Feiba
Feiba (anti‐inhibitor coagulant complex) is used for people with hemophilia A or hemophilia B who have developed inhibitors. Inhibitors are antibodies that can make other clotting factor treatments not work as well. Feiba works as a bypassing agent to help control and prevent bleeding episodes. It can also help manage bleeding from surgery. Feiba comes as a powder that's mixed with sterile water and injected into a vein. It’s given as needed for bleeds or surgery. And for routine prevention of bleeding, it's given every other day. Some side effects are nausea, vomiting, and diarrhea. Serious blood clots can also happen, especially with high daily doses.
What is Feiba?
What is Feiba used for?
- For people with hemophilia A or hemophilia B with inhibitors to:
- Control and prevent bleeding episodes
- Control bleeding before and after surgery
- Prevent or reduce how often bleeds happen overall
How Feiba works
People with hemophilia are missing essential clotting factors to help stop bleeding. They're often treated with specific clotting factors. These are factor VIII products for hemophilia A and factor IX products for hemophilia B. But sometimes, the body makes antibodies, called inhibitors, that stop these treatments from working well.
This is where Feiba can come in to help. It works as a bypassing agent. It contains several clotting factors (mainly non‑activated factors II, IX, X and activated factor VII). It helps the blood clot in a way that goes around the blocked step caused by inhibitors. This helps form a stable clot so bleeding can stop.
Drug facts
| Common Brands | Feiba |
|---|---|
| Drug Class | Anti-inhibitor coagulant complex |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | No lower-cost generic available |
| Availability | Prescription only |
Side effects of Feiba
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Bleeding in a joint (8%)
- Anemia (low red blood cells, 6%)
- Diarrhea (6%)
- Nausea (6%)
- Vomiting (6%)
Less Common Side Effects
- Infusion reaction (chills, fever, chest discomfort, dizziness)
Note: Side effects were reported by people taking Feiba for routine bleeding prevention.
Feiba serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Serious allergic reactions: hives; rash; swelling of the face, lips, or tongue; tightness in the throat; wheezing; dizziness; fainting
- Infusion reactions: chills, fever, feeling unwell, high blood pressure, chest tightness
- Blood clots: chest pain or pressure, shortness of breath, sudden weakness or numbness on one side of the body, trouble speaking or walking, vision changes, leg swelling or pain, coughing up blood
The following Feiba side effects have also been reported
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
Incidence not known
Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
chest pain or discomfort
difficulty with swallowing
dizziness
fast heartbeat
hives or welts
hoarseness
irritation
joint pain, stiffness, or swelling
pain in the injection site
pain or discomfort in the arms, jaw, back, or neck
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
redness of the skin
shortness of breath
skin rash
sweating
swelling of the eyelids, face, lips, hands, or feet
tightness in the chest
troubled breathing or swallowing
unusual tiredness or weakness
vomiting
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Pros and cons of Feiba
Pros
- Works even when you have inhibitors to factor VIII or IX
- Only medication of its kind that's approved for routine bleeding prevention in people with hemophilia A or B who have inhibitors
- Helps control active bleeds and bleeding from surgery
- Used for general bleeding prevention in people with hemophilia A or B who have inhibitors
Cons
- Must be mixed before it's given through a vein
- Might need to take up to 4 times a day for active bleeds
- Risk of serious blood clots, especially with high daily doses
- Can interact with some medications that prevent clots from breaking down (antifibrinolytics)
Pharmacist tips for Feiba
- Depending on the situation, you might be able to give Feiba to yourself at home. This is if your prescriber thinks it's safe and appropriate for you. Make sure you complete the training with your care team on how to use, prepare, and give it safely on your own.
- Make sure you know how much Feiba to give each time. Also avoid extra or early doses. Taking too much in a day can raise the risk of dangerous blood clots. Your care team can help you adjust your plan if needed.
- Watch for symptoms of blood clots while taking Feiba. This medication can raise your risk of blood clots, which can be serious. Get medical help right away if you have chest pain, sudden trouble breathing, severe headache, trouble speaking, vision changes, numbness on one side of the body, or a swollen, painful arm or leg.
- Tell your care team and pharmacist about all the medications you take. Some medications can raise your risk of dangerous blood clots when used with Feiba. This includes medications that help stabilize blood clots, like tranexamic acid (Cyklokapron). Your care team can check for harmful drug interactions and adjust your treatment to keep you safe.
- Also tell your care team if you're taking or have recently taken Hemlibra (emicizumab). Using Feiba with Hemlibra can raise the risk of serious blood clots and blood vessel problems. This risk can still be there months after stopping Hemlibra. Never change your Feiba dose on your own while taking these medications. Your hemophilia specialist will monitor for clot problems and change your treatment plan if needed to help keep you safe.
- How to store Feiba: Keep unopened Feiba vials at 36°F to 77°F. Store in the original box to protect the medication from light. Don’t freeze the vials.
How to mix and give Feiba at home:
- Review the instructions that came with your prescription. Ask your hemophilia specialist or care team if you have any questions.
- Write down the product name and lot and batch number each time you use Feiba. This helps with safety tracking if side effects happen.
- Don’t mix Feiba with other medications in the same IV line or tubing. Flush the IV line with saline before and after using Feiba. This helps make sure the medication is given correctly and lowers the risk of drug interactions or reactions.
- Before mixing and injecting Feiba: Wash your hands with soap and water to prevent infection. Let the Feiba vial and the sterile water reach room temperature if refrigerated.
- How to mix Feiba: Clean the tops of the Feiba vial and sterile water vial with an alcohol wipe. Then, connect the BAXJECT II Hi‑Flow transfer device to the vials as shown in your kit instructions. After the vials are connected, the vacuum will pull the sterile water into Feiba powder vial. Gently swirl (don’t shake) until the powder dissolves. The solution should look clear and colorless to slightly yellow.
- When to use the prepared Feiba solution after mixing: Inject or infuse the dose within 3 hours after mixing. Don’t refrigerate the prepared solution. And, discard any leftover solution safely.
- How to draw up Feiba into a syringe and give the medication: Connect a plastic Luer lock syringe to the BAXJECT II Hi‑Flow device. Turn the system so the Feiba solution is on top. Then, slowly draw the medication into the syringe to avoid foaming. Disconnect the syringe, attach the needle or tubing, and give into a vein as you were trained. It shouldn't be given any faster than 10 units/kg per minute.
- How to clean up your Feiba supplies: Throw away used vials and needles in a sharps container. This helps protect you and others from getting hurt from needles.
Risks and warnings for Feiba
Feiba can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Blood clots
- Risk factors: History of blood clot | Blood-clotting problems | Severe plaque buildup in the blood vessels (atherosclerotic disease) | Past crush injuries | History of a serious blood infection (sepsis) | Receiving recombinant factor VIIa | Taking Feiba following treatment with Hemlibra (emicizumab) | Daily doses of Feiba above 200 units/kg
The way Feiba works to stop bleeding can also raise your risk for blood clots. These clots can happen in parts of your body other than where your bleeding is and can be very dangerous. Because of this, your prescriber will make sure the benefits of treatment are greater than the risks. They'll choose the lowest Feiba dose you need.
To be safe, be aware of the signs of a blood clot. They can be different depending on where the clot is. This can include swelling and pain in your arms, legs, or stomach. More serious blood clots can cause chest pain or pressure, numbness on one side of the body, trouble breathing or speaking, or confusion. If this happens while taking Feiba, get medical help right away.
Using Feiba after Hemlibra (emicizumab) can raise the risk of clots in small blood vessels and other clots. This risk can last for up to 6 months after your last Hemlibra (emicizumab) dose. This is because the medication stays in your body for a long time. Your prescriber will weigh the risks and benefits of using these medications together. If this is the right choice, they'll monitor your blood counts and other labs closely for problems.
Infusion reactions and allergic reactions
Feiba can cause infusion reactions like chills, fever, and high blood pressure. In rare cases, serious allergic reactions, including anaphylaxis, can also happen. Symptoms include hives, swelling of the face or throat, wheezing, or severe stomach upset. Other symptoms are low blood pressure or even shock.
If you have signs of a serious allergic reaction, stop the Feiba infusion and get emergency help right away. Your care team might recommend keeping rescue medications nearby. It's a good idea to make sure someone is with you during your infusion in case you need help.
Risk of infection
Feiba is made from human blood products. Because of this, there's a risk that it could contain viruses or other germs that can cause infection. But the risk is very low. Blood donors are carefully screened, and the blood products are tested for germs. Also during the manufacturing process, there are protocols and high standards to make sure the germs are killed or removed.
To help prevent serious infections just in case, make sure you're up to date on your vaccines before starting Feiba. During treatment, watch for signs of infection. This includes fever, chills, runny nose followed by rash or joint pain, poor appetite, tiredness, belly pain, dark urine, or yellow skin or eyes. Call your care team right away if you start to feel sick or have any of these symptoms.
Feiba dosage
Typical dosage for Feiba
The dose will depend on the situation you're in. In general, your prescriber will calculate the dose based on your body weight.
Feiba is given through your vein as an injection or infusion (intravenous or IV). A trained healthcare professional usually gives it. In some cases, your prescriber might decide it's appropriate and safe for you to give Feiba to yourself after you've been properly trained.
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Control and prevention of bleeding: The dose depends on where the bleed is and how serious it is. The dose ranges from 50 units/kg to 100 units/kg. This dose is given every 6 to 12 hours until the bleeding stops.
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Control of bleeding around surgery
- Before surgery: The typical dose is 50 units/kg to 100 units/kg given once just before surgery.
- After surgery: The typical dose is 50 units/kg to 100 units/kg given every 6 to 12 hours until bleeding stops and there are signs of healing.
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Routine prevention of bleeding: The typical dose is 85 units/kg given every other day.
Your dose can differ based on how you respond to the medication and your overall health.
The maximum recommended dose is 100 units/kg or a total of 200 units/kg in 24 hours. The infusion rate should not be faster than 10 units/kg per minute.
Interactions between Feiba and other drugs
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Aminocaproic Acid
- Coagulation Factor VIIa
- Emicizumab
- Tranexamic Acid
Feiba contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Feiba will not be safe for you to take.
- History of allergic reaction to Feiba
- Blood-clotting problem called disseminated intravascular coagulation (DIC)
- Blood clot, including heart attack
What are alternatives to Feiba?
To treat active bleeds or to prevent bleeding episodes during surgery in people with the following conditions:
