AlphaNine SD
AlphaNine SD (factor IX) is a clotting factor replacement made from human plasma. It's used to prevent and control bleeding in people with hemophilia B (also known as Christmas disease or factor IX deficiency). It's given through the vein (intravenously, or IV) as an infusion. AlphaNine SD (factor IX) isn't as commonly prescribed as other recombinant (lab-made) factor IX products, such as Benefix (factor IX).
What is AlphaNine SD (factor IX)?
What is AlphaNine SD (factor IX) used for?
- To prevent or treat bleeding in adults with hemophilia B
How AlphaNine SD (factor IX) works
AlphaNine SD (factor IX) is a clotting factor replacement used for people who are missing the clotting factor called factor IX. Factor IX (a protein) is one of many clotting factors that works in your body to form blood clots. AlphaNine SD (factor IX) replaces the missing factor IX to help prevent and treat bleeding in people with hemophilia B.
Drug facts
Side effects of AlphaNine SD (factor IX)
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
- Mild chills
- Nausea
- Stinging at the injection site
AlphaNine SD (factor IX) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Serious allergic reaction (anaphylaxis): difficulty breathing, hives, itching, fast heartbeat, tightness in the throat, nausea, stomach pain, dizziness, lightheadedness, swelling in the face or tongue
- Blood clots: lungs (cough, difficulty breathing, chest pain), legs (redness, pain, tenderness, swelling of the skin), heart attack (chest pain, pain in the arms or shoulders, pain in the neck or jaw), stroke (difficulty speaking, numbness on one side of the body, confusion)
The following AlphaNine SD (factor IX) 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 immediately if any of the following side effects occur:
Check with your doctor immediately if any of the following side effects occur:
More common
Bluish coloring (especially of the hands and feet)
convulsions
dizziness or lightheadedness when getting up from a lying or sitting position
increased heart rate
large blue or purplish patches in the skin (at places of injection)
nausea or vomiting
pains in chest, groin, or legs (especially calves)
persistent bleeding from puncture sites, gums, or inner linings of the nose and/or mouth, or blood in the stool or urine
severe pain or pressure in the chest and/or the neck, back, or left arm
severe, sudden headache
shortness of breath or fast breathing
sudden loss of coordination
sudden and unexplained slurred speech, vision changes, and/or weakness or numbness in arm or leg
Check with your doctor immediately if any of the following side effects occur:
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.
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Common questions about AlphaNine SD (factor IX)
Hemophilia B is a rare blood condition that makes it difficult for your blood to clot. This condition is typically genetic, meaning it's passed down from parent to child. But in some cases, people with this condition have no prior family history. If you have hemophilia B, your body is missing factor IX, which is one of the clotting factors your body needs to make clots. Without this clotting factor, you're at a higher risk for bleeds and can experience symptoms ranging from minor bruising and bleeding to more serious bleeding in the muscles and joints, depending on how severe your condition is.
AlphaNine SD (factor IX) is typically only used on an "as-needed" basis, meaning you'll only receive treatment when you experience a bleed or to prevent bleeds during surgery. Your length of treatment typically ranges from 1 to 10 days, depending on how serious your condition is and how well your body responds to this medication. Some people with hemophilia B need to have regular factor IX replacements to prevent future bleeds (prophylaxis treatment), but AlphaNine SD (factor IX) isn't approved for prophylaxis. Talk with your provider if you've any questions about how long you need AlphaNine SD (factor IX) treatment.
Ask your provider if it's okay for you to give yourself AlphaNine SD (factor IX) infusions at home. Because this product is typically used during an active bleed or during surgery, you'll probably receive AlphaNine SD (factor IX) under the care of a healthcare provider. But sometimes, it might be possible for you to receive AlphaNine SD (factor IX) at home. Ask your provider if or when home infusions might be appropriate for you.
Both AlphaNine SD (factor IX) and Benefix (factor IX) are clotting factor replacements used to treat hemophilia B. The main difference between them is how they're made. AlphaNine SD (factor IX) is made from donated human plasma, while Benefix (factor IX) is made in a lab using recombinant technology. Because AlphaNine SD (factor IX) is made from donated human plasma, there's a very small chance that it can contain viruses or other infectious material from human blood (though the manufacturer takes many steps to make sure it's safe). Recombinant products, such as Benefix (factor IX), are generally considered safer because they're made in the lab and don't carry the same risk of potential infections from receiving human-derived products. Currently, providers typically prefer recombinant factor IX products over ones made from human plasma.
AlphaNine SD (factor IX) hasn't been well studied in human pregnancy, so it's not known whether this medication is safe in pregnant females. AlphaNine SD (factor IX) should only be used in pregnancy only if it's clearly needed. If you're pregnant, or thinking of becoming pregnant, talk with your provider about the risks and benefits of using AlphaNine SD (factor IX) before starting this medication.
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Risks and warnings for AlphaNine SD (factor IX)
AlphaNine SD (factor IX) 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.
Serious allergic reactions
Serious allergic reactions to AlphaNine SD (factor IX) are possible, including life-threatening reactions like anaphylaxis (closing of the throat). This can happen anytime during or after an infusion. If you're being treated with AlphaNine SD (factor IX) for the first time, your risk of an allergic reaction might be higher around days 10 to 12 of treatment. If you notice dizziness, a choking sensation, sweating, dizziness, nausea, swelling around your eyes, swelling of the lips or tongue, or difficulty breathing after using AlphaNine SD (factor IX), stop using it and get medical help right away.
Risk of blood clots
- Risk factors: History of blood clot problems | High blood pressure | High cholesterol | High blood sugar | Obesity | Cancer | Surgery | Taking estrogen-containing birth control | Not moving much or exercising | Smoking tobacco | Pregnancy | Liver problems
AlphaNine SD (factor IX) can raise your risk of getting blood clots in various parts of your body as well as also cause a condition called disseminated intravascular coagulation (DIC), which is when your body forms abnormal clots throughout your body. Symptoms of a blood clot might be different depending on the location of the clot, but they can include chest pain, difficulty breathing, swelling or warmth in the legs, and weakness of the face, legs, or arms. Call 911 if you have any of the symptoms above because this is a medical emergency.
Infections
- Risk factors: Medical conditions that weaken your immune system | Taking medications that can weaken your immune system
Because AlphaNine SD (factor IX) is made from human blood products, there's a risk that it might contain viruses that can make you sick. But your risk of infection is pretty low because donors of these blood products are screened. Also, there are high manufacturing standards put into place to make sure the viruses are killed or removed. To prevent serious infections in the rare case that your medication is affected, let your provider know right away if you start to feel sick or have symptoms such as feeling confused and anxious, or having trouble maintaining your balance. Make sure you're up to date on your vaccines before starting AlphaNine SD (factor IX) to prevent infections.
AlphaNine SD (factor IX) dosage
Kit| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| single dose of 500iu blue | 2 kits | $1,607.16 | $803.58 |
| single dose of 1000iu red | 45 kits | $77,406.26 | $1,720.14 |
| single dose of 1500iu black | 10 kits | $24,069.09 | $2,406.91 |
Typical dosage for AlphaNine SD (factor IX)
Your provider will determine your dose of AlphaNine SD (factor IX) based on the reason you're using it, your weight, how severe your bleed is, and how well your body responds to this medication. It's typically given to you twice a day through your veins (IV) by a healthcare provider.
Interactions between AlphaNine SD (factor IX) 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
How much does AlphaNine SD (factor IX) cost?
$1,607.16
