CINRYZE® (C1 esterase inhibitor [human]) is an injectable prescription medicine that is used to help prevent swelling and/or painful attacks in children (6 years of age and older), teenagers and adults with Hereditary Angioedema (HAE).
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About CINRYZE
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Q
What is CINRYZE used for?
A
CINRYZE is a prescription medicine used to help prevent swelling and/or painful attacks in children (6 years of age and older), teenagers and adults with HAE.
CINRYZE contains C1 esterase inhibitor, or C1-INH, a protein that is missing, deficient or working improperly in most patients with HAE. CINRYZE was the first C1-INH therapy approved by the FDA for the routine prevention of HAE attacks in children (6 years of age and older), teenagers and adults. CINRYZE can help reduce the frequency and severity of attacks.
Q
Who can use CINRYZE?
A
CINRYZE is an injectable prescription medicine that is used to help prevent swelling and painful attacks in children (6 years of age and older), teenagers and adults. Teenagers and adults can be taught how to self-administer CINRYZE. A healthcare provider can also train a parent or caregiver to administer CINRYZE to a child. Do not try to self-administer CINRYZE until a healthcare professional has taught you how.
You should not use CINRYZE if you have had life-threatening immediate hypersensitivity reactions, including anaphylaxis to the product.
Would you like to see if preventing HAE attacks with CINRYZE could be an option for you? Fill out this Doctor Discussion Guide for help talking with your doctor.
Q
What should I tell my doctor before using CINRYZE?
A
Tell your healthcare provider about all of your medical conditions, including if you:
- Have an indwelling catheter or access device in one of your veins
- Have a history of blood clots, heart disease, or stroke
- Are taking birth control pills or androgens
- Are pregnant or planning to become pregnant. It is not known if CINRYZE can harm your unborn baby
- Are breastfeeding or plan to breastfeed. It is not known if CINRYZE passes into your milk and if it can harm your baby
Tell your healthcare provider and pharmacist about all of the medicines you take, including all prescription and nonprescription medicines, such as over-the-counter medicines, supplements and herbal remedies.
Would you like more help preparing to talk with your doctor about CINRYZE?
Q
How is CINRYZE made?
A
CINRYZE is made from purified human blood. It is collected from plasma donors at licensed collection centers throughout the United States. Then it goes through a complex purification process designed to reduce the chance that certain viruses could be transmitted.
This process includes:
- Careful donor screening
- Testing for the presence of viruses
- Pasteurization
- Nanofiltration
Because CINRYZE is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
Q
What are the side effects of CINRYZE?
A
Allergic reactions may occur with CINRYZE. Call your healthcare provider or get emergency support services right away if you have any of the following symptoms:
- Wheezing
- Difficulty breathing
- Chest tightness
- Turning blue (look at lips and gums)
- Fast heartbeat
- Swelling of the face
- Faintness
- Rash
- Hives
Serious blood clots may occur with CINRYZE. Call your healthcare provider or get emergency support services right away if you have any of the following symptoms:
- Pain and/or swelling of an arm or leg with warmth over the affected area
- Discoloration of an arm or leg
- Unexplained shortness of breath
- Chest pain or discomfort that worsens on deep breathing
- Unexplained rapid heart rate
- Numbness or weakness on one side of the body
In clinical studies, the most common side effects seen with CINRYZE were headache, nausea, rash and vomiting.
These are not all the possible side effects of CINRYZE.
Tell your healthcare provider about any side effect that bothers you or that does not go away. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Q
Who should not use CINRYZE?
A
You should not use CINRYZE if you have had a life-threatening allergic reaction, including anaphylaxis, to the product.
Q
Will my insurance cover CINRYZE?
A
If eligible when starting CINRYZE, you can enroll in Takeda Patient Support, Takeda's product support program. Once enrolled, a support specialist will facilitate a benefits investigation and can help you understand your coverage and benefits. They can also provide you with information about financial assistance options.
Q
How do I take CINRYZE?
A
CINRYZE is given by intravenous (or IV) injection every 3 or 4 days. Depending on your prescribed dose, it takes about 10 minutes to inject a dose of CINRYZE in adults and adolescents, and about 5 minutes to inject in children (≥6 years). You can choose to have your injection administered by a healthcare provider or caregiver, or you can be trained to give it to yourself. This is called self-administration. Do not try to self-administer CINRYZE until a healthcare professional has taught you how. A healthcare provider can also train a parent or caregiver to administer CINRYZE to a child.
Q
How often is CINRYZE administered?
A
CINRYZE is administered every 3 or 4 days to help prevent HAE attacks in people with HAE. Your doctor will determine exactly how often you should use CINRYZE.
Q
Who can give the CINRYZE injection?
A
Your healthcare provider or a caregiver who has been trained by a healthcare professional can administer CINRYZE. Or, a healthcare professional can teach you how to administer CINRYZE on your own. Once you learn how to self-administer, be sure to follow your doctor's instructions carefully. If you find that you need additional training on how to self-administer CINRYZE, you can learn through the Path to Independence program. Do not try to self-administer CINRYZE until a healthcare professional has taught you how.
Q
What if I'm traveling when I need to take CINRYZE?
A
You should plan to bring enough CINRYZE for your treatment when traveling, so talk to your doctor about your supply and treatment plan. You may also want to learn how to self-administer CINRYZE through the Path to Independence™ Program. Do not try to self-administer CINRYZE until a healthcare professional has taught you how.
Q
How can I get started with CINRYZE?
A
Talk to your doctor about whether CINRYZE might be right for you. If your doctor prescribes CINRYZE, you have the option to enroll in Patient Support, a product support service for eligible patients.
If you'd like help talking with your doctor about CINRYZE, you can fill out a discussion guide and bring it with you to your appointment.
Q
How should I store CINRYZE?
A
Store CINRYZE in a refrigerator or at room temperature between 36° to 77° F (2° to 25° C). In addition:
- Do not freeze CINRYZE
- Keep CINRYZE in the original carton to protect it from light until ready for use
- Do not use CINRYZE after the expiration date on the vial
- After preparing CINRYZE, you can store it at room temperature for up to 3 hours. If you have not used it within 3 hours, throw it away
Q
What is HAE?
A
Hereditary angioedema (HAE) is a rare genetic condition that can cause sudden attacks of sometimes painful swelling anywhere in the body, but the most common locations include the face, hands, feet, genitals, abdomen and throat.
It's important to remember that an HAE attack that affects the throat is potentially life-threatening, because it can interfere with breathing. It's important that you have a plan in place for this type of attack and seek emergency care as soon as possible.
Q
What causes HAE?
A
Most people with HAE either don't have enough of a protein called C1 esterase inhibitor (C1-INH) or the protein they have doesn't work the way it should. When there isn't enough C1 esterase inhibitor or it isn't working properly, it can initiate episodes of swelling.
75% of HAE cases are passed down through families. The other 25% develop HAE because of a spontaneous change in their genetic code, so family history doesn't always help with diagnosis.
Q
Can it be difficult to get an HAE diagnosis?
A
HAE is rare, so getting an accurate diagnosis can be challenging. The average person with HAE searches for approximately 10 years before receiving a diagnosis, and one survey of 313 patients showed that up to 65% of people with HAE have been previously misdiagnosed with another condition.
If you'd like help talking with a doctor about your symptoms, you can fill out our discussion guide and bring it with you to your appointment.
Q
If I have HAE, will I pass it on to my child?
A
HAE is a genetic disorder that can be passed on from parent to child. If you have HAE, there is a 50% chance you will pass it on to your child. Ask your doctor about any family planning questions you may have.
Q
What are the symptoms of an HAE attack?
A
HAE can cause sudden attacks of sometimes painful swelling anywhere in the body, but the most common locations include the face, hands, feet, genitals, abdomen and throat.
HAE symptoms can be very different from person to person. HAE symptoms can also change within the same person. For instance, the frequency of attacks might increase as a patient enters adolescence.
To learn more about HAE symptoms, how they can affect various parts of the body, and what can trigger an attack, take a look at the information on our HAE symptoms and triggers page.
Q
What can trigger an HAE attack?
A
Although triggers can be different for everyone with HAE, some common triggers include:
- Emotional stress
- Injury
- Infection
- Hormonal influences, like menstruation
- Mechanical pressure from physical activities like typing or mowing the lawn
It's also important to remember that HAE attacks can happen without warning or an obvious trigger.
Q
Are there any signs that an HAE attack is coming on?
A
Some people experience early warning signs before an attack, such as a tingling sensation in the affected area. It's also not uncommon for people to get a rash before the swelling begins. Please keep in mind that an HAE attack can also happen without warning, so you should always be prepared in case of an emergency.
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