Ruconest is a brand-name prescription medication. It’s FDA-approved to treat acute attacks of hereditary angioedema (HAE) in adults as well as children ages 13 years and older. “Acute” means sudden and severe.

HAE is a rare genetic condition in which you have attacks of swelling called angioedema. The swelling can occur almost anywhere in your body, but most commonly affects the face, arms, legs, intestines, tongue, and throat.*

Ruconest contains the active drug C1 esterase inhibitor, recombinant.

* Note: It’s not known if Ruconest is effective for treating HAE attacks that affect your throat.

Ruconest drug form and strength

Ruconest comes as a single-use vial of powder and is available in one strength: 2,100 units (U) / 25 milliliter (mL). The powder is mixed with a liquid to form a solution, which is then given as an intravenous (IV) infusion. This is an injection into a vein that’s given over a period of time. A healthcare provider can give you Ruconest infusions, or they can teach you or a caregiver how to give the infusions at home.

You’ll take Ruconest only when you need to treat an attack of HAE. The drug isn’t used to help prevent HAE attacks.

Effectiveness

Clinical studies have found Ruconest to be effective for treating acute attacks of HAE. To read about the effectiveness of Ruconest, see the “Ruconest for hereditary angioedema (HAE)” section below.

Ruconest is available only as a brand-name medication. It’s a biologic drug that isn’t currently available in generic or biosimilar form.

Biologic drugs are made using living cells. It’s not possible for drug companies to produce exact copies of these medications. A generic drug, by contrast, is an exact copy of a brand-name drug that’s made from chemicals.

A biosimilar drug is a bit like a generic version of a biologic drug. It’s a very similar version of the parent biologic drug but isn’t identical. Biosimilar drugs are made to treat the same conditions as the parent drug. They’re considered to be as safe and effective as the parent drug.

The Ruconest dosage your doctor prescribes will depend on your body weight in kilograms (kg).

The following information describes Ruconest 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

Ruconest comes as a single-use vial of powder. The powder is mixed with sterile water to form a liquid solution, which is then given as an intravenous (IV) infusion. This is an injection into a vein that’s given over a period of time. Ruconest infusions are given over the course of about 5 minutes. A healthcare provider can give you the infusions, or they can teach you or a caregiver how to give the infusions at home.

Ruconest is available in one strength: 2,100 units (U) / 25 milliliters (mL).

Dosage for hereditary angioedema

To treat an acute attack of hereditary angioedema (HAE), the recommended dosage of Ruconest is described below. “Acute” means sudden and severe.

  • Adults and children who weigh less than 185 pounds (84 kilograms) should take 50 U per kg. They may need to use up to two vials. For example, if you weigh 150 lb (68 kg), your dose would be 3,400 U (68 x 50 = 3,400).
  • Adults and children who weigh 185 lb (84 kg) or more should take 4,200 U (two vials).

Most people need only one dose of Ruconest to relieve their symptoms. However, if your symptoms don’t start to ease, you can take a second dose. Ask your doctor how long you should wait before having the second dose. You shouldn’t take more than 4,200 U per dose. And don’t take more than two doses in 24 hours.

Pediatric dosage

Ruconest is approved for use in children ages 13 years and older. The recommended dosage for this age group is the same as for adults, as described above.

Ruconest isn’t approved for use in children younger than age 13 years.

What if I miss a dose?

Ruconest isn’t meant to be taken regularly every day. You should take it only when you need to treat an acute attack of HAE. The medication isn’t used to help prevent HAE attacks.

Will I need to use this drug long term?

Ruconest is meant to be used as a long-term treatment. If you and your doctor determine that Ruconest is safe and effective for you, you’ll likely take it whenever you need to treat an acute attack.

The Food and Drug Administration (FDA) approves prescription drugs such as Ruconest to treat certain conditions. Ruconest is FDA-approved to treat acute attacks of hereditary angioedema (HAE)* in adults as well as children ages 13 years and older. “Acute” means sudden and severe.

* Ruconest can treat HAE attacks that affect many places in your body (see below). However, it’s not known if it’s effective for treating attacks that affect your throat.

HAE explained

HAE is a rare genetic condition in which you have attacks of severe swelling, called angioedema. The swelling is caused by a buildup of fluid underneath your skin or mucous membranes. (Mucous membranes are linings of tissue that protect areas of the body, such as the mouth, with mucus.)

HAE attacks can occur almost anywhere in your body, but most commonly affect the:

Swelling of the mucous membranes in your intestines can cause severe belly pain, nausea, and vomiting. Swelling of your tongue or throat can tighten your airway and cause trouble breathing. This can be life threatening.

Many factors can trigger attacks of HAE. These include emotional stress, injury, dental procedures, surgery, infection, and hormonal changes, as well as certain foods and medications. Without treatment, attacks tend to last for 3 to 4 days.

Cause of HAE

HAE is caused by an abnormality, also called an error, in one of your genes. The genetic change leads to problems with a protein in your blood called C1 esterase inhibitor. This protein normally helps control inflammation (swelling or damage). With HAE, you have low levels of C1 esterase inhibitor, or you have a faulty version of it. Or your body may not produce this protein at all.

Ruconest is an artificial copy of the C1 esterase inhibitor protein. The drug replaces the missing or faulty protein in your blood and helps control attacks of swelling.

Effectiveness

Clinical studies have found Ruconest to be effective for treating acute attacks of HAE.

In one study, Ruconest was compared with a placebo (an injection containing no active drug) for treating acute attacks of HAE. Symptoms of an attack started to ease after:

  • 90 minutes in at least 50% of people who took Ruconest
  • 152 minutes in at least 50% of people who took a placebo

In this study, between 50% and 88% of people who took Ruconest had relief from their attack within 4 hours. The effectiveness depended on the site of the swelling. By comparison, between 0% and 58% of people who took a placebo had relief from their attack within 4 hours.

Of the people whose attack was relieved within 4 hours, symptoms returned within 24 hours for 3% of those who took Ruconest. This was compared with 27% of those who took a placebo.

In an extension to this study, all participants used Ruconest to treat their attacks. Researchers found that Ruconest started to ease symptoms of attacks within an average of 75 minutes.

Ruconest and children

Ruconest isn’t FDA-approved for use in children younger than age 13 years. However, sometimes the drug may be used off-label to treat acute attacks of HAE in younger children. The condition tends to first develop in childhood or the teenage years.

A recent study found Ruconest to be effective for treating attacks of HAE in children as young as age 5 years.

Ruconest is approved to treat HAE in children in some countries other than the United States.

If your child has HAE and you’re interested in using Ruconest to treat them, talk with your doctor.

Ruconest can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Ruconest. These lists don’t include all possible side effects.

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

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to report to the FDA a side effect you’ve had with Ruconest, you can do so through MedWatch.

Mild side effects

Mild side effects of Ruconest, which are explained below in “Side effect details,” can include:*

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 Ruconest. To learn about other mild side effects, talk with your doctor or pharmacist, or visit Ruconest’s patient product information.

Serious side effects

Serious side effects from Ruconest 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, which are explained below in “Side effect details,” include:

Side effects in children

Ruconest is approved only for children ages 13 years and older. In clinical studies, the most common side effects reported in this age group were headache, abdominal (belly) pain, and mouth or throat pain. No serious side effects were reported in this age group.

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail on certain side effects this drug may cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Ruconest. However, it’s not known how often allergic reactions occur with the drug.

Symptoms of allergic reactions

Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (warmth and redness in your skin)

A more severe allergic reaction, such as angioedema or anaphylaxis, 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 or wheezing
  • chest tightness
  • feeling dizzy or faint
  • low blood pressure

Some of these symptoms can be similar to those of a hereditary angioedema attack.

Rabbit allergy

In clinical studies, a severe allergic reaction occurred in one person who took Ruconest and was allergic to rabbits. (Ruconest is produced using rabbits.)

You shouldn’t take Ruconest if you’re allergic to rabbits, because it could trigger a severe allergic reaction. Ask your doctor what other treatments are better options for you.

Call your doctor right away if you think you have a severe allergic reaction to Ruconest. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Headache

Headache can occur after Ruconest use. This was the most common side effect reported in clinical studies of the drug.

In studies that compared Ruconest with a placebo (treatment containing no active drug), headache was reported in:

  • 0% to 10% of people who took Ruconest
  • 4% of people who took a placebo

Across all studies of Ruconest, headache was reported in 9% of people who took Ruconest. The studies included ones in which Ruconest wasn’t compared with a placebo or different drug.

If you’re using Ruconest and have headaches that are bothersome, ask your doctor to recommend a suitable pain reliever.

Nausea

Nausea is a possible side effect after Ruconest treatment.

Nausea was reported in 2% of people who took Ruconest in clinical studies. It’s not known how often nausea was reported in people who took a placebo.

If you have nausea that’s bothersome to you when using Ruconest, ask your doctor for advice on how to best manage this side effect.

Diarrhea

Diarrhea can occur after Ruconest use.

Diarrhea was reported in 2% of people who took Ruconest in clinical studies. It’s not known how often this side effect was reported in people who took a placebo.

If you’re taking Ruconest and have diarrhea that’s bothersome, ask your doctor for ways to help manage this side effect.

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

Ruconest comes as a single-use vial of powder. The powder is mixed with sterile water to form a liquid solution, which is then given as an intravenous (IV) infusion. This is an injection into a vein that’s given over a period of time. Ruconest infusions are given over the course of about 5 minutes.

A healthcare provider can give you the infusions, or they can teach you or a caregiver how to give the infusions at home.

Step-by-step instructions for giving yourself an infusion of Ruconest are provided in the pamphlet that comes with your medication. The manufacturer’s website also has a step-by-step instruction video on giving an infusion.

When to use

Be sure to take Ruconest as soon as possible after you first notice the symptoms of an acute attack of hereditary angioedema (HAE). “Acute” means sudden and severe.

Some people have symptoms other than swelling that can be early signs of an attack. Examples of these symptoms can include:

Talk with your doctor about any symptoms you have that may be early signs of an HAE attack. They can advise you on what to do.

Ruconest is used to treat acute attacks of hereditary angioedema (HAE). “Acute” means sudden and severe. But your doctor may recommend that you also take medication on a regular basis to help prevent these attacks.

Examples of drugs that help prevent HAE attacks include:

  • C1 esterase inhibitor, human (Cinryze, Haegarda)
  • lanadelumab-flyo (Takhzyro)
  • danazol

Ruconest isn’t known to interact with alcohol.

If you drink alcohol, talk with your doctor about whether it’s safe for you to do so during your Ruconest treatment.

Ruconest isn’t known to interact with other medications. And it’s not known to interact with supplements or foods.

However, to help keep yourself safe, talk with your doctor and pharmacist before taking Ruconest. 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.

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.

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

As with all medications, the cost of Ruconest can vary. To find current prices for Ruconest in your area, check out WellRx.com. The cost you find on WellRx.com is what you may pay without insurance. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

It’s important to note that you’ll have to get Ruconest 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 Ruconest, 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 if you’ll need to get prior authorization for Ruconest, contact your insurance company.

Financial and insurance assistance

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

Pharming Americas B.V., the manufacturer of Ruconest, offers the Ruconest Patient Savings Program and the Ruconest Patient Assistance Program. For more information and to find out if you’re eligible for support, call 855-613-4423 or visit the drug website.

Generic or biosimilar version

Ruconest is a brand-name biologic drug that doesn’t have a generic or biosimilar version.

Biologic drugs are made using living cells. It’s not possible for drug companies to produce exact copies of these drugs.

A biosimilar drug is a very similar version of the parent biologic drug, but is not identical. Biosimilar drugs are made to treat the same conditions as the parent drug. They’re considered to be as safe and effective as the parent drug. A generic drug, on the other hand, is an exact copy of a brand-name drug that’s made from chemicals.

Biosimilars and generics tend to cost less than brand-name drugs.

Other drugs are available that can treat acute attacks of swelling in people with hereditary angioedema (HAE). “Acute” means sudden and severe. Some of these drugs may be a better fit for you than others. If you’re interested in finding an alternative to Ruconest, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Alternatives for hereditary angioedema

Examples of other drugs that may be used to treat acute attacks of swelling in HAE include:

  • C1 esterase inhibitor, human (Berinert)
  • icatibant acetate (Firazyr)
  • ecallantide (Kalbitor)

Examples of drugs that may be used to help prevent acute attacks of swelling in HAE include:

  • C1 esterase inhibitor, human (Cinryze, Haegarda)
  • lanadelumab-flyo (Takhzyro)
  • danazol

You may wonder how Ruconest compares with other medications that are prescribed for similar uses. Here we look at how Ruconest and Berinert are alike and different.

Ingredients

Ruconest contains recombinant (artificial) C1 esterase inhibitor.

Berinert contains human C1 esterase inhibitor, which is made from plasma in human blood.

Uses

The Food and Drug Administration (FDA) approved Ruconest to treat acute attacks of hereditary angioedema (HAE) in adults as well as children ages 13 years and older. “Acute” means sudden and severe. It’s not known if Ruconest is effective for treating attacks of HAE that affect your throat.

Berinert is FDA-approved to treat acute attacks of HAE in adults and children. Specifically, the drug is used for attacks affecting the face, intestines, and throat.

Drug forms and administration

Ruconest and Berinert both come as a single-use vial of powder. The powder is mixed with a liquid to form a solution, which is then given as an intravenous (IV) infusion. This is an injection into a vein that’s given over a period of time. A healthcare provider can give you Ruconest or Berinert infusions, or they can teach you or a caregiver how to give the infusions at home.

You’ll take Ruconest or Berinert only when you need to treat an acute attack of HAE. The drugs aren’t approved to help prevent HAE attacks.

Side effects and risks

Ruconest and Berinert both contain C1 esterase inhibitor. Therefore, these medications can cause very similar side effects, but some different ones as well. Below are examples of these side effects.

Mild side effects

These lists contain up to 10 of the most common mild side effects that can occur with Ruconest, with Berinert, or with both drugs (when taken individually).

Serious side effects

These lists contain examples of serious side effects that can occur with Ruconest, with Berinert, or with both drugs (when taken individually).

Effectiveness

The only condition both Ruconest and Berinert are used to treat is acute attacks of HAE.

These drugs haven’t been directly compared in clinical studies, but studies have found both Ruconest and Berinert to be effective for treating HAE attacks. While Berinert is specifically approved to treat laryngeal attacks, it’s not known if Ruconest is effective for this type of attack.

Costs

According to estimates on WellRx.com, Ruconest costs significantly more than Berinert. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Ruconest and Berinert are both brand-name medications. Currently, there aren’t generic or biosimilar versions of either drug.

A biosimilar is a medication that’s similar to a brand-name drug. A generic medication, on the other hand, is an exact copy of the active ingredient in a brand-name drug.

Biosimilars are based on biologic medications, which are made from parts of living organisms. Generics are based on regular medications created from chemicals. Both biosimilars and generics tend to cost less than brand-name drugs.

Like Berinert (above), the drug Haegarda has uses similar to those of Ruconest. Here’s a comparison of how Ruconest and Haegarda are alike and different.

Ingredients

Ruconest contains recombinant (artificial) C1 esterase inhibitor.

Haegarda contains human C1 esterase inhibitor, which is made from human blood plasma.

Uses

The Food and Drug Administration (FDA) has approved Ruconest to treat acute attacks of hereditary angioedema (HAE) in adults as well as children ages 13 years and older. “Acute” means sudden and severe. It’s not known if Ruconest is effective for treating HAE attacks affecting the throat.

Haegarda is FDA-approved to help prevent attacks of HAE in adults as well as children ages 12 years and older.

Drug forms and administration

Ruconest and Haegarda both come as a single-use vial of powder that’s mixed with liquid to form a solution.

Ruconest is given as an intravenous (IV) infusion. This is an injection into a vein that’s given over a period of time. You’ll take Ruconest only when you need to treat an acute attack of HAE. The drug isn’t approved for helping prevent HAE attacks.

Haegarda is given as a subcutaneous injection (under the skin). You’ll likely take the medication twice a week (every 3 to 4 days) on a regular basis. Haegarda is used to help prevent HAE attacks.

In both cases, a healthcare provider can give you the drug, or they can teach you or a caregiver how to take Ruconest or Haegarda at home.

Side effects and risks

Ruconest and Haegarda both contain C1 esterase inhibitor. Therefore, these medications can cause very similar side effects, but some different ones as well. Below are examples of these side effects.

Mild side effects

These lists contain up to 10 of the most common mild side effects that can occur with Ruconest or Haegarda:

  • Can occur with Ruconest:
    • nausea
  • Can occur with Haegarda:
    • dizziness
    • reaction in the spot the drug was injected, such as rash, redness, bruising, and itching
  • Can occur with both Ruconest and Haegarda:
    • few shared mild side effects

Serious side effects

These lists contain examples of serious side effects that can occur with Ruconest, with Haegarda, or with both drugs (when taken individually).

Effectiveness

The only condition both Ruconest and Haegarda are used for is HAE.

These drugs haven’t been directly compared in clinical studies, but studies have found both Ruconest and Haegarda to be effective for managing HAE.

Costs

According to estimates on WellRx.com, the costs of Ruconest and Haegarda will vary depending on your treatment plan. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Ruconest and Haegarda are both brand-name drugs. Currently, there aren’t generic or biosimilar versions of either drug.

A biosimilar is a medication that’s similar to a brand-name drug. A generic medication, on the other hand, is an exact copy of the active ingredient in a brand-name drug.

Biosimilars are based on biologic medications, which are made from parts of living organisms. Generics are based on regular medications created from chemicals. Both biosimilars and generics tend to cost less than brand-name drugs.

The Food and Drug Administration (FDA) has approved Ruconest to treat acute attacks of hereditary angioedema (HAE). “Acute” means sudden and severe.

What happens in HAE

HAE is caused by an abnormality (error) in one of your genes. The genetic change leads to problems with a protein in your blood called C1 esterase inhibitor. With type 1 HAE, you have low levels of C1 esterase inhibitor in your blood or your body may not produce this protein at all. With type 2 HAE, you have faulty versions of this protein.

C1 esterase inhibitor normally controls level of another protein known as bradykinin. Your body produces bradykinin as part of its immune and inflammatory responses. Bradykinin allows fluid to leak out of blood vessels.

If you have low levels or faulty versions of C1 esterase inhibitor, your body will produce too much bradykinin. This allows excessive amounts of fluid to leak out of your blood vessels. The fluid builds up underneath your skin or mucous membranes, causing attacks of severe swelling. (Mucous membranes are linings of tissue that protect areas of the body, such as the mouth, with mucus.)

What Ruconest does

Ruconest is an artificial copy of the C1 esterase inhibitor protein. The drug replaces the missing or faulty protein in your blood, so it helps reduce the level of bradykinin. This stops your blood vessels from leaking and helps control attacks of swelling.

How long does it take to work?

On average, Ruconest starts to reduce swelling in about 75 to 90 minutes.

It’s not known if Ruconest is safe to take during pregnancy. The drug hasn’t been studied in pregnant women.

If you’re pregnant or plan to become pregnant, talk with your doctor about the risks and benefits of taking Ruconest. And if you become pregnant while taking Ruconest, tell your doctor right away.

It’s not known if Ruconest is safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Ruconest.

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

It’s not known if Ruconest passes into breast milk.

If you’re breastfeeding or plan to breastfeed, talk with your doctor about the risks and benefits of taking Ruconest.

Here are answers to some frequently asked questions about Ruconest.

Is it OK to take another dose of Ruconest if my symptoms don’t get better?

Yes. If your symptoms haven’t improved after taking your first dose of Ruconest, you can take a second dose. Ask your doctor how long you should wait before having the second dose. Be sure not to take more than two doses of Ruconest in 24 hours.

Does Ruconest help prevent attacks of hereditary angioedema?

It might. A study found that people with hereditary angioedema (HAE) who took Ruconest once or twice a week had fewer HAE attacks than people who took a placebo. (A placebo is a treatment containing no active drug).

Over 4 weeks, the following results were seen:

  • People who took Ruconest twice a week had an average of 2.7 HAE attacks.
  • People who took Ruconest once a week had an average of 4.4 HAE attacks.
  • People who took placebo once or twice a week had an average of 7.2 HAE attacks.

The Food and Drug Administration hasn’t approved Ruconest to help prevent attacks of HAE, so using the drug this way would be an off-label use of Ruconest. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

If you’re interested in using Ruconest to help prevent HAE attacks, talk with your doctor.

Can I use Ruconest for a laryngeal attack?

You can, but it’s not known how effective this is. Ruconest wasn’t assessed for treating laryngeal (throat) attacks in clinical studies.

With laryngeal attacks, you have swelling of your throat. You may have swelling or discomfort in your throat. These attacks can be life threatening because they can narrow your airway and make it hard to breathe.

If you have a laryngeal attack, take a dose of Ruconest, then immediately call 911 or your local emergency number, or go to the nearest emergency room.

Why do I have to avoid taking Ruconest if I’m allergic to rabbits?

Ruconest is produced using rabbits, so if you have a rabbit allergy, this drug could cause an allergic reaction. You shouldn’t take Ruconest if you’ve ever had an allergic reaction to rabbits or products made from rabbits.

If you’re allergic to rabbits, ask your doctor what other medications are better options for you.

Will Ruconest cure hereditary angioedema?

No, Ruconest won’t cure HAE because there’s no cure for the condition. However, when you take the drug to treat an HAE attack, Ruconest should help bring your symptoms under control within a few hours. Attacks that aren’t treated tend to take 3 to 4 days to ease.

Taking medication on a regular basis to help prevent HAE attacks may help reduce the number of attacks you have. For more information, see the “Ruconest use with other drugs” section above. Ruconest is approved to treat HAE attacks, not help prevent them.

If you have questions about how to best prevent or treat attacks of HAE, talk with your doctor.

This drug comes with several precautions. Before taking Ruconest, talk with your doctor about your health history. Ruconest may not be right for you if you have certain medical conditions or other factors affecting your health, including the following.

Rabbit allergy. You shouldn’t take Ruconest if you’ve ever had an allergic reaction to rabbits or products made from rabbits. Ruconest is produced using rabbits and could cause allergic reactions in people who have a rabbit allergy. Ask your doctor what other medications are better options for you.

Allergic reaction. You shouldn’t take Ruconest if you’ve ever had a life threatening allergic reaction (such as anaphylaxis) to Ruconest or any of its ingredients, or to any other C1 esterase inhibitor product. These include Cinryze, Berinert, and Haegarda. Ask your doctor what other medications are better options for you.

Risk of blood clots. Drugs that contain C1 esterase inhibitor from human plasma (such as Cinryze, Berinert, Haegarda) can cause blood clots in certain people. Ruconest contains an artificial C1 esterase inhibitor. It’s not known if Ruconest can cause blood clots.

You could be at risk for developing a blood clot while taking Ruconest if you’ve had one in the past or if you have an indwelling catheter in a vein. (An indwelling catheter in a vein is a tube that delivers medication or other fluids to your bloodstream.) Other risk factors for blood clots include having a high cholesterol level and being very overweight. Another risk for blood clots is being immobile, which means not moving for a time, such as during a long stay in a hospital.

If you could be at risk for developing a blood clot, talk with your doctor about whether Ruconest is right for you.

Pregnancy. It’s not known if Ruconest is safe to use during pregnancy. For more information, please see the “Ruconest and pregnancy” section above.

Breastfeeding. It’s not known if Ruconest passes into breast milk. For more information, please see the “Ruconest and breastfeeding” section above.

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

Do not use more Ruconest 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 Ruconest

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.

When you get Ruconest from the pharmacy, the pharmacist will add an expiration date to the label on the box. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee that the medication is effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk to your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

You should store unopened Ruconest vials at room temperature (36°F to 77°F / 2°C to 25°C). Don’t freeze Ruconest. Be sure to keep the vials in the box they come in to protect them from light. Avoid storing this medication in areas where it could get damp or wet, such as bathrooms.

If you add sterile water to a Ruconest vial, use the vial right away or within 8 hours, keeping it at 36°F to 46°F (2°C to 8°C).

Each vial is for single-use only. If there is medication left in the vial after you’ve taken your dose, you should dispose of this.

Disposal

Right after you’ve used a vial, syringe, or needle, dispose of it in an FDA-approved sharps disposal container. This helps prevent others, including children and pets, from taking the drug by accident or harming themselves with the needle. You can buy a sharps container online, or ask your doctor, pharmacist, or health insurance company where to get one.

This article provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.

The following information is provided for clinicians and other healthcare professionals.

Indications

Ruconest is approved by the Food and Drug Administration (FDA) to treat acute attacks of hereditary angioedema (HAE) in adults as well as children ages 13 years and older.

Ruconest was not studied for treating laryngeal attacks. It is not known if the medication is effective for treating laryngeal attacks of HAE.

Administration

Ruconest is administered by slow intravenous injection over 5 minutes. Patients or their caregivers can be trained to administer Ruconest.

Mechanism of action

HAE is caused by a genetic abnormality. People with type 1 HAE have low levels of C1 esterase inhibitor, while people with type 2 HAE have faulty versions of this protein. A lack of functioning C1 esterase inhibitor leads to a buildup of bradykinin, causing attacks of severe swelling.

C1 esterase inhibitor normally controls levels of bradykinin, which is produced as part of immune and inflammatory responses. Bradykinin allows fluid to leak out of blood vessels. C1 esterase inhibitor binds to and inactivates various proteases, including kallikrein and factor XIIa, thereby preventing the formation of bradykinin.

Ruconest contains recombinant C1 esterase inhibitor protein, which works in the same manner as human plasma-derived C1 esterase inhibitor. The drug replaces the missing or faulty protein, so it helps to reduce levels of bradykinin. This stops blood vessels from leaking and controls attacks of swelling.

Pharmacokinetics and metabolism

Following administration of Ruconest at a dose of 50 units (U) per kilogram, the average maximum concentration (Cmax) is 1.2 U/mL, reached after an average of 31 minutes.

Ruconest has an elimination half-life of approximately 2.5 hours.

Contraindications

Ruconest is contraindicated in people with:

  • history of allergy to rabbits or products made from rabbits
  • past sudden hypersensitivity reaction, such as anaphylaxis, to products containing C1 esterase inhibitor

Storage

Store unopened Ruconest vials at room temperature (36°F to 77°F / 2°C to 25°C). Do not freeze Ruconest. Keep the vial in the box it comes in to protect it from light.

Ruconest vials to which sterile water has been added should be used right away or within 8 hours when kept at a temperature of 36°F to 46°F (2°C to 8°C).

Each vial is for single-use only. Dispose of any medication remaining in the vial after giving a dose.

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 other 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.