coagulation factor ix (recombinant), fc fusion protein

Contraindicated in:

Known hypersensitivity.

Use Cautiously in:

OB: Use during pregnancy only if clearly needed;
Lactation: Safety not established in breastfeeding;
Pedi: Children <12 yr have ↑ clearance, shorter duration of action (↑ dose/kg or more frequent dosing may be required).

Adv. Reactions/Side Effects ⬆ ⬇

CV: THROMBOEMBOLISM ( RISK WITH CONTINUOUS INFUSION VIA CENTRAL CATHETER)↑ risk with continuous infusion via central catheter)

GI: perioral paresthesia

Neuro: headache

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS), including anaphylaxis), production of neutralizing antibodies (inhibitors)

Interactions ⬆ ⬇

Drug-drug:

None reported.

Availability ⬆ ⬇

Lyophilized powder for injection: 250 IU/vial; 500 IU/vial; 1,000 IU/vial; 2,000 IU/vial; 3,000 IU/vial; 4,000 IU/vial

Route/Dosage ⬆ ⬇

One unit/kg ↑ circulating Factor IX level by 1%.
IV (Adults and Children ): Minor and moderate bleeding: amount needed to produce a circulating Factor IX level of 30–60 IU/dL; repeat every 48 hr, as needed; Major bleeding: amount needed to produce a circulating Factor IX level of 80–100 IU/dL; repeat after 6–10 hr, then every 24 hr for 3 days, then every 48 hr until healing occurs; Perioperative management (minor procedures): amount needed to produce a circulating Factor IX level of 50–80 IU/dL as a single infusion; may repeat after 24–48 hr until bleeding ceases and healing has occurred; Perioperative management (major procedures): amount needed to produce a circulating Factor IX level of 60–100 IU/dL as a single infusion; may repeat after 6–10 hr and then every 24 for 3 days until bleeding ceases and healing occurs (additional doses may be given every 48 hr if needed);Routine prophylaxis: 50 IU/kg once weekly or 100 IU/kg every 10 days. Doses may be modified according to need/response.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Replaces deficient Factor IX in patients with hemophilia B.

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 clotting process.

Half-Life: Adults: 86.5 hr; Children 12–17 yr: 84 hr; Children 6–11 yr: 72.2 hr; Children 2–5 yr: 66.4 hr.

Time/Action Profile ⬆ ⬇

(↓ bleeding/risk of bleeding)

ROUTE	ONSET	PEAK	DURATION
IV	rapid	unknown	6–48 hr ‡

‡Up to 10 days when used prophylactically.

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication. Advise patient to read Patient Information before starting therapy.
Instruct patient on appropriate steps for administration technique and disposal of equipment, if self-administration is appropriate.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Advise patient to notify health care professional immediately if signs/symptoms of allergic reaction (angioedema, chest tightness, hypotension, rash, nausea, vomiting, paresthesia, restlessness, wheezing, dyspnea) or a blood clot (sudden severe headache, pain, swelling, warmth, or redness in legs, arms or chest) occurs.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Pronunciation ⬆ ⬇

ko-A-gyoo-LAY-shun FAC-tor nine eff-cee FYOO-zhun PROH-teen

Code ⬆

NDC Code

71104- Bioverativ Therapeutics Inc.
- 71104-911- ALPROLIX
  - 71104-911-01- 1 KIT in 1 KIT (71104-911-01) * 5 mL in 1 VIAL (71104-953-09) * 5 mL in 1 VIAL (71104-045-01)

71104- Bioverativ Therapeutics Inc.
- 71104-922- ALPROLIX
  - 71104-922-01- 1 KIT in 1 KIT (71104-922-01) * 5 mL in 1 VIAL (71104-954-09) * 5 mL in 1 VIAL (71104-045-01)

71104- Bioverativ Therapeutics Inc.
- 71104-933- ALPROLIX
  - 71104-933-01- 1 KIT in 1 KIT (71104-933-01) * 5 mL in 1 VIAL (71104-955-09) * 5 mL in 1 VIAL (71104-045-01)

71104- Bioverativ Therapeutics Inc.
- 71104-944- ALPROLIX
  - 71104-944-01- 1 KIT in 1 KIT (71104-944-01) * 5 mL in 1 VIAL (71104-956-09) * 5 mL in 1 VIAL (71104-045-01)

71104- Bioverativ Therapeutics Inc.
- 71104-966- ALPROLIX
  - 71104-966-01- 1 KIT in 1 CARTON (71104-966-01) * 5 mL in 1 VIAL (71104-952-01) * 5 mL in 1 VIAL (71104-045-01)

71104- Bioverativ Therapeutics Inc.
- 71104-977- ALPROLIX
  - 71104-977-01- 1 KIT in 1 CARTON (71104-977-01) * 5 mL in 1 VIAL (71104-951-09) * 5 mL in 1 VIAL (71104-045-01)

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Indications ⬇

Contraind./Precautions ⬆ ⬇