ALECENSA Patient Counseling Information

Advise the patient to read the patient information leaflet. Inform patients of the following: Hepatotoxicity: Inform patients of the signs and symptoms of bilirubin and hepatic transaminase elevations. Advise patients to contact their healthcare provider immediately for signs or symptoms of bilirubin and hepatic transaminase elevations (see Precautions).
Interstitial Lung Disease (ILD)/Pneumonitis: Inform patients of the risks of severe ILD/pneumonitis. Advise patients to contact their healthcare provider immediately to report new or worsening respiratory symptoms (see Precautions).
Renal Impairment: Inform patients of the risk of severe and potentially fatal renal impairment. Advise patients to contact their healthcare provider for change in urine color, reduced urine output, or swelling in the legs and feet (see Precautions).
Bradycardia: Inform patients that symptoms of bradycardia including dizziness, lightheadedness, and syncope can occur while taking ALECENSA. Advise patients to contact their healthcare provider to report these symptoms and to inform their healthcare provider about the use of any heart or blood pressure medications (see Precautions).
Severe Myalgia/CPK elevation: Inform patients of signs and symptoms of myalgia, including unexplained and/or persistent muscle pain, tenderness, or weakness. Advise patients to contact their healthcare provider immediately to report new or worsening symptoms of muscle pain or weakness (see Precautions).
Hemolytic Anemia: Advise patients to contact their healthcare provider if they develop any signs or symptoms of hemolytic anemia (see Precautions).
Photosensitivity: Inform patients of the signs and symptoms of photosensitivity. Advise patients to avoid prolonged sun exposure while taking ALECENSA and for at least 7 days after study drug discontinuation and to use proper protection from the sun. Advise patients to use a broad spectrum ultraviolet A (UVA)/ultraviolet B (UVB) sunscreen and lip balm (SPF ≥50) to help protect against potential sunburn (see Adverse Reactions).
Embryo-Fetal Toxicity: ALECENSA can cause fetal harm if taken during pregnancy. Advise a pregnant woman of the potential risk to a fetus (see Precautions and Use in Pregnancy & Lactation).
Advise females of reproductive potential to use effective contraception during treatment with ALECENSA and for at least 1 week after the last dose of ALECENSA. Advise patients to inform their healthcare provider of a known or suspected pregnancy (see Precautions and Use in Pregnancy & Lactation).
Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ALECENSA and for 3 months after the last dose (see Precautions and Pharmacology: Toxicology: Nonclinical Toxicology: Carcinogenesis, Mutagenesis, Impairment of Fertility under Actions).
Lactation: Advise women not to breastfeed during treatment with ALECENSA and for one week after the last dose (see Use in Pregnancy & Lactation).
Administration: Instruct patients to take ALECENSA twice a day. Advise patients to take ALECENSA with food and to swallow ALECENSA capsules whole (see Dosage & Administration).
Missed Dose: Advise patients that if a dose of ALECENSA is missed or if the patient vomits after taking a dose of ALECENSA, patients should be advised not to take an extra dose, but to take the next dose at the regular time (see Dosage & Administration).