Asfotase Alfa
Generic Name: asfotase alfa
Brand Names:
Strensiq
11 DESCRIPTION Asfotase alfa is a tissue nonspecific alkaline phosphatase (TNSALP) produced by recombinant DNA technology in a Chinese hamster ovary cell line. Asfotase alfa is a soluble glycoprotein composed of two identical polypeptide chains. Each chain contains 726 amino acids with a theoretical mass of 161 kDa. Each chain consists of the catalytic domain of human TNSALP, the human immunoglobulin G 1 Fc domain and a deca-aspartate peptide used as a bone targeting domain.
Overview
11 DESCRIPTION Asfotase alfa is a tissue nonspecific alkaline phosphatase (TNSALP) produced by recombinant DNA technology in a Chinese hamster ovary cell line. Asfotase alfa is a soluble glycoprotein composed of two identical polypeptide chains. Each chain contains 726 amino acids with a theoretical mass of 161 kDa. Each chain consists of the catalytic domain of human TNSALP, the human immunoglobulin G 1 Fc domain and a deca-aspartate peptide used as a bone targeting domain.
Uses
1 INDICATIONS AND USAGE STRENSIQ ® is indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP). STRENSIQ is a tissue nonspecific alkaline phosphatase indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP). ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION Perinatal/Infantile-Onset HPP ( 2.2 ) Recommended dosage regimen is 2 mg/kg administered subcutaneously three times per week, or 1 mg/kg administered six times per week. Injection site reactions may limit the tolerability of the six times per week regimen. The dose may be increased to 3 mg/kg three times per week for insufficient efficacy. Juvenile-Onset HPP ( 2.3 ) Recommended dosage regimen is 2 mg/kg administered subcutaneously three times per week, or 1 mg/kg administered six times per week. Injection site reactions may limit the tolerability of the six times per week regimen.
Side Effects
6 ADVERSE REACTIONS The following adverse reactions are described below and elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Lipodystrophy [see Warnings and Precautions (5.2) ] Ectopic Calcifications [see Warnings and Precautions (5.3) ] Possible Immune-Mediated Clinical Effects [see Warnings and Precautions (5.4) ] Most common adverse reactions (≥ 10%) are injection site reactions, lipodystrophy, ectopic calcifications and hypersensitivity reactions. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alexion Pharmaceuticals, Inc. at 1-844-259-6783 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Interactions
7 DRUG INTERACTIONS Drug Interference with Laboratory Tests: Alkaline Phosphatase (ALP) is used as a detection reagent in many laboratory tests and the presence of asfotase alfa in clinical laboratory samples could result in erroneous test results. Inform laboratory personnel and discuss use of an alternative testing platform for patients on treatment. ( 7.1 ) Serum Alkaline Phosphatase : Serum ALP measurements are expected to be elevated during treatment and may be unreliable for clinical decision making.
Warnings
WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS Patients treated with enzyme replacement therapies have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. Initiate STRENSIQ under the supervision of a healthcare provider with appropriate medical monitoring and support measures. 5 WARNINGS AND PRECAUTIONS Lipodystrophy: Localized reactions were reported after several months of treatment; follow proper injection technique and rotate injection sites. ( 5.2 ) Ectopic Calcifications (eye and kidneys): Monitor using ophthalmologic examinations and renal ultrasounds at baseline and periodically during treatment. ( 5.3 ) Possible Immune-Mediated Clinical Effects: Evaluate patients for antibody formation if clinically indicated. ( 5.4 ) 5.1 Hypersensitivity Reactions Including Anaphylaxis Life-threatening hypersensitivity reactions, including anaphylaxis, have been reported in patients treated with enzyme replacement therapies, including STRENSIQ. 4 CONTRAINDICATIONS None. None. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary There are no available data on STRENSIQ use in pregnant women to inform a drug associated risk. In animal reproduction studies, asfotase alfa administered intravenously to pregnant rats and rabbits during the period of organogenesis showed no evidence of fetotoxicity, embryolethality or teratogenicity at doses causing plasma exposures up to 21 and 24 times, respectively, the exposure at the recommended human dose (see Data ) . In the U.S.
Storage
STRENSIQ vials must be stored in the original carton until the time of use under refrigerated conditions at 2°C to 8°C (36°F to 46°F) and protected from light. Once removed from refrigeration, STRENSIQ should be administered within 3 hours. Do not use beyond the expiration date stamped on the carton. DO NOT FREEZE OR SHAKE. Vials are for one time use only. Discard any unused product.
Frequently Asked Questions
What is Asfotase Alfa used for?▼
1 INDICATIONS AND USAGE STRENSIQ ® is indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP). STRENSIQ is a tissue nonspecific alkaline phosphatase indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP). ( 1 )
What are the side effects of Asfotase Alfa?▼
6 ADVERSE REACTIONS The following adverse reactions are described below and elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Lipodystrophy [see Warnings and Precautions (5.2) ] Ectopic Calcifications [see Warnings and Precautions (5.3) ] Possible Immune-Mediated Clinical Effects [see Warnings and Precautions (5.4) ] Most common adverse reactions (≥ 10%) are injection site reactions, lipodystrophy, ectopic calcifications and hypersensitivity reactions. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alexion Pharmaceuticals, Inc. at 1-844-259-6783 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Can I take Asfotase Alfa during pregnancy?▼
8.1 Pregnancy Risk Summary There are no available data on STRENSIQ use in pregnant women to inform a drug associated risk. In animal reproduction studies, asfotase alfa administered intravenously to pregnant rats and rabbits during the period of organogenesis showed no evidence of fetotoxicity, embryolethality or teratogenicity at doses causing plasma exposures up to 21 and 24 times, respectively, the exposure at the recommended human dose (see Data ) . In the U.S.
What are the important warnings for Asfotase Alfa?▼
WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS Patients treated with enzyme replacement therapies have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. Initiate STRENSIQ under the supervision of a healthcare provider with appropriate medical monitoring and support measures. 5 WARNINGS AND PRECAUTIONS Lipodystrophy: Localized reactions were reported after several months of treatment; follow proper injection technique and rotate injection sites. ( 5.2 ) Ectopic Calcifications (eye and kidneys): Monitor using ophthalmologic examinations and renal ultrasounds at baseline and periodically during treatment. ( 5.3 ) Possible Immune-Mediated Clinical Effects: Evaluate patients for antibody formation if clinically indicated. ( 5.4 ) 5.1 Hypersensitivity Reactions Including Anaphylaxis Life-threatening hypersensitivity reactions, including anaphylaxis, have been reported in patients treated with enzyme replacement therapies, including STRENSIQ. 4 CONTRAINDICATIONS None. None. ( 4 )
Related Medications
Agnus Castus, Angelica Sin, Apis Mel, Cimicifuga Rac, Estradiol, Estriol, Folliculinum, Galium, Glycyrrhiza, Oophorinum, Progesterone, Sepia
agnus castus, angelica sin, apis mel, cimicifuga rac, estradiol, estriol, folliculinum, galium, glycyrrhiza, oophorinum, progesterone, sepia
Standardized Insect Venom Allergenic Extract [EPC]
Active ingredients Purpose Agnus Castus, Angelica Sin, Apis Mel, Cimicifuga Rac, Estradiol, Estriol, Folliculinum, Galium, Glycyrrhiza, Oophorinum, Progesterone, Sepia To rebalance estrogen and progesterone output
Bm Potassium Iodide (kali Iod)
bm potassium iodide (kali iod)
Uses See the leaflet enclosed for detail.
Meb Painguard Patch
meb painguard patch
MEB Gluco-Vitality Patch Active Ingredients Purpose Ferum Metalicum 7X HPUS …………………… Congestion of Blood Magnesia Sulphurica 7X HPUS ……………….. Diabetes Phosphorus 6X HPUS …………………………… Vascular Deases Calcarea Fluorata 6X HPUS …………………… Vessels-lipids Zincum Metallicum 8X HPUS ………………….. Varicose Vein Vanadium Metallicum 12X HPUS……………….. Atheroma of Arteries Sulphur 4X HPUS…………………………………. Varicosities MEB PainGuard Patch Active Ingredient ................................................ Purpose Alumin
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.