ROLVEDON (eflapegrastim-xnst)

There are 1 contraindications. Absolute contraindication.

Contraindication List
Acute respiratory distress syndrome

There are 4 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Capillary leak syndrome
Glomerulonephritis
Nontraumatic splenic rupture
Sickle cell disease with crisis

There are 4 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Acute myeloid leukemia
Myelodysplastic syndrome
Sickle cell disease
Thrombocytopenic disorder

There are 11 severe adverse reactions.

More Frequent	Less Frequent
Anemia	None.

Rare/Very Rare
Acute myeloid leukemia Acute respiratory distress syndrome Anaphylaxis Aortitis Capillary leak syndrome Glomerulonephritis Leukocytosis Myelodysplastic syndrome Splenomegaly Thrombocytopenic disorder

There are 19 less severe adverse reactions.

More Frequent	Less Frequent
Anorexia Arthralgia Back pain Bone pain Diarrhea Fatigue Fever Headache disorder Myalgia Nausea Skin rash	Acute abdominal pain Cough Dizziness Dyspnea Flushing Pain in extremities Peripheral edema

Rare/Very Rare
Injection site sequelae

There are no available data on eflapegrastim-xnst use in pregnant females; however, data from published studies with the use of otherrhG-CSF products in pregnant females have not identified any drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies were conducted in rats and rabbits. In rats, eflapegrastim-xnst did not adversely affect embryofetal or postnatal development when administered from organogenesis throughout lactation at doses that produced maternal exposures up to 7 times the exposure at the recommended clinical dose.

In rabbits, eflapegrastim-xnst caused embryofetal lethality (including post-implantation loss and reduced number of live fetuses) and reduced fetal weight when administered during the organogenesis period at approximately 6 times the exposure at the clinical dose. No malformations were observed at up to 10 times the clinical exposure, based on area under the concentration-time curve (AUC).

There are no data on the presence of eflapegrastim-xnst in human milk, the effects on the breast-fed child, or the effects on milk production. EndogenousG-CSF is present in human milk. Other rhG-CSF products are present in human milk at low levels and are not orally absorbed by infants. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for eflapegrastim-xnst and any potential adverse effects on the breast-fed child from eflapegrastim-xnst or from the underlying maternal condition.

Of the 314 patients in clinical studies of eflapegrastim-xnst, 39% were aged 65 years and over and 6% were aged 75 years and older. No overall differences in safety or effectiveness were observed between these patients and younger patients.