Kresladi (marnetegragene autotemcel)

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.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Marnetegragene Autotemcel/Anti-Retrovirals

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

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

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

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Discontinue antiretrovirals for at least one month prior to mobilization (or the expected duration of time needed for elimination of the antiretrovirals) 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.(1)

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

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.

*The most common non-laboratory adverse reactions (>= 30%): mucositis, upper respiratory tract infection, viral infection, febrile neutropenia, skin lesion, nausea/vomiting, rash/dermatitis, pyrexia, device related infection, and skin infection.

*The most common laboratory adverse reactions (>= 30%): hemoglobin decreased, platelet count decreased, neutrophil count decreased, leukocyte count decreased, aspartate aminotransferase increased, and alanine aminotransferase increased.

More Frequent

• Anemia
• Leukopenia
• Neutropenic disorder
• Thrombocytopenic disorder

Rare or Very Rare

• Hepatic veno-occlusive disease
• Pulmonary arterial hypertension
• Severe infection

More Frequent

• Abnormal hepatic function tests
• Alopecia
• Bacterial skin and skin structure infection
• Constipation
• Cutaneous candidiasis
• Fever
• Gastroenteritis
• Increased alanine transaminase
• Increased aspartate transaminase
• Lower respiratory infection
• Nausea and vomiting
• Skin inflammation
• Skin lesion
• Skin rash
• Stomatitis
• Upper respiratory infection
• Urinary tract infection
• Viral infection

Rare or Very Rare

• Hearing loss

No enhanced messaging available.

The safety and efficacy of marnetegragene autotemcel have been established in pediatric patients with severe LAD-I. The use of marnetegragene autotemcel in the pediatric population was supported by one clinical study which treated 9 patients 9.8 months to 9.8 years of age.

There are no available data from marnetegragene autotemcel administration in pregnant women.

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

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

Marnetegragene autotemcel must not be administered during pregnancy because of the risk associated with conditioning.

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 available data regarding the presence of marnetegragene autotemcel in human milk, the effect on the breastfed infant, and the effects on milk production. Because of the potential risks associated with myeloablative conditioning, discontinue breastfeeding during conditioning. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for marnetegragene autotemcel and any potential adverse effects on the breastfed child from marnetegragene autotemcel or from the underlying maternal condition.

The safety and effectiveness of marnetegragene autotemcel has not been established in geriatric patients. Clinical studies of marnetegragene autotemcel for this indication did not include patients 65 years of age and over.