MARGENZA (margetuximab-cmkb)

There are 0 contraindications.

There are 1 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Pregnancy

There are 0 moderate contraindications.

There are 6 severe adverse reactions.

More Frequent	Less Frequent
None.	Anemia Hypotension Left ventricular failure Leukopenia Lymphopenia Neutropenic disorder

Rare/Very Rare
None.

There are 25 less severe adverse reactions.

More Frequent	Less Frequent
Acute abdominal pain Alopecia Anorexia Arthralgia Constipation Cough Diarrhea Dyspnea Fatigue Fever General weakness Myalgia Nausea Pain in extremities Vomiting	Chills Dysgeusia Hyperhidrosis Insomnia Pruritus of skin Skin rash Syncope Tachycardia Urticaria Weight loss

Rare/Very Rare
None.

Margetuximab may cause fetal harm if administered to pregnant women based on its mechanism of action and animal findings. Advise patients of potential risks to a fetus. There are clinical considerations if margetuximab is used during pregnancy or within 4 months prior to conception.

Monitor women who received margetuximab during pregnancy or within 4 months prior to conception for oligohydramnios. If oligohydramnios occurs, perform fetal testing that is appropriate for gestational age and consistent with community standards of care.

It is not known whether margetuximab is distributed into human milk or whether the drug has any effects on the nursing infant or on milk production. The benefits of breast-feeding should be considered along with the importance of margetuximab to the woman and any potential adverse effects on the breast-fed infant from the drug or underlying maternal condition. This consideration should also take into account the margetuximab-cmkb washout period of 4 months. Human IgG is distributed into human milk but does not enter neonatal or infant circulation in substantial amounts.

Of the 266 patients treated with margetuximab-cmkb in the SOPHIA study, 20% were >=65 years of age and 4% were >=75 years of age. No overall differences in efficacy were observed between patients >=65 years of age compared to younger patients. There was a higher incidence of grade 3 and higher adverse reactions observed in patients >=65 years of age (56%) compared to younger patients (47%), as well as adverse reactions associated with potential cardiotoxicity (35% vs 18%).