asfotase alfa

Contraindicated in:

None.

Use Cautiously in:

OB: Safety not established in pregnancy;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant.

Adv. Reactions/Side Effects ⬆ ⬇

EENT: ectopic calcification of eye

GU: ectopic calcification of kidney

Metab: lipodystrophy

Misc: hypersensitivity reactions (including anaphylaxis), injection site reactions

Interactions ⬆ ⬇

Drug-drug:

None known.

Availability ⬆ ⬇

Solution for injection: 18 mg/0.45 mL; 28 mg/0.7 mL; 40 mg/mL; 80 mg/0.8 mL

Route/Dosage ⬆ ⬇

Perinatal/Infantile-Onset HPP

SC (Neonates and Infants): 2 mg/kg 3 times weekly or 1 mg/kg 6 times weekly; if suboptimal response, may ↑ to 3 mg/kg 3 times weekly.
SC (Children ≤16 yr): 2 mg/kg 3 times weeklyor 1 mg/kg 6 times weekly.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

As a recombinant form of tissue nonspecific alkaline phosphatase, it promotes bone mineralization.

Therapeutic effects:

Improved survival in patients with perinatal/infantile-onset HPP; improved growth and mobility in patients with juvenile-onset HPP.

Classifications ⬆ ⬇

Therapeutic Classification: none assigned

Pharmacologic Classification: enzymes

Pharmacokinetics ⬆ ⬇

Absorption: 60% absorbed after SUBQ administration.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: 5 days.

Time/Action Profile ⬆ ⬇

(reduction in plasma tissue nonspecific alkaline phosphatase substrates)

ROUTE	ONSET	PEAK	DURATION
SUBQ	6–12 wk	unknown	unknown

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of asfotase alfa to patient and/or caregiver.
Advise patient and/or caregiver to readPatient Information before starting therapy.
Advise patient and/or caregiver 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.
Instruct patient and/or caregiver if a dose is missed, take as soon as remembered. If it is close to the time of the next dose, skip the missed dose and go back to the normal time. Do not give simultaneous double or extra doses.
Teach patient and/or caregiver the signs and symptoms of an hypersensitivity reaction; if any occur, seek immediate medical care.
Advise patients and/or caregiver to monitor for skin thickening or pits at injection sites. Rotate injection sites to prevent lipodystrophy.
Explain need for eye and kidney exams periodically during therapy to patient and/or caregiver.
Encourage patient and/or caregiver to enroll patient in the Hypophosphatasia (HPP) Registry to better understand HPP and monitor long-term progress of patients. Participation is voluntary at www.hppregistry.com.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

section name header

Indications ⬇

Contraind./Precautions ⬆ ⬇