Strensiq

Drug overview for STRENSIQ (asfotase alfa):

Generic name: ASFOTASE ALFA
Drug class: Metabolic Disease Enzyme Replacement - Hypophosphatasia
Therapeutic class: Metabolic Disease Enzyme Replacement Agents

Asfotase alfa is a biosynthetic (recombinant DNA origin) form of human tissue-nonspecific alkaline phosphatase (TNSALP), a metalloenzyme that catalyzes the hydrolysis of phosphomonoesters.

No enhanced Uses information available for this drug.

DRUG IMAGES

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The following indications for STRENSIQ (asfotase alfa) have been approved by the FDA:

Indications:
Childhood hypophosphatasia
Infantile hypophosphatasia

Professional Synonyms:
Childhood HPP
Childhood-type hypophosphatasia
Fetal HPP
Fetal hypophosphatasia
Infantile HPP
Infantile-type hypophosphatasia
Juvenile HPP
Juvenile hypophosphatasia
Perinatal hypophosphatasia

Moderate List
No disease contraindications

The following adverse reaction information is available for STRENSIQ (asfotase alfa):

Overview
Severe
Less Severe

Adverse reaction overview.

Adverse effects reported in more than 10% of patients receiving asfotase alfa in clinical trials include injection site reactions (e.g., erythema, discoloration/hypopigmentation, pain/tenderness, pruritus, swelling, induration, macules, bruising, nodules), ectopic calcifications, lipodystrophy (e.g., injection site atrophy, injection site hypertrophy), and hypersensitivity reactions (e.g., vomiting/emesis). The incidence of injection site reactions, lipodystrophy, and ectopic calcifications was higher in patients with juvenile-onset HPP than in patients with perinatal/infantile-onset HPP.

There are 5 severe adverse reactions.

More Frequent	Less Frequent
Hypersensitivity drug reaction	None.

Rare/Very Rare
Anaphylaxis Calcification of cornea Hepatitis Nephrocalcinosis

There are 19 less severe adverse reactions.

More Frequent	Less Frequent
Dyschromia Erythema Induration of skin Injection site sequelae Lipodystrophy Pruritus of skin Skin swelling	Skin atrophy Skin hypertrophy

Rare/Very Rare
Chills Drug-induced pyridoxine deficiency Fever Flushing Headache disorder Hypocalcemia Irritability Oral hypoesthesia Skin rash Vomiting

The following precautions are available for STRENSIQ (asfotase alfa):

Pediatric
Pregnant
Lactation
Geriatric

Most patients (90%) included in clinical trials of asfotase alfa were pediatric patients 1 day to 16 years of age.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

No data on the use of asfotase alfa in pregnant women are available. In animal reproduction studies in rats and rabbits, IV administration of asfotase alfa (at dosages resulting in plasma exposures up to 21 and 24 times the exposure at the recommended human dosage, respectively) during the period of organogenesis resulted in no evidence of fetotoxicity, embryolethality, or teratogenicity.

It is not known whether asfotase alfa is distributed into human milk. The effects of the drug on milk production or on the breast-fed infant also are unknown. The known benefits of breast-feeding should be considered along with the mother's clinical need for asfotase alfa and any potential effects of the drug or disease on the infant.

Clinical studies of asfotase alfa did not include patients 65 years of age or older. It is not known whether geriatric patients respond differently than younger patients.