ﺑﺎﺯﮔﺸﺖ ﺑﻪ ﺻﻔﺤﻪ ﻗﺒﻠﯽ
خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده : 3 مورد

Vosoritide: Drug information

Vosoritide: Drug information
2025© UpToDate, Inc. and its affiliates and/or licensors. All Rights Reserved.
For additional information see "Vosoritide: Pediatric drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Voxzogo
Pharmacologic Category
  • C-type Natriuretic Peptide
Dosing: Pediatric

(For additional information see "Vosoritide: Pediatric drug information")

Note: Adjust dose based on actual body weight as patient grows; vial strength and resultant concentration varies based on patient weight. Permanently discontinue upon closure of epiphyses.

Achondroplasia

Achondroplasia: Note: Ensure patient is well hydrated and has adequate food intake 1 hour prior to dose to reduce the risk of low blood pressure and related symptoms (eg, dizziness, fatigue, nausea).

Infants ≥4 months, Children, and Adolescents: SUBQ:

Vosoritide SUBQ Dosing in Infants ≥4 Months, Children, and Adolescents With Achondroplasia

Actual body weight

Daily dose

Injection volume

Vial strength needed for reconstitution

Reconstituted concentration

3 kg

0.096 mg once daily

0.12 mL

0.4 mg/vial

0.8 mg/mL

4 kg

0.12 mg once daily

0.15 mL

5 kg

0.16 mg once daily

0.2 mL

6 to <8 kg

0.2 mg once daily

0.25 mL

8 to <12 kg

0.24 mg once daily

0.3 mL

12 to <17 kg

0.28 mg once daily

0.35 mL

0.56 mg/vial

0.8 mg/mL

17 to <22 kg

0.32 mg once daily

0.4 mL

22 to <33 kg

0.4 mg once daily

0.5 mL

33 to <44 kg

0.5 mg once daily

0.25 mL

1.2 mg/vial

2 mg/mL

44 to <60 kg

0.6 mg once daily

0.3 mL

60 to <90 kg

0.7 mg once daily

0.35 mL

≥90 kg

0.8 mg once daily

0.4 mL

Dosing: Kidney Impairment: Pediatric

Altered kidney function: Infants ≥4 months, Children, and Adolescents:

eGFR ≥60 mL/minute/1.73 m2: SUBQ: No dosage adjustment necessary.

eGFR <60 mL/minute/1.73 m2: SUBQ: Use not recommended.

Dosing: Liver Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions (Significant): Considerations
Decreased blood pressure

Mild, transient decreased blood pressure was observed in clinical trials and may be associated with dizziness, fatigue, and/or nausea (all cases were deemed inconsequential and were self-limiting) (Savarirayan 2020). Resolution occurred within a median of 31 minutes (range: 5 to 90 minutes). Patients with significant cardiac/vascular disease or taking antihypertensive medications were excluded from clinical trials.

Mechanism: Dose-related; related to the pharmacologic action. Vosoritide is structurally similar to atrial natriuretic peptide and may result in vascular side effects (Duggan 2021; Savarirayan 2020).

Onset: Rapid; median onset 31 minutes (range: 18 to 120 minutes).

Risk factors:

• Inadequate food and/or fluid intake prior to administration

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in children and adolescents.

>10%:

Cardiovascular: Decreased blood pressure (13%) (table 1)

Vosoritide: Adverse Reaction: Decreased Blood Pressure

Drug (Vosoritide)

Placebo

Number of Patients (Vosoritide)

Number of Patients (Placebo)

13%

5%

60

61

Gastrointestinal: Gastroenteritis (13%), vomiting (27%)

Hepatic: Increased serum alkaline phosphatase (17%)

Immunologic: Antibody development (35%)

Local: Injection-site reaction (85%; including bleeding at injection site, bruising at injection site, erythema at injection site [75%], induration at injection site, injection-site pruritus, pain at injection site, skin discoloration at injection site, swelling at injection site [62%], urticaria at injection site [25%])

Neuromuscular & skeletal: Arthralgia (15%)

1% to 10%:

Dermatologic: Xeroderma (5%)

Gastrointestinal: Diarrhea (10%)

Infection: Influenza (10%)

Nervous system: Dizziness (10%) (table 2), fatigue (8%) (table 3)

Vosoritide: Adverse Reaction: Dizziness

Drug (Vosoritide)

Placebo

Number of Patients (Vosoritide)

Number of Patients (Placebo)

10%

3%

60

61

Vosoritide: Adverse Reaction: Fatigue

Drug (Vosoritide)

Placebo

Number of Patients (Vosoritide)

Number of Patients (Placebo)

8%

3%

60

61

Otic: Otalgia (10%)

Postmarketing: Dermatologic: Hypertrichosis

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Warnings/Precautions

Dosage form specific issues:

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Subcutaneous [preservative free]:

Voxzogo: 0.4 mg (1 ea); 0.56 mg (1 ea); 1.2 mg (1 ea) [contains polysorbate 80]

Generic Equivalent Available: US

No

Pricing: US

Solution (reconstituted) (Voxzogo Subcutaneous)

0.4 mg (per each): $1,289.52

0.56 mg (per each): $1,289.52

1.2 mg (per each): $1,289.52

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Pediatric

Parenteral: SUBQ: Ensure patient has adequate food and liquid intake (240 to 300 mL [8 to 10 ounces]) within 1 hour prior to administration (to reduce the risk of low blood pressure and associated symptoms). Administer SUBQ into the thigh (front middle part), lower abdomen (≥2 inches from navel), back of upper arm, or top of the buttocks. Rotate injection sites; the same injection area should not be used on 2 consecutive days. Administer at the same time each day. Do not inject into sites that are red, swollen, or tender.

Missed doses: Administer dose as soon as possible; if the next scheduled dose is due in <12 hours, skip the missed dose and resume the regular dosing schedule.

Use: Labeled Indications

Achondroplasia: To increase linear growth in pediatric patients with achondroplasia with open epiphyses.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Alfuzosin: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Amifostine: Blood Pressure Lowering Agents may increase hypotensive effects of Amifostine. Management: When used at chemotherapy doses, hold blood pressure lowering medications for 24 hours before amifostine administration. If blood pressure lowering therapy cannot be held, do not administer amifostine. Use caution with radiotherapy doses of amifostine. Risk D: Consider Therapy Modification

Amisulpride (Oral): May increase hypotensive effects of Hypotension-Associated Agents. Risk C: Monitor

Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may increase hypotensive effects of Antipsychotic Agents (Second Generation [Atypical]). Risk C: Monitor

Arginine: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Barbiturates: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Benperidol: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Blood Pressure Lowering Agents: May increase hypotensive effects of Hypotension-Associated Agents. Risk C: Monitor

Brimonidine (Topical): May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Bromperidol: May decrease hypotensive effects of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may increase hypotensive effects of Bromperidol. Risk X: Avoid

Diazoxide: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

DULoxetine: Blood Pressure Lowering Agents may increase hypotensive effects of DULoxetine. Risk C: Monitor

Herbal Products with Blood Pressure Lowering Effects: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Hypotension-Associated Agents: Blood Pressure Lowering Agents may increase hypotensive effects of Hypotension-Associated Agents. Risk C: Monitor

Iloperidone: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Levodopa-Foslevodopa: Blood Pressure Lowering Agents may increase hypotensive effects of Levodopa-Foslevodopa. Risk C: Monitor

Lormetazepam: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Metergoline: May decrease antihypertensive effects of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may increase orthostatic hypotensive effects of Metergoline. Risk C: Monitor

Molsidomine: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Naftopidil: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Nicergoline: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Nicorandil: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Nitroprusside: Blood Pressure Lowering Agents may increase hypotensive effects of Nitroprusside. Risk C: Monitor

Obinutuzumab: May increase hypotensive effects of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Risk D: Consider Therapy Modification

Pentoxifylline: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Pholcodine: Blood Pressure Lowering Agents may increase hypotensive effects of Pholcodine. Risk C: Monitor

Phosphodiesterase 5 Inhibitors: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Prostacyclin Analogues: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Quinagolide: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Silodosin: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Reproductive Considerations

A phase 2 dose-finding study of vosoritide did not include patients of reproductive potential (Savarirayan 2019).

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies.

Breastfeeding Considerations

It is not known if vosoritide is present in breast milk.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.

Monitoring Parameters

Monitor body weight, growth, and physical development every 3 to 6 months; monitor for epiphyseal closure. Signs and symptoms of low BP (eg, dizziness, fatigue, nausea); BP (as clinically appropriate).

Mechanism of Action

Vosoritide is 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) via inhibition of extracellular signal-regulated kinases 1 and 2 in the mitogen-activated protein kinase pathway at the level of rapidly accelerating fibrosarcoma serin/threonine protein kinase. Antagonism of the mutant form of FGFR3 (which negatively regulates endochondral bone growth in achondroplasia) results in positive regulation/promotion of chondrocyte proliferation and differentiation.

Pharmacokinetics (Adult Data Unless Noted)

Note: Pharmacokinetic data in pediatric patients were similar from ages 4 months to 15 years.

Distribution: Vd: Children ≥5 years and Adolescents ≤13 years: Mean range: 2.88 ± 2.45 to 3.02 ± 1.98 L/kg.

Metabolism: Degrades into small peptide fragments and amino acids via catabolic pathways.

Half-life elimination: Children ≥5 years and Adolescents ≤13 years: Mean range: 21 ± 4.7 to 27.9 ± 9.9 minutes.

Time to peak: Children ≥5 years and Adolescents ≤13 years: SUBQ: Median: 15 minutes.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AT) Austria: Voxzogo;
  • (BG) Bulgaria: Voxzogo;
  • (CZ) Czech Republic: Voxzogo;
  • (DE) Germany: Voxzogo;
  • (EE) Estonia: Voxzogo;
  • (ES) Spain: Voxzogo;
  • (FR) France: Voxzogo;
  • (IE) Ireland: Voxzogo;
  • (IT) Italy: Voxzogo;
  • (JP) Japan: Voxzogo;
  • (LU) Luxembourg: Voxzogo;
  • (PL) Poland: Voxzogo;
  • (PR) Puerto Rico: Voxzogo;
  • (PT) Portugal: Voxzogo;
  • (QA) Qatar: Voxzogo;
  • (SA) Saudi Arabia: Voxzogo;
  • (SE) Sweden: Voxzogo;
  • (SI) Slovenia: Voxzogo;
  • (SK) Slovakia: Voxzogo
  1. Alade SL, Brown RE, Paquet A. Polysorbate 80 and E-Ferol toxicity. Pediatrics. 1986;77(4):593-597. [PubMed 3960626]
  2. Centers for Disease Control (CDC). Unusual syndrome with fatalities among premature infants: association with a new intravenous vitamin E product. MMWR Morb Mortal Wkly Rep. 1984;33(14):198-199. http://www.cdc.gov/mmwr/preview/mmwrhtml/00000319.htm [PubMed 6423951]
  3. Isaksson M, Jansson L. Contact allergy to Tween 80 in an inhalation suspension. Contact Dermatitis. 2002;47(5):312-313. [PubMed 12534540]
  4. Lucente P, Iorizzo M, Pazzaglia M. Contact sensitivity to Tween 80 in a child. Contact Dermatitis. 2000;43(3):172. [PubMed 10985636]
  5. Savarirayan R, Irving M, Bacino CA, et al. C-type natriuretic peptide analogue therapy in children with achondroplasia. N Engl J Med. 2019;381(1):25-35. doi:10.1056/NEJMoa1813446 [PubMed 31269546]
  6. Shelley WB, Talanin N, Shelley ED. Polysorbate 80 hypersensitivity. Lancet. 1995;345(8980):1312-1313. [PubMed 7746084]
  7. Voxzogo (vosoritide) [prescribing information]. Novato, CA: BioMarin Pharmaceutical Inc; April 2024.
Topic 134442 Version 59.0