Kalbitor Side Effects: What They Are and How to Manage Them

Kalbitor (ecallantide) is a prescription biologic drug used to treat severe swelling caused by hereditary angioedema (HAE). Kalbitor can cause side effects that range from mild to serious. Examples include nausea, injection-site reactions, and anaphylaxis.

Specifically, Kalbitor is a biologic drug used to treat severe swelling caused by HAE in people ages 12 and older.

The active ingredient in Kalbitor is ecallantide. (An active ingredient is what makes a drug work.) The drug comes as a liquid solution for injection under the skin. These injections are given by a healthcare professional in a hospital or clinic.

Keep reading to learn about the common, mild, and serious side effects Kalbitor can cause. For a general overview of the drug, including details about its uses, see this article.

* A biologic drug is made from living cells, while other drugs are made from chemicals.

Boxed warning: Risk of anaphylaxis

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

For details, see the “Side effects explained” section below.

What are the more common side effects of Kalbitor?

Some people may experience mild to serious side effects during Kalbitor treatment. Examples of the drug’s commonly reported side effects include:

* To learn more about this side effect, see the “Side effects explained” section below.

What are the mild side effects of Kalbitor?

Mild side effects have been reported with Kalbitor. These include:

  • diarrhea
  • fever*
  • nausea
  • injection site reactions
  • runny or stuffy nose
  • mild allergic reaction*

In most cases, these side effects should be temporary. And some may be easily managed. But if you have symptoms that are ongoing or bothersome, talk with your doctor or pharmacist. And do not stop Kalbitor treatment unless your doctor recommends it.

Kalbitor may cause mild side effects other than those listed above. See the drug’s prescribing information for details.

* To learn more about this side effect, see the “Side effects explained” section below.

What are the serious side effects of Kalbitor?

Severe allergic reactions, including anaphylaxis, have been reported with Kalbitor. In fact, Kalbitor has a boxed warning for anaphylaxis. To learn more about this side effect, see the “Side effects explained” section below.

If you develop serious side effects during Kalbitor treatment, call your doctor right away. If the side effects seem life-threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you’d like to notify the FDA about a side effect you’ve had with Kalbitor, visit MedWatch.

Side effects explained

Severe allergic reactions

Although rare, anaphylaxis, a severe allergic reaction, is listed as a boxed warning for Kalbitor and was reported in the drug’s studies. A boxed warning is the most serious warning from the FDA.

You can suddenly develop anaphylaxis symptoms, such as:

Kalbitor injections are given in a hospital or clinic by a trained healthcare professional. This is so that any HAE or allergic reaction symptoms (which are similar) can be closely monitored and managed. Most allergic reaction symptoms will occur within the first hour following the injection.

What might help?

If you have mild symptoms of an allergic reaction, such as a mild skin rash or itchiness, between doses of Kalbitor, call your doctor right away. They may suggest a treatment to manage your symptoms. Examples include:

  • an oral antihistamine, such as diphenhydramine (Benadryl)
  • a product you apply to your skin, such as hydrocortisone cream

If your doctor confirms you’ve had a mild allergic reaction to Kalbitor, they’ll decide whether you should continue treatment.

If you have symptoms of a severe allergic reaction, such as swelling or difficulty breathing when not in a hospital or clinic, call 911 or your local emergency number right away. These symptoms could be life-threatening and require immediate medical care.

If your doctor confirms you’ve had a serious allergic reaction to Kalbitor, they may have you switch to a different treatment.

Fever

Fever was a common side effect reported in studies of Kalbitor. Fever may cause symptoms such as:

  • an increase in body temperature
  • sweating
  • chills (feeling cold without an apparent cause)
  • fatigue or low energy
  • decreased appetite

What might help?

If you have fever symptoms during Kalbitor treatment, talk with your doctor. They’ll likely recommend the following:

  • drinking plenty of clear fluids, such as water
  • taking a lukewarm bath or shower
  • taking acetaminophen (Tylenol) or ibuprofen (Advil)

If your temperature is 103°F (39.4°C) or higher, call your doctor right away.

If any of your side effects seem life-threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Keeping track of side effects

During your Kalbitor treatment, consider taking notes on any side effects you’re having. You can then share this information with your doctor. This is especially helpful when you first start a new drug or combination of treatments.

Your side effect notes can include things such as:

  • what dose of the drug you were taking when you had the side effect
  • how soon you had the side effect after starting that dose
  • what your symptoms were
  • how your symptoms affected your daily activities
  • what other medications you were taking
  • any other information you feel is important

Taking notes and sharing them with your doctor will help them learn more about how Kalbitor affects you. They can then use this information to adjust your treatment plan if needed.

Warnings for Kalbitor

Below is important information you should consider before starting Kalbitor treatment.

Boxed warning: Risk of anaphylaxis

Kalbitor has a boxed warning for the risk of anaphylaxis. A boxed warning is the most serious warning from the FDA.

Although rare, Kalbitor can cause anaphylaxis and other serious allergic reactions. These allergic reactions can be life-threatening and require hospital treatment.

To learn more, see the “Side effects explained” section above.

Other warnings

Kalbitor can sometimes cause harmful effects in people with certain conditions. This is known as a drug-condition interaction. Other factors may also affect whether Kalbitor is a good treatment option for you. Talk with your doctor about your health history before starting Kalbitor. Be sure to tell them if any of the following factors apply to you:

  • past allergic reaction to Kalbitor
  • pregnancy
  • breastfeeding

Alcohol and Kalbitor

There are no known interactions between alcohol and Kalbitor. If you have questions about consuming alcohol during Kalbitor treatment, talk with your doctor or pharmacist.

Pregnancy and breastfeeding with Kalbitor

There is limited information about the safety of Kalbitor use during pregnancy or while breastfeeding.

Pregnancy

Studies are not available on the use of Kalbitor during pregnancy, so it’s not known whether treatment is safe for pregnant people.

If you’re pregnant or planning to become pregnant, talk with your doctor before starting this medication.

Breastfeeding

It isn’t known whether Kalbitor is safe while breastfeeding. Studies are not available on the use of Kalbitor in people who are breastfeeding or the drug’s effects on a child who is breastfed.

If you’re breastfeeding or planning to do so, talk with your doctor before starting this medication.

What to ask your doctor

Like most drugs, Kalbitor can cause a number of side effects that range from mild to serious. But most are temporary and go away after a few days or weeks. If you have questions about side effects this drug can cause, talk with your doctor. Examples of questions to help get you started include:

  • How soon after I receive Kalbitor might symptoms of anaphylaxis appear?
  • What medications could I take during Kalbitor treatment to decrease the risk of injection site reactions?
  • What signs and symptoms of fever should alert me to call my doctor or seek emergency care?

To learn more about Kalbitor, see these articles:

3 Comments

  1. Thanks for sharing this informative article! It’s important to know what to expect when starting a new medication. Managing side effects can be challenging, but being aware of them is definitely a step in the right direction. This will be helpful for anyone considering Kalbitor.

  2. Great post! It’s really important to raise awareness about the potential side effects of medications like Kalbitor. Understanding both the benefits and risks can help patients make informed decisions and manage any adverse effects more effectively. Thanks for shedding light on how to handle these side effects proactively!

  3. Thanks for the detailed information on Kalbitor side effects! It’s really helpful to know what to expect and how to manage them if they occur. Understanding the potential reactions and having strategies in place definitely makes the treatment process less daunting.

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