How Assistance Works
Streamlining our patient’s specialty pharmacy experience with unmatched full-service convenience
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1. Check Your Coverage/Benefits Verification
Our team of expert billers finds the best avenues of coverage that minimize out-of-pocket costs.
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2. Transfer Prescription to AmeriPharma®
We process your prescription by working with your previous pharmacy or prescriber, making the transition quick and easy.
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3. Prior Authorization
Our team of specialists obtains approval from your insurance companies within 24 to 72 hours.
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4. Copay Assistance & Financial Aid
We secure financial aid and decrease copays, out-of-pocket expenses, and high deductibles. To date, AmeriPharma® Specialty Care has secured $55 million in financial assistance for our patients.
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5. Nursing Care Coordination If Needed
AmeriPharma® puts your schedule and home environment first when scheduling and coordinating one of our specialized nurses for your in-home infusions.
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6. Delivery Coordination
Medications are always delivered in strict compliance with the specific requirements for shipping. Next-day and overnight cold-chain deliveries are coordinated around your schedule.
What Is Profilnine SD?
Profilnine SD (Factor IX complex) is a replacement therapy used to prevent and control bleeding in people with factor IX deficiency due to hemophilia B. Hemophilia B is an inherited bleeding disorder in which the body does not produce enough functional factor IX, a protein needed for normal blood clotting.
Profilnine SD is made from pooled human plasma and is administered intravenously (into a vein). It temporarily increases factor IX levels to help the blood clot properly and prevent or control excessive bleeding.
Profilnine SD is manufactured by Grifols Biologicals LLC and was originally approved by the FDA on July 20, 1981. In this article, we’ll discuss important information about Profilnine SD, including its uses, dosage, administration, side effects, warnings, and precautions.
Profilnine SD: Approved Uses
Profilnine SD is FDA-approved for the prevention and control of bleeding in people with factor IX deficiency due to hemophilia B.
Hemophilia B, sometimes called Christmas disease, is an inherited bleeding disorder caused by a deficiency or dysfunction of clotting factor IX. Without enough functional factor IX, the blood does not clot properly, which can cause prolonged or excessive bleeding.
Profilnine SD temporarily replaces deficient factor IX to help prevent or control bleeding.
Mode of Action
Profilnine SD contains clotting factor IX along with factors II and X and low levels of factor VII. In people with hemophilia B, Profilnine SD temporarily replaces deficient factor IX, increasing factor IX activity in the blood and helping the normal blood-clotting process occur.
The effects of factor IX replacement therapies are temporary, so additional doses may be necessary depending on the severity and location of bleeding, the desired factor IX level, and the patient’s response to treatment.
How Profilnine SD Copay Assistance Works
AmeriPharma® Specialty Pharmacy alleviates financial burdens for patients and their families
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Advanced software locates funding sources to match you with top-dollar foundation programs
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One of our copay assistance specialists will assist with the application process
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Automatic updates will be sent to you and your physician on the status of the funding
Dosage and Administration
Profilnine SD is administered intravenously after reconstitution. The infusion rate should not exceed 10 ml per minute because administering the medication too rapidly may cause vasomotor reactions. The appropriate dose varies from person to person and should be determined by a healthcare provider.
The dose may depend on factors such as:
- Body weight
- Baseline factor IX level
- Desired factor IX level
- Location and severity of bleeding
- Individual response to treatment
- Whether treatment is needed around a surgical procedure
How Is the Profilnine SD Dose Calculated?
According to the prescribing information, approximately 1 unit of factor IX per kilogram of body weight can be expected to increase circulating factor IX levels by about 1%. However, individual responses may vary.
A healthcare provider may estimate the required dose using the following formula:
Body weight (kg) × desired increase in factor IX (%) × 1 unit/kg = factor IX units required
Factor IX levels should be monitored to help determine whether the desired level has been achieved and maintained.
Typical Dose of Profilnine SD for Hemophilia B
Factor IX dosing depends on bleeding severity. For minor to moderate bleeding, levels are raised to 20–30% every 16–24 hours, with treatment lasting 1–2 days for minor bleeds and 2–7 days for moderate ones.
For major bleeding, levels are first raised to 30–50%, then maintained at 20% until healing, typically over 3–10 days.
For surgery, levels are raised to 30–50% beforehand (up to 50% for dental extractions) and maintained until healing, usually 7–10 days, with doses given every 16–24 hours throughout. In short, more severe bleeding requires higher factor IX levels and longer treatment.
Profilnine SD Side Effects
Side effects include:
- Headache
- Fever
- Chills
- Flushing
- Nausea
- Vomiting
- Tingling
- Lethargy (lack of energy)
- Hives
Serious adverse reactions include:
- Severe allergic or hypersensitivity reactions, including anaphylaxis
- Abnormal blood clot formation (thrombosis), including deep vein thrombosis (DVT) and pulmonary embolism (PE)
- Disseminated intravascular coagulation (DIC), a serious condition that causes abnormal clotting throughout the body’s blood vessels
- Development of factor IX inhibitors, which can make factor IX replacement therapy less effective
Insurances Accepted
We accept Medicare, multi-state Medicaid, Medi-Cal, Blue Shield, and most private insurances. Call us to find out more about your coverage.
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