factor ix (human)

REMS

Treatment of active or impending bleeding due to factor IX deficiency (hemophilia B, Christmas disease).
Treatment of bleeding in patients with factor VIII inhibitors (Proplex T only).
Prevention and treatment of bleeding in patients with factor VII deficiency (Proplex T only).

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Factor VII deficiency (except Proplex T);
Intravascular coagulation or fibrinolysis associated with liver disease;
Allergy to mouse protein (Mononine).

Use Cautiously in:

Postoperative period (increased risk of thrombosis).

Adv. Reactions/Side Effects ⬆ ⬇

CV: changes in heart rate, changes in BP

Derm: flushing, urticaria

GI: nausea, vomiting

Hemat: disseminated intravascular coagulation, thrombosis

Neuro: drowsiness, headache, lethargy, tingling

Resp: dyspnea

Misc: risk of transmission of HIV virus, chills, fever, hypersensitivity reactions, risk of transmission of viral hepatitis

Interactions ⬆ ⬇

Drug-drug:

Use with aminocaproic acid may ↑ risk of thrombosis.

Availability ⬆ ⬇

Injection: Vials containing 250 units; 500 units; 1000 units; 1200 units; 1500 units

Route/Dosage ⬆ ⬇

The following general formula may be used: Human-derived products: Dose (units) = body weight (kg) × 1 unit/kg × desired factor IX increase (% of normal). Recombinant DNA product: Dose (units) = body weight (kg) × 1.2 units/kg × desired factor IX increase (% of normal)

Hemophilia B

IV (Adults and Children ): Major bleeding: 50–100% activity q 12–24 hr for 7–10 days; moderate bleeding: 25–50% activity q 12–24 hr until bleeding stops and healing begins (2–7 days);minor bleeding: 20–30% activity q 12–24 hr for 1–2 days.

Factor VII Deficiency(Proplex Tonly)

IV (Adults and Children ): 75 units/kg.

US Brand Names ⬆ ⬇

AlphaNine SD, BenFix, Mononine, Profilnine SD, Proplex T, Bebulin VH

Action ⬆ ⬇

Factor IX complex preparations (Bebulin VH, Profilnine SD, Proplex T) contain blood coagulation factors II, VII, IX, and X. Purified protein preparations (AlphaNine SD, Benefix, Mononine) contain factor IX activity only. Benefix is made via recombinant DNA technology.

Therapeutic effects:

Replacement of deficient factor IX in hemophilia B.
Restoration of hemostasis.

Classifications ⬆ ⬇

Therapeutic Classification: hemostatic agents

Pharmacologic Classification: blood products, clotting factors replacements

Pharmacokinetics ⬆ ⬇

Absorption: Administered IV only, resulting in complete bioavailability.

Distribution: Unknown.

Metabolism/Excretion: Rapidly cleared from plasma by utilization in clotting process.

Half-Life: Factor IX: 24–32 hr; factor VII: 3–6 hr.

Time/Action Profile ⬆ ⬇

(hemostasis)

ROUTE	ONSET	PEAK	DURATION
IV	immediate	10–30 min	1–2 days

Patient/Family Teaching ⬆

Instruct patient to notify health care professional immediately if bleeding recurs.
Advise patient to carry identification describing disease process at all times.
Caution patient to avoid products containing aspirin or NSAIDs, because they may further impair clotting.
Review with patient methods of preventing bleeding (use soft toothbrush, avoid IM and SUBQ injections, avoid potentially traumatic activities).
Advise patient that the risk of hepatitis or AIDS transmission may be decreased by use of heat-treated preparations. Current screening programs and vaccination with hepatitis B vaccine should help decrease the risk.
Reinforce need for patients with hemophilia to receive close medical supervision.

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Indications ⬇