Zevaskyn (prademagene zamikeracel)
Dermatological - Gene Therapy Agents Topical Sheet (Ea)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Prademagene zamikeracel is an autologous cell-based gene therapy.
Generic name: prademagene zamikeracel
Drug class: Dermatological - Gene Therapy Agents
Therapeutic class: Dermatological
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Zevaskyn
Indications
The following indications are listed for Zevaskyn:
- Dystrophic Epidermolysis Bullosa
Also known as: Epidermolysis Bullosa Dystrophica.
Dosing
It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:
No dosing information is available for this tab.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
None.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
- No disease contraindications
Adverse reactions
The most common adverse reactions (incidence >=5%) were procedural pain and pruritus.
There are no severe adverse reactions for this drug.
More Frequent
- Pruritus of skin
Precautions
No enhanced messaging available.
The safety and effectiveness of prademagene zamikeracel have been established in pediatric patients. The use of prademagene zamikeracel in pediatric patients was supported by evidence from one clinical study which included two pediatric patients 6 years and 16 years of age.
There are no available data with prademagene zamikeracel use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with prademagene zamikeracel.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Women of childbearing potential should be advised to use an effective method of contraception to prevent pregnancy at the time of treatment with prademagene zamikeracel.
There is no information regarding the presence of prademagene zamikeracel in human milk, its effect on the breastfed infant, or its effects on milk production. Animal lactation studies have not been conducted with prademagene zamikeracel.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for prademagene zamikeracel and any potential adverse effects on the breast-fed infant from prademagene zamikeracel or from the underlying maternal condition.
The safety and effectiveness of prademagene zamikeracel have not been studied in geriatric patients >= 65 years of age.
ICD codes
| Code | Type | Description |
|---|---|---|
| Dystrophic epidermolysis bullosa | ||
| Q81.2 | ICD10CM | Epidermolysis bullosa dystrophica |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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