Endari (glutamine)

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

*5 grams to 15 grams orally, twice daily based on body weight.

*Each dose of L-glutamine should be mixed in 8 oz. (240 mL) of cold or room temperature beverage or 4 oz. to 6 oz. of food before ingestion.

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.

Disease Modifying Agents/Exagamglogene Autotemcel

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: The interaction potential of disease modifying agents with exagamglogene autotemcel is unknown.(1)

CLINICAL EFFECTS: Disease modifying agents may interfere with exagamglogene autotemcel therapy.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Discontinue disease modifying therapies for sickle cell disease (e.g. voxelotor, crizanlizumab) at least 8 weeks prior to the start of mobilization.(1) It is recommended that patients be transfused at least 8 weeks prior to the initiation of myeloablative conditioning. At initiation of red blood cell exchange or simple transfusions, discontinue disease modifying therapies for sickle cell disease (e.g. voxelotor, crizanlizumab).(1)

DISCUSSION: There is no experience with the use of disease modifying agents with exagamglogene autotemcel infusion.(1)

Disease Modifying Agents/Lovotibeglogene Autotemcel

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: The interaction potential of disease modifying agents with lovotibeglogene autotemcel is unknown.(1)

CLINICAL EFFECTS: Disease modifying agents may interfere with lovotibeglogene autotemcel therapy.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Discontinue disease modifying therapies (e.g. voxelotor, crizanlizumab) for sickle cell disease at least 8 weeks prior to start of mobilization and conditioning.(1)

DISCUSSION: There is no experience with the use of disease modifying agents with lovotibeglogene autotemcel infusion.(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.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Most common adverse reactions (incidence >10%) are constipation, nausea, headache, abdominal pain, cough, pain in extremity, back pain, and chest pain.

Rare or Very Rare

• Neuropsychiatric disorder

More Frequent

• Acute abdominal pain
• Constipation
• Cough
• Headache disorder
• Nausea

Less Frequent

• Abdominal distension
• Abnormal hepatic function tests
• Back pain
• Chest pain
• Pain in extremities
• Vomiting

Rare or Very Rare

• Behavioral disorders

No enhanced messaging available.

The safety and effectiveness of L-glutamine have been established in pediatric patients 5 years and older. Use of L-glutamine is supported by evidence from 2 placebo-controlled studies in adult and pediatric patients with sickle cell disease. The clinical studies enrolled 110 pediatric patients in the following age groups: 46 children (5 years up to less than 12 years) and 64 adolescents (12 years to less than 17 years).

The safety and effectiveness of L-glutamine in pediatric patients with sickle cell disease younger than 5 years old has not been established.

There are no available data on L-glutamine use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. Animal reproduction studies were not conducted with L-glutamine.

Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. The background risk of major birth defects and miscarriage for the indicated population are unknown. In the US 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 are no data on the presence of L-glutamine in human milk, the effect on the breastfed infant or the effect on milk production. The developmental and health benefits from breastfeeding should be considered along with the mother's clinical need for L-glutamine and any potential adverse effects on the breastfed child from L-glutamine or from the underlying maternal condition.

Clinical studies of L-glutamine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.