Posology : מינונים

4.2    Posology and method of administration

Treatment should be initiated by a physician experienced in the management of patients with metabolic or bone disorders.



Posology
Recommended dosage regimen of asfotase alfa is 2 mg/kg of body weight administered subcutaneously three times per week, or a dosage regimen of 1 mg/kg of body weight administered subcutaneously six times per week.
Maximum recommended dose of asfotase alfa is 6 mg/kg/week (see Section 5.1).
Refer to the dosing chart below for more details.
If injecting 3x per week                       If injecting 6 x per week Body
Weight                    Volume       Vial type    Dose to    Volume Dose to be
(kg)                       to be      used for        be        to be      Vial type used for injection injected injected     injection    injected   injected

3       6 mg          0.15 ml     0.3 ml
4       8 mg          0.20 ml     0.3 ml
5       10 mg         0.25 ml     0.3 ml
0.3 ml
6       12 mg         0.30 ml     0.3 ml        6 mg        0.15 ml     (STRENSIQ ® 40 MG/ML) 0.3 ml
7       14 mg         0.35 ml     0.45 ml       7 mg        0.18 ml     (STRENSIQ ® 40 MG/ML) 0.3 ml
8       16 mg         0.40 ml     0.45 ml       8 mg        0.20 ml     (STRENSIQ ® 40 MG/ML) 0.3 ml
9       18 mg         0.45 ml     0.45 ml       9 mg        0.23 ml     (STRENSIQ ® 40 MG/ML) 0.3 ml
10      20 mg         0.50 ml     0.7 ml        10 mg       0.25 ml     (STRENSIQ ® 40 MG/ML) 0.3 ml
11      22 mg         0.55 ml     0.7 ml        11 mg       0.28 ml     (STRENSIQ ® 40 MG/ML) 0.3 ml
12      24 mg         0.60 ml     0.7 ml        12 mg       0.30 ml     (STRENSIQ ® 40 MG/ML) 0.45 ml
13      26 mg         0.65 ml     0.7 ml        13 mg       0.33 ml     (STRENSIQ ® 40 MG/ML) 0.45 ml
14      28 mg         0.70 ml     0.7 ml        14 mg       0.35 ml     (STRENSIQ ® 40 MG/ML) 0.45 ml
15      30 mg         0.75 ml     1 ml          15 mg       0.38 ml     (STRENSIQ ® 40 MG/ML) 0.45 ml
16      32 mg         0.80 ml     1 ml          16 mg       0.40 ml     (STRENSIQ ® 40 MG/ML) 0.45 ml
17      34 mg         0.85 ml     1 ml          17 mg       0.43 ml     (STRENSIQ ® 40 MG/ML) 0.45 ml
18      36 mg         0.90 ml     1 ml          18 mg       0.45 ml     (STRENSIQ ® 40 MG/ML) 0.7 ml
19      38 mg         0.95 ml     1 ml          19 mg       0.48 ml     (STRENSIQ ® 40 MG/ML) 0.7 ml
20      40 mg         1.00 ml     1 ml          20 mg       0.50 ml     (STRENSIQ ® 40 MG/ML)
0.7 ml
25      50 mg         0.50 ml     0.8 ml        25 mg       0.63 ml     (STRENSIQ ® 40 MG/ML)
1 ml
30      60 mg         0.60 ml     0.8 ml        30 mg       0.75 ml     (STRENSIQ ® 40 MG/ML) 1 ml
35      70 mg         0.70 ml     0.8 ml        35 mg       0.88 ml     (STRENSIQ ® 40 MG/ML) 1 ml
40      80 mg         0.80 ml     0.8 ml        40 mg       1.00 ml     (STRENSIQ ® 40 MG/ML)
0.8 ml
50                                              50 mg       0.50 ml     (STRENSIQ ® 100 MG/ML) 0.8 ml
60                                              60 mg       0.60 ml     (STRENSIQ ® 100 MG/ML) 0.8 ml
70                                              70 mg       0.70 ml     (STRENSIQ ® 100 MG/ML) 80                                              80 mg       0.80 ml     0.8 ml 
(STRENSIQ ® 100 MG/ML)

0.8 ml (x2)
90                                                90 mg        0.90 ml      (STRENSIQ ® 100 MG/ML) 0.8 ml (x2)
100                                               100 mg       1.00 ml      (STRENSIQ ® 100 MG/ML) 

Missed dose
If a dose of asfotase alfa is missed, a double dose should not be injected to make up for the missed dose.

Special population

Adult patients
Efficacy and safety data in patients with hypophosphatasia >18 years old are limited.
Elderly
The safety and efficacy of asfotase alfa in elderly patients have not been established and no specific dose regimen can be recommended for these patients.

Renal impairment
The safety and efficacy of asfotase alfa in patients with renal impairment have not been evaluated and no specific dose regimen can be recommended for these patients.

Hepatic impairment
The safety and efficacy of asfotase alfa in patients with hepatic impairment have not been evaluated and no specific dose regimen can be recommended for these patients.

Method of administration

Strensiq is for subcutaneous use only. It is not intended for intravenous or intramuscular injection.
The maximum volume of medicinal product per injection should not exceed 1 ml. If more than 1 ml is required, multiple injections may be administered at the same time.
Strensiq should be administered using sterile disposable syringes and injection needles. The syringes should be of small enough volume that the prescribed dose can be withdrawn from the vial with reasonable accuracy.

Injections sites should be rotated and carefully monitored for signs of potential reactions (see section 4.4).

Patients can self-inject only if they have properly been trained on administration procedures.
For handling of the medicinal product before administration, see section 6.6.