serious infections, including pneumonia, bacteremia (bacteria in your bloodstream) and a severe urinary tract infection (UTI). Symptoms may include:
    • groin pressure or cramps
  • Sepsis (severe immune reaction to infection). Symptoms may include:
    • shortness of breath or difficulty breathing
  • Obstruction in your small intestine. Symptoms may include:
    • bloating and cramps in the stomach
  • Infusion reactions, which can happen after receiving an intravenous (IV) infusion of a drug. Symptoms may include any of the following, within 24 hours of receiving a Trodelvy infusion:
    • feeling dizzy or dizzy
    • swelling of the face, lips, throat, or tongue
  • Severe nausea and vomiting.
  • Neutropenia (low level of white blood cells called neutrophils). * †
  • Severe diarrhea. * †
  • Allergic reaction.*

* Trodelvy has a boxed warning regarding these risks. A boxed warning is the strongest warning required by the Food and Drug Administration (FDA). Boxed warnings alert doctors and patients to the effects of drugs that can be dangerous.
† For more information about this side effect, see “Side effect details” below.

Details of side effects

Here are some details about some side effects that this medicine can cause.

Low level of neutrophils

Trodelvy can cause neutropenia (a low level of white blood cells called neutrophils). In fact, the drug has a boxed warning on this risk.

A boxed warning is the most serious warning the FDA can give to a drug. It alerts doctors and patients to the effects of drugs which can be dangerous.

Your body makes neutrophils to help fight infections and repair damaged body tissue. If your neutrophil count is too low, your body cannot respond to infections as usual.

Neutropenia was the most frequently reported side effect in the treatment of Trodelvy. clinical tests. Almost half of the people who took the drug had severe neutropenia. (If you have severe neutropenia, your neutrophil levels are very low.) In most cases, their neutrophil count returned to normal after stopping Trodelvy for 2 to 3 weeks.

In rare cases, people receiving Trodelvy in these trials have developed febrile neutropenia. It is a rare but potentially fatal type of neutropenia. With febrile neutropenia, you have:

  • a fever greater than 101 ° F or greater than 100.4 ° F for 1 hour or more, more
  • a neutrophil level below a certain threshold

Symptoms of neutropenia

Neutropenia itself does not cause symptoms. So, during your treatment, your doctor will order a blood test to check your neutrophil count.

If your levels are too low, your doctor will probably stop your treatment with Trodelvy. They probably will do this until your levels return to a healthy value. Your doctor will also give you medicine to help increase your neutrophil count. If your doctor tells you to resume treatment with Trodelvy, your doctor will probably reduce your dose in the future.

However, you can develop symptoms of infection due to neutropenia. In people with neutropenia, infections should be treated immediately. Symptoms of an infection can include:

  • chills
  • cough
  • fever
  • nausea, vomiting, or diarrhea
  • shortness of breath

What do we do for neutropenia?

If you develop neutropenia more than twice while receiving Trodelvy, your doctor will probably recommend that you stop the medicine. They may also recommend stopping treatment if you develop neutropenia that lasts longer than 3 weeks.

If you have febrile neutropenia or an infection while taking Trodelvy, your doctor will prescribe antibiotics. Depending on the severity of the infection or neutropenia, you may need hospital treatment.

After treatment, your doctor may recommend a medicine to help your body make neutrophils. This medicine helps keep your levels from getting low again. To find out more about these medicines, see ‘Using Trodelvy with other medicines’ below. You can also discuss this with your doctor or pharmacist.

Severe diarrhea

Trodelvy can cause severe diarrhea. In fact, the drug has a boxed warning for this risk.

A boxed warning is the most serious warning the FDA can give to a drug. It alerts doctors and patients to the effects of drugs which can be dangerous.

Diarrhea was one of the most common side effects in people taking Trodelvy in clinical tests. In most people, this side effect was mild. However, in some people it was serious.

Because of the risk of severe diarrhea, you should call your doctor if you have diarrhea with Trodelvy. Your doctor will want to check if you are infected.

If your diarrhea is not caused by an infection, your doctor may prescribe another medicine to treat or prevent it. Here are some examples of these drugs:

Your doctor will also probably ask you to temporarily stop taking Trodelvy until your diarrhea goes away or becomes less severe. Then they will probably reduce your dose of Trodelvy when you resume treatment.

Your doctor may recommend fluid and electrolyte replacement if you develop diarrhea while taking Trodelvy.

Hair loss

It is possible that hair loss is a side effect of Trodelvy. This is one of the most common side effects reported in clinical tests. However, there have been no reports of severe hair loss in the trials.

If you have lost your hair with Trodelvy, you can talk to your doctor about it. They may recommend treatment for this side effect.

Allergic reaction

As with most medicines, some people may have an allergic reaction after taking Trodelvy.

Symptoms of a mild allergic reaction, including infusion reactions, may include:

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

  • swelling under the skin, usually on the eyelids, lips, hands or feet
  • swelling of the tongue, mouth, or throat
  • difficulty in breathing

Call your doctor right away if you have an allergic reaction to Trodelvy, as the reaction could get serious. Call 911 or your local emergency number if your symptoms are life-threatening or if you think you have a medical emergency.


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