Profilnine SD
Profilnine SD (factor IX) is a clotting factor replacement made from human blood products. It's used to prevent and control bleeding in people with a blood condition called hemophilia B (factor IX deficiency). This medication is given as an infusion into the vein (intravenously, or IV).
What is Profilnine SD (factor IX)?
What is Profilnine SD (factor IX) used for?
- To prevent or treat bleeding in people with hemophilia B
How Profilnine SD (factor IX) works
Profilnine SD (factor IX) is a coagulation (clotting) factor replacement. It consists of a complex (mixture) of different clotting factors used for bleeding problems in people with hemophilia B. Clotting factors are proteins in the blood that help control bleeding.
Hemophilia B is a genetic problem where people have a missing or defective clotting protein called factor IX. This causes them to bleed for a longer time than other people. Profilnine SD (factor IX) temporarily raises the blood levels of factor IX to help prevent or control this bleeding problem.
Drug facts
Side effects of Profilnine 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
- Headache
- Fever
- Chills
- Flushing or reddening of the skin
- Nausea
- Vomiting
- Tingling
- Weakness
- Hives
Profilnine SD (factor IX) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Serious allergic reaction: difficulty breathing, wheezing, chest tightness, hives, swelling of the face or tongue, dizziness, fast heart rate
- Blood clot: in the lungs (cough, difficulty breathing, chest pain); in the legs (redness, pain, tenderness, swelling of the skin); heart attack (chest pain, pain in the neck, jaw, arms, or shoulders); stroke (difficulty speaking, numbness on one side of the body, confusion)
The following Profilnine 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 Profilnine SD (factor IX)
No, Profilnine SD (factor IX) is only used for people with hemophilia B (factor IX deficiency). This medication contains a mixture of many clotting factors (clotting factors II, X, VII, and IX). The mixture has a high amount of factor IX, but not enough of the other factors in the mixture to treat other clotting factor deficiencies. If you have bleeding problems due to reasons other than factor IX deficiency, speak with your provider to find the right treatment for you.
How long you need to receive Profilnine SD (factor IX) depends on how severe your bleed is. It can be as short as 1 day for a minor bleed. It can also be up to 10 days for a major, more serious bleed or for surgery procedures. In some cases, your treatment might be longer depending on how long it takes for you to heal from the bleed or from the surgery and the factor IX levels in your blood. Speak with your provider to see how long you need to continue your treatment with Profilnine SD (factor IX).
It's not known whether Profilnine SD (factor IX) can cause harm to your unborn baby if it's given during pregnancy. This medication should only be given during pregnancy only if clearly needed. Speak to your provider if you're pregnant or planning to become pregnant to discuss whether Profilnine SD (factor IX) is the right treatment for you.
Bebulin (factor IX complex) is another brand of medication similar to Profilnine SD (factor IX). The difference between the two medications is that Bebulin contains heparin (a blood thinner) to lower the risk of blood clots, while Profilnine SD (factor IX) doesn't. Bebulin has been discontinued by its manufacturer (Shire) due to low demand, and not because of any safety or effectiveness concerns with the medication.
Both Profilnine SD (factor IX) and AlphaNine SD (factor IX human plasma) are made from human blood and are used to prevent and treat bleeding in people with hemophilia B or factor IX deficiency. The differences between the two medications include the amount of clotting factors, the inactive ingredients, and how they're made. Speak to your provider to determine which medication is right for you.
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Risks and warnings for Profilnine SD (factor IX)
Profilnine 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.
Blood clots
- Risk factors: Blood clot problems | During or right after surgery | Liver problems
Profilnine SD (factor IX) can raise your risk of blood clots. Your risk is higher if you're getting surgery, recovering from a surgery, have a history of liver problems, and have signs of bleeding or blood clotting problems. If you're at high risk of getting blood clots, your provider will check your blood work and monitor you for signs of clots. Depending on the location of the clot in your body, you might experience different symptoms. In general, get emergency medical help if you have any signs and symptoms of a blood clot, such as cough, chest pain, difficulty breathing, swelling or warmth in the legs, and weakness on one side of the face, legs, or arm.
Development of antibodies
Some people can develop antibodies (also called inhibitors) against Profilnine SD (factor IX) after treatment. These antibodies can block the medication from working as well as it should and can make Profilnine SD (factor IX) less effective. Let your provider know if you notice your bleeding isn't under control after receiving your Profilnine SD (factor IX) treatment. They can check your antibody levels and make adjustments to your treatment plan, if needed.
Allergic reaction
- Risk factors: Allergy to latex
Although rare, Profilnine SD (factor IX) can cause allergic reactions, including anaphylaxis. Some of the packaging of Profilnine SD (factor IX) can contain natural rubber latex, so let your provider know if you have an allergy to latex. Get emergency medical help right away if you experience any signs or symptoms of an allergic reaction, such as hives, swelling, chest tightness, shortness of breath, wheezing, dizziness, or fast heart rate.
Infections
- Risk factors: Medical conditions that lower your immune system | Taking medications that can lower your immune system
Because Profilnine 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 low, because the donors of these blood products are carefully screened. Also, there are high manufacturing standards put into place to test the blood for infections and 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.
Profilnine SD (factor IX) dosage
Kit| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 500iu of blue | 1 kit | $754.25 | $754.25 |
| 1500iu of black | 1 kit | $2,250.25 | $2,250.25 |
Typical dosage for Profilnine SD (factor IX)
This medication is infused through the veins, typically by a healthcare provider. Your dose will depend on your body weight, the reason you're using it, and how severe your bleed is.
In general, you'll receive Profilnine SD (factor IX) every 16 to 24 hours, for 1 to 10 days.
Your provider will adjust the dose throughout your treatment based on how your body responds to the medication.
Interactions between Profilnine 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 Profilnine SD (factor IX) cost?
$754.25
