Waskyra (etuvetidigene autotemcel)

It is essential 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.

There is no enhanced messaging for this drug.

Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

Etuvetidigene Autotemcel/Anti-Retrovirals

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Etuvetidigene autotemcel is prepared from apheresed cells that are transduced with a replication defective, self-inactivating HIV-based lentiviral vector. Antiretrovirals may interfere with the manufacturing of the apheresed cells.

CLINICAL EFFECTS: Use of antiretrovirals before mobilization and apheresis may interfere with the production of etuvetidigene autotemcel.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Patients should not take antiretrovirals for at least one month prior to mobilization and until at least 7 days after etuvetidigene autotemcel infusion.(1) If a patient requires antiretroviral agents for HIV post-exposure prophylaxis, etuvetidigene autotemcel treatment should be delayed until HIV testing is negative at 6 months post-exposure.(1)

DISCUSSION: Antiretroviral medications may interfere with the manufacturing of etuvetidigene autotemcel therapy.(1)

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Hypersensitivity to the active substance or to any of the excipients.

*Previous treatment with HSCT within 6 months prior to screening or HSCT with evidence of residual donor cells.

*Previous treatment with hematopoietic stem cell gene therapy.

*Contraindications to the mobilization and the conditioning regimen.

There are no contraindication contraindications for this drug.

• Infection

There are no moderate contraindications for this drug.

The most common adverse reactions (incidence >= 20%) are catheter related infections, bacterial and viral infections, diarrhea, vomiting, stomatitis, liver injury, head injury, rhinitis, cough, rash, petechiae, hypersensitivity, anemia, febril neutropenia, epistaxis, pyrexia, catheter site complications.

More Frequent

• Anemia
• Bacterial infection
• Cytomegalovirus disease
• Diarrhea
• Drug-induced hepatitis
• Fever
• Hyperkalemia
• Hypersensitivity drug reaction
• Hypokalemia
• Hypomagnesemia
• Hyponatremia
• Idiopathic thrombocytopenic purpura
• Infection
• Injection site sequelae
• Lower respiratory infection
• Neutropenic disorder
• Skin rash
• Stomatitis
• Upper respiratory infection
• Urinary tract infection
• Viral infection
• Vomiting

Rare or Very Rare

• Aspergillosis
• Hepatic veno-occlusive disease
• Papillary thyroid carcinoma

More Frequent

• Acute abdominal pain
• Balanoposthitis
• Bloody stools
• Conjunctivitis
• Constipation
• Cough
• Eosinophilia
• Epistaxis
• Gastroenteritis
• Headache disorder
• Hemorrhage
• Hypocalcemia
• Infection of ear
• Infectious mononucleosis
• Injection site inflammation
• Lymphadenopathy
• Oral candidiasis
• Oral hemorrhage
• Pain in oropharynx
• Petechiae
• Rhinitis
• Wheezing

No enhanced messaging available.

The safety and efficacy of etuvetidigene autotemcel for the treatment of WAS have been established in pediatric patients 6 months of age and older. The use of etuvetidigene autotemcel in pediatric patients is supported by evidence from 2 open-label clinical studies and patients in an expanded access program which included 25 pediatric patients 1 to 16 years of age.

The safety and effectiveness of etuvetidigene autotemcel have not been established in pediatric patients younger than 6 months of age.

There are no clinical data from the use of etuvetidigene autotemcel in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with etuvetidigene autotemcel to assess whether it can cause fetal harm when administered to a pregnant woman. Etuvetidigene autotemcel must not be administered during pregnancy because of the risk associated with conditioning. Pregnancy after etuvetidigene autotemcel infusion should be discussed with the treating physician.

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.

There are no data on the presence of etuvetidigene autotemcel in human or animal milk, the effects on the breastfed child, or the effects on milk production. Because of the potential risks associated with conditioning, breast-feeding should be discontinued during conditioning. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for etuvetidigene autotemcel and any potential adverse effects on the breastfed child from etuvetidigene autotemcel or from the underlying maternal condition.

No enhanced messaging available.