BeneFIX

Name: BeneFIX

Storage

Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Reviewed on 4/16/2014 References

Uses of BeneFIX

BeneFIX is a prescription medication used for:

  • control and prevention of bleeding episodes in adults with hemophilia B
  • perioperative (before and after surgery) use in adults with hemophilia B

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

BeneFIX Drug Class

BeneFIX is part of the drug class:

  • Blood coagulation factors

BeneFIX and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

BeneFIX falls into category C. No studies have been done in animals, and there are no well-done studies in pregnant women. BeneFIX should be given to a pregnant woman only if clearly needed.

BeneFIX Usage

Take BeneFIX exactly as prescribed.

BeneFIX is given directly into the vein. BeneFIX should be administered as ordered by your healthcare provider. 

You may have to have blood tests done after getting BeneFIX to be sure that your blood level of factor IX is high enough to clot your blood. Call your healthcare provider right away if your bleeding does not stop after taking BeneFIX.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of BeneFIX at the same time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

BeneFIX (coagulation factor IX) side effects

Get emergency medical help if you have signs of an allergic reaction: hives; wheezing, tightness in your chest, difficult breathing, fast heartbeats, blue lips, feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • swelling in your feet or ankles, weight gain, loss of appetite;

  • fever or chills;

  • continued bleeding after treatment;

  • new or worsened bleeding; or

  • signs of excessive blood clotting--sudden numbness or weakness (especially on one side of the body), slurred speech, problems with vision or balance, chest pain, coughing up blood, or pain, swelling, warmth and redness in one or both legs.

Common side effects may include:

  • nausea;

  • headache;

  • dizziness;

  • altered sense of taste;

  • mild skin rash; or

  • pain, stinging, or other irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Commonly used brand name(s)

In the U.S.

  • Alphanine SD
  • Alprolix
  • Bebulin
  • Bebulin VH
  • Benefix
  • Idelvion
  • Ixinity
  • Mononine
  • Profilnine SD
  • Proplex T
  • Rebinyn
  • Rixubis

Available Dosage Forms:

  • Powder for Solution

Therapeutic Class: Antihemophilic Agent

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • A burning, numbness, or tingling feeling that is not normal.
  • Upset stomach or throwing up.
  • Shortness of breath.
  • Dizziness or passing out.
  • Chest pain or pressure or a fast heartbeat.
  • Feeling confused.
  • Coughing up blood.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Swelling, warmth, numbness, change of color, or pain in a leg or arm.
  • Restlessness.
  • Change in color of mouth to blue.
  • Cough.
  • Flushing.
  • Feeling very tired or weak.

Dosage Forms and Strengths

BeneFIX is supplied as a white lyophilized powder in the following dosages:

  • 250 IU
  • 500 IU
  • 1000 IU
  • 2000 IU

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

BeneFIX, Coagulation Factor IX (Recombinant), has been shown to be nonmutagenic in the Ames assay and non-clastogenic in a chromosomal aberrations assay. No investigations on carcinogenesis or impairment of fertility have been conducted.

How Supplied/Storage and Handling

How Supplied

BeneFIX, Coagulation Factor IX (Recombinant), is supplied in single-use vials which contain nominally 250, 500, 1000 or 2000 IU per vial (NDC 58394-003-06, 58394-002-06, 58394-001-06, and 58394-008-02, respectively) with sterile pre-filled diluent syringe, vial adapter reconstitution device, sterile infusion set, and two (2) alcohol swabs, one bandage and one gauze pad. Actual factor IX activity in IU is stated on the label of each vial.

Storage and Handling

Product as packaged for sale: BeneFIX, Coagulation Factor IX (Recombinant), Store under refrigeration at a temperature of 2 to 8°C (36 to 46°F).

Prior to the expiration date, BeneFIX may also be stored at room temperature not to exceed 30°C (86°F) for up to 6 months.

Advise patient to make note of the date the product was placed at room temperature in the space provided on the outer carton.

Do not put the product back into the refrigerator at the end of the 6-month period. Use it immediately or discard.

Do not freeze to prevent damage to the diluent syringe. Do not use BeneFIX after the expiration date on the label.

Product after reconstitution: The product does not contain a preservative and should be used within 3 hours.

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