Voxzogo
(vosoritide)Dosage & Administration
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Voxzogo Prescribing Information
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 [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
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 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)].
| Actual Body Weight * | Dose | Injection Volume | Vial Strength for Reconstitution † |
|---|---|---|---|
| |||
| 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.
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.
Preparation and Administration
Reconstitute VOXZOGO before administration using the provided diluent syringe containing Sterile Water for Injection, USP (see Reconstitution Instructions below).
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)].
| 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 Use document 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.
Pregnancy
Risk Summary
There are no available data on vosoritide use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, there was no evidence of embryo-fetal toxicity or congenital malformations when pregnant rats and rabbits were administered vosoritide subcutaneously at doses equivalent to 14-times and 200-times, respectively, the exposure at the maximum recommended human dose (MRHD) (see Data).
The estimated background risk of major birth defects for the indicated population is higher than the general population. The estimated background risk of miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data
Animal Data
In an embryofetal developmental toxicity study in rats, vosoritide was administered at 90, 270, 540 mcg/kg once daily by subcutaneous injection during the period of major organogenesis from gestation day (GD) 6 – 17. There were no effects on maternal animals or on embryofetal development at the highest dose administered (14-times the exposure at the MRHD).
In an embryofetal developmental toxicity study in rabbits, vosoritide was administered at 45, 135, 240 mcg/kg once daily by subcutaneous injection during the period of major organogenesis (GD 7 – 19). No effects were observed in maternal animals or on embryofetal development at the highest dose administered (200-times the exposure at the MRHD).
In a pre- and postnatal toxicity study in rats, vosoritide was administered at 90, 270, and 540 mcg/kg once daily by subcutaneous injection during the period of major organogenesis and continuing to weaning (GD 6 through postpartum day 20). There were no effects on maternal animals, including maintenance of pregnancy, parturition, or care of offspring, and no effects were noted on offspring growth and development or ability to reproduce at the highest dose (14-times the exposure at the MRHD).
Lactation
Risk Summary
There is no information regarding the presence of vosoritide in human milk, the effects on the breastfed infant, or the effects on milk production. Vosoritide is present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for VOXZOGO and any potential adverse effects on the breastfed child from VOXZOGO or from the underlying maternal condition.
Pediatric Use
The safety and effectiveness of VOXZOGO have been established in pediatric patients for the improvement in linear growth in patients with achondroplasia with open epiphyses.
Use of VOXZOGO for this indication is supported by evidence from an adequate and well-controlled study in 121 pediatric patients aged 5 to 15 years with achondroplasia, pharmacokinetic data in pediatric patients aged 4.5 months to 15 years, and additional safety data in pediatric patients aged 4.4 months to <5 years [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14)].
Renal Impairment
The effect of renal impairment on the pharmacokinetics of VOXZOGO has not been evaluated. No dosage adjustment is needed for patients with eGFR ≥ 60 mL/min/1.73 m2. VOXZOGO is not recommended for patients with eGFR < 60 mL/min/1.73 m2.
None
Risk of Low Blood Pressure
Transient decreases in blood pressure were observed in clinical studies of VOXZOGO. Subjects with significant cardiac or vascular disease and patients on anti-hypertensive medicinal products were excluded from participation in VOXZOGO clinical trials. To reduce the risk of a decrease in blood pressure and associated symptoms (dizziness, fatigue and/or nausea), instruct patients to be well hydrated and have adequate food intake prior to administration of VOXZOGO [see Dosage and Administration (2.1) and Adverse Reactions (6.1)].