Voxzogo

VOXZOGO is indicated to increase linear growth in pediatric patients with achondroplasia with open epiphyses. This indication is approved under accelerated approval based on an improvement in annualized growth velocity

• Ensure adequate food and fluid intake prior to administration. (
  2.1 Important Instructions Prior to Administration of VOXZOGO

  To reduce the risk of low blood pressure and its associated signs and symptoms, instruct the caregiver and patient that the patient should

  [see Warnings and Precautions (5.1)]

  :

  • Have adequate food intake prior to VOXZOGO administration.
  • Drink approximately 240 to 300 mL of fluid in the hour prior to VOXZOGO administration.
  )
• Recommended dosage is based on patient's actual body weight. Administer VOXZOGO subcutaneously once daily. (
  2.2 Recommended Dosage and Administration

  The recommended dosage of VOXZOGO is based on the patient's actual body weight (see Table 1). VOXZOGO is administered by subcutaneous injection once daily

  [see Dosage and Administration (2.4)]

  .

  Inject VOXZOGO at approximately the same time each day, if possible. The volume of VOXZOGO to be administered (injection volume) is based on the patient's actual body weight and the concentration of reconstituted VOXZOGO (0.8 mg/mL or 2 mg/mL) (see Table 1). VOXZOGO must be reconstituted prior to use

  [see Dosage and Administration (2.4)]

  .

  Table 1: Recommended VOXZOGO Daily Dosage and Injection Volume

  Actual Body WeightIntermediate body weights that fall within these weight bands should be rounded to the nearest whole number.	Dose	Injection Volume	Vial Strength for ReconstitutionThe concentration of vosoritide in reconstituted 0.4 mg vial and 0.56 mg vial is 0.8 mg/mL. The concentration of vosoritide in reconstituted 1.2 mg vial is 2 mg/mL.
  3 kg	0.096 mg	0.12 mL	0.4 mg
  4 kg	0.12 mg	0.15 mL	0.4 mg
  5 kg	0.16 mg	0.2 mL	0.4 mg
  6 to 7 kg	0.2 mg	0.25 mL	0.4 mg
  8 to 11 kg	0.24 mg	0.3 mL	0.4 mg
  12 to 16 kg	0.28 mg	0.35 mL	0.56 mg
  17 to 21 kg	0.32 mg	0.4 mL	0.56 mg
  22 to 32 kg	0.4 mg	0.5 mL	0.56 mg
  33 to 43 kg	0.5 mg	0.25 mL	1.2 mg
  44 to 59 kg	0.6 mg	0.3 mL	1.2 mg
  60 to 89 kg	0.7 mg	0.35 mL	1.2 mg
  ≥ 90 kg	0.8 mg	0.4 mL	1.2 mg

  Missed dose

  If a dose of VOXZOGO is missed, it can be administered within 12 hours of the scheduled time of administration. Beyond 12 hours, skip the missed dose and administer the next daily dose according to the usual dosing schedule.
  )
• Reconstitute prior to use. Injection volume is based on both patient's weight and concentration of reconstituted VOXZOGO. (
  2.2 Recommended Dosage and Administration

  The recommended dosage of VOXZOGO is based on the patient's actual body weight (see Table 1). VOXZOGO is administered by subcutaneous injection once daily

  [see Dosage and Administration (2.4)]

  .

  Inject VOXZOGO at approximately the same time each day, if possible. The volume of VOXZOGO to be administered (injection volume) is based on the patient's actual body weight and the concentration of reconstituted VOXZOGO (0.8 mg/mL or 2 mg/mL) (see Table 1). VOXZOGO must be reconstituted prior to use

  [see Dosage and Administration (2.4)]

  .

  Table 1: Recommended VOXZOGO Daily Dosage and Injection Volume

  Actual Body WeightIntermediate body weights that fall within these weight bands should be rounded to the nearest whole number.	Dose	Injection Volume	Vial Strength for ReconstitutionThe concentration of vosoritide in reconstituted 0.4 mg vial and 0.56 mg vial is 0.8 mg/mL. The concentration of vosoritide in reconstituted 1.2 mg vial is 2 mg/mL.
  3 kg	0.096 mg	0.12 mL	0.4 mg
  4 kg	0.12 mg	0.15 mL	0.4 mg
  5 kg	0.16 mg	0.2 mL	0.4 mg
  6 to 7 kg	0.2 mg	0.25 mL	0.4 mg
  8 to 11 kg	0.24 mg	0.3 mL	0.4 mg
  12 to 16 kg	0.28 mg	0.35 mL	0.56 mg
  17 to 21 kg	0.32 mg	0.4 mL	0.56 mg
  22 to 32 kg	0.4 mg	0.5 mL	0.56 mg
  33 to 43 kg	0.5 mg	0.25 mL	1.2 mg
  44 to 59 kg	0.6 mg	0.3 mL	1.2 mg
  60 to 89 kg	0.7 mg	0.35 mL	1.2 mg
  ≥ 90 kg	0.8 mg	0.4 mL	1.2 mg

  Missed dose

  If a dose of VOXZOGO is missed, it can be administered within 12 hours of the scheduled time of administration. Beyond 12 hours, skip the missed dose and administer the next daily dose according to the usual dosing schedule.
  )
• Monitor growth and adjust dosage according to actual body weight. Permanently discontinue upon closure of epiphyses. (
  2.3 Growth Monitoring

  Monitor and assess patient body weight, growth, and physical development regularly every 3 to 6 months. Adjust the dosage according to the patient's actual body weight

  [see Dosage and Administration (2.2)]

  .

  Permanently discontinue VOXZOGO upon confirmation of no further growth potential, indicated by closure of epiphyses.
  )
• See full prescribing information for reconstitution, dilution, and administration instructions. (
  2.4 Preparation and Administration

  Reconstitute VOXZOGO before administration using the provided diluent syringe containing Sterile Water for Injection, USP (see Reconstitution Instructionsbelow).

  Caregivers may inject VOXZOGO subcutaneously after proper training by a healthcare professional on the preparation and administration of VOXZOGO

  [see Instructions for Use].

  Reconstitution Instructions

  • Select the correct VOXZOGO vial strength (co-packaged with prefilled syringe with Sterile Water for Injection diluent) based on the patient's actual body weight
    [see Dosage and Administration (2.2)]
    .
  • Remove VOXZOGO vial and prefilled diluent syringe from the refrigerator and allow the vial and prefilled diluent syringe to reach room temperature before reconstituting VOXZOGO.
  • Attach the diluent needle provided with ancillary supplies to the diluent prefilled syringe.
  • Inject the entire diluent prefilled syringe volume into the vial (see Table 2).
  • Gently swirl the diluent in the vial until the white powder is completely dissolved. Do not shake.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Once reconstituted VOXZOGO is a clear, colorless to yellow liquid. The solution should not be used if discolored or cloudy, or if particles are present. The concentration of reconstituted solution is 0.8 mg/mL or 2.0 mg/mL (see Table 2).
  • After reconstitution, VOXZOGO can be held in the vial at a room temperature 20°C to 25°C (68°F to 77°F) for a maximum of 3 hours.
  • For administration, extract the required dose volume from the vial using the supplied administration syringe
    [see Dosage and Administration (2.2)]
    .

  Table 2: Dilution Requirements for VOXZOGO Prior to Administration

  Vial Strength	Reconstitution Volume	Reconstituted Concentration
  0.4 mg	0.5 mL	0.8 mg/mL
  0.56 mg	0.7 mL	0.8 mg/mL
  1.2 mg	0.6 mL	2 mg/mL

  Discard any unused portion. Do not pool unused portions from the vials. Do not administer more than 1 dose from a vial. Do not mix with other medications.

  Instructions for Subcutaneous Administration

  See the Instructions for Usedocument for detailed, illustrated instructions.

  • Ensure patients have had adequate food and fluid intake prior to VOXZOGO administration
    [see Dosage and Administration (2.1)]
    . Slowly withdraw the dosing volume of the reconstituted VOXZOGO solution from the single-dose vial into a syringe.
  • Rotate sites for subcutaneous injections.
  • The recommended injection sites for VOXZOGO are: the front middle of the thighs, the lower part of the abdomen at least 2 inches (5 centimeters) away from the navel, top of the buttocks or the back of the upper arms. The same injection area should not be used on two consecutive days. Do not inject VOXZOGO into sites that are red, swollen, or tender.
  )

For Injection: 0.4 mg, 0.56 mg, or 1.2 mg of vosoritide as a white to yellow lyophilized powder in a single-dose vial for reconstitution.