AVLAYAH (TIVIDENOFUSP ALFA-EKNM)
AVLAYAH (TIVIDENOFUSP ALFA-EKNM) is one of 8,063 medications in the MedPlain dataset. Key details — Brand name: AVLAYAH; Generic name: TIVIDENOFUSP ALFA-EKNM; Manufacturer: Denali Therapeutics Inc..
| Brand name | AVLAYAH |
|---|---|
| Generic name | TIVIDENOFUSP ALFA-EKNM |
| Manufacturer | Denali Therapeutics Inc. |
| Used for | 1 INDICATIONS AND USAGE AVLAYAH is indicated for the treatment of neurologic manifestations of Hunter syndrome (Mucopolysaccharidosis type II, MPS II) when initiated in presymptomatic or symptomatic pediatric patients weighing at least 5 kg prior to advanced neurologic impairment. This indication is approved under accelerated approval based on the reduction of cerebrospinal fluid heparan sulfate [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Limitations of Use AVLAYAH is not recommended for use in combination with other enzyme replacement therapies for the treatment of H |
| Dosage | 2 DOSAGE AND ADMINISTRATION Administration of AVLAYAH should be supervised by a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis. (2.1) Obtain a baseline hemoglobin value in all patients. ( 2.1 ) Recommended AVLAYAH maintenance dosage for pediatric patients who weigh at least 5 kg is 15 mg/kg administered once weekly as an intravenous infusion over approximately 4 hours. ( 2.2 , 2.6 ) Initiate AVLAYAH treatment with a dose escalation regimen |
| Warnings | WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS Patients treated with enzyme replacement therapies, including AVLAYAH, have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. Initiate AVLAYAH in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. If a se |
| Active ingredient(s) | TIVIDENOFUSP ALFA |
| Route | INTRAVENOUS |
| Official label | https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=014d92c1-b643-4680-8ca6-f0b3307da915 |