antihemophilic factor (recombinant), porcine sequence

Contraindicated in:

Life-threatening hypersensitivity reactions to this product or any of its components (including hamster protein).

Use Cautiously in:

OB: Safety not established in pregnancy; ;
Lactation: Safety not established in breastfeeding;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

Misc: development of inhibitory antibodies to porcine factor VIII, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS)

Interactions ⬆ ⬇

Drug-drug:

Bleeding may be ↑ by aspirin, NSAIDs, clopidogrel, prasugrel, ticagrelor, dabigatran, apixaban, rivaroxaban, edoxaban, warfarin, or SSRIs.

Availability ⬆ ⬇

Lyophilized powder for injection: 500 units/vial

Route/Dosage ⬆ ⬇

IV (Adults ): 200 units/kg initially; further doses every 4–12 hr are titrated and based on clinical response and factor VIII recovery levels.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Temporarily replaces deficient levels of factor VIII.

Therapeutic effects:

Decreased incidence and severity of bleeding.

Classifications ⬆ ⬇

Therapeutic Classification: hemostatic agents

Pharmacologic Classification: clotting factors replacements

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Unknown.

Metabolism/Excretion: Used up in the hemostatic process.

Half-Life: Unknown.

Time/Action Profile ⬆ ⬇

(effect on factor VIII levels)

ROUTE	ONSET	PEAK	DURATION
IV	rapid	30 min	4–12 hr

Patient/Family Teaching ⬆ ⬇

Explain the purpose and side effects of antihemophilic factor porcine. Do not stop receiving drug without consulting health care provider. If an appointment is missed, reschedule as soon as possible. Advise patient to read Medication Guide before starting and periodically during therapy in case of changes.
Instruct patient to notify health care professional immediately if bleeding recurs. Advise patient to observe for bleeding in gums, skin, urine, stool, or emesis.
Inform patient that inhibitor formation may occur with treatment of hemophilia A. Advise patient to contact their health care professional if they experience lack of clinical response to Factor VIII replacement therapy; may be due to an inhibitor.
Caution patient to avoid products containing aspirin or NSAIDs; they may further impair clotting.
Review prevention of bleeding with patient (use soft toothbrush, avoid IM and SUBQ injections, avoid potentially traumatic activities).
Advise patients and family to call 911 and seek urgent treatment for signs/symptoms of hypersensitivity reactions.
Advise patients to consult health care professional prior to travel. While traveling advise patients to bring an adequate supply of antihemophilic factor based on their current treatment regimen.
Advise patient to carry identification describing disease process at all times.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Pronunciation ⬆ ⬇

an-tee-HEE-moh-fill-ik FAK-to ree-KOM-bi-nant POR-seen SEE-qwence

Code ⬆

NDC Code

0944- Takeda Pharmaceuticals America, Inc.
- 0944-5001- OBIZUR
  - 0944-5001-01- 1 KIT in 1 CARTON (0944-5001-01) * 1 mL in 1 VIAL, GLASS (0944-5011-01) * 1 mL in 1 SYRINGE, GLASS (0944-0011-01)

64538- Rentschler Biopharma SE
- 64538-500-
  - 64538-500-00- 1 mL in 1 VIAL (64538-500-00)

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Indications ⬇

Contraind./Precautions ⬆ ⬇