Alphanine SD

Name: Alphanine SD

AlphaNine SD Overview

AlphaNine SD is a brand name medication included in a group of medications called Blood coagulation factors. For more information about AlphaNine SD see its generic Coagulation factor IX

Dosing & Uses

Dosage Forms & Strengths

solution reconstituted

  • 250 IU (Mononine)
  • 500 IU (AlphaNine SD, Mononine)
  • 1000 IU (AlphaNine SD, Mononine)
  • 1500 IU (Alphanine)

Hemophilia B

Indicated for control or prevention of bleeding in Factor IX deficient patients

Individualize dosing based on severity of factor IX deficiency, extent and location of bleeding, and clinical status of patient

AlphaNine SD, Mononine: 1 unit/kg x body wt (kg) x desired increase (% of normal) = Number of factor IX units required

Dosage Forms & Strengths

solution reconstituted

  • 250 IU (Mononine)
  • 500 IU (AlphaNine SD, Mononine)
  • 1000 IU (AlphaNine SD, Mononine)
  • 1500 IU (Alphanine)

Hemophilia B

Indicated for control or prevention of bleeding in Factor IX deficient patients

Individualize dosing based on severity of factorIX deficiency, extent and location of bleeding, and clinical status of patient

AlphaNine SD, Mononine: 1 unit/kg x body wt (kg) x desired increase (% of normal) = Number of factor IX units required

What is Alphanine SD (coagulation factor IX)?

Coagulation factor IX is a man-made protein similar to a natural protein in the body that helps the blood to clot.

Coagulation factor IX is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency.

Coagulation factor IX may also be used for purposes not listed in this medication guide.

How should I use Alphanine SD (coagulation factor IX)?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Your doctor may want to give your first dose of this medicine in a hospital or clinic setting to quickly treat any serious side effects that occur.

Coagulation factor IX is injected into a vein through an IV. You may be shown how to use an IV at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of needles, IV tubing, and other items used.

Coagulation factor IX is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

The mixture should appear clear, yellow, or colorless. Do not use the mixed medicine if it has changed colors or has particles in it. Prepare a new kit or call your pharmacist for a new supply of coagulation factor IX.

Gently swirl but do not shake the medicine bottle when mixing or you may ruin the medicine. Use the injection within 3 hours after mixing your dose.

Coagulation factor IX comes with patient instructions for proper mixing and storage. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Use a disposable needle only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

While using coagulation factor IX, you may need frequent blood tests.

Wear a medical alert tag or carry an ID card stating that you have hemophilia. Any medical care provider who treats you should know that you have a bleeding disorder.

If you store this medicine at home, carefully follow the directions on your medicine label about how to store the powder medicine and the diluent. Some forms of coagulation factor IX can be stored at room temperature, and others should be kept in a refrigerator. Do not freeze. Avoid exposing the medication to light.

Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Throw away any coagulation factor IX not used before the expiration date on the medicine label.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of this medicine.

What should I avoid while using Alphanine SD (coagulation factor IX)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

How is this medicine (AlphaNine SD) best taken?

Use AlphaNine SD as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given as a shot into a vein.
  • This medicine may be given at home.
  • If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
  • Follow how to use as you have been told by the doctor or read the package insert.
  • Wash your hands before and after you give the shot.
  • If stored in a refrigerator, let this medicine come to room temperature before mixing. Do not heat AlphaNine SD.
  • This medicine needs to be mixed before use. Follow how to mix as you were told by the doctor.
  • Do not shake.
  • Do not use if the solution is cloudy, leaking, or has particles.
  • Do not use if solution changes color.
  • Use within 3 hours of making.
  • Throw away any part of opened vial not used after use.
  • Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

  • Call your doctor to find out what to do.

How do I store and/or throw out AlphaNine SD?

  • Most of the time, AlphaNine SD will be given in a hospital or doctor's office. If stored at home, follow how to store as you were told by the doctor.
  • If this medicine is given at home, store unopened vials in a refrigerator. Do not freeze.
  • Store in original container.
  • You may store at room temperature for 1 month.
  • If stored at room temperature, make a note of the date it was placed at room temperature.
  • If stored at room temperature, throw away any unused vials after 1 month or after the expiration date, whichever comes first.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Adverse Reactions

The administration of plasma preparations may cause allergic reactions, mild chills, nausea or stinging at the infusion site. For most reactive individuals, slowing the infusion rate relieves the symptoms. For those highly reactive individuals, a different lot may be satisfactory.

Adverse reactions, characterized by either thrombosis or disseminated intravascular coagulation (DIC), have been reported following administration of Factor IX Complex concentrates. Patients who receive Coagulation Factor IX (Human), AlphaNine SD, following operation, or those with known liver disease, should be kept under close observation for potential signs or symptoms of intravascular coagulation. Continued administration should be left to the discretion of the physician.

In the clinical study that compared the in vivo half-life and recovery of Alphanine SD and HT products, no adverse events were associated with 18 infusions of Alphanine SD administered to 18 individuals with severe to moderate hemophilia B.2 Short term safety of the earlier version of this product, AlphaNine, was demonstrated by an absence of adverse events after 225 infusions of this product were received by 31 patients participating in three clinical trials. In the clinical trial to evaluate efficacy of AlphaNine in providing hemostatic protection during and after surgery, 13 patients received a total of 370,655 IU of AlphaNine. In 208 total infusions, each patient received approximately 15,000 IU (range 3,295 to 52,200 IU Factor IX) in an average of 16 infusions (range 2 to 26 infusions). Results from this study showed no bleeding episodes during the course of postsurgery therapy. There was no hematological evidence (measured by hematocrit, partial thromboplastin time, prothrombin time, fibrinogen/fibrin degradation products, fibrin monomers, D-dimers and platelet counts) of thrombogenicity.12

To report SUSPECTED ADVERSE REACTIONS, contact Grifols at 1-888-GRIFOLS (1-888-474-3657) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

How supplied

Alphanine SD is supplied in sterile, lyophilized form in single dose vials accompanied by 10 mL diluent (Sterile Water for Injection, USP). Factor IX activity, expressed in International Units (IU) which is referenced to WHO International Standard, is stated on the label of each concentrate vial. Alphanine SD is packaged with a Mix2Vial filter transfer set for use in administration.

It is available in the following potencies, and the product is also color coded based upon assay on the carton and vial label as follows:

Potency NDC Assay Color Code
500 IU FIX/10 mL single dose vial 68516-3601-2 500 IU FIX Range - blue box
1000 IU FIX/10 mL single dose vial 68516-3602-2 1000 IU FIX Range - red box
1500 IU FIX/10 mL single dose vial 68516-3603-2 1500 IU FIX Range - black box

STORAGE

Alphanine SD should be stored at temperatures between 2 and 8 °C. Do not freeze to prevent damage to diluent vial. May be stored at room temperature not to exceed 30 °C for 1 month. When removed from refrigeration, record the date removed on the space provided on the carton.

Rx only

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