Tzield (teplizumab-mzwv)

Tzield generic or biosimilar

Tzield is available only as a brand-name drug. Tzield is a biologic medication, which is also called a biologic.

Tzield isn’t currently available as a generic or biosimilar medication. A biosimilar is a drug that’s similar to a brand-name biologic drug (the parent drug).

Biologic drugs are made from living cells. It’s not possible to copy these drugs exactly. A generic, on the other hand, refers to drugs made from chemicals. A generic is an exact copy of the active drug in a brand-name medication.

Biosimilars are considered to be just as safe and effective as the parent drug. And like generics, biosimilars tend to cost less than brand-name medications.

Tzield uses

The Food and Drug Administration (FDA) approves prescription drugs such as Tzield to treat certain conditions.

Tzield for delay of stage 3 type 1 diabetes

Tzield is prescribed to delay the worsening of type 1 diabetes. Specifically, Tzield is prescribed to delay the onset (start) of stage 3 type 1 diabetes in adults and children ages 8 years and older who have stage 2 type 1 diabetes.

With type 1 diabetes, a person develops diabetes autoantibodies. These are immune system proteins that attack and destroy beta cells (insulin-producing cells in the pancreas). Insulin is a hormone that regulates blood sugar levels.

There are three stages of type 1 diabetes:

• Stage 1: At least one diabetes autoantibody can be detected, but blood sugar levels are normal. There are no symptoms at this stage.
• Stage 2: At least two diabetes autoantibodies can be detected, and blood sugar levels are abnormal. There are no symptoms at this stage.
• Stage 3: Many beta cells have been destroyed, and blood sugar levels are abnormal. Symptoms can include:
  • frequent urination
  • feeling hungrier and thirstier than usual
  • fatigue
  • blurred vision
  • weight loss

A person is usually diagnosed with type 1 diabetes when they’ve already reached stage 3. At this point, individuals typically need to receive insulin treatment to manage their blood sugar levels.

Tzield works to slow the progression of type 1 diabetes and thus delay the need for insulin treatment. In clinical trials, Tzield was shown to delay the onset of stage 3 type 1 diabetes in people with stage 2 type 1 diabetes.

You can learn more about the condition by visiting our diabetes hub.

Tzield and children

Tzield is FDA-approved for use in children ages 8 years and older who have stage 2 type 1 diabetes. It isn’t known whether Tzield is safe or effective for children younger than this.

Tzield cost

As with all medications, the cost of Tzield can vary. The actual price you’ll pay depends on your insurance plan, your location, and where you receive Tzield treatment.

Drug coupons: You can visit Optum Perks* for price estimates of Tzield. 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 Tzield, or if you need help understanding your insurance coverage, help is available.

A program called Provention Bio COMPASS is available for Tzield. For more information and to find out whether you’re eligible for support, call 844-778-2246 or visit the program website.

To learn more about saving money on prescriptions, check out this article.

Biosimilar form: Tzield isn’t currently available as a generic or biosimilar medication. A biosimilar is a drug that’s similar to a brand-name biologic drug (the parent drug).

Biologic drugs are made from living cells, so it’s not possible to copy them exactly. However, biosimilars are considered to be just as safe and effective as the parent drug. And like generics, biosimilars tend to cost less than brand-name medications.

* Optum Perks is a sister site of Medical News Today.

Tzield side effects

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

For more information about the possible side effects of Tzield, 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 Tzield, you can do so through MedWatch.

Mild side effects

Below is a partial list of mild side effects of Tzield. To learn about other mild side effects, talk with your doctor or pharmacist, or view Tzield’s prescribing information.

Mild side effects of Tzield can include:

• skin rash
• headache
• temporary, mild decrease in white blood cell levels
• mild allergic reaction*

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.

* For more information about allergic reaction and Tzield, see “Allergic reaction” below.

Serious side effects

Serious side effects from Tzield 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 if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

• Cytokine release syndrome (CRS), also called “cytokine storm.” (CRS can develop when your immune system overreacts and suddenly releases an excess of proteins called cytokines.) Signs and symptoms may include:
  • fever
  • nausea
  • fatigue
  • headache
  • pain in your joints and muscles
  • increased liver enzymes
• Serious infection, such as pneumonia. Symptoms of an infection can vary but may include:
  • fever
  • chills
  • fatigue
  • cough
• Severe leukopenia (decrease in white blood cell levels) that lasts for a week or longer. This side effect doesn’t cause symptoms but increases the risk of infection.
• Severe allergic reaction.*

* For details about allergic reaction and Tzield, see “Allergic reaction” below.

ALLERGIC REACTION

As with most drugs, some people can have an allergic reaction after taking Tzield.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing

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

Mild allergic reactions were a common side effect in clinical trials of this drug, while severe allergic reactions were rare.

Call your doctor right away if you have an allergic reaction to Tzield, 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.

Tzield dosage

The following information describes dosages that are commonly used or recommended.

Drug forms and strengths

Tzield comes as a clear solution in a single-dose vial. Each vial contains 2 milligrams (mg) of the drug in 2 milliliters (mL) of solution.

Your doctor or another healthcare professional will mix Tzield with saline solution. They’ll administer it as an intravenous (IV) infusion.

Dosage for delay of stage 3 type 1 diabetes

Tzield is given as an IV infusion. It’s administered once a day for 14 consecutive days. Each infusion takes at least 30 minutes.

Your doctor will determine your dosage of Tzield based on your body surface area (BSA). BSA is calculated using your height and weight and is measured in square meters (m²).

The typical dosing schedule for Tzield is shown below:

On Days 1–5, your doctor will give you premedications before you receive Tzield. (Premedications help prevent or minimize certain side effects.) Premedications may include:

• an antihistamine, such as diphenhydramine (Benadryl)
• a pain reliever and fever reducer, such as acetaminophen (Tylenol), or a nonsteroidal anti-inflammatory drug (NSAID), such as ibuprofen (Advil, Motrin)
• an antiemetic (antinausea drug), such as ondansetron

If needed, your doctor may give you premedications before your remaining Tzield infusions.

To learn more about how Tzield is given, talk with your doctor. You can also visit the manufacturer’s website.

Children’s dosage

Tzield is given as an IV infusion. It’s administered once a day for 14 consecutive days. Each infusion takes at least 30 minutes.

As in adults, your child’s doctor will determine the dosage of Tzield based on the child’s body surface area (BSA). BSA is calculated using your child’s height and weight and is measured in square meters (m²).

The 14-day dosing schedule for Tzield is shown in the section just above.

On days 1–5 of treatment, your child may be given premedications before their dose of Tzield. (Premedications help prevent or minimize certain side effects of Tzield.) Premedications may include:

• an antihistamine, such as diphenhydramine (Benadryl)
• a pain reliever and fever reducer, such as acetaminophen (Tylenol), or a nonsteroidal anti-inflammatory drug (NSAID), such as ibuprofen (Advil, Motrin)
• an antiemetic (antinausea drug), such as ondansetron

If needed, your child may receive premedications before all of their remaining Tzield infusions as well.

To learn more about how Tzield is given, talk with your doctor. You can also visit the manufacturer’s website.

About taking Tzield

Below you’ll find information about key dosage issues.

• Length of use: Tzield is meant to be used as a short-term treatment. It’s typically given once daily for 14 days in a row (every day for 2 consecutive weeks).
• If you miss a dose: If you miss your appointment for your dose of Tzield, contact your doctor’s office right away. They’ll help you reschedule your appointment as soon as possible. Then you’ll continue receiving Tzield once daily until you complete the 14-day treatment. You won’t receive more than one dose of Tzield on the same day.

Tzield interactions

Tzield is not known to interact with other medications, herbs, supplements, foods, or alcohol. However, Tzield can interact with certain vaccines.

Tzield may reduce the effectiveness of vaccines. Tzield can also increase the risk of getting an illness from a live vaccine. Because of how Tzield works, the drug can weaken certain processes within your immune system.

Before you start Tzield, your doctor will check for any vaccines you’re currently due to receive based on your age. They’ll likely recommend getting any necessary vaccines before starting Tzield. Then they’ll prescribe Tzield when it’s safe to do so, after enough time has passed. The length of time depends on the type of vaccine.

Also, before starting Tzield, tell your doctor about any immunizations you’ve received in the last year. Sharing this information can help avoid potential interactions.

Interactions with vaccines

Below are some examples of vaccines that are not recommended with Tzield. This list does not contain all vaccines that may interact with Tzield.

If you have questions about vaccine or drug interactions that may affect you, ask your doctor or pharmacist.

Alcohol interaction

Alcohol is not known to interact with Tzield.

If you have questions about how much alcohol is safe to drink while taking Tzield, talk with your doctor or pharmacist.

Things to consider when taking Tzield

If you can become pregnant, consider the following information about pregnancy, birth control, and breastfeeding.

Tzield and pregnancy

Tzield should not be given during pregnancy. This advice is based on animal studies in which offspring of animals exposed to the drug had weakened immune systems. However, animal studies don’t always predict what will happen in people.

If you’re planning a pregnancy or can become pregnant, talk with your doctor before starting this medication. Your doctor may suggest birth control options to use during treatment with Tzield. They’ll likely suggest continuing to use birth control for at least 30 days after completing Tzield treatment.

If you become pregnant during Tzield treatment, tell your doctor right away. They’ll likely stop treatment with Tzield. If you become pregnant within 30 days of completing Tzield treatment, you should still tell your doctor. In either case, they’ll suggest reporting your pregnancy to Provention Bio by calling 844-778-2246. This can help the drug’s manufacturer learn more about Tzield’s effects during pregnancy.

Tzield and breastfeeding

It’s not known whether Tzield is safe to receive while breastfeeding.

If you’re currently breastfeeding or planning to do so, talk with your doctor before starting this medication. They may recommend other ways to feed your child during this time. Your doctor may also suggest pumping and discarding your breast milk during treatment with Tzield and for at least 20 days after your last dose of Tzield.

Common questions about Tzield

Here are answers to some frequently asked questions about Tzield.

How does Tzield work?

With type 1 diabetes, a person’s immune system attacks and destroys beta cells (insulin-producing cells in the pancreas). Insulin is a hormone that regulates levels of sugar in the blood.

As beta cells are destroyed, the body eventually stops making insulin naturally. This causes blood sugar levels to become too high, and the symptoms of diabetes become noticeable.

Tzield works by stopping the immune system from attacking and destroying beta cells. It helps the body continue to make natural insulin for a longer time. This may delay the symptoms of diabetes from starting. It may also delay the need to start treatment.

If you have questions about how Tzield works, talk with your doctor or pharmacist.

Does Tzield cause long-term side effects?

It’s possible. Because of how Tzield works, the drug can weaken your immune system. Your immune system may be weakened during treatment and for up to a year after receiving Tzield.

As a result, Tzield can reduce the effectiveness of vaccines. (Vaccines depend on your immune system to work.) Also, having a weakened immune system can increase the risk of getting an illness after receiving certain vaccines. Because of this, certain vaccines aren’t recommended for specific lengths of time before, during, and after receiving Tzield.

For more details and examples of these types of vaccines, see the “Tzield interactions” section above.

Talk with your doctor or pharmacist if you have questions about potential long-term side effects of Tzield.

Is Tzield effective at delaying the onset of stage 3 type 1 diabetes?

Yes, in clinical trials, people who received Tzield had a 2-year delay in the onset of stage 3 type 1 diabetes, on average. This was compared with people who received a placebo (a treatment that contained no active drug).

For more information about how Tzield performed in clinical trials, see the drug’s prescribing information. You can also read about the clinical trial results on the manufacturer’s website.