vosoritide

Contraindicated in:

Moderate or severe renal impairment (eGFR <60 mL/min/1.73 m²).

Use Cautiously in:

Significant cardiac or vascular disease or taking antihypertensive medications;
OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding.

Adv. Reactions/Side Effects ⬆ ⬇

CV: hypotension

Derm: dry skin

EENT: ear pain

GI: diarrhea, vomiting

Local: injection site reactions

MS: arthralgia

Neuro: dizziness, fatigue

Interactions ⬆ ⬇

Drug-drug:

None reported.

Availability ⬆ ⬇

Lyophilized powder for injection: 0.4 mg/vial; 0.56 mg/vial; 1.2 mg/vial

Route/Dosage ⬆ ⬇

SC (Children ≥90 kg): 0.8 mg once daily. Discontinue therapy once there is no further growth potential (i.e., closure of epiphyses).
SC (Children 60–89 kg): 0.7 mg once daily. Discontinue therapy once there is no further growth potential (i.e., closure of epiphyses).
SC (Children 44–59 kg): 0.6 mg once daily. Discontinue therapy once there is no further growth potential (i.e., closure of epiphyses).
SC (Children 33–43 kg): 0.5 mg once daily. Discontinue therapy once there is no further growth potential (i.e., closure of epiphyses).
SC (Children 22–32 kg): 0.4 mg once daily. Discontinue therapy once there is no further growth potential (i.e., closure of epiphyses).
SC (Children 17–21 kg): 0.32 mg once daily. Discontinue therapy once there is no further growth potential (i.e., closure of epiphyses).
SC (Children 12–16 kg): 0.28 mg once daily. Discontinue therapy once there is no further growth potential (i.e., closure of epiphyses).
SC (Children 8–11 kg): 0.24 mg once daily. Discontinue therapy once there is no further growth potential (i.e., closure of epiphyses).
SC (Children 6–7 kg): 0.2 mg once daily. Discontinue therapy once there is no further growth potential (i.e., closure of epiphyses).
SC (Children 5 kg): 0.16 mg once daily. Discontinue therapy once there is no further growth potential (i.e., closure of epiphyses).
SC (Children 4 kg): 0.12 mg once daily. Discontinue therapy once there is no further growth potential (i.e., closure of epiphyses).
SC (Children 3 kg): 0.096 mg once daily. Discontinue therapy once there is no further growth potential (i.e., closure of epiphyses).

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Acts as a C-type natriuretic peptide analog that binds to natriuretic peptide receptor-B and indirectly antagonizes downstream signaling from mutant fibroblast growth factor receptor 3 (FGFR3), which results in positive regulation/promotion of chondrocyte proliferation and differentiation.

Therapeutic effects:

Increased linear growth.

Classifications ⬆ ⬇

Therapeutic Classification: none assigned

Pharmacologic Classification: temporary class

Pharmacokinetics ⬆ ⬇

Absorption: Unknown.

Distribution: Extensively distributed to tissues.

Metabolism/Excretion: Degraded into small peptides via catabolic pathways. Excretion pathway unknown.

Half-Life: 21–27.9 min.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	15 min	unknown

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects. Teach patient or caregiver proper preparation, technique, and placement of injections. The patient should have adequate food intake and drink approximately 8–10 ounces of fluid within 1 hr prior to administration to reduce the risk of ↓ BP. Advise patient to read Patient Information before starting therapy.
Administer a missed dose as soon as possible if within 12 hr of the scheduled time; if >12 hr, skip the missed dose and administer the next daily dose according to usual dosing schedule.
Advise patients and family to call 911 and immediately seek treatment for signs and symptoms of hypersensitivity reactions (difficulty breathing; chest tightness; hives; rash; light-headedness; itching; swelling of the face, lips, tongue, or throat).
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

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Indications ⬇

Contraind./Precautions ⬆ ⬇