Scemblix Patient Counseling Information

Advise the patient to read the patient labeling (Patient Information).
Myelosuppression: Inform patients of the possibility of developing low blood cell counts. Advise patients to immediately report fever, any suggestion of infection, or signs or symptoms suggestive of bleeding or easy bruising [see Myelosuppression under Precautions].
Pancreatic Toxicity: Inform patients of the possibility of developing pancreatitis that may be accompanied by nausea, vomiting, severe abdominal pain, or abdominal discomfort, and to promptly report these symptoms [see Pancreatic Toxicity under Precautions].
Hypertension: Inform patients of the possibility of developing hypertension. Advise patients to contact their healthcare provider for elevated blood pressure or if symptoms of hypertension occur, including confusion, headache, dizziness, chest pain, or shortness of breath [see Hypertension under Precautions].
Hypersensitivity: Advise the patient to discontinue SCEMBLIX and seek immediate medical attention if any signs or symptoms of a hypersensitivity reaction, such as rash, edema, or bronchospasm occur [see Hypersensitivity under Precautions].
Cardiovascular Toxicity: Inform patients of the possibility of the occurrence of cardiovascular toxicity, especially those with a history of cardiovascular risk factors. Advise patients to immediately contact their healthcare provider or get medical help if they develop cardiovascular signs and symptoms [see Cardiovascular Toxicity under Precautions].
Embryo-Fetal Toxicity: Advise females to inform their healthcare provider if they are pregnant or become pregnant. Inform female patients of the potential risk to a fetus [see Pregnancy under Use in Pregnancy & Lactation].
Advise females of reproductive potential to use effective contraception during treatment and for 1 week after receiving the last dose of SCEMBLIX [see Embryo-Fetal Toxicity under Precautions; Pregnancy and Females and Males of Reproductive Potential under Use in Pregnancy & Lactation].
Lactation: Advise women not to breastfeed during treatment with SCEMBLIX and for 1 week after the last dose [see Lactation under Use in Pregnancy & Lactation].
Infertility: Advise females of reproductive potential of the potential for impaired fertility from SCEMBLIX [see Females and Males of Reproductive Potential under Use in Pregnancy & Lactation; Pharmacology: Toxicology: Nonclinical Toxicology: Carcinogenesis, Mutagenesis, Impairment of Fertility under Actions)].
Drug Interactions: Advise patients that SCEMBLIX and certain other medicines, including over-the-counter medications or herbal supplements, can interact with each other and may alter the effects of SCEMBLIX [see Interactions].
Instructions for Taking SCEMBLIX: Advise patients to take SCEMBLIX exactly as prescribed and not to change their dose or schedule or to stop taking SCEMBLIX unless they are told to do so by their healthcare provider.
Advise patients to take SCEMBLIX orally without food. Advise patients to avoid food for at least 2 hours before and 1 hour after taking SCEMBLIX. SCEMBLIX tablets should be swallowed whole. Patients should not break, crush, or chew the tablets [see Administration under Dosage & Administration].
Advise patients that if they take SCEMBLIX once daily and miss a dose by more than 12 hours to skip the missed dose.
Advise patients that if they take SCEMBLIX twice daily and miss a dose by more than 6 hours to skip the missed dose.
Advise patients to take the next dose as scheduled [see Missed Dose under Dosage & Administration].