HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all information needed to use LUCIVOSO safely and effectively. See full prescribing information for LUCIVOSO.

INDICATIONS AND USAGE

LUCIVOSO is a C-type natriuretic peptide (CNP) analog indicated to increase linear growth in pediatric patients with achondroplasia with open epiphyses.

DOSAGE AND ADMINISTRATION

Important Instructions Prior to Administration

•  To reduce the risk of low blood pressure, ensure adequate food intake before dosing and drink approximately 240 to 300 mL of fluid in the hour prior to administration.

Recommended Dosage and Administration

•  The recommended dosage is based on actual body weight. Administer LUCIVOSO by subcutaneous injection once daily, at approximately the same time each day if possible. Reconstitute before use.

•  Injection volume depends on actual body weight and the concentration of reconstituted LUCIVOSO (0.8 mg/mL or 2 mg/mL).

Recommended LUCIVOSO Daily Dosage and Injection Volume

* Round intermediate body weights within the specified bands to the nearest whole number.

** Reconstituted 0.4 mg and 0.56 mg vials contain 0.8 mg/mL; reconstituted 1.2 mg vials contain 2 mg/mL.

Missed Dose

If a dose is missed, it can be administered within 12 hours of the scheduled time. Beyond 12 hours, skip the missed dose and administer the next daily dose according to the usual schedule.

Growth Monitoring

Monitor and assess body weight, growth and physical development every 3 to 6 months. Adjust the dose according to actual body weight. Permanently discontinue LUCIVOSO upon confirmation of no further growth potential, indicated by closure of epiphyses.

Reconstitution and Administration

•  Select the correct vial strength based on actual body weight. Reconstitute with the supplied prefilled diluent syringe containing Sterile Water for Injection. Caregivers may administer LUCIVOSO subcutaneously only after appropriate training by a healthcare professional on preparation and administration.

•  Allow the vial and prefilled diluent syringe to reach room temperature. Attach the supplied diluent needle to the prefilled diluent syringe. Inject the entire diluent volume into the vial. Gently swirl until the powder is completely dissolved; do not shake.

Dilution Requirements Prior to Administration

•  The reconstituted solution should be clear, colorless to yellow. Do not use if discolored, cloudy or containing particulate matter. It may be held in the vial at 20°C to 25°C for a maximum of 3 hours.

•  Slowly withdraw only the prescribed dose from the vial using the provided administration syringe. Discard unused solution. Do not combine portions from different vials, administer more than one dose from a vial or mix with other medications.

•  Rotate subcutaneous injection sites among the front middle of the thighs, lower abdomen (at least 5 cm from the navel) and top of the buttocks. Healthcare professionals or trained caregivers may also inject into the back of the upper arms. Do not inject into the same site twice in a row or into red, swollen or tender sites.

DOSAGE FORMS AND STRENGTHS

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.

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

•  Risk of Low Blood Pressure: Transient decreases in blood pressure have been observed following administration. Exercise caution in patients with significant cardiac or vascular disease and in those receiving antihypertensive medications.

ADVERSE REACTIONS

The most common adverse reactions (occurring in ≥5% of patients) include:

•  Injection site reactions: erythema, swelling, urticaria, pain, bruising, pruritus, hemorrhage, discoloration and induration.

•  Gastrointestinal disorders: vomiting, gastroenteritis (including viral gastroenteritis) and diarrhea.

•  General disorders: fatigue (including lethargy and malaise) and dizziness (including presyncope, procedural dizziness and vertigo).

•  Other: arthralgia, transient decreased blood pressure, ear pain, influenza, seasonal allergy and dry skin.

In pediatric patients younger than 5 years, the most common adverse reactions are injection site reactions and rash; the overall safety profile is similar to that in older pediatric patients. Increases in alkaline phosphatase and postmarketing reports of hypertrichosis have also been described.

USE IN SPECIFIC POPULATIONS

•  Pregnancy: No available data in pregnant women to evaluate drug-associated risks.

•  Lactation: No information is available on presence in human milk, effects on the breastfed infant or effects on milk production. Consider the benefits of breastfeeding and the clinical need for LUCIVOSO.

•  Pediatric Use: Safety and effectiveness have been established in pediatric patients with achondroplasia with open epiphyses for improvement of linear growth.

•  Renal Impairment: No dose adjustment is needed for eGFR ≥60 mL/min/1.73 m². LUCIVOSO is not recommended for patients with eGFR<60 mL/min/1.73 m².

STORAGE

•  Refrigerate LUCIVOSO vials and prefilled diluent syringes at 2°C to 8°C. Do not freeze.

•  LUCIVOSO can be stored at 20°C to 25°C, with excursions permitted to 15°C to 30°C, for up to 90 days. Do not return it to the refrigerator once stored at room temperature.

•  After reconstitution, LUCIVOSO may be held in the vial at 20°C to 25°C for up to 3 hours. Store in the original package to protect from light.