Skysona (elivaldogene autotemcel)

It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

For autologous use only. For IV use only.

*Patients must undergo hematopoietic stem cell (HSC) mobilization and apheresis to obtain CD34+ cells for elivaldogene autotemcel manufacturing.

*Before mobilization, apheresis, and conditioning are initiated, confirm that hematopoietic stem cell (HSC) transplantation is appropriate for the patient.

*Dosing of elivaldogene autotemcel is based on the number of CD34+ cells in the infusion bag(s) per kg of body weight. The dose is calculated based on the patient's weight prior to first apheresis.

*The minimum recommended dose is 5.0 x 106 CD34+ cells/kg.

*Full myeloablative and lymphodepleting conditioning must be administered before infusion of elivaldogene autotemcel. Do not begin conditioning until elivaldogene autotemcel has been received and stored at the treatment center and the availability of the back-up collection of CD34+ cells is confirmed. After completion of conditioning, allow a minimum of 48 hours of washout before elivaldogene autotemcel infusion.

*Verify the patient's identity matches the unique patient identification information on the elivaldogene autotemcel infusion bag(s) prior to infusion. Do not infuse elivaldogene autotemcel if the information on the patient-specific label does not match the intended patient.

*Do not sample, alter, or irradiate elivaldogene autotemcel.

*Do not use an in-line blood filter or an infusion pump.

*Standard procedures for patient management after HSC transplantation should be followed after elivaldogene autotemcel infusion.

*See Full Prescribing Information for additional details on preparation and administration.

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.

Elivaldogene 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: Elivaldogene autotemcel is prepared from apheresed cells that are transduced with a replication defective, self-inactivating lentiviral vector. Antiretrovirals may interfere with the manufacturing of apheresed cells.

CLINICAL EFFECTS: Use of antiretrovirals before mobilization and apheresis may interfere with the production of elivaldogene autotemcel.

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Discontinue antiretrovirals for at least one month prior to mobilization and until all cycles of apheresis are completed. If a patient requires antiretrovirals for HIV prophylaxis, then confirm a negative HIV test before beginning mobilization and apheresis of CD34+ cells.

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

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

None.

There are no contraindication contraindications for this drug.

• Infection

There are no moderate contraindications for this drug.

*Most common non-laboratory adverse reactions (>= 20%): mucositis, nausea, vomiting, febrile neutropenia, alopecia, decreased appetite, abdominal pain, constipation, pyrexia, diarrhea, headache, rash.

*Most common Grade 3 or 4 laboratory abnormalities (>=40%): leukopenia, lymphopenia, thrombocytopenia, neutropenia, anemia, hypokalemia.

More Frequent

• Anemia
• Hypokalemia
• Leukopenia
• Lymphopenia
• Neutropenic disorder
• Thrombocytopenic disorder

Less Frequent

• Hypertension
• Infection
• Seizure disorder

Rare or Very Rare

• Acute myeloid leukemia
• Hematologic malignancy
• Hypersensitivity drug reaction
• Myelodysplastic syndrome
• Pancytopenia

More Frequent

• Acute abdominal pain
• Alopecia
• Anorexia
• Constipation
• Diarrhea
• Fever
• Headache disorder
• Nausea
• Skin rash
• Stomatitis
• Vomiting

Less Frequent

• Blurred vision
• Cough
• Epistaxis
• Pain in oropharynx
• Pruritus of skin
• Skin pigmentation enhancement
• Symptoms of anxiety
• Tachycardia

No enhanced messaging available.

The safety and efficacy of elivaldogene autotemcel in children younger than 4 years of age have not been established. No data are available.

There are no available data with elivaldogene autotemcel administration in pregnant women. Consider the risks associated with mobilization and conditioning agents on pregnancy and fertility.

No animal reproductive and developmental toxicity studies have been conducted to assess whether elivaldogene autotemcel can cause fetal harm when administered to a pregnant woman.

No nonclinical germline transmission studies have been conducted with elivaldogene autotemcel.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

There is no information regarding the presence of elivaldogene autotemcel in human milk, the effect on the breastfed infant, and the effects on milk production.

No enhanced messaging available.