SCEMBLIX (asciminib hydrochloride)

There are 1 contraindications. Absolute contraindication.

Contraindication List
Lactation

There are 7 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Elevated serum amylase
Elevated serum lipase
Hypertension
Neutropenic disorder
Pancreatitis
Pregnancy
Thrombocytopenic disorder

There are 2 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Anemia
Atherosclerotic cardiovascular disease

There are 24 severe adverse reactions.

More Frequent	Less Frequent
Anemia Elevated serum amylase Elevated serum lipase Increased alanine transaminase Neutropenic disorder Thrombocytopenic disorder	Cardiac arrhythmia Heart failure Hemorrhage Hyperbilirubinemia Hypersensitivity drug reaction Hypertension Hypocalcemia Hypophosphatemia Hypothyroidism Increased aspartate transaminase Influenza Lower respiratory infection Pancreatitis Pleural effusions Pneumonia

Rare/Very Rare
Arterial thrombosis Bronchospastic pulmonary disease Myocardial ischemia

There are 29 less severe adverse reactions.

More Frequent	Less Frequent
Diarrhea Fatigue Hypertriglyceridemia Increased creatine kinase level Musculoskeletal pain Nausea Skin rash Upper respiratory infection	Acute abdominal pain Anorexia Arthralgia Blurred vision Constipation Cough Dizziness Dry eye Dyspnea Edema Fever Headache disorder Hypercholesterolemia Hyperlipidemia Hyperuricemia Palpitations Peripheral neuropathy Pruritus of skin Urinary tract infection Urticaria Vomiting

Rare/Very Rare
None.

Based on animal studies and the mechanism of action, asciminib can cause embryo-fetal harm when administered to a pregnant woman. There are no available data on the use of asciminib in pregnant women to evaluate a drug-associated risk. Animal reproduction studies demonstrated that oral administration of asciminib during organogenesis induced structural abnormalities, embryo-fetal mortality, and alterations to growth. Advise patients of the potential risk to a fetus.

There are no data on the presence of asciminib or its metabolites in human milk, the effects on the breastfed child, or milk production. Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with asciminib and for 1 week after the last dose.

In the ASCEMBL study, 44 of the 233 (19%) patients were >=65 years of age and 6 (2.6%) were >=75 years of age. In the CABL001X2101 study, 16 of the 48 (33%) patients with the T315I mutation were >=65 years of age and 4 (8%) were >=75 years of age. Overall, no differences in safety or efficacy of asciminib were observed between patients >=65 years of age compared to younger patients. There is an insufficient number of patients >=75 years of age to assess whether there are differences in safety or efficacy.