Tividenofusp Alfa-Eknm: uses, dosing, side effects & brands
Tividenofusp Alfa-Eknm is a medicine sold in the U.S. under one brand, for mucopolysaccharidosis ii. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Mucopolysaccharidosis II
- Available as
- Injectable
- Sold as
- Avlayah
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
How tividenofusp alfa-eknm is dosed
From the FDA label for Avlayah (application BLA761485). Other tividenofusp alfa-eknm products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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. ( 2.2 ) See the full prescribing information for dosage and administration modifications and monitoring. ( 2.3 ) See the full prescribing information for preparation and administration instructions. ( 2.4 , 2.6 ) 2.1 Important Recommendations Prior to AVLAYAH Treatment Initiation Administer AVLAYAH under the supervision of a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis [see Warnings and Precautions (5.1) ] . Initiate AVLAYAH in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment [see Warnings and Precautions (5.1) ]. Consider pretreatment with antihistamines, antipyretics, and/or corticosteroids [see Warnings and Precautions (5.1 , 5.2) ] . Obtain a baseline hemoglobin value in all patients [see Warnings and Precautions (5.3) ] . 2.2 Recommended Dosage The recommended…
Tividenofusp Alfa-Eknm side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions Including Anaphylaxis [see Warnings and Precautions (5.1) ] Infusion-Associated Reactions [see Warnings and Precautions (5.2) ] Anemia [see Warnings and Precautions (5.3) ] Membranous Nephropathy [see Warnings and Precautions (5.4) ] Most common adverse reactions (incidence ≥20%) were IAR, upper respiratory tract infection, ear infection, pyrexia, anemia, cough, vomiting, diarrhea, rash, COVID-19, rhinorrhea, nasal congestion, fall, headache, skin abrasion, and urticaria. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Denali Therapeutics toll-free at 1-833-ONE-DNLI (1-833-663-3654) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of AVLAYAH was evaluated in male pediatric patients with Hunter syndrome in Trial 1 [see Clinical Studies (14) ] . A total of 47 male patients (age range: 3 months to 13 years) received intravenous AVLAYAH at 3 mg/kg to 30 mg/kg (0.2 to 2 times the approved recommended maintenance dose) weekly, and the majority of…
Who shouldn’t take tividenofusp alfa-eknm
None. None ( 4 )
Every tividenofusp alfa-eknm product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Avlayah.
Related calculators
Frequently asked questions
What is tividenofusp alfa-eknm?
Tividenofusp alfa-eknm is a fusion protein consisting of the hydrolytic lysosomal glycosaminoglycan (GAG)-specific enzyme iduronate-2-sulfatase (IDS) fused to the N-terminus of an immunoglobulin G1 (IgG1) fragment, crystallizable (Fc).
Can you take tividenofusp alfa-eknm with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run tividenofusp alfa-eknm against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does tividenofusp alfa-eknm come in?
Across the brands we track, tividenofusp alfa-eknm is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic tividenofusp alfa-eknm?
We do not currently list a generic-labelled tividenofusp alfa-eknm product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Tividenofusp Alfa-Eknm: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/tividenofusp-alfa-eknm
- MLA
- “Tividenofusp Alfa-Eknm: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/tividenofusp-alfa-eknm.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for tividenofusp alfa-eknm on DailyMed (NIH) ↗ — including its boxed warning in full.